Document:

EXHIBIT 10.1

 

 

 

 

 

 

 

MERCADOLIBRE, INC. 2017 LONG TERM RETENTION PROGRAM

 

 

 

 

 

 

 

 

 

Effective as of January 1, 2017

 

 

	 
	Contents
	 

 

 

MercadoLibre, Inc. 2017 Long Term Retention Program

	Article 1.   Purpose	1
	Article 2.   Definitions	1
	Article 3.   Participation; Performance Goals and Award Opportunities	6
	Article 4.   Review of Participant’s Performance	6
	Article 5.   Payment of Awards	6
	Article 6.   Termination of Employment; Forfeitures	9
	Article 7.   Administrative Provisions	11

 

 

 

 

 

 

 

 

    i 

     

    

MERCADOLIBRE, INC.
2017 LONG TERM RETENTION PROGRAM

 

Article 1.                
Purpose

 

The MercadoLibre, Inc. 2017 Long Term Retention Program (the “Plan”) is effective
as of January 1, 2017. The principal purpose of the Plan is to assist the Company in the retention of key employees that have
valuable industry experience and developed competencies by rewarding Participants in relation to their individual results and their
contributions to the organization, as well as overall Company goals and performance.

 

Article 2.                
Definitions

 

When used in the Plan, the following terms shall have the meanings set forth below:

 

“Affiliate” means with respect to any Person, a Person that
controls, is controlled by, or is under common control with such Person (it being understood, that a Person shall be deemed to
“control” another Person, for purposes of this definition, if such Person directly or indirectly has the power to direct
or cause the direction of the management and policies of such other Person, whether through holding ownership interests in such
other Person, through agreements or otherwise, and that direct or indirect ownership of ten percent (10%) or more of the voting
interests of another Person shall always be deemed to constitute “control”).

 

“Award” means any Fixed Award or any Variable Award.

 

“Award Committee” means the Compensation Committee of the
Board, or such other committee that the Board appoints to administer this Plan, which shall have general administrative authority
concerning the Plan, and shall, subject to Article 7, have the sole and absolute authority and discretion to resolve any and all
terms and conditions of any Awards and disputes concerning the Plan and any Awards hereunder.

 

“Board” means the board of directors of the Company.

 

“Cause” means “cause” or a similar term set
forth in the Participant’s employment agreement with the Company or, if no such agreement is then in effect, shall mean (A)
the Participant’s material disregard of his responsibilities, authorities, powers, functions or duties or failure to act,
(B) repeated or material negligence or misconduct by the Participant in the performance of his duties, (C) appropriation (or attempted
appropriation) of a business opportunity of the Company, including attempting to secure or securing any personal profit in connection
with any transaction entered into on behalf of the Company, (D) the commission by the Participant of any act of fraud, theft or
financial dishonesty with respect to the Company, or any felony or criminal act involving moral turpitude or dishonesty on the
part of the Participant, (E) the Participant’s habitual drunkenness or excessive absenteeism not related to sickness, and/or
(F) the material breach by the Participant of any provision of his employment agreement that is not cured by the Participant within
thirty (30) days after written notice of breach has been delivered to the Participant by the Company, unless such breach is incapable
of cure (in which case the Participant shall not be entitled to an opportunity to cure), in each case of clauses (A) through (F)
above, as determined by the Board in good faith.

 

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“Change in Control” shall mean a change in control of the
Company which will be deemed to have occurred after the date hereof if:

 

		(a)	any “person” as such term is used in Section 3(a)(9) of the Exchange Act, as modified and used in Sections 13(d)
and 14(d) thereof, is or becomes the beneficial owner, as such term is defined in Rule 13d-3 under the Exchange Act, directly or
indirectly, of securities of the Company representing at least fifty percent (50%) of the combined voting power or Shares of the
Company; provided, however, that such term shall not include (A) the Company or any of its subsidiaries, (B) any trustee or other
fiduciary holding securities under an employee benefit plan of the Company or any of its affiliates, (C) an underwriter temporarily
holding securities pursuant to an offering of such securities, (D) any corporation owned, directly or indirectly, by the shareholders
of the Company in substantially the same proportions as their ownership of the Company’s Shares, or (E) any person or group
as used in Rule 13d-1(b) under the Exchange Act;
	 	 	 

		(b)	there is consummated a merger or consolidation of the Company or any of its direct or indirect subsidiaries with any other
corporation, other than a merger or consolidation which would result in the voting securities of the Company outstanding immediately
prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving
entity or any parent thereof) more than fifty percent (50%) of the combined voting power and Shares of the Company or such surviving
entity or any parent thereof outstanding immediately after such merger or consolidation; or
	 	 	 

		(c)	there is completed a sale or disposition by the Company of all or substantially all of the Company’s assets (or any transaction
having a similar effect, including a liquidation) other than a sale or disposition by the Company of all or substantially all of
the Company’s assets to an entity, more than fifty percent (50%) of the combined voting power and Shares of which is owned
by shareholders of the Company in substantially the same proportions as their ownership of the Shares of the Company immediately
prior to such sale.

 

“Company” means MercadoLibre, Inc. and its consolidated
subsidiaries, and MercadoLibre, Inc.’s successors or assigns.

 

“Covered Termination” means (i) a termination of a Participant’s
employment by the Company without Cause and for a reason other than the Participant’s death or disability (as determined
under Article 6(a)) or (ii) a Participant’s resignation from the Company with Good Reason).

 

“Eligible Employee” means an individual who is designated
by the Award Committee as eligible for this Plan and who is employed by the Company as determined by the Award Committee.

 

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“Fixed Award” means a specified cash award, calculated in
accordance with Article 5, payable to a Participant under this Plan for services provided to the Company in 2017, as determined
by the Award Committee from time to time in its sole discretion. Fixed Award payments shall be contingent on the attainment of
one or more Performance Goals. The timing and conditions of the payment of the Fixed Award are subject to the terms and conditions
of the Plan and, subject to Article 7 of the Plan, any other terms and conditions determined by the Award Committee to be appropriate.
The Fixed Award may, but is not required to, be evidenced by a separate agreement executed by the Participant.

 

“Good Reason” means (i) a material diminution in the Participant’s
duties, functions and responsibilities to the Company without the Participant’s consent or the Company preventing the Participant
from fulfilling or exercising the Participant’s materials duties, functions and responsibilities to the Company without the
Participant’s consent; (ii) a material reduction in the Participant’s base salary or bonus opportunity or (iii) a requirement
that the Participant relocate the Participant’s employment more than fifty (50) miles from the location of the Participant’s
principal office without the consent of the Participant. A Participant’s resignation shall not be a resignation with Good
Reason unless the Participant gives the Company written notice (delivered within thirty (30) days after the Participant knows of
the event, action, etc. that the Participant asserts constitutes Good Reason), the event, action, etc. that the Participant asserts
constitutes Good Reason is not cured, to the reasonable satisfaction of the Participant, within thirty (30) days after such notice
and the Participant resigns effective not later than thirty (30) days after the expiration of such cure period.

 

“Market Value” of a Share, as of any date, means (i) the
average closing sale price of one Share as reported on a national stock exchange, including, but not limited to, the NASDAQ Global
Market (a “National Stock Exchange”) during the sixty (60) trading day period (or such shorter period as the Shares
are so listed) ending on the last trading day immediately preceding such date; (ii) if the Shares are not listed for trading on
a National Stock Exchange during any day in that sixty (60) trading day period but are quoted on the Over-the-Counter-Bulletin
Board (the “OTCBB”), the mean between the closing bid and closing asked prices for the Shares as quoted on the OTCBB
during the sixty (60) trading day period (or such shorter period as the Shares are so quoted) ending on the last trading day immediately
preceding such date, (iii) if the Shares are not listed for trading on a National Stock Exchange or quoted on the OTCBB during
any day in that sixty (60) trading day period and the Shares were last traded on a National Stock Exchange, the average closing
sale price of one Share as reported on the National Stock Exchange during the ninety (90) trading day period ending on the last
day the Shares were listed for trading on such Exchange or (iv) if the Shares are not listed for trading on a National Stock Exchange
or quoted on the OTCBB during any day in that sixty (60) trading day period and the Shares were last traded on the OTCBB, the mean
between the closing bid and closing asked prices for the Shares as quoted on the OTCBB during the ninety (90) trading day period
ending on the last day the Shares were quoted on the OTCBB. For purposes of calculating the benefits and valuing Shares for the
single cash payment payable within fifteen (15) days after a Change in Control, the term “Market Value” means the amount
determined under the preceding sentence determined as of the date on which the Change in Control occurs. For purposes of calculating
benefits and valuing Shares for other payments payable after a Change of Control, the term “Market Value” means, (x)
in the event the Company is not the surviving entity in the Change in Control, the amount determined under the first sentence of
this paragraph and determined as of the date on which the Change in Control occurs, or, (y) in the event the Company is the surviving
entity in the Change in Control, the greater of (A) the amount determined under the first sentence of this paragraph and determined
as of the date the benefit is a payable (e.g., as of March 31 of the appropriate year or the date of a Participant’s
Covered Termination, as applicable) or (B) the amount determined under the first sentence of this paragraph and determined as of
the date on which the Change in Control occurs.

 

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“MercadoLibre Business” means any activities directly or
indirectly related to Online Transactional Platforms, Online Classified Advertisements and/or Payment Platforms.

 

“Minimum Eligibility Conditions” means the minimum conditions
established by the Award Committee and approved by the Board that a Participant must meet in order to be eligible to receive payments
under any Award hereunder.

 

“Online Classified Advertisements” means listings of goods,
products or services on Internet sites, which listings (1) serve the same purpose as the listings appearing in the classifieds
section of printed newspapers, (2) include direct contact information of the seller via telephone, e-mail or any offline method,
which contact information is readily and continuously available to any visitor without restriction or special action required from
the visitor, or provide for a method to contact the seller so that the seller may then respond providing direct contact information,
and (3) are on Internet sites the operator or administrator of which does not (x) play any role in consummating the transaction
to which the listing relates, or (y) provide any information (other than contact information) to the seller regarding the potential
buyer or interested party, or otherwise serve as middle-man between a potential buyer and seller (other than for the limited purposes
expressly set forth in this paragraph), or (z) charge any fee or commission for such transaction (including, without limitation,
any fees for completion of transactions and/or fees based on number of users contacting another user) other than a listing fee,
which is a fee for placing the listing on the website and is chargeable before or at the time such listing appears. Examples of
Online Classifieds Advertisements include Craigslist.com, Kijiji.com, and olx.com.

 

“Online Transactional Platforms” means online transactional
platforms or similar as determined by the Award Committee including, but not limited to, (a) any online platform offering a wide
variety of product lines and/or services, operating in a manner similar to Amazon.com or Submarino.com as of the date hereof and/or
(b) online transactional marketplaces located on websites in which sellers and potential buyers transact for any kinds of goods
and/or services, which goods and/or services are displayed on such website, and in which the sellers’ and potential buyers’
initial contact can only be made through such website (for purposes of initial contact, direct contact information of another user
is not made available to users, in accordance with the terms of use of such website), such as eBay.com, MercadoLibre.com, DeRemate.com,
etc. (and any such domain name with country suffixes).

 

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“Participant” means an Eligible Employee who is designated
as eligible to receive an Award for services provided in 2017. The designation of an individual as a Participant under this Plan
shall not provide the individual with any rights to any future participation for any subsequent long term retention plans that
may be adopted by the Company in future years but, subject to the terms of the Plan, an individual shall remain a Participant for
purposes of receiving a payment of an Award until such individual ceases to be an Eligible Employee.

 

“Payments Platforms” means websites or platforms enabling
the sending, receipt, holding and/or transfer of money from one user to another user through an account that is funded by, among
other things, traditional payment methods and then used to transact with another user electronically, such as PayPal.com, MercadoPago.com,
or Dineromail.com (and any such domain name with country suffixes).

 

“Performance Goals” means any goals, metrics or other performance
measures of the Company in 2017 that is established for a Participant, the attainment of which will result in an Award becoming
payable to the Participant, subject to the terms of the Plan. It is currently anticipated that Performance Goals generally will
be based on pre-set goals for financial and operational performance of the Company.

 

“Person” means and includes a natural person, a corporation,
an association, a partnership, a limited liability company, a trust, a joint venture, an unincorporated organization or any other
similar entity or a governmental or quasi-governmental body.

 

“Shares” means shares of common stock of the Company, $0.001
par value per share.

 

“Territory” means the United States of America and each
country and territory in Latin America and the Caribbean, including, without limitation, Argentina, Bolivia, Brazil, Chile, Colombia,
Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Puerto Rico,
Uruguay, and Venezuela.

 

“Variable Award” means a specified cash award, calculated
in accordance with Article 5, payable to a Participant under this Plan for services provided to the Company in 2017, as determined
by the Award Committee from time to time in its sole discretion. Variable award payments hereunder shall be contingent on the attainment
of one or more Performance Goals. The timing and conditions of the payment of the Variable Award are subject to the terms and conditions
of the Plan and any other terms and conditions determined by the Award Committee to be appropriate in accordance with Article 7
of the Plan. The Variable Award may, but is not required to, be evidenced by a separate agreement executed by the Participant.

 

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Article 3.                
Participation; Performance Goals and Award Opportunities

 

The amount of the Awards for each Plan Participant and the Performance Goals applicable
to such Awards will be established by the Award Committee and communicated to each Plan Participant. The amount of each Award may
be different for each Participant or levels of Participants as determined by the Award Committee.

The amount of each Award shall be enumerated as a specified amount, calculated in accordance
with Article 5 hereof, of United States dollars, unless the Award Committee determines the amount of any such Award in a local
currency. The amount of each Award, to the extent it becomes payable, shall be paid in the form of cash only.

 

Article 4.                
Review of Participant’s Performance

 

Performance Goals will generally be set and determined for the 2017 calendar year by
the Award Committee. The Award Committee, with input from the Company officer responsible for each Participant, will evaluate such
Participant’s performance relative to the Performance Goals.

 

Article 5.                
Payment of Awards

 

(a)        If a Participant does not satisfy the Minimum
Eligibility Conditions, then any Award granted to such Participant and subject to such Minimum Eligibility Conditions shall be
forfeited, and shall not become payable to such Participant under this Plan. If the Participant meets the Minimum Eligibility Conditions,
then any Award granted to such Participant and subject to such Minimum Eligibility Conditions shall become payable to the Participant
in accordance with and subject to the terms of this Article 5 and Article 6.

 

Subject to the following paragraphs and Article 6, only if the Participant is employed
as an Eligible Employee on the date each portion of the Fixed and the Variable Awards, as applicable, are to be paid to such Participant,
any such Awards shall be payable as follows:

 

If a Participant has been granted a Fixed Award:

 

		(1)	Sixteen and two-thirds percent (16.66%) of such Fixed Award shall be payable to the Participant on or about March 31 of
each calendar year for a period of six (6) years starting in 2017; and

 

If a Participant has been granted a Variable Award:

 

		(2)	the Participant shall receive on or about March 31 of each calendar year for a period of six (6) years starting in 2017,
a Variable Award payment equal in value to the product of (i) multiplied by (ii), where (i) equals sixteen and two-thirds percent
(16.66%) of the Variable Award and (ii) equals the quotient of (a) divided by (b), where (a), the numerator, equals the Market
Value as of the applicable payment date and (b), the denominator, equals $164.17 (the average closing price of the Company’s
common stock on the NASDAQ Global Market during the final sixty (60) trading days of 2015).

 

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(b)        Notwithstanding anything in the Plan or
any other agreement entered into in connection with or pursuant to the Plan:

 

		(1)	Each Participant who is employed by the Company on the date a Change in Control occurs shall be vested in the right to receive
fifty percent (50%) of the Award payments scheduled to be paid thereafter.
	 	 	 

		(2)	As soon as practicable after the date a Change in Control occurs, but in no event more than fifteen (15) days after the date
a Change in Control occurs, each Participant described in clause (1) of this paragraph shall receive a single cash payment equal
to fifty percent (50%) of the Award payments scheduled to be paid after the Change in Control (based on the Market Value on the
date the Change in Control occurs).
	 	 	 

		(3)	Each Award payment scheduled to be paid after the Change in Control shall be reduced by fifty percent (50%), i.e., to
reflect the single cash payment under clause (2) of this paragraph, and shall continue to be paid on each March 31 in accordance
with the preceding paragraph, subject to the Participant’s continued employment; provided, however, that if a Participant
described in clause (1) of this paragraph experiences a Covered Termination on or after Change in Control, then any Award payments
scheduled to be paid after the Covered Termination shall be paid in a single cash payment (based on the Market Value on the date
of the Covered Termination) within fifteen (15) days after the Covered Termination.

 

(c)        Notwithstanding anything in the Plan or
any agreement entered into in connection with or pursuant to the Plan:

 

		(1)	The portion of any Award under this Plan that was forfeited or forfeitable upon the Participant’s Covered Termination
before a Change in Control shall be reinstated (or if not yet forfeited, retained) as of the date of the Change in Control if such
date is not more than one hundred and twenty (120) days after the date of the Covered Termination.
	 	 	 

		(2)	As soon as practicable after the date a Change in Control occurs, but in no event more than fifteen (15) days after the date
a Change in Control occurs, each Participant described in clause (1) of this paragraph shall receive a single cash payment equal
to one hundred percent (100%) of the Award payments scheduled to be paid after the date of the Participant’s Covered Termination.
With respect to any Award payment originally scheduled to have been paid before the date of the Change in Control, the amount of
such payment will be based on the Market Value on the date of the Covered Termination. With respect to any Award payments scheduled
to be paid on or after the Change in Control, the amount of such payment will be based on the Market Value on the date the Change
in Control occurs.
	 	 	 

 

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(d)        Notwithstanding anything
in the Plan or any other agreement entered into in connection with or pursuant to the Plan:

 

		(1)	If any portion of an Award received or to be received by a Participant (either alone or together with other payments or benefits
which such Participant received or realized or is then entitled to receive or realize from the Company under any other plan, program,
arrangement or agreement in connection with a Change in Control or a Participant’s termination of employment) (all such payments
and benefits, being hereinafter referred to as the “Total Payments”) would be subject (in whole or part), to any excise
tax imposed under section 4999 of the Internal Revenue Code of 1986 (the “Code”, and such excise tax, the “Excise
Tax”), then, after taking into account any reduction in the Total Payments provided by reason of section 280G of the Code
in any other plan, program, arrangement or agreement, the Company will reduce the payment of the Award to the extent necessary
so that no portion of the Total Payments is subject to the Excise Tax (but in no event to less than zero); provided, however,
that the Award will only be reduced if (i) the net amount of any Total Payments, as so reduced (and after subtracting the net amount
of United States federal, state, municipal and local income taxes on such reduced Total Payments and after taking into account
the phase out, if any, of itemized deductions and personal exemptions attributable to such reduced Total Payments), is greater
than or equal to (ii) the net amount of such Total Payments without such reduction (but after subtracting the net amount of federal,
state, municipal and local income taxes on such Total Payments and the amount of Excise Tax to which the Participant would be subject
in respect of such unreduced Total Payments and after taking into account the phase out, if any, of itemized deductions and personal
exemptions attributable to such unreduced Total Payments).
	 	 	 

