Document:

Exhibit 10.4

 

BUILD
TO SUIT

FACILITY
LEASE AGREEMENT

(Triple Net
Lease)

 

THIS
BUILD TO SUIT FACILITY LEASE AGREEMENT (the “Lease”) is made and entered into as of the 27th day
of February, 2009, by and between ELM ROAD MOB, II, LLC, an Indiana limited liability company (the
“Landlord”) and SAINT JOSEPH REGIONAL MEDICAL CENTER — SOUTH BEND CAMPUS, INC., an Indiana not for profit
corporation (the “Tenant”).

 

WITNESSETH:

 

For
good and valuable consideration, the receipt, adequacy and sufficiency of which is hereby acknowledged, Landlord and Tenant, intending
to be legally bound hereby, agree that Landlord shall lease to Tenant and Tenant shall lease from Landlord the Premises hereinafter
defined, pursuant to the terms and conditions set forth in this Lease.

 

ARTICLE
I

 

DEFINITIONS
AND FUNDAMENTAL PROVISIONS

 

in
addition to other terms which are defined in subsequent sections of this Lease, the following terms shall have the meanings set
forth below when used in this Lease, except as may otherwise be specifically provided.

 

		1.1	Addresses:

 

	Landlord:	Elm Road
    MOB II, LLC
	 	53880
    Carmichael Drive
	 	South
    Bend, Indiana 46635
	 	Attention:
    President
	 	 
	Tenant:	Saint
    Joseph Regional Medical Center — South Bend Campus, Inc.
	 	801
    E. LaSalle Avenue
	 	South
    Bend, IN 46617
	 	Attention:
    President and CEO

 

or such
other address or addresses as a party may designate by written notice to the other party.

 

    	 	1	 

     

    

 

1.2       Common
Area Costs:
The cost of maintaining, repairing, landscaping, painting, and operating the Common Areas of the Elm Road Medical Campus, to be
set forth in the Declaration of Protective Covenants and Restrictions for Elm Road Medical Campus dated December 20, 2007 and
recorded on January 18, 2008 as Document Number 0802055 in the office of the Recorder of St. Joseph County, Indiana (“Declaration”)
pursuant to an amendment to the Declaration, shall specifically include, but not necessarily limited to: repairs to, striping
and patching of the parking areas or other Common Areas, lighting, removal of snow, ice, trash, rubbish and other refuse from
the Common Areas, costs associated with any of Landlord’s obligations set forth in Section 7.2, and the cost of leasing or the
depreciation on any equipment used to implement the foregoing maintenance. Tenant shall pay Tenant’s Percentage Share of
Common Area Costs herein in accordance with the Declaration as provided in Section 7.3. The Declaration amendment shall provided
that Common Area Costs shall specifically exclude the following: the cost of any item for which Landlord is reimbursed by insurance
or otherwise; the cost of repairs made in accordance with Landlord’s obligations pursuant to Section 6.1;
the cost of any additions to the Common Areas pursuant to an expansion of the Elm Road Medical Campus’s leasable square
footage; Tenant’s Percentage Share of Real Estate Taxes or Insurance (which are provided for by separate agreement herein); the
cost of any alterations, additions, changes, replacements, improvements and repairs and other items which under generally accepted
accounting and auditing principles consistently applied (as pertaining to the real estate industry) are properly classified as
capital expenditures (except as provided herein) or which are made in order to prepare space for occupancy by a new tenant or
other occupant of the Elm Road Medical Campus; the cost of any initial installations for any tenant or other occupant of the Elm
Road Medical Campus; reserves for the replacement or repair of portions of, or for equipment and machinery used in connection
with, the Elm Road Medical Campus; legal, accounting and other professional fees; interest or amortization payments in connection
with the Elm Road Medical Campus; leasing commissions, advertising expenses and other costs incurred in leasing or attempting
to lease any portion of the Elm Road Medical Campus; the cost of any services, maintenance, or repairs performed specifically
for certain tenants and not for the common use and benefit of all the tenants of the Elm Road Medical Campus; the cost of correcting
defects in the construction of the buildings, improvements and equipment of the Elm Road Medical Campus; the cost of Landlord’s
membership (and costs related thereto) in any organizations representing Elm Road Medical Campus owners; and any political or
charitable contributions. Common Area Costs payable by Tenant during the first (1st) Lease Year of the Lease Term are
estimated at Twelve Thousand AND 00/100 DOLLARS ($12,000,00), payable by Tenant in twelve (12) equal installments during the first
(1st) Lease Year of the Lease Term of One Thousand AND 00/100 DOLLARS ($1,000.00) per month.

 

1.3       Common
Areas:
All areas, space, signage, installations and equipment provided from time to time by Declarant pursuant to the Declaration for
the common use and benefit of the owners, occupants and tenants of the Elm Road Medical Campus, their employees, agents, licensees,
customers and other invitees, including, without limitation, parking areas, exits,
entrances, access roads, driveways, sidewalks, retaining walls, loading platforms and ramps, and landscaped areas, excluding areas
conveyed to an owner for exclusive use by the owner and the owner’s tenants, all as provided in the Declaration.

 

1.4       Application
of Non-Refundable Fee:The parties agree that a Twenty Five
Thousand and 00/100 Dollars ($25,000.00) non-refundable (except in the event of Landlord’s default), good faith earnest
money fee shall be paid by Tenant to Landlord on or upon the execution of this Lease, which fee shall be applied first to the
first month’s rent for the first (1st) Lease year.

 

    	 	2	 

     

    

 

1.5       Lease
Year: The Lease Term shall commence upon the Commencement Date.
If the Commencement Date is any day other than the first day of a calendar month, the first Lease Year shall be the period of
time from the Commencement Date until the end of the month in which said Commencement Date shall occur plus twelve
(12) calendar months. Each Lease Year thereafter shall be a successive period of twelve (12) months, subject to the extension
of the final Lease Year of the Lease Term pursuant to Section 2.2 hereof. Rent shall be proportionately increased (or decreased)
to reflect the number of days by which the first or final lease year exceeds (or is less than) twelve (12) calendar months, as
the case may be.

 

1.6      Minimum
Rent:
(a) Tenant agrees to pay to Landlord, in accordance with the terms and provisions of Article III hereof, as annual Minimum Rent,
during the first (1st) Lease Year of the initial fifteen (15) Lease Year term of the Lease, One Million Two Hundred
Twenty-Five Thousand Dollars ($1,225,000.00) ($26.68 per square foot of the Premises), payable in equal monthly installments of
One Hundred Two Thousand Eighty Three and 33/100 Dollars ($102,083.33) each.

 

(b)      The
Minimum Rent shall be increased for each year of the first (1st) Lease Term by two percent (2 %) over the Minimum Rent
for the previous Lease Year, as set forth in Schedule 1.6 attached hereto and incorporated herein by reference.

 

1.6.1       Minimum
Rent - First Extension Period:During eachLease Year of the first five (5) Lease
Year Extension Period, if applicable, Tenant agrees to pay to Landlord, in accordance with the terms and provisions of Article
III hereof, as annual Minimum Rent an amount to be negotiated and agreed upon in good faith by the parties based on a market analysis
of comparable commercial leases in existence at the commencement of the lease extension period. Landlord shall notify Tenant of
its initial proposal for Minimum Rent in a written notice to Tenant no later than the date which is three hundred (300) days prior
to the expiration of the Initial Term of this Lease. The agreement between Landlord and Tenant shall be reached no later than
the date which is two hundred seventy (270) days prior to the expiration of the initial Term of this Lease. In the event that
Landlord and Tenant are unable to come to an agreement within such period, then the fair rental value shall be determined in accordance
with the procedures set forth on Exhibit “A” attached hereto.

 

 

1.6.2         Minimum
Rent - Second Extension Period:
During each Lease Year of the second five (5) Lease Year Extension
Period, if applicable, Tenant agrees to pay to Landlord, in accordance with the terms and provisions of Article III hereof, as
annual Minimum Rent an amount to be negotiated and agreed upon in good faith by the parties based on a market analysis of comparable
commercial leases in existence at the commencement of the lease extension period. Landlord shall notify Tenant of its initial
proposal for Minimum Rent in a written notice to Tenant no later than the date which is three hundred (300) days prior to the
expiration of the First Extension Period of this Lease. The agreement between Landlord and Tenant shall be reached no later than
the date which is two hundred seventy (270) days prior to the expiration of the First Extension Period of this Lease. In the event
that Landlord and Tenant are unable to come to an agreement within such period, then the fair rental value shall be determined
in accordance with the procedures set forth on Exhibit “A” attached hereto.

 

    	 	3	 

     

    

 

1.7       Security
Deposit:Landlord
and Tenant agree that there shall be no security deposit,

 

1.8       Permitted
Use; Restriction:
Tenant may use the Premises for any lawful medical use, including but not limited to the operation of a rehabilitation hospital
(“Permitted Use”), Tenant covenants: (i) not to use the Premises for any illegal purpose, nor in such a manner as
to violate any applicable and valid law, rule or regulation of any governmental body having jurisdiction over the Premises; (ii)
not to permit waste thereon; (iii) not to use the Premises for an outpatient medical office providing orthopaedic rehabilitation
or physical therapy services; and (iv) not to use the Premises for any purpose prohibited by the Declaration.

 

1.8.1         Landlord’s
Limited Right to Recapture Premises: Landlord and Tenant hereby
agree that if Tenant ceases business operations within the Premises for any period of one hundred eighty (180) or more consecutive
days (for a reason other than the repair and reconstruction from casualty, remodeling, condemnation or other reason permitted
in this Lease), then Landlord, at its option, at any time prior to re-commencement of business operations in the Premises by Tenant,
or Landlord’s receipt of a notice of a proposed assignment of the interest of Tenant in and to this Lease or of a proposed subletting
of the Premises, may terminate this Lease upon thirty (30) days prior written notice to Tenant, in which event, this Lease shall
be of no further force or effect, except that the obligations of the parties arising prior to the termination, and the applicable
indemnifications contained in this Lease, shall remain in effect. Neither an assignment of the interest of Tenant in and to this
Lease, nor a subletting of the Premises, shall be deemed a cessation of business operations which would trigger Landlord’s right
to terminate under this Section.

 

1.9       Premises:
The leased premises shall consist of the land located in St. Joseph
County, Indiana, commonly referred to as Lot 3 of the Elm Road Medical Campus and legally described on Exhibit “B”
attached hereto and incorporated herein by reference (“Land”) together with certain improvements to be designed and
constructed upon the Land by Landlord for Tenant’s occupancy and use (“Improvements”) as provided in Article
IV of this Lease (“Premises”).

 

1.10     Real
Estate Taxes:
All Real Estate Taxes and assessments which shall be validly levied, assessed or imposed upon the Premises during the Lease Term
shall be paid by Tenant. Real Estate Taxes shall specifically exclude; (i) income, profits, intangible, documentary stamp, transfer,
franchise, corporate, capital stock, succession, estate, gift or inheritance taxes or taxes substituted for or in lieu of the
foregoing exclusions; (ii) any assessment or additional tax associated with either a change in ownership of the Elm Road Medical
Campus or the further improvement of the Elm Road Medical Campus (including but not limited to widening of exterior roads, the
installation of or hook up to sewer lines, sanitary and storm drainage systems and other utility lines and installations), (iii)
taxes on rents, gross receipts or revenues of Landlord from the Premises; and (iv) any penalties, late charges or the like attributable
to the late payment by Landlord of Real Estate Taxes or Landlord’s delay in delivering the Real Estate Tax bill to Tenant for
payment, and (v) assessments and taxes based on the assessed valuation of land not improved with commercial buildings or Common
Areas Real Estate Taxes shall reflect any discount available to Landlord by prompt payment of such tax bill regardless of whether
such prompt payment is actually made but only so long as Tenant shall have made its contribution within the applicable discount
period. Landlord agrees to use best efforts to cause any new construction in the Elm Road Medical Campus to be assessed separately
from the Premises and/or the existing Elm Road Medical Campus. Tenant’s Real Estate Taxes for the first Lease Year of the
Lease Term are estimated to be One Hundred Seventy Five Thousand Eight Hundred Seventy Three and 60/100 Dollars ($175,873,60)
($3.83 per square foot of the Premises).

 

    	 	4	 

     

    

 

Tenant shall
have the exclusive right to contest and appeal all real estate taxes and assessments against the Premises during the term of this
Lease and Landlord hereby agrees to cooperate and assist Tenant in any such contest and appeal including but not limited to the
execution of any documents necessary to prosecute any contest or appeal of real estate taxes and assessments. Tenant shall be
entitled to all refunds and/or rebates applicable to real estate taxes and assessments paid by Tenant pursuant to this Lease and
Landlord agrees to pay said refund or rebate to Tenant to the extent said refund or rebate is granted or paid to Landlord in the
form of cash or credit.

 

1.11     Rent;
Triple Net Lease: Rent shall mean Minimum Rent and all other amounts
and charges payable by Tenant under any provision of this Lease. Sums other than Minimum Rent are designated as “Rent”
or “additional rent” hereunder solely for the purpose of enabling Landlord to enforce its rights hereunder, Such sums
shall not be deemed Rent for purposes of computing taxes or for governmental regulations thereon. This Lease shall be deemed and
construed to be a “net, net, net lease” and, except as otherwise expressly provided, Landlord shall receive all Rent
and “additional rent” and all other payments hereunder to be made by Tenant free from any charges, assessments, impositions,
expenses or deductions of any and every kind or nature.

 

1.12     Elm
Road Medical Campus:
That certain medical office planned unit development located on all of the certain tracts or parcels of land located in Penn Township,
St Joseph County, State of Indiana, as more particularly described on Exhibit “C” attached hereto. The name of the Elm
Road Medical Campus may be changed upon one hundred twenty (120) days advance written notice to Tenant; provided however, in no
event shall the name of the Elm Road Medical Campus contain the name of any tenant or occupant of the Elm Road Medical Campus.

 

1.13     Tenant’s
Percentage Share:
Tenant’s Percentage Share shall be the percentage share applicable to the Premises pursuant to the Declaration for the payment
of assessments and will be the percentage obtained by dividing the total floor area of the Premises, which equals Forty Five Thousand
Nine Hundred Twenty (45,920) square feet, by the total floor area of the buildings erected in the Elm Road Medical Campus (i.e.,
the area leased or available for lease or occupied or available for occupancy) as of December 1 of each calendar year of the Lease
Term as provided in and subject to the terms and conditions of the Declaration. The Declaration amendment shall provide for calculation
of assessments uniformly for all lots within Elm Road Medical Campus.

 

    	 	5	 

     

    

 

ARTICLE
II

 

DEMISE
OF PREMISES AND TERM

 

2.1       Demise
of Premises: Landlord hereby leases to Tenant, and Tenant hereby
takes from Landlord+, the Premises, together with all rights, privileges, benefits, rights- of-way, tenements, hereditaments and
easements now or hereafter appurtenant or belonging thereto.

 

2.2       Lease Term:
Tenant shall have and hold the Premises for a term of fifteen
(15) Lease Years (hereinafter, as extended in accordance with Section 2.3 hereof, being sometimes referred to as the “Lease
Term”) to commence on the earlier of (i) sixty (60) days after Tenant’s acceptance of possession of the Premises in substantial
accordance with the terms and provisions of Section 4.8 hereof, or (ii) the date Tenant opens for business to the public (said
earlier date being herein sometimes referred to as the “Commencement Date”), Additionally, Landlord and Tenant further
agree that the final Lease Year of the Lease Term may be extended, upon prior written notice to Landlord, to conclude on the January
31 next following the natural expiration of the Lease Term (as extended). The parties shall, following the commencement of the
Lease Term, execute a supplement hereto confirming the Commencement Date and expiration date of the Lease Term.

 

2.3       Options
to Extend:
Except as provided hereinbelow, Tenant shall have the right of extending the term of this Lease for a total of two (2) successive
periods of five (5) Lease Years each (the “Extension Periods”), upon the same terms and conditions as the Initial Term,
except as otherwise provided herein with respect to Rent and the additional rent. Tenant shall notify Landlord in writing of its
intent to extend the Lease Term at least one hundred twenty (120) days prior to the date of commencement of the Extension Period
and thereupon the term of this Lease shall be extended without the requirement of any further documentation. In the event Tenant
fails to timely notify Landlord of its intent to extend the Lease Term as provided herein, then such option to extend shall nevertheless
remain in full force and effect for a period of thirty (30) days after Tenant’s receipt of notice from Landlord advising Tenant
that its extension option shall terminate at the conclusion of said thirty (30) day notice period unless Tenant exercises the
extension option by written notice to Landlord and upon such exercise of the Option, the Lease Term shall be deemed extended.
Tenant shall pay Minimum Rent during said Extension Periods in the amounts prescribed in Sections 1.6.1 and 1.6.2 of this Lease.
All of the terms and conditions of this Lease shall apply during the Extension Periods.

 

    	 	6	 

     

    

 

ARTICLE
III

 

RENT AND
OTHER CHARGES

 

3.1       Payment
of Rent:
During the Lease Term, Tenant covenants and agrees to pay to Landlord at the place designated in Section 1.1 hereof, without demand,
deduction or set-off, except as otherwise provided in this Lease, all Rent as defined in Article I hereof. Tenant shall not be
liable for relying and acting upon any notice changing the payee and purporting to be signed by or on behalf of Landlord and believed
by Tenant in good faith to be genuine.

 

3.2       Payment
of Minimum Rent:
On or before the first (1st) day of each and every calendar month following the Commencement Date, Tenant covenants to pay Landlord
in advance the monthly installment of Minimum Rent for each such month. If the Commencement Date shall not be the first (1st)
day of the month, then the first (1st) month’s installment of Minimum Rent shall be prorated accordingly and paid along with the
Minimum Rent payable by Tenant to Landlord for the first (1st) full calendar month of the Lease Term.

 

3.3       Utilities:
Tenant shall make application for, obtain, pay for, and be
solely responsible for all utilities required, used or consumed in the Premises, including, but not limited to gas, water, telephone,
electricity, sewer service, garbage collection services, or any similar service; it being agreed and understood, however, that
Tenant’s obligation for the payment of utilities shall commence upon the date the Premises are delivered to Tenant Ready for Occupancy
(as defined herein). In the event that any charge for any utility supplied to the Premises is not paid by Tenant to the utility
supplier when due, then Landlord may, after delivery of fifteen (15) days written notice to Tenant, but shall not be required
to, pay such charge for and on behalf of Tenant, with any such amount paid by Landlord being repaid by Tenant to Landlord, as
additional rent, within fifteen (15) days after demand by Landlord. Except for the gross negligence or intentional misconduct
of Landlord, its agents, and employees, Landlord shall not be liable for any interruptions or curtailment in utility services
whatsoever.

 

3.4       Personal
Property Taxes:
Tenant shall be responsible for and shall pay before delinquency municipal, county or state taxes, levies and fees, including
general or special assessments, assessed daring the Lease Term against any personal property of any kind owned by Tenant or placed
in, upon or about the Premises by Tenant. 

 

    	 	7	 

     

    

 

ARTICLE
IV

 

CONSTRUCTION

 

4.1       Premises
to be Constructed,
Plans and Specifications: The Improvements to be constructed
upon the Land shall be designed and constructed by Landlord in accordance with: (i) the Approved Final Plans and Specifications
to be prepared in accordance with the terms and provisions of Section 4.2 hereof, (ii) applicable laws, ordinances, codes, rules
and regulations of any public authority with jurisdiction over the Premises, and (iii) the legal construction standards associated
with the construction of the Improvements as an I-2 Hospital and regulatory requirements of the Indiana Department of Health (hereafter,
the “Construction”). In the event the Landlord and the Tenant disagree regarding any individual construction
standard, Landlord will be released from the obligation to comply with that individual construction standard if the resolution
of the disputed construction issue is directed by the Tenant. Landlord shall pay all costs associated with designing and constructing
the Improvements upon the Land in accordance with the Approved Final Plans and Specifications (the “Construction Costs”)
in the maximum amount of Ten Million Seven Hundred Seventy- Eight Thousand Eight Hundred Dollars ($10,778,800) ($234.73 per square
foot of the Premises) (the “Construction Cap”). Landlord further agrees that in addition to the Construction Cap, Landlord
shall pay for Landlord’s Work (as hereinafter defined) and all fees, costs and expenses associated with preparing the Approved
Final Plans and Specifications in accordance with Section 4.2 (up to the amount of the Plan Cap as hereinafter defined) and, prior
to commencement of Landlord’s Work or the Construction, Landlord shall maintain insurance covering Landlord’s liability
with respect to any construction that Landlord may perform in connection with the Premises or the Elm Road Medical Campus, Construction
Costs shall include general conditions, the general contractor’s overhead and profits, sales tax and the cost of insurance so
long as all such costs are reasonable for the industry.

 

4.1.1       Landlord’s
Work:
The following construction obligations of Landlord shall not be included in the Construction Costs or the Construction Cap, it
being understood and agreed that Landlord shall perform or cause to be performed these obligations at Landlord’s sole cost and
expense (said obligations being referred to herein as “Landlord’s Work’’): (i) pay all architectural and engineering
fees and the costs associated with preparing and reviewing the plans and specifications for the Improvements to the Premises as
recited in Section 4.2 hereof and pay all fees and costs associated with the preparation of the site and civil engineering drawings;
(ii) provide landscaping throughout the Common Areas of the Elm Road Medical Campus consistent with local governmental code, ordinances
or standards; (iii) provide lighting uniformly distributed throughout the Common Areas of the Elm Road Medical Campus (including
the exterior of the Premises) with a minimum capacity of at least two footcandles; and (iv) construct, grade, pave and Stripe
roadways for ingress and egress to the Premises and the Elm Road Medical Campus in substantial accordance with Exhibit “D”
attached hereto.

 

4.1.2       Construction
Bids and Completion of Landlord’s Work: Landlord
shall be responsible for completion of the Construction of the Improvements upon the Land and Landlord’s Work. Landlord shall
choose, in Landlord’s sole discretion, qualified contractors for the Construction. Landlord shall enter into a contract
with the general contractor (the “General Contractor’’) for the Construction of the Improvements in accordance
with the Approved Final Plans and Specifications (the “Construction Contract”) and promptly deliver a copy of said
fully executed Construction Contract to Tenant. The Construction Contract shall be amended to provide that Tenant shall have notice
and opportunity to cure any default by Landlord and further, that in the event of an uncured default by Landlord, that Tenant
shall have the option of assuming the Construction Contract. In the event that Tenant shall cure any default by Landlord or assume
the Construction Contract, any amounts paid by Tenant may be offset against Rent or other amounts due to Landlord. The Construction
Contract shall obligate the Contractor to comply with the applicable Turnover Date and pay liquidated damages for failure to comply
with the Turnover Date as provided in Section 4.4 of this Lease. The Construction shall be performed in a good and workmanlike
manner with new material of good quality in accordance with all applicable governmental rules and regulations or ordinances. All
of the work performed by the General Contractor to and upon the Land which are so attached to the Land that the same shall by
law be deemed to be part of the Land (except trade fixtures and such other property as may be encompassed within the definition
of Tenant’s Property pursuant to Section 6.4 of the Lease) shall be the property of Landlord and remain upon and be surrendered
with the Premises as a part thereof upon termination of the Lease Term. In the event actual Construction Costs (exclusive of Landlord’s
Work) exceed the Construction Cap (“Excess Costs”), Tenant shall pay such costs, but only to the extent that: (1) said
Excess Costs relate to change orders made by Tenant after the date of the Construction Contract; and (2) the total additional
costs related to such change orders exceed any savings resulting therefrom. In the event Tenant must pay Excess Costs in accordance
herewith, Tenant may elect to pay such costs by Rent Adjustment (in accordance with Section 4.1.3 below) or by lump sum payment
(in accordance with Section 4.1.4 below). Tenant shall be permitted to coordinate with the Landlord and the General Contractor
to ensure the conduct of the Construction in conformance with the Approved Final Plans and Specifications. In no event shall Tenant
be responsible for Excess Costs without the same being documented on a written change order signed by Tenant.

 

 

    	 	8	 

     

    

 

Within thirty
(30) days following the Turnover Date, Landlord shall deliver to Tenant a copy of the final application and certificate for payment
and summary of the construction expenditures constituting the Construction Costs.

 

4.1.3       Additional
Construction Costs; Rent Adjustment: In the event the Construction Cap is exceeded and Tenant elects to pay the Landlord
the Excess Costs by Rent Adjustment, the annualized Minimum Rent for the initial term of the Lease (as recited in Section 1.6
of this Lease) shall be increased by the product derived from multiplying such Excess Costs (subject to any adjustments made pursuant
to Section 4.1.2 hereof), by Six and 66/100ths Percent (6.66%). (By way of illustration only, in the event
that the Additional Construction Costs are $100,000.00, then the annualized Minimum Rent would be increased by $6,666.66 [i.e.,
$100,000.00 times 6.66%] during Lease Years one (1) through fifteen
(15) of the Lease Term). In the event the Construction Costs of the Premises (exclusive of Landlord’s Work) are less than
the Construction Cap, Landlord shall, at Tenant’s option, either (a) within twenty (20) days following receipt of written
notice of Tenant’s election, deliver to Tenant a sum of money equal to the difference between the Construction Cap and the
actual Construction Costs (exclusive of Landlord’s Work) (hereinafter referred to as the “Adjusted Construction Costs”)
or (b) immediately decrease the Annual Minimum Rent for each Lease Year of the Lease Term by the product derived from multiplying
the Adjusted Construction Costs by Six and 66/100ths Percent (6.66%). In the event the annual Minimum Rent is adjusted pursuant
to this Section 4.1.3, Landlord and Tenant shall execute a modification to the Lease reflecting such increase and adjustment to
the Minimum Rent.

 

    	 	9	 

     

    

 

4.1.4       Payment
for Additional Construction Costs:
In the event the Construction Cap is exceeded and Tenant elects to pay Landlord the Excess Costs in a lump sum payment, Landlord
may seek and obtain reimbursement of the Excess Costs from Tenant by providing Tenant with: (i) an A.I.A. application for payment
and summary of construction expenditures, acknowledging compliance with the Approved Final Plans and Specifications showing all
expenditures constituting Excess Costs and all written change orders; (ii) certificate of substantial completion signed by an
architect licensed to do business in the State in which the Premises is located; and (iii) an affidavit of the General Contractor
listing all subcontractors and acknowledging full payment to all such subcontractors with waivers of liens from the General Contractor
(collectively referred to as the “Construction Documents”). Within thirty (30) days after receipt of such Construction
Documents, Tenant shall pay such Excess Costs (subject to any adjustments made pursuant to Section 4.1.2 hereof) to Landlord,
unless Tenant has exercised its option to make the Rent Adjustment recited in Sections 4.1.3 hereinabove.

 

4.2       Plans
and Specifications: Landlord shall submit to Tenant a complete
set of the proposed construction plans, working drawings, and specifications (the “Plans”) prepared at Landlord’s
sole cost and expense. Tenant shall be allowed fifteen (15) days within which to examine the Plans and to advise Landlord of Tenant’s
approval or disapproval of the same; provided, however, Tenant’s approval shall not be unreasonably withheld, conditioned
or delayed. The failure of Tenant to advise Landlord within such fifteen (15) day period shall be deemed to constitute the approval
of the Plans by Tenant as of the fifteenth (15th) day following Tenant’s receipt of the Plans. If Tenant shall have a reasonable
basis for disapproval of any portion of the Plans, Tenant shall give Landlord its reasons therefor in writing within said fifteen
(15) day period and, provided said changes are reasonable, Landlord shall cause the Plans to be revised so as to meet Tenant’s
reasonable objections. Landlord shall submit the revised Plans to Tenant within fifteen (15) days after receipt of Tenant’s
reasons for disapproval of the Plans. Within fifteen (15) days after Tenant’s receipt of the revised Plans, Tenant shall
advise Landlord in writing of its approval of the revised Plans or notify Landlord of any additional objections. Landlord and
Tenant and General Contractor shall use good faith efforts to resolve any dispute regarding revisions to the Plans in an expeditious
manner to the mutual satisfaction of Landlord and Tenant; provided however, in the event a dispute cannot be so resolved, Landlord’s
architect and an architect selected by Tenant shall agree upon a resolution to said dispute and the resolution shall be binding
upon Landlord and Tenant. The Plans which have been approved by Tenant are referred to as the “Approved Final Plans and Specifications.”
Landlord shall have the right to make changes in the Approved Final Plans and Specifications (subject to Tenant’s further
review and approval of same as provided above and which approval shall not be unreasonably withheld) in which event, to the extent
said changes cause Construction Costs to exceed the Construction Cap, Landlord shall pay the amount by which the total additional
cost related to such changes exceeds any savings resulting therefrom. Tenant shall be responsible, at Tenant’s sole cost
and expense, for any change orders requested solely by Tenant or any governmental permitting authority. Tenant shall have the
right to make changes in the Approved Final Plans and Specifications in which event, to the extent said changes cause Construction
Costs to exceed the Construction Cap, Tenant shall pay the amount by which the total additional cost related to such changes exceeds
any savings resulting therefrom as provided in subsection 4.1.3.

 

Landlord
shall, at Landlord’s sole cost and expense outside the Construction Cap, pay any architectural or engineering fees, costs
or expenses associated with: (i) preparation of the Approved Final Plans and Specifications, (ii) any independent architectural
inspection of the Construction, if any, and (iii) preparation of the site and civil engineering drawings, all as a part of Landlord’s
Work, Landlord shall pay such amounts directly to the architectural or engineering firm responsible for plan preparation.

 

 

    	 	10	 

     

    

 

4.3       Construction
Schedule: Landlord
and Tenant acknowledge and agree Tenant was, among other things, induced into entering this Lease by certain representations
made by Landlord as to the timing of delivery of tie Premises to Tenant Ready for Occupancy. Accordingly, Landlord and Tenant
deem it imperative that a construction schedule be established which accurately sets forth the timing for completion of
construction by Landlord of the Premises Ready for Occupancy. Landlord covenants to use its best efforts to meet the
construction schedule attached hereto as Schedule 4.3 and incorporated herein by reference (“Construction
Schedule”). If Landlord shall not have obtained all necessary approvals, licensing and building permits and shall not
have commenced construction by April 30, 2009, Tenant
may, without liability or further obligation, terminate this Lease upon written notice to Landlord, and in such case this Lease shall
have no further force or effect. It is understood and agreed that if Landlord fails to deliver the Premises Ready for
Occupancy (as hereinafter defined) or commence the Construction in the manner and time period specified in this Section 4.3,
then, in such event, Landlord shall be deemed in default under the Lease, and Landlord shall not have any additional time to
cure such default, notwithstanding the cure period provided in Section 14.2 hereof.

 

4.3.1       Turnover
Dates: Landlord
shall use its best efforts to deliver the Premises to Tenant Ready for Occupancy (as defined
hereinafter) on February 26, 2010 (the “Initial Turnover Date”), In the event Premises shall not be
delivered to Tenant Ready for Occupancy by the Initial Turnover Date, Landlord shall use its best efforts to deliver the
Premises to Tenant Ready for Occupancy on March 26, 2010 (the “Second Turnover Date”), Landlord covenants to deliver
written notice to Tenant by February 1,2010, which notice shall state whether the Premises shall be delivered to Tenant Ready
for Occupancy on the Initial or Second Turnover Date, or provide that Landlord is unable
to meet either Turnover Date (the “Turnover Date Notice”). The Turnover Date Notice shall not give notice of intent
to deliver the Premises to Tenant Ready for Occupancy on any date between the Initial Turnover Date and the Second Turnover Date
or subsequent to the Second Turnover Date unless Landlord pays liquidated damages in accordance with Section 4.4 hereof. It is
agreed and understood that failure to deliver the Turnover Date Notice in accordance with this Section 4.3.1 shall result in a
presumption for the purposes of this Article IV that Landlord has notified Tenant that the Premises will be delivered to Tenant
Ready for Occupancy by the Initial Turnover Date.

 

Notwithstanding
anything to the contrary herein, if Tenant fails to provide Landlord with all programing and other specific information necessary
for Landlord to complete construction in a timely manner, as requested by Landlord by written notice thereof, within seven (7)
days of said written request, then the Turnover Date shall be extended for a period of time commensurate with the delay caused
by the Tenant.

 

4.3.2       Termination
Option: If
the Turnover Date Notice indicates that, despite the best good-faith efforts of Landlord, the Premises shall not be delivered
to Tenant Ready for Occupancy by the Second Turnover Date, unless such failure to timely deliver the Premises resulted directly
from delays caused by Tenant (net of delays caused by Landlord) and subject to force majeure
delays as set forth in Section 18.7, then Tenant shall not be required to accept possession of the Premises, and Tenant shall
have the right to terminate this Lease (Landlord not having any additional time to cure notwithstanding the cure period provided
in Section 14.2 hereof). In the event this Lease shall be terminated by Tenant pursuant to this Section 4.3.2, neither party shall
have any further obligations hereunder.

 

    	 	11	 

     

    

 

4.4       Liquidated
Damages: If Landlord fails to deliver the Premises to Tenant Ready
for Occupancy by the Initial or Second Turnover Date, as applicable pursuant to the Turnover Date Notice or otherwise presumed
pursuant hereto, unless such failure to timely deliver the Premises resulted directly from delays caused by Tenant (net of delays
caused by Landlord) or by force majeure delays as provided in Section 18.7 of this Lease, then, in such event, Landlord shall
be deemed in default under this Lease (it being understood that Landlord shall not be allowed additional time to cure such default,
notwithstanding the curative period described in Section 14.2 hereof), and Landlord shall be obligated for payment to Tenant as
liquidated damages the sum of money equivalent to three (3) times the daily Minimum Rent for each day after the Initial or Second
Turnover Date, as applicable pursuant to the Turnover Date Notice or otherwise presumed pursuant hereto, until the Premises are
delivered to Tenant Ready for Occupancy or this Lease is terminated in accordance with Section 4.3.2. If the Turnover Date Notice
states a date for delivery of the Premises to Tenant other than the Initial or Second Turnover Date, Landlord shall be obligated
to pay the foregoing liquidated damages for each day after the immediately preceding Turnover Date that delivery is to be delayed.
It is hereby agreed that the liquidated damages to which Tenant is entitled hereunder are a reasonable estimate of the damages
that would be caused to Tenant by Landlord’s delay in completing and delivering the Premises to Tenant Ready for Occupancy
by the applicable Turnover Date. Tenant shall not be deemed to have waived liquidated damages accruing between the applicable
Turnover Date and the date the Premises are Ready for Occupancy by accepting delivery of the Premises prior to the date the Premises
are Ready for Occupancy.

 

4.5       Ready
For Occupancy: The Premises shall be deemed “Ready for Occupancy”
when:

 

(i)       The
Premises have been substantially completed in accordance with (yy) applicable
laws, ordinances, codes, rules and regulations, and (zz) the Approved Final Plans and Specifications, except for the installation
of Tenant’s fixtures and such minor “punchlist” items as shall not justify Tenant to refuse to accept delivery of the
Premises;

 

(ii)       Landlord
has received a final certificate of occupancy for the Premises (or a conditional certificate of occupancy which requires only
the installation of Tenant’s fixtures prior to being deemed final) if required by any governmental authority and delivered a copy
thereof to Tenant;

 

(iii)       Landlord
has substantially completed Landlord’s Work except for minor punchlist items as shall not justify Tenant to refuse to accept
delivery; and

 

(iv)       Landlord
has provided Tenant with a copy of the General Contractor’s final application for payment and an affidavit of the General
Contractor listing all subcontracts and acknowledging full payment of the General Contractor and all subcontractors with lien
waivers from each.

 

    	 	12	 

     

    

 

4.6       Correction
of Defects and Omissions: Within sixty (60) days after Landlord
delivers to Tenant and Tenant accepts possession of the Premises in accordance with Section 4.8 hereof, Tenant shall prepare and
deliver to Landlord, with respect to those items not constructed according to the Approved Final Plans and Specifications, a list
of defects and omissions in the Construction of the Premises (the “Punchlist”), and Landlord shall correct same within
thirty (30) days after receipt of the Punchlist. Landlord agrees that Landlord shall not pay General Contractor the final retainage
due under the Construction Contract until the Construction items on the Punchlist prepared by Tenant have been completed by General
Contractor, to Tenant’s reasonable satisfaction. If at any time within one year following the date of substantial completion of
the Construction any of the work performed by Landlord or General Contractor (or within one year following the date said work
was purported to be corrected) is found to be not in accordance with the Approved Final Plans and Specifications, upon receipt
of written notice from Tenant, the Landlord shall promptly cause the condition to be corrected within thirty (30) days of the
date of Tenant’s notice. This obligation does not extend to remedy for damage or defect caused by abuse, modifications not
executed by Landlord, improper or insufficient maintenance, improper operation or normal wear and tear.

 

4.7       Acceptance
of Premises: Landlord shall deliver exclusive possession of the
Premises to Tenant as soon as they are Ready for Occupancy, and Tenant shall be required to accept possession thereof when so
delivered. Landlord shall have access to the Premises after exclusive possession has been delivered to Tenant for the purpose
of correcting defects and omissions in construction so long as Landlord does not unreasonably interfere with Tenant’s business
or fixturing activities. The taking of possession of the Premises shall not constitute a waiver of any defects or omissions in
the construction of the Premises or any failure of Landlord to perform its obligations hereunder.

 

Landlord shall
provide Tenant with access to the Premises at least thirty (30) days prior to the Turnover Date for the purpose of installing
Tenant’s fixtures, equipment and personal property upon the Premises. Tenant’s early access shall not unreasonably
interfere with Landlord’s Construction.

 

4.8       Signs:
Subject to local governmental codes and ordinances, as a part of
the construction of the Elm Road Medical Campus and prior to the Turnover Date, Landlord may, at its own expense, erect, or cause
to be erected one or more free-standing sign (hereinafter sometimes referred to as the “Elm Road Medical Campus Sign”),
in the area designated on Exhibit “E” attached hereto. Prior to commencing construction of the Elm Road Medical Campus
Sign, Landlord shall submit to Tenant a proposed drawing of the structure
for Tenant’s
approval, not to be unreasonably withheld. Landlord shall maintain, repair and illuminate said Elm Road Medical Campus Sign during
the Lease Term, with the cost of such maintenance, repairs, and illumination being included within the purview of Common Area
Costs.

 

    	 	13	 

     

    

 

4.9       Exterior
Signage: Tenant, or Tenant’s assignee or sublessee, shall have
the right to place and maintain during the Lease Term its usual and customary signs on the exterior of the Premises, provided,
however, said signage is at all times professionally produced, high-quality in nature and in keeping with the family-orientation
of the Elm Road Medical Campus; it being agreed that Landlord hereby approves Tenant’s exterior signage plans set forth in Exhibit
“F” attached hereto, and provided further, that such exterior signage meets the requirements of the Elm Road Medical
Campus Development Standards, a copy of which are attached hereto as Exhibit “G” and incorporated herein by reference,
Tenant shall maintain such signs in good order and repair in compliance with all applicable governmental rules, regulations or
ordinances. Tenant shall have the right to determine the location
of its sign(s) subject to written approval of the sign(s)’ location by the Landlord, which approval shall not be unreasonably
withheld.

 

4.10     Alterations
to Elm Road Medical Campus and Outlots: Landlord agrees that the
layout and design of the Elm Road Medical Campus shall be substantially as is set forth on Exhibit “C” attached hereto.
The Amendment to the Declaration referred to in Section 1.2 shall
provide that d shall not (a) substantially alter the area of the Elm Road Medical Campus or the location or size of any building
or improvement in the Elm Road Medical Campus, (b) change the number, location or layout of parking spaces in the Elm Road Medical
Campus, (c) construct any additional buildings or structures in the Common Areas of the Elm Road Medical Campus or on parcels
adjacent to the Common Areas of the Elm Road Medical Campus, or (d) change the entrances, exits, access roads, and service roads
to and from the Elm Road Medical Campus or the Protected Parking Area (as hereinafter defined) without the prior written consent
of Tenant in each instance. Tenant shall not unreasonably withhold its consent to changes in the Common Areas of the Elm Road
Medical Campus beyond the area crosshatched on Exhibit “C” attached hereto (the “Protected Parking Area”),
so long as the number of parking spaces provided complies with the St Joseph County Code for hospital parking, and so long as
said change does not impair or adversely affect (i) ingress to or egress from the Premises or any loading dock serving the Premises;
or (ii) visibility of the Premises or Tenant’s exterior signage.

 

4.11     Build-To-Suit
Building:
The hospital shall be a build-to-suit building and there shall be no Tenant improvement allowances.

 

ARTICLE
V

 

USE
OF PREMISES

 

5.1       Tenant’s
Use: Tenant shall use the Premises solely for the Permitted Use
specified in Section 1.8 and/or such additional uses which are ancillary or incidental thereto.

 

    	 	14	 

     

    

 

5.2       Operating
Covenants:Landlord
covenants and agrees that the Amendment to the Declaration referred to in Section 1.2 shall provide (i) that during the Lease
Term Elm Road Medical Campus will continuously operate as a medical office center in a manner consistent with first-class medical
office center practice; and (ii) that no portion of the Elm Road Medical Campus shall be used in violation of the REA (as hereinafter
defined), Declaration or for the following purposes: a bowling alley, skating rink, bar (as distinguished
from a restaurant deriving at least 60% of its gross sales from the sale of nonalcoholic
beverages and food), theater, amusement park, carnival, meeting hall, banquet facility, entertainment facility, disco or other
dance hall, nightclub establishment, sporting events, for any manufacturing, for wholesale or non-retail operation, for the lease,
sale or repair of cars or boats (new or used), trailers, mobile homes, lumber yard, video arcade or other game parlor, pool hall,
billiard parlor, amusement center, off-track betting establishment, flea-market, massage parlor, tattoo or body piercing facility,
auditorium, or for the sale and display of obscene or pornographic materials or any so called “social encounter” restaurants
which serve alcoholic beverages for on-premises consumption and whose primary purpose is the meeting and mingling of its patrons,
and (iii) no portion of the Elm Road Medical Campus shall be used for a drive-thru, fast-food restaurant. During the term hereof,
Landlord shall maintain a parking ratio on Lot Three (3) of not less than the minimum required by applicable local ordinances.

 

5.3       Exclusive
Use:
Tenant shall have the exclusive right to the delivery of inpatient rehabilitation hospital” services at the Elm Road Medical
Campus throughout the term of this Lease so long as Tenant is operating the Premises as an inpatient rehabilitation hospital.

 

5.4       Subletting
and Assignment: Tenant may sublet or assign the Premises at any
time provided the business which such subtenant or assignee proposes to conduct and actually conducts does not conflict with the
use provisions set forth in Section 1.8 of this Lease, In the event Tenant shall assign this Lease as permitted hereunder or shall
sublease any portion of the Premises as permitted hereunder, Tenant shall remain liable for performance of each and every term
of this Lease to be performed by Tenant hereunder. Notwithstanding anything to the contrary contained herein, Landlord and Tenant
hereby expressly agree that Tenant shall be permitted, without the prior written consent of Landlord being required, to sublet
or license portions of the Premises to concessionaires or licensees, provided such use does not conflict with the use provisions
set forth in Section 1.8 of this Lease. Tenant shall likewise have the absolute right, without the prior written consent of, or
notice to, Landlord being required, to assign or sublet the Premises to any parent, subsidiary or affiliate company of Tenant,
or in connection with any merger, consolidation, sale of all or substantially all of Tenant’s assets or stock, or a public or
private offering.

 

    	 	15	 

     

    

 

ARTICLE
VI

 

REPAIRS
AND MAINTENANCE

 

6.1       Tenant’s
Repairs: Except as otherwise provided herein, Tenant shall maintain
in clean condition and good repair, and pay the costs and expense thereof, the nonstructural walls (including all patching and
painting thereof), gutters, downspouts, exterior and all interior nonstructural portions of the Premises, all healing, ventilating
and air conditioning systems and all plumbing, electrical, gas, sprinkler and sewage systems, located within the building constructed
by Landlord upon the Premises. Landlord shall be responsible for maintenance, repair and replacement of all structural walls,
the foundation, the roof and all mechanical and utility installations located outside of the building constructed by Landlord
upon the Premises. Landlord and Tenant shall cause to be established a reserve fund for the expense of said Landlord’s repairs,
as determined by an independent, objective third party experienced in the determination of appropriate and necessary reserves
for the Premises (“Reserve”), which Reserve amounts shall be payable by Tenant as
additional Rent on a monthly basis and which amounts shall be escrowed and set aside as a separate Reserve for payment of said
expenses. Notwithstanding the Reserve, Landlord shall be responsible for the full cost of Landlord’s repairs in excess of
the Reserve at the time of the repair. Tenant further covenants to inspect, maintain and repair, and pay the costs and expense
thereof, the fire sprinkler system serving the Premises, (if any) including without limitation the performance of flow tests on
such systems on a periodic basis, but in no event less frequently than as may be required or
recommended by industry standards for a like-kind system. Landlord agrees to correct any defects in Landlord’s Work or the
Construction arising prior to the first anniversary of the Commencement Date provided Tenant gives written notice of such defects
to Landlord within thirty (30) days after the first anniversary of the Commencement Date, This time limitation shall not apply
to latent defects in Landlord’s Work or the Construction which Tenant could not reasonably have discovered prior to the
expiration of such time period. Landlord further agrees to make all repairs to the Premises, unless occasioned by the negligence
of Tenant or Tenant’s employees, servants, agents or contractors, for a period of one (1) year after the Commencement Date, Landlord
shall maintain on file warranties and guaranties pertaining to the General Contractor’s work and the mechanical systems
of the Premises. Thereafter, to the extent assignable, Landlord shall assign to Tenant all applicable warranties and guaranties
benefiting Landlord or Tenant in connection with the construction of and systems serving the
Premises for which Tenant has a repair obligation hereunder. Notwithstanding the foregoing to
the contrary, Tenant shall be obligated to make those repairs which (i) are occasioned by its negligence, or the negligence
of its employees, agents, servants and contractors; (ii) relate to damage encompassed in the insurance coverage required to be
maintained by Tenant pursuant to Section 9.3 hereof (except to the extent that Tenant’s insurance coverage overlaps or is secondary
to Landlord’s primary coverage); or (iii) arises as a direct and proximate result of Tenant’s failure to perform Tenant’s
repair obligations in Section 6.2 below.

 

6.2       Non-Structural
Repairs. Tenant shall further
be responsible for, and pay the costs and expense thereof, (i) all interior, non-structural repairs to the Premises (including
the replacement of plate glass in the building), and (ii) except as provided hereinbelow, all
maintenance and repairs to the heating, ventilating and air conditioning (“HVAC”) Equipment (e.g., replacement of filters,
belts, freon, and routine cleaning, including inspections and filter changes and repair or replacement of major component parts)
servicing the Premises. Notwithstanding the foregoing to the contrary, Landlord shall be obligated to make those repairs
(nonstructural or HVAC) which (i) are occasioned by Landlord’s negligence, or the negligence of Landlord’s employees, agents,
servants and contractors; (ii) relate to damage encompassed in the insurance coverage required to be maintained by Landlord pursuant
to Section 9.1 hereof (except to the extent that Landlord’s insurance coverage overlaps or is secondary to Tenant’s primary coverage);
or (iii) arise as a direct and proximate result of Landlord’s failure to perform Landlord’s repair obligations in Section 6.1
above.

 

    	 	16	 

     

    

 

Notwithstanding the above, in the event of
the necessity of a substantial repair to (exceeding a cost of $75,000.00) or the replacement of the heating, ventilating or air
conditioning systems serving the Premises at any time during the last three (3) years of the Lease Term, Landlord shall be responsible
for the cost of said repair or replacement and Tenant shall reimburse Landlord for a portion of said cost equal to the amortized
monthly amount of said cost for the remaining Term of the Lease amortized over the useful life of said repair or replacement as
determined by Tenant subject to Landlord’s approval, which approval shall not be unreasonably withheld, conditioned or delayed.

 

6.3       Alterations:
Subject to local governmental code, Tenant shall have the right to
make from time to time, at its sole cost and expense, interior, non-structural alterations to the Premises without the necessity
of first obtaining Landlord’s consent; provided, however, such alterations do not affect the structural integrity or diminish
the value of the Premises. Tenant shall not make any structural changes to the Premises without Landlord’s prior written consent,
said consent not being unreasonably withheld, conditioned or delayed.

 

6.4       Tenant’s
Property:Any
and all trade fixtures, equipment, signs, appliances, furniture and other personal property of whatever nature or kind installed
in the Premises at any time (all of the foregoing being collectively referred to in this Lease as “Tenant’s Property”),
including, without limitation, all counters, shelving, lighting and track lighting, panel wall systems and valance accents (to
the extent that the same can be removed without irreparable damage to the structure of the Premises) shall not become a part of
the realty and may be removed from the Premises by Tenant at any time during the Lease Term or within sixty (60) days after termination
thereof (subject to Tenant’s repair obligations as stated in Section 15.1 hereof).

 

6.5       Tenant
Financing: Tenant shall have the right to finance the acquisition
and installation of Tenant’s Property (by granting a security interest therein or entering into an equipment lease therefor);
and in connection therewith, Landlord agrees to execute and to use reasonable efforts to cause the holder of any mortgage covering
all or any portion of the Elm Road Medical Campus to execute and deliver a Landlord’s and mortgagee’s waiver and all
other documentation reasonably required by any lessor or holder of any security interest in and to Tenant’s Property.

 

6.6       Liens:
Each party hereto shall promptly pay when due the entire cost
of all work done by it to the Premises and shall keep the Premises free of liens for labor or materials. Should mechanics’, materialmen’s
or other liens be filed against the Premises by reason of the acts of either party hereto, such party shall cause the lien to
be canceled and discharged of record by bond or otherwise within sixty (60) days of receiving actual notice of such lien.

 

ARTICLE
VII

 

COMMON
AREAS

 

7.1       Use
of Common Areas:
Landlord hereby grants to Tenant, its licensees, sublessees, successors and assigns, and its and their employees, agents, licensees
and invitees, the non-exclusive right to use the Common Areas during the Lease Term continuously and without interruption. In
the event that Landlord should designate an employee parking area for all employees of tenants and occupants of the Elm Road Medical
Campus, Landlord shall use reasonable efforts to require all such employees to utilize such designated areas, and from and after
receipt of notice of such designated parking area, Tenant shall use its reasonable efforts to cause its employees to utilize such
designated employee parking areas.

 

    	 	17	 

     

    

 

7.2       Maintenance: Landlord
shall maintain or cause to be maintained in compliance with the Declaration and in keeping with the high standards of a Class
A medical office center in St. Joseph County, Indiana, the Common Areas in clean condition and good repair, including, but
not limited to: (i) maintaining all signs, landscaped areas, and parking areas and access roads in good condition and repair
(including re-striping, repairing and re-paving same when required, and removing any ice, snow or rubbish therefrom); (ii)
adequately illuminating the parking areas and other Common Areas while Tenant remains open for business and for one (1) hour
thereafter but no later than 9:00 p.m. unless Tenant pays the additional utility charges on a pro rata basis with any other
tenant open later than 8:00 p.m.; and (iii) keeping the parking area of the Elm Road Medical Campus free from obstructions
including, but not limited to, tractor trailer/delivery trucks (which remain parked in the parking area in excess of twelve
(12) consecutive hours).

 

7.3       Tenant’s
Contribution: Tenant shall pay to Landlord on a monthly basis
along with the monthly installment of Rent payable by Tenant to Landlord, as additional rent during each full or partial Lease
Year of the Lease Term, one-twelfth (1/12th) of Tenant’s Percentage Share of Common Area Costs for Elm Road Medical Campus as
established in the Declaration (as defined in Section 1.2). Tenant’s Percentage Share of Common Area Costs for the first (1st)
Lease Year of the Lease Term shall be reasonably estimated by Landlord in Section 1.2 of this Lease; it being agreed that for
each Lease Year of the Lease Term after the first (1st) Lease Year, the estimated percentage share of Common Area Costs payable
by Tenant to Landlord on a monthly basis shall be based upon Tenant’s Percentage Share of Common Area Costs payable by Tenant
pursuant hereto for the preceding Lease Year of the Lease Term (e.g., the estimated Common Area Costs for the second [2nd] Lease
Year of the Lease Term shall be based upon the actual Common Area Costs payable by Tenant hereunder which Landlord incurs for
the first [1st] Lease Year of the Lease Term). In the event that during any Lease Year of the Lease Term Tenant’s Percentage Share
of the actual Common Area Costs for said Lease Year shall exceed the estimated amount paid by Tenant to Landlord in accordance
with the foregoing, then Tenant shall pay such deficiency to Landlord with the next due installment of Rent after receipt by Tenant
of the detailed statement from Landlord hereinafter described; it being agreed that in the event Tenant’s Percentage Share of
the actual Common Area Costs for any respective Lease Year of the Lease Term is less than the amount paid therefor by Tenant,
then such excess amount shall be taken as a credit by Tenant against the next installments of Rent due to Landlord hereunder until
such amount has been fully refunded, Landlord shall furnish to Tenant, within sixty (60) days after the close of each calendar
year during the Lease Term, a reasonably detailed statement (prepared in accordance with generally accepted accounting principles
and certified as true and accurate by an authorized member of Landlord) of the Common Area Costs incurred during the previous
calendar year (after the Commencement Date) and the methodology employed (including all
appropriate figures and supporting documentation and invoices) in determining Tenant’s Percentage Share thereof. Landlord shall
keep good and accurate books and records in accordance with generally accepted accounting principles concerning the operation,
maintenance and repair of the Common Areas, and Tenant and its agents shall have the right, upon at least thirty (30) days’
notice, to audit, inspect and copy such books and records for the prior two (2) Lease Years. Landlord shall promptly pay Tenant
all Common Area Costs shown by such audit to be overpaid by Tenant.

 

    	 	18	 

     

    

 

7.4       Reciprocal
Easement Agreement (“REA”):If Elm Road Medical
Campus, LLC, Landlord and Tenant enter into an REA, then with respect to the REA, Landlord covenants and agrees as follows;

 

(i)       Without
the prior written consent of Tenant, the REA shall not be terminated, nor amended nor modified in any manner which shall increase
the liabilities and obligations of Tenant, or diminish the rights and privileges of Tenant under this Lease;

 

(ii)       Landlord
hereby grants, assigns and conveys to Tenant on a non- exclusive basis all of the easement rights and other rights of Landlord
contained in the REA, with the same force and effect as if said rights had been granted directly to Tenant; and

 

(iii)       Landlord
agrees to use all reasonable efforts to enforce the easement rights and other rights contained in the REA on Tenant’s behalf,
and if Landlord fails to enforce said rights on Tenant’s behalf, within thirty (30) days after written notice thereof from Tenant,
Landlord agrees that Tenant shall have the right to enforce said rights under the REA directly in the name of, and on behalf of,
Landlord (if so required), Landlord hereby confirming such enforcement rights to Tenant.

 

ARTICLE
VIII

 

REAL ESTATE
TAXES

 

8.1       Real
Estate Taxes:
From and after the Commencement Date, Tenant shall pay any and all Real Estate Taxes (as defined in Section 1.10) relating
to the Premises. Landlord shall furnish Tenant, immediately upon receipt, with a copy of any bill for Real Estate Taxes
relating to the Premises. At least twenty (20) days prior to the date the Real Estate Taxes become delinquent or begin to
accrue penalties and interest, Tenant shall pay to Landlord the Real Estate Taxes (provided Tenant receives the bill from
Landlord at least thirty (30) days prior to the date the Real Estate Taxes become delinquent or begin to accrue penalties
and/or interest). If Tenant receives the bill less than thirty (30) days prior to the date it becomes delinquent, Tenant
shall use commercially reasonable efforts to pay such bill prior to delinquency. Tenant’s liability for Real Estate Taxes
shall be prorated during the first and last years of the Lease Term, as extended, based on the number of days Tenant occupied
the Premises in accordance with this Lease Agreement. Tenant shall not be obligated to pay any additional assessment or
penalty associated with Landlord’s delinquency in delivering the tax bill to Tenant for payment or paying the Real
Estate Tax promptly when due. Tenant shall not be obligated to pay Real Estate Taxes accruing after the Lease is lawfully
terminated in accordance with the provisions hereof prior to expiration of the Initial Term of the Lease. The Real Estate
Taxes for the first (1st) Lease Year of the Lease Term are estimated at One Hundred Seventy Five Thousand Eight Hundred and
Seventy Three and 60/100 Dollars ($175,873.60) ($3.83 per square foot of the Premises). If Tenant desires to contest any real
estate tax, charge or assessment. Tenant shall promptly notify Landlord and Tenant shall have the right to do so at its
expense, and Landlord shall fully cooperate with Tenant in any such proceeding at Tenant’s sole cost and expense.

 

    	 	19	 

     

    

 

8.2       Refunds
and Rebates: Tenant shall receive any Real Estate Tax or assessment
refunds or rebates paid to Landlord and attributable to the Premises net of any reasonable expenses incurred by Landlord in any
proceeding to obtain such refunds or rebates.

 

ARTICLE
IX

 

INSURANCE
AND INDEMNIFICATION

 

9.1       Landlord’s
Insurance: Landlord shall at all times maintain or cause to be
maintained commercial general liability insurance and property damage insurance covering the Elm Road Medical Campus, including,
but not limited to, the Common Areas, against claims for bodily injury, personal injury and damage to property naming Tenant as
an additional insured under any liability policy, with minimum combined single limits of $1,000,000.00 for bodily injury, death
or property damage, and no less than $1,000,000.00 for personal injury, and excess umbrella coverage of at least $3,000,000.00.
Landlord shall also maintain Workers’ Compensation or similar insurance to the extent required by law, covering all of its
employees performing work in the Elm Road Medical Campus and throughout Landlord’s Construction, and contractual liability insurance
in Landlord’s name, naming Tenant as additional insured.

 

9.2       Tenant’s
Contribution:From and after the Commencement Date, Tenant
covenants to pay to Landlord on a monthly basis along with the monthly installment of Minimum
Rent payable by Tenant to Landlord, as additional rent during each Lease Year of the Lease Term, one-twelfth (1/12th) of
Tenant’s Percentage Share of all insurance required to be maintained by Landlord (specifically excluding any rent loss insurance
or administrative or management fee of Landlord) in connection with the Elm Road Medical Campus as set forth in Section 9.1 of
this Lease (herein sometimes referred to as the “Insurance Premiums”) for such respective Lease Year of the Lease Term.
Tenant’s Percentage Share of Insurance Premiums for the first (1st) Lease Year of the Lease Term is reasonably estimated by Landlord
to be Four Thousand Three Hundred Twenty Dollars ($4,320.00) payable by Tenant in twelve (12) equal installments of Three Hundred
Sixty Dollars ($360.00) per month; it being agreed that for each Lease Year of the Lease Term after the first (1st) Lease Year,
the estimated percentage share of Insurance Premiums payable by Tenant to Landlord on a monthly basis shall be based upon Tenant’s
Percentage Share of the actual Insurance Premiums paid for the preceding Lease Year of the Lease Term (e.g., the estimated Insurance
Premiums for the second [2nd] Lease Year of the Lease Term shall be based upon the actual Insurance Premiums payable by Landlord
in connection with the Elm Road Medical Campus for the first [1st] Lease Year of the Lease Term). In the event that during any
Lease Year of the Lease Term Tenant’s Percentage Share of the actual Insurance Premiums for said Lease Year shall exceed the estimated
amount paid by Tenant to Landlord in accordance with the foregoing, then Tenant shall pay such deficiency to Landlord with Tenant’s
next due installment of Minimum Rent after request therefor by Landlord; it being agreed that in the event Tenant’s Percentage
Share of the actual Insurance Premiums are less than the amount paid therefor by Tenant, then such excess amount shall be taken
as a credit by Tenant against the next installments of Rent due to Landlord hereunder until such amount has been fully refunded.
Landlord shall furnish Tenant, within sixty (60) days after the close of each calendar year during the Lease Term, copies of the
insurance company’s invoice pursuant to which Landlord’s insurance payments were made and a statement showing calculation of Tenant’s
Percentage Share thereof.

 

    	 	20	 

     

    

 

9.3       Tenant
Insurance: Tenant shall maintain and pay any and all premiums
for commercial general liability and property damage insurance covering the Premises, including fire and all peril coverage, naming
Landlord as an additional insured with minimum combined single limits of $10,000,000.00 for bodily injury, death or property damage,
and not less than $2,000,000.00 for personal injury, with excess umbrella coverage of $5,000,000.00, and worker’s compensation
in accordance with state statutory limits. Tenant shall also maintain property insurance covering Tenant’s Property including
trade fixtures, inventory and other personal property as defined in Section 6.4 hereof. Landlord and Tenant hereby agree that
all of the coverages and the limits of coverage required to be maintained pursuant to Section 9.1 and Section 9.3 hereof may be
maintained under blanket or umbrella insurance policies; provided, however, the Elm Road Medical Campus, and the Premises, as
the case may be, are specifically covered under such coverages, and the coverages required under the terms and provisions of Section
9.1 and Section 9.3 are not thereby diminished.

 

From and after
the Turnover Date and throughout the term of the Lease, Tenant shall procure and pay for windstorm, fire and extended coverage
insurance, insuring the completed building upon the Premises of not less than the full replacement value thereof in a responsible
insurance company authorized to do business in the State of Indiana. Such insurance policies shall insure against loss or damage
from fire, windstorm, tornado, hail, disaster, earthquake, vandalism, riot, malicious mischief (and including boiler insurance
and war risk insurance if then available), insurance against flood if required by the Federal Flood Disaster Protection Act of
1973 and Regulations issued thereunder, and such other insurance as commonly, or in the judgment of Tenant prudently, maintained
by those whose business, improvement to and use of the Premises is similar to that of Tenant. Such insurance shall contain the
so-called Replacement Cost or Restoration Endorsement, a provision to the effect that the waiver of subrogation rights by the
insured does not void the coverage, and such special endorsements as determined by Tenant. Such insurance policies shall be issued
in the joint names of Landlord and Tenant as the insured, and any mortgagee of Landlord or Tenant, if so requested. Tenant may
self-insure all or any portion of said risk with the prior written consent of Landlord, which consent Landlord shall not unreasonably
withhold, condition or delay.

 

9.4       Insurance
Certificates: All of the insurance policies required pursuant
to Sections 9.1 and Section 9.3 shall be written with companies licensed to do business in the State in which the Premises is
located and shall provide that the other party hereto shall be given a minimum of ten (10) days’ written notice by any such insurance
company prior to the cancellation, termination or alteration of the terms or limits of such coverage. The foregoing insurance
policies or certificates thereof shall be delivered to the respective parties prior to the date the Premises are Ready for Occupancy
with evidence of all renewals or replacements of same being delivered to the respective parties not less than ten (10) days prior
to the expiration date of such policies.

 

    	 	21	 

     

    

 

9.5       Mutual
Release; Waiver of Subrogation; and Mutual Indemnifications:
Landlord and Tenant hereby release each other and anyone claiming through or under the other by way of subrogation or otherwise
from any and all liability for any loss of or damage to property, which are insurable under the policies of property insurance
required to be maintained pursuant to this Article IX, whether or not caused by the negligence or fault of the other party, caused
by a casualty to the Premises or to the Elm Road Medical Campus. In addition, Landlord and Tenant shall cause each such insurance
policy carried by them insuring the Premises or the Elm Road Medical Campus or the contents thereof, to be written to provide
that the insurer waives all rights of recovery by way of subrogation against the other party hereto in connection with any loss
or damage covered by the policy. Furthermore, Landlord and Tenant agree to indemnify, release and hold each other harmless from
and against any and all claims, damages or causes of action for damages which are insurable under the policies of general liability
insurance required to be maintained pursuant to this Article IX, and brought on account of injury to any person or persons or
property, or loss of life, arising out of the use, operation or maintenance of the Elm Road Medical Campus and Common Areas by
Landlord and the Premises by Tenant, respectively.

 

ARTICLE
X

 

DAMAGE
AND DESTRUCTION

 

10.1     Damage
and Destruction to the Premises:
If the Premises shall be damaged or destroyed by fire or other casualty (any of such causes being referred to herein as a “Casualty”),
but the Premises shall not be thereby rendered wholly or partially untenantable (i.e., “untenantable” meaning Tenant
is not able to conduct its regular business in the whole of the Premises without interruption or interference), Tenant shall with
due diligence remove any resulting debris and repair/rebuild same in accordance with the Plans set forth in Section 4.2 hereof.
If, as a result of a Casualty, the Premises shall be rendered wholly or partially untenantable (i.e., Tenant shall not be able
to conduct its regular business in the whole of the Premises without interruption or interference), then, Tenant shall, at Tenant’s
sole cost and expense, with due diligence, remove any resulting debris and repair/rebuild same in accordance with the Plans set
forth in Section 4.2 hereof and all Rent, including Minimum Rent, additional rent and other charges hereby reserved, shall be
abated proportionately as to the portion of the Premises rendered untenantable during the period of such untenantability. All
prepaid Rent and other charges, if any, paid by Tenant for periods after the date of such damage or destruction shall be refunded
and/or prorated based on the portion of the Premises rendered untenantable during the period of untenantability. If Tenant does
not commence the repair and restoration work required pursuant to this Section 10.1 within the earlier to occur of: (i) sixty
(60) days after the settlement of the insurance claims between Tenant and its insurance company, or (ii) one hundred twenty (120)
days after the date of such destruction, or thereafter does not diligently pursue such work to completion, then Landlord shall
have the right, at Landlord’s option, to either: (i) upon ten (10) days prior notice to Tenant, perform such repair/restoration
work at the sole cost of Tenant, which cost Tenant shall pay to Landlord during the course of such repairs within ten (10) days
of invoice by Landlord; (ii) seek to obtain specific performance of Tenant’s repair and restoration obligations pursuant
to the laws of the State in which the Premises is located; or (iii) terminate this Lease by thirty (30) days written notice to
Tenant, without waiving Landlord’s rights to damages for Tenant’s failure to perform its covenants and obligations
hereunder. The rights granted Landlord in this Section 10.1 shall be in furtherance and not in limitation of any rights Landlord
may have pursuant to Section 13.1 hereof.

 

    	 	22	 

     

    

 

10.2     Damage
and Destruction to the Common Areas or Other Portions of the Elm Road Medical Campus: If
the Common Areas in the Elm Road Medical Campus (exclusive of the Premises) shall, either previous to the beginning of the Lease
Term or during the Lease Term, be damaged or destroyed, Landlord shall with due diligence remove any resulting debris and repair
and/or rebuild the damaged or destroyed Common Areas to substantially the same condition which existed on the date immediately
preceding the date of the casualty. If greater than thirty (30%) percent of the gross leasable area of the Elm Road Medical Campus
is damaged, or, if Landlord does not commence the repair and restoration work required pursuant to this Section 10.2 within the
earlier to occur of (a) sixty (60) days after the settlement of the insurance claims between Landlord and its insurance company,
or (b) one hundred twenty (120) days after the date of such destruction, or thereafter does not diligently pursue such work to
completion, then, in either such event, Tenant shall have the right, at Tenant’s option, to either: (i) upon
ten (10) days prior notice to Landlord, perform such repair/restoration work at the sole cost of Landlord, which cost Landlord
shall pay to Tenant during the course of such repairs within ten (10) days of invoice by Tenant; (ii) seek to obtain specific
performance of Landlord’s repair and restoration obligations pursuant to the laws of the State in which the Premises is located;
or (iii) terminate this Lease by thirty (30) days written notice to Landlord, without waiving Tenant’s right to damages
for Landlord’s failure to perform its covenants and obligations hereunder. The rights granted Tenant in this Section 10.2 shall
be in furtherance and not in limitation of any rights Tenant may have pursuant to Section 13.1 hereof.

 

10.2.1      Damage During Last
Three Years:       Notwithstanding
the provisions of Sections 10.1 and Section 10.2 hereof, if during the last three (3) years of the initial term of the Lease,
or any renewal thereof, the Premises or the Elm Road Medical Campus are damaged to the extent of thirty-five (35%) percent or
more of the replacement cost (exclusive of the land and foundations), then this Lease may be terminated at the election of either
Landlord or Tenant, provided that notice of such election shall be delivered by the electing party to the other within sixty (60)
days after the occurrence of such damage or destruction. Upon the exercise of such option to terminate by either party hereto,
this Lease shall be deemed null and void, the parties shall be released from all further liabilities thereafter arising under
this Lease, and all Rent and other charges paid by Tenant for periods after the date of termination shall be promptly refunded.

 

    	 	23	 

     

    

 

ARTICLE XI

 

EMINENT DOMAIN

 

11.1         Condemnation:
If, after the execution of this Lease and prior to the expiration of the Lease Term, the whole of the Premises shall be taken
under power of eminent domain by any public or private authority, or conveyed by Landlord to said authority in lieu of such taking,
then this Lease and the term hereof shall cease and terminate as of the date of such taking, subject, however, to the right of
Tenant, at its election, to continue to occupy the Premises, subject to the terms and provisions of this Lease, for all or such
part, as Tenant may determine, of the period between the date of such taking and the date when possession of the Premises shall
have been taken by the taking authority, and any unearned Rent and other charges, if any, paid in advance, shall be promptly refunded
to Tenant.

 

11.2         Termination
Right: If, after the execution of this Lease and prior to the expiration of the term hereof, any taking under the power
of eminent domain by a public or private authority or any conveyance by Landlord in lieu thereof shall result in:

 

(i)          A
reduction of any portion of the Premises or fifteen (15%) percent or more of the gross leasable area of the balance of the Elm
Road Medical Campus exclusive of the Premises;

 

(ii)         The
reduction of the parking area for the Elm Road Medical Campus below a parking ratio of 3.5 spaces per 1,000 square feet of improvements;

 

(iii)        A
taking that results in the closing of any entrance or exit to the Elm Road Medical Campus where no suitable alternative entrances
or exits are substituted therefor in the reasonable judgment of Tenant; or

 

(iv)        A
taking of either a portion of the Common Areas or the access roads to the Premises or the Elm Road Medical Campus, which taking
materially impedes or materially interferes with access to the Premises;

 

then Tenant may, at its election, terminate
this Lease by giving Landlord notice of the exercise of Tenant’s election within thirty (30) days after Tenant shall receive
notice of such taking. In the event of termination by Tenant under the provisions of this Section, this Lease and the term hereof
shall cease and terminate as of the date of such taking, and unearned Rent and other charges, if any, paid in advance by Tenant
shall be promptly refunded to Tenant provided however, Tenant, at its election, may continue to occupy the Premises, subject to
the terms and provisions of this Lease, for all or such part, as Tenant may determine, of the period between the date of such
taking and the date when possession of the Premises shall be taken by the appropriating authority.

 

    	 	24	 

     

    

 

11.3         Restoration:
In the event of a taking in respect of which Landlord or Tenant shall not have the right to elect to terminate this Lease
or, having such right, shall not elect to terminate this Lease, this Lease and the term thereof shall continue in full force and
effect and Tenant, at Tenant’s sole cost and expense, forthwith shall restore the remaining portions of the Premises, including
any and all improvements made theretofore, together with the remaining portions of the parking areas, to an architectural whole
in substantially the same condition that the same were in prior to such taking, A just proportion of the Minimum Rent reserved
hereunder and any other charges payable by Tenant hereunder, according to the nature and extent of the injury to the Premises
and to Tenant’s business operations in the Premises, shall be suspended or abated until the completion of such restoration and
thereafter the Rent and any other charges shall be reduced to equitably reflect the effect of such talking on Tenant’s business
operations in the Premises. Should Tenant fail to promptly commence and diligently proceed to so restore the remaining portions
of the Premises, Landlord may at its option exercise any of the rights granted Landlord for failure by Tenant to repair or restore
pursuant to Section 10.2 hereof.

 

11.4         Award:
All compensation awarded for any taking, whether for the whole or a portion of the Premises, shall belong to Landlord; provided
that Tenant shall be entitled to any award made to Landlord or to Tenant to the extent such award includes the unamortized cost
of Tenant’s betterments and improvements, moving expenses and the value of Tenant’s fixtures, and further provided that Tenant
may apply for and receive an award for the loss of Tenant’s leasehold estate so long as such award in no way diminishes any award
to Landlord or to any mortgagee of Landlord with respect to Landlord’s remainder. If Landlord’s award does not include such expenses,
Tenant may pursue its own claim so long as it does not reduce the award to Landlord for the land and buildings.

 

11.5         Termination:
In the event of any termination of this Lease pursuant to the provisions of this Article XI, the parties, effective as of
such termination, shall be released, each to the other, from all liability and obligations thereafter arising under this Lease.

 

ARTICLE XII

 

SUBORDINATION AND ATTORNMENT

 

12.1         Subordination:
Landlord hereby acknowledges that Tenant’s interest in and to this Lease is superior to any mortgage, lien or other security
interest affecting the Elm Road Medical Campus or any portion thereof. Notwithstanding the foregoing, Tenant shall, upon the written
request of Landlord, subordinate this Lease to the lien of any present or future mortgage upon the Premises or the Elm Road Medical
Campus, provided that the holder of any such mortgage (the “Mortgagee”) shall enter into a written agreement including
an agreement that Tenant shall not be disturbed in its possession of the Premises as provided in this Lease so long as Tenant
complies with the terms and conditions of this Lease, in a form and substance approved by Tenant which approval shall not be unreasonably
withheld, conditioned or delayed. As used herein, “mortgage” shall include mortgages, deeds of trust, deeds to secure
debt or other similar instruments, and any modifications, extensions, renewals and/or replacements thereof.

 

    	 	25	 

     

    

 

12.2         Attornment: Should
Landlord sell, convey or transfer its interest in the Elm Road Medical Campus or should any mortgagee of Landlord succeed to
Landlord’s interest through foreclosure or deed in lieu thereof, then Tenant shall attorn to such succeeding party as
its landlord under this Lease promptly upon any such succession, provided that such succeeding party assumes, in a writing
acceptable to Tenant in its reasonable judgment, all of Landlord’s duties and obligations under this Lease.

 

ARTICLE XIII

 

SELF HELP

 

13.1        Self
Help: If either party defaults in the performance of any obligation imposed on such party by this Lease and does not cure
such default within thirty (30) days after written notice (unless otherwise specified elsewhere in this Lease) from the other
party specifying the default (or does not within said period commence and diligently proceed to cure such default), the other
party, without waiver of or prejudice to any other right or remedy it may have, shall have the right at any time thereafter to
cure such default for the account of the defaulting party, and the defaulting party shall reimburse the other party for any reasonable
amount paid and any expense or contractual liability so incurred upon invoice; it being agreed that any amounts expended by Tenant
on behalf of Landlord and not reimbursed by Landlord as provided above maybe setoff by Tenant with interest at the rate provided
in Section 14.3 against future Rent owing under this Lease. The foregoing to the contrary notwithstanding, Tenant shall have no
right to cure any default hereunder unless and until Tenant has given not less than thirty (30) days prior written notice of such
default to the holder of any mortgage on the Premises or the Elm Road Medical Campus of which Tenant has received notice from
Landlord and such holder fails to cure or cause Landlord to cure said default.

