Exhibit 10.77


 


FOURTH AMENDMENT TO LICENSE AGREEMENT


 


                This Fourth
Amendment to License Agreement (“Fourth Amendment”) is effective as of the 19th
day of April, 2004 (the “Effective Date”), by and among Gilead Sciences, Inc.
(formerly Triangle Pharmaceuticals, Inc.), a Delaware corporation having its
principal place of business at 333 Lakeside Drive, Foster City, CA 94404 (“COMPANY”)
and Emory University, a not-for-profit Georgia corporation with offices at 1380
South Oxford Road, N.E., Atlanta, Georgia 30322 (“LICENSOR”), and amends
certain terms of that certain License Agreement, dated April 17, 1996, between
LICENSOR and COMPANY, as amended by the First Amendment to License Agreement,
dated May 6, 1999 (“First Amendment”) and as further amended by the Second
Amendment to License Agreement dated July 10, 2000 (“Second Amendment”) and as
further amended by the Third Amendment to the License Agreement dated May 31,
2002 (such License Agreement as amended by the First, Second and Third
Amendments is referred to herein as the “Agreement”).


 


WHEREAS LICENSOR and COMPANY wish to clarify a fair
and equitable formula for Net Selling Price of Licensed Products which contain
as their active ingredients both Licensed Compounds and compounds other than
Licensed Compounds;


 


WHEREAS LICENSOR and COMPANY wish
to clarify definitions related to an expanded access program such as COMPANY’S
Global Access Program;


 


                NOW, THEREFORE,
for good and valuable consideration, the receipt and sufficiency of which are
acknowledged by each of the parties, COMPANY and LICENSOR hereby agree as
follows:


 


1.                                       Definitions.


1.1.                              Use of Existing Definitions. 
All terms used in this Fourth Amendment and not otherwise defined herein
shall have the same meanings ascribed to them in the Agreement.


1.2.                              Amendment of Definitions. 
The Agreement is hereby amended to provide that:


1.2.1.                     Sections 1.20 and 1.21 and 1.25 are deleted in their
entirety and replaced with the following:


“1.20       “Net Selling Price” of a product
(including a Licensed Product) shall mean, with respect to a particular fiscal
quarter, the gross invoice price (i.e. the total invoiced price therefore prior
to any deductions made pursuant to clauses (i) through (iv)) paid by a
purchaser of such product (including Distributors), to COMPANY, an Affiliate or
sublicensee of COMPANY and their sublicensees or any other party authorized by
COMPANY to sell that product (which shall not include Distributors)
(collectively the “Sellers”), plus, if applicable, the value of all properties
and services received in consideration of a Sale of such product, less only:


 


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(i)                                     discounts, including cash and quantity
discounts, charge-back payments and rebates granted to managed health care
organizations or to federal, state and local governments, their agencies,
purchasers and reimbursers or to trade customers;


(ii)                                  credits or allowances actually granted upon
claims, damaged goods, rejections or returns of such Licensed Products,
including recalls;


(iii)                               freight, postage, shipping,
transportation and insurance charges actually allowed or paid for delivery of
Licensed Products to the extent billed; and


(iv)                              taxes (other than income taxes), duties
or other governmental charges levied on, absorbed or otherwise imposed on sale
of such Licensed Products, including without limitation value-added taxes, or
other governmental charges otherwise measured by the billing, when included in
the billing, as adjusted for rebates and refunds.


(a)           Notwithstanding the foregoing in this
Section 1.20, amounts received by COMPANY, its Affiliates or sublicensees for
the sale of Licensed Products among COMPANY, its Affiliates and sublicensees
for resale shall not be included in the computation of Net Selling Price
hereunder.