		(2)	If (A) any portion of the Total Payments other than an Award (the “Other Payments”) is required to be reduced pursuant
to a provision substantially similar to this Article 5.5(d), (B) any portion of an Award is required to be reduced pursuant to
this Article 5.5(d); and (C) there is no other provision in any other plan, program, arrangement or agreement governing the payment
of the Other Payments which dictates the order of the reduction in the Other Payments, then the Total Payments will be reduced
in the following order: (i) payments that are payable in cash that are valued at full value under Treasury Regulation Section 1.280G-1,
Q&A 24(a) will be reduced (if necessary, to zero), with amounts that are payable last reduced first; (ii) payments and benefits
due in respect of any equity valued at full value under Treasury Regulation Section 1.280G-1, Q&A 24(a), with the highest values
reduced first (as such values are determined under Treasury Regulation Section 1.280G-1, Q&A 24) will next be reduced; (iii)
payments that are payable in cash that are valued at less than full value under Treasury Regulation Section 1.280G-1, Q&A 24,
with amounts that are payable last reduced first, will next be reduced; (iv) payments and benefits due in respect of any equity
valued at less than full value under Treasury Regulation Section 1.280G-1, Q&A 24, with the highest values reduced first (as
such values are determined under Treasury Regulation Section 1.280G-1, Q&A 24) will next be reduced; and (v) all other non-cash
benefits not otherwise described in clauses (ii) or (iv) will be next reduced pro-rata. Any reductions made pursuant to each of
clauses (i)-(v) above will be made in the following manner: first, a pro-rata reduction of cash payment and payments and benefits
due in respect of any equity not subject to section 409A of the Code, and second, a pro-rata reduction of cash payments and payments
and benefits due in respect of any equity subject to section 409A of the Code as deferred compensation.
	 	 	 
	

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		(3)	For purposes of determining whether and the extent to which the Award will be subject to the Excise Tax and the amount of such
Excise Tax: (i) no portion of the Award the receipt or enjoyment of which the Participant shall have waived at such time and in
such manner as not to constitute a “payment” within the meaning of section 280G(b) of the Code will be taken into account;
and (ii) no portion of the Award will be taken into account which, in the opinion of the accounting firm which was, immediately
prior to the Change in Control, the Company’s independent auditor, does not constitute a “parachute payment”
within the meaning of section 280G(b)(2) of the Code (including by reason of section 280G(b)(4)(A) of the Code) and, in calculating
the Excise Tax, no portion of such Award will be taken into account which constitutes reasonable compensation for services actually
rendered, within the meaning of section 280G(b)(4)(B) of the Code, in excess of the Base Amount (as defined in section 280G(b)(3)
of the Code) allocable to such reasonable compensation.
	 	 	 

		(4)	The fact that the Participant’s right to payments or benefits may be reduced by reason of the limitations contained in
this Article 5.5 will not of itself limit or otherwise affect any other rights of the Participant under the Plan. The Participant
and the Company shall each reasonably cooperate with the other in connection with any administrative or judicial proceedings concerning
the existence or amount of liability for Excise Tax with respect to the Award.

 

Article 6.                
Termination of Employment; Forfeitures

 

(a)               
Except as provided in Article 5 with respect to a Covered Termination within one hundred and twenty (120) days before a
Change in Control or a Covered Termination on or after a Change in Control, participation in the Plan shall cease immediately upon
a Participant’s retirement, resignation or termination of employment as an Eligible Employee for any reason (with or without
Cause), or if determined by the Award Committee, upon the Participant’s death or disability. Disability will be determined
under the Company’s long term disability plan, if any, or upon receipt of a letter of determination or similar of the Participant’s
complete disability by the applicable governmental authority under local applicable law, which complete disability entitles the
Participant to disability payments under local law.

 

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(b)              
In the event that:

 

		(1)	while the Participant is employed by the Company, he or she engages in, directly or indirectly, any other business or activity
that could materially or adversely affect the Company’s business or his or her ability to perform his or her duties for the
Company, including, but not limited to, any activities adversely affecting the MercadoLibre Business anywhere in the Territory;
	 	 	 

		(2)	while the Participant is employed by the Company or during the one-year period following the termination of the Participant’s
employment for any reason, he or she directly or indirectly, on his or her own behalf or on behalf of another Person or entity,
hires or solicits for hire any employees of the Company or its Affiliates or in any manner attempts to influence or induce any
employee of the Company or its Affiliates to leave their employment; or
	 	 	 

		(3)	while the Participant is employed by the Company or during the one-year period following the termination of the Participant’s
employment for any reason, he or she alone (or in association with any other Person) directly or indirectly, in any capacity, owns,
operates, manages, controls, engages in, invests in, becomes employed by, acts as a consultant or advisor to, or provides services
for, or otherwise assists any other Person in activities that are competitive with the MercadoLibre Business anywhere in the Territory,

 

he or she will automatically forfeit any and all benefits received under the Plan and
any and all benefits which the Participant may otherwise be entitled to receive under the Plan. If the Participant terminates employment
with the Company for any reason (with or without Cause) and he or she alone (or in association with any other Person) takes any
of the action set forth in subparagraph (1), (2) or (3) above, the Participant will be required to immediately, and in no event
more than five (5) days following the termination of the Participant’s employment, return all amounts which the Participant
has received under the terms of the Plan (the “Recovery Amount”), and the Participant and the Company hereby agree
to the following, notwithstanding any Plan provision to the contrary:

 

		(i)	that the Company may withhold all or a portion of the Recovery Amount from any salary, wages or other amounts due to the Participant
from the Company; and
	 	 	 

		(ii)	in addition to the Recovery Amount, the Company may also recover any fees incurred by the Company in seeking to collect the
Recovery Amount, including, but not limited to, the Company’s reasonable attorneys’ fees.

 

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Notwithstanding the foregoing, ownership of less than five percent (5%) of the outstanding
capital stock of any Person whose securities are registered under the Securities Exchange Act of 1934, as amended, in and of itself
shall not be cause for automatic forfeiture under Article 6(b)(3), whether or not the subject Person is competitive with the Company.

 

(c)               
Except as provided in Article 5 with respect to a Covered Termination within one hundred and twenty (120) days before a
Change in Control or a Covered Termination on or after a Change in Control, the portion of any Award under this Plan that has not
been actually paid to the Participant prior to the date of such resignation or other termination of employment shall be forfeited,
except that the Award Committee, in its discretion, may pay all or part of the amount that remains payable under an Award upon
the disability or death of the Participant in accordance with such rules or procedures established by the Award Committee provided,
however, that any amount of the Award payment that the Award Committee determines to pay shall be paid no later than March 15
of the year following the year that the Participant’s employment ends on account of disability or death. Notwithstanding
any provision of the Plan to the contrary, any Award paid to the Participant shall be subject to recovery by the Company in the
event that the Participant is terminated for Cause and shall, to the extent permitted by law, be subject to recovery from any amounts
owed by the Company to the Participant, including, but not limited to, offsetting any amounts owed under the Plan to the Company
against any amounts otherwise owed to the Participant by the Company.

 

(d)              
If the Award Committee decides to pay all or part of an Award after the death of a Participant in accordance with this Article
6, the Participant may designate in writing one or more persons (“beneficiary”) to receive any unpaid portion of the
Participant’s Award upon the death of the Participant. By similar action, the Participant may designate a change of beneficiary
at any time, which change shall be effective only upon receipt by the Award Committee of said notice. The last such designation
form filed with the Award Committee prior to the Participant’s death shall control. The Award Committee may establish a form
or other requirements for such designation. If the Participant designates his spouse as a beneficiary, the divorce of Participant
shall automatically revoke that designation of his spouse as beneficiary except to the extent otherwise provided in a subsequent
beneficiary designation filed by the Participant with the Award Committee. In the absence of a written designation, or in the event
the Participant dies without a beneficiary surviving him, any amount which would otherwise be payable on account of his death shall
be paid to the surviving spouse of the Participant or if none, to the Participant’s estate. A beneficiary of a Participant
shall have no interest or rights hereunder during the lifetime of the Participant.

 

Article 7.                
Administrative Provisions

 

(a)                                 
The Plan was approved by the Board on March [•], 2017 to be effective as of January 1, 2017 for all services provided
by Participants in 2017.

 

(b)                                
Unless the Board provides otherwise, the Plan shall be administered and interpreted by the Award Committee, which has been
provided absolute authority hereunder to administer the Plan. The Board and its members, the members of the Award Committee and
any other individual who may, from time to time, have been delegated responsibility with respect to the administration of this
Plan (collectively, “Authorized Persons”), shall have the full authority, discretion and power necessary or desirable
to administer and interpret this Plan, in accordance with the Plan terms. Benefits under the Plan shall be payable only if the
Authorized Persons in their respective sole and absolute discretion determine that any such benefits are properly payable under
the Plan. Without in any way limiting the foregoing, all Authorized Persons shall have complete authority, sole discretion and
power to: (i) determine the Participants; (ii) determine the Performance Goals applicable to each Participant, as well as the relative
weighting of each such Performance Goals to determine eligibility for payment of an Award hereunder; (iii) evaluate and determine
the performance of Participants; (iv) determine the amount of the Award for each Participant; (v) interpret the provisions of this
Plan and any other documentation used in connection with this Plan, including documentation specifying individual Participant Performance
Goals, Award opportunities and the like; (vi) establish and interpret rules, regulations and procedures (written or by practice)
for the administration of the Plan; and (vii) make all other determinations and take all other actions necessary or desirable for
the administration or interpretation of this Plan. The express grant in the Plan of any specific power to Authorized Persons shall
not be construed as limiting any power or authority of such Authorized Person. All actions, decisions and interpretations of the
Authorized Persons shall be final, conclusive and binding on all parties. All expenses of administering the Plan shall be borne
by the Company.

 

    	11

     

    

(c)                                 
Nothing in this Plan shall be deemed by implication, action or otherwise to constitute a contract of employment or otherwise
to impose any limitation on any right of the Company to terminate a Participant’s employment at any time for any or no reason.

 

(d)      
A Participant shall have no right to anticipate, alienate, sell, transfer, assign, pledge or encumber any right to receive any
Award made under the Plan, nor will any Participant have any lien on any assets of the Company by reason of any Award made under
the Plan.

 

(e)                                 
The Company shall have the right to deduct or withhold, or require a Participant to remit to the Company, any taxes required
by law to be withheld from Awards made under this Plan.

 

(f)                                 
The Plan may be amended, suspended or terminated at any time and from time to time, by action of the Board or the Award
Committee, but in any event, the Plan will be terminated no later than upon the last date the Company pays all Participants any
and all amounts that may due under the Plan and no amounts remain due and payable under the Plan to any person as determined by
Award Committee. The preceding sentence to the contrary notwithstanding, on and after a Change in Control, no amendment, suspension
or termination of the Plan that adversely affects the rights of a Participant (or the beneficiary of a deceased Participant who
has not received payment of an amount approved by the Award Committee under Article 6), shall be effective without the written
consent of that Participant or beneficiary.

 

(g)                                
The adoption of the Plan does not imply any commitment to continue to maintain the Plan, or any modified version of the
Plan, or any other plan for incentive compensation for such Participant for any period of time. Neither the adoption of this Plan,
its operation, nor any documents describing or referring to this Plan (or any part thereof) shall confer upon any employee any
right to continue in the employ of the Company or in any way affect any right and power of the Company to terminate the employment
of any employee at any time without assigning a reason therefor.

 

    	12

     

    

(h)                                
This Plan, insofar as it provides for Awards, shall be unfunded, and the Company shall not be required to segregate any
assets that may at any time be represented by Awards under the Plan. Any liability of the Company to any person with respect to
any Awards under this Plan shall be based solely upon any contractual obligations which may be created pursuant to this Plan. No
such obligation of the Company shall be deemed to be secured by any pledge of, or other encumbrance on, any property of the Company.

 

(i)                                  
In order to be effective, any amendment of this Plan or any Award must be in writing and made by the Award Committee. No
oral statement, representation, written presentation or the like shall have the effect of amending or modifying this Plan or any
Award, or otherwise have any binding effect on the Company, the Board, the Chief Executive, the Award Committee or any individual
who has been delegated authority to administer this Plan.

 

(j)                                  
The Plan shall be construed in accordance with and governed by the substantive laws of the State of Delaware, without regard
to principles of conflicts of law.

 

(k)                                
In case any provision of the Plan shall be held illegal or void, such illegality or invalidity shall not affect the remaining
provisions of this Plan, but shall be fully severable, and the Plan shall be construed and enforced as if said illegal or invalid
provisions had never been inserted herein.

 

(l)                                  
Except for their own gross negligence or gross misconduct regarding the performance of the duties specifically assigned
to them under, or their willful breach of the terms of this Plan, the Company (and its affiliates), Board and its members, the
Award Committee and its members, and any other entity or individual administering any aspect of this Plan shall be held harmless
by the Participants and their respective representatives, heirs, successors, and assigns, against liability or losses occurring
by reason of any act or omission under the Plan.

 

(m)                              
Should the Company effect one or more stock dividends, stock splits, subdivisions or consolidations of Shares or other similar
changes in capitalization, then the terms of outstanding Awards shall be adjusted as the Award Committee shall determine to be
equitably required. Any determination made under this Article 7(m) by the Award Committee shall be final and conclusive. The issuance
by the Company of shares of stock of any class, or securities convertible into shares of stock of any class, for cash or property,
or for labor or services, either upon direct sale or upon the exercise of rights or warrants to subscribe therefor, or upon conversion
of shares or obligations of the Company convertible into such shares or other securities, shall not affect, and no adjustment by
reason thereof shall be made with respect to, Awards.

 

 

 

    	13

     

    

Executed on the 3rd day of April, 2017 to be effective as of the 1st
day of January, 2017.

 

	 	 	MercadoLibre, Inc.
	 	 	 
	 	 	 
	 	 	By: 	 
	 	 	 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14Exhibit 10.1

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

 

 

LICENSE AGREEMENT

 

between

 

BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.

 

and

 

BRISTOL-MYERS SQUIBB COMPANY

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

EXECUTION COPY

 

LICENSE AGREEMENT

 

THIS LICENSE AGREEMENT (this “Agreement”) is made and entered into as of the date last signed by a party below (the “Effective Date”), by and between Bristol-Myers Squibb Company, a Delaware corporation, headquartered at 345 Park Avenue, New York, New York 10154 (“BMS”), and Biohaven Pharmaceutical Holding Company Ltd., a British Virgin Islands business company, with its registered office address of P.O. Box 173, Kingston Chambers, Road Town, Tortola, British Virgin Islands (“Company”). BMS and Company are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS, BMS and its Affiliates Control (as defined below) certain intellectual property rights with respect to the Licensed Compounds (as defined below); and

 

WHEREAS, Company desires to obtain from BMS the licenses set forth herein, and BMS desires to grant such licenses to Company, all on the terms and conditions set forth in this Agreement;

 

NOW, THEREFORE in consideration of the foregoing and the mutual agreements set forth below, the Parties agree as follows:

 

ARTICLE 1

 

DEFINITIONS

 

The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below or, if not listed below, the meaning designated in places throughout this Agreement.

 

1.1                               “Act” means the United States Food, Drug and Cosmetic Act, as amended.

 

1.2                               “Affiliate” of a Person means any other Person which (directly or indirectly) is controlled by, controls or is under common control with such Person. For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person, shall mean the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise, and “control” shall be presumed to exist if either of the following conditions is met: (i) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors or (ii) in the case of a non-corporate entity, direct or indirect ownership of at least fifty percent (50%) of the equity interests with the power to direct the management and policies of such entity.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

1.3                               “Approval” means, with respect to any Licensed Product in any regulatory jurisdiction, approval from the applicable Regulatory Authority sufficient for the manufacture, distribution, use, marketing, and sale of the Licensed Product in such jurisdiction in accordance with applicable Laws; provided, however that for purposes of the U.S., Approval means NDA Approval, for purposes of the EU, Approval means MAA Approval and for purposes of Japan, Approval means PMDA Approval.

 

1.4                               “BMS Know-How” means Know-How that, as of the Effective Date, is Controlled by BMS and directly relates to and is reasonably necessary and/or useful for, Company’s Development and Commercialization of the Licensed Compounds and/or Licensed Products in the Field.

 

1.5                               “BMS Patent Rights” means (a) the Patent Rights listed in Appendix 1a and Appendix 1b, (b) all divisionals, continuations, continuations-in-part thereof (excluding claims in continuations-in-part that necessarily rely on new matter invented by BMS after the Effective Date) or any other patent application claiming priority directly or indirectly to (i) any of the patents or patent applications in subsection (a), or (ii) any patent or patent application from which the patents or patent applications in (a) claim direct or indirect priority, (c) all patents issuing on any of the foregoing in (a) and (b), (d) all foreign counterparts of any of the foregoing in (a) through (c), including any patent applications filed under the Patent Cooperation Treaty (“PCT Applications”), and (e) all registrations, reissues, re-examinations, supplemental protection certificates, or extensions of any of the foregoing in (a) through (d). BMS Patent Rights shall also include any claims in any patents or patent applications existing as of the Effective Date that are Controlled by BMS and cover the composition of matter of any intermediate or starting material reasonably necessary in or reasonably useful for the manufacture of any Licensed Compound as manufactured by BMS as of the Effective Date.

 

1.6                               “Business Day” or “business day” means a day other than Saturday, Sunday or any day on which commercial banks located in New York, New York are authorized or obligated by Law to close.

 

1.7                               “Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 and December 31.

 

1.8                               “Calendar Year” means each one-year period commencing on January 1 and ending on December 31.

 

1.9                               “cGMP” means as to the United States and the European Union, applicable good manufacturing practices as in effect in the United States and the European Union, respectively, during the term of this Agreement and, with respect to any other jurisdiction, manufacturing practices equivalent to good manufacturing practices as then in effect in the United States or the European Union.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

2

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

1.10                        “CGRP” means any and all isoforms of the signaling peptide Calcitonin Gene-Related Peptide.