 

13.2        
Emergencies: Notwithstanding the terms and provisions of Section 13.1 hereof, in the event of emergencies, or where
necessary to prevent injury to persons or damage to property, either party may cure a default by the other before the expiration
of the waiting period but after giving written or oral notice to the other party.

 

ARTICLE XIV

 

DEFAULT AND REMEDIES

 

14.1         Remedies
Upon Tenant’s Default: In the event Tenant shall at any time be in default in the payment of Rent, or other charges herein
required to be paid by Tenant or in the observance or performance of any of the other covenants and agreements required to be
performed and observed by Tenant hereunder and any such default shall continue for a period of fifteen (15) days after written
notice to Tenant for monetary obligations and thirty (30) days after written notice to Tenant for all other obligations (or if
such default is incapable of being cured in a reasonable manner within thirty (30) days, then if Tenant has not commenced to cure
such default within said thirty (30) day period or thereafter does not diligently prosecute said cure to completion) and Tenant
shall not thereafter cure such default, or should Tenant at any time use the Premises or any portion thereof for any illegal or
unlawful purpose, or commit, or permit or tolerate the commission therein of any act made punishable by fine or imprisonment under
the laws of the United States or the State in which the Premises is located or utilize the Premises or place on the Premises any
objects which would give any fire or casualty insurer the right to cancel such coverage or otherwise endanger the safety of the
property and persons thereon, and should such actions continue for a period of ten (10) days after written notice has been given
to Tenant, then Landlord shall be entitled at its election, to exercise concurrently or successively, any one or more of the following
rights in addition to all remedies otherwise provided in this Lease and otherwise available at law or in equity under the laws
of the United States or the State in which the Premises is located:

 

    	 	26	 

     

    

 

(i)          to
bring suit for the collection of the Rent or other amounts for which Tenant may be in default or for the performance of any other
covenant or agreement devolving upon Tenant, all without entering into possession or terminating this Lease;

 

(ii)         to
re-enter the Premises with process of law and take possession thereof, without thereby terminating this Lease, and thereupon Landlord
may expel all persons and remove all property therefrom, without becoming liable to prosecution therefor, and re-let the Premises
and receive the rent therefrom applying such rent first to the payment of the reasonable expenses of such re-entry and the reasonable
cost of such re-letting, and then to the payment of the monthly Rent accruing hereunder, the balance, if any, to be paid to Tenant.
Tenant shall remain liable for any deficiency after each such monthly application. Landlord shall use its best efforts to re-let
the Premises (Landlord having the duty and obligation to mitigate damages of Tenant). The commencement and prosecution of any
action by Landlord in forcible entry and detainer, ejectment or otherwise, or the appointment of a receiver, or any execution
of any decree obtained in any action to recover possession of the Premises, or any re-entry, shall not be construed as an election
to terminate this Lease unless Landlord shall, in writing, expressly exercise its election to declare the Lease Term ended and
to terminate this Lease, and, unless this Lease be expressly terminated, such re-entry or entry by Landlord, whether taken under
summary proceedings or otherwise, shall not be deemed to have absolved or discharged Tenant from any of its obligations and liabilities
for the remainder of the initial term of this Lease or any applicable extension period;

 

    	 	27	 

     

    

 

(iii)        to
terminate this Lease upon ten (10) days written notice to Tenant, re-enter the Premises and take possession thereof. In the event
Landlord shall elect to terminate this Lease, as aforesaid, all rights and obligations of Landlord, and of any permitted successors
or assigns, shall cease and terminate, except that Landlord shall have and retain full right to sue for and collect all Rent,
including without limitation, acceleration of Rent (“Accelerated Rent”), or other amounts for which Tenant may be in
default, or for the performance of any other covenant or agreement devolving upon Tenant; provided, however, that Accelerated
Rent shall be discounted to present value at an annual interest rate equal to the then current yield of actively traded U.S. Treasury
bonds with 10-year maturities, as published by the Federal Reserve Statistical Release for the week prior to the mailing of the
notice of acceleration, and all other amounts for the payment of which Tenant shall then be in arrears and Tenant shall surrender
and deliver up the Premises to Landlord and upon any default by Tenant in so doing, Landlord shall have the right to recover possession
by summary proceedings or otherwise and to apply for the appointment of a receiver and for other ancillary relief in such action,
provided Tenant shall have ten (10) days written notice after such application may have been filed and before any hearing thereon,
and Landlord shall again have and enjoy the Premises, fully and completely, as if this Lease had never been made. Tenant hereby
expressly waives any and all rights of redemption granted by or under any present or future laws in the event of Landlord’s obtaining
possession of the Premises by reason of the breach or violation by Tenant of any of the covenants and conditions in this Lease
contained.

 

14.2         Remedies
Upon Landlord’s Default: In the event that Landlord shall at any time be in default in the observance or performance
of any of the covenants and agreements required to be performed and observed by Landlord hereunder and any such default shall
continue for a period of thirty (30) days after written notice to Landlord (or if such default is incapable of being cured in
a reasonable manner within thirty [30] days, then if Landlord has not commenced to cure such default within said thirty [30] day
period or, having commenced thereafter does not diligently prosecute such cure to completion), then Tenant shall be entitled,
at its election, to exercise concurrently or successively, any one or more of the following rights, in addition to all remedies
otherwise provided in this Lease and otherwise available at law or in equity under the laws of the United States or the State
in which the Premises is located:

 

(i)          to
bring suit for the collection of any amounts for which Landlord may be in default, or for the performance of any other covenant
or agreement devolving upon Landlord, together with all damages to Tenant by reason of any such breach, without terminating this
Lease;

 

(ii)         to
set off any damages awarded to Tenant as a result of said suit against the Rent provided in this Lease and during any period of
Landlord’s default, to pay Rent pursuant to this Lease to the court in which said suit is pending until a judgment awarding
damages to Tenant is made; and/or

 

(iii)        to
terminate this Lease upon thirty (30) days written notice to Landlord without waiving Tenant’s rights to damages for Landlord’s
failure to perform its obligations hereunder. In the event Tenant shall elect to terminate this Lease, as aforesaid, all rights
and obligations of Tenant, and of any permitted successors or assigns, shall cease and terminate, except that Tenant shall have
and retain full right to sue for and collect all amounts for the payment of which Landlord shall then be in default and all damages
to Tenant by reason of any such breach.

 

    	 	28	 

     

    

 

14.3        Cumulative
Remedies: All remedies of Landlord and Tenant herein created or remedies otherwise existing at law or equity are cumulative
and the exercise of one or more rights or remedies shall not be taken to exclude or waive the right to the exercise of any other.
All such rights and remedies may be exercised and enforced concurrently and whenever and as often as Landlord and Tenant shall
deem necessary.

 

ARTICLE XV

 

SURRENDER OF PREMISES

 

15.1         Surrender
of Premises: Tenant shall, on or before the last day
of the Lease Term hereof, or upon the sooner termination hereof, peaceably and quietly leave, surrender, and yield to Landlord
the Premises, together with all alterations, additions, and improvements (other than trade fixtures, equipment, and other items
of Tenant’s Property) in good order, condition and repair, ordinary wear and tear, damage by casualty and taking by condemnation
excepted; it being specifically agreed and understood that in no event shall Tenant ever be required to remove any of the alterations,
additions or improvements made to the Premises as permitted under the terms and provisions of this Lease, Such trade fixtures
and other items of Tenant’s Property shall be removed by Tenant in accordance with Section 6.4 hereof. Tenant shall repair any
damage to the Premises resulting from the removal of such trade fixtures and other items of Tenant’s Property. All such trade
fixtures and other items of Tenant’s Property not so removed may, upon notice to Tenant, be removed and stored by Landlord at
Tenant’s cost.

 

15.2         Holding
Over: In the event of Tenant’s continued occupancy of the Premises after the expiration of the Lease Term, or any earlier
termination provided or permitted by this Lease, such tenancy shall be from month-to-month and such continued occupancy shall
not defeat Landlord’s right to possession of the Premises. All other covenants, provisions, obligations and conditions of
this Lease shall remain in full force and effect during such month- to-month tenancy.

 

ARTICLE XVI

 

ACCESS TO PREMISES

 

16.1         Access
and Entry: To the extent permitted by law, Landlord or Landlord’s agents or designees shall have the right, after
reasonable notice to Tenant, to enter upon the Premises at any reasonable time during normal business hours to examine the Premises
or to make any repairs or maintenance required of Landlord hereunder, provided Landlord shall use its best efforts not to unreasonably
interfere with the conduct of Tenant’s normal business operations in the Premises. The foregoing notwithstanding, in the event
of an emergency situation which Landlord reasonably believes may threaten life or property, Landlord shall only be required to
give notice which is reasonable under those exigent circumstances. Landlord shall be allowed to take all materials into and upon
the Premises that may be required to make such repairs or maintenance required of Landlord hereunder so long as it does not constitute
an eviction of Tenant in whole or in part, provided if Tenant cannot reasonably conduct its business in the Premises as a result
of Landlord’s actions for greater than forty-eight (48) hours, then the Rent shall abate after said forty-eight (48) hour period
until Tenant is once again reasonably able to conduct its business in the Premises.

 

    	 	29	 

     

    

 

16.2         Tenant
Rights: Landlord grants Tenant, its employees and agents, the right to enter the Premises at any time after this Lease
has been executed to inspect the progress of Landlord’s Work and/or the Construction and to determine if the same are being
performed in accordance with the requirements of this Lease without being deemed to have taken possession or having obligated
itself to pay Minimum Rent and other charges due hereunder after the Commencement Date or any other additional charges and to
prepare for Tenant’s operation in the Premises; provided, however that Tenant agrees that it shall not unreasonably interfere
with Landlord’s Work or the Construction.

 

ARTICLE XVII

 

QUIET ENJOYMENT

 

17.1         Zoning;
Building and Use Restrictions: Landlord covenants: (i) that it has a right to acquire and within sixty (60) days shall
acquire fee simple title in and to the Premises and that Elm Road Medical Campus, LLC has fee simple title in and to Elm Road
Medical Campus; (ii) it has the right to make this Lease for the entire Lease Term, without obtaining consent from any other person
or entity; (iii) there are no zoning ordinances or building and use restrictions (including but not limited to exclusive use rights
held by other tenants or occupants of the Elm Road Medical Campus) affecting the Premises or Common Areas that would interfere
with the use of the Premises by Tenant for the purposes permitted in this Lease; and (iv) there are no underlying or superior
leases with respect to the Premises.

 

17.2         Evidence
of Title: Landlord shall provide Tenant with evidence satisfactory to Tenant and Tenant’s counsel that
Landlord’s title to the Premises is in the condition required by Section 17.1 hereof. Such evidence of title shall be
deemed satisfactory if it is in the form of a policy of title insurance issued by a recognized title insurance company
authorized to  do business in the State in which the Premises is located.

 

17.3         Quiet
Enjoyment: So long as Tenant shall pay the Rent herein reserved and perform all of the covenants and provisions of
this Lease to be performed by Tenant, Tenant shall during the Lease Term freely, peaceably, and quietly enjoy and occupy the
full possession of the Premises and the rights herein granted with respect to the Common Areas and the tenements,
hereditaments and appurtenances thereunto belonging or in anywise appertaining, without molestation or hindrance by any
person or entity whomsoever. In the event Tenant’s quiet possession of the Premises or the Common Areas shall be disturbed by
any person or entity claiming title to the Premises or the Common Areas superior to Landlord’s title, (i) the Minimum Rent
and other charges due hereunder shall be equitably abated during any such period, and (ii) the running of the Lease Term
shall be tolled during such period, and the expiration date of the Lease Term (or Extension Period, as applicable) shall be
extended for the same number of days as the Lease Term was tolled. If such period shall continue for more than thirty (30)
days after notice from Tenant, Tenant shall have the right, in addition to its other remedies at law or in equity, to
terminate this Lease, and all of its rights to damages shall survive such termination.

 

    	 	30	 

     

    

 

ARTICLE XVIII

 

MISCELLANEOUS

 

18.1         Notices:
Any notice or consent required to be given by, or delivered to, Landlord or Tenant hereunder shall be in writing and mailed
by registered or certified mail, return receipt requested or delivered by a nationally recognized overnight courier, addressed
to the respective parties at the addresses designated in Section 1.1 hereof or at such other address as may be designated in writing
by the parties. All such notices shall be deemed effective upon receipt.

 

18.2         Successors
and Assigns: All covenants, promises, conditions, representations, and agreements herein contained shall be binding upon,
apply, and inure to the parties hereto and their respective heirs, executors, administrators, successors, and assigns.

 

18.3         Entire
Agreement: This Lease and the exhibits attached hereto constitute the sole and exclusive agreement between the parties
with respect to the Premises. No amendments, modifications of or supplements of this Lease shall be effective unless in writing
and executed by both Landlord and Tenant. All exhibits and schedules, if any, attached hereto are by this reference made a part
hereof,

 

18.4         Time
is of the Essence: The time of the performance of all of the covenants, conditions, and agreements of this Lease is of
the essence of this Agreement; it being agreed that this provision shall in no event be construed as vitiating any of the cure
periods for compliance set forth by virtue of the terms and provisions of this Lease.

 

18.5         Recording
of Lease: This Lease shall not be recorded. A short form or memorandum of this Lease in a form substantially similar to
the form attached hereto as Exhibit “F” shall be prepared by Tenant, at Tenant’s expense, and recorded by Landlord,
at Landlord’s expense. Landlord shall cause the short form or memorandum of lease to be recorded promptly upon the final execution
of this Lease by both parties. Landlord shall provide Tenant evidence of the recordation of such short form or memorandum of lease
within ten (10) days after the execution of this Lease by both parties.

 

18.6        
Relationship of Parties: Nothing herein shall be construed so as to constitute a joint venture or partnership between
Landlord and Tenant.

 

18.7         Force
Majeure: In the event that either party shall be delayed or hindered in, or prevented from, the performance of any work,
service, or other act required under this Lease to be performed by such party and such delay or hindrance is due to strikes, lockouts,
Acts of God, governmental restrictions, enemy act, civil commotion, fire or other casualty, or other causes of a like nature beyond
the control of the party so delayed or hindered, then performance of such work, service, or other act shall be excused for the
period of such delay and the period for the performance of such work, service, or other act shall be extended for a period equivalent
to the period of such delay. In no event shall a lack of financing be deemed an unavoidable delay hereunder.

 

    	 	31	 

     

    

 

18.8         Governing
Law: This Lease shall be construed under the laws of the State in which the Premises is located.

 

18.9         Partial
Invalidity: If any provision of this Lease or the application thereof to any person or circumstance shall to any extent
be held invalid, then the remainder of this Lease or the application of such provision to persons or circumstances other than
those as to which it is held invalid shall not be affected thereby, and each provision of this Lease shall be valid and enforced
to the fullest extent permitted by law.

 

18.10       Submission
of Lease: The submission of this Lease for examination, does not constitute an offer to lease, or a reservation of or
option for the Premises, and this Lease shall be effective only upon execution and delivery thereof by Landlord and Tenant.

 

18.11       Interpretation:
In interpreting this Lease in its entirety, the printed provisions of this Lease and any additions written or typed thereon
shall be given equal weight, and there shall be no inference, by operation of law or otherwise, that any provision of this Lease
shall be construed against either party hereto.

 

18.12       Brokers:
Landlord and Tenant hereby warrant and represent that in connection with this Lease that neither has dealt with any broker
or other person or entity entitled to any brokerage commission, fee, or other compensation. Each party shall indemnify, defend,
protect and hold harmless the other, their agents and legal representatives, against any fee, commission, or other compensation
due to any person, firm, or corporation claiming to have acted in said party’s behalf.

 

18.13       Survival
of Obligations: The provisions of this Lease with respect to any obligation of Tenant to pay any sum in order to perform
any act required by this Lease after the expiration or other termination of this Lease shall survive the expiration or other termination
of this Lease.

 

18.14       Headings,
Captions and References: The Section captions contained in this Lease are for convenience only and do not in any way limit
or amplify any term or provision hereof. The use of the terms “hereof,” “hereunder” and “herein”
shall refer to this Lease as a whole, inclusive of the exhibits, except when noted otherwise. The use of the masculine or neuter
genders herein shall include the masculine, feminine and neuter genders and the singular form shall include the plural, or plural
shall include the singular, when the context so requires.

 

18.15       Attorney’s
Fees: The unsuccessful party in any action or proceeding shall pay for all costs, expenses and reasonable attorney’s
fees incurred by the prevailing party or its agents or both in enforcing the covenants and agreements of this Lease. The term
“prevailing party” as used herein shall include without limitation a party who obtains legal counsel and brings an
action against the other party by reason of the other party’s breach or default and obtains substantially the
relief sought, whether by compromise, settlement or judgment.

 

    	 	32	 

     

    

 

18.16       Hazardous
Substances:

 

(i)        As
used in this Section, “Hazardous Substances” shall mean and include any of the substances, materials, elements or compounds
that are contained in the list of hazardous substances adopted by the United States Congress or the Environmental Protection Agency
(“EPA”) or any substances, materials, elements or compounds affected by any other federal, state or local statute, law,
ordinance, code, rule, regulation, order or decree (collectively, “Environmental Law”) now or at any time hereafter
in effect, regulating, relating to, or imposing liability or standards of conduct concerning any hazardous, toxic, dangerous,
restricted or otherwise regulated waste, substance or material. As used in this Section, “Environmental Cleanup Work”
shall mean any cleanup, re-mediation, removal, construction, alteration, demolition or installation that is required in connection
with Hazardous Substances installed, used, stored, handled or located on the Premises or Elm Road Medical Campus in order to comply
with any Environmental Law.

 

(ii)         Upon
reasonable inquiry and investigation, Landlord has received no notice of, nor is the Landlord aware of, the existence of any areas
in the Elm Road Medical Campus where any Hazardous Substances have been generated, disposed of, released or found, and the Landlord
has no knowledge of the existence of any such areas for the storage or disposal of any Hazardous Substances in the Elm Road Medical
Campus.

 

(iii)        Upon
reasonable inquiry and investigation, Landlord is not aware of any storage tanks located in the Elm Road Medical Campus, either
above or below ground, and the Landlord has no knowledge that the Elm Road Medical Campus was previously used as a landfill or
as a dump for garbage or refuse.

 

(iv)        Unless
occasioned by the actions of Tenant, its agents, employees or independent contractors, Landlord shall indemnify, defend, protect
and hold harmless Tenant (and anyone claiming by, through, or under Tenant) from and against any and all claims, liabilities,
damages, losses, costs, and expenses (including reasonable attorneys’ fees and court costs) actually incurred by Tenant or anybody
claiming by, through, or under Tenant as a result of the existence of any Hazardous Substances on the Elm Road Medical Campus
or any environmental problems relating to the Elm Road Medical Campus; it being agreed and understood that this indemnity shall
specifically survive the expiration or earlier termination of this Lease.

 

    	 	33	 

     

    

 

(v)         Tenant
agrees that it will not use any Hazardous Substances in the Premises in violation of any governmental laws, ordinances or
restrictions. Tenant shall indemnify, defend, protect and hold harmless Landlord (and anyone claiming by, through, or under
Landlord) from and against any and all claims, liabilities, damages, losses, costs, and expenses (including attorneys’ fees
and court costs) actually incurred by Landlord or anybody claiming by, through, or under Landlord as a result of Tenant’s use
of any Hazardous Substances in the Premises in violation of any governmental laws, ordinances or restrictions unless said
Hazardous Substances or environmental problems existed in the Premises prior to the date of this Lease or were caused by acts
of Landlord, its agents, employees or contractors in which event this indemnity shall not apply; it being agreed and
understood that this indemnity shall specifically survive the expiration or earlier termination of this Lease.

 

18.17       Communication
Dish: Tenant shall have the right to place a single communication /satellite dish on the roof of the Premises but preferably
a ground mount dish, if possible, for the purpose of transmitting business information within the Premises (the “Communication
Dish”) which shall be for Tenant’s sole use only. No Communication Dish may exceed three (3) feet in diameter nor
shall it be permitted to exceed five (5) feet in height from the lowest point of the roof, including any mounting mast or tower.
In any event, any Communication Dish shall be located so as to be effectively unnoticeable from the public right-of-way or from
adjoining property. Prior to installation, Tenant shall give Landlord notice of the installation, maintenance and use of the Communication
Dish. Tenant shall be responsible for the cost of installation, maintenance and removal of the Communication Dish.

 

Tenant’s Communication Dish shall
be considered Tenant’s Property under this Lease. Any damage by fire or any other casualty to the Communication Dish shall be
at Tenant’s sole risk and expense, and any such damage, whether partial or complete, shall in no way operate to terminate this
Lease or affect Tenant’s obligations hereunder. No taking or condemnation of the roof or other parts of the Elm Road Medical
Campus used in connection with the Communication Dish shall give rise to any right of Tenant to terminate this Lease, nor shall
Tenant share with Landlord in any award or damages with respect thereto, unless the Communication Dish is included in the condemnation
or taking. If permitted by the condemning authority, Tenant shall be permitted to remove its Communication Dish prior to the effective
date of any such condemnation.

 

Tenant agrees to pursue receipt of all
approvals from all governmental authorities in connection with the installation, operation and maintenance of the Communication
Dish, and to assume the costs of securing such approvals. Tenant shall use reasonable efforts not to install or operate or permit
anyone claiming by, through or under Tenant to install or operate antennae, communications dishes or other equipment on the roof
which will interfere with the use or operation (including the reception and transmission of signals to and from the same) of other
antennae or communications dishes in the Elm Road Medical Campus which were installed prior to the date of Tenant’s installation
of Tenant’s Communication Dish.

 

18.18       Generator/Alternative
Power Source: Landlord shall install a generator as an alternative power source for the building as required by Indiana
Code for Hospitals (410 IAC 15-1.5-8).

 

    	 	34	 

     

    

 

18.19       Triple
Net Lease: This Commercial Lease is a triple net lease, and the net rents, additional rents in the form of taxes, assessments,
insurance premiums and maintenance expenses, and all other sums payable under this Lease to Landlord shall be paid by Tenant without
notice or demand and without setoff, counterclaim, abatement, reduction or defense.

 

ARTICLE XIX

 

LANDLORD’S ADDITIONAL COVENANTS

 

19.1         Landlord
covenants and agrees that its construction loan and permanent loan agreements and the documents evidencing those agreements shall
provide that Tenant shall be given at least ten (10) days notice and opportunity to cure any default by Landlord in the event
Landlord shall fail to cure a default. In the event Tenant shall elect to cure a default by Landlord, Landlord agrees that Tenant
may offset the cost of said cure against the Rent payable to Landlord pursuant to this Lease.

 

19.2         Prior
to Tenant’s obligation to take possession of the Premises on the Turnover Date and commence the payment of Rent pursuant
to this Lease, Landlord shall deliver to Tenant a valid, signed and recorded amendment to the Declaration, in a form acceptable
to Tenant (which acceptance shall not be unreasonably withheld, conditioned or delayed), providing that (a) Common Areas and Common
Area Costs shall be as provided in this Lease; (b) the Tenant’s share of Common Area Costs shall be calculated as provided
in this Lease; and (c) the Declaration may not be altered, amended or terminated without the prior written consent of Tenant so
long as this Lease remains in full force and effect.

 

19.3         Prior
to Tenants obligation to take possession of the Premises on the Turnover Date and commence the payment of Rent pursuant to this
Lease, Landlord shall deliver to Tenant a valid, signed and recorded restriction, in a form acceptable to Tenant (which acceptance
shall not be unreasonably withheld, conditioned or delayed), applicable to all lots within Elm Road Medical Campus prohibiting
the use of any lot therein for Tenant’s exclusive use as an inpatient rehabilitation hospital (so long as Tenant is operating
the Premises as an inpatient rehabilitation hospital), said restriction being enforceable by Landlord and Tenant.

 

IN WITNESS WHEREOF this Lease has
been executed as of the day and year first above written.

 

	 	LANDLORD:
	 	 
	 	ELM ROAD MOB II, LLC
	 	An Indiana limited liability
    corporation
	 	 
	 	By:	/s/ J.
    Michael Kelbel
	 	 	J. Michael Kelbel, M.D.
	 	Its: 	President

 

    	 	35	 

     

    

 

	 	TENANT:
	 	 
	 	SAINT JOSEPH REGIONAL MEDICAL CENTER—SOUTH BEND CAMPUS, INC.,

                    an Indiana not for profit corporation

	 	 
	 	By:	/s/ Nancy R. Hellyer
	 	 	Nancy R. Hellyer
	 	Its: 	President and Chief Executive Officer

 

GUARANTY OF LEASE

 

The undersigned, Saint
Joseph Regional Medical Center, Inc., the parent company of Tenant, Saint Joseph Regional Medical Center—South Bend Campus, Inc.,
hereby absolutely and unconditionally guarantees the prompt performance and payment in full of all obligations of Tenant under
this Lease as and when they become due and payable. If the obligations are not performed and/or paid when due and payable, Landlord
shall have the right to proceed directly against Saint Joseph Regional Medical Center, Inc, to enforce and/or collect the payment
of the obligations. This is a guaranty of payment and not merely a guaranty of collection and Saint Joseph Regional Medical Center,
Inc. waives any suretyship defense, generally.

 

This guaranty shall
bind Saint Joseph Regional Medical Center, Inc. and its successors and assigns and shall inure to the benefit of Landlord and
its successors and assigns, including each successor without any further consent or agreement by Saint Joseph Regional Medical
Center, Inc,

 

Executed as of the 28 day of February,
2009.

 

	 	SAINT JOSEPH REGIONAL MEDICAL
    CENTER, INC.,
	 	an Indiana not for profit corporation
	 	 
	 	By:	/s/ Nancy R. Hellyer
	 	 	Nancy R. Hellyer
	 	Its: 	President and Chief Executive Officer

 

    	 	36	 

     

    

 

LEASE AMENDMENT

 

THIS FIRST AMENDMENT
TO LEASE (“Amendment”), is made and entered into as of the 28thday of March 2013, between ELM Road MOB II, LLC (“Landlord”),
and Saint Joseph Regional Medical Center- South Bend Campus, Inc. (“Tenant”).

 

WHEREAS, Landlord
and Tenant are parties to that certain Build to Suit Facility Lease Agreement (the “Lease”) dated February 27, 2009,
with respect to property described as Lot Numbered Three (3) as shown on the Recorded Plat of Elm Road Medical Campus, Recorded
November 16, 2007 as Document Number 0745026 in the Office of the Recorder of St. Joseph County, Indiana (the “Property”);
and

 

WHREAS, the
Property is subject to that certain Declaration of Protective Covenants & Restrictions for Elm Road Medical Campus dated as
of December 20, 2007 and recorded as Document Number 0749133 in the Office of the Recorder of St. Joseph County, Indiana, as amended
by Document Number 0802055 recorded January 18, 2008 in the Office of the Recorder of St. Joseph County, Indiana, First Amendment
to the Declaration of Protective Covenants & Restrictions for Elm Road Medical Campus dated December 3, 2009 and recorded
as Document Number 0939788 in the Office of the Recorder of St. Joseph County, Indiana, and by Second Amendment to the Declaration
of Protective Covenants & Restrictions for Elm Road Medical Campus dated of even date herewith and to be recorded in the Office
of the Recorder of St. Joseph County, Indiana (the “Declaration”) created by Elm Road Medical Campus, LLC (the “Developer”);
and

 

WHEREAS, Landlord is an affiliate
of the Developer; and

 

WHEREAS, the
Lease contains certain provisions concerning the common areas of the Elm Road Medical Campus (as such term is defined in the Declaration)
which are not subject to the control of Landlord, but rather Landlord and Tenant agree that such provisions are more appropriately
governed by the Declaration; and

 

WHEREAS, Landlord
has agreed to sell the Property to TST Mishawaka IRF, LLC (“New Landlord”), and in order to facilitate such transaction
Landlord and Tenant have agreed to execute this Amendment;

 

NOW, THEREFORE,
in consideration of the premises, Landlord and Tenant hereby agree as follows:

 

1.          Common
Area Costs:The definition of Common Area Costs in Section 1.2 of the Lease is hereby amended by inserting the
following after the phrase ‘implement the foregoing maintenance’ in the tenth (10th) line thereof:
‘and Tenant’s Percentage Share of Real Estate Taxes and Insurance.’ Such definition is further amended by
deleting the phrase ‘Tenant’s Percentage Share of Real Estate Taxes or Insurance (which are provided for by
separate agreement herein)’ from lines 16 – 17 thereof.

 

2.          Tenant’s
Percentage Share: The definition of Tenant’s Percentage Share in Section 1.13 of the Lease is hereby amended in its
entirety to read as follows:

 

     

     

    

 

“Tenant’s Percentage
Share shall be the percentage share applicable to the Premises pursuant to the Declaration for the payment of assessments and
will be the percentage obtained by dividing the total acres of the Premises, which equals 6.40 acres, by the total acres of Developed
Lots in the Elm Road Medical Campus. The term ‘Developed Lots’ shall mean those lots which contain building(s) erected
on the Elm Road Medical Campus which are leased or available for lease or occupied or available for occupancy.”

 

3.          Construction:
Tenant acknowledges that it has accepted the Premises, and that the provisions of Sections 4.1 — 4.7 and 4.10 - 4.11 are
hereby deleted in their entirety.

 

4.          Exclusive
Use: Section 5.3 is hereby deleted in its entirety. Tenant agrees that Landlord does not control use of the Elm Road Medical
Campus, and that it shall look to the provisions of the Declaration with respect to this issue,

 

5.          Subletting
and Assignment: Section 5.4 is hereby amended to insert the following at the end of Section 5.4.

 

“Upon assignment
by Tenant, the Lease Guaranty shall remain in full force and effect and shall not be released, discharged or in any way affected
by such assignment and, at the request of Landlord, Guarantor shall execute a ratification of the Guaranty.”

 

6.          Use,
Maintenance and Repair of Common Areas:Tenant acknowledges that Landlord does not own or control the operation and maintenance
of the common areas of the Elm Road Campus, and that the obligations with respect to use, maintenance and repair of such common
areas described in Sections 7.1 and 7.2 of the Lease are obligations of the Owners Association, as defined in the Declaration.
Sections 7.1 and 7.2 are hereby deleted in their entirety from the Lease. To the extent of its rights under the Declaration, Landlord
shall use commercially reasonable efforts to enforce compliance with the Declaration by the Owners Association.

 

7.          Insurance
Obligation for Elm Road Medical Campus: Sections 9.1 and 9.2 of the Lease are hereby deleted in their entirety, and Landlord
shall have no obligation with respect to providing general liability or property damage insurance with respect to any portion
of the Elm Road Medical Campus. Landlord may be assessed with the cost of such insurance as a member of the Owners Association,
and Tenant shall reimburse Landlord for such costs pursuant to Section 7.3 of the Lease. In addition, the phrase ’Section
9.1 and’ is hereby deleted from lines 9 and 13 of Section 9.3 of the Lease, and the phrase ’Sections 9.1 and’ is hereby
deleted from line 2 of Section 9.4 of the Lease.

 

8.          Damage
and Destruction to the Common Areas: Section 10.2 of the Lease is hereby deleted in its entirety and “or the Elm Road
Medical Campus” is hereby deleted from the second line of Section 10.2.1.

 

     

     

    

 

9.          Subordination
and Attornment: Sections 12.1 and 12.2 are hereby replaced with the following:

 

“12.1 Subordination:
Tenant shall, upon the written request of Landlord, subordinate this Lease to the lien of any present or future mortgage upon
the Premises, provided that the holder of any such mortgage (the “Mortgagee”) shall enter into a written agreement
including an agreement that Tenant shall not be disturbed in its possession of the Premises as provided in this Lease so long
as Tenant complies with the terms and conditions of this Lease, in a form and substance approved by Tenant which approval shall
not be unreasonably withheld, conditioned or delayed. As used herein, “mortgage” shall include mortgages, deeds of
trust, deeds to secure debt or other similar instrument, and any modifications, extensions, renewals and/or replacements thereof.
Tenant approves the form of subordination, nondisturbance and attornment agreement attached hereto as Exhibit ‘A’”

 

“12.2  Attornment:
Should Landlord sell, convey or transfer its interest in the Premises or should any Mortgage succeed to Landlord’s interest
through foreclosure or deed in lieu thereof, then Tenant shall attorn to such succeeding party as its landlord under this Lease
promptly upon any such succession, provided that such succeeding party assumes, in a writing acceptable to tenant in its reasonable
judgment, all of Landlord’s duties and obligations under this Lease.”

 

10.          Estoppel:
Article XII is hereby amended by adding new Section 12.3 thereto reading as follows:

 

“12.3
Estoppel: Upon request of Landlord, Tenant shall execute and deliver to Landlord or any proposed Purchaser or
Mortgagee of the Property an Estoppel Certificate in substantially the form set forth as Exhibit ‘B’
hereto.”

 

11.         Hazardous
Substances on Elm Road Medical Campus: Section 18.16(iv) of the Lease is hereby amended by deleting the phrase ‘Elm
Road Medical Campus’ from lines 7 and 8 thereof, and inserting in lieu thereof the term ‘Premises.’

 

12.         Landlord’s
Additional Covenants: Sections 19.2 and 19.3 of the Lease are hereby deleted in their entirety.

 

13.         Financial
Statements: If required by Landlord’s mortgagee, as soon as available, and in any event within one hundred twenty (120)
days after each calendar year end, Tenant shall deliver to Landlord company prepared financial statements of Tenant and Saint
Joseph Regional Medical Center, Inc. (“Guarantor”) setting forth the balance sheet of each such entity as of the end
of such year, and the statement of income, statement of cash flows, and statement of retained earnings for such year, all certified
as being true and accurate by an authorized individual representing Tenant and Guarantor.

 

14.         No
Further Modifications. Except as set forth in this Amendment, all of the terms and provisions of the Lease shall remain unmodified
and in full force and effect. Effective as of the date hereof, all references to the “Lease” shall refer to the Lease
as amended by this Amendment. In the event of any conflict between the terms of the Lease and the terms of this Amendment, the
terms of this Amendment shall control.

 

15.         Successors
and Assigns. This Amendment shall be binding upon and inure to the benefit of Landlord, Tenant and their respective successors
and permitted assigns.

 

     

     

    

 

16.         Counterparts;
Facsimile. This Amendment may be executed in any number of counterparts, each of which shall be an original and all of which
taken together shall constitute one and the same instrument. The parties agree that (a) this Amendment may be transmitted between
them by facsimile or pdf, (b) faxed or pdf signatures constitute original signatures, (c) a faxed or pdfed Amendment containing
the signatures of all the parties is binding on the parties, and (d) facsimile or pdf transmission constitutes delivery.

 

IN WITNESS HEREOF, this Amendment
has been executed as of the day and year first above written.

 

	 	LANDLORD:
	 	 
	 	ELM ROAD MOB II, LLC
	 	 
	 	By:	/s/ J. Michael Kelbel     
	 	Name:	J. Michael Kelbel,     MD.
	 	Its: 	President
	 	 	 
	 	TENANT:
	 	 
	 	Saint Joseph Regional Medical Center-South Bend Campus, Inc.
	 	 
	 	By:	/s/ Janice L. Dunn
	 	Name:	Janice L. Dunn
	 	Its:	CFO

 

     

     

    

 

GUARANTOR ACKNOWLEDGMENT

 

The undersigned, being
the guarantor of the obligations of Tenant under the Lease pursuant to that certain Guaranty of Lease dated February 27, 2009
executed by Guarantor in favor of Landlord, acknowledges the terms and conditions of this Amendment and that its Guaranty of Lease
remains in full force and effect in favor of Landlord and is hereby ratified and confirmed.

 

	 	Saint Joseph Regional Medical Center,
    Inc.
	 	 
	 	By:	/s/ Janice L. Dunn
	 	 	Janice L. Dunn
	 	Its: 	CFO

 

     

     

    

 

CONSENT, SUBORDINATION,

NON-DISTURBANCE, AND ATTORNMENT AGREEMENT

 

THIS CONSENT,
SUBORDINATION, NON-DISTURBANCE, AND ATTORNMENT AGREEMENT (this “Agreement”) is made and entered into as of
March 28, 2013, by and among SAINT JOSEPH REGIONAL MEDICAL CENTER - SOUTH BEND CAMPUS, INC, a Indiana not for profit corporation
(“Tenant”), TST MISHAWAKA IRF, LLC, a Delaware limited liability company (the “Landlord”),
and FIRST TENNESSEE BANK, NATIONAL ASSOCIATION, a national banking association (“Lender”).

 

WITNESSETH:

 

A.          The
Tenant is the tenant under a Lease dated February 27, 2009 executed by Elm Road MOB, 11, LLC, as landlord, as assigned to Landlord
pursuant to an assignment of even date herewith, and Tenant, covering the property commonly known as Lot 3 of the Elm Road Medical
Campus, which includes a 45,920 sq.ft. medical office building and is more particularly described in the Lease (as such may be
amended and/or restated from time to time, the “Lease”).

 

B.           Lender
has committed to extend credit to Landlord (the “Loan”), secured by the Property as evidenced by a first mortgage
lien and security interest against the Property, which mortgage lien and security interest will be evidenced by certain documentation
approved by Lender and executed between the Landlord and Lender (the “Security Instrument”).

 

C.           As
a condition to the extension of credit under the Loan, the Lender requires that the Landlord and the Tenant enter into this Agreement.

 

NOW THEREFORE, in
consideration of the mutual promises and covenants of the parties hereto, and for other good and valuable consideration, the receipt
and sufficiency of all of which are hereby acknowledged, the parties hereto mutually covenant and agree as follows:

 

1.           Consent.
The Tenant consents to the execution of the Security Instrument by Landlord, and the Tenant consents to the assignment of the
Lease to Lender as collateral pursuant to that certain Collateral Assignment of Rents and Leases executed of even date herewith
by Landlord and Lender.

 

2.           Subordination.
Tenant hereby subordinates all of its right, title and interest in, to, and under the Lease to the lien and security interest
to be evidenced by the Security Instrument, and acknowledges and agrees that the Lease shall at all times hereafter be subject
and subordinate in all respects to the Security Instrument and to all renewals, modifications and extensions thereof, subject
to the terms and conditions of this Agreement.

 

3.           Non-Disturbance
of Tenant’s Possession. So long as Tenant is not in default in the payment of rent, additional rent, or other charges,
or in the performance of any of the other terms, covenants or conditions of the Lease, Tenant shall not be disturbed by Lender
in Tenant’s occupancy of the Demised Premises during the original or any renewal term of the Lease or any extension thereof;
foreclosure of the Security Instrument, exercise of the power of sale thereunder, acceptance of a deed in lieu of foreclosure,
or exercise of any remedy provided in the Security Instrument or in any assignment of leases and rents in favor of Lender or pursuant
to the laws of the state in which the Property is situated notwithstanding.

 

EXHIBIT A

 

    	 	- 1 -	 

     

    

 

4.           Notice
to Lender; Lender’s Cure. Notwithstanding any provision in the Lease to the contrary, no default in the performance
of any of Landlord’s obligations under the Lease that is of such a nature as to give Tenant a right to terminate the Lease
or to reduce the rent payable under the Lease or to any credit, reduction or offset against future rents shall entitle Tenant
to exercise any such right, power or remedy unless and until written notice of such default is given to Lender (in accordance
with the timeframes set forth in Section 14.2 of the Lease and with such notice being provided concurrent with notice to
the Landlord as provided therein) and unless and until ten (10) days shall have elapsed following receipt of such notice by Lender,
during which period Lender shall have the right, but not the obligation, to remedy or cure such default; provided, however, that
if such default cannot be cured within ten (10) days, then Lender shall have such longer period of time as may be reasonably necessary
to cure such default so long as Lender pursues the cure of same with due diligence.

 

5.           Lender’s
Obligations. No person or entity who exercises a right arising under the Security Instrument or any assignment of the Lease
or receives the rents payable by Tenant under the Lease shall thereby become obligated to Tenant for the performance of any of
the terms, covenants, conditions and agreements of Landlord under the Lease. Landlord and Tenant agree that Tenant shall make
all payments to be made by Tenant under the Lease to such person or entity upon receipt of written notice of the exercise of such
right. Receipt of rent by such other person shall not relieve Landlord of its obligations under the Lease, and Tenant shall continue
to look only to Landlord for performance thereof.

 

6.           Special
Rights of Lender. In addition  to and not in lieu of any other provisions of this Agreement, Lender shall not in any way
or to any extent be:

 

(a)          liable
for any act or omission of any landlord (including Landlord) in contravention of any provision of the Lease; or

 

(b)          subject
to any offsets or defenses that Tenant might have against any prior landlord (including Landlord) which accrues prior to acquisition
of title to the Demised Premises by Lender; or

 

(c)          bound
by any rent or additional rent that Tenant might have paid for more than thirty (30) days in advance to any prior landlord (including
Landlord); or

 

(d)          bound
by any agreement or modification of the Lease made without Lender’s written consent; or

 

(e)          in
any way responsible for any deposit or security that was delivered to Landlord but which was not subsequently delivered to Lender.

 

7.           Attornment.
Tenant agrees that if Lender acquires title to the Property as a result of foreclosure of the Security Instrument, exercise of
the power of sale thereunder or the acceptance of a deed in lieu of foreclosure, or if Lender obtains control of the Property
pursuant to any other rights, powers or remedies contained in the Security Instrument, any assignment of leases and rents in favor
of Lender, or the laws of the state in which the Property is situated, Tenant will, upon request of Lender or any other person
or entity succeeding to the interest of Lender as a result of the exercise of any such right, power or remedy, automatically become
the lessee or tenant of Lender or such successor in interest, without any change in the terms and provisions of the Lease, and
Tenant will, upon request of Lender or said successor in interest, deliver an instrument or instruments in recordable form, confirming
such attornment.

 

8.           Representations,
Warranties, and Covenants of Tenant. Tenant, in order to induce Lender to enter into this Agreement, hereby affirms that:

 

(a)          the
Lease is in full force and effect and has not been modified or amended;

 

    	 	- 2 -	 

     

    

 

(b)          to
the best of Tenant’s knowledge, Landlord is not in default in performanceof any of Landlord’s obligations under
the Lease;

 

(c)          to
the best of Tenant’s knowledge, Tenant has no present right of offset against any rent dueor to become due under the
Lease;

 

(d)          Tenant
will not materially amend or modify the Lease without the prior written consent of Lender which consent shall not be unreasonably
withheld or delayed; and

 

(e)          upon
the occurrence of an Event of Default under the Security Instrument, Lender may, at its option but without obligation, notify
Tenant in writing of the occurrence of such Event of Default and direct Tenant to make all future payments of the rents, issues
and profits and any other sums due under the Lease (“Rent Payments”) directly to Lender or its assignee (the “Default
Notice”). Landlord hereby directs Tenant, and Tenant hereby agrees, to make all Rent Payments directly to Lender or
assignee following Tenant’s receipt of a Default Notice. The parties hereto hereby agree that Tenant shall have no obligation
to determine the accuracy of the statements set forth in a Default Notice and Tenant shall be permitted to rely on correctness
of the statements contained in a Default Notice without further inquiry.

 

9.           Notices.
All communications under or in connection with this Agreement shall be in writing and shall be mailed by first class certified
mail, postage prepaid, return receipt requested or shipped with a reputable overnight courier that provides written confirmation
of receipt, or otherwise sent by facsimile, telecopy or other similar form of rapid transmission confirmed by mailing (in either
manner stated above) a written confirmation at substantially the same time as such rapid transmission, or personally delivered
to an officer or partner of the receiving party. All such communications shall be mailed, sent, or delivered as follows:

 

	If to Tenant:	Saint Joseph Regional Medical
    Center — South
	 	Bend Campus, Inc.
	 	801 E. LaSalle Avenue
	 	South Bend, IN 46617
	 	 
	if to Lender to:	First Tennessee Bank, National Association
	 	511 Union Street
	 	Nashville, TN 37219
	 	Attn: Cathy Wind
	 	 
	with copy to:	Bradley Arant Boult Cummings LLP
	 	1600 Division Street, Suite 700
	 	Nashville, TN 37203
	 	Attn: Bob Hannon

 

or to such other address or to
such individual’s or department’s attention as Lender may have furnished Tenant and Landlord in writing.

 

	If to Landlord, to:	 TST Mishawaka IRF,
    LLC
	 	1000 Urban Center Dr., Suite 675
	 	Birmingham, AL 35242
	 	Attn: Steve Hewett

 

    	 	- 3 -	 

     

    

 

	With copy to:	Michael J. Brandt
	 	Wallace, Jordan, Ratliff & Brandt, LLC
	 	800 Shades Creek Parkway, Suite 400
	 	Birmingham, AL 35209

 

Any communication
so addressed and mailed shall be deemed to be given when so mailed. Rejection or other refusal to accept or inability to deliver
because of a changed address of which no notice has been given shall have no effect on a communication properly sent.

 

10.         Miscellaneous.
This Agreement shall be binding upon and inure to the benefit of the parties and their respective heirs, successors and assigns.
Numbered and titled paragraph headings are for convenience of reference only, and neither amplify nor limit the provisions hereof.
When used herein, the singular shall include the plural, and vice versa, and the use of any gender shall include all other genders.
If any provision of this Agreement or the application thereof to any person or circumstance shall be held invalid or unenforceable
to any extent, the remainder of this Agreement and the application of such other provisions to other persons or circumstances
shall not be affected thereby and shall be enforced to the greatest extent permitted by law.

 

[signatures commence on
next page]

 

    	 	- 4 -	 

     

    

 

IN WITNESS
WHEREOF, the parties hereto have executed this Agreement, or caused this Agreement to be executed by a duly authorized officer,
as of the day and year first above written.

 

	 	TENANT:
	 	 
	 	SAINT JOSEPH REGIONAL MEDICAL
    CENTER —      SOUTH BEND CAMPUS, INC.
	 	 
	 	By:	             
	 	 
	 	Title:	 
	 	 
	 	LANDLORD:
	 	 
	 	TST MISHAWAKA IRF, LLC
	 	 
	 	By:	 
	 	 
	 	Title:	 
	 	 
	 	LENDER:
	 	 
	 	FIRST TENNESSEE BANK, NATIONAL ASSOCIATION
	 	 
	 	By:	 
	 	 	Cathy Wind, Senior Vice President

 

	STATE OF INDIANA 	)	 
	COUNTY OF _______________________	)	 

 

Before me, _______________________,
the undersigned, a Notary Public in and for the County and State aforesaid, personally appeared ___________________, with whom
I am personally acquainted (or proved to me on the basis of satisfactory evidence), and who, upon oath, acknowledged himself/herself
to be _____________________ of Saint Joseph Regional Medical Center — South Bend Campus, Inc., an Indiana not for profit
corporation, the within named bargainor, and that as such ____________________ of the corporation, he/she, being authorized so
to do, executed the foregoing instrument for the purposes therein contained, by signing the name of the corporation by himself/herself
as such ___________________ for the corporation.

 

WITNESS my hand and
seal at office in ___________________, Indiana, this the day of March, 2013.

 

	 	 
	 	Notary Public
	 	My Commission Expires:	 

 

(Signature Page to Consent, Subordination,
Non-Disturbance and Attornment Agreement – page 1 of 2)

 

    	 	- 5 -	 

     

    

 

	STATE OF ALABAMA	)	 
	COUNTY OF _______________________	)	 

  

I, the undersigned
authority, a Notary Public in and for said county in said State, hereby certify that ___________________, whose name as ______________________
of TST Mishawaka 1RF, LLC, a Delaware limited liability company, is signed to the foregoing instrument and who is known to me,
acknowledged before me on this day that, being informed of the contents of said instrument, he, as such authorized representative
and with full authority, executed the same voluntarily for and as the act of said limited liability company.

 

Given under my hand and official seal, this _________________
day of March, 2013.

 

	 	 
	 	Notary Public
	 	My Commission Expires:	 

 

	STATE OF TENNESSEE	)	 
	COUNTY OF _______________________	)	 

  

Before me, _____________________________
, the undersigned, a Notary Public in and for the County and State aforesaid, personally appeared Cathy Wind, with whom
I am personally acquainted (or proved to me on the basis of satisfactory evidence), and who, upon oath, acknowledged herself to
be Senior Vice President of First Tennessee Bank, National Association, a national banking association, the within named bargainor,
and that as such Senior Vice President of the national banking association, she, being authorized so to do, executed the foregoing
instrument for the purposes therein contained, by signing the name of the national banking association by herself as such Senior
Vice President for the national banking association.

 

WITNESS my hand and seal at office in _______________,
Indiana, this the ______________ day of March, 2013.

 

	 	 
	 	Notary Public
	 	My Commission Expires:	 

 

(Signature Page to Consent, Subordination,
Non-Disturbance and Attornment Agreement – page 2 of 2)

 

    	 	- 6 -	 

     

    

 

TENANT ESTOPPEL CERTIFICATE

 

	Tenant:	Saint Joseph Regional Medical
    Center – South Bend Campus, Inc.
	 	 
	Lease Effective Date:	February 27, 2009
	 	 
	Lease Term:	Fifteen (15) years after Commencement Date (_______________), plus two Tenant option five (5) year extensions
	 	 
	Property:	Lot 3 of the Elm Road Medical Campus, which
    includes a 45,920 sq.ft. medical office building

 

As of March 15, 2013, the undersigned
Tenant under the above-referenced Lease, certifies to TST Mishawaka IRF, LLC (the “Owner”) and First Tennessee
Bank, National Association (the “Lender”) as followswith respect to the Lease:

 

		1.	The Lease is the
                                         only lease affecting said premises and has not beenamended, modified, changed altered
                                         or supplemented, except as shown above. The above information is true and correct.

 

		2.	The Lease is in
                                         full force and effect and to Tenant’s knowledge there are no defaults by Landlord
                                         thereunder or any conditions which with only the passage of time or giving of notice
                                         or both would become a default by Landlord under the terms of said Lease.

 

		3.	As of the date
                                         of this Certificate, monthly Minimum Rent is $___________ per month. No Rent has been prepaid under
                                         the Lease more than one (1) month in advance and all Rent has been paid through the date
                                         of _____________.

 

		4.	Tenant currently
                                         pays Landlord $__________ per month for charges other than Minimum Rent, including real estate
                                         tax pass throughs, which are due and payable under the Lease, Such payments have notbeen
                                         made for any period more than one (1) month in advance and all such charges have been
                                         paid through the date of _____________.

 

		5.	No rents have been
                                         prepaid except as provided by said Lease, but in no event have rents been paid more than
                                         thirty (30) days in advance and that there are no offsets or credits against future accruing
                                         rents.

 

		6.	Landlord and Tenant
                                         have fulfilled and complied with all conditions precedent to the acceptance and possession
                                         of the Premises by Tenant and any and all improvements and space required to be furnished
                                         by Landlord to the undersigned by the terms of the Lease have been completed to the full
                                         satisfaction of Tenant.

 

		7.	Tenant is open
                                         and operating and in full and complete possession of the premises demised pursuant to
                                         the terms of said Lease. The demised premises satisfy the requirements of said Lease
                                         and have been accepted and approved in all respects by Tenant.

 

		8.	All duties of an
                                         inducement nature and all inducement clauses have been fulfilled by Landlord.

 

		9.	As of the date
                                         of this Certificate, there are no monetary amounts currently owing to Tenant by Landlord
                                         which have not been paid except the following: None

 

		10.	Tenant has received
                                         no notice of a prior sale, transfer, assignment, hypothecation or pledge of said Lease
                                         or of the rents secured therein.

 

		11.	Saint Joseph Regional
                                         Medical Center, Inc. guarantees the prompt performance and payment in full of all obligations
                                         of Tenant under the Lease. Said guaranty is in full force and effect, and has not been
                                         amended or modified.

 

EXHIBIT B

 

    	 	1	 

     

    

 

The undersigned understands and acknowledges
that Owner is relying on this Certificate in purchasing the Premises and Lender will rely on this Certificate in making a mortgage
loan and. that in connection with said loan, Owner’s interest in the Lease is being assigned to Lender as additional security
for the Loan and the undersigned has the authority to execute and deliver this Estoppel Certificate on behalf of Tenant.

 

	 	TENANT:
	 	 
	 	SAINT JOSEPH REGIONAL MEDICAL CENTER
    – SOUTH BEND CAMPUS, INC.
	 	 
	 	By:	        
	 	 
	 	Title:	 

 

    	 	2	 

     

    

 

TENANT ESTOPPEL CERTIFICATE

 

	Tenant:	Saint Joseph Regional Medical
    Center – South Bend Campus, Inc.
	 	 
	Lease Effective Date:	February 27, 2009
	 	 
	Lease Term:	Fifteen (15) years after Commencement Date (
    ______ ), plus two Tenant option five (5) year extensions
	 	 
	Property:	Lot 3 of the Elm Road Medical Campus, which
    includes a 45,920 sq.ft. medical office building

 

As of March 15, 2013, the undersigned
Tenant under the above-referenced Lease, certifies to TST Mishawaka IRF, LLC (the “Owner”) and First Tennessee
Bank, National Association (the “Lender”) as followswith respect to the Lease;

 

		1.	The Lease is the
                                         only lease affecting said premises and has not been amended, modified, changed, altered
                                         or supplemented, except as shown above. The above information is true and correct.

 

		2.	The Lease is in
                                         full force and effect and to Tenant’s knowledge there are no defaults by Landlord
                                         thereunder or any conditions which with only the passage of time or giving of notice
                                         or both would become a default by Landlord under the terms of said Lease.

 

		3.	As of the date
                                         of this Certificate, monthly Minimum Rent is $__________per month. No Rent has been prepaid
                                         under the Lease more than one (1) month in advance and all Rent has been paid through
                                         the date of ____________.

 

		4.	Tenant currently
                                         pays Landlord $_______ per month for charges other than Minimum Rent, including real estate
                                         tax pass throughs, which are due and payable under the Lease. Such payments have notbeen
                                         made for any period more than one (1) month in advance and all such charges have been
                                         paid through the date of _______________.

 

		5.	No rents have been
                                         prepaid except as provided by said Lease, but in no event have rents been paid more than
                                         thirty (30) days in advance and that there are no offsets or credits against future accruing
                                         rents.

 

		6.	Landlord and Tenant
                                         have fulfilled and complied with all conditions precedent to the acceptance and possession
                                         of the Premises by Tenant and any and all improvements and space required to be furnished
                                         by Landlord to the undersigned by the terms of the Lease have been completed to the full
                                         satisfaction of Tenant.

 

		7.	Tenant is open
                                         and operating and in full and complete possession of the premises demised pursuant to
                                         the terms of said Lease. The demised premises satisfy the requirements of said Lease
                                         and have been accepted and approved in all respects by Tenant.

 

		8.	All duties of an
                                         inducement nature and all inducement clauses have been fulfilled by Landlord.

 

		9.	As of the date
                                         of this Certificate, there are no monetary amounts currently owing to Tenant by Landlord
                                         which have not been paid except the following: None

 

		10.	Tenant has received
                                         no notice of a prior sale, transfer, assignment, hypothecation or pledge of said Lease
                                         or of the rents secured therein.

 

		11.	Saint Joseph Regional
                                         Medical Center, Inc. guarantees the prompt performance and payment in full of all obligations
                                         of Tenant under the Lease. Said guaranty is in full force and effect, and has not been
                                         amended or modified.

 

EXHIBIT B

 

    	 	1	 

     

    

 

The undersigned understands and acknowledges
that Owner is relying on this Certificate in purchasing the Premises and Lender will rely on this Certificate in making a mortgage
loan and that in connection with said loan, Owner’s interest in the Lease is being assigned to Lender as additional security
for the Loan and the undersigned has the authority to execute and deliver this Estoppel certificate on behalf of Tenant.

 

	 	TENANT:
	 	 
	 	SAINT JOSEPH REGIONAL MEDICAL CENTER
    – SOUTH BEND CAMPUS, INC.
	 	 
	 	By:	        
	 	 
	 	Title:	 

 

    	 	2Exhibit

Exhibit 10.42

AMENDED AND RESTATED EVG LICENSE AGREEMENT

  
JAPAN TOBACCO INC.
AND
GILEAD SCIENCES, INC.

As of November 29, 2018

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

    
 
        

AMENDED AND RESTATED EVG LICENSE AGREEMENT
THIS AMENDED AND RESTATED EVG LICENSE AGREEMENT (the “Agreement”) is made and entered into as of November 29, 2018 (the “A&R Execution Date”) by and between JAPAN TOBACCO INC., a Japanese corporation having its principal place of business at JT Building, 2-1 Toranomon, 2-chome, Minato-ku, Tokyo 105-8422, Japan (“JT”), and GILEAD SCIENCES, INC., a Delaware corporation having its principal place of business at 333 Lakeside Drive, Foster City, CA 94404, United States (“Gilead”).  JT and Gilead are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, JT has developed a proprietary anti-viral compound originally known as JTK-303 and now known as Elvitegravir or EVG, to be used in a product or products for the treatment of HIV; 
WHEREAS, the Parties entered into that certain License Agreement dated March 22, 2005 (such agreement as amended prior to the Amended Effective Date, the “Original Agreement”) governing the grant to Gilead of exclusive rights to Develop and Commercialize, for itself and its Affiliates certain formulations and dosages of Elvitegravir outside of Japan; 
WHEREAS, the Parties have entered into that certain Master Agreement as of the A&R Execution Date (the “Master Agreement”) pursuant to which JT is transferring the rights to the Products in Japan to Gilead and the Parties have agreed to expand Gilead’s territory under the Original Agreement to include Japan; and
WHEREAS, the Parties also intend to consolidate prior amendments into an amended and restated version of the Original Agreement;
NOW THEREFORE, based on the foregoing premises and the mutual covenants and obligations set forth below, the Parties agree as follows:
ARTICLE 1
DEFINITIONS

The following terms shall have the following meanings; capitalized terms used herein but not defined herein shall have the meaning set forth in the Master Agreement:
1.1    “A&R Execution Date” shall have the meaning set forth in the Preamble of this Agreement.
1.2    “ABC Schedules” shall mean the schedules included in Schedule 1.2.
1.3    “Access Countries” shall mean the countries listed on Schedule 1.2, as may be modified pursuant to this Agreement in accordance with Paragraph 4 of Schedule 6.2.

1

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(a)    “Access Group A Countries” shall have the meaning set forth on Schedule 1.2A, as may be modified pursuant to this Agreement in accordance with Paragraph 4 of Schedule 6.2.
(b)    “Access Group B Countries” shall have the meaning set forth on Schedule 1.2B, as may be modified pursuant to this Agreement in accordance with Paragraph 4 of Schedule 6.2.
(c)    “Access Group C Countries” shall have the meaning set forth on Schedule 1.2C, as may be modified pursuant to this Agreement in accordance with Paragraph 4 of Schedule 6.2.
1.4    “Affiliate” shall mean, except as provided below, an entity that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with JT or Gilead.  The term “control” as used in this definition means ownership of more than fifty percent (50%) of the voting interest in the entity in question or having otherwise the power to govern the financial and the operating policies or to appoint the management of an organization.
1.5    “Alliance Manager” shall have the meaning set forth in Section 2.3.
1.6    “Amended Effective Date” shall mean the Marketer Change Date.
1.7    “Ancillary Agreements” shall mean the meaning defined in the Master Agreement except excluding this Agreement.
1.8    “API” shall mean active pharmaceutical ingredients.
1.9    “Branded Products” shall mean the Products sold by Gilead or its Affiliates or Sublicensees other than Generic Versions.
1.10    “Calendar Quarter” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.11    “Change in Control” shall mean any sale of voting securities, any sale or purchase of assets, or any merger, consolidation or similar transaction that, directly or indirectly: (i) results in the transfer of substantially all of a Party’s assets that relate to or are engaged in the Commercialization of any Products to any Third Party; or (ii) results in any Third Party becoming an Affiliate of a Party.
1.12    “Combination Product” shall mean any Product in the form of a combination product that contains Compound in addition to one or more active pharmaceutical ingredients.
1.13    “Commercial Launch” shall mean, with respect to a Product, the first commercial sale of such Product to a Third Party occurring after Regulatory Approval for such Product.
1.14    “Commercialization Report” shall have the meaning set forth in Section 5.2(a).

2

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

1.15     “Commercialize” shall mean to promote, market, distribute, sell or provide product support for a Product (other than in connection with clinical trials of such Product), and “Commercializing” and “Commercialization” shall be interpreted accordingly.
1.16    “Component” shall mean an API component of a Combination Product.  For Stribild, Component shall mean FTC, TDF, EVG and COBI.  For Genvoya, Component shall mean FTC, TAF, EVG and COBI.
1.17    “Compound” shall mean (i) the compound now known as Elvitegravir or EVG, the chemical structure of which is shown in Schedule 1.17A; (ii) the salts, esters, hydrates, isomers, and metabolites of that compound; (iii) any other compounds claimed in or covered by a Valid Claim in the Patent(s) described on Schedule 1.17B; and (iv) crystalline forms of (i) through (iii).
1.18    “Confidential Disclosure Agreements” shall mean (i) the Confidential Disclosure Agreement between the Parties dated September 16, 2004, as amended by the Amendment to Confidential Disclosure Agreement dated October 29, 2004 and the Second Amendment to Confidential Disclosure Agreement dated February 1, 2005; (ii) the Confidential Disclosure Agreement between the Parties dated February 1, 2005 (JT as recipient); and (iii) the Confidential Disclosure Agreement between the Parties dated February 1, 2005 (Gilead as recipient).
1.19    “Confidential Information” shall mean (i) all information and materials, received by either Party from the other Party pursuant to the Original Agreement or this Agreement and (ii) all information and materials disclosed pursuant to the Confidential Disclosure Agreements or the Material Transfer Agreements, in each case other than that portion of such information or materials that:
(a)    is publicly disclosed by the disclosing Party, either before or after it becomes known to the receiving Party;
(b)    was known to the receiving Party, without obligation to keep it confidential, prior to when it was received from the disclosing Party, as evidenced by competent written proof;
(c)    is subsequently disclosed to the receiving Party by a Third Party lawfully in possession thereof without obligation to keep it confidential;
(d)    has been publicly disclosed other than by the disclosing Party and without breach of an obligation of confidentiality with respect thereto; or
(e)    has been independently developed by the receiving Party without the aid, application or use of Confidential Information, as evidenced by competent written proof.
Notwithstanding clause (i) above in this definition of Confidential Information, (A) any information or materials deemed to be Confidential Information of Gilead under the Master Agreement shall be considered Gilead’s Confidential Information hereunder rather than JT’s Confidential Information (even if it were JT’s Confidential Information under the Original Agreement) and (B) any information or materials deemed to be Confidential 

3

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Information of both Parties under the Master Agreement shall be considered the Confidential Information of both Parties hereunder rather than solely JT’s Confidential Information (even if it were JT’s Confidential Information under the Original Agreement).
1.20    “Control”, “Controls” and “Controlled” shall mean, with respect to a particular item of information or intellectual property right, that the applicable Party owns or has a license to such item or right and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such item or rights as provided for herein without violating the terms of any agreement or other arrangement with any Third Party, and without incurring material additional costs to procure such Third Party rights beyond those already incurred.
1.21    “Develop” shall mean the conduct of any pre-clinical, clinical or other studies or activities with respect to, or required for obtaining Regulatory Approval of, a Product (including, without limitation, quality assurance and quality control activities) or for Commercialization of a Product, along with any other clinical studies that may be conducted in accordance with this Agreement.  The terms “Developing” and “Development” shall be interpreted accordingly.
1.22    “Diligent Efforts” shall mean, with respect to a Party’s obligation under this Agreement to Develop or Commercialize a Product, the level of efforts required to carry out such obligation in a sustained manner consistent with the efforts a similarly situated pharmaceutical company devotes to a product of similar market potential, risk, profit potential and strategic value resulting from its own research efforts, based on conditions then prevailing.  [*].
1.23    “Dispute” shall have the meaning set forth in Section 15.1.
1.24    “Dollar” shall mean a United States dollar, and “$” shall be interpreted accordingly.
1.25    “Elvitegravir” or “EVG” or “JTK-303” have the meaning set forth in Section 1.17.
1.26    “EMA” shall mean the European Medicines  Agency, or any successor thereto, which coordinates the scientific review of human pharmaceutical products under the centralized licensing procedures of the EU.
1.27    “Emtriva” or “FTC” shall mean an enantiomeric mixture of emtricitabine (which is the (-) enantiomer of the chemical [*], in which the ratio of such (-) enantiomer to its (+) enantiomer is equal to or greater than [*], including without limitation the ratio of such enantiomers being [*].
1.28    “EU” shall mean the European Union.  For the purposes of this Agreement, in the event that any country leaves the European Union or a new country is formed from an existing country in the European Union, such country shall still be deemed to be a country within the European Union.
1.29    “Excluded Net Sales” shall mean Net Sales of Branded Products sold by Gilead or its Affiliates or Sublicensees for distribution solely within [*] and Net Sales [*].

4

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

1.30    “FDA” shall mean the United States Food and Drug Administration, or a successor thereto.
1.31     “GAAP” shall mean generally accepted accounting principles in the United States as consistently applied.
1.32    “Generic Licensee” shall mean a Sublicensee of Gilead or its Affiliate that has been granted a Generic License to make or sell API of EVG or Generic Versions under this Agreement  and that has been granted no other rights to Products, except that a Generic Licensee may be granted the right to distribute Branded Products solely within countries in the Generic Territory.  For clarity, unless otherwise expressly provided in this Agreement, both of the MPPF and any third party granted the sublicense from MPPF under Section 2 of Schedule 6.2 shall be deemed to be included in Generic Licensee.
1.33    “Generic Licenses” shall mean a sublicense by Gilead or its Affiliate of its rights granted under Article 6 of the Original  Agreement or Article 6 of this Agreement to a Generic Licensee to (i) sell Generic Versions solely within the Generic Territory, (ii) make Generic Versions in India from Qualified EVG API solely for the purpose of selling them in the Generic Territory, (iii) make Generic Versions in China from Qualified EVG API solely for the purpose of selling them in the Generic Territory, (iv) make Generic Versions in South Africa from Qualified EVG API solely for the purposes of selling them in the Generic Territory, or (v) make API of EVG in India, China or South Africa and sell such API of EVG to other Generic Licensees in India, China or in South Africa, solely for the purpose of making Generic Versions pursuant to 1.32(ii) or 1.32(iii) or 1.32(iv) set forth above. For clarity, both of the sublicenses granted by Gilead to MPPF as well as MPPF License shall be deemed to be included in Generic Licensee.  “Qualified EVG API” shall mean EVG API made by a Generic Licensee in India, China or South Africa or made by a contract manufacturer that makes EVG API for Gilead’s Branded Product. “India” shall mean Republic of India and “China” shall mean the People’s Republic of China but, for clarity, excluding Hong Kong SAR, Macau SAR, and Chinese Taipei.
1.34    “Generic Net Sales” shall mean the net sales of EVG Generic Versions in the Generic Territory as such net sales are defined in the applicable Generic License, and as reported by the applicable Generic Licensee. For products containing EVG and one or more other APIs, such net sales shall mean the portion of net sales allocated to the EVG component as set forth in Section 4.2 of the Generic License templates attached as Exhibit 1 and Exhibit 2 (for Exhibit 2, Section 12 of the form of sublicense agreements attached thereto) to Schedule 6.2. If such allocations are not reported by the Generic Licensee(s), then Gilead and JT shall agree on the allocation based on available data on net selling prices of applicable generic products in the Generic Territory.
1.35    “Generic Product” shall mean a Product that is sold by an unlicensed Third Party (i) in any country where there are no JT Patents or Gilead Patents; (ii) in a country where there are no Valid Claims in the JT Patents or Gilead Patents; (iii) in a country where the laws do not provide for the effective enforcement of Patent rights; or (iv) in any other country where the Parties both determine that it is not commercially reasonable to pursue Third Party infringers.  A Generic Product is also a Product that is sold pursuant to a compulsory license for the Licensed Indication (which 

5

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

compulsory license is for sales at a Net Selling Price that is less than or equal to what would be the Net Selling Price of a Product sold by an unlicensed Third Party in a comparable non-patent country).
1.36    “Generic Territory” shall mean the Access Group A Countries and the Access Group B Countries.
1.37    “Generic Versions” shall mean the Products manufactured by Generic Licensees that are not sold under any Regulatory Approvals obtained by or for Gilead or its Affiliate, and which are marketed and promoted using different product trademarks than the Product Trademark.   For clarity, it is expected that Generic Versions will receive Regulatory Approvals based on reference to Regulatory Approvals obtained by or for Gilead for Branded Products.
1.38    “Genvoya” shall mean that certain Product containing the following four active ingredients: Elvitegravir, COBI, FTC and TAF, that is Commercialized under the Product Trademark GENVOYA®. 
1.39    “Gilead Expanded Territory” shall mean all countries of the world, including Japan.
1.40    “Gilead Global Access Program” shall mean the distribution of Product by Gilead, or its Affiliates, through government agencies, not-for-profit, non-governmental organizations, physicians, pharmacies or patients in the countries listed in Schedule 1.2 at reduced rates.
1.41    “Gilead Indemnitees” shall have the meaning set forth in Section 11.1.
1.42    “Gilead Know-How” shall mean: (a) Know-How Controlled by Gilead or a Gilead Affiliate that is necessary for, or that has been otherwise actually used during the Original Agreement Term or the Term in the research, Development, manufacture, use, sale, offer for sale, or importation of Compounds or Products; and (b) Sublicensee Know-How.
1.43    “Gilead Original Territory” shall mean all countries of the world except Japan.
1.44    “Gilead Patent” shall mean: (a) any Patent Controlled by Gilead or a Gilead Affiliate that is necessary for, or that has otherwise actually been used during the Original Agreement Term or the Term in the research, Development, manufacture, use, sale, offer for sale, or importation of a Compound or a Product, including without limitation Gilead’s interest in Joint Patents; and (b) any Sublicensee Patent.
1.45     “Gilead Technology” shall mean all Gilead Patents and Gilead Know-How.  
1.46    “GS-9350” or “COBI” shall mean [*].
1.47     “HIV” shall mean the human immunodeficiency virus.
1.48    “IND” shall mean (a) an Investigational New Drug Application as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder by the FDA, or (b) an equivalent application to the equivalent agency in any other country or group 

6

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

of countries, the filing of which is necessary to commence clinical testing of a pharmaceutical product in humans in a particular jurisdiction.
1.49    “Indemnify” shall have the meaning set forth in Section 11.1.
1.50    “Infringe” shall mean the carrying out of an Infringement.
1.51    “Infringement” shall have the meaning set forth in Section 9.4(a)(i). 
1.52    “IP Subcommittee” shall have the meaning set forth in Section 9.2(a).
1.53    “Japan” shall mean Japan and its possessions and territories thereof.
1.54    “Joint Committee” shall have the meaning set forth  in Section 2.1. 
1.55    “Joint Invention” shall have the meaning set forth in Section 9.1(a).
1.56    “Joint Patent” shall have the meaning set forth in Section 9.3(d).  As of the A&R Execution Date, the Joint Patents include those Patents listed as “Joint Patents” on Schedule 1.59, and it shall include those added to such Schedule by both Parties. 
1.57     “JT Indemnitees” shall have the meaning set forth in Section 11.2.
1.58    “JT Know-How” shall mean Know-How that is Controlled by JT or a JT Affiliate that is necessary for, or that has been otherwise actually used during the Original Agreement Term or the Term in, the research, Development, manufacture, use, sale, offer for sale, or importation of Compounds or Products.
1.59    “JT Patent” shall mean any Patent Controlled by JT or a JT Affiliate that is necessary for, or that has been otherwise actually used during the Original Agreement Term or the Term in, the research, Development, manufacture, use, sale, offer for sale, or importation of Compounds or Products, including without limitation JT’s interest in any Joint Patents.  As of the A&R Execution Date, the JT Patents include those Patents listed on Schedule 1.59 (other than the Joint Patents), and it shall include those added to such Schedule pursuant to Section 9.1(c) of this Agreement or the Original Agreement.
1.60    “JT Patent Expenses in Access Group A Countries” shall mean [*] expenses (including attorneys’ fees) actually incurred by JT to file, maintain, Prosecute or enforce any JT Patents in or for the Access Group A Countries.
1.61     “JT Technology” shall mean all JT Patents and JT Know-How.
1.62     “Key JT Personnel” shall mean, for [*], [*], and, for [*], [*].
1.63    “Know-How” shall mean (i) all information, know-how, techniques and data specifically relating to development, manufacture, use or sale of a Compound or a Product, including but not limited to, inventions, practices, methods, knowledge, know-how, skill, experience, test 

7

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

data (including without limitation pharmacological, toxicological, clinical, analytical and quality control data, regulatory submissions, correspondence and communications, and marketing.  pricing, distribution, cost, sales, manufacturing, patent and legal data or descriptions); (ii) Regulatory Information containing know-how; and (iii) compositions of matter, assays and biological materials specifically relating to development, manufacture, use or sale of a Compound or a Product.
1.64    “Licensed Indication” shall mean all possible therapeutic and prophylactic uses (including without limitation, mono-and combination uses in the treatment of HIV infection).
1.65    “Losses” shall have the meaning set forth in Section 11.1.
1.66    “MAH Transfer” shall mean the transfer of all of the marketing authorizations for the Products in Japan from JT to GSJ pursuant to the Master Agreement.
1.67    “MAH Transfer Date” shall mean the date upon which the MAH Transfer occurs. 
1.68    “Major EU Countries” shall mean France, Germany, Italy, Spain and the United Kingdom, and “Major EU Country” shall mean any one of the foregoing[*].
1.69    “Major Market” shall mean any of the United States and the Major EU Countries.
1.70    “Manufacturing Cost” shall mean an amount equal to Gilead’s cost to produce Product consisting of the amounts described in clauses (a), (b) or (c) below, as appropriate:
(a)    Internal Costs.
(i)    Material Costs, which means the prices paid to Third Parties for raw materials including intermediates and active compounds, excipients, components, packaging and labeling materials to the extent used in the manufacture and transportation of Product and purchased finished goods which are purchased from outside vendors as well as any freight and duty where applicable.  Material Costs includes the quantity of the components included in the bill of material multiplied by the purchase price and the waste factor (i.e., scrap percentage) included in the bill of materials.  It also includes the normal quality assurance sample quantity which is included in the bill of materials; and
(ii)    Direct Labor Costs, which means the standard labor hours required for an operation according to the standard operating procedures multiplied by the direct labor rate (i.e., the employment costs per man-hour including, without limitation, salary and employee benefits) for work centers within the relevant manufacturing operating unit; and
(iii)    Overhead Costs, which means a reasonable allocation of overhead calculated by Gilead in accordance with reasonable cost accounting methods that comply with GAAP and consistent with the way Gilead allocates such costs to products it supplies to other of its customers pursuant to contract manufacturing relationships, specifically excluding products supplied pursuant to corporate partnering or other co-development relationships.  Overhead Costs shall include administrative costs directly in support of Gilead’s manufacturing operation and 

8

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

expenses associated with quality assurance, manufacturing and engineering associated with the operating unit(s) manufacturing a Product and shall include depreciation and property taxes associated with the plant(s) manufacturing a Product.  These costs shall be allocated to each product line in such operating unit(s) or plant(s), whichever is applicable, based on specific criteria consistent with the standard operating procedures for each product and work center overhead rates of the party performing the work determined and allocated in a manner consistently applied within and across operating unit(s); and
(iv)    Third-Party royalties and costs of manufacturing to the extent not already paid or credited under the Original Agreement or this Agreement and not including royalties Gilead is obligated to pay under Section 8.3(a) of the Original Agreement or this Agreement.
(b)    Contract Manufacturing Costs.  Gilead’s costs to acquire a Product from suppliers (which amount will be net of rebates, if any, from suppliers).
(c)    Combined Costs.  For a Product that has costs arising under both Section 1.70(a) and Section 1.70(b), “Manufacturing Costs” shall consist of the sum of the costs described in each such subsection.
1.71    “Marketer Change Date” shall have the meaning set forth in the Master Agreement.
1.72    “Marketing Authorization Application” or “MAA” shall mean an application for Regulatory Approval (but excluding Price Approvals) required for marketing of pharmaceutical product.  Solely as used in Section 8.2, “MAA” shall mean the application for Regulatory Approval (but excluding Price Approvals) required for marketing of the first Product in the EU.
1.73    “Master Agreement” shall have the meaning set forth in the recitals.
1.74    “Material Transfer Agreements” shall mean the Material Transfer Agreement between the Parties dated October 6, 2004, and the Clinical Trial Material Transfer Agreement between the Parties dated as of March 17, 2005.
1.75    “MPPF” shall mean the Medicines Patent Pool Foundation, at Chemin Louis-Dunant 17, 1202, 1202 Geneva, Switzerland. The sublicense of the Generic License granted by Gilead to MPPF pursuant to Section 2 of Schedule 6.2 shall be referred to as the “MPPF License”.
1.76    “MPPF License” shall have the meaning set forth in Section 1.75.
1.77    “NDA” shall mean a New Drug Application filed with the FDA to seek Regulatory Approval for a pharmaceutical product in the United States.
1.78    “Net Sales” means [*]. 
1.79    “Net Selling Price” shall mean the Net Sales (as defined in the [*] of the definition of “Net Sales”, without giving effect to the [*] of such definition) of a Product divided by the number of units of Product sold.