(b)           For purposes of this Section 1.20, “Distributor”
shall mean any third party (i) to which a Seller has granted (at any time
during the term) a right to sell or distribute a Licensed Product, (ii) that
sells Licensed Products to hospitals and/or pharmacies for their sale to or use
with patients (rather than to other third parties for resale to hospitals
and/or pharmacies for their sale to or use with patients), and (iii) that does
not make payments to COMPANY or such COMPANY Affiliate that are calculated on
the basis of a percentage of, or profit share on, such third party’s sales of
Licensed Products.  For purposes of
calculating Net Selling Price, no Distributor shall be deemed to be a
sublicensee of COMPANY or its Affiliates. 
Net Selling Price for the quantities of License Product sold by
Distributors shall be calculated based on the amount invoiced the Distributors
by COMPANY and/or its Affiliates and/or sublicensees of Affiliates and COMPANY
rather than by the Distributors to their customers.


(c)           Where Licensed Product is sold in the
form of a combination product containing one or more active ingredients in
addition to a Licensed Compound (“Combination Product”), Net Selling Price for
such


 


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Combination Product for
purposes of determining royalties payable under this Agreement will be
calculated by multiplying the actual Net Selling Price of such Combination
Product by the fraction A/(A+B) where A is the Net Selling Price for the stock
keeping unit most comparable in formulation and dosing to that used for the
Combination Product of the Licensed Product containing the relevant Licensed
Compound as the sole active ingredient, if sold separately, in such country
during the relevant fiscal quarter, and B is the Net Selling Price for the
stock keeping unit, most comparable in formulation and dosing to that used for
the Combination Product, of any other active ingredient, if sold separately, in
such country during the relevant fiscal quarter.  For clarity, if there are three or more
active ingredients (including the Licensed Compound), additional B terms
calculated in the same manner, shall be included in the denominator so that
such fraction shall be A/(A+B1+ B2+...). 
If, on a country-by-country basis, one or more of the other active
ingredients in the Combination Product are not sold separately in said country,
Net Selling Price for the purpose of determining royalties payable under this
Agreement for the Combination Product shall be calculated by multiplying the
actual Net Selling Price of such Combination Product Combination Product of the
Licensed Product containing the relevant Licensed Compound as the sole active
ingredient, if sold separately, in such country during the relevant fiscal
quarter and C is the Net Selling Price for the Combination Product in such
country during the relevant fiscal quarter. 
If, on a country-by-country basis, the Licensed Product containing a
Licensed Compound as the sole active ingredient is not sold separately in said
country during the relevant fiscal quarter but one or more of the other active
ingredients in the Combination Product are sold separately in said country
during the relevant fiscal quarter, the Net Selling Price for the Combination
Product shall be calculated by multiplying the actual Net Selling Price of such
Combination Product by the fraction (1-(D/C)) where D is the Net Selling Price
for the stock keeping unit most comparable in formulation and dosing to that
used for the Combination Product of the product containing the other active
ingredient as the sole active ingredient and C is the Net Selling Price for the
Combination Product in such country during the relevant fiscal quarter.  If, on a country-by-country basis, the
Licensed Product containing a Licensed Compound as the sole active ingredient
is not sold separately and one or more of the other active ingredients in the
Combination Product are not sold separately in such country during the relevant
fiscal quarter Net Selling Price for the purposes of determining royalties of
the Combination Product shall be deemed to be the Net Selling Price of such
Combination Product multiplied by a fraction, the numerator of which is the
number of Licensed Compounds in such Combination Product and the denominator of
which is the number of all active ingredients in such Combination Product.”


 


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“1.21       Intentionally left blank.”


“1.25       “Sale”
or “Sold” shall mean the sale, transfer, exchange or other disposition of
Licensed Products whether by gift or otherwise, subsequent to Registration in a
given country (if such Registration is required) by  a Seller to make such sale, transfer,
exchange or disposition, to any party that is not a Seller.  Sales of Licensed Products shall be deemed
consummated upon the first to occur of: (a) receipt of payment from the
purchase; (b) delivery of Licensed Products to the purchaser or a common
carrier; (c) release of Licensed Products from consignment; or (d) if otherwise
transferred, exchanged or disposed of, whether by gift or otherwise, when such
transfer, exchange, gift or other disposition occurs. Notwithstanding the
foregoing definition of Sale, to the extent COMPANY distributes any Licensed
Product under a Treatment IND or through an expanded access program or the
Global Access Program, only to the extent that the actual Net Selling Price
exceeds Fully Absorbed Costs therefor will such distribution be considered a
Sale. If the actual Net Selling Price exceeds the Fully Absorbed Costs, the
distribution shall be deemed to be a Sale with a deemed Net Selling Price
(prior to any application of Section 1.20(c)) for purposes of Section 3.4 of
the difference between the actual Net Selling Price and the Fully Absorbed Cost
therefor.”