 

1.11                        “CGRP Receptor” means the heteromeric transmembrane receptor comprised of (a) a 7 transmembrane calcitonin receptor-like receptor (“CRLR”), (b) a single transmembrane receptor activity modifying protein type 1 (“RAMP1”), and (c) an intracellular receptor component protein (“RCP”), in which CRLR and RAMP1 components are required for ligand binding to the CGRP Receptor, and RCP is required for subsequent signal transduction, including any and all isoforms of (a) through (c), and any combination of any of the foregoing.

 

1.12                        “Clinical Trial” means any human clinical study of a pharmaceutical product.

 

1.13                        “Combination Product” means a Licensed Product that includes at least one additional active ingredient other than the Licensed Compound. Drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant, or excipient is recognized by the FDA as an active ingredient in accordance with 21 CFR 210.3(b)(7).

 

1.14                        “Commercialization” or “Commercialize” means activities directed to commercially manufacturing, obtaining pricing and reimbursement approvals and regulatory activities pertaining to same, marketing, promoting, distributing, importing or selling a Licensed Product.

 

1.15                        “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party or its Affiliate with respect to any objective, activity or decision to be undertaken under this Agreement, those efforts that a company within the bio-pharmaceutical industry would reasonably use to accomplish such objective, activity or decision, and specifically means the carrying out of Development and Commercialization activities using efforts that a company within the bio-pharmaceutical industry would reasonably devote to a product at a similar stage in its development or product life and of similar market potential, profit potential, based on conditions then prevailing and taking into account efficacy, safety, approved labeling, the competitiveness of alternative products sold by Third Parties in the marketplace, the patent and other proprietary position of the product, and the likelihood of regulatory approval given the regulatory structure involved. Commercially Reasonable Efforts shall be determined on a country-by-country and indication-by-indication basis for the Licensed Product, and it is anticipated that the level of effort will change over time, reflecting changes in the status of the Licensed Product and the market(s) or country(ies) involved. Without limiting the foregoing, Commercially Reasonable Efforts require that Company: (i) promptly assign responsibility for such Development and Commercialization activities to specific employees who are held accountable for progress and monitor such progress on an on-going basis, (ii) set and consistently seek to achieve specific and meaningful objectives and timelines for carrying out such Development and Commercialization activities, and (iii) consistently make and implement decisions and allocate resources designed to advance progress with respect to such objectives and timelines.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

3

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

1.16                        “Company Change of Control” means any transaction in which the Company: (a) sells, conveys or otherwise disposes of all or substantially all of its property or business; or (b)(i) merges, consolidates with, or is acquired by any other corporation, firm, partnership or other legal entity (each a “Person”) (other than an Affiliate of such Party solely in the case that such Person was an Affiliate of such Party prior to the Effective Date); or (ii) effects any other transaction or series of related transactions; in each case of subsection (i) or (ii), such that the shareholders of the Company immediately prior thereto, in the aggregate, no longer own, directly or indirectly, beneficially or legally, at least fifty percent (50%) of the outstanding voting securities or capital stock of the surviving Person following the closing of such merger, consolidation, other transaction or series of related transactions. Notwithstanding the foregoing, a Company Change of Control cannot occur until after the Financing (as defined in Section 13.2.5 below) has occurred.

 

1.17                        “Competitive Compound” means any molecule that is not a Licensed Compound and that is designed to, and in fact specifically [* * *].

 

1.18                        “Confidential Information” means all trade secrets, processes, formulae, data, Know-How, improvements, inventions, chemical or biological materials, techniques, marketing plans, strategies, customer lists, or other information (including all information and materials of a Party’s customers and any other Third Party and their consultants) that has been disclosed by a Party to the other Party, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other by the disclosing Party in oral, written, graphic, or electronic form. “Confidential Information” of BMS shall include the BMS Know-How.

 

1.19                        “Controlled” or “Controls”, when used in reference to intellectual property, shall mean the legal authority or right of a Party (or any of its Affiliates) to grant a license or sublicense of intellectual property rights to the other Party or any Third Party, or to otherwise disclose proprietary or trade secret information to such other Party or to any Third Party, without breaching the terms of any agreement with any Third Party.

 

1.20                        “Development” means non-clinical and clinical drug development activities reasonably related to the development and submission of information to a Regulatory Authority, including toxicology, pharmacology and other discovery and pre-clinical efforts, test method development and stability testing, process development, formulation development, development manufacturing, delivery system development, quality assurance and quality control development, clinical studies (including pre- and post-Approval studies but specifically excluding regulatory activities directed to obtaining pricing and reimbursement approvals), statistical analysis, and post-marketing commitments/requirements. When used as a verb, “Develop” means to engage in Development.

 

1.21                        “Development Plan” means, with respect to a Licensed Product, a plan prepared by Company for the then current calendar year and the two (2) following years setting forth a summary of the key Development activities to be conducted for such Licensed Product in the Territory, including the indications expected to be targeted, a good faith estimate of reasonable

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

4

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

timelines for completing key Development activities and filing of key regulatory submissions (including estimated timelines for commencement of each stage of clinical Development), and including, where known, the primary endpoints and any comparator or any agents used in combination with a Licensed Compound or Licensed Product for any such studies and any go-no-go decision criteria for any such studies. The initial Development Plan as of the Effective Date is attached hereto as Appendix 2. A copy of the study protocol for a given study will be provided to BMS if available and if requested by BMS.

 

1.22                        “Distributor” means, with respect to a country, any Third Party that is used by pharmaceutical manufacturers generally in such country on a non-exclusive basis, and without any intellectual property right or license grant from the Company or its Sublicensees, to distribute (but not to market or promote) finished, packaged pharmaceutical products to pharmacies, managed care organizations, governmental agencies (e.g., federal, state and local), and other group purchasing organizations (e.g., pharmaceutical benefits managers) and the like in such country. For clarity, a Distributor of a Licensed Product in a country shall not include any person or entity that has been granted a right, whether by license or otherwise and whether express or implied (including by subcontract or agency), by a Party or its Affiliates to research, Develop or manufacture any such Licensed Product or that otherwise assumes any regulatory or other responsibilities with respect to obtaining or maintaining regulatory approvals for such Licensed Product in such country.

 

1.23                        “Dollar” or “$” means the lawful currency of the United States.

 

1.24                        “EMA” means the European Medicines Agency, or any successor agency thereto.

 

1.25                        “Equity Interest” (i) any capital stock or share of a corporation, company, partnership interest, limited liability company interest or other equity interest; (ii) any security or right convertible into, exchangeable for, or evidencing the right to subscribe for any such stock, share, equity interest or security referred in (i); (iii) any stock appreciation rights, contingent value right or similar security or right that is derivative of any such stock, equity interest or security referred to in clause (i) and (ii); and (iv) any contract to grant issue, award, convey or sell any of the foregoing.

 

1.26                        “EU” means the European Union, as its membership may be altered from time to time, and any successor thereto.

 

1.27                        “FDA” means the U.S. Food and Drug Administration, or any successor agency thereto.

 

1.28                        “Field” means the prevention, treatment or control of any disease, disorder or condition in humans.

 

1.29                        “First Commercial Sale” means, with respect to any Licensed Product in a country in the Territory, the first sale for use or consumption by the general public of such

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

5

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Licensed Product in such country after Approval of such Licensed Product has been granted, or such marketing and sale is otherwise permitted, by the Regulatory Authority of such country.

 

1.30                        “GAAP” means the U.S. generally accepted accounting principles, consistently applied.

 

1.31                        “Governmental Authority” means any multi-national, national, federal, state, local, municipal, provincial, county, or other political subdivision, agency or other body, domestic or foreign or other government authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court, tribunal or other entity).

 

1.32                        “Indebtedness” shall mean all liabilities for borrowed money, whether current or funded, secured or unsecured, all obligations evidenced by bonds, debentures, notes or similar instruments, and all liabilities in respect of mandatorily redeemable or purchasable capital stock or shares, or securities convertible into capital stock or shares.

 

1.33                        “IND” means an Investigational New Drug Application, as defined in the Act, filed with the FDA or its foreign counterparts, including as applicable clinical trial applications (CTAs), clinical trial exemptions (CTXs), and investigational medicinal product dossiers.

 

1.34                        “Initiation” means, when used with respect to a Clinical Trial, the dosing of the first patient with the first dose in such Clinical Trial.

 

1.35                        “Know-How” means tangible and intangible information, techniques, technology, practices, inventions (whether patentable or not), methods, knowledge, know-how, trade secrets, data and results (including all biological, chemical, pharmacological, toxicological, clinical, analytical and quality control data and methods (including any applicable reference standards), manufacturing assay and related data, data and results relating to drug substance, drug product, starting materials, and radiolabeled compounds, know-how and trade secrets).

 

1.36                        “Knowledge” means, with respect to a Party or its Affiliates, the actual knowledge of its in-house counsel based on such individuals’ good faith understanding of the facts and information in their possession or control without any duty to conduct any additional investigations with respect to such facts and information.

 

1.37                        “Laws” means all applicable laws, statutes, rules, regulations and other pronouncements having the effect of law of any Governmental Authority that may be in effect from time to time, including for clarity any applicable rules, regulations and other requirements of any Regulatory Authority that may be in effect from time to time.

 

1.38                        “Licensed Compound” means (a) the compounds identified as BMS-927711 (also known as rimegepant) or [* * *], as specifically described in Appendix 3 (each, a “Lead Compound”) and any [* * *] or [* * *] thereof, and any [* * *] or [* * *] of any of the foregoing (collectively

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

6

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

“Derivative Compounds”) and (b) any compound that is within the scope of the BMS Patent Rights.

 

1.39                        “Licensed Product” means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients controlled by the Company), in all forms, presentations, formulations and dosage forms. For clarity, “other active ingredients” does not include any other active ingredients or molecules that are proprietary to, or controlled by, BMS and its Affiliates.

 

1.40                        “MAA” means a marketing authorization application filed for Approval in the EU of the applicable Licensed Product.

 

1.41                        “MAA Approval” means Approval by the EMA of a MAA filed with the EMA for the applicable Licensed Product under the centralized European procedure. If the centralized EMA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any of the following countries: [* * *]; provided, that MAA Approval shall in any event be deemed achieved upon First Commercial Sale in any country in the European Union.

 

1.42                        “MAA Filing” means the validation by the EMA of the filing of an MAA for the applicable Licensed Product. If the centralized EMA filing procedure is not used, MAA Filing shall be achieved upon the first acceptance of an MAA for the applicable Licensed Product for any of the following countries: [* * *].

 

1.43                        “Major Market Countries” means the following countries:  [* * *]. “Major Market Country” means any one of these countries.

 

1.44                        “NDA” means a new drug application filed with the FDA required for marketing approval for the applicable Licensed Product in the U.S., or, if the Licensed Compound is a biologic, a biologics license application (BLA) filed with the FDA required for marketing approval for the applicable Licensed Product in the U.S.

 

1.45                        “NDA Approval” means the final approval of an NDA for a given indication by the FDA for the applicable Licensed Product in the U.S.; provided, that, for milestone payment purposes, NDA Approval shall in any event be deemed achieved upon First Commercial Sale in the U.S. for such indication.

 

1.46                        “NDA Filing” means the acceptance by the FDA of the filing of an NDA for the applicable Licensed Product.

 

1.47                        “Net Sales” means, with respect to any Licensed Product, billed in arm’s-length transactions by a Party, an Affiliate of such Party, or any permitted Sublicensee (or such Sublicensee’s Affiliates) (all of the foregoing persons and entities, for purposes of this definition and Sections 8.4, 8.6, and 8.7), shall be considered a “Related Party”) for sales of such Licensed

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

7

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Product to a Third Party, less the sum of the following (to the extent not reimbursed by any Third Party):

 

(a)                                 discounts (including [* * *] discounts and [* * *] discounts), [* * *];

 

(b)                                 credits or allowances [* * *];

 

(c)                                  taxes or duties levied on, absorbed or otherwise imposed [* * *];

 

(d)                                 any [* * *] bad debt expense recorded in accordance with GAAP from customers related to sales of a Licensed Product, such bad debt not to exceed [* * *].

 

No deduction shall be made for any item of cost incurred by any Related Party in Developing or Commercializing Licensed Products except as permitted pursuant to clauses (a) to (e) of the foregoing sentence; provided that, [* * *].

 

Such amounts shall be determined consistent with a Related Party’s customary practices and in accordance with GAAP.

 

It is understood that any accruals for individual items reflected in Net Sales are periodically (at least quarterly) trued up and adjusted by each Related Party consistent with its customary practices and in accordance with GAAP.

 

Sale or transfer of Licensed Products between any of the Related Parties shall not result in any Net Sales, with Net Sales to be based only on any subsequent sales or dispositions to a non-Related Party. To the extent that any Related Party receives consideration other than or in addition to cash upon the sale or disposition of a Licensed Product to a non-Related Party, Net Sales shall be calculated based on [* * *]. For clarity, (i) Net Sales shall not include amounts or other consideration received by a Related Party from a non-Related Party in consideration of the grant of a (sub)license or co-promotion or distribution right to such non-Related Party, provided that such consideration is not in lieu of all or a portion of the transfer price of the Licensed Product, (ii) sales to a Third Party Distributor, wholesaler, group purchasing organization, pharmacy benefit manager, or retail chain customer shall be considered sales to a non-Related Party and not to a Sublicensee, (iii) Net Sales by a Related Party to a non-Related Party consignee are not recognized as Net Sales by such Related Party until the non-Related Party consignee sells the Licensed Product and (iv) if a Related Party receives in-kind consideration for the sale of the Licensed Product, then Net Sales shall be calculated as [* * *].

 

In the case of any Combination Product sold in the Territory, Net Sales for such Combination Product shall be calculated [* * *]. If, on a country-by-country basis, the other active ingredient or ingredients in the Combination Product are not sold separately in said country, Net Sales for the purpose of determining royalties of the Combination Product shall be calculated [* * *]. If neither the Licensed Product nor the other active ingredient(s) are sold separately in a given country, the Parties shall determine Net Sales in accordance with the formulas provided above in

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

8

 

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this paragraph based on [* * *], or, [* * *], the Parties shall negotiate in good faith a reasonable adjustment to Net Sales in such country that takes into account the medical contribution to the Combination Product of and all other factors reasonably relevant to the relative value of, the Compound(s), on the one hand and all of the other active ingredient(s) collectively, on the other hand, and shall take into account in good faith, if reasonably applicable, any allocations and calculations that may have been made for the same period in other countries [* * *]. Notwithstanding the foregoing, for purposes of [* * *], the portion of Net Sales of the Combination Product [* * *] shall [* * *] in the Combination Product.

 

Should Company, its Affiliates or Sublicensees enter into a Third Party agreement for the purchase of a Licensed Product that provides [* * *] on such Licensed Product that are conditioned on pricing terms or conditions for purchase of another product or products owned or Controlled by Company, its Affiliates or Sublicensees, as the case may be, then the [* * *] on such Licensed Product under such agreement shall be determined, for purposes of determining Net Sales under this Agreement for a given accounting period, based on [* * *] under such agreement.

 

1.48                        “Patent Rights” means (a) patents and patent applications, (b) all divisionals, continuations, continuations-in-part thereof or any other patent application claiming priority directly or indirectly to (i) any of the patents or patent applications in subsection (a), or (ii) any patent or patent application from which the patents or patent applications in (a) claim direct or indirect priority, (c) all patents issuing on any of the foregoing in (a)-(b), (d) all foreign counterparts of any of the foregoing in (a)-(c), including PCT Applications, and (e) all registrations, reissues, re-examinations, supplemental protection certificates, or extensions of any of the foregoing in (a)-(d).

 

1.49                        “Person” means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture, governmental authority, association or other entity.

 

1.50                        “Phase I Trial” means a Clinical Trial of a Licensed Product on a sufficient number of subjects that is designed to provide a preliminary determination of safety, pharmacokinetics, and pharmacodynamic parameters in healthy individuals or patients, as described in 21 C.F.R. 312.21(a), or a similar clinical study prescribed by a Regulatory Authority outside the U.S.

 

1.51                        “Phase II Trial” means a Clinical Trial of a Licensed Product on a sufficient number of subjects that is designed to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, as described in 21 C.F.R. 312.21(b), or a similar clinical study prescribed by a Regulatory Authority outside the U.S.

 

1.52                        “Phase III Trial” means a Clinical Trial of a Licensed Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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that are associated with such pharmaceutical product in the dosage range and dose duration to be prescribed, which trial is intended to support Approval of a Licensed Product, as described in 21 C.F.R. 312.21(c), or a similar clinical study prescribed by a Regulatory Authority outside the U.S.

 

1.53                        “PMDA” means the Japanese Pharmaceutical and Medical Device Agency or its successor, or the Japanese Ministry of Health, Labour and Welfare.

 

1.54                        “PMDA Approval” means Approval by the PMDA of a MAA filed with the PMDA for the applicable Licensed Product in Japan.

 

1.55                        “PMDA Filing” means the acceptance by the PMDA of the filing of an MAA for the applicable Licensed Product in Japan.

 

1.56                        “Regulatory Authority” means any Governmental Authority, including the FDA, PMDA or EMA, that has responsibility in countries in the Territory over the Development and/or Commercialization of the Licensed Compounds and/or Licensed Products.

 

1.57                        “Sublicense Revenues” means all consideration Company receives from a Sublicensee pursuant to any Sublicense, including any upfront payment, milestone payments and royalty payments (excluding that portion of any milestone or royalty payment made by a Sublicensee that is intended to reimburse Company for its milestone and royalty obligations to BMS under Article 8 hereof), collaboration fee, and premiums on equity investments in Company (with the premium to be reasonably allocated to the value of this Agreement as compared the Company’s other assets); provided, that if such equity investment is coupled with a change of control of the Company (as defined under the Securities Exchange Act of 1934, as amended, or equivalent legislation outside of the U.S., if applicable), then any such equity premium will be included only to the extent that such premium is more than [* * *] above the volume weighted average price of the common stock of Company for the [* * *] trading days on the Nasdaq Stock Market ending on the date that is [* * *] trading days on the Nasdaq Stock Market prior to the first public announcement of the proposed equity investment, but excluding, for clarity, any amounts received by Company: (a) as bona fide, fair market value, actual reimbursement for research, Development or Commercialization activities performed or paid for by Company after the grant of a Sublicense, and only to the extent they are documented and are reasonably detailed in a written report provided to BMS; (b) for reimbursement of Company’s fully-burdened cost to manufacture and supply Licensed Products or Licensed Compounds; or (c) in the form of bona fide loans made by Sublicensee to Company. For clarity Sublicense Revenues include the difference between (x) the Sublicense Revenue payment or royalty received by Company from a Sublicensee on Net Sales or for a given milestone event and (y) the payment Company pays to BMS for a particular payment under the Agreement for the same Net Sales or event (e.g., (i) the difference between the milestone payment Company receives from a Sublicensee and the milestone payment Company pays to BMS for the same milestone event or (ii) the difference between the royalty rates for a given tier).