9

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

1.80    “Non-breaching Party” shall have the meaning set forth in Section 14.3(a).
1.81    “Offsetting Patents” shall mean Patents controlled by a Third Party and that are required for the research, Development, manufacture, use, sale, offer for sale or importation of Elvitegravir  based on the formulation furnished by JT to Gilead, as used for treatment or prophylaxis of HIV infection and to the extent based on the manufacturing process provided by JT to Gilead.
1.82    “Original Agreement” shall have the meaning set forth in the recitals.
1.83    “Original Agreement Effective Date” shall mean the date on which the Original Agreement became effective, which date was April 4, 2005.
1.84    “Original Agreement Term” shall mean the period from the Original Agreement Effective Date through the Amended Effective Date.
1.85    “Other Indication” shall mean therapeutic and prophylactic uses other than in the treatment and prophylaxis of HIV infection.
1.86    “Patent” shall mean (a) all patents, certificates of invention, applications for certificates of invention, and patent applications, including without limitation patent applications under the Patent Cooperation Treaty and the European Patent Convention, and abandoned patent applications throughout the world, together with (b) any renewal, divisional, continuation (in whole or in part), or continued prosecution applications of any of such patents, certificates of invention and patent applications, and any all patents or certificates of invention issuing thereon, and any and all reissues, reexaminations, extensions, divisions, renewals, substitutions, confirmations, supplemental protection certificates, registrations, revalidations, revisions, and additions of or to any of the foregoing, and any counterparts in any other country of any of the foregoing and any other patents and patent applications claiming priority back to any of the foregoing.
1.87    “Payment Term” shall have the meaning set forth in Section 8.3(e).
1.88     “Price Approval” shall mean the receipt of approval (to the extent that such approval is required) by the applicable governmental authority with respect to the price at which a pharmaceutical product is sold and can be reimbursed by healthcare insurers, non-profits, government programs, and the like.
1.89    “Product” shall mean (i) any pharmaceutical product that contains Compound as the sole active pharmaceutical ingredient, or (ii) a Combination Product.
1.90    “Product Labeling” shall mean (i) the full prescribing information for any Product, as approved by the relevant Regulatory Authority and (ii) all labels and other written, printed or graphic information included in or placed upon any container, wrapper or package insert used with or for any Product that complies with the Regulatory Approval for such product.
1.91    “Product Trademarks” shall have the meaning set forth in Section 9.7(b).

10

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

1.92    “Promotional Materials” shall mean all written, printed, electronic or graphic material used for promotion or Commercialization of Products, including Combination Products. 
1.93    “Prosecution” shall have the meaning set forth in Section 9.3(a).
1.94     “Regulatory Approval” shall mean all approvals (including, without limitation, supplements, amendments, and Price Approvals), licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the manufacture, distribution, use or sale of a Product in a given regulatory jurisdiction.
1.95    “Regulatory Authority” shall mean the FDA or a counterpart of the FDA outside the United States.
1.96    “Regulatory Information” shall mean know-how, trade secrets, procedures, information, technology, experimental data, pre-clinical, non-clinical and clinical data, clinical safety, post-market safety, efficacy or comparative data, including without limitation raw or patient data, and any and all material information or reports relating to the development, registration, manufacture and commercialization of a Product that is reasonably necessary or required for Regulatory Approval of a Product.  For illustration, Regulatory Information includes, but is not limited to draft and final copies of all NDAs and INDs that are to be submitted or have been submitted by JT and Gilead or their respective Affiliates to the regulatory authorities, including, without limitation, the FDA or EMA, and that are included in other NDAs and INDs for a Product filed by either Party or its Affiliates, together with all material subsequent correspondence and data submissions relating to the foregoing, and all improvements or inventions made or obtained by either Party or its Affiliates, which are reasonably necessary or required to the formulation of a Product or the manufacture, development and registration of a Product.
1.97    “Remaining Competitive Recovery” shall have the meaning set forth in Section 9.4(f)(i).
1.98    “Reverted Country” shall mean a country in the Gilead Original Territory as to which Gilead’s rights under this Agreement are terminated in part by JT pursuant to Section 14.3(c).  
1.99    “Sole Invention” shall have the meaning set forth in Section 9.1(a).
1.100    “Stribild” or “Quad” shall mean a combination pharmaceutical product in oral formulation as developed by Gilead containing as its sole APIs FTC, TDF, EVG and COBI, that is Commercialized under the Product Trademark Stribild®.  
1.101    “Sublicensee” shall mean a Third Party that is a sublicensee of Gilead rights granted under Article 6.

11

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

1.102    “Sublicensee Know-How” shall mean Know-How owned, assigned to, developed by, or in-licensed by a Sublicensee that is necessary for, or actually used during the Term in, the Sublicensee’s Development or Commercialization of a Product.
1.103    “Sublicensee Patent” shall mean any Patent owned, assigned to, or in-licensed by a Sublicensee that is necessary for, or actually used during the Term in, the Sublicensee’s Development or Commercialization of a Product.
1.104    “Supply Agreement” shall mean any supply agreement between the Parties or their respective Affiliates in effect as of the Amended Effective Date or thereafter entered into by the Parties or their respective Affiliates, to the extent governing the commercial supply of the Products, including any supply agreement entered into or amended pursuant to the Master Agreement.
1.105    “TAF” or “GS-7340” shall mean the amidate prodrug of tenofovir having the chemical formula [*].
1.106    “TDF” or “Viread” shall mean tenofovir disoproxil fumarate, having the chemical formula [*]. 
1.107    “Term” shall have the meaning set forth in Section 14.1.
1.108    “Third Party” shall mean any entity other than JT or Gilead or an Affiliate of either Party.
1.109    “Third Party Claim” shall have the meaning set forth in Section 11.1.
1.110    “Third Party Royalties” shall mean up-front, milestone, royalty and any other similar payments paid by Gilead to any Third Party for Offsetting Patents for the Development, manufacture, use sale, offer for sale, or importation of Compound or Product.
1.111    “Truvada” shall mean the combination product sold in Japan under the VTE License Agreement by JT containing both TDF and FTC as its sole APIs.
1.112    “Valid Claim” shall mean a claim of an issued and unexpired Patent, which has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, and which is not appealable or has not been appealed within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise.
1.113    “Viread” shall mean shall mean the pro-drug of Tenofovir known as tenofovir disoproxil fumarate, having the chemical formula (9-[(R)-2-[[bis [[isopropoxycarbonyl)oxy] methoxy] phosphinyl] methoxy] propyl] adenine fumarate).
ARTICLE 2
MANAGEMENT

12

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

2.1    Disbandment of the Joint Committee.  The Parties established a Joint Committee (the “Joint Committee”) under the Original Agreement to provide a forum for the Parties to share and discuss their respective plans relating to the Development and Commercialization of Compound(s) and Products and to coordinate activities to be taken by the Parties with respect to the Development and Commercialization of such Compound(s) and Products.  The Parties have agreed to disband the Joint Committee and any working groups or subcommittees thereunder other than the IP Subcommittee effective as of the Amended Effective Date.  For clarity, until the Amended Effective Date, the Joint Committee will continue to operate in accordance with the Original Agreement.  The decisions of the Joint Committee made prior to its disbandment shall remain in effect to the extent such decisions are not in conflict with this Agreement or the Master Agreement or Ancillary Agreements. If a conflict or inconsistency arises between a previous decision of the Joint Committee and this Agreement, this Agreement shall prevail and the Parties shall disregard such previous decision of the Joint Committee to the extent that such decision is in conflict or inconsistent with this Agreement.  
2.2    Decision-Making Following Disbandment.  Any disputes or disagreements, concerning matters that directly relate to either Party’s Patents or Know-How (other than matters relating to a breach of this Agreement), and that cannot be resolved by the IP Subcommittee, shall be decided by [*].
2.3     Selection of Alliance Managers.  Each Party shall designate an appropriate person to facilitate communication, interaction and coordination of the Parties’ activities under this Agreement relating to Products (each, an “Alliance Manager”).  Each Alliance Manager shall have appropriate experience.  Each Party may change its Alliance Manager from time to time upon notice to the other Party.
2.4    Responsibilities.  The Alliance Managers may attend all meetings of the IP Subcommittee.  Each Alliance Manager shall (i) be the initial point of contact and communication for each Party to identify actual or potential disputes arising in connection with this Agreement; (ii) refer such issues or disputes to the IP Subcommittee for discussion as appropriate; (iii) plan and coordinate cooperative efforts for internal and external communications and notices; and (iv) ensure that governance activities, including production of meeting minutes and relevant action items agreed upon at meetings of the Parties’ representatives and the IP Subcommittee, as applicable, are appropriately carried out, referred to the appropriate employees of each Party, or are otherwise addressed by the Parties.
2.5    [Reserved]
2.6    Collaboration Guidelines.  In all matters relating to this Agreement, each Party shall seek to comply with good pharmaceutical and environmental practices consistent with its own existing practices.  Subject to the terms of this Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity.  The relationship between JT and Gilead is that of independent contractors and neither Party shall have the power to bind or obligate the other Party in any manner, other than as is expressly set forth in this Agreement.

13

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

ARTICLE 3
DEVELOPMENT
3.1    Performance.  As between the Parties, except as otherwise set forth in the Master Agreement and the Ancillary Agreements with respect to Japan, Gilead shall have the sole right to conduct regulatory, non-clinical, clinical, pharmaceutical, commercial development, manufacturing, registering and marketing of a Product for the Licensed Indication in the Gilead Expanded Territory in accordance with this Article 3.  Gilead shall devote Diligent Efforts to the Development of a Product for use in the treatment of HIV infection to support the Commercial Launch of such Product in the Gilead Expanded Territory in accordance with this Agreement. Gilead shall bear all of the costs and expenses incurred in connection with any such activities performed, except as may otherwise be set forth with respect to Japan in the Master Agreement and the Ancillary Agreements. 
3.2    Development Plan.    In the event there are additional Gilead-sponsored clinical studies undertaken to further Develop any Product, then no more frequently than semi-annually, Gilead shall provide JT with a high-level plan for such additional clinical studies in a format mutually agreed  upon in writing (“Gilead Development Plan”).  
3.3    Reports and Information.  Gilead shall update JT periodically regarding significant Development and regulatory activities with respect to Products for the Licensed Indication.  In addition, if Gilead is conducting any additional clinical studies on a Product, Gilead shall deliver a semi-annual high-level written report to JT summarizing Gilead’s significant clinical and regulatory activities with respect to Products pursuant to this Agreement in a format mutually agreed upon in writing.
3.4    Ad Hoc Development Meeting.      Upon JT’s reasonable request, Gilead and JT shall hold an ad hoc meeting to discuss any further development of the Products by Gilead (“Development Meetings”).  Development Meetings may take place by telephonic or video conference or in person at such location as the Parties mutually agree, and they will be limited to no more than [*] Development Meetings per calendar year, provided that additional Development Meetings may also be held with the consent of each Party and neither Party shall unreasonably withhold or delay its consent to hold such additional Development Meetings.  Alliance Managers from each Party shall act as the chairperson for the Development Meetings, and shall send an agenda for each Development Meeting at least [*] Business Days prior to the date of such meeting.  Each Party shall bear its own costs, including travel, lodging, food and telephone or video conference costs, for its personnel attending any Development Meeting.
3.5    Information Exchange.
(a)    Obligation to Exchange Information.  During the Term, subject to Section 3.5(b) and Section 4.2(a):
(i)    JT shall, upon reasonable request by Gilead, make available, on a fully paid-up basis, to Gilead, as soon as practicable after such request, JT Know-How and Regulatory Information which is Controlled by JT or any of its Affiliates, that has not been previously 

14

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

disclosed under the Original Agreement or under the Master Agreement, as a result of JT’s activities in Japan;
(ii)    [Reserved] 
(b)    Limitations.  The obligations in this Section 3.5 are subject to any existing legal or contractual restrictions or limitations on either Party; provided, however, that, if legal or contractual restrictions or limitations exist, the nature of such restrictions or limitations shall be promptly disclosed to the other Party to the extent permissible.  The Party that is subject to such restrictions or limitations shall use its Diligent Efforts to obtain a waiver of such restrictions or limitations to the extent that the other Party agrees to be bound by any terms and conditions associated with any such waiver.  In addition, Gilead acknowledges that, unless otherwise expressly agreed between the Parties, JT may destroy any JT Know-How and Regulatory Information after expiration of retention periods under applicable laws as long as JT has (i) provided reasonable written notice to Gilead of its intent to destroy such JT Know-How or Regulatory Information and (ii) given Gilead the opportunity to retain such JT Know-How or Regulatory Information at Gilead’s reasonable expense.
(c)    Creation of New Data. Without limiting the rights of Gilead and the obligations of JT under the Transition Services Agreement with respect to Japan, the following shall apply:
(i)    Gilead may ask JT to generate new Regulatory Information with respect to any activities conducted by JT under the Original Agreement or under the Transition Services Agreement (i.e., Regulatory Information not already in the possession or Control of Gilead) to satisfy any regulatory requirements applicable to Gilead.
(ii)    Upon receiving such a request, JT will consider such request on a reasonable basis and provide such Regulatory Information if JT can do so without unreasonable burden, additional cost or other disadvantage to JT.
(iii)    If new Regulatory Information requested pursuant to Section 3.5(c)(i) would impose additional costs on JT, Gilead shall pay all of such costs, subject to Gilead’s advance written approval of JT’s incurring such additional costs.
(d)    Permitted Purposes.  Gilead or its Sublicensees may use Regulatory Information received pursuant to this Section 3.5 only for Gilead’s development or marketing activities, including filing regulatory applications unless such Regulatory Information constitutes Assigned Assets under the Master Agreement, in which case this restriction shall not apply.
(e)    Form and Manner of Exchange. The exchanges of Regulatory Information shall be undertaken in written, electronic or oral form from time to time, as necessary or as reasonably requested.  All Regulatory Information under this Section 3.5 will be exchanged in English to the extent necessary and possible; provided, however, that all of the costs and expenses for translation that has been requested by Gilead that are incurred by JT or its Affiliate shall be borne by Gilead, subject to Gilead’s advance approval of such costs and expenses.

15

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

ARTICLE 4
REGULATORY MATTERS
4.1    Gilead Marketing Authorization Applications and Regulatory Approvals.  Gilead shall have the sole right to file and own all INDs (if applicable), Marketing Authorization Applications and Regulatory Approvals for Products for the Licensed Indication in the Gilead Original Territory and, after MAH Transfer Date, shall also have the sole right to do so in Japan, and, except as otherwise set forth in the Master Agreement or Transition Services Agreement for Japan, shall be solely responsible for all communications with Regulatory Authorities in the Gilead Expanded Territory in relation thereto under applicable law. JT shall have the right to file and own  Marketing Authorization Applications and Regulatory Approval for Products in Japan until MAH Transfer Date to the extent contemplated by the Master Agreement or Ancillary Agreements. 
4.2    Gilead Access to JT Know-How and Filings.
(a)    Regulatory Data. To the extent not previously provided, JT shall provide Gilead with additional material information, data (in draft or final report form) and Know-How that is reasonably required for Regulatory Approval of Products for the Licensed Indication in the Gilead Expanded Territory, together with all material subsequent correspondence and data submissions relating to the foregoing, as soon as practicable.  JT will use reasonable efforts to cooperate with Gilead and to advise Gilead with respect to questions raised with Gilead by Regulatory Authorities regarding Products; provided that Gilead shall continue to have the primary responsibility to prepare responses and respond to all such questions and inquiries.
(b)    Form of Transfer; Items not Transferred.  Upon Gilead’s request, to the extent not previously provided, JT shall provide all regulatory data and related documentation that it is required to provide to Gilead hereunder in electronic form, to the extent that an electronic copy is reasonably available to JT or its Affiliates.  JT shall not be required to provide in paper form to Gilead any such item that JT provides to Gilead in electronic form, except items which may be required by Regulatory Authorities in the Gilead Expanded Territory to be submitted in their original form.  Gilead shall have the right, in accordance with Section 4.2(c), to reference (until the MAH Transfer) and incorporate such data in Gilead’s regulatory filings for Products in the Gilead Expanded Territory.  The Parties shall discuss the form in which the Parties shall exchange Know-How pursuant to Section 3.5 and this Section 4.2, where not expressly provided in such Sections.
(c)    Regulatory Filings.  Until the MAH Transfer, JT hereby grants Gilead the right to reference all of JT’s (including its Affiliates, Sublicensees and distributors) Regulatory Approvals for the Products for the Licensed Indication in Japan, and all subsequent correspondence and data submissions relating thereto, in Gilead’s regulatory filings for Products for the Licensed Indication in the Gilead Expanded Territory.  Such right shall be transferable to Gilead’s Affiliates, Sublicensees and distributors.
4.3     [Reserved]
4.4    Adverse Event Reporting and Safety Data Exchange.  The Parties have entered into certain safety data exchange or pharmacovigilance agreements and such agreement will be 

16

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

terminated in accordance with the Amended and Restated Pharmacovigilance Agreement Termination Agreement as set forth in the Master Agreement.
4.5    Communications; Regulatory Filings.
(a)    Gilead Original Territory.  Gilead shall be responsible for making the filings for Regulatory Approval in the Gilead Original Territory.
(b)    Japan.  Subject to the Master Agreement and Transition Services Agreement, JT shall be responsible for making the filings for Regulatory Approval in Japan until the MAH Transfer Date. After the MAH Transfer Date, Gilead shall be responsible for making the filings for Regulatory Approval in Japan.
(c)    Generally.  Except (i) as may be required by law, (ii) unless explicitly requested or permitted in writing to do so by Gilead, or (iii) unless contemplated by the Master Agreement and the Ancillary Agreements, JT shall not communicate regarding any Product with any Regulatory Authority having jurisdiction in the Gilead Expanded Territory or file any IND or Marketing Authorization Application for Products in the Gilead Expanded Territory.  The foregoing restrictions shall cease to be applicable on a country-by-country basis upon the expiration of the last-to-expire Valid Claim of a JT Patent in such country or upon such country becoming a Reverted Country; provided that nothing in the foregoing shall contravene JT’s confidentiality obligations under this Agreement, the Confidential Disclosure Agreements or the Master Agreement.
ARTICLE 5
COMMERCIALIZATION
5.1    Performance; Gilead Activities.  Gilead shall have sole responsibility for Commercializing any Product for the Licensed Indication in the Gilead Expanded Territory, as provided in this Article 5.  Gilead shall devote Diligent Efforts to Commercialize a Product for use in the treatment of HIV infection in the Gilead Expanded Territory in accordance with this Agreement.  Gilead shall bear all of the costs and expenses incurred in connection with all such Commercialization. 
5.2    Commercialization Plans.
(a)    Gilead shall update and deliver to JT the Gilead’s plan for Commercialization of the Products (“Gilead Commercialization Plan”) not less than semi-annually and no later than [*] of each year.  The Gilead Commercialization Plan will describe Gilead’s significant Commercialization activities with respect to Products pursuant to this Agreement in a mutually agreed format. The Gilead Commercialization Plan will provide a level of detail reasonably sufficient to enable JT to determine whether Gilead’s activities are consistent with the requirements of Section 5.1.
(b)    Reports and Information.  Gilead shall update JT regarding Gilead’s significant Commercialization activities for Products for the Licensed Indication in the Gilead Expanded Territory.  Gilead shall deliver a written report (the “Commercialization Report”) in a 

17

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

mutually agreed format no less than semi-annually each year to JT summarizing at a high level Gilead’s significant Commercialization activities with respect to Products pursuant to this Agreement until expiration of the Payment Term.
(c)    Ad Hoc Commercialization Meeting.  Upon JT’s reasonable request, Gilead and JT shall hold an ad hoc meeting to discuss Gilead’s progress with respect to Commercialization of the Products (“Commercialization Meetings”).  Commercialization Meetings may take place by telephonic or video conference or in person at such location as the Parties mutually agree, and there should be no more than [*] Commercialization Meetings per calendar year, provided that additional Commercialization Meetings may also be held with the consent of each Party and neither Party shall unreasonably withhold or delay its consent to hold such additional Commercialization Meetings.  Alliance Managers from each Party shall act as the chairperson for the Commercialization Meetings, and shall send an agenda for each Commercialization Meeting at least [*] Business Days prior to the date of such meeting.  Each Party shall bear its own costs, including travel, lodging, food and telephone or video conference costs, for its personnel attending any Commercialization Meeting. 
5.3    Promotional Materials.  This Section 5.3 does not apply to Promotional Materials of Generic Licensees.
(a)    Preparation of Promotional Materials.  Gilead shall have the sole right to prepare or have prepared Promotional Materials for Products for the Licensed Indication in the Gilead Expanded Territory (or may use the Promotional Materials for the Products provided to Gilead under the Master Agreement or the Transition Services Agreement to the extent provided therein).
(b)    Filing of Promotional Materials.  To the extent required by applicable regulatory requirements, Gilead shall file all Promotional Materials as required by the appropriate Regulatory Authority in the Gilead Expanded Territory; provided, however, that JT shall retain the rights to file the same in Japan until MAH Transfer Date to the extent contemplated by the Master Agreement or Ancillary Agreements.  All Promotional Materials and Product Labeling shall, to the extent permitted by law, identify JT as the licensor of Products.
ARTICLE 6
LICENSES, RIGHTS OF NEGOTIATION AND DISCUSSION
6.1    License to Gilead.  Subject to the terms and conditions of this Agreement(  including Section 6.2 with regard to Generic Licensee(s)), (a) as of the Original Agreement Effective Date, JT granted the following licenses to Gilead for the Gilead Original Territory and (b) hereby amends such license to cover Japan as follows: an exclusive (even as to JT and its Affiliates except to the extent provided in this Article 6 or the Master Agreement or Ancillary Agreements), royalty-bearing  (in the case of the Gilead Original Territory, hereunder, and in the case of Japan, solely as specified in the Master Agreement) license under the JT Technology to Develop, make, have made, use, sell, have sold, offer for sale and import Compounds and Products for the Licensed Indication in the Gilead Expanded Territory, which license with respect to Japan is fully paid-up and perpetual.  

18

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Gilead shall have the right to sublicense, [*].  It is understood by the Parties that [*] for the grant of any sublicense for commercialization rights to any JT Technology [*].
6.2    Generic License for Gilead Global Access Program. JT has provided consents to Gilead entering into Generic Licenses with Generic Licensees under  the Gilead Global Access Program in accordance with the terms and conditions set forth in Schedule 6.2.
6.3    [Reserved]
6.4    Affiliate Obligations.  To the extent applicable, JT shall require its Affiliates to grant Gilead a license under such Affiliates’ Patents and Know-How to the extent necessary for, or actually used during the Original Agreement Term or the Term in, Development and Commercialization activities under this Agreement.
6.5    Covenants Regarding Use of Patents and Know-How.
(a)     JT Scope of License.  JT covenants that it shall not practice the Gilead Technology after the Amended Effective Date outside the scope of the license granted to it under the Master Agreement.
(b)    Gilead Scope of License.  Gilead covenants that it shall not practice the JT Technology outside the scope of the licenses granted to it pursuant to this Article 6.
6.6    Other [*] Products.
(a)    Permitted Gilead Activities.  During the Term, Gilead or its Affiliates or Sublicensees may (i) [*]; provided, however, that Gilead may not use Confidential Information of JT, and JT does not grant and will not grant Gilead any rights under JT Patents, JT Know-How, or other JT intellectual property to conduct such activities.
(b)    Permitted JT Activities.  During the Term, JT or its Affiliates may [*]; provided, however, that JT may not use Confidential Information of Gilead, and Gilead does not grant and will not grant JT any rights under Gilead Patents, Gilead Know-How, or other Gilead intellectual property, including the Assigned Assets, to conduct such activities.
6.7    No Implied Licenses.  Except as expressly set forth in this Agreement, neither Party grants any license under its intellectual property rights (including without limitation Patents) to the other Party.
ARTICLE 7
MANUFACTURE AND SUPPLY
7.1    Manufacturing and Supply.  Except in the case of Japan for (a) activities delegated to JT under the Transition Service Agreement or any Supply Agreement or (b) prior to the Distributor Change Date, those JT is permitted to conduct in Japan as set forth in the Master Agreement, Gilead shall be solely responsible for manufacture and supply of the Compound and finished materials 

19

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

necessary for the Development and Commercialization of Products in the Gilead Expanded Territory. 
ARTICLE 8
COMPENSATION
8.1    License Fee. The license fee paid by Gilead under the Original Agreement were and shall be [*] hereunder. For clarification, the license fee hereunder shall be paid to JT from Gilead or its Affiliates from the United States or up to two (2) other jurisdictions for which no withholding tax is applicable.
8.2    Milestone Payments.
(a)    HIV.  The Parties acknowledge that all milestones payments to JT required under the Original Agreement have been paid and no further amounts are due. Any such payments were and shall be [*] under this Agreement.  
(b)     Other Indications.  If Gilead desires to pursue Development and Commercialization of a Product or Compound for any Other Indication, the Parties will agree on a schedule of payments for achievement of regulatory and Commercialization milestone events with respect thereto for Products in the Gilead Expanded Territory.  If the Parties cannot reach an agreement, they may submit the matter for resolution in accordance with the executive negotiation and arbitration procedures set forth in Section 15.1.
8.3    Royalty Payments.
(a)    Rates.  Gilead shall pay JT a royalty based on Net Sales of Products sold by Gilead and its Affiliates and Sublicensees in each country in the Gilead Original Territory in a given calendar year during the Payment Term for each Product according to the following rates:
(i)    [*] percent ([*]%) of the portion of aggregate Net Sales of Products in the Gilead Original Territory that is less than or equal to [*] Dollars ($[*]) in any calendar year;
(ii)    [*] percent ([*]%) of the portion of aggregate Net Sales of Products in the Gilead Original Territory that exceeds [*] Dollars ($[*]) and that is less than or equal to [*] Dollars ($[*]) in any calendar year; and
(iii)    [*] percent ([*]%) of the portion of aggregate Net Sales of Products in the Gilead Original Territory that exceeds [*] Dollars ($[*]) in any calendar year.
(b)    Global Access Countries.  
(i)    Exclusion of the sales in Access Countries.  For the purpose of Section 8.3, “Net Sales” shall [*], provided, however, that annual net sales and unit sales volume of each of Branded Products and Generic Versions (including, but not limited to, Generic Version containing a combination of APIs that are different from any Product under development or being marketed by Gilead, as set forth in Paragraph 5 of Schedule 6.2) in the Access Countries shall be reported 

20

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

by Gilead to JT in writing on a country-by-country and product-by-product basis, within [*] days after the end of each calendar year, to the extent such information is available to Gilead.
(ii)    Royalties on Generic Net Sales.  In addition to the royalties under subparagraph (a), Gilead shall also pay JT a royalty of [*] of Generic Net Sales only in Access Group B Countries of the Generic Territory. 
(iii)    [*].  [*] shall be reported in the quarterly royalty reports to JT under Section 8.4. 
(c)    Sales by Sublicensees.  Upon request by Gilead, the Parties will in good faith discuss whether an adjustment to the royalty applicable on Net Sales made by Sublicensees outside the [*] in the Gilead Original Territory is appropriate, and if the Parties agree in writing to any adjustment, the royalty rate pursuant to Section 8.3(a) for such sales will reflect such adjustment.
(d)    Example Calculation.  For example, if aggregate Net Sales of a Product for the Licensed Indication throughout the Gilead Original Territory were equal to [*] Dollars ([*]) in a calendar year, and no offsets or reductions described in Sections 8.3(g), (h) or (i) are applicable, then the royalty payable to JT hereunder for such total Net Sales would be equal to ([*]) plus ([*]) plus ([*]), for a total royalty of [*] Dollars ([*]).
(e)    Payment Term.  “Payment Term” shall mean the period of time beginning upon the date of Commercial Launch of a Product in the Gilead Original Territory, and ending upon the later of, on a product-by-product and a country-by-country basis: [*].  
(f)    Payment for Non-Patent Benefits.  This Section 8.3 is intended to provide for payments equal to the percentages of Net Sales set forth above for a minimum of [*] In establishing this payment structure, the Parties recognize, and Gilead acknowledges, the substantial value of the various actions and investments undertaken by JT prior to the Original Agreement Effective Date.  Such value is significant and in addition to the value of JT’s grant to Gilead of a patent license pursuant to Section 6.1, as it enables the rapid and effective market introduction of the Products for the Licensed Indication in the Gilead Original Territory.  The Parties agree that the royalty payments calculated as a percentage of Net Sales in the Gilead Original Territory (plus the license fee and the cost reimbursements provided for elsewhere herein) provide fair compensation to JT for these additional benefits.
(g)    Generic Products.  If a Third Party is selling in any country units of a Generic Product that, in any calendar year, are greater than [*] percent ([*]) of the sales by Gilead, its Affiliates and Sublicensees of units of such Product (where the API for such Product is chemically identical to the API for the Generic Product) in such country in such year, then the Parties will in good faith discuss a reduction of royalties due under Section 8.3(a) for such country; [*].  If the Parties cannot agree on the amount of such reduction, the royalty due by Gilead pursuant to this Section 8.3 for such country shall be reduced by [*] percent ([*]) of that which would otherwise be due under Section 8.3(a) for such year.

21

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(h)    Payment of Patent Costs.  In the event that Gilead reasonably elects to prosecute and maintains a patent application within the JT Patents pursuant to Section 9.3(b) in any country, then Gilead shall provide an accounting of such costs to JT and shall offset [*] percent ([*]) of the reasonable costs thereof against amounts due to JT for such country pursuant to Section 8.3; [*].
(i)    Third Party Royalties.  Promptly upon learning of the need for any payments needed to secure Offsetting Patents in any country, Gilead shall give written notice to JT specifying the amount of such payments and describing the Offsetting Patents.  The royalty payments required to be paid on any given date in such country pursuant to Section 8.3 shall be subject to an offsetting reduction on such date by Gilead in an amount equal to [*] percent ([*]) of the amount of Third Party Royalties that are paid to secure Offsetting Patents in such country; [*].
(j)    Limitation.  Notwithstanding the foregoing, no offsets or reductions made by Gilead in any country pursuant to Section 8.3(g), (h) and (i) shall in the aggregate exceed an amount equal to [*] percent ([*]) of the amount otherwise due pursuant to Section 8.3 in such country.  Any amount that has not been offset because of this Section 8.3(j) shall be eligible for offset against the next succeeding royalty payment or payments due for such Product in such country.  If such deferred offset is again limited by this Section 8.3(j), the deferred amount shall be subject to offset against future royalty payments for such Product successively until a total of [*] percent ([*]) of all Third Party Royalties made in respect of such Product in such country have been offset against royalty payments paid by Gilead for such Product in such country.
8.4    Payment, Rules and Procedures.
(a)    Quarterly Reports.  Royalties, payments hereunder and written reports showing the calculation and the basis for the payments shall be made by Gilead within [*]days after the end of each Calendar Quarter in which such sales of Product occur in the Gilead Expanded Territory.  For clarity, however, only reporting (and not royalties or payments) is required in the case of Japan (as royalties due to JT, if any, for the sales of Product in Japan are set forth in the Master Agreement).
(b)    Other Reports.  Within [*] days following the end of each Calendar Quarter in which sales of Product occur in the Gilead Expanded Territory, in the case of sales by Gilead or its Affiliates, or within [*] days after Gilead receives the account of Net Sales from its Sublicensee in the case of sales by Gilead’s Sublicensees, Gilead shall submit to JT an estimate of the Net Sales in each country of the Gilead Expanded Territory that occurred in the preceding Calendar Quarter, together with any corrections to estimates submitted in prior Calendar Quarter of the same year.
(c)    United States Dollars.  Royalty payments by Gilead to JT hereunder shall be made in United States Dollars, based on calculations of such Net Sales converted and stated in United States Dollars.  For clarification, the royalty payment hereunder shall be paid to JT from Gilead or its Affiliates from the United States or up to two (2) other jurisdictions for which no withholding tax is applicable.

22

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(d)    Exchange Rate.  Gilead shall use an exchange rate equal to the spot rate as published in the Eastern Edition of the Wall Street Journal as of the close of business on the business day that is two (2) Business Days before the last business day of the prior month for each month in the applicable Calendar Quarter.  For example, the rate used to calculate Net Sales in the month of April would be the spot rate from the applicable business day in March; if the last business day in March were Wednesday the 31st, the rate would be based on the applicable spot rate for Monday the 29th, and if the last business day in March were Monday the 31st, the rate would be based on the applicable spot rate for Thursday the 27th.  If Gilead changes its currency system, Gilead shall provide JT with prompt written notice and the Parties shall negotiate in good faith a new methodology which is acceptable under GAAP.
8.5    Additional Information.  Gilead shall provide to JT any other information reasonably requested by JT to determine whether Gilead has made all payments due to JT pursuant to this Article 8.
8.6    Taxes and Payments.  Each Party shall be responsible for any and all taxes levied on amounts it receives from the other under this Agreement.
8.7    Withholding Taxes.  If Gilead is required by law, rule or regulation to withhold taxes from payments due JT hereunder, Gilead shall (i) deduct those taxes from the amount remittable to JT hereunder, (ii) promptly pay the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of payment to JT within [*] days following that payment to enable JT to claim all foreign tax credits available to it under law.  The Parties understand that under the laws and regulations currently in effect, no withholding taxes apply to any payments made under this Agreement.  If changes in the applicable laws and regulations result in withholding tax obligations on payments hereunder, the Parties will engage promptly in good faith discussions in order to adopt changes in order to minimize such obligations.
8.8    Payments to or Reports by Affiliates.  Any payment required under any provision of this Agreement to be made to either Party, or any report required to be made by any Party, shall be made to or by an Affiliate of that Party if designated in writing by that Party and agreed to by the other as the appropriate recipient or reporting entity.
8.9    Late Payments.  Any amounts not paid by Gilead when due under this Agreement shall be subject to interest from and including the date payment is due, through and including the date upon which Gilead has made a wire transfer of immediately available funds into an account designated by JT, at an annual rate equal to the sum of [*] percent ([*]%) plus the prime rate of interest quoted in (i) the Money Rates section of the New York edition of the Wall Street Journal calculated daily on the basis of a 365-day year, or (ii) if such edition is unavailable, a similar reputable data source, or (iii) if lower, the highest rate permitted under applicable law: provided that if a higher interest rate applies to payments JT must make to Third Party licensors that are based upon or derived from any late payment by Gilead under this Article 8, then such higher rate shall apply to the portion of such late payment attributable to amounts owed to such Third Party.
8.10    Accounting.  Each Party shall determine any costs and expenses that may be reimbursed to a Party or reported by a Party under this Agreement using its standard accounting 

23

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

procedures, consistently applied, to the maximum extent practical as if such Product were a solely owned product of the determining Party, except as specifically provided in this Agreement.  The Parties also recognize that such procedures may change from time to time and that any such changes may affect the calculation of such costs and expenses.  The Parties agree that, where such changes are economically material to either Party, adjustments shall be made to compensate the affected Party in order to preserve the same economics as reflected under this Agreement.
ARTICLE 9
INTELLECTUAL PROPERTY
9.1    Ownership and Rights.
(a)    Ownership of Inventions.  Each Party shall own any inventions made solely by its employees, agents or independent contractors in conducting their activities hereunder (each a “Sole Invention”).  Inventions hereunder made jointly by employees, agents or independent contractors of each Party in the course of performing under this Agreement shall be owned jointly by the Parties in accordance with joint ownership interests of co-inventors as determined under United States patent laws (“Joint Inventions”).  Inventorship shall be determined in accordance with United States patent laws.
(b)    Cooperation.     Each Party shall promptly execute all papers and instruments, or require its employees or contractors to execute such papers and instruments, as applicable, so as to effectuate the ownership of JT Technology and Gilead Technology.
(c)    Updates to Schedules.
(i)     The list of Patents covering the structure of, or manufacture or use of, Elvitegravir originally set forth on Schedule 1.9B of the Original Agreement is hereby updated and shall be updated from time to time by JT, as applicable, as set forth on Schedule 1.59. 
(ii)    Upon Gilead’s reasonable request, JT agrees to amend or supplement the list of JT Patents set forth on Schedule 1.59.
9.2    IP Subcommittee.
(a)    Establishment and Scope.  Promptly after the Original Agreement Effective Date, the Parties  established, as a subcommittee of the Joint Committee, a joint IP subcommittee (the “IP Subcommittee”) to function, until the Parties agree to disband such committee, to facilitate and discuss (i) the filing, Prosecution and maintenance of JT Patents and Gilead Patents under Section 9.3; (ii) the filing, prosecution, registration and maintenance of Product Trademarks under Section 9.7; and (iii) the need for or usefulness of any Third Party license.  The IP Subcommittee shall operate under the procedures established in this Section 9.2.
(b)    Composition.  The IP Subcommittee shall be composed of three (3) named representatives of Gilead and three (3) named representatives of JT.  Each Party shall appoint its respective representatives to the IP Subcommittee from time to time, and may substitute one or 

24

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

more of its representatives, in its sole discretion, effective upon notice to the other Party of such change.  The members of the IP Subcommittee shall have appropriate technical or legal credentials, experience and knowledge, and ongoing familiarity with the Development and Commercialization of Compound(s) and Products, and related Patents and other IP issues arising under this Agreement.  Members of the IP Subcommittee may delegate from time-to-time certain matters arising within the IP Subcommittee as they deem appropriate.  Additional representatives or consultants may from time to time, by mutual consent of the Parties, be invited to attend IP Subcommittee meetings, subject to such representative’s or consultant’s written agreement to comply with the confidentiality and non-use obligations equivalent to those set forth in Article 13.  Gilead shall select one (1) of its representatives as the initial chairperson of the IP Subcommittee.  On each anniversary of the Original Agreement Effective Date, the Parties shall rotate designation of the chairperson.
(c)    Governance.  The IP Subcommittee may resolve any issue before it based on a consensus of its members.  In the event that the IP Subcommittee cannot or does not, after [*] days of good faith negotiation, reach a consensus on an issue, such conflict shall be resolved pursuant the dispute resolution set forth in Section 2.2.  With respect to the need for any Third Party license described in Section 9.2(a)(iii), [*] shall make the final determination of whether to obtain such license.
(d)    Meetings.  The IP Subcommittee shall meet on an as needed basis as requested by one or both Parties, in a location mutually agreed upon by the Parties, or by means of teleconference, videoconference or other similar communications equipment.  Each Party shall bear its own expenses related to the attendance of such meetings by its representatives.  No IP Subcommittee meeting may be conducted unless at least two (2) representatives of each Party are participating.  The IP Subcommittee may choose to disband, as appropriate based on the reduced need for oversight of JT Patents or Gilead Patents under Section 9.3, or the reduced need for oversight of Product Trademark issues under Section 9.7.
9.3    Prosecution of Patents.
(a)    Prosecution.  As used herein, “Prosecution” shall mean any procedure or practice before an administrative agency such as the United States Patent and Trademark Office, or an equivalent agency, including but not limited to interferences, reexaminations, reissues, oppositions.  and the like.
(b)    JT Patents.
(i)    General. Except as otherwise set forth in this Section 9.3 and, in the case of the Access Group A Countries, subject to Schedule 6.2, JT shall be responsible for the filing, Prosecution and maintenance of JT Patents on a worldwide basis at its sole expense.  If JT determines to abandon or not file or maintain any (i) Patent within the JT Patents in any country in the Gilead Expanded Territory; or (ii) any claim or subject matter directed to a composition of matter, manufacture or use of a Compound or Product in the Licensed Indication in any country in the Gilead Expanded Territory, then JT shall promptly notify the representatives of the IP Subcommittee and shall provide Gilead with thirty (30) days prior written notice of such determination (or such other period of time reasonably necessary to allow Gilead to assume such responsibilities).  Gilead 

25

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

shall then have the opportunity to file,  Prosecute or maintain such Patent, claims or subject matter in such country in Gilead’s name and at Gilead’s sole expense, and if Gilead is Commercializing Product in such country, [*] percent ([*]) of any such costs incurred by Gilead shall be creditable against royalties to be paid to JT under Section 8.3 in that country; [*]. 
(ii)    JT Patent Expenses in Access Group A Countries.  JT Patent Expenses in Access Group A Countries shall be billed to Gilead quarterly and shall be paid by Gilead to JT within thirty (30) days from receipt of invoice, such invoice and payments to be in United States Dollars (converted from other currencies pursuant to JT’s central currency conversion system). The IP Subcommittee shall determine a reasonable strategy, including the [*] that would cause JT to incur JT Patent Expenses in Access Group A Countries. If the IP Subcommittee agrees on the strategy for such proceeding or action, then Gilead will reimburse JT for such JT Patent Expenses in Access Group A Countries. If the IP Subcommittee does not agree on a strategy for such proceeding or action at any time, then (a) JT will be entitled to pursue its own strategy for such proceeding or action, keeping Gilead reasonably informed, and (b) Gilead [*] for such proceeding or action. Any such failure by the IP Subcommittee to agree shall not be subject to further review under Section 9.2(c) or Article 15. For clarity, [*] even if Gilead does not agree on the strategy thereof.
(iii)    Interference, Opposition, Reexamination and Reissue.  If JT becomes aware of any request for, or filing or declaration of any interference, opposition, or reexamination relating to JT Patents in the Gilead Expanded Territory for which JT is responsible for Prosecution, JT shall inform Gilead within thirty (30) days of learning of such event.  The Parties shall reasonably cooperate with respect to such interference, opposition, or reexamination.  Gilead shall have the right to review and consult with JT regarding any submission to be made in connection with such proceeding.  JT shall give Gilead timely notice of any proposed settlement of an interference relating to an JT Patent, and shall not enter into such settlement without Gilead’s prior written consent (such consent not to be unreasonably withheld or delayed).
(iv)    English Translation of JT Patents.  JT has provided Gilead with English language translations of the JT Patents listed on Schedule 1.48 of the Original Agreement, and will provide Gilead with English language translations of any other JT Patents included in Schedule 1.59 as soon as practicable.
(c)    Gilead Patents.  Except as otherwise set forth in this Section 9.3, Gilead shall be responsible for the filing, Prosecution and maintenance of the Gilead Patents at its sole expense.  If Gilead determines to abandon or not file or maintain any (i) Patent within the Gilead Patents in any country; or (ii) any claim or subject matter directed to a composition of matter, manufacture or use of a Compound or Product in the Licensed Indication in any country, then Gilead shall promptly notify the representatives of the IP Subcommittee and shall provide JT with thirty (30) days prior written notice of such determination (or such other period of time reasonably necessary to allow JT to assume such responsibilities).  JT shall then have the opportunity to file, Prosecute or maintain such Patent, claims or subject matter in any such country in JT’s name and at JT’s sole expense.

26

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(d)    Joint Patents.  Except as otherwise set forth in this Section 9.3 and in the case of certain Access Countries, subject to Schedule 6.1, with respect to Joint Inventions, the IP Subcommittee shall determine which Party shall file, Prosecute or maintain Patents covering such Joint Inventions (“Joint Patents”).  Except as provided in the final sentence of this Section 9.3(d), if either Party Prosecutes a Joint Patent, such Party shall solely bear its own internal costs thereof, and the external costs for such Prosecution (e.g., outside counsel, filing fees, etc.) shall be borne equally by the Parties.  Except to the extent either Party is restricted by the licenses granted to the other Party and covenants contained herein, and to the extent permitted by law, each Party shall be entitled to practice, and to grant to Third Parties or its Affiliates the right to practice, inventions claimed in a Joint Patent without restriction or an obligation to account to the other Party.  Either Party may disclaim its interest in any particular Joint Patent, in which case (i) the disclaiming Party shall assign its ownership interest in such Joint Patent to the other Party for no additional consideration, (ii) the Party that is then the sole owner shall he solely responsible for all future costs of such Patent, and (iii) the disclaiming Party shall hold no further rights thereunder and such Patent shall thereafter not be a Joint Patent.
(e)    Cooperation.
(i)    If Gilead determines that (A) regulatory exclusivity of a Patent is required in a country in Gilead Expanded Territory and (B) the failure to obtain such regulatory exclusivity will have a material adverse impact on Gilead’s activities with respect to the Compound or Product in such country, then it shall notify JT in writing of such determinations and propose a commercially reasonable means to obtain such regulatory exclusivity.  The Parties shall cooperate with each other in good faith to take whatever actions are reasonably appropriate in a timely manner to address the material adverse impact.  JT shall not be required to effect any transfer or assignment of its Patent rights for the purpose of obtaining regulatory exclusivity in any country in the Gilead Expanded Territory without JT’s express written consent, which shall not be unreasonably withheld.
(ii)    Neither Party may take any action under this Section 9.3 that would otherwise interfere with or prevent the other Party from fulfilling its diligence obligations under this Agreement. 
(iii)    If either Party becomes aware of any Patents, information or proceeding that relate to any JT Patent, Gilead Patent or Joint Patent that may adversely impact the validity, title or enforceability of such JT Patent, Gilead Patent or Joint Patent, such Party shall promptly notify the other Party of such patent, information or proceeding, provided that such notification would not contravene any existing, relevant obligations of confidentiality to which such Party may be subject.
(f)    Diligence.  The Parties shall use Diligent Efforts to pursue claims and subject matter in Patents directed to Elvitegravir  (a) in each [*]; and (b) in such other countries in the Gilead Expanded Territory where Gilead reasonably requests.  In the United States the Parties shall use Diligent Efforts to [*].  In all [*] the Parties shall use Diligent Efforts to pursue claims in such Patents so that such claims would issue in a timely manner.

27

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(g)    Third Party License Rights.  To the extent any rights granted under this Article 9 relate to Patents subject to a license to either Party of Third Party technology, such rights shall be subject to the terms and conditions of such licenses, and the provisions of this Article 9 shall apply to such Patents only to the extent consistent with such licenses.
9.4    Infringement of Patents by Third Parties.
(a)    Notification.
(i)    Notice.  If either Party learns of any alleged or threatened infringement of the JT Patents or Gilead Patents, or any misappropriation or misuse of Know-How, of which the other Party is a sole owner, co-owner or licensee, such Party shall promptly notify, in writing, the other Party of such infringement, misappropriation or misuse. Any infringement reported hereunder shall be an “Infringement”.
(ii)    Certifications.  Each Party shall inform the other Party of any certification regarding any JT Patent or Gilead Patent that it has received pursuant to either 21 U.S.C. §§ 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its successor provisions, or Canada’s Patented Medicines (Notice of Compliance) Regulations Article 5, or any similar provisions in a country other than the United States and Canada, and shall provide the other Party with a copy of such certification within [*] days of receipt by such Party.  JT’s and Gilead’s rights with respect to the initiation and prosecution of any legal action as a result of such certification or any recovery obtained as a result of such legal action shall be as defined in this Section 9.4.
(b)    Infringement of JT Patents.
(i)    First Right.  JT shall have the first right, but not the obligation, to prosecute Infringement of the JT Patents by activities conducted by Third Parties.  Except as otherwise provided in Schedule 6.2 in the case of certain Access Countries, such prosecution shall be at JT’s own expense and responsibility; provided, however, that Gilead may separately represent itself in such prosecution by counsel of its own choice (at Gilead’s own expense), in which case Gilead shall cooperate fully with JT.
(ii)    Back-up Right for Infringement in the Gilead Expanded Territory.  If within [*] days after notification pursuant to Section 9.4(a)(i), or [*] days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, JT does not prosecute Infringement, then Gilead shall have the right, but not the obligation, to bring at Gilead’s expense and in its sole control, such appropriate action in the Gilead Expanded Territory.  Such prosecution shall be at Gilead’s own expense and responsibility; provided, however, that JT may separately represent itself in such prosecution by counsel of its own choice (at JT’s own expense), in which case JT shall cooperate fully with Gilead.
(c)    Infringement of Gilead Patents.  Gilead shall have the first right, but not the obligation, to bring, at its own expense, an appropriate action against the person or entity Infringing a Gilead Patent. JT shall be entitled to separate representation in such matter by counsel of its own choice (at its own expense), in which case JT shall cooperate fully with Gilead.

28

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(d)    Cooperation and Diligence.
(i)    For any action to terminate any Infringement of JT Patents, or any misappropriation or misuse of JT Know-How, if either Party is unable to initiate or prosecute such action solely in its own name, the other Party shall join such action voluntarily and shall execute all documents necessary to initiate litigation to prosecute and maintain such action.  In connection with any such action, Gilead and JT shall cooperate fully and will provide each other with any information or assistance that either reasonably requests.  Each Party shall keep the other informed of developments in any such action or proceeding, including, to the extent permissible by law, the consultation and approval of any offer related thereto.
(ii)    Notwithstanding the obligations under Sections 9.4(b) and 9.4(c), neither Party may take any action under this Section 9.4 that would otherwise interfere with or prevent the other Party from fulfilling its diligence obligations under this Agreement.
(e)    Joint Patents.  With respect to Third Party Infringement of jointly owned Joint Patents other than that Infringement described in Sections 9.4(b) and 9.4(c), the Parties shall confer and take such action in such manner as they shall agree.  If the Parties are unable after a reasonable period of time to agree on how to proceed, then each Party may exercise its rights as joint owner of the affected Joint Patent in accordance with Section 9.1.  The Parties shall allocate their expenses and recoveries in relation to such actions as they shall agree, provided that unless the Parties otherwise agree in writing, they shall divide such recoveries as set forth in Section 9.4(f)(iii).
(f)    Allocation of Proceeds.  If either Party recovers monetary damages from any Third Party in an action brought under Section 9.4(b), Section 9.4(c) or Section 9.4(e), whether such damages result from the Infringement of JT Patents or Gilead Patents, such recovery shall be allocated first to the reimbursement of any expenses incurred by the Parties in such litigation (including, for this purpose, a reasonable allocation of expenses of internal patent officers).  Any remaining amounts after such allocations (“Net Recovery”) shall be split as follows:
(i)    The portion of any Net Recovery that represents recovery for Infringement in the Gilead Original Territory relating to Products (“Remaining Competitive Recovery”) shall be allocated to JT in an amount equal to the total royalty that would have been payable to JT under Article 8 if Gilead had made Net Sales equivalent to the sales made by the Third Party underlying the award.  The remaining portion of the Remaining Competitive Recovery shall be allocated to Gilead.
(ii)    [Reserved] 
(iii)    The portion of any Net Recovery that represents recovery for Infringement in an action brought pursuant to Section 9.4(e) shall be [*] percent ([*]) to Gilead and [*] percent ([*]) to JT, unless Gilead and JT otherwise agree in writing.
9.5    Infringement of Third Party Rights.

29

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(a)    Defense.
(i)    Gilead shall have the right, but not the obligation, to defend against any claim or initiate any declaratory judgment action relating to a Compound or Product, or bring any such action necessary to protect its interest in such Compound or Product, in the Gilead Expanded Territory at its own expense, and JT shall have the right to participate in any such suit, at its own expense.  The Parties shall reasonably cooperate with respect to the defense of the claim, including if required to conduct such defense, furnishing a power of attorney.
(ii)    If, within [*] days of receiving the notice provided for in Section 9.4(a), or [*] days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of a claim or response in such actions, whichever comes first, Gilead fails to take such action, or if Gilead informs JT that it elects not to exercise such first right, JT (or its designee) thereafter shall have the right to defend against such claim or initiate any declaratory judgment action relating to a Compound or Product or bring any such action necessary to protect its interest in such Compound or Product.  The Parties shall reasonably cooperate with respect to the defense of the claim, including if required to conduct such defense, furnishing a power of attorney, provided that JT shall have the right to approve in advance (such approval not to be unreasonably withheld or delayed) Gilead’s strategy in any such action to the extent that such claim potentially relates to the scope, validity or enforceability of the JT Patents.
(b)    Noncontravention.  Nothing in this Section 9.5 shall be deemed to relieve either Party of its obligations under Article 11.
9.6    Settlement.  Each Party shall give the other Party timely written notice of the proposed settlement of any action under Sections 9.4 or 9.5, and neither Party shall consent to the entry of any judgment or settlement or otherwise compromise any such action or suit in a way that adversely affects the other Party’s intellectual property rights or its rights or interests with respect to the Compound  or a Product without such other Party’s prior written consent (not to be unreasonably withheld).
9.7    Selection, Registration and Use of Product Trademarks.
(a)    [Reserved]
(b)    Registration.
(i)    Gilead will own all trademarks for the Products in the Gilead Expanded Territory (“Product Trademarks”) and be responsible for registering any Product Trademarks within the Gilead Expanded Territory.  For clarity, Product Trademarks shall not include corporate names, logos or trademarks for JT and its Affiliates or Gilead and its Affiliates.  Gilead shall use commercially reasonable efforts to maintain the Product Trademarks as a valid and effective trademark registration in the Gilead Expanded Territory and shall be responsible for all taxes and fees required in connection therewith.  JT agrees to provide Gilead with all reasonable assistance for that purpose.

30

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

9.8    Trademark Infringement.
(a)    Gilead.  Gilead shall have the right, but not the obligation, to defend against any claim or initiate any action relating to the Product Trademarks (including Third Party Claims of infringement against any such Product Trademarks) for any Product in the Gilead Expanded Territory at its own expense, and JT shall have the right to participate in any such suit, at its own expense.
(b)    [Reserved] 
(c)    Damages.  The damages, if any, recovered from any such action under this Section 9.8 shall first go to reimbursement of each Party’s respective costs with the remainder of recovery going to the Party who initiated such action or defense.  The Parties shall reasonably cooperate with respect to the defense of the claim, including if required to conduct such defense, furnishing a power of attorney.
ARTICLE 10
REPRESENTATIONS AND WARRANTIES
10.1    Mutual Representations and Warranties.  Each Party hereby represents, warrants and covenants (as applicable) to the other Party as of the Original Execution Date and, where specified, the A&R Execution Date as follows:
(a)    Corporate Existence and Power.  It is a company or corporation duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including, without limitation, the right to grant the licenses granted hereunder.
(b)    Authority and Binding Agreement.  (i) It has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms.
(c)    No Conflict.  It has not entered, and shall not enter, into any agreement with any Third Party that is in conflict with the rights granted to the other Party under this Agreement, and has not taken and shall not take any action that would in any way prevent it from granting the rights granted to the other Party under this Agreement, or that would otherwise materially conflict with or adversely affect the rights granted to the other Party under this Agreement.  Its performance and execution of this Agreement shall not result in a material breach of any other contract to which it is a Party.

31

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(d)    No Misappropriation.  It has not misappropriated, and shall not misappropriate, the trade secret of any Third Party in the course of performing its responsibilities under this Agreement.
(e)    Rights in Technology.   It has sufficient right in and to its Know-How and Patents, free and clear of any conflicting Third Party rights, to grant the rights set forth in this Agreement.  During the Term, each Party shall devote Diligent Efforts not to diminish the rights under Know-How and Patents owned or Controlled by it that are granted to the other Party herein, including without limitation by not committing or permitting any acts or omissions which would cause the material breach of any agreements between itself and Third Parties that provide access to or rights under intellectual property rights applicable to the development, manufacture, use or sale of Products.  Each Party agrees to provide promptly to the other Party notice of any such alleged breach.  Each Party is in compliance in all material respects with any such agreements with Third Parties.  Furthermore, where an agreement or arrangement between a Party and a Third Party governing licenses under intellectual property that, but for a requirement to obtain such Third Party’s consent to grant a license or sublicense as provided for in the Agreement, would be included in the JT Technology or the Gilead Technology, as applicable, the relevant Party to such agreement or arrangement shall use commercially reasonable efforts to obtain such consent, provided that if obtaining such consent would impose an economic burden on the other Party, then such intellectual property shall not be deemed to be Controlled by the Party requesting consent unless the other Party agrees in writing to assume such economic burden.
10.2    JT Representations.  JT represents and warrants to Gilead as of the Original Execution Date and where specified, the A&R Execution Date:
(a)    JT Patents.  As of the A&R Execution Date, the JT Patents listed in Schedule 1.59 are all of the Patents that JT Controls that would be infringed, but for the licenses granted to Gilead or its Affiliates pursuant to this Agreement, by the manufacture, Development, use, sale, offer for sale or importation of Products for treatment and prophylaxis of HIV infection in the Gilead Expanded Territory by Gilead.
(b)    No Liens on JT Patents.  To the actual knowledge of the Key JT Personnel, the JT Patents are free and clear of any liens and encumbrances except for any minor liens and encumbrances that arise in the ordinary course of business and that do not materially detract from JT’s ability to grant licenses thereunder to Gilead as provided herein.
(c)    Third Party Know-How.  To the actual knowledge of Key JT Personnel, all Know-How required for the licenses granted to Gilead in this Agreement is Controlled by JT.
(d)    Commercialization of Products.  To the actual knowledge of the Key JT Personnel there are no Patents (other than the JT Patents) that would be infringed by the manufacture, development, use, sale, offer for sale or importation of Compound for treating HIV infection in the Gilead Expanded Territory.
(e)    Non-Infringement of JT Technology by Third Parties.  To the actual knowledge of the Key JT Personnel there are no activities by Third Parties that would constitute 

32

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

infringement or misappropriation of the JT Technology as applied to treating HIV infection within the Gilead Expanded Territory.
(f)    No Sublicensee.  There is no Third Party that is or has been a (sub)licensee of JT or its Affiliates with respect to any (i) Patents or (ii) Know-How that is, in either case ((i) or (ii)), necessary for, or actually used during the term of the Original Agreement in, the Development or Commercialization of a Product.
10.3    Non-infringement of Third Party Rights.  To the actual knowledge of the Key JT Personnel there are no claims by a Third Party that any Patent or trade secret right owned or controlled by such Third Party would be infringed or misappropriated by the manufacture, develop, use, sale, offer for sale or importation of Compound for use in treating HIV infection in the Gilead Expanded Territory.    
10.4    Knowledge of Specified Individuals.  No knowledge shall be imputed to any Key JT Personnel, and no Key JT Personnel shall be expected or required to undertake any investigation or inquiry of any nature for the purpose of verifying the accuracy of any representation, warranty or other statement set forth in this Agreement.
10.5    Gilead Representations and Covenant.  Gilead represents and warrants to JT as of the A&R Execution Date that neither Gilead nor its Affiliates is a party to any agreement which would (i) restrict Gilead or its Affiliates from [*], or any other [*] for [*] that Gilead or its Affiliate or Sublicensee owns or Controls (or comes to Control) together with [*], and (ii) as a result of such restriction, would inhibit the Development or Commercialization of Product.  Gilead agrees not to enter into and to cause its Affiliates not to enter into any such agreement during the Term.
10.6    Disclaimer.  Gilead understands that Compound or Products are the subjects of ongoing clinical research and development and that JT cannot assure the safety or usefulness of Compound and Products.  JT makes no warranty except as set forth in this Article 10 (other than those set forth in the Master Agreement or any Ancillary Agreement) concerning its Patents or Know-How.
10.7    No Other Representations.  The express representations and warranties stated in this Article 10 (other than those set forth in the Master Agreement or any Ancillary Agreement) are in lieu of all other representations and warranties, express, implied, or statutory, including without limitation, warranties of merchantability, fitness for a particular purpose, non-infringement or non-misappropriation of Third Party intellectual property rights.
ARTICLE 11
INDEMNIFICATION
11.1    Indemnification by JT.  JT hereby agrees to defend, hold harmless and indemnify (collectively “Indemnify”) Gilead and its Affiliates, agents, directors, officers and employees (the “Gilead Indemnitees”) from and against any and all liabilities, expenses or losses, including without limitation reasonable legal expenses and attorneys’ fees (collectively “Losses”) in each case resulting from Third Party suits, claims, actions and demands (each, a “Third Party Claim”) arising 

33

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

directly or indirectly out of (i) a breach of any of JT’s obligations under this Agreement, including without limitation JT’s representations and warranties or covenants pursuant to Article 10 (other than those set forth in the Master Agreement or any Ancillary Agreement); or (ii) (A) the research, development, or use of Compounds or Products by JT or its Affiliates anywhere in the world, or (B) the sale, offer for sale or importation of Compound or Products by JT or its Affiliates or Third Party licensees conducted in Japan and to the extent that such sale, offer for sale or importation is conducted  prior to January 1, 2019.  JT’s obligation to Indemnify the Gilead Indemnitees pursuant to this Section 11.1 shall not apply to the extent that any such Losses (A) arise from the negligence or intentional misconduct of any Gilead Indemnitee; (B) arise from any breach by Gilead of this Agreement or any Supply Agreement (including without limitation any such breach that results in any defect in Compound or Products or failure of Compound or Products to conform to relevant specifications arising out of Gilead’s failure to manufacture and supply, or to have manufactured and supplied Compound or Product to JT in compliance with any Supply Agreement); or (C) are Losses for which Gilead is obligated to Indemnify the JT Indemnitees pursuant to Section 11.2.
11.2    Indemnification by Gilead.  Gilead hereby agrees to Indemnify JT and its Affiliates, agents, directors, officers and employees (the “JT Indemnitees”) from and against any and all Losses resulting from Third Party Claims arising directly or indirectly out of (i) a breach of any obligations of Gilead under this Agreement, including without limitation Gilead’s representations and warranties or covenants pursuant to Article 10; or (ii) the Development, manufacture (to the extent of any formulation work performed by Gilead pursuant to Article 7), storage, distribution, promotion, labeling, handling, use, sale, offer for sale or importation of Compound or Products by Gilead, its Affiliates, its Third Party licensees or its Generic Licensees in the Gilead Expanded Territory (subject to Section 11.3).  Gilead’s obligation to Indemnify the JT Indemnitees pursuant to the foregoing sentence shall not apply to the extent that any such Losses (A) arise from the negligence or intentional misconduct of any JT Indemnitee; (B) arise from any breach by JT of this Agreement or any Supply Agreement; or (C) are Losses for which JT is obligated to Indemnify the Gilead Indemnitees pursuant to Section 11.1.  A Supply Agreement, if any, may provide additional indemnification obligations of Gilead as the supplier of Compound or Products, including without limitation that Gilead shall indemnify JT for any Third Party Claims arising out of any failure by Gilead to manufacture and supply, or to have manufactured and supplied, Compound or Products in compliance with such agreements.
11.3    Unknown Source Product Liability.  All other liabilities, losses, damages, costs or expenses (including reasonable legal fees) relating to or involving the Compound or Products, including the inherent properties and characteristics of Compound or Products, which are not covered by Section 11.1 or Section 11.2 shall be the responsibility of the Party marketing the Compound or Products in the country in which the Compound or Products were sold at the time of such sale.  Both Parties hereby acknowledge and agree that the Party marketing the Compound and Products sold in Japan prior to January 1, 2019 shall be JT and that the Party marketing the Compound and Products sold in Japan on or after January 1, 2019 shall be Gilead (whether or not Gilead has commenced marketing the Products as of such date). Such marketing Party shall Indemnify the other Party, its Affiliates, directors, officers, employees and agents from and against any and all Losses which the other Party or its Affiliates, directors, officers, employees or agents may incur or be required to pay resulting from or arising in connection therewith.

34

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

11.4    Procedure.  To be eligible to be Indemnified hereunder, the indemnified Party shall provide the indemnifying Party with prompt notice of the claim giving rise to the indemnification obligation pursuant to this Article 11 and the exclusive ability to defend (with the reasonable cooperation of the indemnified Party) or settle any such claim; provided, however, that the failure to so notify the indemnifying Party shall not relieve the indemnifying Party from any Liability that it may have to the indemnified Party, except to the extent that such failure actually and materially prejudices the indemnifying Party’s ability to defend such claim; and further provided, that the indemnifying Party shall not enter into any settlement for damages other than monetary damages without the indemnified Party’s written consent, such consent not to be unreasonably withheld, delayed or conditioned.  The indemnified Party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying Party.  If the Parties cannot agree as to the application of Sections 11.1, 11.2 or 11.3 to any particular Third Party Claim, the Parties may conduct separate defenses of such Third Party Claim.  
11.5    Insurance.   Each Party shall procure and maintain insurance (or self-insure or retain risks at each Party’s discretion), including product liability insurance, adequate to cover its obligations hereunder and which are consistent with normal business practices of prudent companies similarly situated at all times during which any Product is being clinically tested with human subjects or commercially distributed or sold.  It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 11.  Each Party shall provide the other with written evidence of such insurance or ability to retain risks upon request.  Each Party shall provide the other with written notice at least thirty (30) days prior to the cancellation, non-renewal or material change in such insurance or self-insurance or ability to retain risks which materially adversely affects the rights of the other.
11.6    Limitation of Liability.  EXCEPT TO THE EXTENT SUCH PARTY MAY BE REQUIRED TO INDEMNIFY THE OTHER PARTY UNDER THIS ARTICLE 11 OR UNDER THE MASTER AGREEMENT OR ANY ANCILLARY AGREEMENTS, AND EXCEPT FOR A PARTY’S BREACH OF ITS OBLIGATIONS UNDER SECTION 6.5 OR ARTICLE 13, NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES AND LICENSEES SHALL BE LIABLE FOR SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE.
ARTICLE 12
RECORDS; AUDITS; PUBLICATIONS
12.1    Records; Audits.  Each Party shall keep or cause to be kept such records as are required to determine, in a manner consistent with generally accepted accounting principles in the United States with respect to JT, and in Japan with respect to Gilead, the sums or credits due under this Agreement.  If either Party requires additional information from the other Party in order to comply with the generally accepted accounting principles in the United States (for JT) or Japan (for Gilead), then the other Party shall make its reasonable efforts to provide such information promptly.  At the request (and expense) of either Party (the “Auditing Party”), the other Party (the “Audited Party”) and its Affiliates and licensees and Sublicensees shall permit an independent 

35

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

certified public accountant appointed by the Auditing Party and reasonably acceptable to the Audited Party, at reasonable times and in the presence of representatives of the Audited Party, upon reasonable notice and no more frequently than [*] per [*], to examine only those records as may be necessary to determine, with respect to any [*] ending not more than [*] years prior to such Auditing Party’s request, the correctness or completeness of any report or payment made under this Agreement.  The auditor’s reports of any such examination shall be (i) limited to information relating to the Products, (ii) made available to both Parties, and (iii) subject to Article 13.  The Auditing Party shall bear the full cost of the performance of any such audit, unless such audit discloses an underpayment of more than [*] from the amount actually due to the Auditing Party.  In such case, the Audited Party shall [*] of the performance of such audit.  Notwithstanding the foregoing, Schedule 6.2 shall govern the Parties’ respective rights and obligations with respect to the audit of Generic Licensees. 
12.2    Review of Publications and Marketing Materials.  If a Party wishes to publish or present the results of any clinical or other studies permitted to be performed by such Party under this Agreement, such Party shall provide the other Party a copy of any proposed abstracts, manuscripts or presentations (including verbal presentations) that relate to any Product as soon as practicable prior to their intended submission for publication or presentation.  The other Party shall have the right to (i) review and propose modifications to the publication or presentation for patent reasons, trade secret reasons or business reasons or (ii) to request a reasonable delay (not to exceed [*] days) in publication or presentation in order to protect patentable information.  If the other Party requests modification to the publication or presentation, the publishing Party shall edit such publication or presentation to prevent disclosure of trade secret or proprietary business information of the other Party prior to submission of the publication or presentation.  Neither Party shall publish or present the other Party’s Confidential Information.
ARTICLE 13
CONFIDENTIALITY
13.1    Treatment of Confidential Information.  The Parties agree that during the Term, and for a period of [*] years after this Agreement expires or terminates, a Party receiving Confidential Information of the other Party shall (i) maintain in confidence such Confidential Information to the same extent such Party maintains its own proprietary industrial information of similar kind and value (but at a minimum each Party shall use commercially reasonable efforts to maintain Confidential Information in confidence); (ii) not disclose such Confidential Information to any Third Party without prior written consent of the disclosing Party, except for disclosures made in confidence to any Third Party pursuant to a plan approved by the Parties, or to its licensees or Sublicensees who agree to be bound by obligations of non-disclosure and non-use at least as stringent as those contained in this Article 13; and (iii) not use such Confidential Information for any purpose except those purposes permitted by this Agreement or the Master Agreement.
13.2    Authorized Disclosure.  Notwithstanding any other provision of this Agreement or the Master Agreement, each Party may disclose Confidential Information of the other Party:

36

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(i)    to the extent and to the persons and entities required by an applicable law, rule, regulation or order; provided, however, that the Party required to disclose Confidential Information shall first have given prompt notice to the other Party hereto to enable such Party  to seek any available exemptions from, or limitations on, such disclosure requirement and shall reasonably cooperate in such efforts with the other Party;
(ii)    to the extent and to the persons and entities required by rules of the National Association of Securities Dealers, the Japanese Securities Dealers Association or any other applicable association governing the stock exchange on which a Party’s stock is listed; and 
(iii)    as necessary to file or prosecute patent applications, prosecute or defend litigation or otherwise establish rights or enforce obligations under this Agreement, but only to the extent that any such disclosure is necessary.
13.3    Publicity; Terms of Agreement. The Parties agree that the material terms of this Agreement, and the fact that discussions concerning this Agreement are taking place, are included within the Confidential Information of both Parties, subject to the special authorized disclosure provisions set forth in Sections 13.2 and 13.4 and the Master Agreement. JT acknowledges that Gilead may wish or be required to issue press releases relating to the activities under this Agreement. Except as permitted under Sections 13.4(b)-(d), JT shall have the right to issue press releases relating to the activities under this Agreement only with the prior written approval of Gilead.
13.4    Review of Press Releases    .
(a)    If Gilead wishes to issue press releases or otherwise make public statements or disclosures concerning this Agreement, Gilead shall give reasonable prior advance notice of the proposed text of such announcement to JT for review and comment (except as otherwise provided herein). 
(b)    A Party may repeat any information as to the terms of this Agreement that have already been publicly disclosed by such Party in accordance with Section 13.2 or 13.3 without going through the review procedures set forth in this Section 13.4(a).
(c)    A Party may disclose the terms of this Agreement to potential investors, sublicensees or commercial partners who are bound in writing by obligations of non-disclosure and non-use of the terms of this Agreement at least as stringent as those contained in this Article 13.
(d)    A Party may disclose the financial terms of this Agreement to any Third Party or in any press release only (i) with the prior written approval of the other Party, or (ii) if required by applicable Law, rule or regulation.
ARTICLE 14
TERM AND TERMINATION
14.1    Term.  This Agreement shall be effective and commence on the Amended Effective Date and until such date, the Original Agreement shall continue in effect.  As of the Amended 

37

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Effective Date, the Original Agreement is hereby automatically terminated, except that the surviving terms of the Original Agreement shall continue to govern activities that occurred under the Original Agreement. This Agreement, unless terminated earlier pursuant to (a) Sections 14.2, 14.3 and 14.4 or (b) in the event this Agreement terminates as a result of the termination of the Master Agreement (in which case the Original Agreement shall remain in effect), shall be in full force and effect until the expiration of the last to expire Payment Term (the “Term”).  Upon expiration of the Payment Term in a particular country in the Gilead Original Territory, the licenses granted under Article 6 shall become fully paid-up with respect to such country.
14.2    Elective Termination by Gilead.  Gilead shall have the right in its sole discretion and for any reason to terminate this Agreement in its entirety, upon [*] months’ prior written notice to JT.
14.3    Termination for Breach.
(a)    Notice.  If either Party believes that the other Party is in material breach of this Agreement, then the Party holding such belief (the “Non-breaching Party”) may deliver notice of such breach to the other Party (the “Notified Party”).  The Notified Party shall have [*] days to cure such breach to the extent involving non-payment of amounts due hereunder, and [*] days to either cure such breach, or, if cure of such breach other than non-payment cannot reasonably be effected within such [*]-day period, to deliver to the Non-breaching Party a plan reasonably calculated to cure such breach within a timeframe that is reasonably prompt in light of the circumstances then prevailing.  Following delivery of such  plan, the Notified Party shall devote Diligent Efforts to carry out the plan and cure the breach.
(b)    Termination for JT’s Breach.  If JT fails to cure a material breach of this Agreement as provided for in Section 14.3(a) then Gilead shall have the right in its sole discretion, upon written notice to JT, to terminate this Agreement [*].
(c)    Termination for Gilead’s Breach.  If Gilead fails to cure a material breach of this Agreement as provided for in Section 14.3(a), JT shall have the right in its sole discretion, upon written notice to Gilead, to terminate this Agreement[*].
(d)    Disputes.  If a Party gives notice of termination under this Section 14.3 and the other Party disputes whether such termination is proper under this Section 14.3, then the issue of whether this Agreement may properly be terminated upon expiration of the notice period (unless such breach is cured as provided in Section 14.3(a)) shall be resolved in accordance with Article 15.  If as a result of such dispute resolution process it is determined that the notice of termination was proper, then such termination shall be deemed to have been effective [*] days following the date of the notice of breach.  If as a result of such dispute resolution process it is determined that the notice of termination was improper, then no termination shall have occurred and this Agreement shall remain in effect.
14.4    Termination for Bankruptcy/Insolvency.