 


1.2.2                        New Sections 1.29 and 1.30 are hereby
added.


 


“1.29:  “Global Access Program” shall mean a program
through which COMPANY provides Licensed Products to government agencies,
not-for-profit non-governmental organizations, physicians, pharmacies or
patients in identified countries at reduced costs. The countries are identified
on Exhibit C hereto, which Exhibit may be amended from time to time by the
Parties.”


“1.30:  “Fully Absorbed Costs” shall mean an amount
equal to COMPANY’s costs directly allocated to the production of Licensed Products
distributed under a Treatment IND or through an expanded access program or the
Global Access Program, consisting of: (i) direct labor, including all
resources utilized in support of COMPANY’s manufacturing operations;
(ii) materials; (iii) a reasonable allocation of overhead, facilities
expense (including depreciation over the expected life of the buildings and
equipment), and administrative costs directly in support of COMPANY’s
manufacturing operations and such Treatment IND distribution program, expanded
access program or the Global Access Program, if applicable, calculated by
COMPANY in accordance with reasonable cost accounting methods consistent with
the way COMPANY allocates such costs to other products; and
(iv) third-party costs.”


 


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2.                                       Amendment of Other Provisions of the
Agreement.  The provisions of the Agreement, other than definitions, are hereby amended as follows:


 


2.1.                              Section 3.5(d) is deleted in its entirety
and replaced with the following:


 


“(d)         Commencing upon FDA Registration for a
Licensed Product and ending upon expiration of the second calendar year
following the year in which such FDA Registration is granted, COMPANY may
credit solely against running royalties (paid pursuant to Section 3.4), all
reasonable costs incurred by COMPANY after the date hereof (including any
reimbursements to LICENSOR pursuant to Section 7.1 for inter partes Patent Prosecution Activities, as
defined therein) in connection with any litigation, interference, opposition or
other inter partes action pertaining to the validity, enforceability,
allowability or subsistence of the Licensed Patents or whether COMPANY’s
practice of the Licensed Patents infringes a third party patent.  Until the end of such second calendar year,
the amount of such credits shall not exceed in any year one-half (1⁄2) of the
royalty payments due hereunder in such year. 
Commencing upon the third calendar year following the year in which such
FDA registration is granted, such credits shall not exceed in any year one-half
(1⁄2 ) of the Annual Minimum payments due in such year.  Such costs shall not be credited against any
other payments due to LICENSOR under this Agreement.”


 


2.2.                              In Section 4.2 (Right to Audit), first
sentence, insert “including records reasonably necessary to verify of the
accuracy of Net Selling Prices and Fully Absorbed Costs, “ prior to “required
to be furnished by COMPANY pursuant to Section 4.1 of the Agreement”.


 


3.             General Terms.


 


3.1                                 Unamended Terms of Agreement Remain in
Effect.  Except as expressly amended hereby, the
remaining terms of the Agreement shall remain in full force and effect.


 


3.2                                 Entire Agreement. 
The Agreement, as amended by this Fourth Amendment, constitutes the
entire agreement between LICENSOR and COMPANY regarding the subject matters
contained herein.


 


3.3                                 Conflicts.  In the event
of any conflict between the provisions of the Agreement and this Fourth
Amendment, the provisions of this Fourth Amendment shall govern and control.


 


3.4                                 Governing Law.  This
Fourth Amendment shall be governed by, and construed in accordance with, the
laws of the State of Georgia without regard to its conflicts of laws
principles.