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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1.58                        “Sublicense” means a grant of rights by Company to a Sublicensee under any of the rights licensed to Company by BMS under Section 2.1 with respect to the Development, manufacture, or Commercialization of any Licensed Product or Licensed Compound, and includes any reverse co-promotion agreements. For clarity, a Distributor is not considered a Sublicensee.

 

1.59                        “Sublicense Agreement” means a written, definitive agreement for a Sublicense.

 

1.60                        “Sublicensee” means any Third Party to whom rights are granted under any of the rights licensed to Company by BMS under Section 2.1 with respect to any Licensed Product or Licensed Compound, including through any license, sublicense, co-development, co-discovery, co-promotion, distribution, joint venture, Development and Commercialization collaboration or similar transaction between Company (or an Affiliate of Company) and a Third Party.

 

1.61                        “Territory” means worldwide.

 

1.62                        “Third Party” means any Person other than Company, BMS, and their Sublicensees, and any Affiliates of Company, BMS and their Sublicensees.

 

1.63                        “United States” or “U.S.” means the United States of America including Puerto Rico and any U.S. territories and possessions.

 

1.64                        “Valid Claim” means a claim of (i) an issued and unexpired patent or a supplementary protection certificate, which claim has not been held invalid or unenforceable by a court or other government agency of competent jurisdiction from which no appeal can be or has been taken and has not been held or admitted to be invalid or unenforceable through re-examination or disclaimer, opposition procedure, nullity suit or otherwise, or (ii) a pending patent application that has not been finally abandoned, finally rejected or expired; provided, however, that if a claim of a pending patent application shall not have issued within [* * *] years after the earliest filing date from which such claim takes priority, such claim shall not constitute a Valid Claim for the purposes of this Agreement unless and until a patent issues with such claim.

 

Additional Definitions. In addition to those terms defined above, definitions for each of the following terms are found in the body of this Agreement as indicated below:

 

	
Defined Term
    	
 
    	
Section
    	
 
    
	
BMS
    	
 
    	
Preamble
    	
 
    
	
BMS   Reversion Products
    	
 
    	
13.4.1
    	
 
    
	
Business   Combination
    	
 
    	
13.2.4
    	
 
    
	
BVI   Subsidiary
    	
 
    	
2.2
    	
 
    
	
Company
    	
 
    	
Preamble
    	
 
    

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Effective   Date
    	
 
    	
Preamble
    	
 
    
	
Financing   and Financing Period
    	
 
    	
13.2.5
    	
 
    
	
Force   Majeure
    	
 
    	
15.3
    	
 
    
	
Indemnification   Claim
    	
 
    	
12.3
    	
 
    
	
Indemnitee
    	
 
    	
12.3
    	
 
    
	
Indemnitor
    	
 
    	
12.3
    	
 
    
	
Indication
    	
 
    	
8.2.1(iv)
    	
 
    
	
Inventory   Disposal Period
    	
 
    	
13.4.6
    	
 
    
	
Joint   Invention
    	
 
    	
10.1
    	
 
    
	
Joint   Patent Rights
    	
 
    	
10.1
    	
 
    
	
Know-How   Transfer Period
    	
 
    	
3.1
    	
 
    
	
Liability   Cap
    	
 
    	
9.5
    	
 
    
	
Losses   and Claims
    	
 
    	
12.1
    	
 
    
	
Party   or Parties
    	
 
    	
Preamble
    	
 
    
	
PCT   Application
    	
 
    	
1.5
    	
 
    
	
Pharmacovigilance   Agreement
    	
 
    	
3.5
    	
 
    
	
Related   Party
    	
 
    	
1.44
    	
 
    
	
Royalty   Term
    	
 
    	
8.4.2
    	
 
    
	
Surviving   Sublicensee
    	
 
    	
2.2.1(g)
    	
 
    
	
TA   Period
    	
 
    	
3.2
    	
 
    
	
Third   Party Compensation
    	
 
    	
8.4.4
    	
 
    
	
Title   11
    	
 
    	
13.10
    	
 
    
	
Transferred   Materials
    	
 
    	
4.1
    	
 
    
	
Triggering   Event
    	
 
    	
5.6.2
    	
 
    

 

ARTICLE 2

 

LICENSE GRANT

 

2.1                               BMS Patent Rights and BMS Know-How. Subject to all the terms and conditions set forth in this Agreement, BMS hereby grants to Company a non-transferable (except in accordance with Section 15.5), exclusive license, with the right to grant Sublicenses in accordance with Section 2.2, under the BMS Patent Rights and BMS Know-How solely to the

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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extent necessary to research, discover, Develop, make, have made, use, sell, offer to sell, export and import Licensed Compounds and/or Licensed Products in the Field in the Territory.

 

For clarification, nothing in this Section 2.1 or this Agreement shall be interpreted as a grant of rights to make, have made, sell, use, co-formulate or use in combination a Licensed Compound with any compound of BMS or any of its Affiliates (i) that is not a Licensed Compound or (ii) that is, or the manufacture or use of which is, covered by a Patent Right owned or Controlled by, or licensed to, BMS or any of its Affiliates, or (iii) that is or could be subject to a governmental grant providing marketing exclusivity with respect to such compound or such product (such as data exclusivity under the FDA’s Orange Book or under national implementations of Article 10.1 of Directive 2001/EC/83), including but not limited to, in each case (i), (ii) and (iii), any such compound or such product that is being developed or sold (as of the Effective Date or in the future) by BMS or its Affiliates or by contractors or collaborators with or on behalf of BMS or its Affiliates.

 

2.2                               Sublicenses. Company shall have the right to grant Sublicenses with respect to the rights licensed to Company under Section 2.1: (x) to an Affiliate, including to its wholly owned subsidiary, Biohaven Pharmaceutical Product No.2000 Ltd., a British Virgin Island corporation (“BVI Subsidiary”), without the prior written consent of BMS, (y) to a third party manufacturer to make Licensed Compounds or Licensed Product for the benefit of Company without the prior written consent of BMS provided that such Sublicense relates only to the manufacturing of Licensed Compounds or Licensed Products and (z) to a Third Party (other than to any Third Party referred to in (y) above) subject to BMS’ prior written consent (not to be unreasonably withheld or delayed), provided that, in each case (x), (y) and (z), such Sublicenses are granted solely in accordance with this Section 2.2:

 

2.2.1                     Company and BVI Subsidiary shall have the right to enter into a Sublicense Agreement with a Third Party, provided that:

 

(a)                                 such Sublicense Agreement shall refer to this Agreement and shall be subordinate to and consistent with the terms and conditions of this Agreement, and, shall not limit Company’s ability to fully perform all of its obligations under this Agreement or BMS’ rights under this Agreement;

 

(b)                                 in such Sublicense Agreement, the Sublicensee shall agree in writing to be bound to Company or BVI Subsidiary, as applicable, by terms and conditions that allow Company to fully perform the corresponding terms and conditions of this Agreement;

 

(c)                                  promptly after the execution of such Sublicense Agreement, Company or BVI Subsidiary, as applicable, shall provide a full copy of such Sublicense Agreement to BMS;

 

(d)                                 Company shall remain primarily responsible for all payments due and the making of reports under this Agreement by its Sublicensees and for compliance by its

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Sublicensees with all applicable terms of this Agreement (including, without limitation, its payment obligations under Sections 11.1 and Articles 8 and 10 hereof), and Company and BVI Subsidiary shall use Commercially Reasonable Efforts to monitor their Sublicensees’ compliance with the terms of such License. Company shall remain jointly and severally liable with each of its Sublicensees (whether or not such Sublicensee is an Affiliate of Company) for any failure by such Sublicensee to comply with the terms and conditions of this Agreement;

 

(e)                                  the Sublicensee shall assume and agree in writing to be bound by and comply with the terms and conditions of this Agreement in the same manner as Company, including, without limiting the generality of the foregoing, the Sublicensee shall agree in writing (i) to maintain insurance coverage at no less than the levels set forth in Section 12.4, (ii) to keep books and records substantially in accordance with Section 8.7, including permitting audit and inspection rights in accordance with Sections 8.7.3 and 8.7.4, and (iii) the right of termination provided in Section 13.2.5;

 

(f)                                   such Sublicensee shall not have the right to grant further Sublicenses with respect to the Development or Commercialization of Licensed Products, except in accordance with and subject to all of the terms and conditions of this Section 2.2 and all of the other terms and conditions of this Agreement;

 

(g)                                 any Sublicense rights granted by Company or BVI Subsidiary in a Sublicense Agreement (to the extent such Sublicense rights are granted to Company or BVI Subsidiary in this Agreement) shall terminate effective upon the termination under Article 13 of the license from BMS to Company with respect to such sublicensed rights, provided that such Sublicense rights shall not terminate if, as of the effective date of such termination under Article 13, the Sublicensee is not in material breach of its obligations to Company under its Sublicense Agreement, the Sublicensee was previously granted an exclusive Sublicense to Develop and Commercialize the Licensed Products or Licensed Compounds, and within [* * *] days of such termination the Sublicensee agrees in writing to be bound directly to BMS under a license agreement substantially similar to this Agreement with respect to the rights Sublicensed hereunder, substituting such Sublicensee (a “Surviving Sublicensee”) for Company or BVI Subsidiary, and provided further that (A) such license agreement shall not prejudice any remedy either Party may have against the other in connection with such termination of this Agreement (in whole or in part); (B) the scope of the rights granted to the Surviving Sublicensee under such license agreement (with respect to licensed activities, Licensed Products and territory) shall be less than or equal to the scope of the rights that had been sublicensed by Company or BVI Subsidiary to the Surviving Sublicensee pursuant to the Sublicense Agreement; (C) Company shall no longer be obligated under this Agreement to pay amounts set forth in this Agreement, to the extent such amounts are payable based on the activities of such Surviving Sublicensee, its Affiliates and its sublicensees from and after the effective date of such termination; (D) such license agreement shall obligate the Surviving Sublicensee to pay directly to BMS amounts corresponding to those set forth in Article 8 which are payable based on the activities of such Surviving Sublicensee, its Affiliates and its sublicensees from and after the effective date of such termination; (E) the Sublicensee cures any payment default of the Company to BMS as of the

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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effective date of termination; and (F) such license agreement shall not modify the rights and obligations of the Parties following any termination of this Agreement in whole or in part;

 

(h)                                 the provisions of this Section 2.2 shall also apply in the event of any subsequent amendment or modification of any such Sublicense Agreement; and

 

(i)                                    BMS shall be made an express third party beneficiary of the Sublicensee’s obligations under such Sublicense that relate to compliance with the terms and conditions of this Agreement with the direct right to enforce the same directly against the Sublicensee.

 

2.2.2                     For clarity, where provisions of this Agreement provide that Company shall be “solely” responsible or the like with respect to a matter (for example, Sections 5.4, 5.5, or 7.1), it is understood that such responsibilities may be carried out or borne on Company’s behalf by an Affiliate of Company or by a permitted Sublicensee or contractor of Company.

 

2.2.3                     It shall be a material breach of this Agreement for Company or BVI Subsidiary to enter into any Sublicense hereunder not in compliance with this Section 2.2.

 

2.3                               No Trademark License. No right or license, express or implied, is granted to Company to use any trademark, trade name, trade dress, domain name, logos, slogans, or service mark owned or Controlled by BMS or any of its Affiliates. Company, at its sole cost and expense, shall be responsible for the selection, registration and maintenance of all trademarks which it employs in connection with Licensed Products and its activities conducted pursuant to this Agreement, if any, and shall own and Control such trademarks.

 

2.4                               No Implied Licenses. No license or other right is or shall be created or granted hereunder by implication, estoppel or otherwise. All such licenses and rights are or shall be granted only as expressly provided in this Agreement.

 

2.5                               Retained Rights. All rights not expressly granted by a Party hereunder are reserved by such Party and may be used by such Party for any purpose. Without limiting the foregoing, BMS retains all rights to use and for its Affiliates to use the Licensed Compounds, the BMS Know-How and the BMS Patent Rights for any internal research purposes in the Field and to generate analogs and derivatives of the Licensed Compounds in connection therewith, and to research, develop, commercialize and promote other molecules for use with the Licensed Compounds and Licensed Products. BMS also expressly reserves and retains the right to make, have made and use any Licensed Compound for use as an intermediate or starting material in the manufacture of any compound that is not a Licensed Compound. Nothing in this Agreement shall prevent BMS and its Affiliates from using for any purpose any BMS Know-How that is in the public domain Effective Date (or enters the public domain thereafter) and is not covered by a Valid Claim of a BMS Patent Right licensed to Company hereunder.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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ARTICLE 3

 

TRANSFER OF KNOW-HOW, TECHNICAL ASSISTANCE

 

3.1                               Documentation.

 

3.1.1                     During the [* * *] day period following the Effective Date (the “Know-How Transfer Period”) BMS shall provide Company with electronic (or tangible embodiments, if electronic is not available) of the Know-How listed on Appendix 5, including copies of originals of laboratory notebooks or pages thereof and, where required by Company to fulfill its duties under applicable Law, copies of manufacturing run records required to be maintained by BMS under applicable Law; provided that, with respect to BMS Know-How contained in laboratory notebooks, BMS shall only be required to provide Company with copies of those laboratory notebook pages (electronic copies, if they exist) that can be readily located without search and that contain BMS Know-How relating to Lead Compounds. Such documentation is Confidential Information of BMS shall not be used by Company for any purpose other than for the discovery, research, Development or Commercialization (including any import, manufacture, use, offer for sale, or sale) of Licensed Compounds and/or Licensed Products in accordance with this Agreement. Company shall assume full responsibility and liability to BMS for any unauthorized use or disclosure of such Confidential Information. BMS shall be responsible for the cost of providing one (1) set of copies (electronic, where they exist) only. BMS shall have no obligation to reformat or otherwise alter or modify any materials, or to create materials in electronic form, in order to provide them to Company. Any and all materials and other BMS Know-How delivered to Company pursuant to this Section 3.1 are and shall remain the sole property of BMS.

 

Without limiting the foregoing, if, within [* * *] after the Know-How Transfer Period, if Company reasonably determines that there is additional, specific BMS Know-How Controlled by BMS and its Affiliates that existed as of the Effective Date that is reasonably necessary for the continued Development or manufacture (but only those manufacturing and formulation processes, techniques and trade secrets used by BMS for making such Licensed Compounds as of the Effective Date) of any Licensed Compound or Licensed Product that has not been provided during the Know-How Transfer Period, then Company may request within such [* * *] period that BMS transfer to Company such additional BMS Know-How and BMS will endeavor to locate and provide same, provided that BMS shall not be required to conduct an unreasonable search for any such additional BMS Know-How.

 

3.1.2                     Notwithstanding Section 3.1.1 or 3.2, nothing herein shall require BMS to transfer, disclose or provide to Company (i) any reagents, assays or other tangible biological or chemical materials that are not listed on Appendix 4, and (ii) any general information or know-how that should reasonably be known to a pharmaceutical company engaged in the research, development, manufacture or commercialization of small molecules targeting G-protein coupled receptors.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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3.1.3                     Any data or information included in the INDs to be transferred under Section 3.3 does not need to be separately transferred pursuant to Section 3.1.1 or Section 3.2.

 

3.2                               Technical Assistance. During the [* * *] day period following the Know-How Transfer Period (the “TA Period”), BMS shall reasonably cooperate with Company to assist Company with understanding and using the BMS Know-How provided to Company under Section 3.1. Such cooperation shall include, without limitation, providing Company with reasonable access by teleconference or in-person at BMS’ facilities (subject to BMS’ customary rules and restrictions with respect to site visits by non-BMS personnel) to BMS personnel who are appropriately qualified and experienced for such purpose, directly involved in the research and Development of Licensed Compounds and Licensed Products. In no event shall BMS be obligated to provide Company with more than (x) [* * *] of technical assistance and consultation in connection with the BMS Know-How transferred under Section 3.1 to the extent the Know-How does not relate to manufacturing Know-How, and (y) [* * *] technical assistance and consultation in connection with the BMS Know-How transferred under Section 3.1 to the extent it relates to manufacturing Know-How; provided that upon Company’s request, BMS shall provide additional technical assistance beyond the foregoing [* * *], at a mutually agreed commercially reasonable hourly rate, up to an additional [* * *]. Further: (i) such access shall be requested and coordinated through a single contact person to be designated by BMS, (ii) BMS makes no warranty, express or implied, that Company shall be able to successfully implement and use the BMS Know-How, (iii) BMS shall not be in default hereunder for any inadvertent failure to disclose all pertinent information related to the BMS Know-How, provided that such information shall be supplied to Company promptly upon discovery of such failure to disclose or upon request of Company identifying with reasonable specificity the nature of the information to be disclosed. Company shall be responsible for ensuring that its personnel who receive such assistance are appropriately qualified and experienced for such purpose, and (iv) such does not extend to support the integration of the BMS Know-How and related data and information into Company’s systems/repositories.

 

3.3                               INDs. BMS will use its commercially reasonable efforts to assign and transfer within [* * *] days after the Effective Date all of its rights, title and interests in and to any INDs for the Licensed Compounds. Company will cooperate in connection therewith and shall perform all duties under such INDs from and after such assignment. Subject to the foregoing, the Parties will reasonably cooperate to ensure an orderly transition of duties under such INDs and to fulfill applicable filing obligations with regulatory authorities.

 

3.4                               Safety Database. BMS shall transfer to Company the safety database for the Licensed Compounds, in the form in which it is held by BMS, as soon as practicable and in any event within [* * *] days after the Effective Date, and Company shall perform all responsibilities thereafter with respect to reporting of adverse events relating to the Licensed Compounds. If BMS learns of an adverse event based on work already carried out by BMS using a Licensed Compound, it will promptly notify Company of such adverse event.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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3.5                               Pharmacovigilance Agreement. Should the Parties mutually agree, and subject to the terms of this Agreement, as needed, within [* * *] months after the Effective Date, or notification to the Pharmacovigilance Departments of the execution date, BMS and the Company (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Licensed Compound(s). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound(s). Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for Pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled.