38

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(a)    Termination.  Either Party may terminate this Agreement in its entirety if (i) the other Party files in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of Party or of its assets, (ii) the other Party proposes a written agreement of composition or extension of its debts,  (iii) the other Party is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition is not dismissed within [*] days after the filing thereof, (iv) the other Party proposes, or is a Party to, any dissolution or liquidation, or (v) the other Party makes an assignment for the benefit of creditors.
(b)    Rights Under US Bankruptcy Code.  The Parties agree that, in the event either Party becomes subject to proceedings under the US Bankruptcy Code, the other Party, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the US Bankruptcy Code.  This Section 14.4 is not intended to limit any rights such other Party would have under applicable law including, without limitation, 11 U.S.C. § 365(n).
14.5    JT Rights upon Certain Terminations.  If JT terminates this Agreement with respect to the Gilead Original Territory (in whole or in part) pursuant to either Section 14.3 or Section 14.4 or if Gilead terminates this Agreement pursuant to Section 14.2, then the following shall apply:
(a)    Regulatory Filings.  To the extent permitted by law, Gilead, its Affiliates and Sublicensees shall [*] to JT transfer to JT all INDs, Marketing Authorization Applications, and Regulatory Approvals for Products, and all data necessary to support such INDs, Marketing Authorization Applications and Regulatory Approvals, that in each case Gilead, its Affiliate or Sublicensee holds as of the time of such termination in the Gilead Original Territory if this Agreement is terminated in whole, or in a Reverted Country if this Agreement is terminated in part.  In the event of such a termination, Gilead, its Affiliates and Sublicensees shall take all actions reasonably necessary to effect such transfer of such INDs, Marketing Authorization Applications and Regulatory Approvals for Products in the Gilead Original Territory if this Agreement is terminated with respect to the Gilead Original Territory in whole, or in a Reverted Country if this Agreement is terminated in part.
(b)    Licenses.  The licenses granted by JT to Gilead under Article 6 shall terminate with respect to Products in the Gilead Original Territory if this Agreement is terminated with respect to the Gilead Original Territory in whole, or in Reverted Countries if this Agreement is terminated in part.  Gilead shall, and hereby does, grant to JT an exclusive, [*] irrevocable license, with the right to grant sublicenses through one (1) or more tiers of sublicenses without Gilead’s consent, under the Gilead Technology and the Trademark, to research, develop, make, use, sell, offer for sale and import Products in the Gilead Original Territory if this Agreement is terminated with respect to the Gilead Original Territory in whole, or in a Reverted Country if this Agreement is terminated in part.
(c)    No Further Representations.  Gilead and its Affiliates and Sublicensees shall discontinue making any representation and withdraw registrations regarding its status as a licensee of, or distributor for, JT for Products in the Gilead Original Territory if this Agreement is 

39

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

terminated with respect to the Gilead Original Territory in whole, or in a Reverted Country if this Agreement is terminated in part, and shall cease conducting any activities with respect to the marketing, promotion, sale or distribution of Products in the Gilead Original Territory if this Agreement is terminated in whole with respect to the Gilead Original Territory, or in a Reverted Country if this Agreement is terminated in part.
(d)    Transition Assistance.  Gilead and its Affiliates shall provide such assistance, at no cost to JT, as may be reasonably necessary (i) during the period prior to the effective date of such termination, to effect the transfer of all regulatory activities, regulatory filings and Regulatory Approvals held by Gilead, its Affiliates and Sublicensees for Product in the Gilead Original Territory if this Agreement is terminated  with respect to the Gilead Original Territory in whole, or in a Reverted Country if this Agreement is terminated in part; and (ii) to transfer or transition over a reasonable period of time to JT for no additional consideration a non-exclusive license to all Gilead Technology or then-existing commercial arrangements, that is, or are, necessary for, or actually used during the Term by JT to commence or continue Commercializing Products in the Gilead Original Territory if this Agreement is terminated in whole, or in a Reverted Country if this Agreement is terminated in part, including without limitation transferring all rights to the Trademark and any agreements or arrangements with relevant Third Party vendors.  To the extent that any such contract between Gilead, its Affiliate or Sublicensee and a Third Party is not assignable to JT, then Gilead its Affiliate or Sublicensee shall reasonably cooperate with JT to arrange to continue to obtain such services from such entity for Gilead to provide to JT.  Gilead, its Affiliates and Sublicensees shall not, during the period prior to the effective date of such termination, take any action that could adversely affect or impair the further development and commercialization of Products.  The Parties shall use good faith efforts to coordinate the wind-down of Gilead’s efforts under this Agreement with respect to the terminated countries and jurisdictions.
(e)    Remaining Inventories.  If this Agreement is terminated in whole in the Gilead Original Territory, JT shall have the right to purchase from Gilead, its Affiliates and Sublicensees all of the inventory of Product held by Gilead, its Affiliates and Sublicensees as of the effective date of such termination for use in the Gilead Original Territory.  If this Agreement is terminated in part, JT shall have the right to purchase from Gilead, its Affiliates and Sublicensees all of the inventory of Product held by Gilead, its Affiliates and Sublicensees as of the effective date of such termination for the Reverted Countries.  Any such purchase shall be at [*]. All charges, import and export compliance fees, consumption taxes, withholding taxes, customs, duties and other taxes imposed by any government taxing authority upon JT or its Affiliates in connection with the purchase of such inventory of Product shall be paid by JT or such Affiliates. JT shall notify Gilead within [*] days after the effective date of such termination whether JT elects to exercise such right.  If JT does not exercise such right, then Gilead shall have the right to sell in the Gilead Original Territory any such remaining inventory over a period no greater than [*] after the effective date of such termination. 
(f)    Continued Supply.  If JT has terminated this Agreement with respect to the Gilead Original Territory, on a country-by-country basis, after such termination is effective Gilead shall supply the Products to JT, its Affiliate or Sublicensee for the Reverted Countries.  In each case, such supply shall be on terms similar to the terms and conditions of the most recent version 

40

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

of the Supply Agreement pursuant to which Gilead supplied JT for Japan prior to its termination pursuant to the Master Agreement and the Parties shall negotiate and enter into a new Supply Agreement.  In such event the licenses granted to Gilead under Section 6.1 shall survive to the extent necessary to allow Gilead to perform such supply obligations.
14.6    Gilead Rights upon Certain Terminations.
(a)    Continuation of Certain Rights.  If Gilead terminates this Agreement  pursuant to Section 14.3(b), then all the licenses granted to it in Article 6 with respect to those Products which Gilead elects to continue to Develop and Commercialize shall survive such termination until the Term would otherwise expire under Section 14.1, provided that Gilead continues to pay all amounts due to JT pursuant to Article 8 for as long as Gilead is required to pay such amounts hereunder.  The Parties’ obligations under Sections 4.2, 4.4, 4.5, 9.1, 9.3, 9.4, 9.5, 9.6, 9.7, and 9.8 shall continue to the extent applicable.
(b)    Transition Assistance.  JT shall provide such assistance, at no cost to Gilead, as may be reasonably necessary to transfer or transition over a reasonable period of time to Gilead all other technology or Know-How, or then-existing commercial arrangements, that is, or are, necessary or useful for Gilead to continue Commercializing Products to the extent reasonably requested by Gilead.
14.7    Survival.  In addition to as otherwise provided in Article 14, the following provisions shall survive any expiration or termination of this Agreement for the period of time specified therein, or if not specified, then they shall survive indefinitely: Articles 1, 11 (solely as to actions arising during the Term or in the course of a Party’s exercise of licenses it retains after the Term), 12, 13, 14, and 16 and Sections 6.5; 8.6; 8.7; 8.8; 8.9; 9.1; 9.4; 9.5; 9.6; 9.8; 15.1 and 15.2.  Termination of this Agreement shall not relieve the Parties of any liability which accrued hereunder prior to the effective date of such termination nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement.  The remedies provided in this Article 14 are not exclusive of any other remedies a Party may have in law or equity.
ARTICLE 15
DISPUTE RESOLUTION
15.1    Dispute Resolution.  Except as provided in Section 15.1(c) any dispute, controversy or claim arising out of or relating to the validity, formation, enforceability, performance, breach or termination of this Agreement (a “Dispute”) shall be settled in accordance with the provisions of this Section 15.1.  If a Party intends to initiate executive negotiation/mediation or arbitration (as set forth in paragraph (a) or (b) below) to resolve a Dispute, that Party shall provide written notice to the other Party informing such other Party of such intention and of the issues to be resolved.  Nothing herein shall prohibit either Party from initiating arbitration if such Party would be substantially prejudiced by a failure to act during the time that efforts are being made to otherwise resolve the Dispute.

41

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(a)    By the Parties.  The Parties shall make an earnest, good faith attempt to resolve any Dispute through negotiation.  If the Parties are unable to resolve a Dispute, either Party may, by written notice to the other Party, refer such Dispute for good faith negotiation between the Chief Executive Officer of Gilead (or his designee with settlement authority) and the President of the Pharmaceutical Division of JT (or his designee with settlement authority) either in person at the offices of the Party not initiating the action or as otherwise agreed within [*] days after the date of notice.  Immediately after receipt of notice of executive negotiation, the Parties may agree to give good faith consideration to the appointment of a mutually-acceptable mediator to assist in the executive negotiation, in which case the costs of mediation shall be shared equally by the Parties.  Any settlement reached by mediation shall be resolved in writing, signed by the Parties, and shall be binding on them.
(b)    By Arbitration.  If any Dispute (other than a Dispute concerning the ownership of Patents or Product Trademarks) has not been settled by executive negotiation/mediation after [*] days, then upon the request of either Party, the Dispute shall be finally resolved by binding arbitration administered under the Rules of Arbitration of the International Chamber of Commerce (the “ICC Rules”).
(i)    The arbitration shall be conducted by a panel of three (3) neutral arbitrators (the “Panel”) appointed in accordance with the ICC Rules.
(ii)    The arbitration proceedings shall take place in San Francisco, California, USA, if the arbitration is initiated by JT, and in Tokyo, Japan, if the arbitration is initiated by Gilead.  The arbitral proceedings and all pleadings shall be in the English language.  Any written evidence originally in a language other than English shall be submitted in English translation accompanied by the original or true copy thereof.
(iii)    The Panel shall have the power to decide all questions of arbitrability.
(iv)    At the request of either Party, the Panel will enter an appropriate protective order to maintain the confidentiality of information produced or exchanged in the course of the arbitration proceedings.
(v)    The Panel is empowered to award any remedy allowed by law, including monetary damages, prejudgment interest and punitive damages, and to grant final, complete, interim or interlocutory relief, including injunctive relief.
(vi)    The Parties may apply to state or federal court of competent jurisdiction within the County and City of New York, New York, for a temporary restraining order, preliminary injunction, or other interim or conservatory relief, as necessary, without breach of this arbitration agreement and without any abridgment of the powers of the arbitrators.  Judgment on the award rendered by the Panel may be entered in any court having jurisdiction thereof.  Each Party hereby waives any defenses it may have to the personal jurisdiction and venue of such courts to resolve such Disputes, including without limitation the defense of forum non conveniens, and each Party agrees not to file any motion to seek any relief under any forum non conveniens defense.

42

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(vii)    Each Party shall bear its own legal fees arising in connection with the Dispute.  The Panel may assess costs, fees and expenses of the ICC and the Panel to the Parties in the manner the Panel deems appropriate under the circumstances.
(c)    Matters Not Subject to Article 15.  Notwithstanding anything else in this Agreement to the contrary, disputes or disagreements concerning matters that relate to either Party’s Patents or Know-How shall be addressed as provided in Section 2.2 and shall not be resolved or settled pursuant to this Article 15.
15.2    Governing Law.  Resolution of all disputes arising out of or related to this Agreement or the performance, enforcement, breach or termination of this Agreement and any remedies relating thereto, shall be governed by and construed under the substantive laws of the State of New York and the federal law of the United States of America, without regard to its conflicts of law rules that would require the application of the laws of a foreign state or country.
ARTICLE 16
MISCELLANEOUS
(a)    Entire Agreement; Amendment.  This Agreement, including the Schedules attached hereto and incorporated herein, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties with respect to the subject matter hereof and supersedes and terminates all prior agreements and understandings between the Parties, except for the Master Agreement, the Ancillary Agreements, the Confidential Disclosure Agreements and Material Transfer Agreements with respect to such subject matter.  Except for the Master Agreement, the Ancillary Agreements, the Confidential Disclosure Agreements and Material Transfer Agreements, there are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth in this Agreement.  No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party, as amended pursuant to Section 16.1(b) hereof. 
(b)    The Confidential Disclosure Agreements (other than the Confidential Disclosure Agreement dated February 1, 2005 (Gilead as recipient with respect to [*])) and the Material Transfer Agreements are hereby considered amended to the extent necessary to provide that, notwithstanding any provision in such agreements to the contrary, any information and materials provided by one Party to the other Party pursuant to the Confidential Disclosure Agreements or the Material Transfer Agreements may be used by a Party to fulfill any obligation or to pursue any rights such Party has under this Agreement, including without limitation for the Development of Products.
16.2    Force Majeure.  Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by a force majeure event and the nonperforming Party promptly provides notice of the prevention to the other Party.  Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party uses reasonable efforts to remove the condition.  For purposes of this 

43

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Agreement, force majeure shall include conditions beyond the reasonable control of the Parties, including without limitation, an act of God or terrorism, voluntary or involuntary compliance with any regulation, law or order of any government, war, civil commotion, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe; provided, however, the payment of invoices due and owing hereunder shall not be delayed by the payor because of a force majeure affecting the payor.
16.3    Notices.  Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement and shall be deemed to have been sufficiently given for all purposes if delivered by (i) first class certified or registered mail, postage prepaid, (ii) international express delivery service or (iii) personally, or if sent by facsimile and confirmed by electronic transmission.  The notice information for each Party is set forth in the Master Agreement.
16.4    Maintenance of Records.  Gilead shall keep and maintain all records required by law or regulation with respect to Products supplied or sold by Gilead or its Affiliates or Sublicensees and shall make copies of such records available to JT upon JT’s request.
16.5    No Strict Construction.  This Agreement has been prepared jointly and shall not be strictly construed against either Party.
16.6    Assignment.  Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Party, except that, subject to Section 16.7, a Party may make such an assignment or transfer without the other Party’s consent to the assigning Party’s Affiliates or to its successor to all or substantially all of the business of such Party in the field to which this Agreement relates (whether by merger, sale of stock, sale of assets or other transaction), provided that any such successor (other than an Affiliate) shall, in a writing reasonably acceptable to the other Party, expressly assume performance of such rights or obligations.  The JT Technology and the Gilead Technology shall exclude any intellectual property held or developed by such a successor of the relevant Party not in connection with Compound or Products.  Any such assignment shall be binding on the successors of the assigning Party.  Any assignment or attempted assignment by either Party in violation of the terms of this Section 16.6 shall be null and void. 
16.7    Change in Control.
(a)    Gilead Change in Control.  Gilead may, without JT’s consent, assign this Agreement and its rights and obligations hereunder in connection with a Change in Control of Gilead, subject to the conditions contained in this Section 16.7(a).
(i)    Upon a Change in Control, Gilead shall provide written notice to JT [*] days prior to such assignment, which notice shall specify the identity of the acquirer in the Change in Control.
(ii)    If the entity acquiring Gilead is a company that, at the time of the Change in Control, is selling any [*] product that is useful for the treatment of [*], or has [*], the 

44

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Parties, after receipt of the notice described in Section 16.7(a)(i), shall meet and discuss in good faith any adverse effect on JT by a Gilead Change in Control.  
(b)    JT Change in Control.  JT may, without Gilead’s consent, assign this Agreement and its rights and obligations hereunder in connection with a Change in Control of JT, subject to the conditions contained in this Section 16.7(b).
(i)    Upon a Change in Control, JT shall provide written notice to Gilead [*] days prior to such assignment, which notice shall specify the identity of the acquirer in the Change in Control.
(ii)    If the entity acquiring JT is a company that, at the time of the Change in Control, is selling any [*] product that is useful for the treatment of [*], or has [*], the Parties shall at any time within thirty (30) days after receipt of the notice described in Section 16.7(b)(i) meet and discuss in good faith whether and how to amend this Agreement to [*] or [*] the [*] or [*] of [*], or [*] concerning [*] efforts, shared by Gilead with JT pursuant to [*], and whether and how to amend or [*] the obligations of the Parties under [*].
16.8    No Blocking Effect.  If the Parties do not reach a consensus on any issue discussed pursuant to Section 16.7(a) (ii) or Section 16.7 (b) (ii) prior to the applicable Change in Control, the assignment of this Agreement in conjunction with such Change in Control may proceed and the Parties (including any successors to a Party) shall continue to discuss such issues.
16.9    Performance by Affiliates.  Each of JT and Gilead acknowledge that their obligations under this Agreement may be performed by their respective Affiliates and Sublicensees.  Notwithstanding any delegation of obligations under this Agreement by a Party to an Affiliate or Sublicensee, each Party shall remain primarily liable and responsible for the performance of all of its obligations under this Agreement and for causing its Affiliates and Sublicensees to act in a manner consistent herewith.  Wherever in this Agreement the Parties delegate responsibility to Affiliates or Sublicensees or local operating entities, the Parties agree that such entities shall not make decisions inconsistent with this Agreement, amend the terms of this Agreement or act contrary to its terms in any way.
16.10    Further Actions.  Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
16.11    Compliance With Laws.  Each Party covenants to comply in all material respects with all U.S. and non-U.S. federal, state and local laws, rules and regulations applicable to the development, manufacture, distribution import and export and sale of pharmaceutical products, and to the transactions contemplated by this Agreement.
16.12    Severability.  If any one (1) or more of the provisions of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof.  The Parties shall make a good faith effort to replace 

45

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
16.13    Headings.  The headings for each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section.
16.14    No Waiver.  Any delay in enforcing a Party’s rights under this Agreement, or any waiver as to a particular default or other matter, shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.
16.15    Translations.  This Agreement is in the English language only, which language shall be controlling in all respects, and all versions hereof in any other language shall be for accommodation only and shall not be binding upon the Parties.  All communications and notices to be made or given pursuant to this Agreement, and any dispute proceeding related to or arising hereunder, shall be in the English language.  If there is a discrepancy between any Japanese translation of this Agreement and this Agreement, this Agreement shall prevail.
16.16    Certain Conventions.  Any reference in this Agreement to an Article, Section, subsection, paragraph, clause, Schedule or Exhibit will be deemed to be a reference to an Article, Section, subsection, paragraph, clause, Schedule or Exhibit, of or to, as the case may be, this Agreement, unless otherwise indicated. Unless the context of this Agreement otherwise requires, (a) all definitions set forth herein will be deemed applicable whether the words defined are used herein in the singular or the plural, (b) the word “will” will be construed to have the same meaning and effect as the word “shall,” (c) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (d) any reference herein to any Person will be construed to include the Person’s successors and assigns, (e) the word “notice” will mean notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, (f) provisions that require that a Party, the Parties or any committee hereunder “agree,” “consent” or “approve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), (g) references to any specific Law, rule or regulation, or article, section or other division thereof, will be deemed to include the then-current amendments thereto or any replacement or successor Law, rule or regulation thereof and (h) the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or”, (i) words of any gender include each other gender, (j) words such as “herein”, “hereof” and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear, (k) words using the singular will include the plural, and vice versa, (l) the words “include,” “includes” and “including” will be deemed to be followed by the phrase “but not limited to”, “without limitation”, “inter alia” or words of similar import and (m) unless “Business Days” is specified, “days” will mean “calendar days.”

46

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

16.17    Counterparts.  This Agreement may be executed in two (2) or more counterparts.  each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument.
[SIGNATURE PAGE FOLLOWS]

47

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

IN WITNESS WHEREOF the Parties have executed this Agreement in duplicate originals by their duly authorized officers as of the A&R Execution Date.

	
		
	Gilead Sciences, Inc.

By: /s/ John F. Milligan
Name:  John F. Milligan, Ph.D.
Title: Chief Executive Officer

	Japan Tobacco Inc.

By: /s/ Muneaki Fujimoto
Name:  Muneaki Fujimoto
Title: President, Pharmaceutical Business

Signature Page to EVG License Agreement

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

A&R Schedules

Schedule 1.2         ABC Schedules - Access Countries
Schedule 1.2A - Access Group A Countries
Schedule 1.2B - Access Group B Countries
Schedule 1.2C - Access Group C Countries
Schedule 1.17A     Elvitegravir Chemical Structure
Schedule 1.17B     Elvitegravir  Patent Applications
Schedule 1.59         JT Patents and Joint Patents
Schedule 6.2        Generic License

S-1

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Schedule 1.2        ABC Schedules  Access Countries

[*]

S-2

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

SCHEDULE 1.2 B

[*]

S-3

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

SCHEDULE 1.2 C

[*]

S-4

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Schedule 1.17A        Elvitegravir Chemical Structure

Chemical Name
[*] 

S-5

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Schedule 1.17B         Elvitegravir Patent Applications

[*]

S-6

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Schedule 1.59        JT Patents

[*]

S-7

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Schedule 1.59  Joint Patents

[*]

S-8

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Schedule 6.2  Generic License

1.JT Consent.  JT consents to Gilead entering into Generic Licenses with Generic Licensees on the condition that: (i) the terms and conditions of Generic Licenses shall not be less favorable to JT than the agreement templates attached hereto as Attachment A for semi-exclusive license and Attachment B for non-exclusive license; and (ii) Gilead shall use reasonable efforts to cause each Generic Licensee to substantially fulfill all its obligations under Generic License and Gilead’s obligations under this Agreement.  Gilead shall not grant to any Generic Licensee or any other entity the right to sublicense the Generic License to a third party.  Notwithstanding the preceding sentence, Gilead may grant any Generic Licensee the right to sublicense the Generic License to an Affiliate of such Generic Licensee (for purposes of this Section 1 and Section 2 only, “Affiliate” will have the meaning set forth in the Generic License templates attached as Exhibit 1 and Exhibit 2 to this Agreement) on condition that such Generic Licensee (a) shall ensure any such Affiliate complies with the terms of the Generic License as if they were a party to the Generic License, and (b) will be liable for activities of such Affiliates as if such activities were performed by such Generic Licensee.  For clarity, Gilead may sell Branded Products in the Generic Territory.  
2.MPPF License. Notwithstanding Section 1 of this Schedule, Gilead may grant the right to MPPF to issue single tier sublicenses to Generic Licensees under terms and conditions no less favorable to JT than the agreement templates attached hereto as Exhibit 2.  Additionally, Gilead may grant any such Generic Licensees the right to further sublicense the Generic License to an Affiliate of such Generic Licensee on condition that such Generic Licensee (a) shall ensure any such Affiliate complies with the terms of the Generic License as if they were a party to the Generic License, and (b) will be liable for activities of such Affiliates as if such activities were performed by such Generic Licensee. 
3.Prevention of Adverse Effects.  In its program to provide Products in the Access Countries (either by itself or through Generic Licensees), Gilead shall undertake commercially reasonable efforts to seek to prevent adverse effects on Net Sales of Products in countries that are not in the Access Countries, which efforts are consistent with those Gilead uses with its other HIV products. Gilead will discuss in good faith with JT any such preventative efforts and shall keep JT reasonably informed of actions taken in furtherance of such efforts to prevent adverse effects on Net Sales of Product in countries that are not Access Countries. In any Gilead press release announcing an expansion of the Gilead Global Access Program with respect to the Product, Gilead shall comply with Section 13.3 and also shall include a statement to the effect that JT has agreed to reduce or waive its right to a royalty on sales of the Product in the Access Countries.
4.Update of ABC Schedule.  Gilead may remove a country from any of the ABC Schedules upon prior written notice to JT.  If any country on an ABC Schedule (e.g: as was the case with Sudan) is divided into two or more countries, then such countries automatically shall take the place, on such ABC Schedule, of the country which was divided.  If Gilead wishes to add a country to an ABC Schedule, then Gilead shall request the addition of such country to JT along with a justification for such addition, and such addition shall be subject to JT’s written consent.  If the criteria (except routine adjustments to the threshold income levels) of categorization of a country’s 

S-9

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

economic situation by The World Bank or United Nations Conference On Trade and Development is changed, upon JT’s request, Gilead and JT shall discuss in good faith to modify the criteria to amend the ABC Schedules set out in the first paragraph of each ABC Schedule.
5.Generic Version of Different Combination.  If a Generic Licensee proposes to commercialize a Generic Version which contains a combination of APIs that are different (including different dosages, other than of EVG) from any Product under development or being marketed by Gilead, then such commercialization shall be subject to prior review and approval by Gilead with regard to safety considerations.  
6.Sharing of Generic License Agreement.  Upon JT’s request, Gilead shall promptly provide to JT a list of the then-current Generic Licensees and a copy of the Generic License agreement (including any amendment thereto) with each Generic Licensee, and a copy of the MPPF License.  Gilead may redact information pertaining only to products which are not Products.  
7.Generic Licensee Know-How and Patents.  JT understands that Gilead has obligations under Section 6.5 of this Agreement with respect to sublicense of Sublicensee Know-How and Sublicensee Patents, and that [*]. Gilead will keep JT apprised of any  Sublicensee Know-How and Sublicensee Patents of Generic Licensees that is provided or reported to Gilead by the Generic Licensees and sublicensable to JT, including [*].  For purposes of Section 9.3(c) (“Gilead Patents”) and 9.4(c) (“Infringement of Gilead Patents”) of this Agreement, “Gilead Patents” shall not include Patents of Generic Licensees. For clarity, any inconsistent or additional obligations of Gilead to obtain rights to Sublicensee Know-How and Sublicensee Patents of Generic Licensees under this Agreement are hereby superseded.
8.Generic Licensee Information and Regulatory Filings.  JT acknowledges that it shall have no access to or rights to obtain, use or reference any Regulatory Information, records, regulatory filings, correspondence with Regulatory Authorities, Marketing Authorization Applications, INDs and post-approval Phase IIIB/IV data for Products or Regulatory Approvals of Generic Licensees with respect to Generic Versions, except as provided under Section 5 of this Schedule.  Notwithstanding the foregoing, JT shall have the right to obtain, use or reference the above-mentioned data, documents and information, if and to the extent Gilead has the right to obtain, use or reference the above-mentioned data, documents and information.
9.Safety Data.  JT agrees that Section 4.4 (“Adverse Event Reporting and Safety Data Exchange”) of this Agreement shall not apply to Generic Versions. Notwithstanding the foregoing, JT shall have the right to obtain, use or reference such data, documents and information with respect to safety or adverse events, if and to the extent Gilead has the right to obtain, use or reference such data, documents and information with respect to safety or adverse events.
10.Promotional Materials.  JT agrees that Section 5.3 (“Promotional Materials”) of this Agreement shall not apply to Promotional Materials of Generic Licensees.
11.Trademark.  Gilead and JT agree that the Product Trademark shall not be used with respect to the Generic Versions.  The Generic Licenses shall prohibit the Generic Licensee from 

S-10

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

using the Product Trademark with respect to Generic Versions and shall require that the Generic Versions have a trade dress that is distinct from Branded Products.
12.Responsibility for Generic Licensees.  JT acknowledges that enforcing legal rights in some or all of the Access Countries is more challenging than in countries that are not Access Countries.  Therefore, JT agrees that if the actions or inactions of a Generic Licensee cause Gilead to be in breach of this Agreement (including situations where the Generic Licensee acts in a manner inconsistent with this Agreement under Section 16.9), then so long as Gilead is acting in good faith to remedy such breaches (including, without limitation, notifying JT of any material breach (e.g. (A) material quantity of leakage of (i) Generic Versions to the countries other than Access Group A Countries and Access Group B Countries or (ii) API to the countries other than India, China or South Africa or (B) substantial deviation from Good Manufacturing Practices) of this Agreement by Generic Licensees promptly after it is known to Gilead and, upon reasonable request by JT, terminating the Generic License with respect to Products in a timely manner in accordance with the relevant provisions of Generic License), then JT agrees that it will not terminate this Agreement with respect to countries that are not Access Countries because of such breach.  Gilead shall indemnify the JT Indemnitees from any losses or damages arising from any breach of this Agreement due to the acts or omissions of Generic Licensees pursuant to Sections 11.2 and 11.4 of this Agreement.  Except as specifically set forth in this Section 12, nothing in this Agreement limits any rights or remedies of JT for any breach by Gilead of this Agreement.
13.Audit of Generic Licensees.  JT agrees that it shall not have the right to directly audit Generic Licensees under Section 12.1 (“Records; Audits”) of this Agreement. Gilead shall secure the right to audit Generic Licensee in each Generic License. When Gilead has audited Generic Licensee(s), Gilead shall provide the portions of the audit result and report relevant to Products to JT within sixty (60) days from completion of each audit. If requested by JT, Gilead shall promptly audit a Generic Licensee in accordance with Gilead’s audit rights under the applicable Generic License.  For clarity, nothing in this Section 13 affects JT’s right to audit Gilead or its Affiliates.
14.Alternate Dosage. Gilead shall obligate and require Generic Licensees not to manufacture or sell any Generic Versions formulated at a single dose concentration other than those dose concentrations approved by the FDA for such agents, without prior written consent of Gilead.   
15.Generic Licensees’ Quarterly Reports.  Gilead shall obligate and require Generic Licensees to provide Gilead with quarterly reports on manufacturing and sales as set forth in section 4.3 in Exhibit 1 and Exhibit 2 (for Exhibit 2, section 13 of the form of sublicense agreements attached thereto).  Upon JT’s request, Gilead shall provide JT with copies of such quarterly reports; provided that Gilead may redact information which does not pertain to the Products.
16.Annual Reports on Different Combination or Alternate Dosage.  Gilead shall make commercially reasonable efforts to determine, by itself or through Generic Licensees, the regulatory status in each country of the Generic Version (i) with different combination of APIs and (ii) with alternate dosage, for which Gilead give the approval or consent pursuant to Section 3.3 of this Agreement and shall annually report to JT thereon.

S-11

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

17.Third Party’s Infringement.   If Gilead learns of any alleged or threatened infringement of the JT Patents in the Access Countries, Gilead shall promptly report same in writing to JT in accordance with Section 9.4(a)(i) of this Agreement and shall cooperate and assist JT, by itself or through Generic Licensees, in the investigation and enforcement pertaining to such infringement. 
18.JT Mark.  Gilead shall obligate and require Generic Licensees not to use any JT’s trademark, trade name, logo or service mark (each, a “JT Mark”), or any word, logo or any expression that is similar to any JT Mark.
19.Consultation before disclosure of this Agreement.  Notwithstanding Section 13.3(c)(iv) of this Agreement, if Gilead plans to disclose any or all of the contents of this Agreement to any Generic Licensee that are not in public domain, Gilead shall give JT reasonable prior written notice thereof, in which case Gilead and JT shall discuss the necessity and the manner of such disclosure and no disclosure shall be made in the absence of agreement by the parties thereon.
20.Termination of Generic Licenses.  If this Agreement is terminated, Gilead shall terminate the Generic Licenses with respect to the Products as set forth in Section 10.3(b)(iv) in Exhibit 1 as well as shall terminate the MPPF License with respect to the Products.

S-12

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

EXHIBIT 1

AMENDED AND RESTATED LICENSE AGREEMENT

This AMENDED AND RESTATED LICENSE AGREEMENT (the “Agreement”) is made as of _________ (the “Amended and Restated Effective Date”) by and between Gilead Sciences, Inc.Delaware corporation having its principal place of business at 333 Lakeside Drive, Foster City, California 94404, USA (“Gilead”), and _________ , a company  registered  under  the  laws  of  India,  and  having  a  registered  office  at _________ , India (“Licensee”).

R E C I T A L S

WHEREAS, Gilead wishes to facilitate access to its antiviral agents to patients in the developing world to help satisfy unmet medical needs;

WHEREAS, to accomplish this goal, Gilead and Licensee entered into that certain License Agreement, effective [effective date], as amended (the “Original License Agreement”), under which certain non-exclusive rights were granted to Licensee with respect to the manufacture and sale of Gilead’s proprietary antiviral agents (TAF, COBI and EVG); and

WHEREAS, Gilead and Licensee now wish to amend and restate the terms of the Original License Agreement.

NOW, THEREFORE, in consideration of the mutual covenants set forth herein and other good and valuable considerations, the receipt of which is hereby acknowledged, the parties hereto mutually agree as follows:

		
	1.
	Definitions

“Active Pharmaceutical Ingredient” or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), elvitegravir (“EVG”), cobicistat (“COBI”), and bictegravir (“BIC”).

“Affiliate” means, with respect to a party to this Agreement, any corporation, limited liability company or other business entity controlling, controlled by or under common control with such party, for so long as such relationship exists. For the purposes of this definition, control means: (a) to possess, directly or indirectly, the power to direct affirmatively the management and policies of such corporation, limited liability company or other business entity, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; or (b) ownership of more than fifty percent (50%) of the voting stock in such corporation, limited liability company or other business entity (or such lesser percent as may be the maximum that may be owned pursuant to applicable law of the country of incorporation or domicile), as applicable.

“Alternate Dosage” shall have the meaning set forth in Section 6.2(d).

S-13

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

“BIC Combination Product” shall mean a pharmaceutical product containing BIC in combination with any other active pharmaceutical ingredient other than TAF, EVG, or COBI (in each case subject to the restrictions set forth in Section 2.5(c)(iv)), including any co formulation, co-packaged product, bundled product, or other type of combination product.

“BIC Product” shall mean a formulated and finished pharmaceutical product containing BIC as its sole active pharmaceutical ingredient.

“BIC Territory” shall mean those countries listed on Appendix 1.

“China” shall mean the People’s Republic of China but, for clarity, excluding Hong Kong SAR, Macau SAR, and Chinese Taipei.

“COBI Combination Product” shall mean a pharmaceutical product containing COBI in combination with any other active pharmaceutical ingredient other than EVG, including combinations containing COBI together with TAF provided such combination does not also contain EVG (in each case subject to the restrictions set forth in Section 2.5(c)(ii)), including any co-formulation, co-packaged product, bundled product, or other type of combination product. For clarity, the TAF Quad is not a COBI Combination Product.

“COBI Product” shall mean a formulated and finished pharmaceutical product containing COBI as its sole active pharmaceutical ingredient.

“COBI Territory” shall mean those countries listed on Appendix 1. 

“Combination   Products”   shall   mean   BIC   Combination   Products,    COBI
Combination Products, EVG Combination Products, TAF Combination Products, and the
TAF Quad.

“Confidential Information” shall have the meaning set forth in Section 11.1.

 “Distributor” shall mean a third party wholesaler or distributor that is not a Gilead
Distributor and that is operating under an agreement with Licensee for the distribution and sale of Product in the Territory.

“Emtricitabine Patents” shall have the meaning set forth in Section 7.6.

“EVG Combination Product” shall mean a pharmaceutical product containing EVG in combination with any other active pharmaceutical ingredient (in each case subject to the restrictions set forth in Section 2.5(c)(iii)), including any co-formulation, co-packaged product, bundled product, or other type of combination product, but not including the TAF Quad.  For clarity, the TDF Quad is an EVG Combination Product.

“EVG Product” shall mean a formulated and finished pharmaceutical product containing EVG as its sole active pharmaceutical ingredient.

S-14

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

“EVG-TAF Quad Territory” shall mean those countries listed on Appendix 5.

“FDA” shall mean the United States Food and Drug Administration, and any successor agency thereto.

“Field” shall mean with respect to a particular Product any use that is consistent with the label approved by the FDA or applicable foreign regulatory authority in the country of sale for the use of such Product.

“Gilead Distributor” shall mean any third party distributor that is operating under an agreement with Gilead for the distribution and sale of Gilead’s branded product in the Territory. Gilead will provide Licensee with a list, which may be updated by Gilead from time to time, of the identity of the Gilead Distributors and their licensed territories.

“Gilead Indemnitee” shall have the meaning set forth in Section 8.1. “Gilead Mark” shall have the meaning set forth in Section 2.6(b).

“Gilead Supplier” shall mean such contract manufacturing organization designated by Gilead that the parties may agree to include as part of this definition by written amendment to this Agreement.

“Improvements” shall have the meaning set forth in Section 2.4.

“Japan Tobacco” shall mean Japan Tobacco Inc., a Japanese corporation, and its affiliates.

“Japan Tobacco Agreement” shall mean the License Agreement between Gilead and Japan Tobacco dated March 22, 2005, as amended from time to time.

“JT Mark” shall have the meaning set forth in Section 2.6(b).

“Licensed API” shall mean API that is either (a) made by Licensee pursuant to the license grant set forth in Section 2.1; or (b) acquired by Licensee from a Gilead Supplier or from a Licensed API Supplier on the terms and conditions set forth in Section 3.

“Licensed API Supplier” shall mean an entity (other than Licensee) that is licensed by Gilead, either directly or through a sublicense from MPP to: (a) manufacture API in India and sell such API to Licensed Product Suppliers in the Field in India, China or South Africa; or (b) manufacture API in China and sell such API to License Product Suppliers in the Field in India, China or South Africa; or (c) manufacture API in South Africa and sell such API to Licensed Product Suppliers in the Field in India, China or South Africa.

“Licensed Know-How” shall mean (a) the know-how actually transferred to Licensee pursuant to the terms of Section 5.5 (either prior to or following the Amended and Restated  Effective  Date)  and  (b)  any  other  improvements  or  modifications  to   such

S-15

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

transferred know-how (x) that are (i) specific to API and (ii) developed and controlled by Gilead during the term of this Agreement, and (y) specifically excluding any such improvements and modifications, methods and other know-how claimed in any patent or patent application.

“Licensed Product Supplier” shall mean (a) an entity located in India (other than Licensee) that is licensed by Gilead, directly or through a sublicense from MPP, to (i) make Product in India and (ii) use, sell, have sold, offer for sale and export such Product in the Field in the Territory; (b) an entity located in China that is licensed by Gilead, directly or through a sublicense from MPP, to (1) make Product in China and (2) use, sell, have sold, offer for sale and export such Product in the Field in the Territory; or (c) an entity located in South Africa that is licensed by Gilead, directly or through a sublicense from MPP, to (x) make Product in South Africa and (y) use, sell, have sold, offer for sale and export such Product in the Field in the Territory.
“Licensed Technology” shall mean the Patents and the Licensed Know-How.

 “Minimum Quality Standards” shall have the meaning set forth in Section 6.2(a).

 “MPP” shall mean the public health organization referred to as the Medicines
Patent Pool.

“NCE Exclusivity” shall mean five years of marketing exclusivity granted by FDA pursuant to its authority under 21 U.S.C. §§ 355(c)(3)(E)(ii) and 355(j)(5)(F)(ii), or similar regulatory exclusivity granted by the appropriate regulatory authority having jurisdiction over the Products.

“Net Sales” shall mean, with respect to a given calendar quarter, the total amount invoiced by Licensee for sales of Product in the Territory to third parties, less the following deductions calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP): (a) freight, insurance, packing, shipping charges, in each case as actually incurred and included as a specific line item on a bill or invoice to such third party; (b) custom duty of imported components, VAT/Indian excise tax, sales tax, or other governmental charges upon or measured by the production, sale transportation, delivery or use of goods, in each case included as a specific line item on a bill or an invoice to such third party; (c) trade, quantity and cash discounts allowed and taken, refunds, chargebacks and any other allowances given (as determined in accordance with GAAP) and taken which effectively reduce the gross amounts billed or invoiced; in each of (a) through (c) to the extent consistently applied across all products of Licensee. Net Sales on Combination Products shall be calculated based on the portion of product Net Sales attributable to Licensed API, as set forth in Section 4.2.

“Patents” shall mean (a) the patents and patent applications set forth in Appendix 2 hereto and (b) any other patents or patent applications (and resulting patents therefrom) that are in the Territory and owned or controlled by Gilead and its Affiliates during the term of this Agreement, including to the extent falling within clause (b) of this definition (i)

S-16

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

those patents and patent applications exclusively licensed by Gilead from Japan Tobacco pursuant to the Japan Tobacco Agreement and (ii) those patents and patent applications claiming improvements or modifications to the manufacture of API, in the case of each patent and patent application referenced in clauses (a) and (b) solely to the extent necessary for Licensee to practice the licenses granted in Section 2 hereof.

“Pediatric Formulation” shall have the meaning set forth in Section 6.2(e). “Product” shall mean BIC Product, COBI Product, EVG Product, TAF   Product,
BIC Combination Product, COBI Combination Product, EVG Combination Product, TAF Combination Product, and the TAF Quad.
“Quarterly Report” shall have the meaning set forth in Section 4.3. “Royalty Term” shall have the meaning set forth in Section 4.9.

“TAF Combination Product” shall mean a pharmaceutical product containing TAF in combination with any other active pharmaceutical ingredient other than EVG or COBI (in each case subject to the restrictions set forth in Section 2.5(c)(i)), including any co-formulation, co-packaged product, bundled product, or other type of combination product.  For clarity, the TAF Quad is not a TAF Combination Product.

“TAF Product” shall mean a formulated and finished pharmaceutical product containing TAF as its sole active pharmaceutical ingredient.

“TAF Quad” or “the TAF Quad” shall mean the finished pharmaceutical product containing TAF (at the dose concentration approved by the FDA or applicable regulatory authority), emtricitabine (200 mg), EVG and COBI (each at their dose concentration approved by the FDA or applicable regulatory authority) as its only active pharmaceutical ingredients, and that is manufactured and sold as a fixed-dose single-tablet regimen and not as a bundled or co-packaged product.

“TAF Territory” shall mean those countries listed on Appendix 1.

“TDF Quad” shall mean the finished pharmaceutical product containing tenofovir disoproxil fumarate (300mg), emtricitabine (200mg), EVG (150mg) and COBI (150mg) as its only active pharmaceutical ingredients, and that is manufactured and sold as a fixed-dose single-tablet regimen and not as a bundled or co-packaged product.

“Territory” shall mean the TAF Territory, the COBI Territory, the EVG-TAF Quad Territory, and the BIC Territory.

“Third-Party Resellers” shall mean Licensed Product Suppliers, Distributors and Gilead Distributors.

S-17

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	2.
	License Grants

2.1    API License. Subject to the terms and conditions of this Agreement, Gilead hereby grants to Licensee a royalty-free, non-exclusive, non-sublicensable (other than a sublicensee to an Affiliate in accordance with Section 2.3 below), non-transferable license under the Licensed Technology to (i) make API in India solely for the purposes of exercising the licenses described in this Section 2.1; (ii) offer for sale and sell such API to Licensed Product Suppliers in India, China, and South Africa for use solely for purposes set forth in the Licensed Product Suppliers’ direct or indirect license from Gilead as set forth in the definition of Licensed Product Suppliers; (iii) import Licensed API into India for purposes of exercising the license set forth in Section 2.2; or (iv) use Licensed API for Licensee’s own internal use in the applicable Territory.

For clarity, the license granted in this Section 2.1 does not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any active pharmaceutical ingredient owned or controlled by Gilead other than TAF, EVG, COBI, and BIC.

2.2    Product License. Subject to the terms and conditions of this Agreement, Gilead hereby grants to Licensee a royalty-bearing, non-exclusive, non-sublicensable (other than a sublicensee to an Affiliate in accordance with Section 2.3 below), non-transferable license under the Licensed Technology solely to make Product in India, and use, sell, have sold, offer for sale, export from India and import (i) TAF Product and TAF Combination Products in the Field in the TAF Territory, (ii) COBI Product and COBI Combination Products in the Field in the COBI Territory, (iii) EVG Product, EVG Combination Products and TAF Quad in the Field in the EVG-TAF Quad Territory,   and (iv) BIC Product and BIC Combination Products in the Field in the BIC Territory; provided that in each case such Products shall be made only from Licensed API.

For clarity, (I) the licenses granted in this Section 2.2 do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any product containing active pharmaceutical ingredients owned or controlled by Gilead other than Products containing TAF, EVG, COBI, and BIC, and (II) notwithstanding the foregoing, the licenses granted under this Section 2.2 shall not extend to any active pharmaceutical ingredient included within a Product other than TAF, EVG, COBI, and BIC.

2.3    Affiliates. Licensee may grant sublicenses under the licenses granted in Sections 2.1 and 2.2 to its Affiliates located in India upon prior written notice to Gilead. Upon Gilead’s request, Licensee shall provide Gilead with the written copies of the applicable sublicense agreement with such Affiliate(s). Further upon Gilead’s request, Licensee shall name Gilead as a third party beneficiary in any such sublicense agreement, in which case Licensee shall consent and hereby does consent to Gilead’s enforcement of such sublicense agreement to the extent relating to the obligations that Licensee is required hereunder to impose on its Affiliates. Licensee shall ensure that any such Affiliate complies with all the terms of this Agreement as if they were a party to this Agreement, and

S-18

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Licensee will be liable for the activities of such Affiliates as if such activities were performed by Licensee.

2.4    License Grant to Gilead. Licensee hereby grants to Gilead a nonexclusive, royalty-free, worldwide, sublicensable license to all improvements, methods, modifications and other know-how developed by or on behalf of Licensee and relating to API or a Product (“Improvements”), subject to the restrictions on further transfer of Licensee’s technology by Gilead as set forth in Section 5.3. As between Gilead and Licensee, Licensee shall own all such Improvements and have the sole right, but not the obligation, to pursue intellectual property protection with respect to such Improvements.

2.5    Licensee Right to Sell Through Third Party Resellers.

(a)Licensed Product Suppliers. Licensee agrees that it will not sell or offer to sell API to any entity other than Licensed Product Suppliers in India, China and South Africa that have been approved by Gilead in accordance with Section 2.5(e).

(b)Product Sales. Licensee agrees that it will not sell, offer for sale, or assist third parties in selling Product except for the sale and offer for sale of (A) TAF Product and TAF Combination Product for use in the Field and in the countries of the TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, (C) EVG Product, EVG Combination Product and TAF Quad for use in the Field and in the countries of the EVG-TAF Quad Territory, and (D) BIC Product and BIC Combination Products for use in the Field and in the countries of the BIC Territory.

(i)Licensee agrees that during the period in which the Patents are valid and enforceable (on a Product-by-Product basis) it will prohibit its Distributors from selling Product (A) to any other wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field.

(ii)Licensee agrees that it will not administer BIC to humans, or sell a Product containing BIC until Gilead has obtained marketing approval for a Product containing BIC from the FDA.

		
	(c)
	Limitations on Product Combinations.

(i)Licensee will be allowed to manufacture and sell TAF in combination with other active pharmaceutical ingredients in the TAF Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the TAF Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein.

(ii)Licensee will be allowed to manufacture and sell COBI in combination with other active pharmaceutical ingredients in the COBI Territory, provided

S-19

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the COBI Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein.

(iii)Licensee will be allowed to manufacture and sell EVG in combination with other active pharmaceutical ingredients in the EVG-TAF Quad Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the EVG-TAF Quad Territory, (B) such manufacture and sale is in accordance with the licenses granted herein, and (C) Licensee has obtained Gilead’s prior written consent for the manufacture or sale of such product containing EVG, such consent not to be unreasonably withheld. For clarity, the requirement for Gilead’s prior consent set forth in the preceding clause (C) shall not apply to the TDF Quad or TAF Quad.

(iv)Licensee will be allowed to manufacture and sell BIC in combination with other active pharmaceutical ingredients, including without limitation a Terminated API, in the BIC Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the BIC Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein.

		
	(d)
	Terms of Agreements with Third Party Resellers.

(i)Gilead Distributors. Licensee may elect to sell finished Product in the Territory to any Gilead Distributor, provided, however, that (A) Licensee may only sell and offer for sale TAF Product and TAF Combination Product to Gilead Distributors to sell in the TAF Territory, and may not sell or offer for sale TAF Product or TAF Combination Product outside the TAF Territory, and may not import TAF Product or TAF Combination Product into any country outside the TAF Territory, (B) Licensee may only sell and offer for sale COBI Product and COBI Combination Product to Gilead Distributors to sell in the COBI Territory, and may not sell or offer for sale COBI Product or COBI Combination Product outside the COBI Territory, and may not import COBI Product or COBI Combination Product into any country outside the COBI Territory, (C) Licensee may only sell and offer for sale EVG Product, EVG Combination Product and TAF Quad to Gilead Distributors to sell in the EVG-TAF Quad Territory, and may not sell or offer for sale EVG Product, EVG Combination Product or TAF Quad outside the EVG-TAF Quad Territory, and may not import EVG Product, EVG Combination Product or TAF Quad into any country outside the EVG-TAF Quad Territory, (D) Licensee may only sell and offer for sale BIC Product and BIC Combination Product to Gilead Distributors to sell in the BIC Territory, and may not sell or offer for sale BIC Product or BIC Combination Product outside the BIC Territory, and may not import BIC Product or BIC Combination Product into any country outside the BIC Territory, and (E) Licensee shall only sell to such Gilead Distributor those Products that are bioequivalent to the branded products Gilead has granted such Gilead Distributor the right to sell in such country of the applicable Territory. Licensee shall only allow such Gilead Distributor to sell  such Product  in  the  country(ies) of the  applicable Territory for which  such Gilead

S-20

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Distributor has the right to sell branded Gilead product. For example, Licensee shall not sell to a Gilead Distributor (X) a Product containing TAF, emtricitabine (FTC) and efavirenz in a particular country in the TAF Territory, unless Gilead has granted such distributor the right to sell a branded product containing TAF, FTC and efavirenz in such country in the TAF Territory, or (Y) a Product containing both TAF and 3TC.

(ii)Other Third Party Resellers. Licensee shall require any Third Party Reseller to agree, in a written agreement with Licensee, (i) to comply with the applicable terms of this Agreement and (ii) to report to Licensee such information, and allow Licensee to provide Gilead with the information described in Section 4.3 (and also to provide Japan Tobacco with such information to the extent it relates to EVG, EVG Product, EVG Combination Product, or TAF Quad). Gilead has the right to audit, on no less than thirty (30) days’ advance notice to Licensee, such records of Licensee solely to the extent necessary to verify such compliance. Gilead will bear the full cost of any such audit, and shall have the right to share the outcome of any such audit with Japan Tobacco to the extent such outcome relates to EVG, EVG Product, EVG Combination Product, or TAF Quad.

(e)Gilead Approval of Third Party Reseller Agreements. Licensee shall not enter into any agreements with Third Party Resellers on terms inconsistent with this Agreement without obtaining Gilead’s prior written approval. If Licensee enters into an agreement with any Third Party Reseller with respect to API or Product, then Licensee shall notify Gilead in writing, and shall certify that its arrangement with such Third Party Reseller is consistent with the terms and conditions of this Agreement. Upon Gilead’s request, Licensee shall provide Gilead with written copies of all agreements executed between Licensee and Third Party Resellers relating to API or Product. Further upon Gilead’s request, Licensee shall name Gilead as a third party beneficiary in any such agreements, in which case Licensee shall consent and hereby does consent to Gilead’s enforcement of such agreements to the extent relating to the obligations that Licensee is required hereunder to impose upon Third Party Resellers. Licensee shall be allowed to redact confidential financial terms from such agreements prior to sharing them with Gilead. Gilead shall have the right to review all such agreements to verify consistency with the terms and conditions of this Agreement. In the event that any inconsistency is found which had not been specifically discussed and agreed with Gilead, then Gilead shall have the right to require Licensee to terminate such agreement. To the extent any such agreements relate to EVG, EVG Product, EVG Combination Product, or TAF Quad, Gilead shall also have the right to share such agreements with Japan Tobacco.

(f)Termination of Third Party Agreements by Licensee. Licensee shall immediately terminate its agreement(s) with a Third-Party Reseller in the event that Gilead believes in good faith that such Third Party Reseller has engaged in material activities that Licensee is prohibited from performing under this Agreement, or that are inconsistent with Licensee’s covenants under this Agreement, including without limitation the unauthorized use, sale or diversion by such Third Party Reseller of API or Product outside the Field or the applicable Territory, or upon Licensee first reasonably believing that such Third-Party Reseller has engaged in such activities.

S-21

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(g)Termination of Third Party Agreements by Gilead. Gilead may terminate the right of Licensee to sell Product to any Third-Party Reseller pursuant to this Section 2.5, if in Gilead’s reasonable belief the Third-Party Reseller is not acting in a way that is consistent with Licensee’s covenants under this Agreement, or if Licensee does not terminate Licensee’s agreement with such Third-Party Reseller under the circumstances described in Section 2.5(e) or Section 2.5(f).

2.6    License Limitations.

(a)Gilead Retained Rights. Licensee hereby acknowledges that Gilead retains all rights in API and Products except as otherwise provided in this Agreement, and that Gilead may license or otherwise convey to third parties its rights in API and Products as it wishes without obligation or other accounting to Licensee.

(b)Gilead Marks. The licenses granted hereunder do not include any license or other right to use any Gilead trademark, trade name, logo or service mark (each, a “Gilead Mark”) or any word, logo or any expression that is similar to or alludes to any Gilead Mark, except as provided in Section 6.5. Licensee agrees not to use any Japan Tobacco trademark, trade name, logo or service mark (each, a “JT Mark”), or any word, logo or any expression that is similar to any JT Mark.

(c)Sublicensed Technology. The licenses relating to EVG, EVG Product, EVG Combination Product and TAF Quad granted to Licensee under this Agreement include sublicenses of intellectual property rights from Japan Tobacco, and remain subject to the terms and conditions of the Japan Tobacco Agreement. Gilead and Licensee shall not permit any action to be taken or event to occur, in each case to the extent within such party’s reasonable control, that would give Japan Tobacco the right to terminate the Japan Tobacco Agreement. If either party is notified or otherwise becomes aware that Licensee’s activities may constitute a material breach of the Japan Tobacco Agreement, it shall promptly notify the other party. The parties shall confer regarding an appropriate manner for curing any such alleged breach. Licensee shall cure such alleged breach as promptly as possible, and in any case within the time allotted under the Japan Tobacco Agreement. Gilead shall remain responsible for EVG Product, EVG Combination Product, and TAF Quad royalties owed to Japan Tobacco pursuant to the Japan Tobacco Agreement.

		
	(d)
	No Other Licenses.

i.Licensee agrees that it shall not use any contract manufacturers without obtaining Gilead’s prior written consent, or grant any sublicenses hereunder.

ii.Except as expressly set forth in this Agreement, Gilead does not grant any license under any of its intellectual property rights (including, without limitation, patents or rights to any proprietary compounds or drug substances other than API) to Licensee.

S-22

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	3.
	Sourcing of API

3.1    Sourcing of API from API Suppliers. Licensee agrees that it shall not make or use any API other than API that is Licensed API for the manufacture of any Product for sale in the Territory. If Licensee wishes to manufacture Product using API made by either a Gilead Supplier or a Licensed API Supplier, then Licensee shall notify Gilead in writing, and shall certify that its arrangement with such Gilead Supplier or Licensed API Supplier, as applicable, is consistent with the terms and conditions of this Agreement. Licensee shall provide Gilead with written copies of all agreements between Licensee and such Gilead Supplier or Licensed API Supplier upon execution. Licensee shall be allowed to redact confidential financial terms from such agreements prior to sharing them with Gilead. To the extent any such agreements relate to EVG, Gilead shall have the right to share such agreements with Japan Tobacco. In the event that any inconsistency is found which had not been specifically discussed and agreed with Gilead, Gilead shall have the right to require Licensee to terminate such agreement with such Gilead Supplier or Licensed API Supplier and upon notice from Gilead to such effect, Licensee shall immediately terminate such agreement.

3.2    Gilead Assistance with Gilead Suppliers. Upon Gilead’s receipt from Licensee of a written notice describing its intention to obtain Licensed API from a Gilead Supplier as described in Section 3.1, Gilead shall use commercially reasonable efforts to assist Licensee in procuring supply of such API from such Gilead Supplier. Gilead shall not be obligated to assist Licensee in procuring any supply of API from a Licensed API Supplier.

3.3    Conditions of Supply from Gilead Suppliers. Gilead shall be a party to any agreement between Licensee and a Gilead Supplier that provides for the supply of API to Licensee from such Gilead Supplier. Any such agreement between Gilead, Licensee and a Gilead Supplier shall include and be subject to the following conditions:

(a)Gilead Supply Needs. Licensee shall not obtain API from the Gilead Supplier until Gilead has received confirmation in writing from the Gilead Supplier of its ability to continue to supply Gilead with Gilead’s forecasted requirements of API, as reflected in Gilead’s then-current twelve (12) month forecast for API provided to the Gilead Supplier.

(b)Consistency with Agreement. The Gilead Supplier shall be permitted to  supply API to  Licensee only to  the  extent that any such supply    does  not
(A) adversely affect its ability to meet Gilead’s forecasted requirements or (B) adversely affect the Gilead Supplier’s ability to supply Gilead’s requirements, whether or not such requirements are consistent with Gilead’s twelve (12) month forecast. Gilead shall have the right to terminate any agreement between Licensee and its Gilead Suppliers if the supply of API from such Gilead Supplier to Licensee adversely affects Gilead’s supply requirements as set forth in this Section 3.3(b).

S-23

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

3.4    No Other Arrangements. Licensee agrees that it shall not enter into any agreements, nor amend any existing agreements, for the supply of intermediates or API on terms that are inconsistent with this Agreement without Gilead’s prior written approval as provided for in this Section 3.

3.5    Supply of other components. The obligations set forth in Sections 3.1, 3.2 and 3.3 with respect to Licensee’s supply of API shall not apply to active pharmaceutical ingredients other than API that Licensee may incorporate into Combination Products.

		
	4.
	Consideration/Payment Terms/Audit

4.1    Royalty. As consideration for the licenses granted in Section 2, Licensee shall pay Gilead the following royalties on Net Sales of Product in the Territory for the duration of the Royalty Term:

(a)5% of TAF Product Net Sales in the TAF Territory.

(b)5% of the portion of TAF Combination Product Net Sales attributable to the TAF component of such TAF Combination Product in the TAF Territory, as determined in accordance with Section 4.2. In addition, to the extent any such TAF Combination Product also contains BIC, Licensee will pay Gilead 5% of the portion of TAF Combination Product Net Sales attributable to the BIC component of such TAF Combination Product in the TAF Territory, as determined in accordance with Section 4.2.

(c)(i) 5% of the portion of TAF Quad Net Sales attributable to the TAF component of the TAF Quad in the EVG-TAF Quad Territory as determined in accordance with Section 4.2, and (ii) 5% of the portion of TAF Quad Net Sales attributable to the EVG and COBI components of the TAF Quad in the EVG-TAF Quad Territory as determined in accordance with Section 4.2.

		
	(d)
	5% of EVG Product Net Sales in the EVG-TAF Quad Territory.

		
	(e)
	5% of COBI Product Net Sales in the COBI Territory.

(f)5% of the portion of EVG Combination Product (which, for clarity, excludes the TAF Quad) Net Sales attributable to the EVG component of such EVG Combination Product in the EVG-TAF Quad Territory as determined in accordance with Section 4.2. In addition, (i) to the extent any such EVG Combination Product also contains TAF, Licensee will also pay Gilead 5% of the portion of EVG Combination Product (which, for clarity, excludes the TAF Quad) Net Sales attributable to the TAF component of such EVG Combination Product in the EVG-TAF Quad Territory as determined in accordance with Section 4.2 (ii) to the extent any such EVG Combination Product also contains COBI, Licensee will also pay Gilead 5% of the portion of EVG Combination Product (which, for clarity, excludes the TAF Quad) Net Sales attributable to the COBI component of such EVG Combination Product in the EVG-TAF Quad Territory as determined  in  accordance  with  Section  4.2,  and  (iii)  to  the  extent  any  such    EVG

S-24

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Combination Product also contains BIC, Licensee will also pay Gilead 5% of the portion of EVG Combination Product (which, for clarity, excludes the TAF Quad) Net Sales attributable to the BIC component of such EVG Combination Product in the EVG-TAF Quad Territory as determined in accordance with Section 4.2.

(g)5% of the portion of COBI Combination Product (which, for clarity, excludes the TAF Quad) Net Sales attributable to the COBI component of such COBI Combination Product in the COBI Territory, as determined in accordance with Section 4.2. In addition, (i) to the extent any such COBI Combination Product also contains TAF, Licensee will also pay Gilead 5% of the portion of COBI Combination Product (which, for clarity, excludes the TAF Quad) Net Sales attributable to the TAF component of such COBI Combination Product in the COBI Territory, as determined in accordance with Section 4.2, and (ii) to the extent any such COBI Combination Product also contains BIC, Licensee will also pay Gilead 5% of the portion of COBI Combination Product (which, for clarity, excludes the TAF Quad) Net Sales attributable to the BIC component of such COBI Combination Product in the COBI Territory, as determined in accordance with Section 4.2.

		
	(h)
	5% of BIC Product Net Sales in the BIC Territory.

(i)5% of the portion of BIC Combination Product Net Sales attributable to the BIC component of such BIC Combination Product in the BIC Territory, as determined in accordance with Section 4.2.

(j)No royalties will be owed on Pediatric Formulations developed and sold by Licensee in accordance with Section 6.2(e).

(k)No royalties will be owed on the tenofovir disoproxil fumarate or emtricitabine components of any Combination Product.

(l)No royalties will be owed on Licensee’s sale of API to other Licensed Product Suppliers, provided such Licensed Product Supplier has executed an agreement with Gilead requiring such Licensed Product Supplier to pay Gilead royalties on finished Product containing such API.

(m)Royalties on sales of Product to Gilead Distributors will be based on Licensee’s invoice price to such Gilead Distributor.

(n)Royalties will only be owed once on each royalty-bearing API of a Combination Product. By means of example, if Licensee pays royalties on the TAF Quad pursuant to Section 4.1(c), then Licensee will not also have to pay additional royalties on the TAF component for the sale of the TAF Quad pursuant to Section 4.1(a) or (b), the EVG component pursuant to Section 4.1(d) or (f), or the COBI component pursuant to Section 4.1(e) or (g).

(o)On a Product by Product and country by country basis, if there is no Product Patent (as defined below) owned or controlled by Gilead (or its Affiliates) in India

S-25

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

or the country in which such Product is sold, and if there is no reasonable possibility of obtaining such a Product Patent within a reasonable period of time (for example, through pending patent applications, the filing of patent applications, or by legal action (including appeals)) in India or the country in which such Product is sold, then Gilead agrees to negotiate in good faith a reduction on the royalty due with respect to such Product under this Agreement on a country by country basis. As used in this Agreement, “Product Patent” shall mean any patent or patent application claiming any Product or any API contained in such Product, including any patent or patent application claiming the composition of matter for such Product or API, or their formulation, or any patent or patent application claiming the method of use or method of manufacture with respect to such Product or such API.

(p)If any country within the Territory issues a valid, bona fide compulsory license pursuant to (1) the requirements promulgated under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) or (2) valid laws within such country (“Compulsory License”) for any Product, then for the duration of such Compulsory License the royalty payable by Licensee on Net Sales for such Product in such country shall be reduced to the royalty rate paid to Gilead by such country for such Product under such Compulsory License.

4.2    Adjustment for Combination Products. Solely for the purpose of calculating Net Sales of Combination Products, if Licensee sells Product in the form of a Combination Product containing any Licensed API and one or more other active pharmaceutical ingredients in a particular country, Net Sales of such Combination Product in such country for the purpose of determining the royalty due to Gilead pursuant to Section 4.1 will be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/(A+B), where A is the invoice price of such Product if sold separately in such country, and B is the total invoice price of the other active pharmaceutical ingredient(s) in the combination if sold separately in such country. If, on a country-by-country basis, such other active pharmaceutical ingredient or ingredients in the Combination Product are not sold separately in such country, but the Product component of the Combination Product is sold separately in such country, Net Sales for the purpose of determining royalties due to Gilead for the Combination Product will be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/C, where A is the invoice price of such Product component if sold separately, and C is the invoice price of the Combination Product. If, on a country-by-country basis, such Product component is not sold separately in such country, Net Sales for the purposes of determining royalties due to Gilead for the Combination Product will be D/(D+E), where D is the fair market value of the portion of the Combination Products that contains the Product, and E is the fair market value of the portion of the Combination Products containing the other active pharmaceutical ingredient(s) included in such Combination Product, as such fair market values are determined by mutual agreement of the Parties, which shall not be unreasonably withheld.

4.3    Reports. Within sixty (60) days after the end of each calendar quarter, Licensee  shall  provide  Gilead  with  a  detailed  report  (the  “Quarterly  Report”) that

S-26

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

includes at least the information set forth in this Section 4.3. If any Quarterly Reports relate to EVG, EVG Product, EVG Combination Product or TAF Quad, Gilead will have the right to share such Quarterly Reports with Japan Tobacco.

(a)Product and API Information. In each Quarterly Report, Licensee agrees to set forth in reasonable detail: (i) amounts of API and Product manufactured by Licensee, (ii) API and Product in Licensee’s stock, (iii) the Third Party Resellers, if any, to which Licensee has provided Product and in what quantities (on a Third Party Reseller by Third Party Reseller basis), (iv) in the case of the sale of any API to third-party manufacturers of Product, the identity of such third parties and quantities of API sold to each such third party and (v) the volume of API or Product that Licensee intends to manufacture over the course of the following 12-month period, on a month by month basis.

(b)Payment Information. In each Quarterly Report, Licensee shall include the following information: (i) total invoiced sales of Product, Net Sales, the deductions used to determine Net Sales, number of units of Product sold, each of which shall be reported on a Product-by-Product and country-by-country basis, (ii) adjustments for Combination Products (pursuant to Section 4.2) including calculations showing the Net Sales of the EVG component of any EVG Combination Product or the TAF Quad, (iii) total royalties owed for the calendar quarter, the countries to which the Product has been sent and in what quantities, and  (iv) Net Sales by each Third-Party Reseller, if any.

(c)Regulatory Information. In each Quarterly Report, Licensee shall provide Gilead with the following information: (i) a list of countries within the Territory for which such regulatory approvals or authorization have been obtained for Product  and
(ii) a description of activities performed by Licensee, its designee or, to its knowledge any other third party, with respect to the filing, obtaining or maintaining of such regulatory approvals or authorizations for the Territory for any Product.

(d)Certifications; Payments. Together with each Quarterly Report, Licensee shall (i) provide Gilead with a written certification of the accuracy of the contents of the Quarterly Report, signed by an appropriate Licensee senior officer and (ii) pay royalties due to Gilead for the calendar quarter covered by such Quarterly Report. Licensee shall provide Quarterly Reports to Gilead at the address set forth in Section 12.4 below. Licensee shall pay royalties to Gilead by wire transfer to the bank account indicated by Gilead.

(e)Quarterly Reports. In each Quarterly Report, Licensee shall provide Gilead with the following information: (i) any Drug Controller General of India export permits obtained by the Licensee for Product, including the quantity of Product exported, the final destination of the Product and the recipient of the Product; and (ii) any Central Drugs Standard Control Organization (CDSCO) No Objection Certificates (NOC) obtained by third parties for Product for which Licensee provided assistance, including the quantity of Product exported, the final destination of the Product and the recipient of the Product.

S-27

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

4.4    Payment Terms; Conversion. Licensee shall make all payments to Gilead in US Dollars within sixty (60) days following the end of each calendar quarter. With regard to sales in currencies other than US Dollars, conversion from local currency into US Dollars shall be in accordance with Licensee’s normal and customary procedures, as reported in its audited financial statements.

4.5    Records. Licensee shall keep complete and accurate records of API and Product produced and sold in sufficient detail to enable Licensee to determine the amount of royalties due, the parties to whom Product or API was sold, and the countries in which sales occurred.

4.6    Audit. Gilead has the right to engage an independent public accountant to perform, on no less than thirty (30) days’ advance notice to Licensee, an audit, conducted in accordance with generally accepted auditing standards, of such books and records of Licensee that are deemed necessary by such public accountant to report amounts of API and Product produced, gross sales, Net Sales for the periods requested and accrued royalties. Gilead will bear the full cost of any such audit unless such audit discloses a difference of more than five percent (5%) from the amount of royalties due. In such case, Licensee shall promptly pay Gilead any underpayment and shall bear the full cost of such audit. To the extent relevant to EVG, EVG Product, EVG Combination Product, or TAF Quad, Gilead will have the right to disclose such audit results to Japan Tobacco.

4.7    Interest. Any amount payable hereunder by Licensee, which is not paid when due in accordance this Section 4, shall bear a pro rata monthly interest rate of one percent (1%) subject to any necessary approvals that may be required.

4.8    Taxes

(a)Withholding Taxes. Licensee shall promptly pay the withholding tax for and on behalf of Gilead to the proper governmental authority and shall promptly furnish Gilead with the tax withholding certificate furnished by the Licensee. Licensee shall be entitled to deduct the withholding tax actually paid from such payment due Gilead. Each party agrees to assist the other party in claiming exemption from such withholdings under double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted.

(b)Other Taxes. Except as provided in this Section 4.8, all taxes or duties in connection with payments made by Licensee shall be borne by Licensee.

4.9    Royalty Term. Royalty payments shall be paid to Gilead by Licensee on a Product-by-Product and country-by-country basis starting on the date of the first commercial sale of a Product in a country and continuing until the last to occur of the following: (a) the expiration or abandonment of the last-to-expire Patent containing a valid claim covering the manufacture, use, import, offer for sale or sale of API or Product in such country; and (b) the date of expiration or abandonment of the last-to-expire Patent containing a valid claim covering the manufacture, use, import, offer for sale or sale of API

S-28

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

or the Product in the country(ies) in which such Product is manufactured (the “Royalty Term”). Notwithstanding the foregoing, the Royalty Term for any Product will not extend beyond the date on which all patents and patent applications covering such Product (or the API contained therein) in the United States expire.

		
	5.
	Intellectual Property

5.1    Maintenance of Patents. Gilead (or, where applicable, Japan Tobacco) shall not be obligated to maintain or enforce the Patents.

5.2    Cooperation. If either party becomes aware of a suspected infringement of any Patent or the occurrence of any prohibited activity described in 7.2(a)(i)-(ix), such party will notify the other party promptly, and following such notification, the parties will confer. Gilead (except in the case of Patents relating to EVG, EVG Product, EVG Combination Product or TAF Quad that are subject to the Japan Tobacco Agreement and controlled by Japan Tobacco) will have the right, but not the obligation, to bring an infringement or other action at its own expense, in its own name, and entirely under its own direction and control. Licensee will reasonably assist Gilead (or, where applicable, Japan Tobacco) in such actions or proceedings if so requested, and will lend its name to such actions or proceedings if required by law in order for Gilead (or Japan Tobacco) to bring such an action.

5.3    Reporting of Improvements. Licensee shall provide Gilead with an annual report, in writing and in reasonable detail that sets forth any Improvements, including any patent applications claiming Improvements. Licensee shall transfer to Gilead, upon request by Gilead and at Gilead’s expense, any know-how owned or controlled by Licensee relating to such Improvements. Any failure to report any such Improvements to Gilead in accordance with the terms of this Agreement shall constitute a breach of this Agreement and shall provide Gilead with the right to terminate this Agreement pursuant to Section 10.2. Gilead shall not transfer any Improvements obtained from Licensee to any third party, provided, however, that (a) Gilead may transfer Improvements to Gilead’s own Affiliates and suppliers, provided such Affiliates and suppliers utilize such Improvements solely for the benefit of Gilead and/or Japan Tobacco, and (b) Gilead may transfer Improvements relating to EVG, EVG Product, EVG Combination Product, or TAF Quad to Japan Tobacco in accordance with the Japan Tobacco Agreement for use solely for the benefit of Japan Tobacco, including the transfer and use of such Improvements to Japan Tobacco’s suppliers for the benefit of Japan Tobacco. For clarity, Improvements (including EVG Improvements) relating to Pediatric Formulations will remain subject to Section 6.2(e).

5.4    Trademarks

(a)Any Product offered for sale or sold under this Agreement shall have a trade dress, including a distinct color, shape and trade name different from and not likely to be confused with, any product sold by or on behalf of Gilead and, where applicable, the comparable product sold by Japan Tobacco. Licensee’s non-performance of

S-29

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

the obligations set forth in this Section 5.4(a) shall constitute a material breach of Licensee’s material obligations under this Agreement.

(b)Licensee shall provide to Gilead, prior to any regulatory submissions for any Product, or selling or offering for sale any Product, samples of the Product and any packaging, labeling information or marketing materials (including, but not limited to, advertisement and promotional materials) to be used with the Product. Gilead shall have the right to review and approve the trademark and trade dress for such Product and its packaging to determine if such Product or its packaging is likely to be confused with Gilead’s trade dress and trademarks, consistent with the requirements set  forth  in  Section 5.4(a). If Gilead reasonably objects to the trade dress or other aspects of the Product or product packaging based on the requirements set forth in Section 5.4(a), the parties shall discuss in good faith Gilead’s concerns and Licensee agrees to make such modifications to the Product or packaging as are necessary to address Gilead’s concerns.

5.5    Technology Transfer. Licensee acknowledges that as of the Amended and Restated Effective Date Gilead has made the one-time technology transfers available to Licensee, whether directly or through MPP, of know-how owned or controlled by Gilead relating to the manufacture of TAF, EVG, COBI, TAF Product, EVG Product, COBI Product, and TAF Quad, in each case as described in Appendix 3 hereto. Additionally, during the term of this Agreement, within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for a Product containing BIC, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of BIC and such Product to the extent and in the manner specified in Appendix 3 hereto.

With respect to each of the foregoing technology transfers, Licensee shall notify Gilead of its desire to receive such technology transfer within the time period therefor, and following receipt of such notice Gilead will promptly make the applicable technology transfer. If Licensee does not notify Gilead of its desire to receive a particular technology transfer within the time period therefor, then Gilead will be under no obligation to make such technology transfer. Gilead shall have no further obligation to transfer any other know-how under this Agreement.

		
	6.
	Manufacturing and Commercialization of Product

6.1    Promotion of Sales in the Territory. The parties hereto agree that an important purpose of this Agreement is to increase patient access to the Products within the Territory. Except as otherwise provided in this Agreement (including Section 5.4 above), Licensee shall have the sole discretion to manage its own commercial strategy to promote and sell the Product in the Territory, provided, however, that Licensee shall not engage in activities that are inconsistent with the first sentence of this Section 6.1. By means of example and without limitation, Licensee agrees that Licensee shall not accept patient orders that Licensee does not have the capacity to fill, and shall not obtain API or Product without having the means, either directly or through the use of permitted third parties,   to

S-30

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

manufacture such API into Product and/or distribute such Product to patients within the Territory.

6.2    Manufacturing Requirements

(a)Minimum Standards. Licensee agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards;
(ii) either World Health Organization (“WHO”) pre-qualification standards, standards of the European Medicines Agency (“EMA”), or United States Food and Drug Administration (“FDA”) tentative approval standards (“Minimum Quality Standards”); and (iii) on a country-by-country basis, any applicable national, regional or local standards as may be required by the specific country where Product is sold. In addition, Licensee and its permitted Affiliate sublicensees shall meet the Minimum Quality Standards with respect to a particular Product prior to Licensee’s and its permitted Affiliate sublicensees’ sale of such Product to any country within the Territory.