 


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3.5                                 Counterparts. 
This Fourth Amendment may be executed in any number of counterparts,
each of which shall be deemed an original and all of which shall constitute one
and the same instrument.


 


3.6                                 Survival of Provisions. 
If any provision of this Fourth Amendment is for any reason held to be
ineffective, unenforceable or illegal, such condition shall not affect the
validity or enforceability of any of the remaining portions hereof; provided,
further, that the parties shall negotiate in good faith to replace any
ineffective, unenforceable or illegal provision with an effective replacement
as soon as is practical.


 


IN WITNESS WHEREOF,
LICENSOR and COMPANY have each executed this Fourth Amendment through an
authorized officer as of the date first written above.


 


 


	
   

  	
   

  	
   

  	
   

  	
   

  	
  EMORY UNIVERSITY

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
  By:

  	
  /s/ Todd Sherer

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
  Its:

  	
  Asst. V.P. & Director OTT

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
  Date:

  	
  4-20-04

  



 


 


	
   

  	
   

  	
   

  	
   

  	
   

  	
  GILEAD SCIENCES,
  INC.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
  By:

  	
  /s/ John F. Milligan

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
  Its:

  	
  Executive VP and CFO

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
  Date:

  	
  April 19, 2004

  



 


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Exhibit C


	
   

  	
  Global Access Program Countries

  
	
   

  	
   

  
	
  Algeria

  	
   

  	
  Kenya

  	
   

  	
  Togo

  
	
  Angola

  	
   

  	
  Lesotho

  	
   

  	
  Tunisia

  
	
  Benin

  	
   

  	
  Liberia

  	
   

  	
  Uganda

  
	
  Botswana

  	
   

  	
  Libya

  	
   

  	
  Zambia

  
	
  Burkina
  Faso

  	
   

  	
  Madagascar

  	
   

  	
  Zimbabwe

  
	
  Burundi

  	
   

  	
  Malawi

  	
   

  	
   

  
	
  Cameroon

  	
   

  	
  Mali

  	
   

  	
   

  
	
  Cape
  Verde

  	
   

  	
  Mauritania

  	
   

  	
  Afghanistan

  
	
  Central
  African Republic

  	
   

  	
  Mauritius

  	
   

  	
  The
  Bahamas

  
	
  Chad

  	
   

  	
  Morocco

  	
   

  	
  Bangladesh

  
	
  Comoros

  	
   

  	
  Mozambique

  	
   

  	
  Bhutan

  
	
  Congo-Brazzaville

  	
   

  	
  Namibia

  	
   

  	
  Cambodia

  
	
  Cote
  d’Ivoire

  	
   

  	
  Niger

  	
   

  	
  Guyana

  
	
  Democratic
  Republic of Congo

  	
   

  	
  Nigeria

  	
   

  	
  Haiti

  
	
  Djibouti

  	
   

  	
  Rwanda

  	
   

  	
  Kiribati

  
	
  Egypt

  	
   

  	
  Sao
  Tome & Principe

  	
   

  	
  Laos

  
	
  Equatorial
  Guinea

  	
   

  	
  Senegal

  	
   

  	
  Maldives

  
	
  Eritrea

  	
   

  	
  Seychelles

  	
   

  	
  Myanmar

  
	
  Ethiopia

  	
   

  	
  Sierra
  Leone

  	
   

  	
  Nepal

  
	
  Gabon

  	
   

  	
  Somalia

  	
   

  	
  Samoa

  
	
  Gambia

  	
   

  	
  South
  Africa

  	
   

  	
  Solomon
  Islands

  
	
  Ghana

  	
   

  	
  Sudan

  	
   

  	
  Tuvalu

  
	
  Guinea

  	
   

  	
  Swaziland

  	
   

  	
  Vanuatu

  
	
  Guinea
  Bissau

  	
   

  	
  Tanzania

  	
   

  	
  Yeman

  
						



 


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