 

ARTICLE 4

 

TRANSFER OF MATERIALS

 

4.1                               Materials. Within [* * *] days after the Effective Date, BMS shall transfer, free of charge, to Company those Licensed Compounds identified in Appendix 4, ex-works (EXW) BMS’s facility in New Brunswick, NJ, in the quantities set forth in Appendix 4 (any such materials that are actually transferred, the “Transferred Materials”). Title and risk of loss shall be transferred to and borne by Company upon delivery of the Transferred Materials by BMS to a common carrier for shipment to Company, and Company shall be responsible for any indirect taxes levied upon the transfer, including customs duties and import VAT if applicable. Other than the Transferred Materials, unless included within the scope of BMS Know-How and subject to Section 3.2, BMS shall have no obligation to provide Company with any compounds or other materials, such as assays or biomaterials, under this Agreement. The Transferred Materials are provided “AS IS” and BMS makes no representations or warranties, express or implied, as to the Transferred Materials, including any warranty as to merchantability or fitness for a particular use or purpose. Any requalification required for Transferred Materials that are not cGMP materials will be at Company’s expense and responsibility. Company agrees that: (a) Company shall be fully responsible for its and its Affiliates’, Sublicensees’ and contractors’ use, storage, handling and disposition of the Transferred Materials, (b) under no circumstances shall BMS be liable or responsible for Company’s or its Affiliates’, Sublicensees’ and contractors’ use, storage, handling or disposition of the Transferred Materials, and (c) Company assumes sole

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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responsibility for any claims, liabilities, damages and losses that might arise as a result of Company’s and its Affiliates’, Sublicensees’ and contractors’ use, storage, handling or disposition of any Transferred Material. Company shall indemnify, defend and hold harmless BMS and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives, from and against any and all damages, liabilities, losses, costs and expenses (including reasonable legal expenses, costs of litigation and reasonable attorney’s fees) arising in connection with any claims, suits, proceedings, whether for money damages or equitable relief, of any kind, arising out of or relating to Company’s, or any of its Affiliates’, Sublicensees’ or contractors’ use, storage, handling or disposition of any Transferred Material. Transferred Materials may only be provided by Company to Affiliates of Company, Sublicensees and contractors of Company.

 

ARTICLE 5

 

DEVELOPMENT

 

5.1                               Development. Company shall itself or through its Affiliates or Sublicensees use Commercially Reasonable Efforts to Develop Licensed Products, including by (i) setting forth in the Development Plan a program of Development activities and reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for Licensed Compounds and Licensed Products, and (ii) assigning appropriately qualified and experienced personnel to perform and monitor the progress of, or overseeing Third Parties who perform, such Development activities on an on-going basis. The initial Development Plan as of the Effective Date is attached hereto as Appendix 2. During the Term, Company shall (a) promptly provide BMS no later than January 1 of each Calendar Year with a copy of the revised Development Plan for each Licensed Compound and Licensed Product for such Calendar Year and the next two Calendar Years and (b) promptly notify BMS as if, as a result of interactions with Regulatory Authorities in relation to any Licensed Product, Company reasonably determines that the estimated timelines for Development and Commercialization for Licensed Products set forth in the Development Plan are likely to be materially delayed, and shall promptly thereafter update the Development Plan to reflect such revised estimated timelines. Company shall promptly notify BMS of any material change in any study included in the Development Plan last provided to BMS of which it becomes aware and the reasons therefor.

 

5.2                               Development Reports. Company shall provide BMS with written Development reports on or before January 31 of each Calendar Year during the term of Development activities summarizing (but without disclosing specific data or results) such activities in sufficient detail to enable BMS to determine Company’s compliance with its diligence obligations in Section 5.1. Such reports shall include without limitation (a) the research and other Development activities accomplished by Company under the existing Development Plan through the end of the immediately preceding Calendar Year with respect to Licensed Compounds and Licensed Products, (b) updates on Company’s progress against the existing Development Plan, and (c) any revisions proposed to be made to any Development Plan for the then current Calendar Year; provided, however, that the first such report shall be due no later than January 31, 2017. If any

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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such Development obligations have been sublicensed to a Sublicensee, Company shall require the Sublicensee to provide to BMS (directly or through Company) the same information as required of Company hereunder with respect to the progress of the development of Licensed Compounds and Licensed Products by such Sublicensee. If requested by BMS, Company (and, if applicable, Sublicensee) personnel who prepared the report will meet with BMS (which may be by teleconference) to discuss any reasonable questions or comments that BMS might have on the report and Company’s development activities.

 

5.3                               Records. Company shall maintain complete and accurate records of all work conducted in furtherance of the research, Development and Commercialization of the Licensed Compounds and/or Licensed Products and all results, data and developments made in furtherance thereof to the extent required under applicable Laws. Such records shall properly reflect all work done and results achieved in sufficient detail and in good scientific manner to the extent required under applicable Laws.

 

5.4                               Development Responsibilities and Costs. As between the Parties, Company shall have sole responsibility for, and shall bear the cost of conducting, research and Development with respect to the Licensed Compounds and/or Licensed Products. Company shall research and Develop the Licensed Compounds and/or Licensed Products in compliance with all applicable Laws, including all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials.

 

5.5                               Regulatory Responsibilities and Costs. As between the Parties, Company shall have sole responsibility for, and shall bear the cost of preparing, all regulatory filings and related submissions with respect to the Licensed Compounds and/or Licensed Products. Except as set forth in Article 13, Company shall own all INDs, Approvals and submissions in connection therewith and all Approvals shall be obtained by and in the name of Company.

 

5.6                               Competitive Compound.

 

5.6.1                     During the period that ends [* * *] years after the Effective Date, neither Company nor its Affiliates (or any Sublicensee of Company or any Affiliate of such Sublicensee) shall itself or through any Third Party, or in collaboration with any Third Party, engage, directly or indirectly in the clinical Development or Commercialization of a Competitive Compound.

 

5.6.2                     Notwithstanding Section 5.6.1, if Company or any of its Affiliates, either through its own development efforts or by acquisition, or obtains ownership of or a license to, or is acquired by or otherwise merges with an entity (or an Affiliate of such entity) that owns or has a license to, a Competitive Compound, in all such cases that would result in a violation of Section 5.6.1 (any such event, a “Triggering Event”), then Company shall promptly notify BMS in writing and elect (as applicable) one of the following actions within [* * *] days after such Triggering Event:

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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(a)                                 divest itself of such Competitive Compound and notify BMS in writing of such divestiture, which divestiture may occur by an outright sale to a Third Party of all of Company’s and its Affiliate’s rights to such Competitive Compound or by an outlicense arrangement under which Company has no continuing active involvement in the development or commercialization of such Competitive Compound (for clarity, efforts in connection with (i) the receipt and audit of payments in respect of the Competitive Compound, (ii) the maintenance, defense and enforcement of any applicable licensed patents, and (iii) the receipt of information to ensure compliance with the applicable agreement (including efforts to enforce or terminate same, or seek damages, for breach) shall not constitute continuing active involvement) provided that such divestiture occurs within [* * *] after the applicable Triggering Event; provided, that Company or its Affiliate shall have an additional [* * *] to effect such divestiture in the event that Company or its Affiliate can demonstrate it has used commercially reasonable efforts, but has been unable, to effect such divestiture during such [* * *] period; or

 

(b)                                 Company shall notify BMS in writing whether Company desires to negotiate terms under which the Competitive Compound would be included as a Product within this Agreement. If the Parties can agree and execute a binding agreement, within [* * *] after notice from Company electing this option, on the terms (including compensation to BMS) for including the Competitive Compound as a Licensed Product or Licensed Compound within this Agreement and Company’s Commercially Reasonable Efforts obligations under Sections 5.1 and 6.1, then Company shall not be deemed in breach of Section 5.6.1; provided, that BMS shall not be under any obligation, express or implied to negotiate or enter into any such agreement. If the Parties are unable to reach written agreement during the applicable time period, then, this Agreement shall be deemed terminated pursuant to Section 13.3.2 hereof.

 

ARTICLE 6

 

COMMERCIALIZATION

 

6.1                               Company Obligations. Company shall use Commercially Reasonable Efforts to (i) obtain Approvals in each Major Market Country (or from the EMA for the Major Market Countries in Europe) for at least one Licensed Product, (ii) effect the First Commercial Sale of each Licensed Product for which such Approvals are obtained into each Major Market Country as soon as reasonably practicable after receipt of such Approvals and (iii) Commercialize each such Licensed Product in each such Major Market Country following such First Commercial Sale therein with the goal of maximizing the Net Sales of such Licensed Product in such Major Market Country.

 

6.2                               Continued Availability. Following the First Commercial Sale of a Licensed Product in a country in the Territory and until the expiration or termination of this Agreement, Company shall be responsible for manufacturing (or having manufactured) at its sole expense and using Commercially Reasonable Efforts to maintain supplies of such Licensed Product sufficient to satisfy Company’s expected Commercialization efforts in such country.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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6.3                               Reports. Following the First Commercial Sale of a Licensed Product in a country in the Territory, Company shall provide BMS with a written report within [* * *] days of the filing of the Company Annual Report with the U.S. Securities and Exchange Commission (or if no such report is filed, then within [* * *] days after the end of a calendar year), summarizing significant commercial activities with respect to Licensed Products during the just ended Calendar Year in countries in which there has been a First Commercial Sale of a Licensed Product, broken out separately for each applicable Major Market Country, aggregated for all member states of the European Union, if applicable, and aggregated for other countries in the Territory, if applicable, that are not Major Market Countries or member states of the European Union. If requested by BMS, Company personnel who prepared the report will meet with BMS, which may be by teleconference, to discuss and answer any questions or comments that BMS might have on the report and Company’s commercialization activities

 

ARTICLE 7

 

MANUFACTURE AND SUPPLY

 

7.1                               Manufacture and Supply. As between the Parties, Company shall be solely responsible at its expense for all of its requirements for making or having made all of its requirements of the Licensed Compounds and/or Licensed Products, except for Transferred Materials.

 

ARTICLE 8

 

FINANCIAL TERMS

 

In partial consideration of the rights granted by BMS to Company pursuant to this Agreement, Company shall make the payments provided for in this Article 8.

 

8.1                               Initial Payments.

 

8.1.1                     Within three (3) business days after the Effective Date, Company shall pay to BMS a nonrefundable, noncreditable payment of Five Million Dollars ($5,000,000) in cash by wire transfer into an account designated in writing by BMS. Any amount paid by Company to BMS as a consideration for the grant by BMS of any exclusive negotiation period in relation to the subject matter of this Agreement shall be credited against the amount to be paid by Company to BMS under this Section 8.1.1.

 

8.1.2                     Within ninety (90) days after the Effective Date, Company shall pay to BMS a nonrefundable, noncreditable payment of Four Million Dollars ($4,000,000) in cash by wire transfer into an account designated in writing by BMS.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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8.2                               Milestone Payments.

 

8.2.1                     Development Milestones. For each applicable Licensed Compound, Company shall pay to BMS the following one time milestone payments set forth in the table below within [* * *] days after the first achievement of the specified milestone event by Company, its Affiliates, and Sublicensees for each applicable Licensed Compound achieving such milestone event in any indication. Company shall provide written notice to BMS within [* * *] after the first achievement of the specified milestone event by Company for each applicable Licensed Compound, Affiliates, and Sublicensees. Each milestone payment shall not be refundable or returnable in any event, nor shall it be creditable against royalties or other payments:

 

(a)                                 [* * *] (or any Derivative Compound thereof) for [* * *]:

 

	
Milestone
    	
 
    	
Amount of Milestone Payment
   (Dollars)
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
*
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
TOTAL:
    	
 
    	
$
    	
[* * *]
    	
 
    

 

* [* * *]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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(b)                                 [* * *] (or any Derivative Compound thereof) for [* * *]:

 

	
Milestone
    	
 
    	
Amount of Milestone Payment
   (Dollars)
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
TOTAL:
    	
 
    	
$
    	
[* * *]
    	
 
    

 

(c)                                  Any Licensed Compound (including [* * *] but other than [* * *] or a Derivative Compound of [* * *]), for [* * *]:

 

	
Milestone
    	
 
    	
Amount of Milestone Payment
   (Dollars)
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
TOTAL:
    	
 
    	
$
    	
[* * *]
    	
 
    

 

(d)                                 Any Licensed Compound (including [* * *]) other than [* * *] or Derivative Compound of [* * *] for [* * *]:

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Milestone
    	
 
    	
Amount of Milestone Payment
   (Dollars)
    	
 
    
	
[* * *]
    	
 
    	
$
    	
[* * *
    	
]
    
	
[* * *]
    	
 
    	
$
    	
[* * *
    	
]
    
	
[* * *]
    	
 
    	
$
    	
[* * *
    	
]
    
	
[* * *]
    	
 
    	
$
    	
[* * *
    	
]
    
	
TOTAL:
    	
 
    	
$
    	
[* * *
    	
]
    

 

(e)                                  For purposes of this Section 8.2.1:

 

(i)                                    The set of milestone payments in the tables above shall be payable by Company to BMS upon the first achievement of each such milestone event for each such Licensed Compound to achieve the milestone event.

 

(ii)                                Payment of the milestone payments due for milestones achieved under Sections 8.2.1(c) and (d) will be deferred until the earlier of (i) the [* * *] and (ii) the [* * *].

 

(iii)                            “Indication” shall mean any separately defined, well-categorized class of human disease, syndrome or medical condition for which a separate marketing authorization application may be filed with a Regulatory Authority. New forms, presentations, dosages or formulations Developed for a given Licensed Compound shall not be deemed to create a new Licensed Compound for milestones purposes and shall be considered the same Licensed Compound.

 

8.2.2                     Sales-Based Milestones. Each of the following milestone payments shall be paid by Company to BMS for each Licensed Product within [* * *] days after the first achievement by Company, its Affiliates, and/or Sublicensees of the corresponding Net Sales amount in a Calendar Year set forth in the table below:

 

	
Milestone -
   First Achievement of Net Sales
   in any Calendar Year of:
    	
 
    	
Amount of Milestone Payment
   (Dollars)
    	
 
    
	
$[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
$[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
$[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
Total   Sales-Based Milestones
    	
 
    	
$
    	
150,000,000
    	
 
    

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Each milestone payment shall not be refundable or returnable in any event, nor shall it be creditable against royalties or other payments.

 

8.3                               Sublicense Revenue Sharing. In addition to the milestones and royalty payments set forth in Section 8.2, Company shall pay to BMS the following percentage of all Sublicense Revenues Company receives in connection with any Sublicense or any assignment of rights to the BMS Patents, BMS Know-How, the Licensed Compounds and/or Licensed Products, depending on the stage of Development of the most advanced Licensed Compound or Licensed Product that is subject to the applicable Sublicense or such assignment:

 

	
 
    	
 
    	
Development stage of the most advanced Licensed Compound or
   Licensed Product as of the date of the Sublicense or assignment:
    	
 
    
	
 
    	
 
    	
Prior to delivery of
   top line data from the
   first Phase III Trial
    	
 
    	
Prior to the first filing
   for an Approval
    	
 
    	
Thereafter
    	
 
    
	
Percent   of Sublicense Revenues payable to BMS
    	
 
    	
[* * *]
    	
%
    	
[* * *]
    	
%
    	
[* * *]
    	
%
    

 

For clarity the percent stated above shall apply (i) to any particular Sublicense Revenue that is not included in the Agreement (e.g., the upfront payment from the Sublicensee or a milestone payment for a milestone event not included in the Agreement), and (ii) to the difference between (x) the Sublicense Revenue payment received by Company from a Sublicensee and (y) the payment Company pays to BMS for a particular payment under the Agreement (e.g., the difference between the milestone payment Company receives from a Sublicensee and the milestone payment Company pays to BMS for the same milestone event or the difference between the royalty rates).

 

8.4                               Royalty Payments.

 

8.4.1                     Subject to the terms of this Agreement Company shall pay to BMS tiered royalties based on the total annual worldwide Net Sales in the Territory of each Licensed Product (including all indications and formulations for such Licensed Product) during the applicable Royalty Term for such Licensed Product. The royalty payable with respect to each particular Licensed Product shall be calculated by multiplying the applicable royalty rate below by the portion of total annual worldwide Net Sales in the applicable tier in a Calendar Year of the applicable Licensed Product by Company, its Affiliates, and Sublicensees in the Territory, as follows.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

	
Portion of total annual worldwide Net Sales
   in a Calendar Year for such. Licensed
   Product that falls within the following tiers:
    	
 
    	
Royalty Rate
    	
 
    
	
<   $[* * *]
    	
 
    	
[* * *]
    	
%
    
	
> $[* * *]   < $[* * *]
    	
 
    	
[* * *]
    	
%
    
	
> $[* * *]
    	
 
    	
[* * *]
    	
%
    

 

By way of example, in a given Calendar Year, if the total annual worldwide Net Sales for a Licensed Product is $[* * *], the following royalty payment would be payable under this Section 8.4 (subject to the reductions set forth below): ([* * *]) + ([* * *]) + ([* * *]) = $[* * *]. For clarity, all dosages, dosage forms, SKUs, methods of delivery and presentations of a Licensed Product containing the same Licensed Compound shall be considered as one Licensed Product for purposes of this Section 8.4.1.

 

8.4.2                     Royalty Term. Royalties shall be payable on a Licensed Product-by-Licensed Product and country-by-country basis on Net Sales of Licensed Products from the First Commercial Sale of a particular Licensed Product in a country until the later of (i) twelve (12) years after the First Commercial Sale of such Licensed Product in such country, (ii) the expiration of the last to expire BMS Patent Right that would be infringed by the manufacture, use, sale, importation or offer for sale in such country of a given Licensed Product (including by reasons of extensions thereof under applicable Laws, including patent term extensions, pediatric exclusivity or supplemental protection certificates or their equivalents in any country), or (iii) the expiration of any regulatory or marketing exclusivity for such Licensed Product in such country, including but not limited to any data exclusivity (the “Royalty Term”); provided that, if (ii) no longer applies, the royalty payable by Company to BMS for the remainder (if any) of the Royalty Term with respect to such Licensed Product shall be determined by a royalty rate equal to fifty percent (50%) of the royalty rate set forth in Section 8.4.1. At the end of the Royalty Term for any Licensed Product in any country, Company will have a fully paid up, perpetual, irrevocable, royalty-free license to such Licensed Product in such country.

 

8.4.3                     Royalty Conditions. The royalties under Section 8.4.1 shall be subject to the following conditions:

 

(a)                                 only one royalty shall be due with respect to the same unit of Licensed Product;

 

(b)                                 no royalties shall be due upon the sale or other transfer among any Related Party, but in such cases the royalty shall be due and calculated upon the Related Party’s Net Sales of Licensed Product to the first non-Related Party; and

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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(c)                                  no royalties shall accrue on the disposition of Licensed Product in reasonable quantities by any Related Party as part of an expanded access program or as bona fide samples or as donations to non-profit institutions or government agencies for non-commercial purposes or for the performance of clinical trials, provided, in each case, that such Related Party does not receive any payment for such Licensed Product exceeding the cost of goods.