(b)Audit Right. Licensee hereby agrees to allow Gilead reasonable access to Licensee’s books and records, facilities and employees solely for the purpose and to the extent required for Gilead to audit Licensee’s compliance with the requirements of this Section 6.2 and solely with respect to the API and Products licensed hereunder. Gilead agrees that it shall limit its access to Licensee’s employees to the extent required to conduct the audit and that such employees shall not be required to disclose to Gilead information that is subject to obligations of confidentiality with third parties unless such third parties have provided consent for such disclosure. Gilead agrees to provide at least thirty (30) days prior notice of the proposed audit, and agrees that such audits shall not be conducted more than once a year unless circumstances outside the ordinary course of business warrant such an audit (such as an investigation or other government action). To the extent any such audit relates to EVG, EVG Product, EVG Combination Product, or TAF Quad, Gilead will have the right to share reports from any such audit with Japan Tobacco.

(c)Remedy for Failure. If Licensee fails at any time to meet the Minimum Quality Standards with respect to the manufacture of API or Product, Gilead may elect, in its sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to suspend the effectiveness of the licenses granted hereunder until such time Gilead has determined that Licensee has corrected any such failure to Gilead’s reasonable satisfaction. During any such suspension, Gilead and Licensee shall coordinate with each other to provide for the supply of API or Product, as appropriate, to ensure that end-user patient requirements are not disrupted as a result of such suspension.

(d)Dose Requirements. All TAF Product, TAF Combination Product, EVG Product, COBI Product, EVG Combination Product, COBI Combination Product, BIC Product, BIC Combination Product, and TAF Quad manufactured, used or sold by Licensee shall consist of single dose concentrations of TAF, EVG, COBI, and/or BIC, that are the same as the dose concentration for such agent that has been approved by the FDA. Licensee agrees that it shall not manufacture or sell Products (including Combination Products) formulated at a single dose concentration other than those dose   concentrations

S-31

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

approved by the FDA for such agents (each an “Alternate Dosage”), without prior written consent from Gilead, provided, however, that in the case of TAF, COBI, and BIC, Licensee may manufacture or sell TAF Product, TAF Combination Product, COBI Product, COBI Combination Product, BIC Product, or BIC Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product.

(e)Pediatric Formulations. Licensee agrees to use reasonable efforts to develop a TAF Product, TAF Combination Product, EVG Product, EVG Combination Product, COBI Product, COBI Combination Product, BIC Product, or BIC Product Combination, as either a liquid or dispersible tablet formulation for use in pediatric patients less than 12 years of age (each, a “Pediatric Formulation”), provided, however, that with respect to EVG Product and EVG Combination Product, Licensee agrees not to develop any such Pediatric Formulation without Gilead’s prior written consent, not to be unreasonably withheld. Licensee may seek regulatory approval for Pediatric Formulations anywhere in the Territory.

(i)If Licensee is granted regulatory approval to market such Pediatric Formulation, then Licensee will use reasonable efforts to make such Pediatric Formulation available (A) if such Pediatric Formulation is a TAF Product or TAF Combination Product, throughout the TAF Territory, (B) if such Pediatric Formulation is a COBI Product or a COBI Combination Product, throughout the COBI Territory, or (C) if such Pediatric Formulation is an EVG Product or EVG Combination Product, throughout the EVG-TAF Quad Territory, or (D) if such Pediatric Formulation is a BIC Product or BIC Combination Product, throughout the BIC Territory (for purposes of this Section 6.2(e), “Licensee’s Applicable Territory”). Gilead would agree to waive any royalty Gilead otherwise would be entitled to receive for sale of such Pediatric Formulation pursuant to Section 4.1, provided such Pediatric Formulation is sold for use in pediatric populations under age 12 and not in adult populations.

(ii)Licensee will further agree either to license such Pediatric Formulation to Gilead or to other Licensed Product Suppliers or to manufacture and supply such Pediatric Formulation to one or more Gilead Distributors for sale (a) in territories that either are outside the scope of Licensee’s Applicable Territory but within the scope of the licensed territory of such designated Licensed Product Supplier or Gilead Distributor,   or
(b) in territories that are within Licensee’s Applicable Territory but in which Licensee is not able to make such Pediatric Formulation available. Licensee will be entitled to receive compensation for any such license or sale of such Pediatric Formulation to Gilead, a Licensed Product Supplier or Gilead Distributor that would be commensurate with (and not in excess of) the compensation Licensee would receive if Licensee itself sold such Pediatric Formulation in Licensee’s Applicable Territory.

(iii)If Gilead, in its sole discretion, is interested in pursuing the regulatory approval or marketing of such Pediatric Formulation in countries outside Licensee’s Applicable Territory, or in facilitating access to such Pediatric Formulation to countries  within  Licensee’s  Applicable  Territory  where  Licensee  has  not  made such

S-32

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Pediatric Formulation available, then Gilead and Licensee will negotiate a separate agreement relating to such Pediatric Formulation, with such agreement including appropriate compensation for Licensee for such Pediatric Formulation. Gilead shall have the right to sublicense such Pediatric Formulation to Japan Tobacco for use in Japan in accordance with the Japan Tobacco Agreement.

6.3    Regulatory Filings and Inspections. Except as provided otherwise herein, Licensee shall be responsible for obtaining and maintaining all applicable regulatory or other approvals or authorizations to carry out its activities in the Territory as set forth in this Agreement. Gilead may, in its discretion, elect to file for regulatory or other approval or authorization to make and sell API and Product anywhere in the Territory. Upon either party’s request, the other party shall provide non-proprietary data that the other party believes is reasonably necessary to obtain any such approvals, authorizations, permits or licenses. Licensee shall obtain, have and maintain all required registrations for its manufacturing facilities. Licensee shall allow appropriate regulatory authorities to inspect such facilities to the extent required by applicable law, rule or regulation. Gilead agrees to provide Licensee with NCE Exclusivity, or other regulatory exclusivity, waivers as may be required by the applicable regulatory authorities in order to manufacture or sell Product in the Territory, provided such manufacture and sale by Licensee is compliant with the terms and conditions of this Agreement. Licensee agrees not to pursue or obtain regulatory exclusivity on any Product in any country within the Territory.

6.4    Marketing Materials. Any marketing materials (including, but not limited to, advertisement and promotional materials) used by Licensee and its Third-Party Resellers shall not contain any misstatements of fact, shall be fully compliant with the applicable laws, rules and regulations, and shall be distinct from, and not cause any confusion with, any marketing materials or Products used or sold by Gilead, or any marketing materials or products sold by Japan Tobacco. Any statements made in such marketing materials regarding Gilead, including without limitation statements made in reference to Licensee’s collaboration with Gilead, shall require Gilead’s prior written approval.

6.5    Product Labeling. Licensee shall expressly state on the labeling of all Products sold or offered for sale under this Agreement that the Product “is manufactured under a license from Gilead Sciences. Inc.”

6.6    Safety Reporting.

(a)Licensee is responsible for all single and periodic reporting to all applicable regulatory authorities for the Products manufactured by or on behalf of Licensee under the Agreement.

(b)Licensee is responsible for all pharmacovigilance activities with respect to such Products, including but not limited to all associated signal detection, risk management and product labelling requirements.

S-33

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(c)In the event Licensee receives an individual case safety report associated with any Gilead proprietary product, Licensee agrees to forward such reports to Gilead at  E-Mail: SafetyFC@gilead.com   Fax: +1-650-522-5477.

(d)Licensee will forward details of any confirmed safety signals or emerging safety issues relating to Products manufactured by or on behalf of Licensee under this Agreement and any supporting documentation to the risk management contact at Gilead: Neda.Shokrai@gilead.com.

		
	7.
	Representations, Warranties and Covenants

7.1    Ability to Perform.  Gilead and Licensee each represent and warrant that

(a)they are duly organized, validly existing and in good standing under the laws of the jurisdiction of their incorporation and have full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

(b)this Agreement has been duly executed and delivered, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof; and

(c)the execution, delivery and performance of this Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such party.

7.2    Diversion of Product and Technology.

(a)Licensee covenants and agrees that Licensee and its Affiliates shall not, and shall require its Distributors and Third Party Resellers not to: (i) divert or allow the diversion of API outside of India, China, or South Africa, or to third parties that do not constitute Licensed Product Suppliers, (ii) divert or allow the diversion of TAF Product or TAF Combination Product, outside the TAF Territory, (iii) divert or allow the diversion of COBI Product or COBI Combination Product outside the COBI Territory, (v) divert or allow the diversion of EVG Product, EVG Combination Product or TAF Quad outside the EVG-TAF Quad Territory, (vi) divert or allow the diversion of BIC Product or BIC Combination Product, outside the BIC Territory, (vii) divert or allow the diversion of Licensed Technology to any third party, except as expressly permitted under this Agreement, (viii) take any action that Gilead determines in good faith to be in furtherance of the activities described in clauses (i) - (vii), or (ix) assist or support, directly or indirectly, any third party in the conduct of the activities described in clauses (i) - (viii). The parties agree that it shall not be a breach of Section 3.1 or this Section 7.2 for Licensee or its Affiliate to file marketing approval applications for any Product in a country outside of the Territory, or for Licensee or its Affiliate to provide developmental quantities of API or Product in support of such marketing approval applications or a third party’s application for marketing approval, in each case, as required by applicable regulatory authorities in

S-34

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

such country, it being understood that this provision shall not be construed as expressly or implicitly granting Licensee any right or license under any Gilead intellectual property right beyond the licenses granted in Section 2 of this Agreement or otherwise providing any authorization by Gilead to do so, and does not constitute a waiver of any rights of Gilead under law that it may have to contest the filing or granting of such marketing approval applications.

(b)Damages. In the event (i) any Product is diverted (x) by Licensee or its Affiliate sublicensees, or (y) by another party with the assistance of the Licensee or its Affiliate sublicensees, in each case to any country outside the Territory in any manner described in Section 7.2(a), and (ii) a patent covering such Product has been granted in such country or in the country(ies) outside the Territory in which such Product is manufactured (collectively the circumstance described by clause (i) and (ii), a “Diversion Event”), then in addition to any other remedies Gilead may be entitled to at law or in equity, Gilead shall be entitled to injunctive relief and to receive lost profits associated with the Diversion Event, which such lost profits will be determined by taking into consideration the following factors: (1) the quantity of Product that is the subject of such Diversion Event; (2) the average profit Gilead receives from its sale of such Product in the country(ies) outside the Territory into which such Product was sold or otherwise transferred; and (3) any erosion in Gilead’s market share in such country(ies) outside the Territory as a result of such Diversion Event.

7.3    Access Promotion. Licensee covenants and agrees that it shall not engage in activities that are contrary to the goal of promoting patient access to Product to satisfy unmet medical needs within the Territory.

7.4    Compliance

(a)General. Licensee covenants and agrees that it shall perform all activities under this Agreement in accordance with all applicable laws, rules, and regulations, including, without limitation, with respect to privacy, data protection, recalls, safety and reporting requirements and shall obtain, have and maintain all necessary regulatory approvals (including in India), marketing authorizations, permits and licenses, at Licensee’s expense for the manufacture and sale of the API and/or Product and any other Licensee activities contemplated under this Agreement.

(b)FCPA and UK Bribery Act. Licensee covenants and agrees that neither the Licensee, nor any of its Affiliates, nor any of their respective directors, officers, employees or agents (all of the foregoing, including Affiliates collectively, “Licensee Representatives”) has taken any action, directly or indirectly, that would result in a violation by such persons of the Foreign Corrupt Practices Act of 1977, as amended (such act, including the rules and regulations thereunder, the “FCPA”), the U.K. Bribery Act of 2010 (“Bribery Act”), or any other applicable anti-bribery or anticorruption laws, rules or regulations (collectively with the FCPA and the Bribery Act, the “Anticorruption Laws”). Licensee covenants and agrees that Licensee and Licensee Representatives have conducted and will conduct their businesses in compliance with the Anticorruption Laws.

S-35

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Licensee covenants and agrees that it shall provide to Gilead on the Amended and Restated Effective Date and within thirty (30) days after the beginning of each calendar year thereafter, certification in writing by Licensee of Licensee’s compliance with the Anticorruption Laws.

(c)Conflicts. Neither party shall be required to take any action or perform any obligation under this Agreement to the extent that such action or obligation is in direct conflict with any applicable law, rule or regulation, provided, however, that both Licensee and Gilead are in agreement regarding (i) the requirements of such law, rule or regulation, and (ii) the affect that such law, rule or regulation has on such action or obligation required under this Agreement.

7.5    Patent Infringement. Licensee covenants and agrees that it shall not infringe the Patents outside the scope of the licenses granted to it pursuant to Section 2, and shall not infringe the Emtricitabine Patents outside the scope of the covenant not to sue set forth in Section 7.6.

7.6    Covenant Concerning Certain Gilead Patents. Gilead covenants and agrees that it shall not, at any time during the term of this Agreement, bring any claim or proceeding of any kind or nature against Licensee in relation to any of the pending and issued patents identified in Appendix 4 hereto (the “Emtricitabine Patents”) to the extent that Licensee decides to make, use, sell, have sold and export any Product in the Territory that may infringe any claims covering the manufacture, use and sale of emtricitabine contained in such Emtricitabine Patents.

7.7    EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, GILEAD DOES NOT GIVE ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF NON-INFRINGEMENT IN THE TERRITORY. Gilead also does not give any warranty, express or implied, with regard to the safety or efficacy of API or the Product and it shall be the sole responsibility of the Licensee to ensure such safety or efficacy.

		
	8.
	Liability and Indemnity

8.1    Licensee Indemnity. Licensee shall indemnify, hold harmless and defend Gilead, and its subsidiaries, licensors, directors, officers, employees and agents (together, the “Gilead Indemnitees”), from and against any and all losses, damages, expenses, cost of defense (including, without limitation, attorneys’ fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts a Gilead Indemnitee becomes legally obligated to pay because of any claim against it (i) arising out of any breach by Licensee of the terms and conditions of this Agreement, or (ii) for any product liability, liability for death, illness, personal injury or improper business practice, or any other statutory liability or any other liability under any law or regulation, to the extent that such claim or claims are due to reasons caused by or on behalf of Licensee related to API or Product (including, without limitation, its manufacture, use or sale of API or Product). The

S-36

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

indemnification obligations of Licensee stated in this Section 8.1 shall apply only in the event that Gilead provides Licensee with prompt written notice of such claims, grants Licensee the right to control the defense or negotiation of settlement (using counsel reasonably approved by Gilead), and makes available all reasonable assistance in defending the claims. Licensee shall not agree to any final settlement or compromise with respect to any such claim that adversely affects Gilead without obtaining Gilead’s consent.

8.2    Product Liability. Licensee shall be solely responsible in respect of any product liability or any other statutory liability under any regulation, in respect of API or the Product.

8.3    Gilead Liability. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED IN THIS AGREEMENT, IN NO EVENT SHALL GILEAD BE LIABLE TO LICENSEE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY OR INCIDENTAL DAMAGES (INCLUDING BUT NOT LIMITED TO LOSS OF BUSINESS OR PROFITS) RELATED TO THIS AGREEMENT, AND SHALL NOT HAVE ANY RESPONSIBILITIES OR LIABILITIES WHATSOEVER WITH RESPECT TO API OR PRODUCT, EVEN IF, IN ANY SUCH CASE, ADVISED OF THE POSSIBILITY OF SUCH CLAIMS OR DEMANDS, REGARDLESS OF THE FORM OF ACTION OR LEGAL THEORY WHETHER UNDER CONTRACT LAW, TORT LAW (INCLUDING WITHOUT LIMITATION NEGLIGENCE), STRICT LIABILITY, STATUTE, WARRANTY OR OTHERWISE.

		
	9.
	Insurance

Within thirty (30) days prior to the first commercial launch by Licensee of a Product, and each year thereafter for so long as this Agreement is in effect, Licensee shall provide to Gilead certificates of insurance by insurers acceptable to Gilead evidencing public liability coverage in India, including products liability, with a combined limit of no less than one million dollars ($1,000,000.00) for bodily injury, including personal injury, and property damage. Gilead shall have the right to provide any such certificate to Japan Tobacco. Coverage with respect to public liability will be in India and will be global under product liability policy, and shall name Gilead and Japan Tobacco as additional insureds. Licensee shall not cancel any such policy without at least sixty (60) days prior written notice to Gilead, and agrees that such policy shall be maintained (or have an extended reporting period) of at least seven (7) years after the termination of this Agreement.

		
	10.
	Term and Termination

10.1    Term. This Agreement shall enter into force upon the Amended and Restated Effective Date and, unless earlier terminated as provided herein, shall continue until the expiration of the Royalty Term. Upon expiration of the Royalty Term (but not the earlier termination of this Agreement), and with respect to a particular Product in a particular country in the Territory, subject to the terms and conditions herein with respect

S-37

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

to such Product and such country, the license and sublicense granted in Section 2 to Licensee shall become a perpetual, irrevocable, fully paid-up, royalty free license under the Licensed Know-How to develop, make, have made, use, sell, have sold, offer for sale, import and distribute such Product in the Field in such country.

10.2    Termination for Breach. A party (“non-breaching party”) shall have the right to terminate this Agreement in the event the other party (“breaching party”) is in material breach of any of its material obligations under this Agreement. The non-breaching party shall provide written notice to the breaching party. The breaching party shall have a period of thirty (30) days after such written notice is provided to cure such breach. If such breach is not cured within the thirty day period, this Agreement shall effectively terminate.

10.3    Gilead Right to Terminate

(a)Gilead shall have the right to terminate this Agreement and/or one or both of the licenses granted pursuant to Section 2.1 or Section 2.2 (whether or not such event constitutes a right of termination pursuant to Section 10.2), immediately if in the reasonable opinion of Gilead, control (through ownership or otherwise) of Licensee changes.

(b)Gilead shall have the right to terminate this Agreement and/or one or both of the licenses granted pursuant to Section 2.1 or Section 2.2 and/or the covenant contained in Section 7.6 (whether or not such event constitutes a right of termination pursuant to Section 10.2), if:

(i)Gilead determines in good faith that (A) a material quantity of API made or sold by Licensee has been diverted outside of South Africa, China, or India, or to third parties that are not Licensed Product Suppliers, (B) Product made and/or sold by Licensee has been diverted to countries outside the Territory, whether or not by any fault or action or inaction of Licensee, or (C) any of the prohibited activities described in Section 7.2(a)(i)-(ix) has occurred;

(ii)Gilead determines in good faith that, due to material deficiencies in Licensee’s compliance, or repeated failure to comply, with the Minimum Quality Standards, Licensee is unable to reliably and consistently manufacture API or Product in accordance with the Minimum Quality Standards; or

		
	(iii)
	Gilead determines in good faith that Licensee has obtained

(x) material quantities of API from sources outside of India, China, or South Africa, or in ways that are inconsistent with the terms and conditions of Section 3; or

(iv)      Gilead’s rights to EVG terminate due to the termination of   the Japan Tobacco Agreement, provided, however, that in such event, such termination would only apply on a Product-by-Product basis and with respect to Products   containing

S-38

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

EVG that are subject to the sublicense granted by Gilead under the Japan Tobacco Agreement.

Gilead shall give Licensee written notice of any such event and provide Licensee with a period of thirty (30) days after such notice to demonstrate that the conditions giving rise to Gilead’s determination no longer exist to Gilead’s reasonable satisfaction. If Licensee is unable to do so, this Agreement shall be terminated effective upon the thirtieth (30th) day following such notice.
(c)(i) For clarity, and notwithstanding anything to the contrary in this Agreement, with respect to a particular Product, and on a Product-by-Product and country-by-country basis, if there is no Product Patent owned or controlled by Gilead (or its Affiliates) in India and a particular country outside of the Territory, and if there is no reasonable possibility of obtaining such a Product Patent within a reasonable period of time (for example, through pending patent applications, the filing of patent applications, or by legal action (including appeals)) in India and such country outside of the Territory, it shall not be deemed to be a breach of this Agreement for Licensee to supply such Product in such country and Licensee shall not be obligated to pay Gilead any royalty therefor; provided that Licensee obtained applicable regulatory approval in such country.

(ii) Similarly, on an API-by-API and Product-by-Product basis, it shall not be deemed to be a breach of the Agreement for Licensee: (x) to manufacture API in any country where there is no Product Patent owned or controlled by Gilead (or its Affiliates) covering such API in such country, and there is no reasonable possibility of obtaining such a Product Patent within a reasonable period of time (for example, through pending patent applications, the filing of patent applications, or by legal action (including appeals)) in such country; (y) to sell such API referred to in clause (x) of this Section 10.3(c)(ii) in any country where there is no Product Patent owned or controlled by Gilead (or its Affiliates) covering such API in such country, and there is no reasonable possibility of obtaining such a Product Patent within a reasonable period of time (for example, through pending patent applications, the filing of patent applications, or by legal action (including appeals)) in such country; or (z) to manufacture and/or sell Product incorporating such API referred to in clause (x) of this Section 10.3(c)(ii) in any country where there is no Product Patent owned or controlled by Gilead (or its Affiliates) covering such Product (or the API contained therein) in such country, and there is no reasonable possibility of obtaining such a Product Patent within a reasonable period of time (for example, through pending patent applications, the filing of patent applications, or by legal action (including appeals)) in such country.

(d)For further clarity, and notwithstanding anything to the contrary in this Agreement, it shall not be deemed to be a breach of the Agreement for Licensee to supply an API or Product outside the Territory into a country where: (i) the government of such country has issued a Compulsory License relating to such API or Product allowing for the importation of such API or Product into such country, provided that Licensee's supply of Product or API into such country is solely within the scope and geographic range of such Compulsory License and only for the duration that such Compulsory License is in  effect;

S-39

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

and/or (ii) the Government of India has issued a Compulsory License allowing for the export of an API or Product from India and into such country, provided that: (Y)(1) there are no Product Patents owned or controlled by Gilead (or its Affiliates) issued in such country or (2) a Compulsory License has also been issued by the relevant authorities of such country; and (Z) Licensee's supply of Product or API into such country is solely within the scope and geographic range of the Compulsory License issued by the Government of India, and only for the duration that such Compulsory License is in effect.

10.4    Licensee Right to Terminate. Licensee will have the right to terminate this Agreement for its convenience on an API-by-API basis upon thirty (30) days prior written notice to Gilead. Any written notice given under this Section 10.4 shall expressly identify the API(s) for which Licensee desires to terminate its license from Gilead (each, a “Terminated API”). In the event of any such termination, with respect to any such Terminated API, and in each case subject to Section 10.7, the following terms shall apply as of the effective date of termination for such API (the “API Termination Date”).

(a)All licenses granted by Gilead under this Agreement with respect to such Terminated API, and any other rights granted by Gilead with respect to such Terminated API, including without limitation Gilead’s obligation to make a technology transfer available with respect to such API pursuant to Section 5.5 (to the extent such technology transfer has not already occurred), shall terminate and all Sections of this Agreement shall be interpreted to exclude such Terminated API therefrom.

(b)All licenses granted by Gilead under this Agreement with respect to any product containing such Terminated API, and any other rights granted by Gilead with respect to such product(s), shall terminate and all Sections of this Agreement shall be interpreted to exclude such product(s) therefrom. For the avoidance of doubt (i) any termination by Licensee of its license to TAF pursuant to this Section 10.4 shall in turn terminate Licensee’s rights and licenses under all Patents that claim TAF (alone or in combination with any other compounds) to manufacture, sell, use, export or import any Product that contains TAF; (ii) any termination by Licensee of its license to COBI pursuant to this Section 10.4 shall in turn terminate Licensee’s rights and licenses under all Patents that claim COBI (alone or in combination with any other compounds) to manufacture, sell, use, export or import any Product that contains COBI; (iii) any termination by Licensee of its license to EVG pursuant to this Section 10.4 shall in turn terminate Licensee’s rights and licenses under all Patents that claim EVG (alone or in combination with any other compounds) to manufacture, sell, use, export or import any Product that contains EVG and (iv) any termination by Licensee of its license to BIC pursuant to this Section 10.4 shall in turn terminate Licensee’s rights and licenses under all Patents that claim BIC (alone or in combination with any other compounds) to manufacture, sell, use, export or import any Product that contains BIC.

(c)For the avoidance of doubt, (i) nothing set forth in this Section 10.4 shall limit Licensee’s ability to manufacture and sell any API for which it retains a license under this Agreement in combination with any other active pharmaceutical ingredient(s), including without limitation a Terminated API, provided that (Y) Licensee has the legal

S-40

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

right to manufacture and sell such other active pharmaceutical ingredient and products containing such other active pharmaceutical ingredient within the applicable country(ies) within the Territory and (Z) such manufacture and/or sale is in compliance with the licenses, rights and obligations granted herein, including without limitation Section 2.5(c); and (ii) Licensee will have no obligation to pay Gilead any royalties on Net Sales generated from any product containing a Terminated API and not containing any other API (“Terminated Product”) after the API Termination Date.

(d)Termination of any license with respect to any API under this Section 10.4 shall not relieve Licensee of any obligation accruing on or prior to the API Termination Date therefor, including the obligation to pay royalties pursuant to Article 4 on Net Sales of any Product sold prior to the API Termination Date. Upon termination of all API licensed to Licensee under this Agreement, this Agreement shall be deemed terminated in its entirety pursuant to Section 10.4. Nothing set forth in this Section 10.4 shall be deemed a waiver by Gilead to enforce any Patent or any other intellectual property right owned or controlled by Gilead against Licensee for any activities Licensee may undertake with respect to any Terminated API or Terminated Product after any such API Termination Date.

10.5    Insolvency. In the event that Licensee becomes insolvent, makes an assignment to the benefit of creditors, or has a petition in bankruptcy filed for or against it, Gilead shall have the right to treat such event as a material breach.

10.6    Waiver. The waiver by either party of any breach of any term or condition of this Agreement shall not be deemed a waiver as to any subsequent or similar breach.

10.7    Survival. On a Product-by-Product and API-by-API basis, Sections 1, 2.4 (with respect to Improvements developed prior to the effective date of expiration or termination), 2.6(b), 4.3 (with respect to API and Product manufactured and/or sold prior to the effective date of expiration or termination), 4.5 (for a period of 3 years following the effective date of expiration or termination), 4.6 (for a period of 3 years following the effective date of expiration or termination), 5.2 (solely with respect to the obligations set forth in the last sentence of Section 5.2), 5.3 (for a period of 1 year following the effective date of expiration or termination of the Agreement, and solely with respect to Improvements developed prior to the effective date of expiration or termination), 5.4(a), 6.2(e)(iii), 6.3, 7.2(b)(with respect to Products sold prior to such expiration or termination), 7.7, 8, 9, 10.1, 10.4(d), 10.6, 10.7, 11 and 12 shall survive (a) termination or expiry of this Agreement or (b) in the event Licensee terminates its license with respect to any API as provided in Section 10.4, the API Termination Date with respect to such Terminated API and Terminated Product; provided, however, that in the event of such a termination pursuant to this clause 10.7(b), (i) Sections 5.3 and 6.2(e)(iii) shall not survive with respect to such Terminated API or Terminated Product and (ii) Section 2.4 shall survive solely with respect to those Improvements relating to such Terminated API or Terminated Product first developed by Licensee prior to the API Termination Date therefor. Except as otherwise provided in this Section 10.7, all rights and obligations of the parties under this Agreement shall terminate upon the expiration or termination of this Agreement.

S-41

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	11.
	Confidentiality and Publications

11.1    Confidential Information. All information of proprietary nature, including technology and know-how (“Confidential Information”), disclosed by one party (the “Disclosing Party”) to the other party (the “Receiving Party”) hereunder shall (a) be used solely and exclusively by the Receiving Party in a manner consistent with the licenses and rights granted hereunder; (b) be maintained in confidence by the Receiving Party; and (c) not be disclosed to any third party or used for any purpose except to exercise its rights and perform its obligations under this Agreement. The foregoing confidentiality obligations shall not apply if the Receiving Party can demonstrate by competent written evidence that such information: (i) is known by the Receiving Party at the time of its receipt and, not through a prior disclosure by the Disclosing Party, as documented by the Receiving Party’s business records; (ii) is in the public domain other than as a result of any breach of this Agreement by the Receiving Party; (iii) is subsequently disclosed to the Receiving Party on a non-confidential basis by a third party who may lawfully do so; or (iv) is independently discovered or developed by the Receiving Party without the use of Confidential Information provided by the Disclosing Party, as documented by the Receiving Party’s business records. Within thirty (30) days after any expiration or termination of this Agreement, Receiving Party shall destroy (and certify to the Disclosing Party such destruction) or return all Confidential Information provided by the Disclosing Party except as otherwise set forth in this Agreement. One (1) copy of the Confidential Information may be retained in the Receiving Party’s files solely for archival purposes as a means of determining any continuing or surviving obligations under this Agreement. The confidential obligations under this Agreement shall survive this Agreement for a period of five (5) years. To the extent Gilead receives any Confidential Information from Licensee relating to EVG, EVG Product, EVG Combination Product or TAF Quad, Gilead will have the right to disclose such Confidential Information to Japan Tobacco, provided such disclosure remains subject to the obligations of confidentiality and non-disclosure set forth in the Japan Tobacco Agreement.

11.2    Press Release. Each party may disclose to third parties or make public statements, by press release or otherwise, regarding the existence of this Agreement, the identity of the parties, the terms, conditions and subject matter of this Agreement, or otherwise in reference to this Agreement, provided such disclosures or statements are accurate and complete with respect to the subject matter thereof and the information disclosed therein.

11.3    Use of Name. Except as provided for under Section 11.2, neither party shall use the other party’s name, logo or trademarks for any purpose including without limitation publicity or advertising, except with the prior written consent of the other party. Licensee agrees not to use Japan Tobacco’s name, logo or trademarks for any purpose except with the prior written consent of Japan Tobacco.

S-42

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	12.
	Miscellaneous

12.1    Agency. Neither party is, nor will be deemed to be, an employee, agent or representative of the other party for any purpose. Each party is an independent contractor, not an employee or partner of the other party. Neither party shall have the authority to speak for, represent or obligate the other party in any way without prior written authority from the other party.

12.2    Entire Understanding. This Agreement embodies the entire understanding of the parties with respect to the subject matter hereof and supersedes all previous communications, representations or understandings, and agreements, whether oral or written, between the parties relating to the subject matter hereof. Gilead and Licensee hereby expressly agree that this Agreement amends and restates in its entirety the Original License Agreement as of the Amended and Restated Effective Date, and the terms of the Original License Agreement shall apply with respect to the period of time preceding the Amended and Restated Effective Date.

12.3    Severability. The parties hereby expressly state that it is not their intention to violate any applicable rule, law or regulation. If any of the provisions of this Agreement are held to be void or unenforceable with regard to any particular country by a court of competent jurisdiction, then, to the extent possible, such void or unenforceable provision shall be replaced by a valid and enforceable provision which will achieve as far as possible the economic business intentions of the parties. The provisions held to be void or unenforceable shall remain, however, in full force and effect with regard to all other countries.  All other provisions of this Agreement shall remain in full force and effect.

12.4    Notices

(a)Any notice or other communication to be given under this Agreement, unless otherwise specified, shall be in writing and shall be deemed to have been provided when delivered to the addressee at the address listed below (i) on the date of delivery if delivered in person or (ii) three days after mailing by registered or certified mail, postage paid:

In the case of Gilead:

Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 U.S.A.
Attention: General Counsel Facsimile:  (650) 522-5537

S-43

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

In the case of Licensee: [TBD]

(b)Either party may change its address for communications by a notice in writing to the other party in accordance with this Section 12.4.

12.5    Governing Law. This Agreement is made in accordance with and shall be governed and construed under the laws of England, without regard to its choice of law principles.

12.6    Arbitration

(a)All disputes arising out of or in connection with the present Agreement shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by three arbitrators.

(b)Each party shall nominate one arbitrator. Should the claimant fail to appoint an arbitrator in the Request for Arbitration within thirty (30) days of being requested to do so, or if the respondent should fail to appoint an arbitrator in its Answer to the Request for Arbitration within thirty (30) days of being requested to do so, the other party shall request the ICC Court to make such appointment.

(c)The arbitrators nominated by the parties shall, within thirty (30) days from the appointment of the arbitrator nominated in the Answer to the Request for Arbitration, and after consultation with the parties, agree and appoint a third arbitrator, who will act as a chairman of the Arbitral Tribunal. Should such procedure not result in an appointment within the thirty (30) day time limit, either party shall be free to request the ICC Court to appoint the third arbitrator.

		
	(d)
	London, England shall be the seat of the arbitration.

(e)The language of the arbitration shall be English. Documents submitted in the arbitration (the originals of which are not in English) shall be submitted together with an English translation.

(f)This arbitration agreement does not preclude either party seeking conservatory or interim measures from any court of competent jurisdiction including, without limitation, the courts having jurisdiction by reason of either party’s domicile. Conservatory or interim measures sought by either party in any one or more jurisdictions shall not preclude the Arbitral Tribunal granting conservatory or interim measures. Conservatory or interim measures sought by either party before the Arbitral Tribunal shall not preclude any court of competent jurisdiction granting conservatory or interim measures.

S-44

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(g)In the event that any issue shall arise which is not clearly provided for in this arbitration agreement the matter shall be resolved in accordance with the ICC Arbitration Rules.

12.7    Assignment. Gilead is entitled to transfer and assign this Agreement and the rights and obligations under this Agreement on prior notice to Licensee. Licensee is not entitled to transfer or assign this Agreement or the rights and obligations under this Agreement.

12.8    Amendment. No amendment or modification hereof shall be valid or binding upon the parties unless made in writing and signed by both parties.

END OF PAGE
[signatures appear on following page]

S-45

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

IN WITNESS WHEREOF, the parties hereto have executed this Amended and Restated License Agreement as of the Amended and Restated Effective Date.

GILEAD:

Gilead Sciences, Inc.

By_____________________________________     
Name:
Title:

LICENSEE:

By_____________________________________     
Name:
Title:

S-46

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Appendix 1
Countries in the TAF Territory, COBI Territory, and BIC Territory

	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-47

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Appendix 2
Patents

TDF Patents

(221) Title: NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	India
	Pending
	7/25/1997
	2076/DEL/1997
	 
	 

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	SubCase
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

S-48

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

TAF Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	African Regional Industrial Property Organization
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

S-49

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

S-50

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

	El Salvador
	Published
	E-4696/2014
	10/3/2012
	 
	 

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012
	 
	 

	India
	Published
	2953/DELNP/2014
	10/3/2012
	 
	 

	Pakistan
	Pending
	671/2012
	10/3/2012
	 
	 

EVG Patents

(JF-0136) Title: COMPOUND AND METHOD OF USE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	 

	Bolivia
	Pending
	SP-230265
	11/18/2003
	 
	 

	India
	Granted
	01316/CHENP/2004
	11/20/2003
	245833
	2/3/2011

	Indonesia
	Granted
	WO00200401542
	11/20/2003
	P0023507
	6/1/2009

	Nigeria
	Granted
	424/2003
	11/19/2003
	RP.15779
	10/20/2004

	Philippines
	Granted
	1-2004-500895
	11/20/2003
	1-2004-500895
	8/20/2008

	South Africa
	Granted
	2004/4537
	11/20/2003
	2004/4537
	8/31/2005

	Thailand
	Pending
	301004379
	11/20/2003
	 
	 

	Vietnam
	Granted
	1-2004-00605
	11/20/2003
	1-0011884
	10/7/2013

(JF-0179) Title: CRYSTALLINE FORM

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	 

	Bolivia
	Pending
	SP-250121
	5/19/2005
	 
	 

	India
	Pending
	357/CHENP/2010
	5/19/2005
	 
	 

	Philippines
	Granted
	1-2006-502297
	5/19/2005
	1-2006-502297
	11/19/2010

	South Africa
	Granted
	2006/10647
	5/19/2005
	2006/10647
	6/25/2008

	Thailand
	Pending
	100718
	5/19/2005
	 
	 

(JF-0193) Title: MANUFACTURING PROCESS: ROUTE D AND F

	
						
	Country
	Status
	Application No.:
	Filing Date
	Patent No.
	Issue Date

	India
	Granted
	5344/CHENP/2008
	3/6/2007
	258895
	2/13/2014

	India
	Pending
	532/CHENP/2014
	3/6/2007
	 
	 

(JF-0192) Title: MANUFACTURING PROCESS: ROUTE C AND E

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No:
	Issue Date

S-51

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004621
	3/6/2007
	2914
	5/5/2014

	Eurasian Patent Organization
	Granted
	200870321
	3/6/2007
	17861
	3/29/2013

	Indonesia
	Pending
	W00200802860
	3/6/2007
	IDP0032077
	10/22/2012

	India
	Granted
	5341/CHENP/2008
	3/6/2007
	258747
	2/4/2014

	India
	Pending
	613/CHENP/2014
	3/6/2007
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1200800317
	3/6/2007
	14280
	3/31/2009

	Vietnam
	Granted
	1-2008-02431
	3/6/2007
	14450
	8/17/2015

	South Africa
	Granted
	2008/07547
	3/6/2007
	2008/07547
	11/25/2009

(718) Title: METHODS OF IMPROVING THE PHARMACOKINETICS OF HIV INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	 

	Armenia
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004522
	12/29/2006
	AP2702
	7/31/2013

	Eurasian Patent Organization
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Eurasian Patent Organization
	Published
	201201496
	12/29/2006
	 
	 

	Indonesia
	Pending
	W00201102461
	12/29/2006
	 
	 

	Indonesia
	Published
	W00 2008 02128
	12/29/2006
	 
	 

	India
	Pending
	6748/DELNP/2015
	12/29/2006
	 
	 

	India
	Pending
	5576/DELNP/2008
	12/29/2006
	 
	 

	Kyrgyz Republic
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Moldova
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Intellectual Property Organization (OAPI)
	Granted
	1200800239
	12/29/2006
	14320
	6/30/2009

	Tajikistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Turkmenistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Vietnam
	Pending
	1-2008-01921
	12/29/2006
	 
	 

	South Africa
	Granted
	2008/06222
	12/29/2006
	2008/06222
	3/25/2009

(720) Title:  PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS
	
						
	Country
	Status
	Application No.
	Filing Date
	Patent Number
	Issue Date

	Armenia
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004831
	9/11/2007
	AP3004
	10/16/2014

	Eurasian Patent Organization
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

S-52

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Indonesia
	Published
	W00200900634
	9/11/2007
	 
	 

	Kyrgyz Republic
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Kazakhstan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Moldova
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Intellectual Property Organization (OAPI)
	Granted
	1200900070
	9/11/2007
	14458
	9/30/2009

	Thailand
	Published
	701004583
	9/11/2007
	 
	 

	Tajikistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Turkmenistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Vietnam
	Granted
	1-2009-00636
	9/11/2007
	11932
	10/22/2013

	Vietnam
	Granted
	1-2012-01354
	9/11/2007
	14698
	10/20/2015

	South Africa
	Granted
	2009/01576
	9/11/2007
	2009/01576
	2/24/2010

(746) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No
	Filing Date
	Patent Number
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005187
	9/11/2008
	AP 2785
	10/31/2013

	Eurasian Patent Organization
	Granted
	201070256
	9/11/2008
	19431
	3/31/2014

	Ecuador
	Inactive
	SP-10-10081
	9/11/2008
	 
	 

	Indonesia
	Published
	W00201000759
	9/11/2008
	 
	 

	India
	Pending
	1615/DELNP/2010
	9/11/2008
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201000093
	9/11/2008
	15058
	 

	Thailand
	Published
	801004676
	9/11/2008
	 
	 

	Vietnam
	Granted
	1-2010-00483
	9/11/2008
	10866
	11/20/2012

	South Africa
	Granted
	2010/02066
	9/11/2008
	2010/02066
	12/29/2010

(903) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	Eurasian Patent Organization
	Allowed
	201590018
	8/1/2013
	 

	India
	Pending
	1688/DELNP/2015
	8/1/2013
	 

COBI Patents

(692) Title: MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS
	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property
	Granted
	1200800450
	9/30/2009
	14409

S-53

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Organization (OAPI)

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vanuatu
	Unfiled
	 
	 
	 

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

S-54

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

S-55

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/005864
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Published
	SP-0082-2010
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

S-56

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	India
	Abandoned
	6192/DELNP/2014
	 
	 

BIC Patents

(1007) TITLE: POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Pending
	1201500240
	12/19/2013
	 
	 

	African Regional Industrial Property Organization
	Pending
	AP/P/2015/008510
	12/19/2013
	 
	 

	Anguilla
	Pending
	AI/A/2016/00180
	12/19/2013
	 
	 

	Bahamas
	Pending
	2551
	12/19/2013
	 
	 

	Bolivia
	Published
	SP-00412-2013
	12/20/2013
	 
	 

	Congo, Democratic Republic of
	Pending
	 
	12/19/2013
	 
	 

	Ecuador
	Published
	IEPI-2015-31224
	12/19/2013
	 
	 

	El Salvador
	Published
	E-5002-2015
	12/19/2013
	 
	 

	Ethiopia
	Pending
	ET/PI/16/204
	12/19/2013
	 
	 

	Eurasian Patent Organization
	Published
	201591027
	12/19/2013
	 
	 

	Fiji
	Published
	1229
	12/19/2013
	 
	 

	Grenada
	Granted
	 
	12/19/2013
	 
	7/19/2016

	Guyana
	Pending
	1656
	12/19/2013
	 
	 

	Haiti
	Pending
	 
	12/19/2013
	 
	 

	India
	Pending
	5535/DELNP/2015
	12/19/2013
	 
	 

	Indonesia
	Allowed
	P00201503852
	12/19/2013
	 
	 

	Indonesia
	Pending
	P00201607128
	12/19/2013
	 
	 

	Jamaica
	Pending
	18/1/5740
	12/19/2013
	 
	 

	Kiribati
	Granted
	 
	12/19/2013
	 
	9/20/2016

	Moldova
	Pending
	a20150064
	12/19/2013
	 
	 

	Montserrat
	Granted
	 
	12/19/2013
	4 OF 2016
	5/27/2016

S-57

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Nepal
	Pending
	4
	12/19/2013
	 
	 

	Pakistan
	Pending
	908/2013
	12/20/2013
	 
	 

	Philippines
	Published
	1-2015-501445
	12/19/2013
	 
	 

	Philippines
	Pending
	1-2016-500389
	12/19/2013
	 
	 

	Seychelles
	Pending
	2822954
	12/19/2013
	 
	 

	Sierra Leone
	Pending
	 
	12/19/2013
	 
	 

	Solomon Islands
	Granted
	 
	12/19/2013
	J37/379
	8/5/2016

	South Africa
	Pending
	2015/04914
	12/19/2013
	 
	 

	South Africa
	Pending
	2015/07997
	12/19/2013
	 
	 

	South Korea
	Pending
	10-2015-7019194
	12/19/2013
	 
	 

	Thailand
	Pending
	1501003563
	12/19/2013
	 
	 

	Turks and Caicos Islands
	Granted
	10226
	12/19/2013
	10226
	9/7/2016

	Tuvalu
	Granted
	TVP2822954
	12/19/2013
	TVP2822954
	8/15/2016

	Vietnam
	Granted
	1-2015-02321
	12/19/2013
	15503
	5/16/2016

	Vietnam
	Pending
	1-2015-04199
	12/19/2013
	 
	 

	Virgin Islands (British)
	Granted
	EP2822954
	12/19/2013
	427/5/2016
	9/21/2016

(1091) Title: SODIUM
(2R,5S,13AR)-7,9-DIOXO-10-((2,4,6-TRIFLUOROBENZYL)CARBAMOYL)-2,3,4,5,7,9,13,13A-OC TAHYDRO-2,5-METHANOPYRIDO[1',2':4,5]PYRAZINO[2,1-B]OXAZEPIN-8-OLATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Regional Industrial Property Organization
	Pending
	AP/P/2016/009591
	6/19/2015
	 

	African Intellectual Property Organization (OAPI)
	Pending
	1201600454
	6/19/2015
	 

	Bolivia
	Published
	SP 126-2015
	6/19/2015
	 

	Bahamas
	Allowed
	2701
	6/18/2015
	 

	Cuba
	Pending
	2016-0187
	6/19/2015
	 

	Dominican Republic
	Published
	P2016-0327
	6/19/2015
	 

	Eurasian Patent Organization
	Pending
	201692414
	6/19/2015
	 

	Ecuador
	Published
	IEPI-2016-95566
	6/19/2015
	 

	El Salvador
	Pending
	2016005339
	6/19/2015
	 

	Guatemala
	Pending
	A2016-000262
	6/19/2015
	 

	Indonesia
	Unfiled
	 
	 
	 
	 

	India
	Pending
	201617042937.00
	6/19/2015
	 

	Nigeria
	Pending
	NG/PT/C/2016/2106
	6/19/2015
	 

	Philippines
	Pending
	 
	 
	 
	 

	Pakistan
	Pending
	382/2015
	6/18/2015
	 

	Thailand
	Pending
	 
	 
	 
	 

S-58

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
				
	Trinidad and Tobago
	Pending
	TT/A/2016/00132
	6/19/2015

	Vietnam
	Pending
	 
	 

	South Africa
	Pending
	2016/08744
	6/19/2015

(1147) Title: THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bangladesh
	Pending
	272/2016
	11/2/2016
	 
	 

	Bolivia
	Pending
	SP-0260-2016
	11/9/2016
	 
	 

	Bahamas
	Pending
	 
	11/8/2016
	 
	 

	Pakistan
	Pending
	696/2016
	11/9/2016
	 
	 

	Patent Cooperation Treaty
	Entered NP
	US2016/060989
	11/8/2016
	 
	 

(1062) Title: SYNTHESIS OF POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Allowed
	2702
	6/18/2015
	 
	 

	Eurasian Patent Organization
	Pending
	201692412
	6/16/2015
	 
	 

	India
	Pending
	201717000457.00
	6/16/2015
	 
	 

	Patent Cooperation Treaty
	Entered NP
	US2015/036017
	6/16/2015
	 
	 

TDF-Quad Patents

(221) Title:NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	India
	Pending
	7/25/1997
	2076/DEL/1997
	 
	 

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC

S-59

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985
	 

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489
	 

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134
	 

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489
	 

	Fiji
	Published
	1217
	 
	 
	 

	Guyana
	Published
	1642
	 
	 
	 

	Haiti
	Pending
	 
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227
	 

	Jamaica
	Pending
	18/1/5696
	 
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489
	 

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15
	 

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489
	 

	Moldova
	Granted
	200900155
	11/28/2014
	20489
	 

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015
	 

	Nauru
	Pending
	 
	 
	 
	 

	Nepal
	Pending
	894
	 
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506
	 

	Sierra Leone
	Pending
	EP2049506
	 
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370
	 

	South Africa
	Pending
	2008/10399
	 
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489
	 

	Thailand
	Published
	701003404
	 
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489
	 

	Turks and Caicos Islands
	Pending
	10214
	 
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506
	 

	Vietnam
	Pending
	1-2009-00240
	 
	 
	 

S-60

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

S-61

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	India
	Abandoned
	6192/DELNP/2014
	 
	 

(EMU-108) Title:  Antiviral Activity and Resolution of
2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)-1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

S-62

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

TAF-Quad Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

S-63

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	African Intellectual Property Organization (OAPI)
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	African Regional Industrial Property Organization
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

S-64

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	(OAPI)

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

	El Salvador
	Published
	E-4696/2014
	10/3/2012
	 
	 

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012
	 
	 

	India
	Published
	2953/DELNP/2014
	10/3/2012
	 
	 

	Pakistan
	Pending
	671/2012
	10/3/2012
	 
	 

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985
	 

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

S-65

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

S-66

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Organization

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

S-67

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	India
	Abandoned
	6192/DELNP/2014
	 
	 

(899) Title: THERAPEUTIC COMPOUNDS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Eurasian Patent Organization
	Published
	201491287
	2/1/2013
	 
	 

	India
	Pending
	7100/DELNP/2014
	2/1/2013
	 
	 

(EMU-108) Title:  Antiviral Activity and Resolution of
		
	1-
	Hydroxymethyl-5-(5-Fluorocytosin-1-yl)-1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

S-68

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

For purposes of this Appendix 2, references to “PCT,”“OAPI,” “EAPO” and “ARIPO” shall not be construed or interpreted to grant rights to Licensee in any country other than those countries expressly included within the licenses granted to Licensee in Sections 2.2 and 2.3 of this Agreement.

S-69

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Appendix 3

Terms for Technology Transfer

		
	A.
	Licensee acknowledges that, as of the Amended and Restated Effective Date, Gilead has made the following information available to Licensee in accordance with Section 5.5 to fully enable Licensee to manufacture TAF, EVG, COBI, TAF Product, EVG Product, COBI Product, and TAF Quad, at commercial-scale quantities and in compliance with Gilead’s required quality specifications:

		
	1.
	Manufacturing process descriptions, specifications and methods;

		
	2.
	Stability data;

		
	3.
	Analytical method validation; and

		
	4.
	Discussion of impurities.

		
	B.
	Gilead will make available to Licensee the following information in accordance with Section 5.5. to fully enable Licensee to manufacture BIC and such FDA-approved Product containing BIC at commercial-scale quantities and in compliance with Gilead’s required quality specifications :

		
	1.
	Manufacturing process descriptions, specifications and methods;

		
	2.
	Stability data;

		
	3.
	Analytical method validation; and

		
	4.
	Discussion of impurities.

S-70

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Appendix 4 Emtricitabine Patents
(EMU-108) Title:  Antiviral Activity and Resolution of
2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)-1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Dominican Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

S-71

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Appendix 5

Countries in the EVG-TAF Quad Territory

	
					
	1.Afghanistan
	35.
	Gabon
	73.
	Palau

	2.Angola
	36.
	Gambia
	74.
	Papua New Guinea

	3.Anguilla
	37.
	Georgia
	75.
	Rwanda

	4.Antigua and
	38.
	Ghana
	76.
	Saint Kitts and Nevis

	Barbuda
	39.
	Grenada
	77.
	Saint Lucia

	5.Armenia
	40.
	Guatemala
	78.
	Saint Vincent & the

	6.Bahamas
	41.
	Guinea
	 
	Grenadines

	7.Bangladesh
	42.
	Guinea-Bissau
	79.
	Samoa

	8.Barbados
	43.
	Guyana
	80.
	São Tomé and Príncipe

	9.Belize
	44.
	Haiti
	81.
	Senegal

	10.Benin
	45.
	Honduras
	82.
	Seychelles

	11.Bhutan
	46.
	India
	83.
	Sierra Leone

	12.Bolivia
	47.
	Indonesia
	84.
	Solomon Islands

	13.Botswana
	48.
	Jamaica
	85.
	Somalia

	14.British Virgin
	49.
	Kazakhstan
	86.
	South Africa

	Islands
	50.
	Kenya
	87.
	South Sudan

	15.Burkina Faso
	51.
	Kiribati
	88.
	Sri Lanka

	16.Burundi
	52.
	Kyrgyzstan
	89.
	Sudan

	17.Cambodia
	53.
	Lao People's Dem.
	90.
	Suriname

	18.Cameroon
	 
	Rep.
	91.
	Swaziland

	19.Cape Verde
	54.
	Lesotho
	92.
	Syrian Arab Republic

	20.Central African
	55.
	Liberia
	93.
	Tajikistan

	Republic
	56.
	Madagascar
	94.
	Tanzania, U. Rep. of

	21.Chad
	57.
	Malawi
	95.
	Thailand

	22.Comoros
	58.
	Maldives
	96.
	Timor-Leste

	23.Congo, Rep
	59.
	Mali
	97.
	Togo

	24.Congo, Dem.
	60.
	Mauritania
	98.
	Tonga

	Rep. of the
	61.
	Mauritius
	99.
	Trinidad and Tobago

	25.Côte d'Ivoire
	62.
	Moldova, Rep. of
	100.
	Turkmenistan

	26.Cuba
	63.
	Mongolia
	101.
	Turks and Caicos

	27.Djibouti
	64.
	Mozambique
	102.
	Tuvalu

	28.Dominica
	65.
	Myanmar
	103.
	Uganda

	29.Ecuador
	66.
	Namibia
	104.
	Uzbekistan

	30.El Salvador
	67.
	Nauru
	105.
	Vanuatu

	31.Equatorial Guinea
	68.
	Nepal
	106.
	Vietnam

	32.Eritrea
	69.
	Nicaragua
	107.
	Yemen

	33.Ethiopia
	70.
	Niger
	108.
	Zambia

	34.Fiji Islands, Rep.
	71.
	Nigeria
	109.
	Zimbabwe

	of the
	72.
	Pakistan
	 
	 

S-72

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

EXHIBIT 2

FIRST AMENDMENT
TO
SECOND AMENDED AND RESTATED LICENSE AGREEMENT

THIS FIRST AMENDMENT TO SECOND AMENDED AND RESTATED LICENSE AGREEMENT (this “Amendment”) is made as of ________________________(the “Amendment Effective Date”) by and between Gilead Sciences, Inc., a Delaware, USA corporation having its principle place of business at 333 Lakeside Drive, Foster City, California 94404 (“Gilead”) and Medicines Patent Pool, a non-profit foundation registered under the laws of Switzerland having a principal place of business at Rue de Varembé 7, 1202 Geneva, Switzerland (“MPP”). Gilead and MPP are each referred to individually herein as a “Party” and collectively as the “Parties.”

WHEREAS, Gilead and MPP entered into that certain Second Amended and Restated License Agreement effective as of June 10, 2015 (the “Agreement”), pursuant to which Gilead granted MPP certain licenses with respect to its proprietary pharmaceutical agents tenofovir alafenamide, tenofovir disoproxil fumurate, elvitegravir, and cobicistat for treatment of HIV and HBV in developing world countries; and

WHEREAS, Gilead and MPP wish to amend the Agreement to add certain licenses with respect to Gilead’s proprietary pharmaceutical agent bictegravir for treatment of HIV in developing world countries, in accordance with the terms and conditions of this Amendment, all as more fully described below.

NOW, THEREFORE, Gilead and MPP agree as follows:

1.Definitions.

		
	a.
	The definitions of the below terms are hereby deleted from Section 1 of the Agreement and replaced as follows:

“Active Pharmaceutical Ingredient” or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”); tenofovir disoproxil fumurate (“TDF”); elvitegravir (“EVG”); cobicistat (“COBI”); and bictegravir (“BIC”).

“Combination Products” shall mean BIC Combination Products, COBI Combination Products, EVG Combination Products, TAF Combination Products, and the Quad Products.

“Patents” shall mean (a) the patents and patent applications set forth in  Appendix 2 hereto and (b) any other patents or patent applications (and resulting patents therefrom) that are in the Territory and owned or controlled by Gilead  and its Affiliates during the term of this Agreement, including to the extent  falling within clause (b) of this definition (i) those patents and patent applications exclusively licensed by Gilead from Japan Tobacco pursuant to the Japan Tobacco Agreement and (ii) those patents and patent applications claiming improvements or modifications to the manufacture of API, in the case of each patent and patent application referenced in  clauses (a) and (b) solely to the extent

S-73

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

necessary for MPP to grant sublicenses of the license rights granted in Article 2 hereof to Sublicensees under a Sublicense Agreement.

“Product” shall mean TAF Product, TAF Combination Product, TDF Product, TDF Combination Product, COBI Product, COBI Combination Product, EVG Product, EVG Combination Product, BIC Product, BIC Combination Product, and the Quad Products.

“Territory” shall mean the TDF-TAF Territory, the COBI Territory, the EVG- Quad Territory, and the BIC Territory.

		
	b.
	The below terms are hereby added to Section 1 of the Agreement and are defined as follows:

“BIC Combination Product” shall mean a pharmaceutical product containing BIC in combination with any other active pharmaceutical ingredient other than TAF, TDF, EVG, or COBI (in each case subject to the restrictions set forth in Section 2.4(b)(iv)), including any co formulation, co-packaged product, bundled product, or other type of combination product.

“BIC Product” shall mean a formulated and finished pharmaceutical product containing BIC as its sole active pharmaceutical ingredient.

“BIC Territory” shall mean those countries listed on Appendix 7.

		
	c.
	All capitalized terms not otherwise defined in this Amendment shall have the meanings assigned to them in the Agreement.

		
	2.
	License Grants.

		
	a.
	For clarity, the licenses granted by Gilead to MPP in Section 2.2 of the Agreement with respect to API hereby include BIC, in addition to TAF, TDF, EVG, and COBI, pursuant to Section 1(a) of this Amendment.

		
	b.
	Section 2.2 of the Agreement is hereby deleted and replaced with the following: “2.2    API Licenses.

(a)For India. Subject to the terms and conditions of this Agreement, Gilead hereby grants to MPP a royalty-free, non-exclusive, non-transferable license under the Licensed Technology to (i) make API in India solely for the purposes  of exercising the licenses described in this Section 2.2(a); (ii) offer for sale and sell such API to Licensed Product Suppliers in India, China and South Africa for use solely for purposes set forth in the Licensed Product Suppliers’ direct or indirect license from Gilead as set forth in the definition of Licensed Product Suppliers; (iii) import Licensed API into India for purposes of exercising the licenses described in Section 2.3(a) or (iv) use API for internal use in the applicable Territory. MPP has the right to grant sublicenses under the foregoing license solely to Sublicensees located in India pursuant to the terms and conditions of the applicable Sublicense Agreement, and the sublicense rights

S-74

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

granted to each such Sublicensee in India shall be non-sublicensable by such Sublicensee except as expressly provided under the applicable Sublicense Agreement.

(b)For China. Subject to the terms and conditions of  this  Agreement, Gilead hereby grants to MPP a royalty-free, non-exclusive, non-transferable license under the Patents to (i) make API in China solely for the purposes of exercising the licenses described in this Section 2.2(b); (ii) offer for sale and sell such API to Licensed Product Suppliers in India, China and South Africa for use solely for purposes set forth in the Licensed Product Suppliers’ direct or indirect license from Gilead as set forth in the definition of Licensed Product    Suppliers;
(i)import Licensed API into China for purposes of exercising the licenses described in Section 2.3(b) or (iv) use API for internal use in the applicable Territory. MPP has the right to grant sublicenses under the foregoing license solely to Sublicensees located in China pursuant to the terms and conditions of the applicable Sublicense Agreement, and the sublicense rights granted to each such Sublicensee in China shall be non-sublicensable by such Sublicensee except as expressly provided under the applicable Sublicense Agreement.

(c)For South Africa. Subject to the terms and conditions of  this  Agreement, Gilead hereby grants to MPP a royalty-free, non-exclusive, non- transferable license under the Licensed Technology (i) make API in South Africa solely for the purposes of exercising the licenses described in this Section 2.2(c);
(ii) offer for sale and sell such API to Licensed Product Suppliers in India, China and South Africa for use solely for purposes set forth in the Licensed Product Suppliers’ direct or indirect license from Gilead as set forth in the definition of Licensed Product Suppliers; (iii) import Licensed API into South Africa for purposes of exercising the licenses described in Section 2.3(c) or (iv) use API for internal use in the applicable Territory. MPP has the right to grant sublicenses under the foregoing license solely to Sublicensees located in South Africa pursuant to the terms and conditions of the applicable Sublicense Agreement, and the sublicense rights granted to each such Sublicensee in South Africa shall be non-sublicensable by such Sublicensee except as expressly provided under the applicable Sublicense Agreement.

(d)The licenses granted in this Section 2.2 does not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any active pharmaceutical ingredient owned or controlled by Gilead other than TAF, TDF, EVG, COBI, and BIC.”

		
	c.
	Section 2.3 of the Agreement is hereby deleted and replaced with the following:

“(a) To Sublicensees in India. Subject to the terms and conditions of this Agreement, Gilead hereby grants to MPP a non-exclusive, non-transferable license under the Licensed Technology solely to make Product in India and sell, have sold, offer for sale, export from India and import (i) TAF Product, TAF Combination Products, TDF Product and TDF Combination Products in the Field in the TDF-TAF Territory, (ii) COBI Product and COBI Combination Products  in the COBI Territory, (iii) EVG Product, EVG Combination Products and the Quad Products in the Field in the EVG-Quad Territory, and (iv) BIC Product and

S-75

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

BIC Combination Products in the BIC Territory; provided that in each case such Products shall be made only from Licensed API. The licenses granted in this Section 2.3(a) do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any product containing active pharmaceutical ingredients owned or controlled by Gilead other than Products containing TAF, TDF, EVG, COBI, and BIC. The  licenses  granted under this Section 2.3(a) shall not extend to any active pharmaceutical ingredient included within a Product other than TAF, TDF, EVG, COBI, and BIC.

(b)To Sublicensees in China. Subject to the terms and conditions of this Agreement, Gilead hereby grants to MPP a non-exclusive, non-transferable license under the Patents solely to make Product in China and sell, have sold, offer for sale, export from China and import (i) TAF Product, TAF Combination Products, TDF Product and TDF Combination Products in the Field in the TDF- TAF Territory, and (ii) COBI Product and COBI Combination Products in the COBI Territory, (iii) EVG Product, EVG Combination Products and the Quad Products in the Field in the EVG-Quad Territory, and (iv) BIC Product and BIC Combination Products in the BIC Territory; provided that in each case such Products shall be made only from Licensed API. The licenses granted in this Section 2.3(b) do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any product containing active pharmaceutical ingredients owned or controlled by Gilead other than Products containing TAF, TDF, EVG, COBI, and BIC. The  licenses  granted under this Section 2.3(b) shall not extend to any active pharmaceutical ingredient included within a Product other than TAF, TDF, EVG, COBI, and BIC.

(c)To Sublicensees in South Africa. Subject to the terms and conditions of this Agreement, Gilead hereby grants to MPP a non-exclusive, non-transferable license under the Licensed Technology solely to make Product in South Africa and sell, have sold, offer for sale, export from South Africa and import (i) TAF Product, TAF Combination Products, TDF Product and TDF Combination Products in the Field in the TDF-TAF Territory, (ii) COBI Product and COBI Combination Products in the COBI Territory, (iii) EVG Product, EVG Combination Products and the Quad Products in the Field in the EVG-Quad Territory, and (iv) BIC Product and BIC Combination Products in the BIC Territory; provided that in each case such Products shall be made only from Licensed API. The licenses granted in this Section 2.3(c) do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any product containing active pharmaceutical ingredients owned or controlled by Gilead other than Products containing TAF, TDF, EVG, COBI, and BIC. The licenses granted under this Section 2.3(c) shall not extend to any active pharmaceutical ingredient included within a Product other than TAF, TDF, EVG, COBI, and BIC.

(d)MPP shall have the right to grant sublicenses under the foregoing license grant solely to Sublicensees pursuant to the terms and conditions of the applicable Sublicense Agreement, and the sublicense rights granted to each  such

S-76

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Sublicensee shall be royalty bearing and non-sublicensable by such Sublicensee except as expressly provided under the applicable Sublicense Agreement.”

		
	d.
	The following language is hereby added to the Agreement as Section 2.4(b)(iv):

“Each Sublicensee will be allowed to manufacture and sell BIC in combination with other active pharmaceutical ingredients in the BIC Territory, provided in each case (A) such Sublicensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the BIC Territory, and (B) such manufacture and sale is in accordance with the licenses granted in the Sublicense Agreement.”

		
	e.
	Section 2.4(e) of the Agreement is hereby deleted and replaced with the following:

“No Other Licenses.  Except as expressly set forth in this Agreement, Gilead  does not grant any license to MPP under any of its intellectual property rights (including, without limitation, patents or rights to any proprietary compounds or drug substances other than API).”

3.BIC Sublicense Amendment. The following language is hereby added to the Agreement as Section 2.1(f):

“MPP shall have the right to execute an amendment to a Sublicense Agreement with a Sublicensee, pursuant to which MPP shall grant such Sublicensee a sublicense under the rights granted to MPP with respect to BIC, BIC Product, and BIC Combination Products, according to the terms of the applicable form amendment attached hereto as Appendix 8 (each, a “Form BIC Sublicense Amendment”, and once fully executed, a “BIC Sublicense Amendment”). The form amendments attached hereto as Appendix 8-A, Appendix 8-B, Appendix 8-C, and Appendix 8-D correspond to the Form Sublicense Agreements attached hereto as Appendix 6-A, Appendix 6-B, Appendix 6-C, and Appendix 6-D, respectively. Gilead will be a party to each BIC Sublicense Amendment. For clarity, unless and until a particular Sublicensee enters into a BIC Sublicense Amendment corresponding to such Sublicensee’s Sublicense Agreement, such Sublicensee will have no rights or licenses with respect to BIC, BIC Product and/or BIC Combination Products. MPP will not modify the terms and conditions of such form amendments or BIC Sublicense Amendments without Gilead’s written consent, and Gilead will have no obligation to enter into any BIC Sublicense Amendment that varies from the applicable form amendment. Gilead will have the right to provide copies of any BIC Sublicense Amendment to Japan Tobacco. All conditions and restrictions set forth in each BIC Sublicense Amendment shall apply to the license rights granted to MPP hereunder as if fully set forth herein, except as expressly provided for otherwise in this Agreement.”

4.Appendices. Appendices 1, 2, 3, 4, and 5 of the Agreement are hereby deleted and replaced with the new Appendices 1, 2, 3, 4, and 5 attached to this Amendment, respectively. Appendices 7, 8-A, 8-B, 8-C, and 8-D attached to this Amendment are hereby added to the Agreement as Appendices 7, 8-A, 8-B, 8-C, and 8-D, respectively.

5.Miscellaneous. This Amendment embodies the entire understanding of the Parties with respect to the subject matter hereof and supersedes all previous communications,  representations

S-77

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

or understandings, and agreements, whether oral or written, between the Parties relating to the subject matter hereof. Except as expressly amended by this Amendment, the terms and  conditions of the Agreement will remain in full force and effect. This Amendment shall be effective as of the Amendment Effective Date, and may not be modified except by written agreement between the Parties. This Amendment will be governed by and construed under the laws of England, without regard to its choice of law principles, and any dispute that arises hereunder shall be resolved by binding arbitration as set forth in Section 8.6 of the Agreement.

[signatures appear on the following page]

S-78

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

IN WITNESS WHEREOF, the Parties have executed this Amendment by their duly authorized representatives as of the Amendment Effective Date.

	
		
	GILEAD SCIENCES, INC.