 

8.4.4                     Royalty Reduction. If (i) Company, in its reasonable judgment, determines that it is required to obtain a license from any Third Party in order to avoid infringement of such Third Party’s Patent Rights as a result of the practice of the BMS Patent Rights and/or the BMS Know-How in connection with the research, Development or Commercialization of any Licensed Product, (ii) such Patent Rights cover or claim the composition or method of use, of a Licensed Product, and (iii) Company is required to pay to such Third Party a royalty, milestone payments or other monetary compensation in consideration for the grant or maintenance of such license (“Third Party Compensation”), then for the period during which Company owes royalties to BMS hereunder, the amounts that would otherwise have been payable as royalties to BMS under this Agreement shall be reduced by [* * *] of all Third Party Compensation payable by or on behalf of Company to such Third Party. Notwithstanding the foregoing, in no event shall the royalty reductions described in this Section 8.4.4 act to reduce the royalties payable by Company to less than [* * *] of the amounts payable by Company for a given Calendar Quarter pursuant to Section 8.4.1. For clarity, this credit will not apply with respect to Third Party patent rights covering formulation or method of manufacture of a Licensed Compound or Licensed Product. For clarity, Company may not carry over and apply any such royalty reductions, which are incurred or accrued in a Calendar Quarter and are not deducted in such Calendar Quarter, to any subsequent Calendar Quarter(s). Notwithstanding the foregoing, if the royalty rates have been reduced in a given country due to patent no longer covering the applicable Licensed Product as set forth in Section 8.4.2, the provisions of this Section 8.4.4 will not apply for such country.

 

8.4.5                     Forecast. The Company shall provide on or before [* * *] of each Calendar Year a non-binding good faith forecast of sales and royalties for the entire current and next Calendar Year.

 

8.4.6                     Effect of Patent Challenge. In the event Company (or any of its Affiliates or Sublicensees) challenges or knowingly assists (other than in response to a subpoena or court order), including without limitation by providing information, documents, advice, and/or funding, a challenge to the validity, scope, patentability or enforceability of any of the BMS Patent Rights, and such challenge is unsuccessful either because (i) Company files a suit or initiates another legal proceeding to challenging the validity or enforceability of any such BMS Patent Right and then withdraws or terminates the suit or proceeding, (ii) any challenged claim that would be infringed but for the license has been upheld, even in amended form, as determined by a court of competent jurisdiction or other legal tribunal, or (iii) Company, in connection with such challenge, fails to produce reasonably credible evidence demonstrating the invalidity or unenforceability of all applicable patent claims in the BMS Patent Rights in such country; then the royalty rates set forth in Section 8.4.1 above shall be increased by [* * *] of the

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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percentages set forth above (e.g., [* * *]), retroactively effective to the date that such suit or other legal proceeding was filed or otherwise formally initiated.

 

8.5                               Manner of Payment. All payments to be made by Company under this Agreement shall be made in U.S. Dollars by wire transfer of immediately available funds to such bank account as shall be designated by BMS. Late payments shall bear interest at the rate provided in Section 8.10.

 

8.6                               Sales Reports and Royalty Payments. After the First Commercial Sale of a Licensed Product and during the term of this Agreement, Company shall furnish to BMS a written report, within [* * *] days [* * *] days if a Sublicense has been granted) after the end of each Calendar Quarter (or portion thereof, if this Agreement terminates during a Calendar Quarter), showing the amount of royalty due for such Calendar Quarter (or portion thereof). Royalty payments for each Calendar Quarter shall be due at the same time as such written report for the Calendar Quarter. With each quarterly payment, Company shall deliver to BMS a full and accurate accounting to include at least the following information:

 

8.6.1                     the total gross sales for each Licensed Product (by country) by Company and its applicable Related Parties, if any, and the calculation of Net Sales from such gross sales;

 

8.6.2                     the deductions by category of permitted deductions set forth in the Net Sales definition;

 

8.6.3                     the total Net Sales for each Licensed Product (by country) by Company and its applicable Related Parties, if any, and the calculation of Net Sales from such gross sales;

 

8.6.4                     the calculation of royalties payable in Dollars which shall have accrued hereunder in respect of such Net Sales;

 

8.6.5                     withholding taxes, if any, required by applicable Law to be deducted in respect of such royalties; and

 

8.6.6                     the exchange rates used in determining the amount of Dollars payable hereunder.

 

If no royalty or payment is due for any royalty period hereunder, Company shall so report.

 

8.7                               Sales Record Audit.

 

8.7.1                     Company shall keep, and shall cause each of its applicable Related Parties, if any, to keep, complete, true and accurate books of accounts and records in accordance with GAAP, including gross sales in accordance with GAAP and any deductions thereto in accordance with this Agreement’s Net Sales definition in connection with the calculation of Net Sales, sufficient to determine and establish the amounts payable incurred under this Agreement, and compliance with the other terms and conditions of this Agreement.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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8.7.2                     Such books of accounting of Company and its Affiliates shall be kept at their principal place of business and, with all necessary supporting data and records, shall during all reasonable times for the [* * *] years next following the end of the Calendar Year to which each shall pertain, be open for inspection not more than once per Calendar Year at reasonable times by an independent certified public accountant selected by BMS and as to which Company has no reasonable objection, at BMS’ expense, for the purpose of verifying royalty statements and payments for compliance with this Agreement for any period within the preceding three (3) Calendar Years.

 

8.7.3                     Company shall include in its Sublicense Agreements with any Sublicensees, a right for Company to inspect or have such an accountant inspect, not more than once during any Calendar Year, the books of accounting and such supporting data and records of such Sublicensees for the purpose of verifying royalty statements and payments for compliance with this Agreement for any period within the preceding [* * *] Calendar Years.

 

8.7.4                     Results of any inspection under Section 8.7.2 or 8.7.3 shall be made available to both Company and BMS. The independent, certified public accountant shall disclose to BMS only the amounts that the independent auditor believes to be due and payable hereunder to BMS, details concerning any discrepancy from the amount paid (including the reasons therefor) and the amount due, and shall disclose no other information revealed in such audit.

 

8.7.5                     Such accountant must have agreed in writing to maintain all information learned in confidence, except as necessary to disclose to BMS such compliance or noncompliance by Company, and any applicable Related Parties (who must agree in the Sublicense Agreement that such audit report may be disclosed to BMS). The results of each inspection, if any, shall be binding on both Parties. BMS shall pay for such inspections, except that in the event there is any upward adjustment in aggregate royalties payable for any Calendar Year shown by such inspection of more than [* * *] of the amount paid, Company shall pay for such inspection. Any underpayments shall be paid by Company within [* * *] days after notification of the results of such inspection. Any overpayments shall be fully creditable against amounts payable in subsequent payment periods.

 

8.8                               Currency Exchange. The Company’s then current standard exchange rate methodology will be employed for the translation of foreign currency sales into Dollars, provided such methodology is used by the Company in the translation of its foreign currency operating results, is consistent with GAAP, and is audited by the Company’s independent certified public accountants in connection with the audit of the consolidated financial statements of Company, and is used for the Company’s external reporting of foreign currency operating results.

 

8.9                               Taxes.

 

8.9.1                     Each Party will pay any and all taxes levied on account of all payments it receives under this agreement.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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8.9.2                     If laws or regulations require that taxes be withheld with respect to any royalty payments by Company to BMS under this Agreement, Company will: (a) deduct those taxes from the remittable payment, (b) pay the taxes to the proper taxing authority, and (c) send evidence of the obligation together with proof of tax payment to BMS on a reasonable and timely basis following that tax payment. Each Party agrees to cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect. The Parties shall discuss applicable mechanisms for minimizing such taxes to the extent possible in compliance with applicable Laws. Notwithstanding the foregoing, in the event that payments are made by Company other than from the mainland U.S. (e.g., as a result of an assignment under Section 15.5.2), then Company shall, in addition to complying with the foregoing, pay an amount to BMS such that when any taxes that are required to be withheld have been deducted, BMS receives that amount it would have received had the payment been made from the mainland U.S.

 

8.9.3                     The Parties shall cooperate in accordance with applicable Laws to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) in connection with this Agreement.

 

8.10                        Interest Due. Without limiting any other rights or remedies available to BMS, Company shall pay BMS interest on any payments that are not paid on or before the date such payments are due under this Agreement at a rate of [* * *] or the maximum applicable legal rate, if less, calculated on the total number of days payment is delinquent.

 

8.11                        Financing. BMS shall have the opportunity, in its sole discretion, to purchase, as an investor, in the Financing, up to eight percent (8%) of such Financing on a fully diluted basis, with the same protections and rights afforded to other investors in the Financing.

 

8.12                        Equity Consideration. Company will, as additional consideration for the rights granted pursuant to this Agreement, issue to BMS or its Affiliates shares in the Company in an amount equal to Twelve Million Five Hundred Thousand United States Dollars ($12,500,000.00) in accordance with the terms and conditions of Appendix 6 upon the earliest to occur of:

 

8.12.1              the Initiation of the first Phase III Trial for the first Licensed Compound to reach such milestone;

 

8.12.2              an initial public offering involving the shares in the Company or the listing of any of its shares or securities on any stock exchange; and

 

8.12.3              any event resulting in a Company Change of Control.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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ARTICLE 9

 

REPRESENTATIONS AND WARRANTIES; DISCLAIMER;
 LIMITATION OF LIABILITY

 

9.1                               Mutual Representations and Warranties. Each Party represents and warrants to the other Party that, as of the Effective Date: (i) it is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation and has all requisite corporate power and authority to enter into this Agreement and to perform its obligations under this Agreement, (ii) execution of this Agreement and the performance by such Party of its obligations hereunder have been duly authorized, (iii) this Agreement has been duly executed and delivered on behalf of such Party, and is legally binding and enforceable on each Party in accordance with its terms, (iv) the performance of this Agreement by it does not create a breach or default under any other agreement to which it is a Party, (v) the execution, delivery and performance of this Agreement by such Party 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, (vi) no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements, and (vii) neither such Party, nor any of its employees, officers, subcontractors, or consultants who have rendered services relating to the Licensed Compounds: (a) has ever been debarred or is subject to debarment or convicted of a crime for which an entity or person could be debarred by the FDA under 21 U.S.C. Section 335a or (b) has ever been under indictment for a crime for which a person or entity could be so debarred.

 

9.2                               Representations, Warranties, and Covenants of BMS. BMS represents and warrants to Company that, as of the Effective Date: (a) there is no pending litigation, or litigation that has been threatened in writing, which alleges, or any written communication alleging, that BMS’ activities with respect to the research, Development or manufacture of the Lead Compounds prior to the Effective Date have infringed or misappropriated, or would infringe or misappropriate, any of the intellectual property rights of any Third Party, (b) no Third Party has challenged in writing the ownership, scope, duration, validity, enforceability, priority or right to use any BMS Patent Rights listed in Appendix la (including, by way of example, through the institution of or written threat of institution of interference, inter partes review, reexamination, protest, opposition, nullity or similar invalidity proceeding before the United States Patent and Trademark Office or any foreign patent authority or court), (c) all fees required to be paid by BMS in any jurisdiction in order to maintain the Patent Rights licensed to Company hereunder and listed in Appendix la have, to BMS’ Knowledge, been timely paid as of the Effective Date and, to BMS’ Knowledge, the claims included in any issued patents included in such Patent Rights are in full force and effect as of the Effective Date, (d) BMS has not previously assigned, transferred, conveyed, or granted any license or other rights to its right, title and interest in the BMS Patent Rights or the BMS Know-How, in any way that would materially conflict with or materially limit the scope of any of the rights or licenses granted to Company hereunder, (e) BMS’ right, title and interest to all the BMS Patent Rights listed in Appendix la are free of any lien or security interest, (f) except as set forth in Appendix 1, BMS and its Affiliates do not own

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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or control any other Patent Rights that are necessary or, to BMS’s reasonable belief as of the Effective Date, reasonably useful to carry out the Development of Lead Compounds and/or Licensed Products containing a Lead Compound as contemplated by the Development Plan attached as Appendix 2 hereto, and (g) subject to Section 3.1.2, to BMS’ Knowledge, the documents, data and information that are included in the BMS Know-How transferred to Company pursuant to Section 3.1 constitute all of the Know-How owned or Controlled by BMS that is reasonably necessary or useful for the Development or manufacture of the Lead Compounds in accordance with the terms of this Agreement.

 

9.3                               Representations and Warranties of Company. Company represents, warrants and covenants that (a) it shall not engage in any activities that use the BMS Patent Rights and/or BMS Know-How in a manner that is outside the scope of the license rights granted to it hereunder, (b) all of its activities related to its use of the BMS Patent Rights and BMS Know-How, and the research, Development and Commercialization of the Licensed Compounds and/or Licensed Products, pursuant to this Agreement shall comply with all applicable Law, (c) prior to filing the first drug application (i.e., an NDA or its foreign equivalent) for a Licensed Product, Company shall have all licenses that are necessary in order for the manufacture, use or sale of such Licensed Product not to infringe the intellectual property of any Third Party known to Company as of such date, but excluding licenses applicable to any Third Party issued patents for which Company shall have obtained a well-reasoned, written opinion of an outside patent attorney that Company’s activities under the scope of this Agreement are not reasonably likely to infringe any Valid Claim of such Third Party issued patent, and (d) it has available to it (or will have available to it at the time any payment hereunder is due) funds necessary to consummate the transaction contemplated by this Agreement and to Develop and Commercialize the Licensed Compounds and Licensed Products in accordance with the terms of this Agreement.

 

9.4                               DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY LICENSED COMPOUNDS, LICENSED PRODUCTS, TRANSFERRED MATERIALS, THE BMS PATENT RIGHTS OR BMS KNOW-HOW OR ANY RIGHT OR LICENSE GRANTED BY BMS HEREUNDER, AND NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY BY BMS THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE BMS PATENT RIGHTS ARE VALID OR ENFORCEABLE OR THAT USE OF THE BMS PATENT RIGHTS, BMS KNOW-HOW AND TRANSFERRED MATERIALS CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY. NOTWITHSTANDING ANY TO THE CONTRARY IN THIS AGREEMENT, COMPANY ACKNOWLEDGES AND AGREES THAT THE REPRESENTATIONS AND WARRANTIES IN THIS ARTICLE 9 ARE NOT MADE WITH RESPECT TO THE BMS PATENT RIGHTS LISTED IN APPENDIX 1B AND THAT SUCH BMS PATENT RIGHTS LISTED IN APPENDIX IB ARE BEING LICENSED TO COMPANY ON AN AS-IS BASIS.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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9.5                               Limitation of Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR OTHERWISE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF BUSINESS); PROVIDED, HOWEVER, THAT THE FOREGOING SHALL NOT APPLY TO ANY BREACH BY A PARTY OF ARTICLE 11 HEREOF, TO A BREACH BY COMPANY OF SECTION 5.6, THE WILLFUL BREACH, WILLFUL MISCONDUCT, OR GROSS NEGLIGENCE BY A PARTY, OR FOR AMOUNTS SOUGHT BY THIRD PARTIES IN CLAIMS THAT ARE SUBJECT TO THE PARTIES’ RESPECTIVE INDEMNITY OBLIGATIONS UNDER ARTICLE 12. IN ANY CASE, BMS SHALL NOT BE LIABLE FOR ANY DAMAGES OF ANY KIND (INCLUDING DIRECT DAMAGES) IN AN AMOUNT GREATER THAN THE AMOUNTS PAID BY COMPANY TO BMS UNDER SECTIONS 8.1, AND 8.2 OF THIS AGREEMENT. FOR THE AVOIDANCE OF DOUBT, THE FOREGOING LIMITATION SHALL NOT APPLY TO OR LIMIT ANY INFRINGEMENT CLAIM BROUGHT BY A PARTY UNDER THE PATENT LAWS OF ANY COUNTRY AND ANY DAMAGES IN THE NATURE OF LOST ROYALTIES TO BMS SHALL BE CONSIDERED DIRECT DAMAGES.

 

ARTICLE 10

 

PATENT MAINTENANCE; INFRINGEMENT; PATENT EXTENSIONS

 

10.1                        Inventions. Inventorship of inventions conceived or reduced to practice in the course of research and other Development activities under this Agreement shall be determined by application of United States patent Laws pertaining to inventorship. If such inventions are jointly invented in the course of such Development activities by one or more employees or consultants or contractors of both Parties, such inventions shall be jointly owned (“Joint Invention”), and if one or more claims included in an issued patent or pending patent application which is filed in a patent office in the Territory claim such Joint Invention, such patent or patent application shall be jointly owned (“Joint Patent Rights”). If such an invention is solely invented by an employee or consultant of a Party, such invention shall be solely owned by such Party, and any patent filed claiming such solely owned invention shall also be solely owned by such Party. This Agreement shall be understood to be a joint research agreement in accordance with 35 U.S.C. § 102(c), as amended, to develop the Licensed Compounds and/or Licensed Products. Each Party shall enter into binding agreements obligating all employees and consultants performing activities under or contemplated by this Agreement, including activities related to the BMS Patent Rights, Licensed Compounds or Licensed Products, to assign his/her interest in any invention conceived or reduced to practice in the course of such activities to the Party for which such employee or consultant is providing its services, except consultants who by employment contract may only assign to their employers are treated as contractors for the purpose of this Section 10.1. With respect to contractors, Company shall use good faith and reasonable efforts to

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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secure an agreement from such contractor to assign or license (with the right to sublicense) to Company inventions (and patent rights covering such inventions) made by such contractor in performing such services for Company.

 

10.2                        Filing, Prosecution and Maintenance of BMS Patent Rights. Company will have lead responsibility, using its in-house patent counsel or outside patent counsel selected by Company (such determination and outside patent selection to be subject to BMS’ approval, such approval not to be unreasonably withheld), for the preparation, prosecution (including any interferences, reissue proceedings and reexaminations) and maintenance of the BMS Patent Rights. Company shall be responsible for the costs incurred with respect to the filing, prosecution and maintenance of the BMS Patent Rights. Company shall provide BMS with semi-annual updates of the filing, prosecution and maintenance status for each of the BMS Patent Rights, and shall promptly provide copies of any material official correspondence to or from patent offices. The Parties shall reasonably consult with and cooperate with respect to the preparation, prosecution and maintenance of the BMS Patent Rights, including by providing assistance as described in Section 3.2, and will confer regarding where to prosecute the BMS Patent Rights. Company shall not take any action during prosecution and maintenance of the BMS Patent Rights that would materially adversely affect them (including reduction in claims scope), without BMS’ prior express written consent (which consent shall be considered to be given if Company notifies BMS of proposed claim amendments or cancellations and BMS fails to object within thirty (30) days of such notification). Company may file a notice with governmental patent offices of the exclusive license to the BMS Patent Rights granted to Company hereunder. Post-grant proceedings involving the BMS Patent Rights, including oppositions, cancellations, inter partes review, and the like, shall be conducted by Company at the expense of Company, and Company shall promptly notify BMS of the initiation of such proceeding (or vice versa) and Company shall give BMS the opportunity to participate, at the sole expense of BMS, and BMS shall also participate and appear as necessary under the applicable rules governing the proceeding. Any settlement or compromise of such post-grant proceeding shall be subject to the approval of BMS, which approval shall not be unreasonably withheld, delayed or conditioned.

 

10.3                        Patent Abandonment.

 

10.3.1              The Parties will confer and must mutually agree before any of the BMS Patent Rights may be abandoned in any Major Market Country; provided that BMS shall not unreasonably withhold, delay or condition its consent to a request by Company to abandon a BMS Patent Right if such abandonment will not adversely affect the amount or duration of any royalty payable to BMS hereunder. Company shall provide BMS with notice of the allowance and expected issuance date of any patent within the BMS Patent Rights, or any of the deadline for filing a new patent application, and BMS shall provide Company with prompt notice as to whether BMS desires Company to file such new patent application. Company will provide notice to BMS pursuant to Section 103.2 before abandoning any patent rights in non-Major Market Countries.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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10.3.2              Subject to Section 10.3.1, in the event that Company decides either (a) not to continue the prosecution or maintenance of a patent application or patent within the BMS Patent Rights in any country, or (b) not to file any new patent application requested to be filed by BMS, Company shall provide BMS with express written notice of this decision at least thirty (30) days prior to any pending lapse or abandonment thereof, or if a decision not to continue prosecution or maintenance is responsive to an official communication from governmental agency that is received by Company less than forty-five (45) days prior to a deadline for taking action in response thereto, then the deadline for giving such notice to BMS shall be 50% of the time remaining for response after such communication is received by Company. In such event, provided that the Parties have not expressly agreed to abandon a patent or not file a patent application under Section 10.3.1, then Company shall provide BMS with an opportunity to assume responsibility for all external costs reasonably associated with the filing and/or further prosecution and maintenance of such patent application and any patent issuing thereon (such filing to occur prior to the issuance of the patent to which the application claims priority or expiration of the applicable filing deadline, as set forth above). In the event that BMS assumes such responsibility for such filing, prosecution and maintenance costs, Company shall transfer the responsibility for such filing, prosecution and maintenance of such patent applications and patents to BMS and Company shall no longer have any right or license in and to such patent application and patents issuing therefrom under this Agreement. In such case, Company shall provide BMS with an update of the filing, prosecution and maintenance status for each of such patent applications and patents, including copies of any material official correspondence to or from patent offices. Company shall reasonably consult with and cooperate with BMS with respect to the preparation, prosecution and maintenance of such patent applications and patents. Except as described in this Section 10.3.2, Company shall not take any action during prosecution and maintenance of the BMS Patent Rights that would materially adversely affect them, without BMS’ prior express written consent, such consent not to be unreasonably withheld, delayed or conditioned if such action will not adversely affect the amount or duration of any royalty payable to BMS, and which consent shall be considered to be given if Company notifies BMS of proposed claim amendments or cancellations and BMS fails to object within thirty (30) days of such notification.

 

10.4                        Enforcement of BMS Patent Rights against Infringers.

 

10.4.1              Enforcement by Company. In the event that BMS or Company becomes aware of a suspected infringement of any BMS Patent Right in the Field relating to Licensed Compounds, Licensed Products or their manufacture, sale or use, including actual or alleged infringement under 35 USC §271(e)(2) that is or would be infringing activity involving the using, making, importing, offering for sale or selling of articles that the Party reasonably believes infringes any of the Patent Rights conferred under this Agreement, such Party shall notify the other Party promptly, including all information available to such Party with respect to such alleged infringement, and following such notification, the Parties shall confer. Company shall have the first right, but shall not be obligated, to bring an infringement action for suspected infringement in the Field at its own expense, in its own name and entirely under its own direction and control, subject to the following: (a) BMS shall reasonably assist Company (at Company’s

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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expense) in any action or proceeding being prosecuted for suspected infringement in the Field if so requested, including by being named or joined as a plaintiff to such actions or proceedings if requested by Company or required by Law, (b) BMS shall have the right to participate and be represented in any such suit by its own counsel at its own expense, (c) no settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of a BMS Patent Right in the Field may be entered into by Company without the prior written consent of BMS, which consent shall not be unreasonably withheld, delayed or conditioned, and further, no settlement of any such action or proceeding which pertains to the infringement of the BMS Patent Rights by virtue of the Development or Commercialization of a Licensed Compound in the Field by a Third Party that is not a Sublicensee may be entered into by Company without the prior written consent of BMS, which consent shall not be unreasonably withheld, delayed or conditioned.

 

10.4.2              Timing; Enforcement by BMS. Company will have a period of one hundred twenty (120) days after its receipt or delivery of notice and evidence pursuant to Section 10.4.1 or receipt of written notice from a Third Party that reasonably evidences such infringement of the BMS Patent Rights, to elect to so enforce such BMS Patent Rights in the applicable jurisdiction (or to settle or otherwise secure the abatement of such infringement in accordance with Section 10.4.1), provided however, that such period will be (i) more than one hundred twenty (120) days to the extent applicable Law prevents earlier enforcement of such BMS Patent Right (such as the enforcement process set forth in or under the Hatch-Waxman Act), and provided further that if such period is extended because applicable Law prevents earlier enforcement, Company shall have until the date that is thirty (30) days following the date upon which applicable Law first permits such proceeding, and (ii) less than one hundred twenty (120) days to the extent that a delay in bringing such proceeding against such alleged Third Party infringer would limit or compromise the remedies (including monetary relief, and stay of regulatory approval) available against such alleged Third Party infringer. In the event Company does not so elect (or settle or otherwise secure the abatement of such infringement) before the first to occur of (A) the expiration of the applicable period of time set forth in the preceding subsections (i) and (ii), or (B) thirty (30) days before the expiration of any time period under applicable Law, that would, if a proceeding was not filed within such time period, limit or compromise the remedies available from such proceeding, it will so notify BMS in writing and in the case where BMS then desires to commence a suit or take action to enforce the applicable BMS Patent Right in the applicable jurisdiction, BMS will thereafter have the right to commence such a suit or take such action to enforce the applicable BMS Patent Right, as applicable, at BMS’ expense, provided that BMS shall first consult with Company concerning the reasons Company elected not to bring such action and shall consider those reasons in good faith in deciding whether to bring such action. Company shall reasonably assist BMS (at BMS’ expense) in any action or proceeding being prosecuted if so requested, including by being named or joined as a plaintiff to such actions or proceedings if requested by BMS or required by Law. Company shall have the right to participate and be represented in any such suit by its own counsel at its own expense. If BMS decides to bring suit to abate any suspected infringement of any BMS Patent Right in the Field not relating to Licensed Compounds, Licensed Products or their manufacture, sale or use, including actual or alleged infringement under 35 USC §271(e)(2),

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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BMS shall inform the Company. No settlement of any action or proceeding which restricts the scope, or adversely affects the enforceability, of a BMS Patent Right may be entered into by BMS without the prior written consent of Company, which consent shall not be unreasonably withheld, delayed or conditioned.

 

10.4.3              Withdrawal. If either Party brings an action or proceeding under this Section 10.4 and subsequently ceases to pursue or withdraws from such action or proceeding, it shall promptly notify the other Party and the other Party may substitute itself for the withdrawing Party under the terms of this Section 10.4.

 

10.4.4              Damages. In the event that either Party exercises the rights conferred in this Section 10.4 and recovers any damages or other sums in such action, suit or proceeding or in settlement thereof, such damages or other sums recovered shall first be applied to all reasonable out-of-pocket costs and expenses incurred by the Parties in connection therewith, including attorneys’ fees. If such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be shared in proportion to the total of such costs and expenses incurred by each Party. If after such reimbursement any funds shall remain from such damages or other sums recovered, such funds shall be retained by the Party that controlled the action or proceeding under this Section 10.4; provided, however [***].

 

10.5                        Infringement of Third Party Rights.

 

10.5.1              The Parties will promptly notify each other of any allegation that any activity under this Agreement infringes or may infringe the intellectual property rights of any Third Party.

 

10.5.2              In any legal allegation related to the infringement of a Third Party intellectual property right, Company will have the first right to control, at its expense, the defense of such allegation. BMS will have the right, at its own expense and with its own choice of counsel, to be represented in the defense of the allegation.

 

10.5.3              The Parties will reasonably cooperate with each other in all respects with all matters related to the defense of any legal allegation under this section.

 

10.6                        Patent Extensions. BMS and Company shall each reasonably cooperate with one another and shall use Commercially Reasonable Efforts in obtaining patent term extension (including any pediatric exclusivity extensions as may be available) or supplemental protection certificates or their equivalents in any country with respect to Patent Rights covering the Licensed Products. If elections with respect to obtaining such patent term extensions are to be made, Company shall have the right, at its discretion, to make the election to seek patent term extension or supplemental protection with respect to the Patent Right for which such extension or supplemental protection should be sought, provided that Company shall use Commercially

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Reasonable Efforts to make such election so as to maximize the period of marketing exclusivity for the Licensed Product. For such purpose, for all Approvals Company shall provide BMS with written notice of any expected Approval at least thirty (30) days prior to the expected date of Approval, as well as notice within ten (10) business days following receipt of each Approval confirming the date of such Approval. Notification of the receipt of an Approval shall be in accordance with Section 15.2 except that the notification shall be sent to:

 

Bristol-Myers Squibb Company
 P.O. Box 4000
 Route 206 & Province Line Road
 Princeton, New Jersey 08543-4000
 Attention: Vice President and Chief Patent Counsel
 Telephone: 609-252-4825
 Facsimile: 609-252-7884

 

10.7                        Data Exclusivity and Orange Book Listings. With respect to data exclusivity periods (including any available pediatric extensions) or periods under national implementations of Article 10.1 of Directive 2001/EC/83 (and all international equivalents), Company shall use Commercially Reasonable Efforts consistent with its obligations under applicable Law to seek, maintain and enforce all such data exclusivity periods available for the Licensed Products. With respect to patent listing filings in any FDA Orange Book (and equivalents) for issued patents for a Licensed Product, Company shall, consistent with its obligations under applicable Law, list in a timely manner and maintain all applicable BMS Patent Rights. At least thirty (30) days prior to an anticipated deadline for the filing of patent listing information for BMS Patent Rights, Company shall consult with BMS regarding the content of such filing, and shall consider BMS’s comments in good faith, provided that Company shall have the final decision right with respect to such filing, including the Patent Rights to be listed in any FDA Orange Book or equivalent. BMS shall provide, consistent with its obligations under applicable Law, reasonable cooperation to Company in filing and maintaining such Orange Book (and foreign equivalent) listings.

 

10.8                        Notification of Patent Certification. Company shall notify and provide BMS with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of a BMS Patent Right pursuant to (i) if the Licensed Compound is not a biologic, a Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application, an application under §505(b)(2) or other similar patent certification by a Third Party, and any foreign equivalent thereof, and (ii) if the Licensed Compound is a biologic, a bioequivalent or biosimilar application other similar filing or patent certification by a Third Party, and any foreign equivalent thereof. Such notification and copies shall be provided to BMS within seven (7) days after Company receives such certification, and shall be sent to the address set forth in Section 10.4. In addition, upon request by BMS, Company shall provide reasonable assistance and cooperation (including making available to BMS documents possessed by Company that are reasonably required by BMS and making available personnel for interviews and testimony), at BMS’ cost, in any actions reasonably undertaken by BMS to contest any such patent certification.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

39

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

10.9                        No Conflict Actions. BMS shall not be required to take any action pursuant to Sections 10.4, 10.7 or 10.8 that BMS reasonably determines in its sole judgment and discretion conflicts with or violates any court or government order or decree that BMS is then subject to or otherwise may create legal liability on the part of BMS.

 

10.10                 Assignment of BMS Patent Rights. Notwithstanding any provision in this Agreement to the contrary, BMS shall have the right to transfer or assign ownership of any BMS Patent Rights as long as any such transfer or assignment is made expressly subject to the rights and licenses granted to Company under this Agreement and the transferee or assignee of the transferred or assigned BMS Patent Rights agrees in writing to prosecute and maintain such BMS Patent Rights in accordance with the terms of this Article 10.

 

ARTICLE 11

 

NONDISCLOSURE OF CONFIDENTIAL INFORMATION

 

11.1                        Nondisclosure. Each Party agrees that, for so long as this Agreement is in effect and for a period of [* * *] years thereafter, a Party receiving Confidential Information of the other Party (or that has received any such Confidential Information from the other Party prior to the Effective Date) shall (i) maintain in confidence such Confidential Information using not less than the efforts such Party uses to maintain in confidence its own proprietary industrial information of similar kind and value, (ii) not disclose such Confidential Information to any Third Party without the prior written consent of the other Party, except for disclosures expressly permitted below, and (iii) not use such Confidential Information for any purpose except those permitted by this Agreement (it being understood that this clause (iii) shall not create or imply any rights or licenses not expressly granted under Article 2).

 

11.2                        Exceptions. The obligations in Section 11.1 shall not apply with respect to any portion of the Confidential Information that the receiving Party can show by competent proof:

 

11.2.1              is publicly disclosed by the disclosing Party, either before or after it is disclosed to the receiving Party hereunder; or

 

11.2.2              was known to the receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the disclosing Party; or

 

11.2.3              is subsequently disclosed to the receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and is disclosed without any obligation to keep it confidential or any restriction on its use; or

 

11.2.4              is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the receiving Party; or

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

11.2.5              has been independently developed by employees or contractors of the receiving Party or any of its Affiliates without the aid, application or use of Confidential Information of the disclosing Party.

 

11.3                        Authorized Disclosure. The receiving Party may disclose Confidential Information belonging to the other Party to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:

 

11.3.1              filing or prosecuting patents as set forth in this Agreement;

 

11.3.2              Company’s research, Development or Commercialization (including any import, manufacture, use, offer for sale, or sale) activities, including Company’s regulatory filings, with respect to Licensed Compounds and/or Licensed Product, including any Approvals or applications therefor;

 

11.3.3              prosecuting or defending litigation in relation to the BMS Patent Rights, BMS Know How or this Agreement, including responding to a subpoena in a Third Party litigation, provided it has used good faith and reasonable efforts to obtain a protective order for such Confidential Information;

 

11.3.4              subject to Section 11.4, complying with applicable Laws (including the rules and regulations of the Securities and Exchange Commission or any national securities exchange) and with judicial process, if in the reasonable opinion of the receiving Party’s counsel, such disclosure is necessary for such compliance; provided, however, that except where impracticable, the receiving Party shall give the disclosing Party reasonable advance notice of such disclosure requirement (which shall include a copy of any applicable subpoena or order) and shall afford the disclosing Party a reasonable opportunity to oppose, limit or secure confidential treatment for such required disclosure, and in the event of any such required disclosure, the receiving Party shall disclose only that portion of the Confidential Information of the disclosing Party that the receiving Party is legally required to disclose;

 

11.3.5              disclosure, in connection with the performance of this Agreement and solely on a “need to know basis”, to Affiliates, existing or potential collaborators (including existing or potential co-marketing and co-promotion contractors), research collaborators, employees, consultants, or agents, each of whom prior to disclosure must be bound by written obligations of confidentiality and non-use no less restrictive than the obligations set forth in this Article 11; provided, however, that the receiving Party shall remain responsible for any failure by any Person who receives Confidential Information pursuant to this Article 11 to treat such Confidential Information as required under this Article 11; and

 

11.3.6              made by such Party to existing or potential acquirers or merger candidates; investment bankers; public and private sources of funding; existing or potential investors, venture capital firms or other financial institutions or investors for purposes of obtaining financing, provided that such Party has used good faith and reasonable efforts to secure an

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

41

 

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Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

agreement from any such Third Party to be bound by obligations of confidentiality and restrictions on use of Confidential Information that are no less restrictive than the obligations in this Agreement.

 

If and whenever any Confidential Information is disclosed in accordance with this Section 11.3, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (otherwise than by breach of this Agreement). Where reasonably possible and subject to Section 11.4, the receiving Party shall notify the disclosing Party of the receiving Party’s intent to make such disclosure pursuant to this Section 11.3 sufficiently prior to making such disclosure so as to allow the disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information.

 

11.4                        Terms of this Agreement. The Parties acknowledge that the terms of this Agreement shall be treated as Confidential Information of both Parties. For the avoidance of doubt, this Section 11.4 shall in no way prevent a Party from disclosing the existence of this Agreement or any terms of this Agreement in order to seek legal advice whenever deemed appropriate by such Party or to enforce such Party’s rights under this Agreement, whether through arbitral proceedings, court proceedings or otherwise, or to defend itself against allegations or claims relating to this Agreement, or to comply with Applicable Law (except as provided in Section 11.5 below) when advised in a written opinion of outside counsel that terms of the Agreement are required to be disclosed to comply with Applicable Law.

 

11.5                        Securities Filings. Notwithstanding anything to the contrary in this Agreement, in the event either Party proposes to file with the Securities and Exchange Commission or the securities regulators of any state or other jurisdiction a registration statement or any other disclosure document which describes or refers to this Agreement under the Securities Act of 1933, as amended, the Securities Exchange Act, of 1934, as amended, any other applicable securities Law or the rules of any national securities exchange, the Party shall notify the other Party of such intention and shall use reasonable efforts to provide such other Party with a copy of relevant portions of the proposed filing not less than [* * *] prior to (but in no event later than [* * *] prior to) such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), including any exhibits thereto relating to this Agreement, and shall use reasonable efforts to obtain confidential treatment of any information concerning this Agreement that such other Party requests be kept confidential, and shall only disclose Confidential Information which it is advised by counsel is legally required to be disclosed. No such notice shall be required under this Section 11.5 if the substance of the description of or reference to this Agreement contained in the proposed filing has been included in any previous filing made by the either Party hereunder or otherwise approved by the other Party.