By:________________________

Name: _____________________
Title:_______________________
	MEDICINES PATENT POOL

By:________________________

Name: _____________________

Title:_______________________

S-79

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 1
Countries in the TDF-TAF Territory
	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-80

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 2
Patents

TDF Patents

(221) Title: NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	China (People's Republic)
	Granted
	7/25/1997
	200810083233.70
	200810083233.70
	12/12/2012

	China (People's Republic)
	Granted
	7/25/1997
	97197460.8
	ZL97197460.8
	4/30/2008

	India
	Pending
	7/25/1997
	2076/DEL/1997
	 
	 

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	SubCase
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	China (People's Republic)
	Granted
	7/23/1998
	200510099916.80
	ZL200510099916.8
	9/24/2008

	China (People's Republic)
	Granted
	7/23/1998
	200410046290X
	200410046290X
	4/19/2006

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	China (People's Republic)
	Published
	1/13/2004
	201510697340.90
	 
	 

	China (People's Republic)
	Granted
	1/13/2004
	201210094391.90
	ZL201210094391.9
	2/24/2016

	China (People's Republic)
	Granted
	1/13/2004
	200480002190.50
	200480002190.50
	6/6/2012

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

S-81

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

(676) Title:  METHOD AND COMPOSITION FOR PHARMACEUTICAL PRODUCT

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	China (People's Republic)
	Granted
	6/13/2006
	200680026180.40
	ZL200680026180.4
	10/7/2015

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	China (People's Republic)
	Granted
	6/13/2006
	200680026866.30
	200680026866.30
	3/27/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

TAF Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

S-82

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Organization (OAPI)

	African Regional Industrial Property Organization
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	China (People's Republic)
	Granted
	1813161.1
	7/20/2001
	ZL01813161.1
	12/27/2006

	China (People's Republic)
	Granted
	200410097845.30
	7/20/2001
	ZL200410097845.3
	7/16/2008

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing
	Patent
	Issue Date

S-83

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	 
	 
	 
	Date
	No.
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	China (People's Republic)
	Published
	201280039891.00
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-
500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	China (People's Republic)
	Published
	201280048965.70
	10/3/2012
	 
	 

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

	El Salvador
	Published
	E-4696/2014
	10/3/2012
	 
	 

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012
	 
	 

	India
	Published
	2953/DELNP/2014
	10/3/2012
	 
	 

	Pakistan
	Pending
	671/2012
	10/3/2012
	 
	 

EVG Patents

(JF-0136) Title: COMPOUND AND METHOD OF USE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	 

	Bolivia
	Pending
	SP-230265
	11/18/2003
	 
	 

	China (People's Republic)
	Granted
	200380100277.10
	11/20/2003
	ZL200380100277.1
	3/19/2008

S-84

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	India
	Granted
	01316/CHENP/2004
	11/20/2003
	245833
	2/3/2011

	Indonesia
	Granted
	WO00200401542
	11/20/2003
	P0023507
	6/1/2009

	Nigeria
	Granted
	424/2003
	11/19/2003
	RP.15779
	10/20/2004

	Philippines
	Granted
	1-2004-500895
	11/20/2003
	1-2004-500895
	8/20/2008

	South Africa
	Granted
	2004/4537
	11/20/2003
	2004/4537
	8/31/2005

	Thailand
	Pending
	301004379
	11/20/2003
	 
	 

	Vietnam
	Granted
	1-2004-00605
	11/20/2003
	1-0011884
	10/7/2013

(JF-0179) Title: CRYSTALLINE FORM

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	 

	Bolivia
	Pending
	SP-250121
	5/19/2005
	 
	 

	China (People's Republic)
	Granted
	200580016142.60
	5/19/2005
	ZL200580016142.6
	5/26/2010

	India
	Pending
	357/CHENP/2010
	5/19/2005
	 
	 

	Philippines
	Granted
	1-2006-502297
	5/19/2005
	1-2006-502297
	11/19/2010

	South Africa
	Granted
	2006/10647
	5/19/2005
	2006/10647
	6/25/2008

	Thailand
	Pending
	100718
	5/19/2005
	 
	 

(JF-0193) Title: MANUFACTURING PROCESS: ROUTE D AND F

	
						
	Country
	Status
	Application No.:
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	200780016151.40
	3/6/2007
	200780016151.40
	2/6/2013

	India
	Granted
	5344/CHENP/2008
	3/6/2007
	258895
	2/13/2014

	India
	Pending
	532/CHENP/2014
	3/6/2007
	 
	 

(JF-0192) Title: MANUFACTURING PROCESS: ROUTE C AND E

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No:
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004621
	3/6/2007
	2914
	5/5/2014

	China
	Granted
	200780016172.60
	3/6/2007
	ZL200780016172.60
	5/29/2013

	Eurasian Patent Organization
	Granted
	200870321
	3/6/2007
	17861
	3/29/2013

	Indonesia
	Pending
	W00200802860
	3/6/2007
	IDP0032077
	10/22/2012

	India
	Granted
	5341/CHENP/2008
	3/6/2007
	258747
	2/4/2014

	India
	Pending
	613/CHENP/2014
	3/6/2007
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1200800317
	3/6/2007
	14280
	3/31/2009

	Vietnam
	Granted
	1-2008-02431
	3/6/2007
	14450
	8/17/2015

S-85

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	South Africa
	Granted
	2008/07547
	3/6/2007
	2008/07547
	11/25/2009

(718) Title: METHODS OF IMPROVING THE PHARMACOKINETICS OF HIV INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	 

	Armenia
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004522
	12/29/2006
	AP2702
	7/31/2013

	China (People's Republic)
	Published
	201410249622.80
	12/29/2006
	 
	 

	Eurasian Patent Organization
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Eurasian Patent Organization
	Published
	201201496
	12/29/2006
	 
	 

	Indonesia
	Pending
	W00201102461
	12/29/2006
	 
	 

	Indonesia
	Published
	W00 2008 02128
	12/29/2006
	 
	 

	India
	Pending
	6748/DELNP/2015
	12/29/2006
	 
	 

	India
	Pending
	5576/DELNP/2008
	12/29/2006
	 
	 

	Kyrgyz Republic
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Moldova
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Intellectual Property Organization (OAPI)
	Granted
	1200800239
	12/29/2006
	14320
	6/30/2009

	Tajikistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Turkmenistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Vietnam
	Pending
	1-2008-01921
	12/29/2006
	 
	 

	South Africa
	Granted
	2008/06222
	12/29/2006
	2008/06222
	3/25/2009

(720) Title:  PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent Number
	Issue Date

	Armenia
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004831
	9/11/2007
	AP3004
	10/16/2014

	China
	Granted
	200780033907.60
	9/11/2007
	ZL200780033907.6
	10/16/2013

	China
	Granted
	201210224990.80
	9/11/2007
	CN102766098B
	3/30/2016

	China
	Abandoned
	201510922236.50
	9/11/2007
	 
	 

	China
	Published
	201510922511.30
	9/11/2007
	 
	 

	Eurasian Patent Organization
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Indonesia
	Published
	W00200900634
	9/11/2007
	 
	 

	Kyrgyz Republic
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

S-86

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Kazakhstan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Moldova
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Intellectual Property Organization (OAPI)
	Granted
	1200900070
	9/11/2007
	14458
	9/30/2009

	Thailand
	Published
	701004583
	9/11/2007
	 
	 

	Tajikistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Turkmenistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Vietnam
	Granted
	1-2009-00636
	9/11/2007
	11932
	10/22/2013

	Vietnam
	Granted
	1-2012-01354
	9/11/2007
	14698
	10/20/2015

	South Africa
	Granted
	2009/01576
	9/11/2007
	2009/01576
	2/24/2010

(746) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No
	Filing Date
	Patent Number
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005187
	9/11/2008
	AP 2785
	10/31/2013

	China
	Granted
	200880106554.20
	9/11/2008
	ZL200880106554.2
	7/9/2014

	Eurasian Patent Organization
	Granted
	201070256
	9/11/2008
	19431
	3/31/2014

	Ecuador
	Inactive
	SP-10-10081
	9/11/2008
	 
	 

	Indonesia
	Published
	W00201000759
	9/11/2008
	 
	 

	India
	Pending
	1615/DELNP/2010
	9/11/2008
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201000093
	9/11/2008
	15058
	 

	Thailand
	Published
	801004676
	9/11/2008
	 
	 

	Vietnam
	Granted
	1-2010-00483
	9/11/2008
	10866
	11/20/2012

	South Africa
	Granted
	2010/02066
	9/11/2008
	2010/02066
	12/29/2010

(903) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	 

	China (People's Republic)
	Granted
	201380041287.60
	8/1/2013
	ZL201380041287.6
	11/2/2016

	Eurasian Patent Organization
	Allowed
	201590018
	8/1/2013
	 
	 

	India
	Pending
	1688/DELNP/2015
	8/1/2013
	 
	 

COBI Patents

(692) Title: MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

S-87

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	China (People's Republic)
	Granted
	200780025607.30
	5/29/2013
	ZL200780025607.3

	China (People's Republic)
	Granted
	201310141408.60
	4/29/2015
	ZL201310141408.6

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vanuatu
	Unfiled
	 
	 
	 

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

S-88

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	China (People's Republic)
	Granted
	201310326757.50
	6/10/2015
	10326757

	China (People's Republic)
	Granted
	200880013255.40
	8/28/2013
	ZL200880013255.4

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	China (People's Republic)
	Published
	201510408376.00
	 
	 

	China (People's Republic)
	Published
	201310447258.10
	 
	 

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

S-89

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/005864
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Published
	SP-0082-2010
	4/1/2010
	 

	China
	Granted
	201080014307.70
	4/1/2010
	ZL201080014307.7

	China
	Published
	201510160505.90
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	China (People's Republic)
	Granted
	201080006646.00
	9/11/2013
	ZL201080006646.0

S-90

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	China
	Abandoned
	201380007712.X
	 
	 

	India
	Abandoned
	6192/DELNP/2014
	 
	 

BIC Patents

(1007) TITLE: POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Pending
	1201500240
	12/19/2013
	 

	African Regional Industrial Property Organization
	Pending
	AP/P/2015/008510
	12/19/2013
	 

	Anguilla
	Pending
	AI/A/2016/00180
	12/19/2013
	 

	Bahamas
	Pending
	2551
	12/19/2013
	 

	Bolivia
	Published
	SP-00412-2013
	12/20/2013
	 

	China
	Published
	201380073134.X
	12/19/2013
	 

	Congo, Democratic Republic of
	Pending
	 
	12/19/2013
	 

	Ecuador
	Published
	IEPI-2015-31224
	12/19/2013
	 

	El Salvador
	Published
	E-5002-2015
	12/19/2013
	 

S-91

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Ethiopia
	Pending
	ET/PI/16/204
	12/19/2013
	 
	 

	Eurasian Patent Organization
	Published
	201591027
	12/19/2013
	 
	 

	Fiji
	Published
	1229
	12/19/2013
	 
	 

	Grenada
	Granted
	 
	12/19/2013
	 
	7/19/2016

	Guyana
	Pending
	1656
	12/19/2013
	 
	 

	Haiti
	Pending
	 
	12/19/2013
	 
	 

	India
	Pending
	5535/DELNP/2015
	12/19/2013
	 
	 

	Indonesia
	Allowed
	P00201503852
	12/19/2013
	 
	 

	Indonesia
	Pending
	P00201607128
	12/19/2013
	 
	 

	Jamaica
	Pending
	18/1/5740
	12/19/2013
	 
	 

	Kiribati
	Granted
	 
	12/19/2013
	 
	9/20/2016

	Moldova
	Pending
	a20150064
	12/19/2013
	 
	 

	Montserrat
	Granted
	 
	12/19/2013
	4 OF 2016
	5/27/2016

	Nepal
	Pending
	4
	12/19/2013
	 
	 

	Pakistan
	Pending
	908/2013
	12/20/2013
	 
	 

	Philippines
	Published
	1-2015-501445
	12/19/2013
	 
	 

	Philippines
	Pending
	1-2016-500389
	12/19/2013
	 
	 

	Seychelles
	Pending
	2822954
	12/19/2013
	 
	 

	Sierra Leone
	Pending
	 
	12/19/2013
	 
	 

	Solomon Islands
	Granted
	 
	12/19/2013
	J37/379
	8/5/2016

	South Africa
	Pending
	2015/04914
	12/19/2013
	 
	 

	South Africa
	Pending
	2015/07997
	12/19/2013
	 
	 

	South Korea
	Pending
	10-2015-7019194
	12/19/2013
	 
	 

	Thailand
	Pending
	1501003563
	12/19/2013
	 
	 

	Turks and Caicos Islands
	Granted
	10226
	12/19/2013
	10226
	9/7/2016

	Tuvalu
	Granted
	TVP2822954
	12/19/2013
	TVP2822954
	8/15/2016

	Vietnam
	Granted
	1-2015-02321
	12/19/2013
	15503
	5/16/2016

	Vietnam
	Pending
	1-2015-04199
	12/19/2013
	 
	 

	Virgin Islands (British)
	Granted
	EP2822954
	12/19/2013
	427/5/2016
	9/21/2016

(1091) Title: SODIUM (2R,5S,13AR)-7,9-DIOXO-10-((2,4,6- TRIFLUOROBENZYL)CARBAMOYL)-2,3,4,5,7,9,13,13A-OCTAHYDRO-2,5- METHANOPYRIDO[1',2':4,5]PYRAZINO[2,1-B]OXAZEPIN-8-OLATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Regional Industrial Property Organization
	Pending
	AP/P/2016/009591
	6/19/2015
	 
	 

	African Intellectual Property Organization (OAPI)
	Pending
	1201600454
	6/19/2015
	 
	 

	Bolivia
	Published
	SP 126-2015
	6/19/2015
	 
	 

S-92

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
				
	Bahamas
	Allowed
	2701
	6/18/2015

	China
	Published
	201580033152.40
	6/19/2015

	Cuba
	Pending
	2016-0187
	6/19/2015

	Dominican Republic
	Published
	P2016-0327
	6/19/2015

	Eurasian Patent Organization
	Pending
	201692414
	6/19/2015

	Ecuador
	Published
	IEPI-2016-95566
	6/19/2015

	El Salvador
	Pending
	2016005339
	6/19/2015

	Guatemala
	Pending
	A2016-000262
	6/19/2015

	Indonesia
	Unfiled
	 
	 

	India
	Pending
	201617042937.00
	6/19/2015

	Nigeria
	Pending
	NG/PT/C/2016/2106
	6/19/2015

	Philippines
	Pending
	 
	 

	Pakistan
	Pending
	382/2015
	6/18/2015

	Thailand
	Pending
	 
	 

	Trinidad and Tobago
	Pending
	TT/A/2016/00132
	6/19/2015

	Vietnam
	Pending
	 
	 

	South Africa
	Pending
	2016/08744
	6/19/2015

(1147) Title: THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bangladesh
	Pending
	272/2016
	11/2/2016
	 
	 

	Bolivia
	Pending
	SP-0260-2016
	11/9/2016
	 
	 

	Bahamas
	Pending
	 
	11/8/2016
	 
	 

	Pakistan
	Pending
	696/2016
	11/9/2016
	 
	 

	Patent Cooperation Treaty
	Entered NP
	US2016/060989
	11/8/2016
	 
	 

(1062) Title: SYNTHESIS OF POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Allowed
	2702
	6/18/2015
	 
	 

	China
	Pending
	201580033052.10
	6/16/2015
	 
	 

	Eurasian Patent Organization
	Pending
	201692412
	6/16/2015
	 
	 

	India
	Pending
	201717000457.00
	6/16/2015
	 
	 

	Patent Cooperation Treaty
	Entered NP
	US2015/036017
	6/16/2015
	 
	 

TDF-Quad Patents

S-93

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(221) Title:NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	China (People's Republic)
	Granted
	7/25/1997
	200810083233.70
	200810083233.70
	12/12/2012

	China (People's Republic)
	Granted
	7/25/1997
	97197460.8
	ZL97197460.8
	4/30/2008

	India
	Pending
	7/25/1997
	2076/DEL/1997
	 
	 

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	China (People's Republic)
	Granted
	7/23/1998
	200510099916.80
	ZL200510099916.8
	9/24/2008

	China (People's Republic)
	Granted
	7/23/1998
	200410046290X
	200410046290X
	4/19/2006

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985
	 

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489
	 

	China (People's Republic)
	Granted
	200780025607.30
	5/29/2013
	ZL200780025607.3

	China (People's Republic)
	Granted
	201310141408.60
	4/29/2015
	ZL201310141408.6

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134
	 

S-94

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

S-95

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	China (People's Republic)
	Granted
	201310326757.50
	6/10/2015
	10326757

	China (People's Republic)
	Granted
	200880013255.40
	8/28/2013
	ZL200880013255.4

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	China (People's Republic)
	Published
	201510408376.00
	 
	 

	China (People's Republic)
	Published
	201310447258.10
	 
	 

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

S-96

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	China
	Granted
	201080014307.70
	4/1/2010
	ZL201080014307.7

	China
	Published
	201510160505.90
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	China
	Abandoned
	201380007712.X
	 
	 

	India
	Abandoned
	6192/DELNP/2014
	 
	 

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

S-97

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(TRI1010) Non-Homogenous Systems for the Resolution of Enantiomeric Mixtures

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99811893.1
	8-Oct-99
	ZL99811893.1
	28-Nov-07

(TRI1020) Method of Manufacture of 1,3-Oxathiolane Nucleosides

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99809992.9
	12-Aug-99
	ZL99809992.9
	10-Mar-04

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	China (People's Republic)
	Granted
	201080006646.00
	9/11/2013
	ZL201080006646.0

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

S-98

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

TAF-Quad Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	African Regional Industrial Property Organization
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	China (People's Republic)
	Granted
	1813161.1
	7/20/2001
	ZL01813161.1
	12/27/2006

	China (People's Republic)
	Granted
	200410097845.30
	7/20/2001
	ZL200410097845.3
	7/16/2008

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

S-99

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	China (People's Republic)
	Published
	201280039891.00
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-
500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	China (People's Republic)
	Published
	201280048965.70
	10/3/2012
	 
	 

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

	El Salvador
	Published
	E-4696/2014
	10/3/2012
	 
	 

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012
	 
	 

	India
	Published
	2953/DELNP/2014
	10/3/2012
	 
	 

S-100

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
				
	Pakistan
	Pending
	671/2012
	10/3/2012

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985
	 

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489
	 

	China (People's Republic)
	Granted
	200780025607.30
	5/29/2013
	ZL200780025607.3

	China (People's Republic)
	Granted
	201310141408.60
	4/29/2015
	ZL201310141408.6

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134
	 

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489
	 

	Fiji
	Published
	1217
	 
	 
	 

	Guyana
	Published
	1642
	 
	 
	 

	Haiti
	Pending
	 
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227
	 

	Jamaica
	Pending
	18/1/5696
	 
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489
	 

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15
	 

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489
	 

	Moldova
	Granted
	200900155
	11/28/2014
	20489
	 

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015
	 

	Nauru
	Pending
	 
	 
	 
	 

	Nepal
	Pending
	894
	 
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506
	 

	Sierra Leone
	Pending
	EP2049506
	 
	 
	 

S-101

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	China (People's Republic)
	Granted
	201310326757.50
	6/10/2015
	10326757

	China (People's Republic)
	Granted
	200880013255.40
	8/28/2013
	ZL200880013255.4

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

S-102

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	China (People's Republic)
	Published
	201510408376.00
	 
	 

	China (People's Republic)
	Published
	201310447258.10
	 
	 

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	China
	Granted
	201080014307.70
	4/1/2010
	ZL201080014307.7

	China
	Published
	201510160505.90
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

S-103

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	China
	Abandoned
	201380007712.X
	 
	 

	India
	Abandoned
	6192/DELNP/2014
	 
	 

(899) Title: THERAPEUTIC COMPOUNDS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China (People's Republic)
	Published
	201380007670.X
	2/1/2013
	 
	 

	Eurasian Patent Organization
	Published
	201491287
	2/1/2013
	 
	 

	India
	Pending
	7100/DELNP/2014
	2/1/2013
	 
	 

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(TRI1010) Non-Homogenous Systems for the Resolution of Enantiomeric Mixtures

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99811893.1
	8-Oct-99
	ZL99811893.1
	28-Nov-07

S-104

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(TRI1020) Method of Manufacture of 1,3-Oxathiolane Nucleosides

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99809992.9
	12-Aug-99
	ZL99809992.9
	10-Mar-04

For purposes of this Appendix 2, references to “PCT,“OAPI,” “EAPO” and “ARIPO” shall not be construed or interpreted to grant rights to Licensee in any country other than those countries expressly included within the licenses granted to Licensee in Sections 2.2 and 2.3 of this Agreement.

S-105

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 3
Emtricitabine Patents

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Dominican Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(TRI1010) Non-Homogenous Systems for the Resolution of Enantiomeric Mixtures

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99811893.1
	8-Oct-99
	ZL99811893.1
	11/28/07

(TRI1020) Method of Manufacture of 1,3-Oxathiolane Nucleosides

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99809992.9
	12-Aug-99
	ZL99809992.9
	3/10/04

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	China (People's Republic)
	Published
	1/13/2004
	201510697340.90
	 
	 

	China (People's Republic)
	Granted
	1/13/2004
	201210094391.90
	ZL201210094391.9
	2/24/2016

	China (People's Republic)
	Granted
	1/13/2004
	200480002190.50
	200480002190.50
	6/6/2012

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

S-106

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	China (People's Republic)
	Granted
	6/13/2006
	200680026866.30
	200680026866.30
	3/27/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

S-107

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 4
Countries in the COBI Territory
	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-108

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 5
Countries in the EVG- Quad Territory

	
					
	1. Afghanistan
	38.
	Ghana
	75.
	Rwanda

	2. Angola
	39.
	Grenada
	76.
	Saint Kitts and Nevis

	3. Anguilla
	40.
	Guatemala
	77.
	Saint Lucia

	4. Antigua and Barbuda
	41.
	Guinea
	78.
	Saint Vincent & the

	5. Armenia
	42.
	Guinea-Bissau
	 
	Grenadines

	6. Bahamas
	43.
	Guyana
	79.
	Samoa

	7. Bangladesh
	44.
	Haiti
	80.
	São Tomé and Príncipe

	8. Barbados
	45.
	Honduras
	81.
	Senegal

	9. Belize
	46.
	India
	82.
	Seychelles

	10. Benin
	47.
	Indonesia
	83.
	Sierra Leone

	11. Bhutan
	48.
	Jamaica
	84.
	Solomon Islands

	12. Bolivia
	49.
	Kazakhstan
	85.
	Somalia

	13. Botswana
	50.
	Kenya
	86.
	South Africa

	14. British Virgin Islands
	51.
	Kiribati
	87.
	South Sudan

	15.  Burkina Faso
	52.
	Kyrgyzstan
	88.
	Sri Lanka

	16. Burundi
	53.
	Lao People's Dem. Rep.
	89.
	Sudan

	17. Cambodia
	54.
	Lesotho
	90.
	Suriname

	18. Cameroon
	55.
	Liberia
	91.
	Swaziland

	19.  Cape Verde
	56.
	Madagascar
	92.
	Syrian Arab Republic

	20. Central African Republic
	57.
	Malawi
	93.
	Tajikistan

	21. Chad
	58.
	Maldives
	94.
	Tanzania, U. Rep. of

	22. Comoros
	59.
	Mali
	95.
	Thailand

	23.  Congo, Rep
	60.
	Mauritania
	96.
	Timor-Leste

	24.  Congo, Dem. Rep. of the
	61.
	Mauritius
	97.
	Togo

	25.  Côte d'Ivoire
	62.
	Moldova, Rep. of
	98.
	Tonga

	26. Cuba
	63.
	Mongolia
	99.
	Trinidad and Tobago

	27. Djibouti
	64.
	Mozambique
	100.
	Turkmenistan

	28. Dominica
	65.
	Myanmar
	101.
	Turks and Caicos

	29. Ecuador
	66.
	Namibia
	102.
	Tuvalu

	30.  El Salvador
	67.
	Nauru
	103.
	Uganda

	31. Equatorial Guinea
	68.
	Nepal
	104.
	Uzbekistan

	32. Eritrea
	69.
	Nicaragua
	105.
	Vanuatu

	33. Ethiopia
	70.
	Niger
	106.
	Vietnam

	34.  Fiji Islands, Rep. of the
	71.
	Nigeria
	107.
	Yemen

	35. Gabon
	72.
	Pakistan
	108.
	Zambia

	36. Gambia
	73.
	Palau
	109.
	Zimbabwe

	37. Georgia
	74.
	Papua New Guinea
	 
	 

S-109

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 7
Countries in the BIC Territory
	
					
	1.   Afghanistan
	39.
	Gambia
	79.
	Papua NewGuinea

	2.   Angola
	40.
	Georgia
	80.
	Phillipines

	3.   Anguilla
	41.
	Ghana
	81.
	Rwanda

	4.   Antigua and Barbuda
	42.
	Grenada
	82.
	Saint Kitts and Nevis

	5.   Armenia
	43.
	Guatemala
	83.
	Saint Lucia

	6.   Aruba
	44.
	Guinea
	84.
	Saint Vincent & the

	7.   Bahamas
	45.
	Guinea-Bissau
	 
	Grenadines

	8.   Bangladesh
	46.
	Guyana
	85.
	Samoa

	9.   Barbados
	47.
	Haiti
	86.
	São Tomé and Príncipe

	10. Belarus
	48.
	Honduras
	87.
	Senegal

	11. Belize
	49.
	India
	88.
	Seychelles

	12. Benin
	50.
	Indonesia
	89.
	Sierra Leone

	13. Bhutan
	51.
	Jamaica
	90.
	Solomon Islands

	14. Bolivia
	52.
	Kazakhstan
	91.
	Somalia

	15. Botswana
	53.
	Kenya
	92.
	South Africa

	16. British Virgin Islands
	54.
	Kiribati
	93.
	South Sudan

	17. Burkina Faso
	55.
	Kyrgyzstan
	94.
	Sri Lanka

	18. Burundi
	56.
	Lao, People's Dem. Rep.
	95.
	Sudan

	19. Cambodia
	57.
	Lesotho
	96.
	Surinam

	20. Cameroon
	58.
	Liberia
	97.
	Swaziland

	21.  Cape Verde
	59.
	Madagascar
	98.
	Syrian Arab Republic

	22. Central African
	60.
	Malawi
	99.
	Tajikistan

	Republic
	61.
	Malaysia
	100.
	Tanzania, U. Rep. of

	23. Chad
	62.
	Maldives
	101.
	Thailand

	24. Comoros
	63.
	Mali
	102.
	Timor-Leste

	25.  Congo, Rep
	64.
	Mauritania
	103.
	Togo

	26. Congo, Dem. Rep. of
	65.
	Mauritius
	104.
	Tonga

	the
	66.
	Moldova, Rep. of
	105.
	Trinidad and Tobago

	27. Côte d'Ivoire
	67.
	Mongolia
	106.
	Turkmenistan

	28. Cuba
	68.
	Montserrat
	107.
	Turks and Caicos

	29. Djibouti
	69.
	Mozambique
	108.
	Tuvalu

	30. Dominica
	70.
	Myanmar
	109.
	Uganda

	31. Dominican Republic
	71.
	Namibia
	110.
	Ukraine

	32. Ecuador
	72.
	Nauru
	111.
	Uzbekistan

	33.  El Salvador
	73.
	Nepal
	112.
	Vanuatu

	34. Equatorial Guinea
	74.
	Nicaragua
	113.
	Vietnam

	35. Eritrea
	75.
	Niger
	114.
	Yemen

	36. Ethiopia
	76.
	Nigeria
	115.
	Zambia

	37.  Fiji Islands
	77.
	Pakistan
	116.
	Zimbabwe

	38. Gabon
	78.
	Palau
	 
	 

S-110

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 8-A
Form BIC Sublicense Amendment to Form Sublicense Agreement attached hereto as Appendix 6-A

S-111

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 8-B
Form BIC Sublicense Amendment to Form Sublicense Agreement attached hereto as Appendix 6-B

S-112

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 8-C
Form BIC Sublicense Amendment to Form Sublicense Agreement attached hereto as Appendix 6-C

S-113

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 8-D
Form BIC Sublicense Amendment to Form Sublicense Agreement attached hereto as Appendix 6-D

S-114

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

[APPENDIX 8-A FOR EXISTING LICENSEES IN INDIA] 
FIRST AMENDMENT
TO
[FIRST/SECOND/THIRD] AMENDED AND RESTATED LICENSE AGREEMENT

This FIRST AMENDMENT TO [FIRST/SECOND/THIRD] AMENDED AND RESTATED  LICENSE
AGREEMENT (this “Amendment”) is made as of [Insert Date] (the “Amendment Effective Date”) by and among Gilead Sciences, Inc. a Delaware corporation having its principal place of business at 333 Lakeside Drive, Foster City, California 94404, USA (“Gilead”), the Medicines Patent Pool, a non-profit foundation registered under the laws of Switzerland, and having a principal place of business at Rue de Varembé 7, 1202 Geneva, Switzerland (“MPP”), and __________________  a  company  registered  under  the  laws  of  India,  and   having  a registered  office  at _________________,  India (“Licensee”).

R E C I T A L S

WHEREAS, Gilead, MPP, and Licensee entered into that certain [First/Second/Third]][Amended and Restated] License Agreement effective as of ______________  (the “Agreement”), pursuant to which MPP granted Licensee certain licenses with respect to Gilead’s proprietary pharmaceutical agents tenofovir alafenamide, tenofovir disoproxil fumurate, elvitegravir, and cobicistat for treatment of HIV and HBV in developing world countries; and

WHEREAS, Gilead, MPP, and Licensee wish to amend the Agreement to add certain licenses with respect to Gilead’s proprietary pharmaceutical agent bictegravir for treatment of HIV in developing world countries, in accordance with the terms and conditions of this Amendment, all as more fully described below.

NOW, THEREFORE, Gilead, MPP, and Licensee agree as follows:

		
	1.
	Definitions.

		
	a.
	The definitions of the below terms are hereby deleted from Section 1 of the Agreement and replaced as follows:

“Active Pharmaceutical Ingredient” or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), cobicistat (“COBI”), and bictegravir (“BIC”).

“Combination Products” shall mean COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products, BIC Combination Products, and Quad Products.

“Patents” shall mean (a) the patents and patent applications set forth in Appendix 2 hereto and (b) any other patents or patent applications (and resulting patents therefrom) that are in the Territory and owned or controlled by Gilead and its Affiliates during the term of this Agreement including to the extent falling within

S-115

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

clause (b) of this definition (i) those patents and patent applications exclusively licensed by Gilead from Japan Tobacco pursuant to the Japan Tobacco Agreement and (ii) those patents and patent applications claiming improvements or  modifications to the manufacture of API, in the case of each patent and patent application referenced in clauses (a) and (b) solely to the extent necessary for Licensee to practice the licenses granted in Section 2 hereof.

“Product” shall mean COBI Product, EVG Product, TAF Product, TDF Product, COBI Combination Product, EVG Combination Product, TAF Combination Product, TDF Combination Product, BIC Product, BIC Combination Products, and the Quad Products.

“Territory” shall mean the TDF-TAF Territory, the COBI Territory, the EVG-Quad Territory, and the BIC Territory.

		
	b.
	The below terms are hereby added to Section 1 of the Agreement and are defined as follows:

“BIC Combination Product” shall mean a pharmaceutical product containing BIC  in combination with any other active pharmaceutical ingredient other than TAF,  TDF, EVG, or COBI (in each case subject to the restrictions set forth in Section 4 of this Amendment, including any co formulation, co-packaged product, bundled product, or other type of combination product.

“BIC Product” shall mean a formulated and finished pharmaceutical product containing BIC as its sole active pharmaceutical ingredient.

“BIC Territory” shall mean those countries listed on Appendix 7.

		
	c.
	All capitalized terms not otherwise defined in this Amendment shall have the meanings assigned to them in the Agreement.

		
	2.
	API License. Section 2.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

“API License. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a royalty-free, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.3 below), non-transferable license under the Licensed Technology to (i) make API in India solely for the purposes of exercising the licenses described in this Section 2.1; (ii) offer for sale and sell such API to Licensed Product Suppliers in India, China and South Africa for use solely for purposes set forth in the  Licensed Product Suppliers’ direct or indirect license from Gilead as set forth in the  definition of Licensed Product Suppliers; (iii) import Licensed API into India for purposes of exercising the license set forth in Section 2.2 or (iv) use API for Licensee’s own internal use in the applicable Territory. For clarity, the license granted in this Section 2.1 does not  include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any active pharmaceutical ingredient owned or controlled by Gilead other than TAF, TDF, EVG, COBI, and BIC.”

S-116

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	3.
	Product License. Section 2.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

“Product License. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a royalty-bearing, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.3 below), non-transferable license under the Licensed Technology solely to make Product in India and sell, have sold, offer for sale, export from India and import (i) TAF Product, TAF Combination Product, TDF Product and TDF Combination Products in the Field in the TDF-TAF Territory, (ii) EVG Product, EVG Combination Products and the Quad Products in the Field in the EVG-Quad Territory, (iii) COBI Products and COBI Combination Products in the Field and in the COBI Territory,  and
(ii)BIC Product and BIC Combination Products in the Field and in the BIC Territory; provided that in each case such Products shall be made only from Licensed API.  For  clarity,
(a) the licenses granted in this Section 2.2 do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any product containing active pharmaceutical ingredients owned or controlled by Gilead other than Products containing TAF, TDF, EVG, COBI, and BIC, and (b) notwithstanding the foregoing, the licenses granted under this Section 2.2 shall not extend to any active pharmaceutical ingredient included within a Product other than TAF, TDF, EVG, COBI, and BIC.

		
	4.
	Affiliates.  Section 2.3 of the Agreement is hereby deleted in its entirety and replaced with  the following:

“Affiliates. Licensee may grant sublicenses under the licenses granted in Section 2.1 or Section 2.2 to its Affiliates located in India upon prior written notice to Gilead and MPP. Upon Gilead’s or MPP’s request, Licensee shall provide Gilead and/or MPP (as applicable) with the written copies of the applicable sublicense agreement with such Affiliate(s). Further upon Gilead’s or MPP’s request, Licensee shall name Gilead and/or MPP (as applicable) as a third party beneficiary in any such sublicense agreement, in which case Licensee  shall consent and hereby does consent to Gilead’s and/or MPP’s (as applicable) enforcement of such sublicense agreement to the extent relating to the obligations that Licensee is required hereunder to impose on its Affiliates. Licensee shall ensure that any such Affiliate complies with all the terms of this Agreement as if they were a party to this Agreement, and Licensee will be liable for the activities of such Affiliates as if such activities were performed by Licensee.”

		
	5.
	Product Sales.

		
	a.
	Section 2.5(b) of the Agreement is hereby amended to delete the first paragraph of such Section which is hereby replaced with the following:

“Subject to Sections 10.3(c) and 10.3(d) of the Agreement, Licensee agrees that it  will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination, TDF Product and TDF Combination Product for use in the Field in and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, (C) EVG

S-117

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Product, EVG Combination Product and Quad Product for use in the Field and in the countries of the EVG-Quad Territory, and (D) BIC Product and BIC Combination Product for use in the Field and in the countries of the BIC Territory.”

		
	b.
	Section 2.5(b)(ii) is hereby deleted in its entirety and replaced with the following:

“Licensee agrees that it will not administer BIC to humans, or sell Products containing BIC until Gilead has obtained marketing approval for a Product  containing BIC from the FDA.”

		
	6.
	Limitations on Product Combinations. Licensee will be allowed to manufacture and sell BIC in combination with other active pharmaceutical ingredients in the BIC Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the BIC Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein.

		
	7.
	Gilead Distributors. Section 2.5(d)(i) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Licensee may elect to sell finished Product in the Territory to any Gilead Distributor, provided, however, that (A) Licensee may only sell and offer for sale TAF Product, TAF Combination Product, TDF Product and TDF Combination Product to Gilead Distributors to sell in the TDF-TAF Territory, and may not sell or offer for sale TAF Product, TAF Combination Product, TDF Product or TDF Combination Product outside the TDF-TAF Territory, and may not import TAF Product or TAF Combination Product into any country outside the TDF-TAF Territory, (B) Licensee may only sell and offer for sale COBI Product and COBI Combination Product to Gilead Distributors to sell in the COBI Territory, and may not sell or offer for sale COBI Product or COBI Combination Product outside the COBI Territory, and may not import COBI Product or COBI Combination Product into any country outside the COBI Territory, (C) Licensee may only sell and offer for sale EVG Product, EVG Combination Product and Quad Product to Gilead Distributors to sell in the EVG-Quad Territory, and may not sell or offer for sale EVG Product, EVG Combination Product or Quad Product outside the EVG-Quad Territory, and may not import EVG Product, EVG Combination Product or Quad Product into any country outside the EVG-Quad Territory, (D) Licensee may only sell and offer for sale BIC Product and BIC Combination Product to Gilead Distributors to sell in the BIC Territory, and may not sell or offer for sale BIC Product or BIC Combination Product outside the BIC Territory, and may not import BIC Product or BIC Combination Product into any country outside the BIC Territory, and (E) Licensee shall only sell to such Gilead Distributor those Products that are bioequivalent to the branded products Gilead has granted such Gilead Distributor the right to sell in such country of the applicable Territory.  Licensee shall only allow such Gilead Distributor to sell such Product  in the countries within the country of the applicable Territory for which such Gilead Distributor has the right to sell branded Gilead product. For example, Licensee shall not sell to a Gilead Distributor (X) a Product containing TDF, emtricitabine (FTC) and efavirenz in a particular country in the TDF-TAF Territory, unless Gilead has granted such distributor the right to sell a branded product containing TDF, FTC and efavirenz in such country in the TDF-TAF Territory, or (Y) a Product containing both TDF and 3TC or both TAF and 3TC.”

S-118

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	8.
	Third Party Reseller Agreements.    Section 2.5(e) of the Agreement is hereby deleted   in its entirety and replaced with the following:

“Gilead/MPP Approval of Third Party Reseller Agreements.  Licensee shall not enter into  any agreements with Third Party Resellers on terms inconsistent with this Agreement without obtaining Gilead’s prior written approval. If Licensee enters into an agreement with any Third Party Reseller, then Licensee shall notify Gilead and MPP in writing, and shall certify that its arrangement with such Third Party Reseller is consistent with the terms  and  conditions of this Agreement. Upon Gilead’s or MPP’s request, Licensee shall provide  Gilead and/or MPP (as applicable) with written copies of all agreements executed between Licensee and Third Party Resellers. Further upon Gilead’s or MPP’s request, Licensee shall name Gilead and/or MPP (as applicable) as a third party beneficiary in any such agreements, in which case Licensee shall consent and hereby does consent to Gilead’s and/or MPP’s (as applicable) enforcement of such agreements to the extent relating to the obligations that Licensee is required hereunder to impose upon Third Party Resellers. Gilead and/or MPP shall have the right to review all such agreements to verify consistency with the terms and conditions of this Agreement.  In the event that any inconsistency is found which had not  been specifically discussed and agreed with Gilead, then Gilead and/or MPP shall have the right to require Licensee to terminate such agreement. To the extent any such agreements relate to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead shall also have the right to share such agreements with Japan Tobacco.”

		
	9.
	Termination of Third Party Agreement by Gilead. Section 2.5(g) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Termination of Third Party Agreements by Gilead. Gilead may terminate the right of Licensee to sell Product to any Third Party Reseller pursuant to this Section Error! Reference source not found., if Gilead believes in good faith that the Third Party Reseller is not acting in a way that is consistent with Licensee’s covenants under this Agreement, or if Licensee does not terminate Licensee’s agreement with such Third Party Reseller under the circumstances described in Section 2.5(e) or Section 2.5(f).”

		
	10.
	No Other Licenses. Section 2.6(d)(ii) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Except as expressly set forth in this Agreement, MPP does not grant any license under any  of Gilead’s intellectual property rights (including, without limitation, patents or rights to any proprietary compounds or drug substances other than API) to Licensee.”

		
	11.
	Sourcing of API from API Suppliers. The last sentence of Section 3.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

“In the event that any inconsistency is found which had not been specifically discussed and agreed with Gilead, each of Gilead and MPP shall have the right to require Licensee to terminate such agreement with such Gilead Supplier or Licensed API Supplier, and upon notice from Gilead and/or MPP to such effect, Licensee shall immediately terminate such agreement.”

S-119

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	12.
	Royalty. As consideration for the licenses granted in Section 2 of the Agreement,  as  amended by Sections 2 and 3 of this Amendment, Licensee shall pay Gilead the following royalties on Net Sales of BIC Product and BIC Combination Product in the Territory for the duration of the Royalty Term:

		
	a.
	5% of BIC Product Net Sales in the BIC Territory.

		
	b.
	5% of the portion of BIC Combination Product Net Sales attributable to the BIC component of such BIC Combination Product in the BIC Territory, as determined in accordance with Section 4.2 of the Agreement.

		
	c.
	To the extent any TAF Combination Product, TDF Combination Product, EVG Combination Product, and/or COBI Combination Product contains BIC, then in addition to royalties due from Licensee to Gilead for each other royalty bearing API in such Combination Product as set forth in Section 4.1(c), (f) and (h) of the Agreement, respectively, Licensee will pay Gilead 5% of the portion of such Combination Products Net Sales attributable to the BIC component of such Combination Product in the Territory applicable to such Combination Product, as determined in accordance with Section 4.2 of the Agreement.

		
	13.
	Quarterly Reports. In each Quarterly Report, Licensee shall provide Gilead with the  following information (in addition to the information described in Section 4.3 of the Agreement): (i) any Drug Controller General of India export permits obtained by the  Licensee for Product, including the quantity of Product exported, the final destination of the Product and the recipient of the Product; and (ii) any Central Drugs Standard Control Organization (CDSCO) No Objection Certificates (NOC) obtained by third parties for  Product for which Licensee provided assistance, including the quantity of Product exported, the final destination of the Product and the recipient of the Product.

		
	14.
	Cooperation. If any party becomes aware of a suspected occurrence of  any  prohibited activity described in Section 7.2(a)(i)-(viii), such party will notify the other parties promptly, and following such notification, the parties will confer. Gilead (except in the case of Patents relating to EVG, EVG Product, EVG Combination Product or TAF Quad that are subject to the Japan Tobacco Agreement and controlled by Japan Tobacco) will have the right, but not the obligation, to bring an infringement or other action at its own expense, in its own name, and entirely under its own direction and control. Licensee will reasonably assist Gilead (or, where applicable, Japan Tobacco) in such actions or proceedings if so requested, and will lend its name to such actions or proceedings if required by law in order for Gilead (or Japan Tobacco) to bring such an action, which obligations shall survive the expiration  or termination of the Agreement.

		
	15.
	Technology Transfer. Promptly following the later of the Amendment Effective Date and Gilead’s receipt of marketing approval from the FDA for a Product containing BIC, Gilead shall make available a one-time technology transfer of know-how owned or controlled by Gilead relating to the manufacture of BIC and such FDA-approved Product containing BIC, as applicable, to the extent, and in the manner specified in Appendix 3 attached hereto.  Except as expressly provided in this Section 7, Gilead shall have no further obligation to transfer any other know-how under this Amendment.

S-120

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	16.
	Manufacturing  Requirements  Minimum  Standards.    Section  6.2(a)  of  the  Agreement  is hereby deleted in its entirety and replaced with the following:

“Minimum Standards.

(i)Licensee agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards; (ii) either World Health Organization (“WHO”) pre-qualification standards, standards of the European Medicines Agency (“EMA”), or United States Food and Drug Administration (“FDA”) tentative approval standards (“Minimum Quality Standards”); and (iii) on a country-by-country basis, any applicable national, regional or local standards as may be required by the specific country where Product is sold.

(ii)As required by MPP, in the event that any of COBI, EVG, TAF or BIC are included in the WHO Consolidated Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection (“WHO Guidelines”) or in the expression of interest for WHO pre- qualification for active pharmaceutical ingredients, Licensee shall apply for WHO pre- qualification or submit such included API’s Drug Master File (or equivalent) to the FDA no later than by the second anniversary of any such inclusion.

(iii)As required by MPP, in the event that any TAF Product or TAF Combination Product, BIC Product or BIC Combination Product, COBI Product or COBI Combination Product, EVG Product or EVG Combination Product, or the TDF Quad are included in WHO Guidelines or in the expression of interest for WHO pre-qualification of medicines, Licensee shall apply for WHO pre-qualification or FDA conditional approval for each such Product so included no later than by the third anniversary of any such inclusion.”

		
	17.
	Remedy for Failure. Section 6.2(c) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Remedy for Failure. If Licensee fails at any time to meet the Minimum Quality Standards with respect to the manufacture of API or Product, Gilead and/or MPP may elect, in their sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to suspend the effectiveness of  the licenses granted hereunder until such time as Gilead and/or MPP have determined that Licensee has corrected any such failure to Gilead’s and/or MPP's reasonable satisfaction. During any such suspension, Gilead and/or MPP and Licensee shall coordinate with each other to provide for the supply of API or Product, as appropriate, to ensure that end-user patient requirements are not disrupted as a result of such suspension.”

		
	18.
	Dose Requirements. All BIC Product and BIC Combination Products manufactured, used or sold by Licensee shall consist of dose concentrations of BIC that have been approved by the FDA. In the case of Products containing BIC, Licensee may manufacture or  sell  BIC Product, or BIC Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product.

		
	19.
	Pediatric Formulations. Licensee will have the right to develop a BIC Product or BIC Combination Product as either a liquid or dispersible tablet formulation for use in pediatric patients less than 12 years of age (such formulation shall be a Pediatric Formulation).   If

S-121

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Licensee is granted regulatory approval to market such Pediatric Formulation, then Licensee will use reasonable efforts to make such Pediatric Formulation available throughout the BIC Territory (for purposes of Section 6.2(e) of the Agreement, the BIC Territory shall be Licensee’s Applicable Territory with respect to such Pediatric Formulation).

		
	20.
	Regulatory Filings and Inspections. To the extent Regulatory Reports relate to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead will have the right to share  such Regulatory Reports with Japan Tobacco, which right shall survive the expiration or termination of the Agreement.

		
	21.
	Safety Reporting.  The following language is hereby added to the Agreement as Section 6.6:

“Safety Reporting.

		
	a.
	Licensee is responsible for all single and periodic reporting to all applicable regulatory authorities for the Products manufactured by or on behalf of Licensee under the Agreement.

		
	b.
	Licensee is responsible for all pharmacovigilance activities with respect to such Products, including but not limited to all associated signal detection, risk management and product labelling requirements.

		
	c.
	In the event Licensee receives an individual case safety report associated with any Gilead proprietary product, Licensee agrees to forward such reports to Gilead at E-Mail: SafetyFC@gilead.com    Fax: +1-650-522-5477.

		
	d.
	Licensee will forward details of any confirmed safety signals or emerging safety issues relating to Products manufactured by or on behalf of Licensee under this Agreement and any supporting documentation to the risk management contact at Gilead: Neda.Shokrai@gilead.com.”

		
	22.
	Diversion of Product and Technology. Section 7.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

“Diversion of Product and Technology.

		
	(a)
	Licensee covenants and agrees that Licensee and its Affiliates shall not, and shall require its Distributors and Third party Resellers not to: (i) divert or allow the diversion of API outside of India, China or South Africa, or to third parties that do  not constitute Licensed Product Suppliers, (ii) divert or allow the diversion of TDF Product, TDF Combination Product, TAF Product or TAF Combination Product outside the TDF-TAF Territory, (iii) divert or allow the diversion of COBI Product or COBI Combination Product outside the COBI Territory, (iv) divert or allow the diversion of EVG Product, EVG Combination Product or Quad Product outside the EVG-Quad Territory, (v) divert or allow the diversion of BIC Product or BIC Combination Product outside the BIC Territory, (vi) divert or allow the diversion of Licensed Technology to any third party, except as expressly permitted under this Agreement, (vii) take any action that Gilead determines in good faith to be in furtherance of the activities described in clauses (i)    - (vi), or (viii) assist or support,

S-122

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

directly or indirectly, any third party in the conduct of the activities described in clauses (i) - (vii). The parties agree that it shall not be a breach of Section 3.1 or this Section 7.2 for Licensee or its Affiliate to file marketing approval applications for any Product in a country outside of the Territory as required by applicable regulatory authorities in such country for the commercialization of such Product in such  country, or for Licensee or its Affiliate to provide developmental quantities of API or Product in support of its own marketing approval applications or a third party’s application for marketing approval, in each case, as required by applicable regulatory authorities in such country, it being understood that this provision shall not be construed as expressly or implicitly granting Licensee any right or license under any Gilead intellectual property rights beyond the licenses granted in Section 2 of this Agreement or otherwise providing any authorization by Gilead to do so, and does not constitute a waiver of any rights of Gilead under law that it may have to contest the filing or granting of such marketing approval applications.”

		
	(b)
	Damages. In the event (i) any Product is diverted (x) by Licensee or its Affiliate sublicensees, or (y) by another party with the assistance of the Licensee or its Affiliate sublicensees, in each case to any country outside the Territory in  any manner described in Section 7.2(a), and (ii) a patent covering such Product has been granted in such country or in the country(ies) outside the Territory in which such Product is manufactured (collectively the circumstance described by clause (i) and (ii), a “Diversion Event”), then in addition to any other remedies Gilead may be entitled to at law or in equity, Gilead shall be entitled to injunctive relief and to receive lost profits associated with the Diversion Event, which such lost profits will be determined by taking into consideration the following factors: (1) the quantity of Product that is the subject of such Diversion Event; (2) the average profit Gilead receives from its sale of such Product in the country(ies) outside the Territory into which such Product was sold or otherwise transferred; and (3) any erosion in Gilead’s market share in such country(ies) outside the Territory as a result of such Diversion Event. This Section 7.2(b) shall survive the expiration or termination of the Agreement with respect to Products sold prior to such expiration or termination.”

		
	23.
	General Law Compliance. Section 7.3(a) of the Agreement is hereby deleted in its entirety and replaced with the following:

“General Law Compliance. Licensee covenants and agrees that it shall perform all activities under this Agreement in accordance with all applicable laws, rules, and regulations,  including, without limitation, with respect to privacy, data protection, recalls, safety and reporting requirements and shall obtain, have and maintain all necessary regulatory approvals (including in India), marketing authorizations, permits and licenses, at Licensee’s expense for the manufacture and sale of API and/or Product and any other Licensee activities contemplated hereby.”

		
	24.
	FCPA and UK Bribery Act. Section 7.3(b) of the Agreement is hereby deleted in its entirety and replaced with the following:

“FCPA and UK Bribery Act. Licensee covenants and agrees that neither the Licensee, nor  any of its affiliates, nor any of their respective directors, officers, employees or agents (all of the foregoing, including affiliates collectively, “Licensee Representatives”) has taken any

S-123

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

action, directly or indirectly, that would result in a violation by such persons of the Foreign Corrupt Practices Act of 1977, as amended (such act, including the rules and regulations thereunder, the “FCPA”), the U.K. Bribery Act of 2010 (“Bribery Act”), or any other applicable anti-bribery or anticorruption laws, rules or regulations (collectively with  the FCPA and the Bribery Act, the “Anticorruption Laws”). Licensee covenants and agrees that Licensee and Licensee Representatives have conducted and will conduct their businesses in compliance with the Anticorruption Laws. Licensee covenants and agrees that it  shall  provide to Gilead on the Amendment Effective Date and within thirty (30) days after the beginning of each calendar year thereafter, certification in writing by Licensee of Licensee’s compliance with the Anticorruption Laws.”

		
	25.
	Gilead Right to Terminate. Section 10.3(b) of the Agreement is hereby deleted in its entirety and replaced with the following:

“(b) Gilead and/or MPP shall have the right to terminate this Agreement, the  covenant contained in Section 7.5 and/or one or both of the licenses granted pursuant to Section 2.1 or Section 2.2 (whether or not such event constitutes a right of termination pursuant to Section 10.2), if:

(i)Gilead determines in good faith that (A) a material quantity of API made or sold by Licensee has been diverted outside of South Africa, China or India, or to third parties that are not Licensed Product Suppliers, (B) a material quantity of Product made and/or sold by Licensee has been diverted to countries outside the Territory (other than with respect to such diversions occurring solely as a result of the circumstances expressly contemplated in Sections 7.3(c), 10.3(c) and 10.3(d) below), or (C) any of the prohibited activies described in Section 7.2(a)(i)-(viii) has occurred;

(ii)Gilead and/or MPP determines in good faith that, due to material deficiencies in Licensee’s compliance, or repeated failure to comply, with the Minimum Quality Standards, Licensee is unable to reliably and consistently manufacture API or Product in accordance with the Minimum Quality Standards;

(iii)Gilead determines in good faith that Licensee has obtained material quantities of API from sources outside of India, South Africa or China (subject to the provisions set forth in Sections 7.3(c) and 10.3(c)), or in ways that are inconsistent with the terms and conditions of Section 3; or

(iv)Gilead’s rights to EVG terminate due to the termination of the Japan Tobacco Agreement, provided, however, that in such event, such termination would only apply on a Product-by-Product basis and only with respect to Products containing EVG that are subject to the sublicense granted by Gilead under the Japan Tobacco Agreement.

Gilead shall give Licensee and MPP written notice of any such event and provide Licensee with a period of thirty (30) days after such notice to demonstrate that the conditions giving rise to Gilead’s determination no longer exist to Gilead’s reasonable satisfaction. If Licensee is unable to do so, this Agreement shall be terminated effective upon the thirtieth (30th) day following such notice. In the event that MPP independently exercises its right to terminate this Agreement pursuant to Sections 10.2 or 10.3, MPP shall provide notice to Gilead of such intent to terminate.”

S-124

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	26.
	Licensee Right to Terminate License on an API Basis. For the avoidance of doubt any termination by Licensee of its license to BIC pursuant to Section 10.5 of the Agreement shall in turn terminate Licensee’s rights and licenses under all Patents that claim BIC (alone or in combination with any other compounds) to manufacture, sell, use, export or import any Product that contains BIC.

		
	27.
	Appendices. Appendices 1, 2, 3, 4, 5, and 6 of the Agreement are hereby deleted and  replaced with new Appendices 1, 2, 3, 4, 5, and 6 attached to this Amendment, respectively. Appendix 7 attached to this Amendment is hereby added to the Agreement as Appendix 7.

		
	28.
	Miscellaneous. This Amendment embodies the entire understanding of the Parties  with respect to the subject matter hereof and supersedes all previous communications, representations or understandings, and agreements, whether oral or written, between the Parties relating to the subject matter hereof. Except as expressly amended by this Amendment, the terms and conditions of the Agreement will remain in full force and effect. This Amendment shall be effective as of the Amendment Effective Date, and may not be modified except by written agreement between the Parties. This Amendment will be  governed by and construed under the laws of England, without regard to its choice of law principles, and any dispute that arises hereunder shall be resolved by binding arbitration as set forth in Section 12.7 of the Agreement.

[signatures appear on following page]

S-125

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

IN WITNESS WHEREOF, the parties hereto have executed this Amendment as of the Amendment Effective Date.

GILEAD:

Gilead Sciences, Inc.

By_________________________________     
Name:
Title:

LICENSEE:

[Licensee]

By_________________________________     
Name:
Title:

MPP:

Medicines Patent Pool

By_________________________________     
Name:
Title:

S-126

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 1
Countries in the TDF-TAF Territory
	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-127

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 2
Patents

TDF Patents

(221) Title: NUCLEOTIDE ANALOGS

	
				
	Country
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/25/1997
	2076/DEL/1997

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	SubCase
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION

	
	
	CountryStatusFilingApplication No.Patent No.Issue DateDate

S-128

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

TAF Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	African Regional Industrial Property Organization
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

S-129

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-
500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

S-130

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
				
	El Salvador
	Published
	E-4696/2014
	10/3/2012

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012

	India
	Published
	2953/DELNP/2014
	10/3/2012

	Pakistan
	Pending
	671/2012
	10/3/2012

EVG Patents

(JF-0136) Title: COMPOUND AND METHOD OF USE

	
						
	Country
	Status
	Application No.
	Filing DatePatent No.

	Bolivia
	Pending
	SP-230265
	11/18/2003
	 
	 

	India
	Granted
	01316/CHENP/2004
	11/20/2003
	245833
	2/3/2011

	Indonesia
	Granted
	WO00200401542
	11/20/2003
	P0023507
	6/1/2009

	Nigeria
	Granted
	424/2003
	11/19/2003
	RP.15779
	10/20/2004

	Philippines
	Granted
	1-2004-500895
	11/20/2003
	1-2004-500895
	8/20/2008

	South Africa
	Granted
	2004/4537
	11/20/2003
	2004/4537
	8/31/2005

	Thailand
	Pending
	301004379
	11/20/2003
	 
	 

	Vietnam
	Granted
	1-2004-00605
	11/20/2003
	1-0011884
	10/7/2013

(JF-0179) Title: CRYSTALLINE FORM

	
						
	Country
	Status
	Application No.
	Filing DatePatent No.

	Bolivia
	Pending
	SP-250121
	5/19/2005
	 
	 

	India
	Pending
	357/CHENP/2010
	5/19/2005
	 
	 

	Philippines
	Granted
	1-2006-502297
	5/19/2005
	1-2006-502297
	11/19/2010

	South Africa
	Granted
	2006/10647
	5/19/2005
	2006/10647
	6/25/2008

	Thailand
	Pending
	100718
	5/19/2005
	 
	 

(JF-0193) Title: MANUFACTURING PROCESS: ROUTE D AND F

	
						
	Country
	Status
	Application No.:
	Filing Date
	Patent No.
	Issue Date

	India
	Granted
	5344/CHENP/2008
	3/6/2007
	258895
	2/13/2014

	India
	Pending
	532/CHENP/2014
	3/6/2007
	 
	 

(JF-0192) Title: MANUFACTURING PROCESS: ROUTE C AND E

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No:
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004621
	3/6/2007
	2914
	5/5/2014

	Eurasian Patent Organization
	Granted
	200870321
	3/6/2007
	17861
	3/29/2013

S-131

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Indonesia
	Pending
	W00200802860
	3/6/2007
	IDP0032077
	10/22/2012

	India
	Granted
	5341/CHENP/2008
	3/6/2007
	258747
	2/4/2014

	India
	Pending
	613/CHENP/2014
	3/6/2007
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1200800317
	3/6/2007
	14280
	3/31/2009

	Vietnam
	Granted
	1-2008-02431
	3/6/2007
	14450
	8/17/2015

	South Africa
	Granted
	2008/07547
	3/6/2007
	2008/07547
	11/25/2009

(718) Title: METHODS OF IMPROVING THE PHARMACOKINETICS OF HIV INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	Armenia
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004522
	12/29/2006
	AP2702
	7/31/2013

	Eurasian Patent Organization
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Eurasian Patent Organization
	Published
	201201496
	12/29/2006
	 
	 

	Indonesia
	Pending
	W00201102461
	12/29/2006
	 
	 

	Indonesia
	Published
	W00 2008 02128
	12/29/2006
	 
	 

	India
	Pending
	6748/DELNP/2015
	12/29/2006
	 
	 

	India
	Pending
	5576/DELNP/2008
	12/29/2006
	 
	 

	Kyrgyz Republic
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Moldova
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Intellectual Property Organization (OAPI)
	Granted
	1200800239
	12/29/2006
	14320
	6/30/2009

	Tajikistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Turkmenistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Vietnam
	Pending
	1-2008-01921
	12/29/2006
	 
	 

	South Africa
	Granted
	2008/06222
	12/29/2006
	2008/06222
	3/25/2009

(720) Title:  PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent Number
	Issue Date

	Armenia
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004831
	9/11/2007
	AP3004
	10/16/2014

	Eurasian Patent Organization
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Indonesia
	Published
	W00200900634
	9/11/2007
	 
	 

	Kyrgyz Republic
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Kazakhstan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

S-132

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Moldova
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Intellectual Property Organization (OAPI)
	Granted
	1200900070
	9/11/2007
	14458
	9/30/2009

	Thailand
	Published
	701004583
	9/11/2007
	 
	 

	Tajikistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Turkmenistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Vietnam
	Granted
	1-2009-00636
	9/11/2007
	11932
	10/22/2013

	Vietnam
	Granted
	1-2012-01354
	9/11/2007
	14698
	10/20/2015

	South Africa
	Granted
	2009/01576
	9/11/2007
	2009/01576
	2/24/2010

(746) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No
	Filing Date
	Patent Number
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005187
	9/11/2008
	AP 2785
	10/31/2013

	Eurasian Patent Organization
	Granted
	201070256
	9/11/2008
	19431
	3/31/2014

	Ecuador
	Inactive
	SP-10-10081
	9/11/2008
	 
	 

	Indonesia
	Published
	W00201000759
	9/11/2008
	 
	 

	India
	Pending
	1615/DELNP/2010
	9/11/2008
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201000093
	9/11/2008
	15058
	 

	Thailand
	Published
	801004676
	9/11/2008
	 
	 

	Vietnam
	Granted
	1-2010-00483
	9/11/2008
	10866
	11/20/2012

	South Africa
	Granted
	2010/02066
	9/11/2008
	2010/02066
	12/29/2010

(903) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
				
	Country
	Status
	Application No.
	Filing DatePatent No.

	Eurasian Patent Organization
	Allowed
	201590018
	8/1/2013

	India
	Pending
	1688/DELNP/2015
	8/1/2013

COBI Patents

(692) Title: MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

S-133

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vanuatu
	Unfiled
	 
	 
	 

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

S-134

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Organization

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

S-135

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/005864
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Published
	SP-0082-2010
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

S-136

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	India
	Abandoned
	6192/DELNP/2014

BIC Patents

(1007) TITLE: POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE

	
						
	Country
	Status
	Application No.
	FilingPatent No.Issue
DateDate

	African Intellectual Property Organization (OAPI)
	Pending
	1201500240
	12/19/2013
	 
	 

	African Regional Industrial Property Organization
	Pending
	AP/P/2015/008510
	12/19/2013
	 
	 

	Anguilla
	Pending
	AI/A/2016/00180
	12/19/2013
	 
	 

	Bahamas
	Pending
	2551
	12/19/2013
	 
	 

	Bolivia
	Published
	SP-00412-2013
	12/20/2013
	 
	 

	Congo, Democratic Republic of
	Pending
	 
	12/19/2013
	 
	 

	Ecuador
	Published
	IEPI-2015-31224
	12/19/2013
	 
	 

	El Salvador
	Published
	E-5002-2015
	12/19/2013
	 
	 

	Ethiopia
	Pending
	ET/PI/16/204
	12/19/2013
	 
	 

	Eurasian Patent Organization
	Published
	201591027
	12/19/2013
	 
	 

	Fiji
	Published
	1229
	12/19/2013
	 
	 

	Grenada
	Granted
	 
	12/19/2013
	 
	7/19/2016

	Guyana
	Pending
	1656
	12/19/2013
	 
	 

	Haiti
	Pending
	 
	12/19/2013
	 
	 

	India
	Pending
	5535/DELNP/2015
	12/19/2013
	 
	 

	Indonesia
	Allowed
	P00201503852
	12/19/2013
	 
	 

	Indonesia
	Pending
	P00201607128
	12/19/2013
	 
	 

	Jamaica
	Pending
	18/1/5740
	12/19/2013
	 
	 

	Kiribati
	Granted
	 
	12/19/2013
	 
	9/20/2016

	Moldova
	Pending
	a20150064
	12/19/2013
	 
	 

	Montserrat
	Granted
	 
	12/19/2013
	4 OF 2016
	5/27/2016

S-137

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Nepal
	Pending
	4
	12/19/2013
	 
	 

	Pakistan
	Pending
	908/2013
	12/20/2013
	 
	 

	Philippines
	Published
	1-2015-501445
	12/19/2013
	 
	 

	Philippines
	Pending
	1-2016-500389
	12/19/2013
	 
	 

	Seychelles
	Pending
	2822954
	12/19/2013
	 
	 

	Sierra Leone
	Pending
	 
	12/19/2013
	 
	 

	Solomon Islands
	Granted
	 
	12/19/2013
	J37/379
	8/5/2016

	South Africa
	Pending
	2015/04914
	12/19/2013
	 
	 

	South Africa
	Pending
	2015/07997
	12/19/2013
	 
	 

	South Korea
	Pending
	10-2015-7019194
	12/19/2013
	 
	 

	Thailand
	Pending
	1501003563
	12/19/2013
	 
	 

	Turks and Caicos Islands
	Granted
	10226
	12/19/2013
	10226
	9/7/2016

	Tuvalu
	Granted
	TVP2822954
	12/19/2013
	TVP2822954
	8/15/2016

	Vietnam
	Granted
	1-2015-02321
	12/19/2013
	15503
	5/16/2016

	Vietnam
	Pending
	1-2015-04199
	12/19/2013
	 
	 

	Virgin Islands (British)
	Granted
	EP2822954
	12/19/2013
	427/5/2016
	9/21/2016

(1091) Title: SODIUM (2R,5S,13AR)-7,9-DIOXO-10-((2,4,6- TRIFLUOROBENZYL)CARBAMOYL)-2,3,4,5,7,9,13,13A-OCTAHYDRO-2,5- METHANOPYRIDO[1',2':4,5]PYRAZINO[2,1-B]OXAZEPIN-8-OLATE

	
				
	Country
	Status
	Application No.
	FilingPatentIssue Date
DateNo.

	African Regional Industrial Property Organization
	Pending
	AP/P/2016/009591
	6/19/2015

	African Intellectual Property Organization (OAPI)
	Pending
	1201600454
	6/19/2015

	Bolivia
	Published
	SP 126-2015
	6/19/2015

	Bahamas
	Allowed
	2701
	6/18/2015

	Cuba
	Pending
	2016-0187
	6/19/2015

	Dominican Republic
	Published
	P2016-0327
	6/19/2015

	Eurasian Patent Organization
	Pending
	201692414
	6/19/2015

	Ecuador
	Published
	IEPI-2016-95566
	6/19/2015

	El Salvador
	Pending
	2016005339
	6/19/2015

	Guatemala
	Pending
	A2016-000262
	6/19/2015

	Indonesia
	Unfiled
	 
	 

	India
	Pending
	201617042937.00
	6/19/2015

	Nigeria
	Pending
	NG/PT/C/2016/2106
	6/19/2015

	Philippines
	Pending
	 
	 

	Pakistan
	Pending
	382/2015
	6/18/2015

	Thailand
	Pending
	 
	 

	Trinidad and Tobago
	Pending
	TT/A/2016/00132
	6/19/2015

S-138

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
				
	Vietnam
	Pending

	South Africa
	Pending
	2016/08744
	6/19/2015

(1147) Title: THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS

	
				
	Country
	Status
	Application No.
	Filing DatePatent No.Issue Date

	Bangladesh
	Pending
	272/2016
	11/2/2016

	Bolivia
	Pending
	SP-0260-2016
	11/9/2016

	Bahamas
	Pending
	 
	11/8/2016

	Pakistan
	Pending
	696/2016
	11/9/2016

	Patent Cooperation Treaty
	Entered NP
	US2016/060989
	11/8/2016

(1062) Title: SYNTHESIS OF POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS

	
				
	Country
	Status
	Application No.
	FilingPatentIssue
DateNo.Date

	Bahamas
	Allowed
	2702
	6/18/2015

	Eurasian Patent Organization
	Pending
	201692412
	6/16/2015

	India
	Pending
	201717000457.00
	6/16/2015

	Patent Cooperation Treaty
	Entered NP
	US2015/036017
	6/16/2015

TDF-Quad Patents

(221) Title:NUCLEOTIDE ANALOGS

	
				
	Country
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/25/1997
	2076/DEL/1997

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	Country
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC

S-139

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

S-140

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Vietnam
	Pending
	1-2012-02702

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

S-141

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	India
	Abandoned
	6192/DELNP/2014

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

S-142

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

TAF-Quad Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

S-143

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	African Regional Industrial Property Organization
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

S-144

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Organization (OAPI)

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-
500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

	El Salvador
	Published
	E-4696/2014
	10/3/2012
	 
	 

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012
	 
	 

	India
	Published
	2953/DELNP/2014
	10/3/2012
	 
	 

	Pakistan
	Pending
	671/2012
	10/3/2012
	 
	 

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

S-145

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property
	Granted
	1200900273
	6/30/2010
	14749

S-146

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Organization (OAPI)

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

S-147

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
	
	VietnamPending1-2010-02929

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	India
	Abandoned
	6192/DELNP/2014

(899) Title: THERAPEUTIC COMPOUNDS

	
				
	Country
	Status
	Application No.
	FilingPatentIssue Date
DateNo.

	Eurasian Patent Organization
	Published
	201491287
	2/1/2013

	India
	Pending
	7100/DELNP/2014
	2/1/2013

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

S-148

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
	
	PhilippinesGranted551942/20/925519412/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

For purposes of this Appendix 2, references to “PCT,“ “OAPI,” “EAPO” and “ARIPO” shall not be construed or interpreted to grant rights to Licensee in any country other than those countries expressly included within the licenses granted to Licensee in Sections 2.1 and 2.2 of this Agreement.

S-149

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 3
Terms for Technology Transfer

Gilead will make available to Licensee the following information in accordance with Section 5.4 to fully enable Licensee to manufacture FTC, TAF, TDF, EVG, COBI, TDF Product, TAF Product, EVG Product, COBI Product and Quad Product at commercial-scale quantities and in compliance with Gilead’s required quality specifications (but only to the extent not previously provided to Licensee under the Original License Agreement or other separate written agreement with Gilead and/or MPP):

		
	1.
	Manufacturing process descriptions, specifications and methods;

		
	2.
	Stability data;

		
	3.
	Analytical method validation; and

		
	4.
	Discussion of impurities.

Gilead will make available to Licensee the following information in accordance with Section 7 of the First Amendment to this Agreement, to fully enable Licensee to manufacture BIC and such FDA-approved Product containing BIC at commercial-scale quantities and in compliance with Gilead’s required quality specifications:

		
	1.
	Manufacturing process descriptions, specifications and methods;

		
	2.
	Stability data;

		
	3.
	Analytical method validation; and

		
	4.
	Discussion of impurities.

S-150

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 4
Emtricitabine Patents

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Dominican Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

S-151

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

S-152

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 5
Countries in the COBI Territory

	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-153

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 6
Countries in the EVG- Quad Territory

	
				
	1.   Afghanistan
	38.
	Ghana
	75. Rwanda

	2.   Angola
	39.
	Grenada
	76.  Saint Kitts and Nevis

	3.   Anguilla
	40.
	Guatemala
	77.  Saint Lucia

	4.   Antigua and Barbuda
	41.
	Guinea
	78.  Saint Vincent & the

	5.   Armenia
	42.
	Guinea-Bissau
	Grenadines

	6.   Bahamas
	43.
	Guyana
	79. Samoa

	7.   Bangladesh
	44.
	Haiti
	80.  São Tomé and Príncipe

	8.   Barbados
	45.
	Honduras
	81. Senegal

	9.   Belize
	46.
	India
	82. Seychelles

	10. Benin
	47.
	Indonesia
	83.  Sierra Leone

	11. Bhutan
	48.
	Jamaica
	84.  Solomon Islands

	12. Bolivia
	49.
	Kazakhstan
	85. Somalia

	13. Botswana
	50.
	Kenya
	86.  South Africa

	14. British Virgin Islands
	51.
	Kiribati
	87.  South Sudan

	15. Burkina Faso
	52.
	Kyrgyzstan
	88.  Sri Lanka

	16. Burundi
	53.
	Lao People's Dem. Rep.
	89. Sudan

	17. Cambodia
	54.
	Lesotho
	90. Suriname

	18. Cameroon
	55.
	Liberia
	91. Swaziland

	19.  Cape Verde
	56.
	Madagascar
	92.  Syrian Arab Republic

	20. Central African Republic
	57.
	Malawi
	93. Tajikistan

	21. Chad
	58.
	Maldives
	94.  Tanzania, U. Rep. of

	22. Comoros
	59.
	Mali
	95. Thailand

	23.  Congo, Rep
	60.
	Mauritania
	96. Timor-Leste

	24. Congo, Dem. Rep. of the
	61.
	Mauritius
	97. Togo

	25. Côte d'Ivoire
	62.
	Moldova, Rep. of
	98. Tonga

	26. Cuba
	63.
	Mongolia
	99.  Trinidad and Tobago

	27. Djibouti
	64.
	Mozambique
	100.Turkmenistan

	28. Dominica
	65.
	Myanmar
	101.Turks and Caicos

	29. Ecuador
	66.
	Namibia
	102.Tuvalu

	30.  El Salvador
	67.
	Nauru
	103.Uganda

	31. Equatorial Guinea
	68.
	Nepal
	104.Uzbekistan

	32. Eritrea
	69.
	Nicaragua
	105.Vanuatu

	33. Ethiopia
	70.
	Niger
	106.Vietnam

	34.  Fiji Islands, Rep. of the
	71.
	Nigeria
	107.Yemen

	35. Gabon
	72.
	Pakistan
	108.Zambia

	36. Gambia
	73.
	Palau
	109.Zimbabwe

	37. Georgia
	74.
	Papua New Guinea
	 

S-154

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 7
Countries in the BIC Territory
	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-155

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

[APPENDIX 8-B FOR NEW LICENSEES IN INDIA]
FIRST AMENDMENT 
TO
LICENSE AGREEMENT

This FIRST AMENDMENT TO LICENSE AGREEMENT (this “Amendment”) is made as of [Insert Date] (the “Amendment Effective Date”) by and among Gilead Sciences, Inc. a Delaware corporation having its principal place of business at 333 Lakeside Drive, Foster City, California 94404, USA (“Gilead”), the Medicines Patent Pool, a non-profit foundation registered under the laws of Switzerland, and having a principal place of business at Rue de Varembé 7, 1202 Geneva, Switzerland (“MPP”), and ________________ a company registered under the laws of India, and have a registered office at ______________________, India (“Licensee”).

R E C I T A L S

WHEREAS, Gilead, MPP, and Licensee entered into that certain License Agreement effective as of(the “Agreement”), pursuant to which MPP granted  Licensee certain licenses with respect to Gilead’s proprietary pharmaceutical agents tenofovir alafenamide, tenofovir disoproxil fumurate, elvitegravir, and cobicistat for treatment of HIV and HBV in developing world countries; and

WHEREAS, Gilead, MPP, and Licensee wish to amend the Agreement to add certain licenses with respect to Gilead’s proprietary pharmaceutical agent bictegravir for treatment of HIV in developing world countries, in accordance with the terms and conditions of this Amendment, all as more fully described below.

NOW, THEREFORE, Gilead, MPP, and Licensee agree as follows:

		
	1.
	Definitions.

		
	a.
	The definitions of the below terms are hereby deleted from Section 1 of the Agreement and replaced as follows:

“Active Pharmaceutical Ingredient” or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), cobicistat (“COBI”), and bictegravir (“BIC”).

“Combination Products” shall mean COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products, BIC Combination Products, and Quad Products.

“Patents” shall mean (a) the patents and patent applications set forth in Appendix 2 hereto and (b) any other patents or patent applications (and resulting patents therefrom) that are in the Territory and owned or controlled by Gilead and its Affiliates during the term of this Agreement including to the extent falling within clause  (b)  of  this  definition  (i)  those  patents  and  patent  applications exclusively

S-156

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

licensed by Gilead from Japan Tobacco pursuant to the Japan Tobacco Agreement and (ii) those patents and patent applications claiming improvements or  modifications to the manufacture of API, in the case of each patent and patent application referenced in clauses (a) and (b) solely to the extent necessary for Licensee to practice the licenses granted in Section 2 hereof.

“Product” shall mean COBI Product, EVG Product, TAF Product, TDF Product, COBI Combination Product, EVG Combination Product, TAF Combination Product, TDF Combination Product, BIC Product, BIC Combination Products, and the Quad Products.

“Territory” shall mean the TDF-TAF Territory, the COBI Territory, the EVG-Quad Territory, and the BIC Territory.

		
	b.
	The below terms are hereby added to Section 1 of the Agreement and are defined as follows:

“BIC Combination Product” shall mean a pharmaceutical product containing BIC  in combination with any other active pharmaceutical ingredient other than TAF,  TDF, EVG, or COBI (in each case subject to the restrictions set forth in Section 4 of this Amendment, including any co formulation, co-packaged product, bundled product, or other type of combination product.

“BIC Product” shall mean a formulated and finished pharmaceutical product containing BIC as its sole active pharmaceutical ingredient.

“BIC Territory” shall mean those countries listed on Appendix 7.

		
	c.
	All capitalized terms not otherwise defined in this Amendment shall have the meanings assigned to them in the Agreement.

		
	2.
	API License. Section 2.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

“API License. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a royalty-free, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.3 below), non-transferable license under the Licensed Technology to (i) make API in India solely for the purposes of exercising the licenses described in this Section 2.1; (ii) offer for sale and sell such API to Licensed Product Suppliers in India, China and South Africa for use solely for purposes set forth in the  Licensed Product Suppliers’ direct or indirect license from Gilead as set forth in the  definition of Licensed Product Suppliers; (iii) import Licensed API into India for purposes of exercising the license set forth in Section 2.2 or (iv) use API for Licensee’s own internal use in the applicable Territory. For clarity, the license granted in this Section 2.1 does not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any active pharmaceutical ingredient owned or controlled by Gilead other than TAF, TDF, EVG, COBI, and BIC.”

S-157

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	3.
	Product License. Section 2.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

“Product License. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a royalty-bearing, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.3 below), non-transferable license under the Licensed Technology solely to make Product in India and sell, have sold, offer for sale, export from India and import (i) TAF Product, TAF Combination Product, TDF Product and TDF Combination Products in the Field in the TDF-TAF Territory, (ii) EVG Product, EVG Combination Products and the Quad Products in the Field in the EVG-Quad Territory, (iii) COBI Products and COBI Combination Products in the Field and in the COBI Territory,  and
(iv) BIC Product and BIC Combination Products in the Field and in the BIC Territory; provided that in each case such Products shall be made only from Licensed API.  For  clarity,
(a) the licenses granted in this Section 2.2 do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any product containing active pharmaceutical ingredients owned or controlled by Gilead other than Products containing TAF, TDF, EVG, COBI, and BIC, and (b) notwithstanding the foregoing, the licenses granted under this Section 2.2 shall not extend to any active pharmaceutical ingredient included within a Product other than TAF, TDF, EVG, COBI, and BIC.”

		
	4.
	Affiliates.  Section 2.3 of the Agreement is hereby deleted in its entirety and replaced with  the following:

“Affiliates. Licensee may grant sublicenses under the licenses granted in Section 2.1 or Section 2.2 to its Affiliates located in India upon prior written notice to Gilead and MPP. Upon Gilead’s or MPP’s request, Licensee shall provide Gilead and/or MPP (as applicable) with the written copies of the applicable sublicense agreement with such Affiliate(s). Further upon Gilead’s or MPP’s request, Licensee shall name Gilead and/or MPP (as applicable) as a third party beneficiary in any such sublicense agreement, in which case Licensee  shall consent and hereby does consent to Gilead’s and/or MPP’s (as applicable) enforcement of such sublicense agreement to the extent relating to the obligations that Licensee is required hereunder to impose on its Affiliates. Licensee shall ensure that any such Affiliate complies with all the terms of this Agreement as if they were a party to this Agreement, and Licensee will be liable for the activities of such Affiliates as if such activities were performed by Licensee.”

		
	5.
	Product Sales.

		
	a.
	Section 2.5(b) of the Agreement is hereby amended to delete the first paragraph of such Section which is hereby replaced with the following:

“Subject to Sections 10.3(c) and 10.3(d) of the Agreement, Licensee agrees that it  will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination, TDF Product and TDF Combination Product for use in the Field in and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in  the

S-158

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

countries of the EVG-Quad Territory, and (D) BIC Product and BIC Combination Product for use in the Field and in the countries of the BIC Territory.”

		
	b.
	Section 2.5(b)(ii) is hereby deleted in its entirety and replaced with the following:

“Licensee agrees that it will not administer BIC to humans, or sell Products containing BIC until Gilead has obtained marketing approval for a Product  containing BIC from the FDA.”

		
	6.
	Limitations on Product Combinations. Licensee will be allowed to manufacture and sell BIC in combination with other active pharmaceutical ingredients in the BIC Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the BIC Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein.

		
	7.
	Gilead Distributors. Section 2.5(d)(i) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Licensee may elect to sell finished Product in the Territory to any Gilead Distributor, provided, however, that (A) Licensee may only sell and offer for sale TAF Product, TAF Combination Product, TDF Product and TDF Combination Product to Gilead Distributors to sell in the TDF-TAF Territory, and may not sell or offer for sale TAF Product, TAF Combination Product, TDF Product or TDF Combination Product outside the TDF-TAF Territory, and may not import TAF Product or TAF Combination Product into any country outside the TDF-TAF Territory, (B) Licensee may only sell and offer for sale COBI Product and COBI Combination Product to Gilead Distributors to sell in the COBI Territory, and may not sell or offer for sale COBI Product or COBI Combination Product outside the COBI Territory, and may not import COBI Product or COBI Combination Product into any country outside the COBI Territory, (C) Licensee may only sell and offer for sale EVG Product, EVG Combination Product and Quad Product to Gilead Distributors to sell in the EVG-Quad Territory, and may not sell or offer for sale EVG Product, EVG Combination Product or  Quad Product outside the EVG-Quad Territory, and may not import EVG Product, EVG Combination Product or Quad Product into any country outside the EVG-Quad Territory, (D) Licensee may only sell and offer for sale BIC Product and BIC Combination Product to Gilead Distributors to sell in the BIC Territory, and may not sell or offer for sale BIC Product or BIC Combination Product outside the BIC Territory, and may not import BIC Product or BIC Combination Product into any country outside the BIC Territory, and (E) Licensee shall only sell to such Gilead Distributor those Products that are bioequivalent to the branded products Gilead has granted such Gilead Distributor the right to sell in such country of the applicable Territory.  Licensee shall only allow such Gilead Distributor to sell such Product  in the countries within the country of the applicable Territory for which such Gilead Distributor has the right to sell branded Gilead product. For example, Licensee shall not sell to a Gilead Distributor (X) a Product containing TDF, emtricitabine (FTC) and efavirenz in a particular country in the TDF-TAF Territory, unless Gilead has granted such distributor the right to sell a branded product containing TDF, FTC and efavirenz in such country in the TDF-TAF Territory, or (Y) a Product containing both TDF and 3TC or both TAF and 3TC.”

		
	8.
	Third Party Reseller Agreements. Section 2.5(e) of the Agreement is hereby deleted in its entirety and replaced with the following:

S-159

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

“Gilead/MPP Approval of Third Party Reseller Agreements.  Licensee shall not enter into  any agreements with Third Party Resellers on terms inconsistent with this Agreement without obtaining Gilead’s prior written approval. If Licensee enters into an agreement with any  Third Party Reseller, then Licensee shall notify Gilead and MPP in writing, and shall certify that its arrangement with such Third Party Reseller is consistent with the terms  and  conditions of this Agreement. Upon Gilead’s or MPP’s request, Licensee shall provide  Gilead and/or MPP (as applicable) with written copies of all agreements executed between Licensee and Third Party Resellers. Further upon Gilead’s or MPP’s request, Licensee shall name Gilead and/or MPP (as applicable) as a third party beneficiary in any such agreements, in which case Licensee shall consent and hereby does consent to Gilead’s and/or MPP’s (as applicable) enforcement of such agreements to the extent relating to the obligations that Licensee is required hereunder to impose upon Third Party Resellers. Gilead and/or MPP shall have the right to review all such agreements to verify consistency with the terms and conditions of this Agreement.  In the event that any inconsistency is found which had not  been specifically discussed and agreed with Gilead, then Gilead and/or MPP shall have the right to require Licensee to terminate such agreement. To the extent any such agreements relate to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead shall also have the right to share such agreements with Japan Tobacco.”

		
	9.
	Termination of Third Party Agreement by Gilead. Section 2.5(g) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Termination of Third Party Agreements by Gilead. Gilead may terminate the right of Licensee to sell Product to any Third Party Reseller pursuant to this Section 2.5, if Gilead believes in good faith that the Third Party Reseller is not acting in a way that is consistent with Licensee’s covenants under this Agreement, or if Licensee does not terminate Licensee’s agreement with such Third Party Reseller under the circumstances described in Section 2.5(e) or Section 2.5(f).”

		
	10.
	No Other Licenses. Section 2.6(d)(ii) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Except as expressly set forth in this Agreement, MPP does not grant any license under any  of Gilead’s intellectual property rights (including, without limitation, patents or rights to any proprietary compounds or drug substances other than API) to Licensee.”

		
	11.
	Sourcing of API from API Suppliers. The last sentence of Section 3.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

“In the event that any inconsistency is found which had not been specifically discussed and agreed with Gilead, each of Gilead and MPP shall have the right to require Licensee to terminate such agreement with such Gilead Supplier or Licensed API Supplier, and upon notice from Gilead and/or MPP to such effect, Licensee shall immediately terminate such agreement.”

		
	12.
	Royalty.    As  consideration  for  the  licenses  granted  in  Section 2  of  the   Agreement,  as amended by Sections 2 and 3 of this Amendment, Licensee shall pay Gilead the following

S-160

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

royalties on Net Sales of BIC Product and BIC Combination Product in the Territory for the duration of the Royalty Term:

		
	a.
	5% of BIC Product Net Sales in the BIC Territory.

		
	b.
	5% of the portion of BIC Combination Product Net Sales attributable to the BIC component of such BIC Combination Product in the BIC Territory, as determined in accordance with Section 4.2 of the Agreement.

		
	c.
	To the extent any TAF Combination Product, TDF Combination Product, EVG Combination Product, and/or COBI Combination Product contains BIC, then in addition to royalties due from Licensee to Gilead for each other royalty bearing API in such Combination Product as set forth in Section 4.1(c), (f) and (h) of the Agreement, respectively, Licensee will pay Gilead 5% of the portion of such Combination Products Net Sales attributable to the BIC component of such Combination Product in the Territory applicable to such Combination Product, as determined in accordance with Section 4.2 of the Agreement.

		
	13.
	Quarterly Reports. In each Quarterly Report, Licensee shall provide Gilead with the  following information (in addition to the information described in Section 4.3 of the Agreement): (i) any Drug Controller General of India export permits obtained by the  Licensee for Product, including the quantity of Product exported, the final destination of the Product and the recipient of the Product; and (ii) any Central Drugs Standard Control Organization (CDSCO) No Objection Certificates (NOC) obtained by third parties for  Product for which Licensee provided assistance, including the quantity of Product exported, the final destination of the Product and the recipient of the Product.

		
	14.
	Cooperation. If any party becomes aware of a suspected occurrence of  any  prohibited activity described in Section 7.2(a)(i)-(viii), such party will notify the other parties promptly, and following such notification, the parties will confer. Gilead (except in the case of Patents relating to EVG, EVG Product, EVG Combination Product or TAF Quad that are subject to the Japan Tobacco Agreement and controlled by Japan Tobacco) will have the right, but not the obligation, to bring an infringement or other action at its own expense, in its own name, and entirely under its own direction and control. Licensee will reasonably assist Gilead (or, where applicable, Japan Tobacco) in such actions or proceedings if so requested, and will lend its name to such actions or proceedings if required by law in order for Gilead (or Japan Tobacco) to bring such an action, which obligations shall survive the expiration  or termination of the Agreement.

		
	15.
	Technology Transfer. Promptly following the later of the Amendment Effective Date and Gilead’s receipt of marketing approval from the FDA for a Product containing BIC, Gilead shall make available a one-time technology transfer of know-how owned or controlled by Gilead relating to the manufacture of BIC and such FDA-approved Product containing BIC, as applicable, to the extent, and in the manner specified in Appendix 3 attached hereto.  Except as expressly provided in this Section 7, Gilead shall have no further obligation to transfer any other know-how under this Amendment.

		
	16.
	Manufacturing Requirements Minimum Standards. Section 6.2(a) of the Agreement  is  hereby deleted in its entirety and replaced with the following:

S-161

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

“Minimum Standards.

(i)Licensee agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards; (ii) either World Health Organization (“WHO”) pre-qualification standards, standards of the European Medicines Agency (“EMA”), or United States Food and Drug Administration (“FDA”) tentative approval standards (“Minimum Quality Standards”); and (iii) on a country-by-country basis, any applicable national, regional or local standards as may be required by the specific country where Product is sold.

(ii)As required by MPP, in the event that any of COBI, EVG, TAF or BIC are included in the WHO Consolidated Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection (“WHO Guidelines”) or in the expression of interest for WHO pre- qualification for active pharmaceutical ingredients, Licensee shall apply for WHO pre- qualification or submit such included API’s Drug Master File (or equivalent) to the FDA no later than by the second anniversary of any such inclusion.

(iii)As required by MPP, in the event that any TAF Product or TAF Combination Product, BIC Product or BIC Combination Product, COBI Product or COBI Combination Product, EVG Product or EVG Combination Product, or the TDF Quad are included in WHO Guidelines or in the expression of interest for WHO pre-qualification of medicines, Licensee shall apply for WHO pre-qualification or FDA conditional approval for each such Product so included no later than by the third anniversary of any such inclusion.”

		
	17.
	Remedy for Failure. Section 6.2(c) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Remedy for Failure. If Licensee fails at any time to meet the Minimum Quality Standards with respect to the manufacture of API or Product, Gilead and/or MPP may elect, in their sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to suspend the effectiveness of  the licenses granted hereunder until such time as Gilead and/or MPP have determined that Licensee has corrected any such failure to Gilead’s and/or MPP's reasonable satisfaction. During any such suspension, Gilead and/or MPP and Licensee shall coordinate with each other to provide for the supply of API or Product, as appropriate, to ensure that end-user patient requirements are not disrupted as a result of such suspension.”

		
	18.
	Dose Requirements. All BIC Product and BIC Combination Products manufactured, used or sold by Licensee shall consist of dose concentrations of BIC that have been approved by the FDA. In the case of Products containing BIC, Licensee may manufacture or sell  BIC Product, or BIC Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product.

		
	19.
	Pediatric Formulations. Licensee will have the right to develop a BIC Product or BIC Combination Product as either a liquid or dispersible tablet formulation for use in pediatric patients less than 12 years of age (such formulation shall be a Pediatric Formulation). If Licensee is granted regulatory approval to market such Pediatric Formulation, then Licensee will use reasonable efforts to make such Pediatric Formulation available throughout the   BIC

S-162

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Territory (for purposes of Section 6.2(e) of the Agreement, the BIC Territory shall be Licensee’s Applicable Territory with respect to such Pediatric Formulation).

		
	20.
	Regulatory Filings and Inspections. To the extent Regulatory Reports relate to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead will have the right to share  such Regulatory Reports with Japan Tobacco, which right shall survive the expiration or termination of the Agreement.

		
	21.
	Safety Reporting.  The following language is hereby added to the Agreement as Section 6.6:

“Safety Reporting.

		
	a.
	Licensee is responsible for all single and periodic reporting to all applicable regulatory authorities for the Products manufactured by or on behalf of Licensee under the Agreement.

		
	b.
	Licensee is responsible for all pharmacovigilance activities with respect to such Products, including but not limited to all associated signal detection, risk management and product labelling requirements.

		
	c.
	In the event Licensee receives an individual case safety report associated with any Gilead proprietary product, Licensee agrees to forward such reports to Gilead at E-Mail: SafetyFC@gilead.com    Fax: +1-650-522-5477.

		
	d.
	Licensee will forward details of any confirmed safety signals or emerging safety issues relating to Products manufactured by or on behalf of Licensee under this Agreement and any supporting documentation to the risk management contact at Gilead: Neda.Shokrai@gilead.com.”

		
	22.
	Diversion of Product and Technology. Section 7.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

“Diversion of Product and Technology.

		
	(a)
	Licensee covenants and agrees that Licensee and its Affiliates shall not, and shall require its Distributors and Third party Resellers not to: (i) divert or allow the diversion of API outside of India, China or South Africa, or to third parties that do  not constitute Licensed Product Suppliers, (ii) divert or allow the diversion of TDF Product, TDF Combination Product, TAF Product or TAF Combination Product outside the TDF-TAF Territory, (iii) divert or allow the diversion of COBI Product or COBI Combination Product outside the COBI Territory, (iv) divert or allow the diversion of EVG Product, EVG Combination Product or Quad Product outside the EVG-Quad Territory, (v) divert or allow the diversion of BIC Product or BIC Combination Product outside the BIC Territory, (vi) divert or allow the diversion of Licensed Technology to any third party, except as expressly permitted under this Agreement, (vii) take any action that Gilead determines in good faith to be in furtherance of the activities described in clauses (i) - (vi), or (viii) assist or support, directly or indirectly, any third party in the conduct of the activities described in clauses (i) - (vii).  The parties agree that it shall not be a breach of Section 3.1 or  this

S-163

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Section 7.2 for Licensee or its Affiliate to file marketing approval applications for any Product in a country outside of the Territory as required by applicable regulatory authorities in such country for the commercialization of such Product in such  country, or for Licensee or its Affiliate to provide developmental quantities of API or Product in support of its own marketing approval applications or a third party’s application for marketing approval, in each case, as required by applicable regulatory authorities in such country, it being understood that this provision shall not be construed as expressly or implicitly granting Licensee any right or license under any Gilead intellectual property rights beyond the licenses granted in Section 2 of this Agreement or otherwise providing any authorization by Gilead to do so, and does not constitute a waiver of any rights of Gilead under law that it may have to contest the filing or granting of such marketing approval applications.”

		
	(b)
	Damages. In the event (i) any Product is diverted (x) by Licensee or its Affiliate sublicensees, or (y) by another party with the assistance of the Licensee or its Affiliate sublicensees, in each case to any country outside the Territory in  any manner described in Section 7.2(a), and (ii) a patent covering such Product has been granted in such country or in the country(ies) outside the Territory in which such Product is manufactured (collectively the circumstance described by clause (i) and (ii), a “Diversion Event”), then in addition to any other remedies Gilead may be entitled to at law or in equity, Gilead shall be entitled to injunctive relief and to receive lost profits associated with the Diversion Event, which such lost profits will be determined by taking into consideration the following factors: (1) the quantity of Product that is the subject of such Diversion Event; (2) the average profit Gilead receives from its sale of such Product in the country(ies) outside the Territory into which such Product was sold or otherwise transferred; and (3) any erosion in Gilead’s market share in such country(ies) outside the Territory as a result of such Diversion Event. This Section 7.2(b) shall survive the expiration or termination of the Agreement with respect to Products sold prior to such expiration or termination.”

		
	23.
	General Law Compliance. Section 7.3(a) of the Agreement is hereby deleted in its entirety and replaced with the following:

“General Law Compliance. Licensee covenants and agrees that it shall perform all activities under this Agreement in accordance with all applicable laws, rules, and regulations,  including, without limitation, with respect to privacy, data protection, recalls, safety and reporting requirements and shall obtain, have and maintain all necessary regulatory approvals (including in India), marketing authorizations, permits and licenses, at Licensee’s expense for the manufacture and sale of API and/or Product and any other Licensee activities contemplated hereby.”

		
	24.
	FCPA and UK Bribery Act. Section 7.3(b) of the Agreement is hereby deleted in its entirety and replaced with the following:

“FCPA and UK Bribery Act. Licensee covenants and agrees that neither the Licensee, nor  any of its affiliates, nor any of their respective directors, officers, employees or agents (all of the foregoing, including affiliates collectively, “Licensee Representatives”) has taken any action, directly or indirectly, that would result in a violation by such persons of the Foreign Corrupt Practices Act of 1977, as amended (such act, including the rules and regulations

S-164

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

thereunder, the “FCPA”), the U.K. Bribery Act of 2010 (“Bribery Act”), or any other applicable anti-bribery or anticorruption laws, rules or regulations (collectively with  the FCPA and the Bribery Act, the “Anticorruption Laws”). Licensee covenants and agrees that Licensee and Licensee Representatives have conducted and will conduct their businesses in compliance with the Anticorruption Laws. Licensee covenants and agrees that it  shall  provide to Gilead on the Amendment Effective Date and within thirty (30) days after the beginning of each calendar year thereafter, certification in writing by Licensee of Licensee’s compliance with the Anticorruption Laws.”

		
	25.
	Gilead Right to Terminate. Section 10.3(b) of the Agreement is hereby deleted in its entirety and replaced with the following:

“(b) Gilead and/or MPP shall have the right to terminate this Agreement, the  covenant contained in Section 7.5 and/or one or both of the licenses granted pursuant to Section 2.1 or Section 2.2 (whether or not such event constitutes a right of termination pursuant to Section 10.2), if:

(i)Gilead determines in good faith that (A) a material quantity of API made or sold by Licensee has been diverted outside of South Africa, China or India, or to third parties that are not Licensed Product Suppliers, (B) a material quantity of Product made and/or sold by Licensee has been diverted to countries outside the Territory (other than with respect to such diversions occurring solely as a result of the circumstances expressly contemplated in Sections 7.3(c), 10.3(c) and 10.3(d) below), or (C) any of the prohibited activies described in Section 7.2(a)(i)-(viii) has occurred;

(ii)Gilead and/or MPP determines in good faith that, due to material deficiencies in Licensee’s compliance, or repeated failure to comply, with the Minimum Quality Standards, Licensee is unable to reliably and consistently manufacture API or Product in accordance with the Minimum Quality Standards;

(iii)Gilead determines in good faith that Licensee has obtained material quantities of API from sources outside of India, South Africa or China (subject to the provisions set forth in Sections 7.3(c) and 10.3(c)), or in ways that are inconsistent with the terms and conditions of Section 3; or

(iv)Gilead’s rights to EVG terminate due to the termination of the Japan Tobacco Agreement, provided, however, that in such event, such termination would only apply on a Product-by-Product basis and only with respect to Products containing EVG that are subject to the sublicense granted by Gilead under the Japan Tobacco Agreement.

Gilead shall give Licensee and MPP written notice of any such event and provide Licensee with a period of thirty (30) days after such notice to demonstrate that the conditions giving rise to Gilead’s determination no longer exist to Gilead’s reasonable satisfaction. If Licensee is unable to do so, this Agreement shall be terminated effective upon the thirtieth (30th) day following such notice. In the event that MPP independently exercises its right to terminate this Agreement pursuant to Sections 10.2 or 10.3, MPP shall provide notice to Gilead of such intent to terminate.”

S-165

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	26.
	Licensee Right to Terminate License on an API Basis. For the avoidance of doubt any termination by Licensee of its license to BIC pursuant to Section 10.5 of the Agreement shall in turn terminate Licensee’s rights and licenses under all Patents that claim BIC (alone or in combination with any other compounds) to manufacture, sell, use, export or import any Product that contains BIC.

		
	27.
	Appendices. Appendices 1, 2, 3, 4, 5, and 6 of the Agreement are hereby deleted and  replaced with new Appendices 1, 2, 3, 4, 5, and 6 attached to this Amendment, respectively. Appendix 7 attached to this Amendment is hereby added to the Agreement as Appendix 7.

		
	28.
	Miscellaneous. This Amendment embodies the entire understanding of the Parties  with respect to the subject matter hereof and supersedes all previous communications, representations or understandings, and agreements, whether oral or written, between the Parties relating to the subject matter hereof. Except as expressly amended by this Amendment, the terms and conditions of the Agreement will remain in full force and effect. This Amendment shall be effective as of the Amendment Effective Date, and may not be modified except by written agreement between the Parties. This Amendment will be  governed by and construed under the laws of England, without regard to its choice of law principles, and any dispute that arises hereunder shall be resolved by binding arbitration as set forth in Section 12.7 of the Agreement.

[signatures appear on following page]

S-166

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

IN WITNESS WHEREOF, the parties hereto have executed this Amendment as of the Amendment Effective Date.

GILEAD:

Gilead Sciences, Inc.

By _____________________________     
Name:
Title:

LICENSEE:

[Licensee]

By _____________________________     
Name:
Title:

MPP:

Medicines Patent Pool

By _____________________________     
Name:
Title:

S-167

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 1
Countries in the TDF-TAF Territory

	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-168

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 2
Patents

TDF Patents

(221) Title: NUCLEOTIDE ANALOGS

	
				
	Country
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/25/1997
	2076/DEL/1997

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	SubCase
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION

	
	
	CountryStatusFilingApplication No.Patent No.Issue DateDate

S-169

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

TAF Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	African Regional Industrial Property Organization
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

S-170

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-
500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

S-171

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
				
	El Salvador
	Published
	E-4696/2014
	10/3/2012

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012

	India
	Published
	2953/DELNP/2014
	10/3/2012

	Pakistan
	Pending
	671/2012
	10/3/2012

EVG Patents

(JF-0136) Title: COMPOUND AND METHOD OF USE

	
						
	Country
	Status
	Application No.
	Filing DatePatent No.

	Bolivia
	Pending
	SP-230265
	11/18/2003
	 
	 

	India
	Granted
	01316/CHENP/2004
	11/20/2003
	245833
	2/3/2011

	Indonesia
	Granted
	WO00200401542
	11/20/2003
	P0023507
	6/1/2009

	Nigeria
	Granted
	424/2003
	11/19/2003
	RP.15779
	10/20/2004

	Philippines
	Granted
	1-2004-500895
	11/20/2003
	1-2004-500895
	8/20/2008

	South Africa
	Granted
	2004/4537
	11/20/2003
	2004/4537
	8/31/2005

	Thailand
	Pending
	301004379
	11/20/2003
	 
	 

	Vietnam
	Granted
	1-2004-00605
	11/20/2003
	1-0011884
	10/7/2013

(JF-0179) Title: CRYSTALLINE FORM

	
						
	Country
	Status
	Application No.
	Filing DatePatent No.

	Bolivia
	Pending
	SP-250121
	5/19/2005
	 
	 

	India
	Pending
	357/CHENP/2010
	5/19/2005
	 
	 

	Philippines
	Granted
	1-2006-502297
	5/19/2005
	1-2006-502297
	11/19/2010

	South Africa
	Granted
	2006/10647
	5/19/2005
	2006/10647
	6/25/2008

	Thailand
	Pending
	100718
	5/19/2005
	 
	 

(JF-0193) Title: MANUFACTURING PROCESS: ROUTE D AND F

	
						
	Country
	Status
	Application No.:
	Filing Date
	Patent No.
	Issue Date

	India
	Granted
	5344/CHENP/2008
	3/6/2007
	258895
	2/13/2014

	India
	Pending
	532/CHENP/2014
	3/6/2007
	 
	 

(JF-0192) Title: MANUFACTURING PROCESS: ROUTE C AND E

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No:
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004621
	3/6/2007
	2914
	5/5/2014

	Eurasian Patent Organization
	Granted
	200870321
	3/6/2007
	17861
	3/29/2013

S-172

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Indonesia
	Pending
	W00200802860
	3/6/2007
	IDP0032077
	10/22/2012

	India
	Granted
	5341/CHENP/2008
	3/6/2007
	258747
	2/4/2014

	India
	Pending
	613/CHENP/2014
	3/6/2007
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1200800317
	3/6/2007
	14280
	3/31/2009

	Vietnam
	Granted
	1-2008-02431
	3/6/2007
	14450
	8/17/2015

	South Africa
	Granted
	2008/07547
	3/6/2007
	2008/07547
	11/25/2009

(718) Title: METHODS OF IMPROVING THE PHARMACOKINETICS OF HIV INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	Armenia
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004522
	12/29/2006
	AP2702
	7/31/2013

	Eurasian Patent Organization
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Eurasian Patent Organization
	Published
	201201496
	12/29/2006
	 
	 

	Indonesia
	Pending
	W00201102461
	12/29/2006
	 
	 

	Indonesia
	Published
	W00 2008 02128
	12/29/2006
	 
	 

	India
	Pending
	6748/DELNP/2015
	12/29/2006
	 
	 

	India
	Pending
	5576/DELNP/2008
	12/29/2006
	 
	 

	Kyrgyz Republic
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Moldova
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Intellectual Property Organization (OAPI)
	Granted
	1200800239
	12/29/2006
	14320
	6/30/2009

	Tajikistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Turkmenistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Vietnam
	Pending
	1-2008-01921
	12/29/2006
	 
	 

	South Africa
	Granted
	2008/06222
	12/29/2006
	2008/06222
	3/25/2009

(720) Title:  PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent Number
	Issue Date

	Armenia
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004831
	9/11/2007
	AP3004
	10/16/2014

	Eurasian Patent Organization
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Indonesia
	Published
	W00200900634
	9/11/2007
	 
	 

	Kyrgyz Republic
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Kazakhstan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

S-173

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Moldova
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Intellectual Property Organization (OAPI)
	Granted
	1200900070
	9/11/2007
	14458
	9/30/2009

	Thailand
	Published
	701004583
	9/11/2007
	 
	 

	Tajikistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Turkmenistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Vietnam
	Granted
	1-2009-00636
	9/11/2007
	11932
	10/22/2013

	Vietnam
	Granted
	1-2012-01354
	9/11/2007
	14698
	10/20/2015

	South Africa
	Granted
	2009/01576
	9/11/2007
	2009/01576
	2/24/2010

(746) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No
	Filing Date
	Patent Number
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005187
	9/11/2008
	AP 2785
	10/31/2013

	Eurasian Patent Organization
	Granted
	201070256
	9/11/2008
	19431
	3/31/2014

	Ecuador
	Inactive
	SP-10-10081
	9/11/2008
	 
	 

	Indonesia
	Published
	W00201000759
	9/11/2008
	 
	 

	India
	Pending
	1615/DELNP/2010
	9/11/2008
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201000093
	9/11/2008
	15058
	 

	Thailand
	Published
	801004676
	9/11/2008
	 
	 

	Vietnam
	Granted
	1-2010-00483
	9/11/2008
	10866
	11/20/2012

	South Africa
	Granted
	2010/02066
	9/11/2008
	2010/02066
	12/29/2010

(903) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
				
	Country
	Status
	Application No.
	Filing DatePatent No.

	Eurasian Patent Organization
	Allowed
	201590018
	8/1/2013

	India
	Pending
	1688/DELNP/2015
	8/1/2013

COBI Patents

(692) Title: MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

S-174

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vanuatu
	Unfiled
	 
	 
	 

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

S-175

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Organization

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

S-176

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/005864
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Published
	SP-0082-2010
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

S-177

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	India
	Abandoned
	6192/DELNP/2014

BIC Patents

(1007) TITLE: POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE

	
						
	Country
	Status
	Application No.
	FilingPatent No.Issue
DateDate

	African Intellectual Property Organization (OAPI)
	Pending
	1201500240
	12/19/2013
	 
	 

	African Regional Industrial Property Organization
	Pending
	AP/P/2015/008510
	12/19/2013
	 
	 

	Anguilla
	Pending
	AI/A/2016/00180
	12/19/2013
	 
	 

	Bahamas
	Pending
	2551
	12/19/2013
	 
	 

	Bolivia
	Published
	SP-00412-2013
	12/20/2013
	 
	 

	Congo, Democratic Republic of
	Pending
	 
	12/19/2013
	 
	 

	Ecuador
	Published
	IEPI-2015-31224
	12/19/2013
	 
	 

	El Salvador
	Published
	E-5002-2015
	12/19/2013
	 
	 

	Ethiopia
	Pending
	ET/PI/16/204
	12/19/2013
	 
	 

	Eurasian Patent Organization
	Published
	201591027
	12/19/2013
	 
	 

	Fiji
	Published
	1229
	12/19/2013
	 
	 

	Grenada
	Granted
	 
	12/19/2013
	 
	7/19/2016

	Guyana
	Pending
	1656
	12/19/2013
	 
	 

	Haiti
	Pending
	 
	12/19/2013
	 
	 

	India
	Pending
	5535/DELNP/2015
	12/19/2013
	 
	 

	Indonesia
	Allowed
	P00201503852
	12/19/2013
	 
	 

	Indonesia
	Pending
	P00201607128
	12/19/2013
	 
	 

	Jamaica
	Pending
	18/1/5740
	12/19/2013
	 
	 

	Kiribati
	Granted
	 
	12/19/2013
	 
	9/20/2016

	Moldova
	Pending
	a20150064
	12/19/2013
	 
	 

	Montserrat
	Granted
	 
	12/19/2013
	4 OF 2016
	5/27/2016

S-178

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Nepal
	Pending
	4
	12/19/2013
	 
	 

	Pakistan
	Pending
	908/2013
	12/20/2013
	 
	 

	Philippines
	Published
	1-2015-501445
	12/19/2013
	 
	 

	Philippines
	Pending
	1-2016-500389
	12/19/2013
	 
	 

	Seychelles
	Pending
	2822954
	12/19/2013
	 
	 

	Sierra Leone
	Pending
	 
	12/19/2013
	 
	 

	Solomon Islands
	Granted
	 
	12/19/2013
	J37/379
	8/5/2016

	South Africa
	Pending
	2015/04914
	12/19/2013
	 
	 

	South Africa
	Pending
	2015/07997
	12/19/2013
	 
	 

	South Korea
	Pending
	10-2015-7019194
	12/19/2013
	 
	 

	Thailand
	Pending
	1501003563
	12/19/2013
	 
	 

	Turks and Caicos Islands
	Granted
	10226
	12/19/2013
	10226
	9/7/2016

	Tuvalu
	Granted
	TVP2822954
	12/19/2013
	TVP2822954
	8/15/2016

	Vietnam
	Granted
	1-2015-02321
	12/19/2013
	15503
	5/16/2016

	Vietnam
	Pending
	1-2015-04199
	12/19/2013
	 
	 

	Virgin Islands (British)
	Granted
	EP2822954
	12/19/2013
	427/5/2016
	9/21/2016

(1091) Title: SODIUM (2R,5S,13AR)-7,9-DIOXO-10-((2,4,6- TRIFLUOROBENZYL)CARBAMOYL)-2,3,4,5,7,9,13,13A-OCTAHYDRO-2,5- METHANOPYRIDO[1',2':4,5]PYRAZINO[2,1-B]OXAZEPIN-8-OLATE

	
				
	Country
	Status
	Application No.
	FilingPatentIssue Date
DateNo.

	African Regional Industrial Property Organization
	Pending
	AP/P/2016/009591
	6/19/2015

	African Intellectual Property Organization (OAPI)
	Pending
	1201600454
	6/19/2015

	Bolivia
	Published
	SP 126-2015
	6/19/2015

	Bahamas
	Allowed
	2701
	6/18/2015

	Cuba
	Pending
	2016-0187
	6/19/2015

	Dominican Republic
	Published
	P2016-0327
	6/19/2015

	Eurasian Patent Organization
	Pending
	201692414
	6/19/2015

	Ecuador
	Published
	IEPI-2016-95566
	6/19/2015

	El Salvador
	Pending
	2016005339
	6/19/2015

	Guatemala
	Pending
	A2016-000262
	6/19/2015

	Indonesia
	Unfiled
	 
	 

	India
	Pending
	201617042937.00
	6/19/2015

	Nigeria
	Pending
	NG/PT/C/2016/2106
	6/19/2015

	Philippines
	Pending
	 
	 

	Pakistan
	Pending
	382/2015
	6/18/2015

	Thailand
	Pending
	 
	 

	Trinidad and Tobago
	Pending
	TT/A/2016/00132
	6/19/2015

S-179

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
				
	Vietnam
	Pending

	South Africa
	Pending
	2016/08744
	6/19/2015

(1147) Title: THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS

	
				
	Country
	Status
	Application No.
	Filing DatePatent No.Issue Date

	Bangladesh
	Pending
	272/2016
	11/2/2016

	Bolivia
	Pending
	SP-0260-2016
	11/9/2016

	Bahamas
	Pending
	 
	11/8/2016

	Pakistan
	Pending
	696/2016
	11/9/2016

	Patent Cooperation Treaty
	Entered NP
	US2016/060989
	11/8/2016

(1062) Title: SYNTHESIS OF POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS

	
				
	Country
	Status
	Application No.
	FilingPatentIssue
DateNo.Date

	Bahamas
	Allowed
	2702
	6/18/2015

	Eurasian Patent Organization
	Pending
	201692412
	6/16/2015

	India
	Pending
	201717000457.00
	6/16/2015

	Patent Cooperation Treaty
	Entered NP
	US2015/036017
	6/16/2015

TDF-Quad Patents

(221) Title:NUCLEOTIDE ANALOGS

	
				
	Country
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/25/1997
	2076/DEL/1997

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	Country
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC

S-180

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

S-181

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Vietnam
	Pending
	1-2012-02702

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

S-182

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	India
	Abandoned
	6192/DELNP/2014

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

S-183

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

TAF-Quad Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

S-184

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	African Regional Industrial Property Organization
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

S-185

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Organization (OAPI)

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-
500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

	El Salvador
	Published
	E-4696/2014
	10/3/2012
	 
	 

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012
	 
	 

	India
	Published
	2953/DELNP/2014
	10/3/2012
	 
	 

	Pakistan
	Pending
	671/2012
	10/3/2012
	 
	 

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

S-186

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property
	Granted
	1200900273
	6/30/2010
	14749

S-187

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Organization (OAPI)

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

S-188

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
	
	VietnamPending1-2010-02929

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	India
	Abandoned
	6192/DELNP/2014

(899) Title: THERAPEUTIC COMPOUNDS

	
				
	Country
	Status
	Application No.
	FilingPatentIssue Date
DateNo.

	Eurasian Patent Organization
	Published
	201491287
	2/1/2013

	India
	Pending
	7100/DELNP/2014
	2/1/2013

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

S-189

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
	
	PhilippinesGranted551942/20/925519412/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

For purposes of this Appendix 2, references to “PCT,“ “OAPI,” “EAPO” and “ARIPO” shall not be construed or interpreted to grant rights to Licensee in any country other than those countries expressly included within the licenses granted to Licensee in Sections 2.1 and 2.2 of this Agreement.

S-190

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 3
Terms for Technology Transfer

Gilead will make available to Licensee the following information in accordance with Section 5.4 to fully enable Licensee to manufacture FTC, TAF, TDF, EVG, COBI, TDF Product, TAF Product, EVG Product, COBI Product and Quad Product at commercial-scale quantities and in compliance with Gilead’s required quality specifications (but only to the extent not previously provided to Licensee under the Original License Agreement or other separate written agreement with Gilead and/or MPP):

		
	1.
	Manufacturing process descriptions, specifications and methods;

		
	2.
	Stability data;

		
	3.
	Analytical method validation; and

		
	4.
	Discussion of impurities.

Gilead will make available to Licensee the following information in accordance with Section 7 of the First Amendment to this Agreement, to fully enable Licensee to manufacture BIC and such FDA-approved Product containing BIC at commercial-scale quantities and in compliance with Gilead’s required quality specifications:

		
	1.
	Manufacturing process descriptions, specifications and methods;

		
	2.
	Stability data;

		
	3.
	Analytical method validation; and

		
	4.
	Discussion of impurities.

S-191

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 4
Emtricitabine Patents

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Dominican Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

S-192

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

S-193

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 5
Countries in the COBI Territory

	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-194

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 6
Countries in the EVG- Quad Territory

	
				
	1.   Afghanistan
	38.
	Ghana
	75. Rwanda

	2.   Angola
	39.
	Grenada
	76.  Saint Kitts and Nevis

	3.   Anguilla
	40.
	Guatemala
	77.  Saint Lucia

	4.   Antigua and Barbuda
	41.
	Guinea
	78.  Saint Vincent & the

	5.   Armenia
	42.
	Guinea-Bissau
	Grenadines

	6.   Bahamas
	43.
	Guyana
	79. Samoa

	7.   Bangladesh
	44.
	Haiti
	80.  São Tomé and Príncipe

	8.   Barbados
	45.
	Honduras
	81. Senegal

	9.   Belize
	46.
	India
	82. Seychelles

	10. Benin
	47.
	Indonesia
	83.  Sierra Leone

	11. Bhutan
	48.
	Jamaica
	84.  Solomon Islands

	12. Bolivia
	49.
	Kazakhstan
	85. Somalia

	13. Botswana
	50.
	Kenya
	86.  South Africa

	14. British Virgin Islands
	51.
	Kiribati
	87.  South Sudan

	15. Burkina Faso
	52.
	Kyrgyzstan
	88.  Sri Lanka

	16. Burundi
	53.
	Lao People's Dem. Rep.
	89. Sudan

	17. Cambodia
	54.
	Lesotho
	90. Suriname

	18. Cameroon
	55.
	Liberia
	91. Swaziland

	19.  Cape Verde
	56.
	Madagascar
	92.  Syrian Arab Republic

	20. Central African Republic
	57.
	Malawi
	93. Tajikistan

	21. Chad
	58.
	Maldives
	94.  Tanzania, U. Rep. of

	22. Comoros
	59.
	Mali
	95. Thailand

	23.  Congo, Rep
	60.
	Mauritania
	96. Timor-Leste

	24. Congo, Dem. Rep. of the
	61.
	Mauritius
	97. Togo

	25. Côte d'Ivoire
	62.
	Moldova, Rep. of
	98. Tonga

	26. Cuba
	63.
	Mongolia
	99.  Trinidad and Tobago

	27. Djibouti
	64.
	Mozambique
	100.Turkmenistan

	28. Dominica
	65.
	Myanmar
	101.Turks and Caicos

	29. Ecuador
	66.
	Namibia
	102.Tuvalu

	30.  El Salvador
	67.
	Nauru
	103.Uganda

	31. Equatorial Guinea
	68.
	Nepal
	104.Uzbekistan

	32. Eritrea
	69.
	Nicaragua
	105.Vanuatu

	33. Ethiopia
	70.
	Niger
	106.Vietnam

	34.  Fiji Islands, Rep. of the
	71.
	Nigeria
	107.Yemen

	35. Gabon
	72.
	Pakistan
	108.Zambia

	36. Gambia
	73.
	Palau
	109.Zimbabwe

	37. Georgia
	74.
	Papua New Guinea
	 

S-195

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 7
Countries in the BIC Territory
	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-196

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

[APPENDIX 8-C FOR LICENSEES IN CHINA] 
FIRST AMENDMENT
TO
[AMENDED AND RESTATED] LICENSE AGREEMENT

This FIRST AMENDMENT TO [AMENDED AND  RESTATED] LICENSE AGREEMENT (this “Amendment”) is made as of [Insert Date] (the “Amendment Effective Date”) by and among Gilead Sciences, Inc. a Delaware corporation having its principal place of business at 333 Lakeside Drive, Foster City, California 94404, USA (“Gilead”), the Medicines Patent Pool, a non-profit foundation registered under the laws of Switzerland, and having a principal place of business at Rue de Varembé 7, 1202 Geneva, Switzerland (“MPP”), and ____________________ a company registered under the laws of China, and having a registered office at ______________________, China (“Licensee”).

R E C I T A L S

WHEREAS, Gilead, MPP, and Licensee entered into that certain [Amended and Restated] License Agreement effective as of _____________ (the “Agreement”), pursuant to which MPP granted Licensee certain licenses with respect to Gilead’s proprietary pharmaceutical agents tenofovir alafenamide, tenofovir disoproxil fumurate, elvitegravir, and cobicistat for treatment of HIV and HBV in developing world countries; and

WHEREAS, Gilead, MPP, and Licensee wish to amend the Agreement to add certain licenses with respect to Gilead’s proprietary pharmaceutical agent bictegravir for treatment of HIV in developing world countries, in accordance with the terms and conditions of this Amendment, all as more fully described below.

NOW, THEREFORE, Gilead, MPP, and Licensee agree as follows:

		
	1.
	Definitions.

		
	a.
	The definitions of the below terms are hereby deleted from Section 1 of the Agreement and replaced as follows:

“Active Pharmaceutical Ingredient” or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), cobicistat (“COBI”), and bictegravir (“BIC”).

“Combination Products” shall mean COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products, BIC Combination Products, and Quad Products.

“Patents” shall mean (a) the patents and patent applications set forth in Appendix 2 hereto and (b) any other patents or patent applications (and resulting patents therefrom) that are in the Territory and owned or controlled by Gilead and its Affiliates during the term of this Agreement including to the extent falling within

S-197

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

clause (b) of this definition (i) those patents and patent applications exclusively licensed by Gilead from Japan Tobacco pursuant to the Japan Tobacco Agreement and (ii) those patents and patent applications claiming improvements or  modifications to the manufacture of API, in the case of each patent and patent application referenced in clauses (a) and (b) solely to the extent necessary for Licensee to practice the licenses granted in Section 2 hereof.

“Product” shall mean COBI Product, EVG Product, TAF Product, TDF Product, COBI Combination Product, EVG Combination Product, TAF Combination Product, TDF Combination Product, BIC Product, BIC Combination Products, and the Quad Products.

“Territory” shall mean the TDF-TAF Territory, the COBI Territory, the EVG-Quad Territory, and the BIC Territory.

		
	b.
	The below terms are hereby added to Section 1 of the Agreement and are defined as follows:

“BIC Combination Product” shall mean a pharmaceutical product containing BIC  in combination with any other active pharmaceutical ingredient other than TAF,  TDF, EVG, or COBI (in each case subject to the restrictions set forth in Section 4 of this Amendment, including any co formulation, co-packaged product, bundled product, or other type of combination product.

“BIC Product” shall mean a formulated and finished pharmaceutical product containing BIC as its sole active pharmaceutical ingredient.

“BIC Territory” shall mean those countries listed on Appendix 6.

		
	c.
	All capitalized terms not otherwise defined in this Amendment shall have the meanings assigned to them in the Agreement.

		
	2.
	API License. Section 2.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

“API License. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a royalty-free, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.3 below), non-transferable license under the Licensed Technology to (i) make API in China solely for the purposes of exercising the licenses described in this Section 2.1; (ii) offer for sale and sell such API to Licensed Product Suppliers in India, China and South Africa for use solely for purposes set forth in the  Licensed Product Suppliers’ direct or indirect license from Gilead as set forth in the  definition of Licensed Product Suppliers; (iii) import Licensed API into China for purposes  of exercising the license set forth in Section 2.2 or (iv) use API for Licensee’s own internal use in the applicable Territory. For clarity, the license granted in this Section 2.1 does not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any active pharmaceutical ingredient owned or controlled by Gilead other than TAF, TDF, EVG, COBI, and BIC.”

S-198

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	3.
	Product License. Section 2.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

“Product License. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a royalty-bearing, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.3 below), non-transferable license under the Licensed Technology solely to make Product in China and sell, have sold, offer for sale, export from China and import (i) TAF Product, TAF Combination Product, TDF Product and TDF Combination Products in the Field in the TDF-TAF Territory, (ii) EVG Product, EVG Combination Products and the Quad Products in the Field in the EVG-Quad Territory, (iii) COBI Products and COBI Combination Products in the Field and in the COBI Territory,  and
(iv) BIC Product and BIC Combination Products in the Field and in the BIC Territory; provided that in each case such Products shall be made only from Licensed API.  For  clarity,
(a) the licenses granted in this Section 2.2 do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any product containing active pharmaceutical ingredients owned or controlled by Gilead other than Products containing TAF, TDF, EVG, COBI, and BIC, and (b) notwithstanding the foregoing, the licenses granted under this Section 2.2 shall not extend to any active pharmaceutical ingredient included within a Product other than TAF, TDF, EVG, COBI, and BIC.”

		
	4.
	Affiliates.  Section 2.3 of the Agreement is hereby deleted in its entirety and replaced with  the following:

“Affiliates. Licensee may grant sublicenses under the licenses granted in Section 2.1 or Section 2.2 to its Affiliates located in China upon prior written notice to Gilead and MPP. Upon Gilead’s or MPP’s request, Licensee shall provide Gilead and/or MPP (as applicable) with the written copies of the applicable sublicense agreement with such Affiliate(s). Further upon Gilead’s or MPP’s request, Licensee shall name Gilead and/or MPP (as applicable) as a third party beneficiary in any such sublicense agreement, in which case Licensee  shall consent and hereby does consent to Gilead’s and/or MPP’s (as applicable) enforcement of such sublicense agreement to the extent relating to the obligations that Licensee is required hereunder to impose on its Affiliates. Licensee shall ensure that any such Affiliate complies with all the terms of this Agreement as if they were a party to this Agreement, and Licensee will be liable for the activities of such Affiliates as if such activities were performed by Licensee.”

		
	5.
	Product Sales.

		
	a.
	Section 2.5(b) of the Agreement is hereby amended to delete the first paragraph of such Section which is hereby replaced with the following:

“Subject to Sections 10.3(c) and 10.3(d) of the Agreement, Licensee agrees that it  will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination, TDF Product and TDF Combination Product for use in the Field in and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in  the

S-199

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

countries of the EVG-Quad Territory, and (D) BIC Product and BIC Combination Product for use in the Field and in the countries of the BIC Territory.”

		
	b.
	Section 2.5(b)(ii) is hereby deleted in its entirety and replaced with the following:

“Licensee agrees that it will not administer BIC to humans, or sell Products containing BIC until Gilead has obtained marketing approval for a Product  containing BIC from the FDA.”

		
	6.
	Limitations on Product Combinations. Licensee will be allowed to manufacture and sell BIC in combination with other active pharmaceutical ingredients in the BIC Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the BIC Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein.

		
	7.
	Gilead Distributors. Section 2.5(d)(i) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Licensee may elect to sell finished Product in the Territory to any Gilead Distributor, provided, however, that (A) Licensee may only sell and offer for sale TAF Product, TAF Combination Product, TDF Product and TDF Combination Product to Gilead Distributors to sell in the TDF-TAF Territory, and may not sell or offer for sale TAF Product, TAF Combination Product, TDF Product or TDF Combination Product outside the TDF-TAF Territory, and may not import TAF Product or TAF Combination Product into any country outside the TDF-TAF Territory, (B) Licensee may only sell and offer for sale COBI Product and COBI Combination Product to Gilead Distributors to sell in the COBI Territory, and may not sell or offer for sale COBI Product or COBI Combination Product outside the COBI Territory, and may not import COBI Product or COBI Combination Product into any country outside the COBI Territory, (C) Licensee may only sell and offer for sale EVG Product, EVG Combination Product and Quad Product to Gilead Distributors to sell in the EVG-Quad Territory, and may not sell or offer for sale EVG Product, EVG Combination Product or  Quad Product outside the EVG-Quad Territory, and may not import EVG Product, EVG Combination Product or Quad Product into any country outside the EVG-Quad Territory, (D) Licensee may only sell and offer for sale BIC Product and BIC Combination Product to Gilead Distributors to sell in the BIC Territory, and may not sell or offer for sale BIC Product or BIC Combination Product outside the BIC Territory, and may not import BIC Product or BIC Combination Product into any country outside the BIC Territory, and (E) Licensee shall only sell to such Gilead Distributor those Products that are bioequivalent to the branded products Gilead has granted such Gilead Distributor the right to sell in such country of the applicable Territory.  Licensee shall only allow such Gilead Distributor to sell such Product  in the countries within the country of the applicable Territory for which such Gilead Distributor has the right to sell branded Gilead product. For example, Licensee shall not sell to a Gilead Distributor (X) a Product containing TDF, emtricitabine (FTC) and efavirenz in a particular country in the TDF-TAF Territory, unless Gilead has granted such distributor the right to sell a branded product containing TDF, FTC and efavirenz in such country in the TDF-TAF Territory, or (Y) a Product containing both TDF and 3TC or both TAF and 3TC.”

		
	8.
	Third Party Reseller Agreements. Section 2.5(e) of the Agreement is hereby deleted in its entirety and replaced with the following:

S-200

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

“Gilead/MPP Approval of Third Party Reseller Agreements.  Licensee shall not enter into  any agreements with Third Party Resellers on terms inconsistent with this Agreement without obtaining Gilead’s prior written approval. If Licensee enters into an agreement with any  Third Party Reseller, then Licensee shall notify Gilead and MPP in writing, and shall certify that its arrangement with such Third Party Reseller is consistent with the terms  and  conditions of this Agreement. Upon Gilead’s or MPP’s request, Licensee shall provide  Gilead and/or MPP (as applicable) with written copies of all agreements executed between Licensee and Third Party Resellers. Further upon Gilead’s or MPP’s request, Licensee shall name Gilead and/or MPP (as applicable) as a third party beneficiary in any such agreements, in which case Licensee shall consent and hereby does consent to Gilead’s and/or MPP’s (as applicable) enforcement of such agreements to the extent relating to the obligations that Licensee is required hereunder to impose upon Third Party Resellers. Gilead and/or MPP  shall have the right to review all such agreements to verify consistency with the terms and conditions of this Agreement. In the event that any inconsistency is found which had not  been specifically discussed and agreed with Gilead, then Gilead and/or MPP shall have the right to require Licensee to terminate such agreement. To the extent any such agreements relate to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead shall also have the right to share such agreements with Japan Tobacco.”

		
	9.
	Termination of Third Party Agreement by Gilead. Section 2.5(g) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Termination of Third Party Agreements by Gilead. Gilead may terminate the right of Licensee to sell Product to any Third Party Reseller pursuant to this Section 2.5, if Gilead believes in good faith that the Third Party Reseller is not acting in a way that is consistent with Licensee’s covenants under this Agreement, or if Licensee does not terminate Licensee’s agreement with such Third Party Reseller under the circumstances described in Section 2.5(e) or Section 2.5(f).”

		
	10.
	No Other Licenses. Section 2.6(d)(ii) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Except as expressly set forth in this Agreement, MPP does not grant any license under any  of Gilead’s intellectual property rights (including, without limitation, patents or rights to any proprietary compounds or drug substances other than API) to Licensee.”

		
	11.
	Sourcing of API from API Suppliers. The last sentence of Section 3.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

“In the event that any inconsistency is found which had not been specifically discussed and agreed with Gilead, each of Gilead and MPP shall have the right to require Licensee to terminate such agreement with such Gilead Supplier or Licensed API Supplier, and upon notice from Gilead and/or MPP to such effect, Licensee shall immediately terminate such agreement.”

		
	12.
	Royalty.    As  consideration  for  the  licenses  granted  in  Section 2  of  the   Agreement,  as amended by Sections 2 and 3 of this Amendment, Licensee shall pay Gilead the following

S-201

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

royalties on Net Sales of BIC Product and BIC Combination Product in the Territory for the duration of the Royalty Term:

		
	a.
	5% of BIC Product Net Sales in the BIC Territory.

		
	b.
	5% of the portion of BIC Combination Product Net Sales attributable to the BIC component of such BIC Combination Product in the BIC Territory, as determined in accordance with Section 4.2 of the Agreement.

		
	c.
	To the extent any TAF Combination Product, TDF Combination Product, EVG Combination Product, and/or COBI Combination Product contains BIC, then in addition to royalties due from Licensee to Gilead for each other royalty bearing API in such Combination Product as set forth in Section 4.1(c), (f) and (h) of the Agreement, respectively, Licensee will pay Gilead 5% of the portion of such Combination Products Net Sales attributable to the BIC component of such Combination Product in the Territory applicable to such Combination Product, as determined in accordance with Section 4.2 of the Agreement.

		
	13.
	Quarterly Reports. In each Quarterly Report, Licensee shall provide Gilead with the  following information (in addition to the information described in Section 4.3 of the Agreement): (i) any Drug Controller General of India export permits obtained by the  Licensee for Product, including the quantity of Product exported, the final destination of the Product and the recipient of the Product; and (ii) any Central Drugs Standard Control Organization (CDSCO) No Objection Certificates (NOC) obtained by third parties for  Product for which Licensee provided assistance, including the quantity of Product exported, the final destination of the Product and the recipient of the Product.

		
	14.
	Cooperation.  If any party becomes aware of a suspected occurrence of any prohibited  activity described in Section 7.2(a)(i)-(viii), such party will notify the other parties promptly, and following such notification, the parties will confer. Gilead (except in the case of Patents relating to EVG, EVG Product, EVG Combination Product or TAF Quad that are subject to the Japan Tobacco Agreement and controlled by Japan Tobacco) will have the right, but not the obligation, to bring an infringement or other action at its own expense, in its own name, and entirely under its own direction and control. Licensee will reasonably assist Gilead (or, where applicable, Japan Tobacco) in such actions or proceedings if so requested, and will lend its name to such actions or proceedings if required by law in order for Gilead (or Japan Tobacco) to bring such an action, which obligations shall survive the expiration  or termination of the Agreement.

		
	15.
	Manufacturing Requirements Minimum Standards. Section 6.2(a) of the Agreement  is  hereby deleted in its entirety and replaced with the following:

“Minimum Standards.

(i)Licensee agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards; (ii) either World Health Organization (“WHO”) pre-qualification standards, standards of the European Medicines Agency (“EMA”), or United States Food and Drug Administration (“FDA”) tentative approval standards (“Minimum Quality Standards”); and (iii) on a country-by-country basis, any

S-202

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

applicable national, regional or local standards as may be required by the specific country where Product is sold.

(ii)As required by MPP, in the event that any of COBI, EVG, TAF or BIC are included in the WHO Consolidated Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection (“WHO Guidelines”) or in the expression of interest for WHO pre- qualification for active pharmaceutical ingredients, Licensee shall apply for WHO pre- qualification or submit such included API’s Drug Master File (or equivalent) to the FDA no later than by the second anniversary of any such inclusion.

(iii)As required by MPP, in the event that any TAF Product or TAF Combination Product, BIC Product or BIC Combination Product, COBI Product or COBI Combination Product, EVG Product or EVG Combination Product, or the TDF Quad are included in WHO Guidelines or in the expression of interest for WHO pre-qualification of medicines, Licensee shall apply for WHO pre-qualification or FDA conditional approval for each such Product so included no later than by the third anniversary of any such inclusion.”

		
	16.
	Remedy for Failure. Section 6.2(c) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Remedy for Failure. If Licensee fails at any time to meet the Minimum Quality Standards with respect to the manufacture of API or Product, Gilead and/or MPP may elect, in their sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to suspend the effectiveness of  the licenses granted hereunder until such time as Gilead and/or MPP have determined that Licensee has corrected any such failure to Gilead’s and/or MPP's reasonable satisfaction. During any such suspension, Gilead and/or MPP and Licensee shall coordinate with each other to provide for the supply of API or Product, as appropriate, to ensure that end-user patient requirements are not disrupted as a result of such suspension.”

		
	17.
	Dose Requirements. All BIC Product and BIC Combination Products manufactured, used or sold by Licensee shall consist of dose concentrations of BIC that have been approved by the FDA. In the case of Products containing BIC, Licensee may manufacture or  sell  BIC Product, or BIC Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product.

		
	18.
	Pediatric Formulations. Licensee will have the right to develop a BIC Product or BIC Combination Product as either a liquid or dispersible tablet formulation for use in pediatric patients less than 12 years of age (such formulation shall be a Pediatric Formulation). If Licensee is granted regulatory approval to market such Pediatric Formulation, then Licensee will use reasonable efforts to make such Pediatric Formulation available throughout the BIC Territory (for purposes of Section 6.2(e) of the Agreement, the BIC Territory shall be Licensee’s Applicable Territory with respect to such Pediatric Formulation).

		
	19.
	Regulatory Filings and Inspections. To the extent Regulatory Reports relate to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead will have the right to share  such Regulatory Reports with Japan Tobacco, which right shall survive the expiration or termination of the Agreement.

S-203

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	20.
	Safety Reporting.  The following language is hereby added to the Agreement as Section 6.6:

“Safety Reporting.

		
	a.
	Licensee is responsible for all single and periodic reporting to all applicable regulatory authorities for the Products manufactured by or on behalf of Licensee under the Agreement.

		
	b.
	Licensee is responsible for all pharmacovigilance activities with respect to such Products, including but not limited to all associated signal detection, risk management and product labelling requirements.

		
	c.
	In the event Licensee receives an individual case safety report associated with any Gilead proprietary product, Licensee agrees to forward such reports to Gilead at E-Mail: SafetyFC@gilead.com    Fax: +1-650-522-5477.

		
	d.
	Licensee will forward details of any confirmed safety signals or emerging safety issues relating to Products manufactured by or on behalf of Licensee under this Agreement and any supporting documentation to the risk management contact at Gilead: Neda.Shokrai@gilead.com.”

		
	21.
	Diversion of Product and Technology. Section 7.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

“Diversion of Product and Technology.

		
	(a)
	Licensee covenants and agrees that Licensee and its Affiliates shall not, and shall require its Distributors and Third party Resellers not to: (i) divert or allow the diversion of API outside of India, China or South Africa, or to third parties that do  not constitute Licensed Product Suppliers, (ii) divert or allow the diversion of TDF Product, TDF Combination Product, TAF Product or TAF Combination Product outside the TDF-TAF Territory, (iii) divert or allow the diversion of COBI Product or COBI Combination Product outside the COBI Territory, (iv) divert or allow the diversion of EVG Product, EVG Combination Product or Quad Product outside the EVG-Quad Territory, (v) divert or allow the diversion of BIC Product or BIC Combination Product outside the BIC Territory, (vi) divert or allow the diversion of Licensed Technology to any third party, except as expressly permitted under this Agreement, (vii) take any action that Gilead determines in good faith to be in furtherance of the activities described in clauses (i) - (vi), or (viii) assist or support, directly or indirectly, any third party in the conduct of the activities described in clauses (i) - (vii). The parties agree that it shall not be a breach of Section 3.1 or this Section 7.2 for Licensee or its Affiliate to file marketing approval applications for any Product in a country outside of the Territory as required by applicable regulatory authorities in such country for the commercialization of such Product in such  country, or for Licensee or its Affiliate to provide developmental quantities of API or Product in support of its own marketing approval applications or a third party’s application for marketing approval, in each case, as required by applicable regulatory authorities in such country, it being understood that this provision shall not be construed as expressly or implicitly granting Licensee any right or license under  any

S-204

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Gilead intellectual property rights beyond the licenses granted in Section 2 of this Agreement or otherwise providing any authorization by Gilead to do so, and does not constitute a waiver of any rights of Gilead under law that it may have to contest the filing or granting of such marketing approval applications.”

		
	(b)
	Damages. In the event (i) any Product is diverted (x) by Licensee or its Affiliate sublicensees, or (y) by another party with the assistance of the Licensee or its Affiliate sublicensees, in each case to any country outside the Territory in  any manner described in Section 7.2(a), and (ii) a patent covering such Product has been granted in such country or in the country(ies) outside the Territory in which such Product is manufactured (collectively the circumstance described by clause (i) and (ii), a “Diversion Event”), then in addition to any other remedies Gilead may be entitled to at law or in equity, Gilead shall be entitled to injunctive relief and to receive lost profits associated with the Diversion Event, which such lost profits will be determined by taking into consideration the following factors: (1) the quantity of Product that is the subject of such Diversion Event; (2) the average profit Gilead receives from its sale of such Product in the country(ies) outside the Territory into which such Product was sold or otherwise transferred; and (3) any erosion in Gilead’s market share in such country(ies) outside the Territory as a result of such Diversion Event. This Section 7.2(b) shall survive the expiration or termination of the Agreement with respect to Products sold prior to such expiration or termination.”

		
	22.
	General Law Compliance. Section 7.3(a) of the Agreement is hereby deleted in its entirety and replaced with the following:

“General Law Compliance. Licensee covenants and agrees that it shall perform all activities under this Agreement in accordance with all applicable laws, rules, and regulations,  including, without limitation, with respect to privacy, data protection, recalls, safety and reporting requirements and shall obtain, have and maintain all necessary regulatory approvals (including in China), marketing authorizations, permits and licenses, at Licensee’s expense for the manufacture and sale of API and/or Product and any other Licensee activities contemplated hereby.”

		
	23.
	FCPA and UK Bribery Act. Section 7.3(b) of the Agreement is hereby deleted in its entirety and replaced with the following:

“FCPA and UK Bribery Act. Licensee covenants and agrees that neither the Licensee, nor  any of its affiliates, nor any of their respective directors, officers, employees or agents (all of the foregoing, including affiliates collectively, “Licensee Representatives”) has taken any action, directly or indirectly, that would result in a violation by such persons of the Foreign Corrupt Practices Act of 1977, as amended (such act, including the rules and regulations thereunder, the “FCPA”), the U.K. Bribery Act of 2010 (“Bribery Act”), or any other applicable anti-bribery or anticorruption laws, rules or regulations (collectively with  the FCPA and the Bribery Act, the “Anticorruption Laws”). Licensee covenants and agrees that Licensee and Licensee Representatives have conducted and will conduct their businesses in compliance with the Anticorruption Laws. Licensee covenants and agrees that it  shall  provide to Gilead on the Amendment Effective Date and within thirty (30) days after the beginning of each calendar year thereafter, certification in writing by Licensee of Licensee’s compliance with the Anticorruption Laws.”

S-205

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	24.
	Gilead Right to Terminate. Section 10.3(b) of the Agreement is hereby deleted in its entirety and replaced with the following:

“(b) Gilead and/or MPP shall have the right to terminate this Agreement, the  covenant contained in Section 7.5 and/or one or both of the licenses granted pursuant to Section 2.1 or Section 2.2 (whether or not such event constitutes a right of termination pursuant to Section 10.2), if:

(i)Gilead determines in good faith that (A) a material quantity of API made or sold by Licensee has been diverted outside of South Africa, China or India, or to third parties that are not Licensed Product Suppliers, (B) a material quantity of Product made and/or sold by Licensee has been diverted to countries outside the Territory (other than with respect to such diversions occurring solely as a result of the circumstances expressly contemplated in Sections 7.3(c), 10.3(c) and 10.3(d) below), or (C) any of the prohibited activies described in Section 7.2(a)(i)-(viii) has occurred;

(ii)Gilead and/or MPP determines in good faith that, due to material deficiencies in Licensee’s compliance, or repeated failure to comply, with the Minimum Quality Standards, Licensee is unable to reliably and consistently manufacture API or  Product in accordance with the Minimum Quality Standards;

(iii)Gilead determines in good faith that Licensee has obtained material quantities of API from sources outside of India, South Africa or China (subject to the provisions set forth in Sections 7.3(c) and 10.3(c)), or in ways that are inconsistent with the terms and conditions of Section 3; or

(iv)Gilead’s rights to EVG terminate due to the termination of the Japan Tobacco Agreement, provided, however, that in such event, such termination would only apply on a Product-by-Product basis and only with respect to Products containing EVG that are subject to the sublicense granted by Gilead under the Japan Tobacco Agreement.

Gilead shall give Licensee and MPP written notice of any such event and provide Licensee with a period of thirty (30) days after such notice to demonstrate that the conditions giving rise to Gilead’s determination no longer exist to Gilead’s reasonable satisfaction. If Licensee is unable to do so, this Agreement shall be terminated effective upon the thirtieth (30th) day following such notice. In the event that MPP independently exercises its right to terminate this Agreement pursuant to Sections 10.2 or 10.3, MPP shall provide notice to Gilead of such intent to terminate.”

		
	25.
	Licensee Right to Terminate License on an API Basis. For the avoidance of doubt any termination by Licensee of its license to BIC pursuant to Section 10.5 of the Agreement shall in turn terminate Licensee’s rights and licenses under all Patents that claim BIC (alone or in combination with any other compounds) to manufacture, sell, use, export or import any Product that contains BIC.

		
	26.
	Appendices. Appendices 1, 2, 3, 4, and 5 of the Agreement are hereby deleted and replaced with new Appendices 1, 2, 3, 4, and 5 attached to this Amendment, respectively. Appendix 6 attached to this Amendment is hereby added to the Agreement as Appendix 6.

S-206

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	27.
	Miscellaneous. This Amendment embodies the entire understanding of the Parties  with respect to the subject matter hereof and supersedes all previous communications, representations or understandings, and agreements, whether oral or written, between the Parties relating to the subject matter hereof. Except as expressly amended by this Amendment, the terms and conditions of the Agreement will remain in full force and effect. This Amendment shall be effective as of the Amendment Effective Date, and may not be modified except by written agreement between the Parties. This Amendment will be  governed by and construed under the laws of Hong Kong, without regard to its choice of law principles, and any dispute that arises hereunder shall be resolved by binding arbitration as set forth in Section 12.7 of the Agreement.

[signatures appear on following page]

S-207

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

IN WITNESS WHEREOF, the parties hereto have executed this Amendment as of the Amendment Effective Date.

GILEAD:

Gilead Sciences, Inc.

By __________________________________     
Name:
Title:

LICENSEE:

[Licensee]

By __________________________________     
Name:
Title:

MPP:

Medicines Patent Pool

By __________________________________     
Name:
Title:

S-208

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 1
Countries in the TDF-TAF Territory
	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-209

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 2
Patents

APPENDIX 2
Patents

TDF Patents

(221) Title: NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	China (People's Republic)
	Granted
	7/25/1997
	200810083233.70
	200810083233.70
	12/12/2012

	China (People's Republic)
	Granted
	7/25/1997
	97197460.8
	ZL97197460.8
	4/30/2008

	India
	Pending
	7/25/1997
	2076/DEL/1997
	 
	 

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	SubCase
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	China (People's Republic)
	Granted
	7/23/1998
	200510099916.80
	ZL200510099916.8
	9/24/2008

	China (People's Republic)
	Granted
	7/23/1998
	200410046290X
	200410046290X
	4/19/2006

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	China (People's Republic)
	Published
	1/13/2004
	201510697340.90
	 
	 

	China (People's Republic)
	Granted
	1/13/2004
	201210094391.90
	ZL201210094391.9
	2/24/2016

	China (People's Republic)
	Granted
	1/13/2004
	200480002190.50
	200480002190.50
	6/6/2012

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

S-210

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

(676) Title:  METHOD AND COMPOSITION FOR PHARMACEUTICAL PRODUCT

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	China (People's Republic)
	Granted
	6/13/2006
	200680026180.40
	ZL200680026180.4
	10/7/2015

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	China (People's Republic)
	Granted
	6/13/2006
	200680026866.30
	200680026866.30
	3/27/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

TAF Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

S-211

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	African
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	Intellectual
	 
	 
	 
	 
	 

	Property
	 
	 
	 
	 
	 

	Organization
	 
	 
	 
	 
	 

	(OAPI)
	 
	 
	 
	 
	 

	African Regional
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Industrial
	 
	 
	 
	 
	 

	Property
	 
	 
	 
	 
	 

	Organization
	 
	 
	 
	 
	 

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	China (People's Republic)
	Granted
	1813161.1
	7/20/2001
	ZL01813161.1
	12/27/2006

	China (People's Republic)
	Granted
	200410097845.30
	7/20/2001
	ZL200410097845.3
	7/16/2008

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

S-212

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	China (People's Republic)
	Published
	201280039891.00
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-
500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	China (People's Republic)
	Published
	201280048965.70
	10/3/2012
	 
	 

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

	El Salvador
	Published
	E-4696/2014
	10/3/2012
	 
	 

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012
	 
	 

	India
	Published
	2953/DELNP/2014
	10/3/2012
	 
	 

	Pakistan
	Pending
	671/2012
	10/3/2012
	 
	 

EVG Patents

(JF-0136) Title: COMPOUND AND METHOD OF USE

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

S-213

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Bolivia
	Pending
	SP-230265
	11/18/2003
	 
	 

	China (People's Republic)
	Granted
	200380100277.10
	11/20/2003
	ZL200380100277.1
	3/19/2008

	India
	Granted
	01316/CHENP/2004
	11/20/2003
	245833
	2/3/2011

	Indonesia
	Granted
	WO00200401542
	11/20/2003
	P0023507
	6/1/2009

	Nigeria
	Granted
	424/2003
	11/19/2003
	RP.15779
	10/20/2004

	Philippines
	Granted
	1-2004-500895
	11/20/2003
	1-2004-500895
	8/20/2008

	South Africa
	Granted
	2004/4537
	11/20/2003
	2004/4537
	8/31/2005

	Thailand
	Pending
	301004379
	11/20/2003
	 
	 

	Vietnam
	Granted
	1-2004-00605
	11/20/2003
	1-0011884
	10/7/2013

(JF-0179) Title: CRYSTALLINE FORM

	
						
	Country
	Status
	Application No.
	FilingPatent No. Date

	Bolivia
	Pending
	SP-250121
	5/19/2005
	 
	 

	China (People's Republic)
	Granted
	200580016142.60
	5/19/2005
	ZL200580016142.6
	5/26/2010

	India
	Pending
	357/CHENP/2010
	5/19/2005
	 
	 

	Philippines
	Granted
	1-2006-502297
	5/19/2005
	1-2006-502297
	11/19/2010

	South Africa
	Granted
	2006/10647
	5/19/2005
	2006/10647
	6/25/2008

	Thailand
	Pending
	100718
	5/19/2005
	 
	 

(JF-0193) Title: MANUFACTURING PROCESS: ROUTE D AND F

	
						
	Country
	Status
	Application No.:
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	200780016151.40
	3/6/2007
	200780016151.40
	2/6/2013

	India
	Granted
	5344/CHENP/2008
	3/6/2007
	258895
	2/13/2014

	India
	Pending
	532/CHENP/2014
	3/6/2007
	 
	 

(JF-0192) Title: MANUFACTURING PROCESS: ROUTE C AND E

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No:
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004621
	3/6/2007
	2914
	5/5/2014

	China
	Granted
	200780016172.60
	3/6/2007
	ZL200780016172.60
	5/29/2013

	Eurasian Patent Organization
	Granted
	200870321
	3/6/2007
	17861
	3/29/2013

	Indonesia
	Pending
	W00200802860
	3/6/2007
	IDP0032077
	10/22/2012

	India
	Granted
	5341/CHENP/2008
	3/6/2007
	258747
	2/4/2014

	India
	Pending
	613/CHENP/2014
	3/6/2007
	 
	 

S-214

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	African Intellectual Property Organization (OAPI)
	Granted
	1200800317
	3/6/2007
	14280
	3/31/2009

	Vietnam
	Granted
	1-2008-02431
	3/6/2007
	14450
	8/17/2015

	South Africa
	Granted
	2008/07547
	3/6/2007
	2008/07547
	11/25/2009

(718) Title: METHODS OF IMPROVING THE PHARMACOKINETICS OF HIV INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	Armenia
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004522
	12/29/2006
	AP2702
	7/31/2013

	China (People's Republic)
	Published
	201410249622.80
	12/29/2006
	 
	 

	Eurasian Patent Organization
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Eurasian Patent Organization
	Published
	201201496
	12/29/2006
	 
	 

	Indonesia
	Pending
	W00201102461
	12/29/2006
	 
	 

	Indonesia
	Published
	W00 2008 02128
	12/29/2006
	 
	 

	India
	Pending
	6748/DELNP/2015
	12/29/2006
	 
	 

	India
	Pending
	5576/DELNP/2008
	12/29/2006
	 
	 

	Kyrgyz Republic
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Moldova
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Intellectual Property Organization (OAPI)
	Granted
	1200800239
	12/29/2006
	14320
	6/30/2009

	Tajikistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Turkmenistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Vietnam
	Pending
	1-2008-01921
	12/29/2006
	 
	 

	South Africa
	Granted
	2008/06222
	12/29/2006
	2008/06222
	3/25/2009

(720) Title:  PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent Number
	Issue Date

	Armenia
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004831
	9/11/2007
	AP3004
	10/16/2014

	China
	Granted
	200780033907.60
	9/11/2007
	ZL200780033907.6
	10/16/2013

	China
	Granted
	201210224990.80
	9/11/2007
	CN102766098B
	3/30/2016

	China
	Abandoned
	201510922236.50
	9/11/2007
	 
	 

	China
	Published
	201510922511.30
	9/11/2007
	 
	 

S-215

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Eurasian Patent Organization
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Indonesia
	Published
	W00200900634
	9/11/2007
	 
	 

	Kyrgyz Republic
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Kazakhstan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Moldova
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Intellectual
	Granted
	1200900070
	9/11/2007
	14458
	9/30/2009

	Property
	 
	 
	 
	 
	 

	Organization
	 
	 
	 
	 
	 

	(OAPI)
	 
	 
	 
	 
	 

	Thailand
	Published
	701004583
	9/11/2007
	 
	 

	Tajikistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Turkmenistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Vietnam
	Granted
	1-2009-00636
	9/11/2007
	11932
	10/22/2013

	Vietnam
	Granted
	1-2012-01354
	9/11/2007
	14698
	10/20/2015

	South Africa
	Granted
	2009/01576
	9/11/2007
	2009/01576
	2/24/2010

(746) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No
	Filing Date
	Patent Number
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005187
	9/11/2008
	AP 2785
	10/31/2013

	China
	Granted
	200880106554.20
	9/11/2008
	ZL200880106554.2
	7/9/2014

	Eurasian Patent Organization
	Granted
	201070256
	9/11/2008
	19431
	3/31/2014

	Ecuador
	Inactive
	SP-10-10081
	9/11/2008
	 
	 

	Indonesia
	Published
	W00201000759
	9/11/2008
	 
	 

	India
	Pending
	1615/DELNP/2010
	9/11/2008
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201000093
	9/11/2008
	15058
	 

	Thailand
	Published
	801004676
	9/11/2008
	 
	 

	Vietnam
	Granted
	1-2010-00483
	9/11/2008
	10866
	11/20/2012

	South Africa
	Granted
	2010/02066
	9/11/2008
	2010/02066
	12/29/2010

(903) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	China (People's Republic)
	Granted
	201380041287.60
	8/1/2013
	ZL201380041287.6
	11/2/2016

	Eurasian Patent Organization
	Allowed
	201590018
	8/1/2013
	 
	 

	India
	Pending
	1688/DELNP/2015
	8/1/2013
	 
	 

S-216

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

COBI Patents

(692) Title: MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	China (People's Republic)
	Granted
	200780025607.30
	5/29/2013
	ZL200780025607.3

	China (People's Republic)
	Granted
	201310141408.60
	4/29/2015
	ZL201310141408.6

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vanuatu
	Unfiled
	 
	 
	 

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

S-217

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
	
	Virgin Islands (British)Granted415/6/201512/1/2015415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	China (People's Republic)
	Granted
	201310326757.50
	6/10/2015
	10326757

	China (People's Republic)
	Granted
	200880013255.40
	8/28/2013
	ZL200880013255.4

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	China (People's Republic)
	Published
	201510408376.00
	 
	 

	China (People's Republic)
	Published
	201310447258.10
	 
	 

	Ecuador
	Pending
	SP-10-10636
	 
	 

S-218

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/005864
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Published
	SP-0082-2010
	4/1/2010
	 

	China
	Granted
	201080014307.70
	4/1/2010
	ZL201080014307.7

	China
	Published
	201510160505.90
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

S-219

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	China (People's Republic)
	Granted
	201080006646.00
	9/11/2013
	ZL201080006646.0

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	China
	Abandoned
	201380007712.X

	India
	Abandoned
	6192/DELNP/2014

BIC Patents

(1007) TITLE: POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE

	
				
	Country
	Status
	Application No.
	FilingPatent No.Issue
DateDate

	African Intellectual Property Organization (OAPI)
	Pending
	1201500240
	12/19/2013

	African Regional Industrial Property Organization
	Pending
	AP/P/2015/008510
	12/19/2013

	Anguilla
	Pending
	AI/A/2016/00180
	12/19/2013

	Bahamas
	Pending
	2551
	12/19/2013

	Bolivia
	Published
	SP-00412-2013
	12/20/2013

	China
	Published
	201380073134.X
	12/19/2013

	Congo, Democratic
	Pending
	 
	12/19/2013

S-220

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Republic of

	Ecuador
	Published
	IEPI-2015-31224
	12/19/2013
	 
	 

	El Salvador
	Published
	E-5002-2015
	12/19/2013
	 
	 

	Ethiopia
	Pending
	ET/PI/16/204
	12/19/2013
	 
	 

	Eurasian Patent Organization
	Published
	201591027
	12/19/2013
	 
	 

	Fiji
	Published
	1229
	12/19/2013
	 
	 

	Grenada
	Granted
	 
	12/19/2013
	 
	7/19/2016

	Guyana
	Pending
	1656
	12/19/2013
	 
	 

	Haiti
	Pending
	 
	12/19/2013
	 
	 

	India
	Pending
	5535/DELNP/2015
	12/19/2013
	 
	 

	Indonesia
	Allowed
	P00201503852
	12/19/2013
	 
	 

	Indonesia
	Pending
	P00201607128
	12/19/2013
	 
	 

	Jamaica
	Pending
	18/1/5740
	12/19/2013
	 
	 

	Kiribati
	Granted
	 
	12/19/2013
	 
	9/20/2016

	Moldova
	Pending
	a20150064
	12/19/2013
	 
	 

	Montserrat
	Granted
	 
	12/19/2013
	4 OF 2016
	5/27/2016

	Nepal
	Pending
	4
	12/19/2013
	 
	 

	Pakistan
	Pending
	908/2013
	12/20/2013
	 
	 

	Philippines
	Published
	1-2015-501445
	12/19/2013
	 
	 

	Philippines
	Pending
	1-2016-500389
	12/19/2013
	 
	 

	Seychelles
	Pending
	2822954
	12/19/2013
	 
	 

	Sierra Leone
	Pending
	 
	12/19/2013
	 
	 

	Solomon Islands
	Granted
	 
	12/19/2013
	J37/379
	8/5/2016

	South Africa
	Pending
	2015/04914
	12/19/2013
	 
	 

	South Africa
	Pending
	2015/07997
	12/19/2013
	 
	 

	South Korea
	Pending
	10-2015-7019194
	12/19/2013
	 
	 

	Thailand
	Pending
	1501003563
	12/19/2013
	 
	 

	Turks and Caicos Islands
	Granted
	10226
	12/19/2013
	10226
	9/7/2016

	Tuvalu
	Granted
	TVP2822954
	12/19/2013
	TVP2822954
	8/15/2016

	Vietnam
	Granted
	1-2015-02321
	12/19/2013
	15503
	5/16/2016

	Vietnam
	Pending
	1-2015-04199
	12/19/2013
	 
	 

	Virgin Islands (British)
	Granted
	EP2822954
	12/19/2013
	427/5/2016
	9/21/2016

(1091) Title: SODIUM (2R,5S,13AR)-7,9-DIOXO-10-((2,4,6- TRIFLUOROBENZYL)CARBAMOYL)-2,3,4,5,7,9,13,13A-OCTAHYDRO-2,5- METHANOPYRIDO[1',2':4,5]PYRAZINO[2,1-B]OXAZEPIN-8-OLATE

	
				
	Country
	Status
	Application No.
	FilingPatentIssue Date
DateNo.

	African Regional Industrial Property Organization
	Pending
	AP/P/2016/009591
	6/19/2015

S-221

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
				
	African Intellectual Property Organization (OAPI)
	Pending
	1201600454
	6/19/2015

	Bolivia
	Published
	SP 126-2015
	6/19/2015

	Bahamas
	Allowed
	2701
	6/18/2015

	China
	Published
	201580033152.40
	6/19/2015

	Cuba
	Pending
	2016-0187
	6/19/2015

	Dominican Republic
	Published
	P2016-0327
	6/19/2015

	Eurasian Patent Organization
	Pending
	201692414
	6/19/2015

	Ecuador
	Published
	IEPI-2016-95566
	6/19/2015

	El Salvador
	Pending
	2016005339
	6/19/2015

	Guatemala
	Pending
	A2016-000262
	6/19/2015

	Indonesia
	Unfiled
	 
	 

	India
	Pending
	201617042937.00
	6/19/2015

	Nigeria
	Pending
	NG/PT/C/2016/2106
	6/19/2015

	Philippines
	Pending
	 
	 

	Pakistan
	Pending
	382/2015
	6/18/2015

	Thailand
	Pending
	 
	 

	Trinidad and Tobago
	Pending
	TT/A/2016/00132
	6/19/2015

	Vietnam
	Pending
	 
	 

	South Africa
	Pending
	2016/08744
	6/19/2015

(1147) Title: THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS

	
				
	Country
	Status
	Application No.
	Filing DatePatent No.Issue Date

	Bangladesh
	Pending
	272/2016
	11/2/2016

	Bolivia
	Pending
	SP-0260-2016
	11/9/2016

	Bahamas
	Pending
	 
	11/8/2016

	Pakistan
	Pending
	696/2016
	11/9/2016

	Patent Cooperation Treaty
	Entered NP
	US2016/060989
	11/8/2016

(1062) Title: SYNTHESIS OF POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS

	
				
	Country
	Status
	Application No.
	FilingPatentIssue
DateNo.Date

	Bahamas
	Allowed
	2702
	6/18/2015

	China
	Pending
	201580033052.10
	6/16/2015

	Eurasian Patent Organization
	Pending
	201692412
	6/16/2015

	India
	Pending
	201717000457.00
	6/16/2015

	Patent Cooperation Treaty
	Entered NP
	US2015/036017
	6/16/2015

S-222

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

TDF-Quad Patents

(221) Title:NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	China (People's Republic)
	Granted
	7/25/1997
	200810083233.70
	200810083233.70
	12/12/2012

	China (People's Republic)
	Granted
	7/25/1997
	97197460.8
	ZL97197460.8
	4/30/2008

	India
	Pending
	7/25/1997
	2076/DEL/1997
	 
	 

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	China (People's Republic)
	Granted
	7/23/1998
	200510099916.80
	ZL200510099916.8
	9/24/2008

	China (People's Republic)
	Granted
	7/23/1998
	200410046290X
	200410046290X
	4/19/2006

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.Issue Date

	African Intellectual
	Granted
	1200800450
	9/30/2009
	14409

	Property
	 
	 
	 
	 

	Organization
	 
	 
	 
	 

	(OAPI)
	 
	 
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	China (People's Republic)
	Granted
	200780025607.30
	5/29/2013
	ZL200780025607.3

	China (People's Republic)
	Granted
	201310141408.60
	4/29/2015
	ZL201310141408.6

	Congo, Democratic
	Pending
	NP/004/EXT/2016
	 
	 

S-223

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Republic of

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

S-224

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	China (People's Republic)
	Granted
	201310326757.50
	6/10/2015
	10326757

	China (People's Republic)
	Granted
	200880013255.40
	8/28/2013
	ZL200880013255.4

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	China (People's Republic)
	Published
	201510408376.00
	 
	 

	China (People's Republic)
	Published
	201310447258.10
	 
	 

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

S-225

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
			
	Turkmenistan
	Granted
	2010711733/31/201622950

	Vietnam
	Pending
	1-2010-02929

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	China
	Granted
	201080014307.70
	4/1/2010
	ZL201080014307.7

	China
	Published
	201510160505.90
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	China
	Abandoned
	201380007712.X

	India
	Abandoned
	6192/DELNP/2014

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

S-226

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(TRI1010) Non-Homogenous Systems for the Resolution of Enantiomeric Mixtures

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99811893.1
	8-Oct-99
	ZL99811893.1
	28-Nov-07

(TRI1020) Method of Manufacture of 1,3-Oxathiolane Nucleosides

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99809992.9
	12-Aug-99
	ZL99809992.9
	10-Mar-04

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	China (People's Republic)
	Granted
	201080006646.00
	9/11/2013
	ZL201080006646.0

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

S-227

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

TAF-Quad Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME
	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	Intellectual
	 
	 
	 
	 
	 

	Property
	 
	 
	 
	 
	 

	Organization
	 
	 
	 
	 
	 

	(OAPI)
	 
	 
	 
	 
	 

	African Regional
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Industrial
	 
	 
	 
	 
	 

	Property
	 
	 
	 
	 
	 

	Organization
	 
	 
	 
	 
	 

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	China (People's Republic)
	Granted
	1813161.1
	7/20/2001
	ZL01813161.1
	12/27/2006

	China (People's Republic)
	Granted
	200410097845.30
	7/20/2001
	ZL200410097845.3
	7/16/2008

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

S-228

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	China (People's Republic)
	Published
	201280039891.00
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-
500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	China (People's Republic)
	Published
	201280048965.70
	10/3/2012
	 
	 

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

	El Salvador
	Published
	E-4696/2014
	10/3/2012
	 
	 

S-229

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
				
	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012

	India
	Published
	2953/DELNP/2014
	10/3/2012

	Pakistan
	Pending
	671/2012
	10/3/2012

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.Issue Date

	African Intellectual
	Granted
	1200800450
	9/30/2009
	14409

	Property
	 
	 
	 
	 

	Organization
	 
	 
	 
	 

	(OAPI)
	 
	 
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	China (People's Republic)
	Granted
	200780025607.30
	5/29/2013
	ZL200780025607.3

	China (People's Republic)
	Granted
	201310141408.60
	4/29/2015
	ZL201310141408.6

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

S-230

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Nepal
	Pending
	894

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	China (People's Republic)
	Granted
	201310326757.50
	6/10/2015
	10326757

	China (People's Republic)
	Granted
	200880013255.40
	8/28/2013
	ZL200880013255.4

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

S-231

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	China (People's Republic)
	Published
	201510408376.00
	 
	 

	China (People's Republic)
	Published
	201310447258.10
	 
	 

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	China
	Granted
	201080014307.70
	4/1/2010
	ZL201080014307.7

	China
	Published
	201510160505.90
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

S-232

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	China
	Abandoned
	201380007712.X

	India
	Abandoned
	6192/DELNP/2014

(899) Title: THERAPEUTIC COMPOUNDS

	
				
	Country
	Status
	Application No.
	FilingPatentIssue Date
DateNo.

	China (People's Republic)
	Published
	201380007670.X
	2/1/2013

	Eurasian Patent Organization
	Published
	201491287
	2/1/2013

	India
	Pending
	7100/DELNP/2014
	2/1/2013

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(TRI1010) Non-Homogenous Systems for the Resolution of Enantiomeric Mixtures

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

S-233

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 	
						
	China
	Granted
	99,811,893.1
	8-Oct-99
	ZL99811893.1
	28-Nov-07

(TRI1020) Method of Manufacture of 1,3-Oxathiolane Nucleosides

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99809992.9
	12-Aug-99
	ZL99809992.9
	10-Mar-04

For purposes of this Appendix 2, references to “PCT,“OAPI,” “EAPO” and “ARIPO” shall not be construed or interpreted to grant rights to Licensee in any country other than those countries expressly included within the licenses granted to Licensee in Sections 2.2 and 2.3 of this Agreement.

S-234

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 3
Emtricitabine Patents

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Dominican Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(TRI1010) Non-Homogenous Systems for the Resolution of Enantiomeric Mixtures

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99811893.1
	8-Oct-99
	ZL99811893.1
	11/28/07

(TRI1020) Method of Manufacture of 1,3-Oxathiolane Nucleosides

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	China
	Granted
	99809992.9
	12-Aug-99
	ZL99809992.9
	3/10/04

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY
	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	China (People's Republic)
	Published
	1/13/2004
	201510697340.90
	 
	 

	China (People's Republic)
	Granted
	1/13/2004
	201210094391.90
	ZL201210094391.9
	2/24/2016

	China (People's Republic)
	Granted
	1/13/2004
	200480002190.50
	200480002190.50
	6/6/2012

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

S-235

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	China (People's Republic)
	Granted
	6/13/2006
	200680026866.30
	200680026866.30
	3/27/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

S-236

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 4
Countries in the COBI Territory
	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-237

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 5
Countries in the EVG- Quad Territory

	
				
	1.   Afghanistan
	38.
	Ghana
	75. Rwanda

	2.   Angola
	39.
	Grenada
	76.  Saint Kitts and Nevis

	3.   Anguilla
	40.
	Guatemala
	77.  Saint Lucia

	4.   Antigua and Barbuda
	41.
	Guinea
	78.  Saint Vincent & the

	5.   Armenia
	42.
	Guinea-Bissau
	Grenadines

	6.   Bahamas
	43.
	Guyana
	79. Samoa

	7.   Bangladesh
	44.
	Haiti
	80.  São Tomé and Príncipe

	8.   Barbados
	45.
	Honduras
	81. Senegal

	9.   Belize
	46.
	India
	82. Seychelles

	10. Benin
	47.
	Indonesia
	83.  Sierra Leone

	11. Bhutan
	48.
	Jamaica
	84.  Solomon Islands

	12. Bolivia
	49.
	Kazakhstan
	85. Somalia

	13. Botswana
	50.
	Kenya
	86.  South Africa

	14. British Virgin Islands
	51.
	Kiribati
	87.  South Sudan

	15. Burkina Faso
	52.
	Kyrgyzstan
	88.  Sri Lanka

	16. Burundi
	53.
	Lao People's Dem. Rep.
	89. Sudan

	17. Cambodia
	54.
	Lesotho
	90. Suriname

	18. Cameroon
	55.
	Liberia
	91. Swaziland

	19.  Cape Verde
	56.
	Madagascar
	92.  Syrian Arab Republic

	20. Central African Republic
	57.
	Malawi
	93. Tajikistan

	21. Chad
	58.
	Maldives
	94.  Tanzania, U. Rep. of

	22. Comoros
	59.
	Mali
	95. Thailand

	23.  Congo, Rep
	60.
	Mauritania
	96. Timor-Leste

	24. Congo, Dem. Rep. of the
	61.
	Mauritius
	97. Togo

	25. Côte d'Ivoire
	62.
	Moldova, Rep. of
	98. Tonga

	26. Cuba
	63.
	Mongolia
	99.  Trinidad and Tobago

	27. Djibouti
	64.
	Mozambique
	100.Turkmenistan

	28. Dominica
	65.
	Myanmar
	101.Turks and Caicos

	29. Ecuador
	66.
	Namibia
	102.Tuvalu

	30.  El Salvador
	67.
	Nauru
	103.Uganda

	31. Equatorial Guinea
	68.
	Nepal
	104.Uzbekistan

	32. Eritrea
	69.
	Nicaragua
	105.Vanuatu

	33. Ethiopia
	70.
	Niger
	106.Vietnam

	34.  Fiji Islands, Rep. of the
	71.
	Nigeria
	107.Yemen

	35. Gabon
	72.
	Pakistan
	108.Zambia

	36. Gambia
	73.
	Palau
	109.Zimbabwe

	37. Georgia
	74.
	Papua New Guinea
	 

S-238

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 6
Countries in the BIC Territory

	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-239

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

[APPENDIX 8-D FOR LICENSEES IN SOUTH AFRICA] 
FIRST AMENDMENT
TO
LICENSE AGREEMENT

This FIRST AMENDMENT TO LICENSE AGREEMENT (this “Amendment”) is made as of [Insert Date] (the “Amendment Effective Date”) by and among Gilead Sciences, Inc. a Delaware corporation having its principal place of business at 333 Lakeside Drive, Foster City, California 94404, USA (“Gilead”), the Medicines Patent Pool, a non-profit foundation registered under the laws of Switzerland, and having a principal place of business at Rue de Varembé 7, 1202 Geneva, Switzerland   (“MPP”), and _______________________ a company registered    under    the    laws    of    South    Africa,    and    having    a    registered    office     at _______________________________ , South Africa (“Licensee”).

R E C I T A L S

WHEREAS, Gilead, MPP, and Licensee entered into that certain License Agreement effective  as  of    _____________________ (the  “Agreement”),  pursuant  to  which  MPP  granted  Licensee certain licenses with respect to Gilead’s proprietary pharmaceutical agents tenofovir alafenamide, tenofovir disoproxil fumurate, elvitegravir, and cobicistat for treatment of HIV and HBV in developing world countries; and

WHEREAS, Gilead, MPP, and Licensee wish to amend the Agreement to add certain licenses with respect to Gilead’s proprietary pharmaceutical agent bictegravir for treatment of HIV in developing world countries, in accordance with the terms and conditions of this Amendment, all as more fully described below.

NOW, THEREFORE, Gilead, MPP, and Licensee agree as follows:

		
	1.
	Definitions.

		
	a.
	The definitions of the below terms are hereby deleted from Section 1 of the Agreement and replaced as follows:

“Active Pharmaceutical Ingredient” or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), cobicistat (“COBI”), and bictegravir (“BIC”).

“Combination Products” shall mean COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products, BIC Combination Products, and Quad Products.

“Patents” shall mean (a) the patents and patent applications set forth in Appendix 2 hereto and (b) any other patents or patent applications (and resulting patents therefrom) that are in the Territory and owned or controlled by Gilead and its Affiliates during the term of this Agreement including to the extent falling within clause  (b)  of  this  definition  (i)  those  patents  and  patent  applications exclusively

S-240

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

licensed by Gilead from Japan Tobacco pursuant to the Japan Tobacco Agreement and (ii) those patents and patent applications claiming improvements or  modifications to the manufacture of API, in the case of each patent and patent application referenced in clauses (a) and (b) solely to the extent necessary for Licensee to practice the licenses granted in Section 2 hereof.

“Product” shall mean COBI Product, EVG Product, TAF Product, TDF Product, COBI Combination Product, EVG Combination Product, TAF Combination Product, TDF Combination Product, BIC Product, BIC Combination Products, and the Quad Products.

“Territory” shall mean the TDF-TAF Territory, the COBI Territory, the EVG-Quad Territory, and the BIC Territory.

		
	b.
	The below terms are hereby added to Section 1 of the Agreement and are defined as follows:

“BIC Combination Product” shall mean a pharmaceutical product containing BIC  in combination with any other active pharmaceutical ingredient other than TAF,  TDF, EVG, or COBI (in each case subject to the restrictions set forth in Section 4 of this Amendment, including any co formulation, co-packaged product, bundled product, or other type of combination product.

“BIC Product” shall mean a formulated and finished pharmaceutical product containing BIC as its sole active pharmaceutical ingredient.

“BIC Territory” shall mean those countries listed on Appendix 7.

		
	c.
	All capitalized terms not otherwise defined in this Amendment shall have the meanings assigned to them in the Agreement.

		
	2.
	API License. Section 2.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

“API License. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a royalty-free, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.3 below), non-transferable license under the Licensed Technology to (i) make API in South Africa solely for the purposes of exercising the licenses described in this Section 2.1; (ii) offer for sale and sell such API to Licensed Product Suppliers in India, China and South Africa for use solely for purposes set forth in the  Licensed Product Suppliers’ direct or indirect license from Gilead as set forth in the  definition of Licensed Product Suppliers; (iii) import Licensed API into South Africa for purposes of exercising the license set forth in Section 2.2 or (iv) use API for Licensee’s own internal use in the applicable Territory. For clarity, the license granted in this Section 2.1  does not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any active pharmaceutical ingredient owned or controlled by Gilead other than TAF, TDF, EVG, COBI, and BIC.”

S-241

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	3.
	Product License. Section 2.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

“Product License. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a royalty-bearing, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate in accordance with Section 2.3 below), non-transferable license under the Licensed Technology solely to make Product in South Africa and sell, have sold, offer for sale, export from South Africa and import (i) TAF Product, TAF Combination Product, TDF Product and TDF Combination Products in the Field in the TDF-TAF Territory, (ii) EVG Product, EVG Combination Products and the Quad Products in the Field in the EVG-Quad Territory, (iii) COBI Products and COBI Combination Products in the Field and in the COBI Territory,  and
(iv) BIC Product and BIC Combination Products in the Field and in the BIC Territory; provided that in each case such Products shall be made only from Licensed API.  For  clarity,
(a) the licenses granted in this Section 2.2 do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any product containing active pharmaceutical ingredients owned or controlled by Gilead other than Products containing TAF, TDF, EVG, COBI, and BIC, and (b) notwithstanding the foregoing, the licenses granted under this Section 2.2 shall not extend to any active pharmaceutical ingredient included within a Product other than TAF, TDF, EVG, COBI, and BIC.”

		
	4.
	Affiliates.  Section 2.3 of the Agreement is hereby deleted in its entirety and replaced with  the following:

“Affiliates. Licensee may grant sublicenses under the licenses granted in Section 2.1 or Section 2.2 to its Affiliates located in South Africa upon prior written notice to Gilead and MPP. Upon Gilead’s or MPP’s request, Licensee shall provide Gilead and/or MPP (as applicable) with the written copies of the applicable sublicense agreement with such Affiliate(s). Further upon Gilead’s or MPP’s request, Licensee shall name Gilead and/or  MPP (as applicable) as a third party beneficiary in any such sublicense agreement, in which case Licensee shall consent and hereby does consent to Gilead’s and/or MPP’s (as applicable) enforcement of such sublicense agreement to the extent relating to the obligations that Licensee is required hereunder to impose on its Affiliates.  Licensee shall ensure that any  such Affiliate complies with all the terms of this Agreement as if they were a party to this Agreement, and Licensee will be liable for the activities of such Affiliates as if such activities were performed by Licensee.”

		
	5.
	Product Sales.

		
	a.
	Section 2.5(b) of the Agreement is hereby amended to delete the first paragraph of such Section which is hereby replaced with the following:

“Subject to Sections 10.3(c) and 10.3(d) of the Agreement, Licensee agrees that it  will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination, TDF Product and TDF Combination Product for use in the Field in and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in  the

S-242

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

countries of the EVG-Quad Territory, and (D) BIC Product and BIC Combination Product for use in the Field and in the countries of the BIC Territory.”

		
	b.
	Section 2.5(b)(ii) is hereby deleted in its entirety and replaced with the following:

“Licensee agrees that it will not administer BIC to humans, or sell Products containing BIC until Gilead has obtained marketing approval for a Product  containing BIC from the FDA.”

		
	6.
	Limitations on Product Combinations. Licensee will be allowed to manufacture and sell BIC in combination with other active pharmaceutical ingredients in the BIC Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the BIC Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein.

		
	7.
	Gilead Distributors. Section 2.5(d)(i) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Licensee may elect to sell finished Product in the Territory to any Gilead Distributor, provided, however, that (A) Licensee may only sell and offer for sale TAF Product, TAF Combination Product, TDF Product and TDF Combination Product to Gilead Distributors to sell in the TDF-TAF Territory, and may not sell or offer for sale TAF Product, TAF Combination Product, TDF Product or TDF Combination Product outside the TDF-TAF Territory, and may not import TAF Product or TAF Combination Product into any country outside the TDF-TAF Territory, (B) Licensee may only sell and offer for sale COBI Product and COBI Combination Product to Gilead Distributors to sell in the COBI Territory, and may not sell or offer for sale COBI Product or COBI Combination Product outside the COBI Territory, and may not import COBI Product or COBI Combination Product into any country outside the COBI Territory, (C) Licensee may only sell and offer for sale EVG Product, EVG Combination Product and Quad Product to Gilead Distributors to sell in the EVG-Quad Territory, and may not sell or offer for sale EVG Product, EVG Combination Product or Quad Product outside the EVG-Quad Territory, and may not import EVG Product, EVG Combination Product or Quad Product into any country outside the EVG- Quad Territory,
(D) Licensee may only sell and offer for sale BIC Product and BIC Combination Product to Gilead Distributors to sell in the BIC Territory, and may not sell or offer for sale BIC Product or BIC Combination Product outside the BIC Territory, and may not import BIC Product or BIC Combination Product into any country outside the BIC Territory, and (E) Licensee shall only sell to such Gilead Distributor those Products that are bioequivalent to the branded products Gilead has granted such Gilead Distributor the right to sell in such country of the applicable Territory.  Licensee shall only allow such Gilead Distributor to sell such Product  in the countries within the country of the applicable Territory for which such Gilead Distributor has the right to sell branded Gilead product. For example, Licensee shall not sell to a Gilead Distributor (X) a Product containing TDF, emtricitabine (FTC) and efavirenz in a particular country in the TDF-TAF Territory, unless Gilead has granted such distributor the right to sell a branded product containing TDF, FTC and efavirenz in such country in the TDF-TAF Territory, or (Y) a Product containing both TDF and 3TC or both TAF and 3TC.”

		
	8.
	Third Party Reseller Agreements. Section 2.5(e) of the Agreement is hereby deleted in its entirety and replaced with the following:

S-243

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

“Gilead/MPP Approval of Third Party Reseller Agreements.  Licensee shall not enter into  any agreements with Third Party Resellers on terms inconsistent with this Agreement without obtaining Gilead’s prior written approval. If Licensee enters into an agreement with any  Third Party Reseller, then Licensee shall notify Gilead and MPP in writing, and shall certify that its arrangement with such Third Party Reseller is consistent with the terms  and  conditions of this Agreement. Upon Gilead’s or MPP’s request, Licensee shall provide  Gilead and/or MPP (as applicable) with written copies of all agreements executed between Licensee and Third Party Resellers. Further upon Gilead’s or MPP’s request, Licensee shall name Gilead and/or MPP (as applicable) as a third party beneficiary in any such agreements, in which case Licensee shall consent and hereby does consent to Gilead’s and/or MPP’s (as applicable) enforcement of such agreements to the extent relating to the obligations that Licensee is required hereunder to impose upon Third Party Resellers. Gilead and/or MPP shall have the right to review all such agreements to verify consistency with the terms and conditions of this Agreement.  In the event that any inconsistency is found which had not  been specifically discussed and agreed with Gilead, then Gilead and/or MPP shall have the right to require Licensee to terminate such agreement. To the extent any such agreements relate to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead shall also have the right to share such agreements with Japan Tobacco.”

		
	9.
	Termination of Third Party Agreement by Gilead. Section 2.5(g) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Termination of Third Party Agreements by Gilead. Gilead may terminate the right of Licensee to sell Product to any Third Party Reseller pursuant to this Section 2.5, if Gilead believes in good faith that the Third Party Reseller is not acting in a way that is consistent with Licensee’s covenants under this Agreement, or if Licensee does not terminate Licensee’s agreement with such Third Party Reseller under the circumstances described in Section 2.5(e) or Section 2.5(f).”

		
	10.
	No Other Licenses. Section 2.6(d)(ii) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Except as expressly set forth in this Agreement, MPP does not grant any license under any  of Gilead’s intellectual property rights (including, without limitation, patents or rights to any proprietary compounds or drug substances other than API) to Licensee.”

		
	11.
	Sourcing of API from API Suppliers. The last sentence of Section 3.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

“In the event that any inconsistency is found which had not been specifically discussed and agreed with Gilead, each of Gilead and MPP shall have the right to require Licensee to terminate such agreement with such Gilead Supplier or Licensed API Supplier, and upon notice from Gilead and/or MPP to such effect, Licensee shall immediately terminate such agreement.”

		
	12.
	Royalty.    As  consideration  for  the  licenses  granted  in  Section 2  of  the   Agreement,  as amended by Sections      2 and 3 of this Amendment, Licensee shall pay Gilead the following

S-244

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

royalties on Net Sales of BIC Product and BIC Combination Product in the Territory for the duration of the Royalty Term:

		
	a.
	5% of BIC Product Net Sales in the BIC Territory.

		
	b.
	5% of the portion of BIC Combination Product Net Sales attributable to the BIC component of such BIC Combination Product in the BIC Territory, as determined in accordance with Section 4.2 of the Agreement.

		
	c.
	To the extent any TAF Combination Product, TDF Combination Product, EVG Combination Product, and/or COBI Combination Product contains BIC, then in addition to royalties due from Licensee to Gilead for each other royalty bearing API in such Combination Product as set forth in Section 4.1(c), (f) and (h) of the Agreement, respectively, Licensee will pay Gilead 5% of the portion of such Combination Products Net Sales attributable to the BIC component of such Combination Product in the Territory applicable to such Combination Product, as determined in accordance with Section 4.2 of the Agreement.

		
	13.
	Quarterly Reports. In each Quarterly Report, Licensee shall provide Gilead with the  following information (in addition to the information described in Section 4.3 of the Agreement): (i) any Drug Controller General of India export permits obtained by the  Licensee for Product, including the quantity of Product exported, the final destination of the Product and the recipient of the Product; and (ii) any Central Drugs Standard Control Organization (CDSCO) No Objection Certificates (NOC) obtained by third parties for  Product for which Licensee provided assistance, including the quantity of Product exported, the final destination of the Product and the recipient of the Product.

		
	14.
	Cooperation. If any party becomes aware of a suspected occurrence of  any  prohibited activity described in Section 7.2(a)(i)-(viii), such party will notify the other parties promptly, and following such notification, the parties will confer. Gilead (except in the case of Patents relating to EVG, EVG Product, EVG Combination Product or TAF Quad that are subject to the Japan Tobacco Agreement and controlled by Japan Tobacco) will have the right, but not the obligation, to bring an infringement or other action at its own expense, in its own name, and entirely under its own direction and control. Licensee will reasonably assist Gilead (or, where applicable, Japan Tobacco) in such actions or proceedings if so requested, and will  lend its name to such actions or proceedings if required by law in order for Gilead (or Japan Tobacco) to bring such an action, which obligations shall survive the expiration  or termination of the Agreement.

		
	15.
	Technology Transfer. Promptly following the later of the Amendment Effective Date and Gilead’s receipt of marketing approval from the FDA for a Product containing BIC, Gilead shall make available a one-time technology transfer of know-how owned or controlled by Gilead relating to the manufacture of BIC and such FDA-approved Product containing BIC, as applicable, to the extent, and in the manner specified in Appendix 3 attached hereto.  Except as expressly provided in this Section 7, Gilead shall have no further obligation to transfer any other know-how under this Amendment.

		
	16.
	Manufacturing Requirements Minimum Standards. Section 6.2(a) of the Agreement  is  hereby deleted in its entirety and replaced with the following:

S-245

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

“Minimum Standards.

(i)Licensee agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards; (ii) either World Health Organization (“WHO”) pre-qualification standards, standards of the European Medicines Agency (“EMA”), or United States Food and Drug Administration (“FDA”) tentative approval standards (“Minimum Quality Standards”); and (iii) on a country-by-country basis, any applicable national, regional or local standards as may be required by the specific country where Product is sold.

(ii)As required by MPP, in the event that any of COBI, EVG, TAF or BIC are included in the WHO Consolidated Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection (“WHO Guidelines”) or in the expression of interest for WHO pre- qualification for active pharmaceutical ingredients, Licensee shall apply for WHO pre- qualification or submit such included API’s Drug Master File (or equivalent) to the FDA no later than by the second anniversary of any such inclusion.

(iii)As required by MPP, in the event that any TAF Product or TAF Combination Product, BIC Product or BIC Combination Product, COBI Product or COBI Combination Product, EVG Product or EVG Combination Product, or the TDF Quad are included in WHO Guidelines or in the expression of interest for WHO pre-qualification of medicines, Licensee shall apply for WHO pre-qualification or FDA conditional approval for each such Product so included no later than by the third anniversary of any such inclusion.”

		
	17.
	Remedy for Failure. Section 6.2(c) of the Agreement is hereby deleted in its entirety and replaced with the following:

“Remedy for Failure. If Licensee fails at any time to meet the Minimum Quality Standards with respect to the manufacture of API or Product, Gilead and/or MPP may elect, in their sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to suspend the effectiveness of  the licenses granted hereunder until such time as Gilead and/or MPP have determined that Licensee has corrected any such failure to Gilead’s and/or MPP's reasonable satisfaction. During any such suspension, Gilead and/or MPP and Licensee shall coordinate with each other to provide for the supply of API or Product, as appropriate, to ensure that end-user patient requirements are not disrupted as a result of such suspension.”

		
	18.
	Dose Requirements. All BIC Product and BIC Combination Products manufactured, used or sold by Licensee shall consist of dose concentrations of BIC that have been approved by the FDA. In the case of Products containing BIC, Licensee may manufacture or sell  BIC Product, or BIC Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product.

		
	19.
	Pediatric Formulations. Licensee will have the right to develop a BIC Product or BIC Combination Product as either a liquid or dispersible tablet formulation for use in pediatric patients less than 12 years of age (such formulation shall be a Pediatric Formulation). If Licensee is granted regulatory approval to market such Pediatric Formulation, then Licensee will use reasonable efforts to make such Pediatric Formulation available throughout the   BIC

S-246

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Territory (for purposes of Section 6.2(e) of the Agreement, the BIC Territory shall be Licensee’s Applicable Territory with respect to such Pediatric Formulation).

		
	20.
	Regulatory Filings and Inspections. To the extent Regulatory Reports relate to EVG, EVG Product, EVG Combination Product, or Quad Product, Gilead will have the right to share  such Regulatory Reports with Japan Tobacco, which right shall survive the expiration or termination of the Agreement.

		
	21.
	Safety Reporting.  The following language is hereby added to the Agreement as Section 6.6:

“Safety Reporting.

		
	a.
	Licensee is responsible for all single and periodic reporting to all applicable regulatory authorities for the Products manufactured by or on behalf of Licensee under the Agreement.

		
	b.
	Licensee is responsible for all pharmacovigilance activities with respect to such Products, including but not limited to all associated signal detection, risk management and product labelling requirements.

		
	c.
	In the event Licensee receives an individual case safety report associated with any Gilead proprietary product, Licensee agrees to forward such reports to Gilead at E-Mail: SafetyFC@gilead.com    Fax: +1-650-522-5477.

		
	d.
	Licensee will forward details of any confirmed safety signals or emerging safety issues relating to Products manufactured by or on behalf of Licensee under this Agreement and any supporting documentation to the risk management contact at Gilead: Neda.Shokrai@gilead.com.”

		
	22.
	Diversion of Product and Technology. Section 7.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

“Diversion of Product and Technology.

		
	(a)
	Licensee covenants and agrees that Licensee and its Affiliates shall not, and shall require its Distributors and Third party Resellers not to: (i) divert or allow the diversion of API outside of India, China or South Africa, or to third parties that do  not constitute Licensed Product Suppliers, (ii) divert or allow the diversion of TDF Product, TDF Combination Product, TAF Product or TAF Combination Product outside the TDF-TAF Territory, (iii) divert or allow the diversion of COBI Product or COBI Combination Product outside the COBI Territory, (iv) divert or allow the diversion of EVG Product, EVG Combination Product or Quad Product outside the EVG-Quad Territory, (v) divert or allow the diversion of BIC Product or BIC Combination Product outside the BIC Territory, (vi) divert or allow the diversion of Licensed Technology to any third party, except as expressly permitted under this Agreement, (vii) take any action that Gilead determines in good faith to be in furtherance of the activities described in clauses (i) - (vi), or (viii) assist or support, directly or indirectly, any third party in the conduct of the activities described in clauses (i) - (vii).  The parties agree that it shall not be a breach of Section 3.1 or  this

S-247

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Section 7.2 for Licensee or its Affiliate to file marketing approval applications for any Product in a country outside of the Territory as required by applicable regulatory authorities in such country for the commercialization of such Product in such  country, or for Licensee or its Affiliate to provide developmental quantities of API or Product in support of its own marketing approval applications or a third party’s application for marketing approval, in each case, as required by applicable regulatory authorities in such country, it being understood that this provision shall not be construed as expressly or implicitly granting Licensee any right or license under any Gilead intellectual property rights beyond the licenses granted in Section 2 of this Agreement or otherwise providing any authorization by Gilead to do so, and does not constitute a waiver of any rights of Gilead under law that it may have to contest the filing or granting of such marketing approval applications.”

		
	(b)
	Damages. In the event (i) any Product is diverted (x) by Licensee or its Affiliate sublicensees, or (y) by another party with the assistance of the Licensee or its Affiliate sublicensees, in each case to any country outside the Territory in  any manner described in Section 7.2(a), and (ii) a patent covering such Product has been granted in such country or in the country(ies) outside the Territory in which such Product is manufactured (collectively the circumstance described by clause (i) and (ii), a “Diversion Event”), then in addition to any other remedies Gilead may be entitled to at law or in equity, Gilead shall be entitled to injunctive relief and to receive lost profits associated with the Diversion Event, which such lost profits will be determined by taking into consideration the following factors: (1) the quantity of Product that is the subject of such Diversion Event; (2) the average profit Gilead receives from its sale of such Product in the country(ies) outside the Territory into which such Product was sold or otherwise transferred; and (3) any erosion in Gilead’s market share in such country(ies) outside the Territory as a result of such Diversion Event. This Section 7.2(b) shall survive the expiration or termination of the Agreement with respect to Products sold prior to such expiration or termination.”

		
	23.
	General Law Compliance. Section 7.3(a) of the Agreement is hereby deleted in its entirety and replaced with the following:

“General Law Compliance. Licensee covenants and agrees that it shall perform all activities under this Agreement in accordance with all applicable laws, rules, and regulations,  including, without limitation, with respect to privacy, data protection, recalls, safety and reporting requirements and shall obtain, have and maintain all necessary regulatory approvals (including in South Africa), marketing authorizations, permits and licenses, at Licensee’s expense for the manufacture and sale of API and/or Product and any other Licensee activities contemplated hereby.”

		
	24.
	FCPA and UK Bribery Act. Section 7.3(b) of the Agreement is hereby deleted in its entirety and replaced with the following:

“FCPA and UK Bribery Act. Licensee covenants and agrees that neither the Licensee, nor  any of its affiliates, nor any of their respective directors, officers, employees or agents (all of the foregoing, including affiliates collectively, “Licensee Representatives”) has taken any action, directly or indirectly, that would result in a violation by such persons of the Foreign Corrupt Practices Act of 1977, as amended (such act, including the rules and regulations

S-248

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

thereunder, the “FCPA”), the U.K. Bribery Act of 2010 (“Bribery Act”), or any other applicable anti-bribery or anticorruption laws, rules or regulations (collectively with  the FCPA and the Bribery Act, the “Anticorruption Laws”). Licensee covenants and agrees that Licensee and Licensee Representatives have conducted and will conduct their businesses in compliance with the Anticorruption Laws. Licensee covenants and agrees that it  shall  provide to Gilead on the Amendment Effective Date and within thirty (30) days after the beginning of each calendar year thereafter, certification in writing by Licensee of Licensee’s compliance with the Anticorruption Laws.”

		
	25.
	Gilead Right to Terminate. Section 10.3(b) of the Agreement is hereby deleted in its entirety and replaced with the following:

“(b) Gilead and/or MPP shall have the right to terminate this Agreement, the  covenant contained in Section 7.5 and/or one or both of the licenses granted pursuant to Section 2.1 or Section 2.2 (whether or not such event constitutes a right of termination pursuant to Section 10.2), if:

(i)Gilead determines in good faith that (A) a material quantity of API made or sold by Licensee has been diverted outside of South Africa, China or India, or to third parties that are not Licensed Product Suppliers, (B) a material quantity of Product made and/or sold by Licensee has been diverted to countries outside the Territory (other than with respect to such diversions occurring solely as a result of the circumstances expressly contemplated in Sections 7.3(c), 10.3(c) and 10.3(d) below), or (C) any of the prohibited activies described in Section 7.2(a)(i)-(viii) has occurred;

(ii)Gilead and/or MPP determines in good faith that, due to material deficiencies in Licensee’s compliance, or repeated failure to comply, with the Minimum Quality Standards, Licensee is unable to reliably and consistently manufacture API or Product in accordance with the Minimum Quality Standards;

(iii)Gilead determines in good faith that Licensee has obtained material quantities of API from sources outside of India, South Africa or China (subject to the provisions set forth in Sections 7.3(c) and 10.3(c)), or in ways that are inconsistent with the terms and conditions of Section 3; or

(iv)Gilead’s rights to EVG terminate due to the termination of the Japan Tobacco Agreement, provided, however, that in such event, such termination would only apply on a Product-by-Product basis and only with respect to Products containing EVG that are subject to the sublicense granted by Gilead under the Japan Tobacco Agreement.

Gilead shall give Licensee and MPP written notice of any such event and provide Licensee with a period of thirty (30) days after such notice to demonstrate that the conditions giving rise to Gilead’s determination no longer exist to Gilead’s reasonable satisfaction. If Licensee is unable to do so, this Agreement shall be terminated effective upon the thirtieth (30th) day following such notice. In the event that MPP independently exercises its right to terminate this Agreement pursuant to Sections 10.2 or 10.3, MPP shall provide notice to Gilead of such intent to terminate.”

S-249

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

		
	26.
	Licensee Right to Terminate License on an API Basis. For the avoidance of doubt any termination by Licensee of its license to BIC pursuant to Section 10.5 of the Agreement shall in turn terminate Licensee’s rights and licenses under all Patents that claim BIC (alone or in combination with any other compounds) to manufacture, sell, use, export or import any Product that contains BIC.

		
	27.
	Appendices. Appendices 1, 2, 3, 4, 5, and 6 of the Agreement are hereby deleted and  replaced with new Appendices 1, 2, 3, 4, 5, and 6 attached to this Amendment, respectively. Appendix 7 attached to this Amendment is hereby added to the Agreement as Appendix 7.

		
	28.
	Miscellaneous. This Amendment embodies the entire understanding of the Parties  with respect to the subject matter hereof and supersedes all previous communications, representations or understandings, and agreements, whether oral or written, between the Parties relating to the subject matter hereof. Except as expressly amended by this Amendment, the terms and conditions of the Agreement will remain in full force and effect. This Amendment shall be effective as of the Amendment Effective Date, and may not be modified except by written agreement between the Parties. This Amendment will be  governed by and construed under the laws of England, without regard to its choice of law principles, and any dispute that arises hereunder shall be resolved by binding arbitration as set forth in Section 12.7 of the Agreement.

[signatures appear on following page]

S-250

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

IN WITNESS WHEREOF, the parties hereto have executed this Amendment as of the Amendment Effective Date.

GILEAD:

Gilead Sciences, Inc.

By __________________________________ 
Name:
Title:

LICENSEE:

[Licensee]

By __________________________________ 
Name:
Title:

MPP:

Medicines Patent Pool

By __________________________________ 
Name:
Title:

S-251

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 1
Countries in the TDF-TAF Territory

	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-252

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

APPENDIX 2
Patents

TDF Patents

(221) Title: NUCLEOTIDE ANALOGS

	
				
	Country
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/25/1997
	2076/DEL/1997

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	SubCase
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION
	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

S-253

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

TAF Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	African Regional Industrial Property Organization
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

S-254

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-
500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

S-255

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
				
	El Salvador
	Published
	E-4696/2014
	10/3/2012

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012

	India
	Published
	2953/DELNP/2014
	10/3/2012

	Pakistan
	Pending
	671/2012
	10/3/2012

EVG Patents

(JF-0136) Title: COMPOUND AND METHOD OF USE

	
						
	Country
	Status
	Application No.
	Filing DatePatent No.

	Bolivia
	Pending
	SP-230265
	11/18/2003
	 
	 

	India
	Granted
	01316/CHENP/2004
	11/20/2003
	245833
	2/3/2011

	Indonesia
	Granted
	WO00200401542
	11/20/2003
	P0023507
	6/1/2009

	Nigeria
	Granted
	424/2003
	11/19/2003
	RP.15779
	10/20/2004

	Philippines
	Granted
	1-2004-500895
	11/20/2003
	1-2004-500895
	8/20/2008

	South Africa
	Granted
	2004/4537
	11/20/2003
	2004/4537
	8/31/2005

	Thailand
	Pending
	301004379
	11/20/2003
	 
	 

	Vietnam
	Granted
	1-2004-00605
	11/20/2003
	1-0011884
	10/7/2013

(JF-0179) Title: CRYSTALLINE FORM

	
						
	Country
	Status
	Application No.
	Filing DatePatent No.

	Bolivia
	Pending
	SP-250121
	5/19/2005
	 
	 

	India
	Pending
	357/CHENP/2010
	5/19/2005
	 
	 

	Philippines
	Granted
	1-2006-502297
	5/19/2005
	1-2006-502297
	11/19/2010

	South Africa
	Granted
	2006/10647
	5/19/2005
	2006/10647
	6/25/2008

	Thailand
	Pending
	100718
	5/19/2005
	 
	 

(JF-0193) Title: MANUFACTURING PROCESS: ROUTE D AND F

	
						
	Country
	Status
	Application No.:
	Filing Date
	Patent No.
	Issue Date

	India
	Granted
	5344/CHENP/2008
	3/6/2007
	258895
	2/13/2014

	India
	Pending
	532/CHENP/2014
	3/6/2007
	 
	 

(JF-0192) Title: MANUFACTURING PROCESS: ROUTE C AND E

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No:
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004621
	3/6/2007
	2914
	5/5/2014

	Eurasian Patent Organization
	Granted
	200870321
	3/6/2007
	17861
	3/29/2013

S-256

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Indonesia
	Pending
	W00200802860
	3/6/2007
	IDP0032077
	10/22/2012

	India
	Granted
	5341/CHENP/2008
	3/6/2007
	258747
	2/4/2014

	India
	Pending
	613/CHENP/2014
	3/6/2007
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1200800317
	3/6/2007
	14280
	3/31/2009

	Vietnam
	Granted
	1-2008-02431
	3/6/2007
	14450
	8/17/2015

	South Africa
	Granted
	2008/07547
	3/6/2007
	2008/07547
	11/25/2009

(718) Title: METHODS OF IMPROVING THE PHARMACOKINETICS OF HIV INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	Armenia
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004522
	12/29/2006
	AP2702
	7/31/2013

	Eurasian Patent Organization
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Eurasian Patent Organization
	Published
	201201496
	12/29/2006
	 
	 

	Indonesia
	Pending
	W00201102461
	12/29/2006
	 
	 

	Indonesia
	Published
	W00 2008 02128
	12/29/2006
	 
	 

	India
	Pending
	6748/DELNP/2015
	12/29/2006
	 
	 

	India
	Pending
	5576/DELNP/2008
	12/29/2006
	 
	 

	Kyrgyz Republic
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Moldova
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	African Intellectual Property Organization (OAPI)
	Granted
	1200800239
	12/29/2006
	14320
	6/30/2009

	Tajikistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Turkmenistan
	Granted
	200801619
	12/29/2006
	18544
	8/30/2013

	Vietnam
	Pending
	1-2008-01921
	12/29/2006
	 
	 

	South Africa
	Granted
	2008/06222
	12/29/2006
	2008/06222
	3/25/2009

(720) Title:  PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent Number
	Issue Date

	Armenia
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004831
	9/11/2007
	AP3004
	10/16/2014

	Eurasian Patent Organization
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Indonesia
	Published
	W00200900634
	9/11/2007
	 
	 

	Kyrgyz Republic
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Kazakhstan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

S-257

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Moldova
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	African Intellectual Property Organization (OAPI)
	Granted
	1200900070
	9/11/2007
	14458
	9/30/2009

	Thailand
	Published
	701004583
	9/11/2007
	 
	 

	Tajikistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Turkmenistan
	Granted
	200900441
	9/11/2007
	22099
	11/30/2015

	Vietnam
	Granted
	1-2009-00636
	9/11/2007
	11932
	10/22/2013

	Vietnam
	Granted
	1-2012-01354
	9/11/2007
	14698
	10/20/2015

	South Africa
	Granted
	2009/01576
	9/11/2007
	2009/01576
	2/24/2010

(746) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
						
	Country
	Status
	Application No
	Filing Date
	Patent Number
	Issue Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005187
	9/11/2008
	AP 2785
	10/31/2013

	Eurasian Patent Organization
	Granted
	201070256
	9/11/2008
	19431
	3/31/2014

	Ecuador
	Inactive
	SP-10-10081
	9/11/2008
	 
	 

	Indonesia
	Published
	W00201000759
	9/11/2008
	 
	 

	India
	Pending
	1615/DELNP/2010
	9/11/2008
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201000093
	9/11/2008
	15058
	 

	Thailand
	Published
	801004676
	9/11/2008
	 
	 

	Vietnam
	Granted
	1-2010-00483
	9/11/2008
	10866
	11/20/2012

	South Africa
	Granted
	2010/02066
	9/11/2008
	2010/02066
	12/29/2010

(903) Title: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS

	
				
	Country
	Status
	Application No.
	Filing DatePatent No.

	Eurasian Patent Organization
	Allowed
	201590018
	8/1/2013

	India
	Pending
	1688/DELNP/2015
	8/1/2013

COBI Patents

(692) Title: MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

S-258

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vanuatu
	Unfiled
	 
	 
	 

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

S-259

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Organization

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

S-260

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/005864
	 
	 

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Published
	SP-0082-2010
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

S-261

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
					
	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	India
	Abandoned
	6192/DELNP/2014

BIC Patents

(1007) TITLE: POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE

	
						
	Country
	Status
	Application No.
	FilingPatent No.Issue
DateDate

	African Intellectual Property Organization (OAPI)
	Pending
	1201500240
	12/19/2013
	 
	 

	African Regional Industrial Property Organization
	Pending
	AP/P/2015/008510
	12/19/2013
	 
	 

	Anguilla
	Pending
	AI/A/2016/00180
	12/19/2013
	 
	 

	Bahamas
	Pending
	2551
	12/19/2013
	 
	 

	Bolivia
	Published
	SP-00412-2013
	12/20/2013
	 
	 

	Congo, Democratic Republic of
	Pending
	 
	12/19/2013
	 
	 

	Ecuador
	Published
	IEPI-2015-31224
	12/19/2013
	 
	 

	El Salvador
	Published
	E-5002-2015
	12/19/2013
	 
	 

	Ethiopia
	Pending
	ET/PI/16/204
	12/19/2013
	 
	 

	Eurasian Patent Organization
	Published
	201591027
	12/19/2013
	 
	 

	Fiji
	Published
	1229
	12/19/2013
	 
	 

	Grenada
	Granted
	 
	12/19/2013
	 
	7/19/2016

	Guyana
	Pending
	1656
	12/19/2013
	 
	 

	Haiti
	Pending
	 
	12/19/2013
	 
	 

	India
	Pending
	5535/DELNP/2015
	12/19/2013
	 
	 

	Indonesia
	Allowed
	P00201503852
	12/19/2013
	 
	 

	Indonesia
	Pending
	P00201607128
	12/19/2013
	 
	 

	Jamaica
	Pending
	18/1/5740
	12/19/2013
	 
	 

	Kiribati
	Granted
	 
	12/19/2013
	 
	9/20/2016

	Moldova
	Pending
	a20150064
	12/19/2013
	 
	 

	Montserrat
	Granted
	 
	12/19/2013
	4 OF 2016
	5/27/2016

S-262

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

	
						
	Nepal
	Pending
	4
	12/19/2013
	 
	 

	Pakistan
	Pending
	908/2013
	12/20/2013
	 
	 

	Philippines
	Published
	1-2015-501445
	12/19/2013
	 
	 

	Philippines
	Pending
	1-2016-500389
	12/19/2013
	 
	 

	Seychelles
	Pending
	2822954
	12/19/2013
	 
	 

	Sierra Leone
	Pending
	 
	12/19/2013
	 
	 

	Solomon Islands
	Granted
	 
	12/19/2013
	J37/379
	8/5/2016

	South Africa
	Pending
	2015/04914
	12/19/2013
	 
	 

	South Africa
	Pending
	2015/07997
	12/19/2013
	 
	 

	South Korea
	Pending
	10-2015-7019194
	12/19/2013
	 
	 

	Thailand
	Pending
	1501003563
	12/19/2013
	 
	 

	Turks and Caicos Islands
	Granted
	10226
	12/19/2013
	10226
	9/7/2016

	Tuvalu
	Granted
	TVP2822954
	12/19/2013
	TVP2822954
	8/15/2016

	Vietnam
	Granted
	1-2015-02321
	12/19/2013
	15503
	5/16/2016

	Vietnam
	Pending
	1-2015-04199
	12/19/2013
	 
	 

	Virgin Islands (British)
	Granted
	EP2822954
	12/19/2013
	427/5/2016
	9/21/2016

(1091) Title: SODIUM (2R,5S,13AR)-7,9-DIOXO-10-((2,4,6- TRIFLUOROBENZYL)CARBAMOYL)-2,3,4,5,7,9,13,13A-OCTAHYDRO-2,5- METHANOPYRIDO[1',2':4,5]PYRAZINO[2,1-B]OXAZEPIN-8-OLATE

	
				
	Country
	Status
	Application No.
	FilingPatentIssue Date
DateNo.

	African Regional Industrial Property Organization
	Pending
	AP/P/2016/009591
	6/19/2015

	African Intellectual Property Organization (OAPI)
	Pending
	1201600454
	6/19/2015

	Bolivia
	Published
	SP 126-2015
	6/19/2015

	Bahamas
	Allowed
	2701
	6/18/2015

	Cuba
	Pending
	2016-0187
	6/19/2015

	Dominican Republic
	Published
	P2016-0327
	6/19/2015

	Eurasian Patent Organization
	Pending
	201692414
	6/19/2015

	Ecuador
	Published
	IEPI-2016-95566
	6/19/2015

	El Salvador
	Pending
	2016005339
	6/19/2015

	Guatemala
	Pending
	A2016-000262
	6/19/2015

	Indonesia
	Unfiled
	 
	 

	India
	Pending
	201617042937.00
	6/19/2015

	Nigeria
	Pending
	NG/PT/C/2016/2106
	6/19/2015

	Philippines
	Pending
	 
	 

	Pakistan
	Pending
	382/2015
	6/18/2015

	Thailand
	Pending
	 
	 

	Trinidad and Tobago
	Pending
	TT/A/2016/00132
	6/19/2015

	
				
	Vietnam
	Pending

	South Africa
	Pending
	2016/08744
	6/19/2015

(1147) Title: THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS

	
				
	Country
	Status
	Application No.
	Filing DatePatent No.Issue Date

	Bangladesh
	Pending
	272/2016
	11/2/2016

	Bolivia
	Pending
	SP-0260-2016
	11/9/2016

	Bahamas
	Pending
	 
	11/8/2016

	Pakistan
	Pending
	696/2016
	11/9/2016

	Patent Cooperation Treaty
	Entered NP
	US2016/060989
	11/8/2016

(1062) Title: SYNTHESIS OF POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS

	
				
	Country
	Status
	Application No.
	FilingPatentIssue
DateNo.Date

	Bahamas
	Allowed
	2702
	6/18/2015

	Eurasian Patent Organization
	Pending
	201692412
	6/16/2015

	India
	Pending
	201717000457.00
	6/16/2015

	Patent Cooperation Treaty
	Entered NP
	US2015/036017
	6/16/2015

TDF-Quad Patents

(221) Title:NUCLEOTIDE ANALOGS

	
				
	Country
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/25/1997
	2076/DEL/1997

(230) Title:  NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD

	
						
	Country
	Status
	Filing Date
	Application No.Patent No.Issue Date

	India
	Pending
	7/24/1998
	896/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	963/DEL/2002
	 
	 

	India
	Pending
	7/24/1998
	1362/DEL/2004
	 
	 

	India
	Granted
	7/24/1998
	2174/DEL/1998
	190780
	3/15/2004

	Indonesia
	Granted
	7/23/1998
	W-991548
	7658
	4/11/2002

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC

AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

	
					
	Vietnam
	Pending
	1-2012-02702

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1200900273
	6/30/2010
	14749

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	
					
	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	Vietnam
	Pending
	1-2010-02929
	 
	 

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	India
	Abandoned
	6192/DELNP/2014

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(783) Title: TABLETS FOR COMBINATION THERAPY

	
					
	Country
	Status
	Application No.FilingPatent No.
Date

	African Intellectual Property Organization (OAPI)
	Pending
	1201100281
	 
	 

	African Regional Industrial Property Organization
	Granted
	AP/P/2011/05857
	5/6/2015
	AP3250

	Armenia
	Granted
	201190125
	5/29/2015
	21313

	Azerbaijan
	Granted
	201190125
	5/29/2015
	21313

	Bolivia
	Pending
	SP-00292010
	 
	 

	Ecuador
	Pending
	SP-11-11307
	 
	 

	Eurasian Patent Organization
	Published
	201491658
	 
	 

	Eurasian Patent Organization
	Granted
	201190125
	5/29/2015
	21313

	India
	Pending
	5823/DELNP/2011
	 
	 

	Indonesia
	Granted
	W00201103098
	3/30/2016
	IDP000040606

	Kazakhstan
	Granted
	201190125
	5/29/2015
	21313

	Kyrgyz Republic
	Granted
	201190125
	5/29/2015
	21313

	Moldova
	Granted
	201190125
	5/29/2015
	21313

	Pakistan
	Allowed
	94/2010
	 
	 

	Singapore
	Published
	2014007744
	 
	 

	South Africa
	Granted
	2011/06154
	5/28/2014
	2011/06154

	Tajikistan
	Granted
	201190125
	5/29/2015
	21313

	Thailand
	Published
	1101001423
	 
	 

	Turkmenistan
	Granted
	201190125
	5/29/2015
	21313

	Vietnam
	Pending
	1-2011-02035
	 
	 

TAF-Quad Patents

(249) Title: PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200300003
	7/20/2001
	12393
	12/29/2003

	African Regional Industrial Property Organization
	Granted
	2003/002724
	7/20/2001
	AP 1466
	9/22/2005

	Anguilla
	Granted
	AI/A/2015/00173
	7/20/2001
	AI/A/2015/00173
	11/2/2015

	Congo, Democratic Republic of
	Granted
	NP/002/EXT/2016
	7/20/2001
	2016/4386
	11/11/2016

	Ethiopia
	Granted
	ET/PI/15/184
	7/20/2001
	135
	5/25/2016

	Eurasian Patent Organization
	Granted
	200300188
	7/20/2001
	4926
	10/28/2004

	Falkland Islands (Malvinas)
	Granted
	 
	7/20/2001
	15365
	8/25/2015

	Fiji
	Published
	1214
	7/20/2001
	 
	 

	Grenada
	Granted
	7 of 2015
	7/20/2001
	7 of 2015
	10/6/2015

	Guyana
	Published
	1641
	7/20/2001
	 
	 

	Haiti
	Pending
	 
	7/20/2001
	 
	 

	India
	Granted
	9/MUMNP/2003
	7/20/2001
	208435
	7/27/2007

	India
	Granted
	00529/MUMNP/2006
	7/20/2001
	241597
	7/14/2010

	Indonesia
	Granted
	W-00200602129
	7/20/2001
	IDP0022897
	2/20/2009

	Indonesia
	Granted
	W-00200804005
	7/20/2001
	IDP000040148
	2/15/2016

	Indonesia
	Granted
	W00200300261
	7/20/2001
	IDP0022911
	2/20/2009

	Jamaica
	Pending
	18/1/5695
	7/20/2001
	 
	 

	Kiribati
	Granted
	14/15
	7/20/2001
	14/15
	10/7/2015

	Montserrat
	Granted
	1961695.2
	7/20/2001
	1301519
	9/23/2015

	Nepal
	Pending
	669
	7/20/2001
	 
	 

	Seychelles
	Granted
	1301519
	7/20/2001
	1301519
	5/25/2016

	Sierra Leone
	Pending
	EP1301519
	7/20/2001
	 
	 

	Solomon Islands
	Granted
	J37/371
	7/20/2001
	J37/371
	3/3/2016

	South Africa
	Granted
	2002/10271
	7/20/2001
	2002/10271
	12/31/2003

	Turks and Caicos Islands
	Pending
	10213
	7/20/2001
	 
	 

	Tuvalu
	Granted
	 
	2/25/2015
	TVP1301519
	1/6/2016

	Vietnam
	Granted
	1-2002-01193
	7/20/2001
	8475
	5/24/2010

	Virgin Islands (British)
	Granted
	414/5/2015
	7/20/2001
	414/5/2015
	12/1/2015

(872) Title: TENOFOVIR ALAFENAMIDE HEMIFUMARATE

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	African Intellectual Property
	Granted
	1201400057
	8/15/2012
	17070
	6/29/2015

	
						
	Organization (OAPI)

	African Regional Industrial Property Organization
	Granted
	AP/P/2014/007437
	8/15/2012
	3639
	3/31/2016

	Bahamas
	Granted
	2441
	8/15/2012
	2441
	6/19/2014

	Bolivia
	Pending
	SP-0277-2012
	8/15/2012
	 
	 

	Ecuador
	Pending
	SP-14-13206-PCT
	8/15/2012
	 
	 

	El Salvador
	Pending
	E-4659-2014
	8/15/2012
	 
	 

	Eurasian Patent Organization
	Published
	201490208
	8/15/2012
	 
	 

	India
	Pending
	1012/DELNP/2014
	8/15/2012
	 
	 

	Indonesia
	Published
	P00201400805
	8/15/2012
	 
	 

	Moldova
	Pending
	A20140011
	8/15/2012
	 
	 

	Pakistan
	Pending
	539/2012
	8/15/2012
	 
	 

	Philippines
	Granted
	1-2014-500349
	8/15/2012
	1-2014-
500349
	2/29/2016

	South Africa
	Allowed
	2014/00582
	8/15/2012
	 
	 

	Thailand
	Pending
	1401000784
	8/15/2012
	 
	 

	Vietnam
	Pending
	1-2014-00440
	8/15/2012
	 
	 

(877) Title:  METHODS FOR PREPARING ANTI-VIRAL NUCLEOTIDE ANALOGS

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Bahamas
	Granted
	2455
	10/3/2012
	2455
	6/24/2014

	Bolivia
	Granted
	SP-0352-2012
	10/3/2012
	6385-B
	11/26/2014

	Ecuador
	Published
	IEPI-2014-74
	10/3/2012
	 
	 

	El Salvador
	Published
	E-4696/2014
	10/3/2012
	 
	 

	Eurasian Patent Organization
	Allowed
	201490753
	10/3/2012
	 
	 

	India
	Published
	2953/DELNP/2014
	10/3/2012
	 
	 

	Pakistan
	Pending
	671/2012
	10/3/2012
	 
	 

(692) Title: DIAMINOALKANE COMPOUNDS (VARIANTS) AND A METHOD OF PREPARING THEREOF (VARIANTS), A PHARMACEUTICAL COMPOSITION AND A THERAPEUTIC AGENT FOR INHIBITING CYTOCHROME-P450-MONOOXYGENASE, METHODS FOR TREATING AN HIV INFECTION AND VIRAL HEPATITS C, A METHOD OF MOD

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.Issue Date

	African Intellectual Property Organization (OAPI)
	Granted
	1200800450
	9/30/2009
	14409

	African Regional Industrial Property Organization
	Granted
	AP/P/2008/004720
	9/30/2014
	AP2985

	
					
	Anguilla
	Granted
	AI/A/2015/00172
	11/2/2015
	AI/A/2015/00172

	Armenia
	Granted
	200900155
	11/28/2014
	20489

	Congo, Democratic Republic of
	Pending
	NP/004/EXT/2016
	 
	 

	Ethiopia
	Granted
	ET/PI/15/185
	5/25/2016
	134

	Eurasian Patent Organization
	Allowed
	201270738
	 
	 

	Eurasian Patent Organization
	Granted
	200900155
	11/28/2014
	20489

	Fiji
	Published
	1217
	 
	 

	Guyana
	Published
	1642
	 
	 

	Haiti
	Pending
	 
	 
	 

	India
	Pending
	10487/DELNP/2008
	 
	 

	Indonesia
	Granted
	W00200900061
	8/12/2016
	IDP00042227

	Jamaica
	Pending
	18/1/5696
	 
	 

	Kazakhstan
	Unfiled
	 
	 
	 

	Kazakhstan
	Granted
	200900155
	11/28/2014
	20489

	Kiribati
	Granted
	13/15
	10/7/2015
	13/15

	Kyrgyz Republic
	Granted
	200900155
	11/28/2014
	20489

	Moldova
	Granted
	200900155
	11/28/2014
	20489

	Montserrat
	Granted
	 
	9/23/2015
	3 of 2015

	Nauru
	Pending
	 
	 
	 

	Nepal
	Pending
	894
	 
	 

	Seychelles
	Granted
	2049506
	5/25/2016
	2049506

	Sierra Leone
	Pending
	EP2049506
	 
	 

	Solomon Islands
	Granted
	J37/370
	2/10/2016
	J37/370

	South Africa
	Pending
	2008/10399
	 
	 

	Tajikistan
	Granted
	200900155
	11/28/2014
	20489

	Thailand
	Published
	701003404
	 
	 

	Turkmenistan
	Granted
	200900155
	11/28/2014
	20489

	Turks and Caicos Islands
	Pending
	10214
	 
	 

	Tuvalu
	Granted
	 
	11/7/2015
	TVP2049506

	Vietnam
	Pending
	1-2009-00240
	 
	 

	Vietnam
	Pending
	1-2012-02702
	 
	 

	Virgin Islands (British)
	Granted
	415/6/2015
	12/1/2015
	415/6/2015

(719) Title:  MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property
	Granted
	1200900273
	6/30/2010
	14749

	
					
	Organization (OAPI)

	African Regional Industrial Property Organization
	Granted
	AP/P/2009/004964
	9/16/2014
	AP2986

	African Regional Industrial Property Organization
	Granted
	AP/P/2013/007042
	11/30/2016
	AP3915

	Armenia
	Granted
	200901155
	7/30/2014
	19893

	Eurasian Patent Organization
	Granted
	200901155
	7/30/2014
	19893

	Fiji
	Granted
	 
	 
	 

	Indonesia
	Granted
	W00200902299
	3/18/2015
	IDP000038076

	Kazakhstan
	Granted
	200901155
	7/30/2014
	19893

	Kyrgyz Republic
	Granted
	200901155
	7/30/2014
	19893

	Moldova
	Granted
	200901155
	7/30/2014
	19893

	South Africa
	Pending
	2009/05882
	 
	 

	South Africa
	Unfiled
	 
	 
	 

	Tajikistan
	Granted
	200901155
	7/30/2014
	19893

	Thailand
	Pending
	801000867
	 
	 

	Turkmenistan
	Granted
	200901155
	7/30/2014
	19893

	Vietnam
	Pending
	1-2009-01990
	 
	 

	Vietnam
	Pending
	1-2012-02696
	 
	 

(757) Title: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201000364
	9/28/2012
	15589

	African Regional Industrial Property Organization
	Granted
	AP/P/2010/005429
	1/30/2015
	3209

	Armenia
	Granted
	201071173
	3/31/2016
	22950

	Belarus
	Granted
	201071173
	3/31/2016
	22950

	Ecuador
	Pending
	SP-10-10636
	 
	 

	Eurasian Patent Organization
	Published
	201591353
	 
	 

	Eurasian Patent Organization
	Granted
	201071173
	3/31/2016
	22950

	India
	Pending
	7565/DELNP/2010
	 
	 

	Indonesia
	Published
	W00201004105
	 
	 

	Kazakhstan
	Granted
	201071173
	3/31/2016
	22950

	Kyrgyz Republic
	Granted
	201071173
	3/31/2016
	22950

	Moldova
	Granted
	201071173
	3/31/2016
	22950

	South Africa
	Granted
	2010/08007
	10/26/2011
	2010/08007

	Tajikistan
	Granted
	201071173
	3/31/2016
	22950

	Turkmenistan
	Granted
	201071173
	3/31/2016
	22950

	
	
	VietnamPending1-2010-02929

(775) Title: METHOD OF PREPARING AN INHIBITOR OF CYTOCHROME P450 MONOOXYGENASE, AND INTERMEDIATES INVOLVED

	
					
	Country
	Status
	Application No.
	Filing Date
	Patent No.

	African Intellectual Property Organization (OAPI)
	Granted
	1201100311.00
	4/1/2010
	15801

	Bolivia
	Abandoned
	11-114.749
	4/1/2010
	 

	Eurasian Patent Organization
	Granted
	201190179.00
	4/1/2010
	22739

	Eurasian Patent Organization
	Published
	201590979.00
	4/1/2010
	 

	Ecuador
	Pending
	SP-11-11391
	4/1/2010
	 

	Indonesia
	Granted
	W00201103554
	4/1/2010
	IDP000041448

	India
	Pending
	7323/DELNP/2011
	4/1/2010
	 

	Pakistan
	Pending
	262/2010
	3/31/2010
	 

	Thailand
	Published
	1101002473.00
	4/1/2010
	 

	Vietnam
	Pending
	1-2011-02324
	4/1/2010
	 

	South Africa
	Granted
	2011/07430
	4/1/2010
	2011/07430

(895) Title: METHODS AND INTERMEDIATES FOR PREPARING PHARMACEUTICAL AGENTS

	
			
	Country
	Status
	Application No.Filing DatePatent No.

	India
	Abandoned
	6192/DELNP/2014

(899) Title: THERAPEUTIC COMPOUNDS

	
				
	Country
	Status
	Application No.
	FilingPatentIssue Date
DateNo.

	Eurasian Patent Organization
	Published
	201491287
	2/1/2013

	India
	Pending
	7100/DELNP/2014
	2/1/2013

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	
						
	Philippines
	Granted
	55,194
	2/20/1992
	55194
	12/19/2008

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Domincan Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

For purposes of this Appendix 2, references to “PCT,“ “OAPI,” “EAPO” and “ARIPO” shall not be construed or interpreted to grant rights to Licensee in any country other than those countries expressly included within the licenses granted to Licensee in Sections 2.1 and 2.2 of this Agreement.

APPENDIX 3
Terms for Technology Transfer

Gilead will make available to Licensee the following information in accordance with Section 5.4 to fully enable Licensee to manufacture FTC, TAF, TDF, EVG, COBI, TDF Product, TAF Product, EVG Product, COBI Product and Quad Product at commercial-scale quantities and in compliance with Gilead’s required quality specifications (but only to the extent not previously provided to Licensee under the Original License Agreement or other separate written agreement with Gilead and/or MPP):

		
	1.
	Manufacturing process descriptions, specifications and methods;

		
	2.
	Stability data;

		
	3.
	Analytical method validation; and

		
	4.
	Discussion of impurities.

Gilead will make available to Licensee the following information in accordance with Section 7 of the First Amendment to this Agreement, to fully enable Licensee to manufacture BIC and such FDA-approved Product containing BIC at commercial-scale quantities and in compliance with Gilead’s required quality specifications:

		
	1.
	Manufacturing process descriptions, specifications and methods;

		
	2.
	Stability data;

		
	3.
	Analytical method validation; and

		
	4.
	Discussion of impurities.

APPENDIX 4
Emtricitabine Patents

(EMU-108) Title: Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-Fluorocytosin-1-yl)- 1,3-Oxathiolane

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Philippines
	Granted
	1-1992-43955
	2/20/92
	1-1992-43955
	2/20/09

	Philippines
	Granted
	55191
	12/27/96
	1-1996-55191
	3/9/07

	Philippines
	Granted
	55192
	2/20/92
	55192
	12/19/08

	Philippines
	Granted
	55193
	2/20/92
	55193
	12/19/08

	Philippines
	Granted
	55194
	2/20/92
	55194
	12/19/08

(EMU-4000) Title:  1,3-Oxathiolane Nucleoside Analogues

	
						
	Country
	Status
	Application No.
	Filing Date
	Patent No.
	Issue Date

	Botswana
	Granted
	BW/A/1998/00163
	4/27/98
	BW/P/2002/00042
	5/22/03

	Dominican Republic
	Granted
	1793970004607.00
	7/10/97
	370
	7/10/17

	Honduras
	Granted
	PICA97118
	8/18/97
	3775
	4/25/00

	Jamaica
	Granted
	697267
	7/8/97
	3615
	5/25/05

	Nicaragua
	Granted
	97.0096
	12/5/97
	1134RPI
	5/17/99

(270) Title:  COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Eurasian Patent Organization
	Published
	1/13/2004
	201100293
	 
	 

	Eurasian Patent Organization
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kazakhstan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

	Kyrgyz Republic
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Kyrgyz Republic
	Granted
	 
	200501134 (PTE
Application)
	15145
	5/31/2012

	Moldova
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Tajikistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Granted
	1/13/2004
	200501134
	15145
	6/13/2011

	Turkmenistan
	Pending
	 
	200501134 (PTE
Application)
	 
	 

(677) Title: A PHARMACEUTICAL COMPOSITION, A METHOD OF PREPARING THEREOF, AND A METHOD OF TREATING VIRAL DISEASES USING SAID COMPOSITION

	
						
	Country
	Status
	Filing Date
	Application No.
	Patent No.
	Issue Date

	Armenia
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Eurasian Patent Organization
	Published
	6/13/2006
	201201265
	 
	 

	Eurasian Patent Organization
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	India
	Pending
	6/13/2006
	9661/DELNP/2007
	 
	 

	Kazakhstan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Kyrgyz Republic
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Moldova
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	South Africa
	Granted
	6/13/2006
	2008/00297
	2008/00297
	4/28/2010

	Tajikistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

	Turkmenistan
	Granted
	6/13/2006
	200800033
	17764
	3/29/2013

APPENDIX 5
Countries in the COBI Territory

	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

APPENDIX 6
Countries in the EVG- Quad Territory

	
				
	1.   Afghanistan
	38.
	Ghana
	75. Rwanda

	2.   Angola
	39.
	Grenada
	76.  Saint Kitts and Nevis

	3.   Anguilla
	40.
	Guatemala
	77.  Saint Lucia

	4.   Antigua and Barbuda
	41.
	Guinea
	78.  Saint Vincent & the

	5.   Armenia
	42.
	Guinea-Bissau
	Grenadines

	6.   Bahamas
	43.
	Guyana
	79. Samoa

	7.   Bangladesh
	44.
	Haiti
	80.  São Tomé and Príncipe

	8.   Barbados
	45.
	Honduras
	81. Senegal

	9.   Belize
	46.
	India
	82. Seychelles

	10. Benin
	47.
	Indonesia
	83.  Sierra Leone

	11. Bhutan
	48.
	Jamaica
	84.  Solomon Islands

	12. Bolivia
	49.
	Kazakhstan
	85. Somalia

	13. Botswana
	50.
	Kenya
	86.  South Africa

	14. British Virgin Islands
	51.
	Kiribati
	87.  South Sudan

	15. Burkina Faso
	52.
	Kyrgyzstan
	88.  Sri Lanka

	16. Burundi
	53.
	Lao People's Dem. Rep.
	89. Sudan

	17. Cambodia
	54.
	Lesotho
	90. Suriname

	18. Cameroon
	55.
	Liberia
	91. Swaziland

	19.  Cape Verde
	56.
	Madagascar
	92.  Syrian Arab Republic

	20. Central African Republic
	57.
	Malawi
	93. Tajikistan

	21. Chad
	58.
	Maldives
	94.  Tanzania, U. Rep. of

	22. Comoros
	59.
	Mali
	95. Thailand

	23.  Congo, Rep
	60.
	Mauritania
	96. Timor-Leste

	24. Congo, Dem. Rep. of the
	61.
	Mauritius
	97. Togo

	25. Côte d'Ivoire
	62.
	Moldova, Rep. of
	98. Tonga

	26. Cuba
	63.
	Mongolia
	99.  Trinidad and Tobago

	27. Djibouti
	64.
	Mozambique
	100.Turkmenistan

	28. Dominica
	65.
	Myanmar
	101.Turks and Caicos

	29. Ecuador
	66.
	Namibia
	102.Tuvalu

	30.  El Salvador
	67.
	Nauru
	103.Uganda

	31. Equatorial Guinea
	68.
	Nepal
	104.Uzbekistan

	32. Eritrea
	69.
	Nicaragua
	105.Vanuatu

	33. Ethiopia
	70.
	Niger
	106.Vietnam

	34.  Fiji Islands, Rep. of the
	71.
	Nigeria
	107.Yemen

	35. Gabon
	72.
	Pakistan
	108.Zambia

	36. Gambia
	73.
	Palau
	109.Zimbabwe

	37. Georgia
	74.
	Papua New Guinea
	 

APPENDIX 7
Countries in the BIC Territory

	
					
	1.   Afghanistan
	40.
	Georgia
	79.
	Papua NewGuinea

	2.   Angola
	41.
	Ghana
	80.
	Phillipines

	3.   Anguilla
	42.
	Grenada
	81.
	Rwanda

	4.   Antigua and Barbuda
	43.
	Guatemala
	82.
	Saint Kitts and Nevis

	5.   Armenia
	44.
	Guinea
	83.
	Saint Lucia

	6.   Aruba
	45.
	Guinea-Bissau
	84.
	Saint Vincent & the

	7.   Bahamas
	46.
	Guyana
	 
	Grenadines

	8.   Bangladesh
	47.
	Haiti
	85.
	Samoa

	9.   Barbados
	48.
	Honduras
	86.
	São Tomé and Príncipe

	10. Belarus
	49.
	India
	87.
	Senegal

	11. Belize
	50.
	Indonesia
	88.
	Seychelles

	12. Benin
	51.
	Jamaica
	89.
	Sierra Leone

	13. Bhutan
	52.
	Kazakhstan
	90.
	Solomon Islands

	14. Bolivia
	53.
	Kenya
	91.
	Somalia

	15. Botswana
	54.
	Kiribati
	92.
	South Africa

	16. British Virgin Islands
	55.
	Kyrgyzstan
	93.
	South Sudan

	17. Burkina Faso
	56.
	Lao, People's Dem. Rep.
	94.
	Sri Lanka

	18. Burundi
	57.
	Lesotho
	95.
	Sudan

	19. Cambodia
	58.
	Liberia
	96.
	Surinam

	20. Cameroon
	59.
	Madagascar
	97.
	Swaziland

	21.  Cape Verde
	60.
	Malawi
	98.
	Syrian Arab Republic

	22. Central African Republic
	61.
	Malaysia
	99.
	Tajikistan

	23. Chad
	62.
	Maldives
	100.
	Tanzania, U. Rep. of

	24. Comoros
	63.
	Mali
	101.
	Thailand

	25.  Congo, Rep
	64.
	Mauritania
	102.
	Timor-Leste

	26. Congo, Dem. Rep. of the
	65.
	Mauritius
	103.
	Togo

	27. Côte d'Ivoire
	66.
	Moldova, Rep. of
	104.
	Tonga

	28. Cuba
	67.
	Mongolia
	105.
	Trinidad and Tobago

	29. Djibouti
	68.
	Montserrat
	106.
	Turkmenistan

	30. Dominica
	69.
	Mozambique
	107.
	Turks and Caicos

	31. Dominican Republic
	70.
	Myanmar
	108.
	Tuvalu

	32. Ecuador
	71.
	Namibia
	109.
	Uganda

	33.  El Salvador
	72.
	Nauru
	110.
	Ukraine

	34. Equatorial Guinea
	73.
	Nepal
	111.
	Uzbekistan

	35. Eritrea
	74.
	Nicaragua
	112.
	Vanuatu

	36. Ethiopia
	75.
	Niger
	113.
	Vietnam

	37.  Fiji Islands
	76.
	Nigeria
	114.
	Yemen

	38. Gabon
	77.
	Pakistan
	115.
	Zambia

	39. Gambia
	78.
	Palau
	116.
	Zimbabwe

S-263

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00294-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00294-of-00352.parquet"}]]