 

11.6                        Publication by Company. Company may publish or present data and/or results relating to a Licensed Compound or Licensed Product developed in the Field in scientific journals and/or at scientific conferences, provided that Company shall notify BMS at least [* * *] days in advance of the intended submission for publication or presentation of any proposed

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

abstract, manuscript or presentation which discloses Confidential Information of BMS or discloses a patentable invention by delivering a copy thereof to BMS. BMS shall have [* * *] days from its receipt of any such abstract, manuscript or presentation in which to notify Company in writing of any specific, reasonable objections to the disclosure, based on concern regarding the specific disclosure of Confidential Information of BMS, and Company will delete any BMS Confidential Information, and consider any other such objections in good faith, including whether it is necessary or advisable to delete any other information from such proposed publication. Once any such abstract or manuscript is accepted for publication, Company shall provide BMS with a copy of the final version of the manuscript or abstract.

 

ARTICLE 12

 

INDEMNITY

 

12.1                        Company Indemnity. Company shall indemnify, defend and hold harmless BMS and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives, from and against any and all damages, liabilities, losses, costs and expenses (including reasonable legal expenses, costs of litigation and reasonable attorney’s fees) arising in connection with any claims, suits, proceedings, whether for money damages or equitable relief, of any kind brought by any Third Party (collectively “Losses and Claims”) and arising out of or relating to (a) the research, Development, Commercialization (including promotion, advertising, offering for sale, sale or other disposition), transfer, importation or exportation, manufacture, labeling, handling or storage, or use of, or exposure to, any Licensed Compound or any Licensed Product by or for Company or any of its Affiliates, Distributors, Sublicensees, agents and contractors, including claims and threatened claims based on product liability, bodily injury, risk of bodily injury, death or property damage, infringement or misappropriation of Third Party patents, copyrights, trademarks or other intellectual property rights (except to the extent such infringement or misappropriation results from a breach of Section 9.2), or the failure to comply with applicable Law related to the matters referred to in this subsection (a) with respect to any Licensed Compound or any Licensed Product, (b) the prosecution, maintenance, enforcement and defense of the BMS Patents by Company, its Affiliates, Sublicensees, representatives and agents; and/or (c) the gross negligence, recklessness or willful misconduct of Company or its Affiliates or its or their respective directors, officers, employees and agents, in connection with Company’s performance of its obligations or exercise of its rights under this Agreement; except in any such case for Losses and Claims to the extent reasonably attributable to any material breach by BMS of Article 11, or BMS having committed an act or acts of gross negligence, recklessness or willful misconduct.

 

12.2                        BMS Indemnity. BMS shall indemnify, defend and hold harmless Company and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives, from and against any and all Losses payable to a Third Party based on Claims brought by a Third Party arising out of or relating to (a) a material breach by BMS of Article 11 or the representations, warranties and covenants of

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

43

 

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Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

BMS set forth in Section 4.1 and/or Article 9, (b) the gross negligence, recklessness or willful misconduct of BMS or its Affiliates or its or their respective directors, officers, employees and agents, in connection with BMS’s performance of its obligations or exercise of its rights under this Agreement, and/or (c) any Development, use, manufacture, or Commercialization of BMS Reversion Products by BMS following the reversion thereof to BMS pursuant to Section 13.4 in the Territory, including any product liability claims in the Territory or any personal injury, property damage or other damage in the Territory arising therefrom; except in any such case for Losses and Claims to the extent reasonably attributable to any material breach by Company of Article 11 of this Agreement, failure of Company to comply with Applicable Law with respect to its Development or Commercialization of the Licensed Compounds or Licensed Products, or Company having committed an act or acts of gross negligence, recklessness or willful misconduct, or to the extent Company has an indemnification obligation to BMS pursuant to Section 12.1.

 

12.3                        Indemnification Procedure. A claim to which indemnification applies under Section 12.1 shall be referred to herein as an “Indemnification Claim”. If any Person or Persons (collectively, the “Indemnitee”) intends to claim indemnification under this Article 12, the Indemnitee shall notify the Party subject to the indemnification obligation (the “Indemnitor”) in writing promptly upon becoming aware of any claim that may be an Indemnification Claim (it being understood and agreed, however, that the failure by an Indemnitee to give such notice shall not relieve Indemnitor of its indemnification obligation under this Agreement except and only to the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice). The Indemnitor shall have the right to assume and control the defense of the Indemnification Claim at its own expense with counsel selected by the Indemnitor and reasonably acceptable to the Indemnitee, provided, however, that an Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitee, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party represented by such counsel in such proceedings. If the Indemnitor does not assume the defense of the Indemnification Claim as aforesaid, the Indemnitee may defend the Indemnification Claim but shall have no obligation to do so. The Indemnitee shall not settle or compromise the Indemnification Claim without the prior written consent of the Indemnitor, and the Indemnitor shall not settle or compromise the Indemnification Claim in any manner which would have an adverse effect on the Indemnitee’s interests (including any rights under this Agreement or the scope or enforceability of the BMS Patents Rights or BMS Know-How), without the prior written consent of the Indemnitee, which consent, in each case, shall not be unreasonably withheld, delayed or conditioned if the settlement or compromise would impose no financial or other obligations or burdens on the Indemnitee. The Indemnitee shall reasonably cooperate with the Indemnitor at the Indemnitor’s expense and shall make available to the Indemnitor all pertinent information under the control of the Indemnitee, which information shall be subject to Article 11.

 

12.4                        Insurance. Company shall, beginning with the initiation of the first clinical trial for a Licensed Product, maintain at all times thereafter during the term of this Agreement, and until the later of (i) [* * *] years after termination or expiration of this Agreement or (ii) the date

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

that all statutes of limitation covering claims or suits that may be brought for personal injury based on the sale or use of a Licensed Product have expired in all states in the U.S., insurance relating to the Licensed Product from a recognized, creditworthy insurance company, on a claims-made basis, with endorsements for contractual liability and for clinical trial and product liability with coverage limits of no less than $[* * *] per claim and $[* * *] in the aggregate. Within ten (10) days following the Effective Date, and within thirty (30) days following any material change or cancellation in coverage, Company shall furnish to BMS a certificate of insurance evidencing such coverage as of such date, and in the case of cancellation, provide a certificate evidencing that Company’s replacement coverage meets the requirements in the first sentence of this Section 12.4. The foregoing insurance requirement shall not be construed to create a limit on the Company’s liability hereunder.

 

ARTICLE 13

 

TERM AND TERMINATION

 

13.1                        Term. This Agreement shall commence as of the Effective Date and, unless sooner terminated in accordance with the terms hereof or by mutual written consent, shall expire on a country-by-country basis and Licensed Product-by-Licensed Product basis, upon the expiration of the Royalty Term with respect to a given Licensed Product in the applicable country.

 

13.2                        Termination by BMS. BMS shall have the right to terminate this Agreement, at BMS’ sole discretion, as follows:

 

13.2.1              Insolvency. To the extent permitted under applicable Laws, BMS shall have the right to terminate this Agreement in its entirety, at BMS’ sole discretion, upon delivery of written notice to Company upon the filing by Company in any court or agency pursuant to any statute or regulation of the United States or any other jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of Company or its assets, upon the proposal by Company of a written agreement of composition or extension of its debts, or if Company is served by a Third Party (and not by BMS) with an involuntary petition against it in any insolvency proceeding, upon the ninety-first (91st) day after such service if such involuntary petition has not previously been stayed or dismissed, or upon the making by Company of an assignment for the benefit of its creditors.

 

13.2.2              Breach. BMS shall have the right to terminate this Agreement in its entirety, at BMS’ sole discretion, (x) as provided in Section 5.6 or (y) upon delivery of written notice to Company in the event of any material breach by Company of this Agreement (except that this Section 13.2.2 shall not apply to any breach of Sections 5.1 or 6.1, which are covered under Section 13.2.3), provided that such breach has not been cured within [* * *] days after written notice is given by BMS to Company; provided, however, that if such breach relates to the failure to make a payment when due, such breach must be cured within [* * *] days after written

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

45

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

notice thereof is given by BMS (except that in the case of a bona fide dispute over whether or to what extent a payment by Company to BMS is due, this Section 13.2.2 shall not be triggered provided that Company shall pay the amount in dispute into escrow until such dispute is resolved). Any such termination of this Agreement shall become effective at the end of the applicable cure period, unless Company has cured any such breach or default prior to the expiration of such cure period.

 

13.2.3              Termination for Failure to Develop or Commercialize. BMS shall have the right to terminate this Agreement in its entirety in the event that Company fails to fulfill its obligations to Develop Licensed Compounds and/or Licensed Products in accordance with Section 5.1, or to Commercialize Licensed Products in accordance with Section 6.1, provided that (a) Company has not cured such breach within [* * *] following written notice by BMS which notice shall be labeled as a “notice of material breach for failure to use Commercially Reasonable Efforts,” and in the case of an alleged breach of Section 6.1, the Major Market Country(ies) in which such breach has occurred. Any such termination of this Agreement shall become effective at the end of the applicable cure period, unless Company has cured any such breach or default prior to the expiration of such cure period.

 

13.2.4              Termination for Patent Challenge.

 

(a)                                 BMS shall have the right to terminate this Agreement in its entirety in the event Company (or any of its Affiliates) challenges or knowingly supports (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim, or in response to a subpoena or court or administrative law request or order), including by providing information, documents, and/or funding, a challenge to the validity, scope, enforceability or patentability of any of the BMS Patent Rights. BMS’s right to terminate this Agreement under this Section 13.2.4 may be exercised at any time after Company (or any of its Affiliates) may have challenged or knowingly supports (other than in response to a subpoena or court order) a challenge to the validity, scope, enforceability or patentability of any of the BMS Patent Rights. For the avoidance of doubt, an action by Company or any Affiliate in accordance with Article 10 to amend claims within a pending patent application within the BMS Patent Rights during the course of Company’s prosecution and maintenance of such pending patent application or in defense of a Third Party proceeding, or to make a negative determination of patentability of claims of a patent application of BMS or to abandon a patent application of BMS during the course of Company’s Prosecution and Maintenance of such pending patent application, shall not, where undertaken in accordance with Article 9 hereof, constitute a challenge under this Section 13.2.4.

 

(b)                                 If a Sublicensee of Company challenges the validity, scope or enforceability of or otherwise opposes any of the BMS Patent Rights under which such Sublicensee is sublicensed, then Company shall, at BMS’ election and upon written notice from BMS, promptly terminate such Sublicense. The Company shall include within each License Agreement with each Sublicensee a right on the part of the Company to terminate such License Agreement in the event such Sublicensee challenges or knowingly supports a Third Party in

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

46

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

challenging (other than in response to a subpoena or court order), in a judicial or administrative proceeding, including without limitation by providing information, documents, or funding, the validity, scope or enforceability of any of the BMS Patent Rights after grant of the patent and (ii) the Company shall exercise such right to terminate the License Agreement with a Sublicensee should such Sublicensee challenge or knowingly support a Third Party in challenging (other than in response to a subpoena or court order) in a judicial or administrative proceeding the validity or enforceability of any of the BMS Patent Rights after grant of the patent. If Company fails to exercise such termination right against such Sublicensee or is unable to do so because it did not include such a provision in its Sublicense, BMS may terminate this Agreement.

 

13.2.5              Termination relating to the Financing. In the event Company should be unable to close the Financing with at least gross proceeds of thirty million US dollars ($30,000,000) in equity investment and/or Indebtedness during the Financing Period (with a minimum of twenty-two million US dollars ($22,000,000) in equity investment), BMS will have the right to terminate the License in its entirety and all licensed rights will revert to BMS. “Financing” means successfully raising gross proceeds of thirty million US dollars ($30,000,000) in equity investment and/or Indebtedness in a single or series of equity raises (with a minimum of twenty-two million US dollars ($22,000,000) in equity investment) and “Financing Period” means the period ending on October 17, 2016, unless extended by mutual agreement of the Parties.

 

13.3                        Termination by Company. Company shall have the right to terminate this Agreement, at Company’s sole discretion, as follows.

 

13.3.1              (x) Upon [* * *] prior written notice in the case where Approval has not been obtained for a Licensed Product or upon [* * *] prior written notice in the case where Approval has been obtained for a Licensed Product, such termination to be effective at the end of such notice period, Company may terminate this Agreement as a whole for any reason, and (y) Company may terminate this Agreement on a country-by-country basis for any non-Major Market Country on [* * *] notice to BMS if it appears that the License is not economically viable for that country(ies).

 

13.3.2              Company may terminate this Agreement in relation to the affected Licensed Product or country in the event of a material breach by BMS, provided that such breach has not been cured within [* * *] days following written notice by Company. Any such termination of this Agreement shall become effective at the end of the applicable cure period, unless BMS has cured any such breach or default prior to the expiration of such cure period.

 

13.4                        Effect of Termination. Upon termination of this Agreement in its entirety by BMS under Section 13.2 or by Company under Section 13.3.1:

 

13.4.1              With respect to termination under Section 13.2 or 13.3.1(x), all rights and licenses granted to Company in Article 2 shall terminate, all rights of Company under the BMS Patent Rights and BMS Know-How shall revert to BMS, and Company and its Affiliates shall

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

cease all use of the BMS Patent Rights, the BMS Know-How and the Transferred Materials, and shall return to BMS all unused portions of the Transferred Materials, subject, in the case of termination pursuant to Section 13.3.1, to BMS’ reimbursement of Company’s actual costs incurred in transferring the Transferred Materials to BMS. If the termination is on a country-by-country basis under Section 13.3.1(y), the above reversion shall only apply to that country(ies). Following the effective date of such termination, all Licensed Compounds and/or Licensed Products shall thereafter be deemed “BMS Reversion Products”.

 

13.4.2              With respect to all regulatory filings (including all INDs and NDAs) and Approvals and all other regulatory documents necessary to further Develop and Commercialize the BMS Reversion Products, as they exist as of the date of such termination (and all of Company’s right, title and interest therein and thereto), BMS shall determine in its sole discretion which of these shall be (i) assigned to BMS, and Company shall provide to BMS one (1) copy of the applicable documents and filings, all documents and filings contained in or referenced in any such filings, together with the raw and summarized data for any preclinical and clinical studies of the BMS Reversion Products as well as any final documentation to inactivate any open INDs as BMS may elect to inactivate, subject, in the case of termination pursuant to Section 13.3.1, to BMS’ reimbursement of Company’s actual costs incurred in transferring such items to BMS, and preparing such items in connection with such transfer, or (ii) withdrawn or inactivated at Company’s expense. For clarity, BMS shall have the right to use the foregoing material information, materials and data developed by Company solely in connection with BMS’ development, manufacture and commercialization of BMS Reversion Products. BMS shall have the right to obtain specific performance of Company’s obligations referenced in this Section 13.4.2 and/or in the event of failure to obtain assignment, Company hereby consents and grants to BMS the right to access and reference (without any further action required on the part of Company, whose authorization to file this consent with any Regulatory Authority is hereby granted) any and all such regulatory filings for any regulatory or other use or purpose in the Territory. Without limiting the foregoing in this paragraph, to the extent applicable, Company’s obligations under Section 10.7 shall continue with respect to all countries in the Territory for which there is a failure to obtain assignment of all regulatory filings and Approvals.

 

13.4.3              All amounts due or payable to BMS that were accrued prior to the effective date of termination shall remain due and payable; but (except as otherwise expressly provided herein) no additional amounts shall be payable based on events occurring after the effective date of termination; provided, that the foregoing shall not be deemed to limit Company’s indemnification obligations under this Agreement for acts or omissions incurring prior to the termination date that are the subject of such indemnification even if the indemnification amount cannot be accrued or determined as of the termination date.

 

13.4.4              BMS shall have the right to retain all amounts previously paid to BMS by Company.

 

13.4.5              Should Company have any inventory of any Licensed Compound included in the BMS Reversion Products suitable for use in clinical trials, Company shall offer to sell such

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Licensed Compound to BMS at the fully burdened manufacturing cost of such Licensed Compound (but BMS shall be under no obligation to purchase same unless it agrees to do so in writing at such time).

 

13.4.6              Should Company have any inventory of any Licensed Product included in the BMS Reversion Products approved and allocated prior to termination, Company shall have six (6) months thereafter in which to dispose of such inventory (subject to the payment to BMS of any royalties due hereunder thereon) (the “Inventory Disposal Period”), provided however, that (i) such right shall terminate at such time that BMS purchases all remaining stocks of inventory of such BMS Reversion Product as described in this Section 13.4.6, below, and (ii) such Licensed Product shall not be sold at a discount to a purchaser that is greater than the average discount provided to such purchaser for the Licensed Product in the applicable country during the twelve (12) month period preceding such termination and, in addition, such sales shall not result in the applicable wholesaler inventory levels for such Licensed Product exceeding the average levels for the twelve (12) month period preceding such termination. Notwithstanding the foregoing, if BMS takes over responsibility for sale of the BMS Reversion Products in any country in the Territory prior to the end of the Inventory Disposal Period, BMS shall be required to purchase all remaining stocks of saleable inventory that meets BMS specifications and return policies of such BMS Reversion Product at Company’s cost of goods sold for such BMS Reversion Product, as accounted for in the Company’s audited financial statements.

 

13.4.7              Company shall provide to BMS the tangible embodiments of all Know-How owned or Controlled by Company and its Affiliates to the extent necessary for the Development and Commercialization of the BMS Reversion Products in existence as of the date of such termination, subject, in the case of termination pursuant to Section 13.3.1, to BMS’ reimbursement of Company’s actual costs and expense incurred in transferring such items, and preparing and making such items in connection with such transfer (without duplicating any amounts reimbursed pursuant to Sections 13.4.2 and 13.4.10), including Company’s manufacturing processes, techniques and trade secrets for making such BMS Reversion Products and all Know-How specifically relating to any composition, formulation, method of use or manufacture of such BMS Reversion Products, and BMS shall automatically have a perpetual, worldwide, transferable, sublicensable right and license under such Know-How solely for (a) researching, Developing, using, importing, selling and offering for sale BMS Reversion Products in the Territory, which license shall be exclusive for purposes of this subpart (a), and (b) making and having made BMS Reversion Products anywhere in the Territory for use, importation, sale and offer for sale in the Territory, which license shall be non-exclusive for purposes of this subpart (b). Company shall reasonably cooperate with BMS to assist BMS with understanding and using the Know-How provided to BMS under this Section 13.4.7. Such cooperation shall include providing BMS with reasonable access by teleconference or in-person at Company’s facilities (subject to Company’s customary rules and restrictions with respect to site visits by non-Company personnel and subject, in the case of termination pursuant to Section 13.3.1, to BMS’ reimbursement of Company’s actual out-of-pocket costs and expense incurred in connection with such cooperation).

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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13.4.8              To the extent that Company owns any trademark(s) and/or domain names that pertain specifically to an BMS Reversion Product that BMS believes would be necessary for the Commercialization of a BMS Reversion Product (as then currently marketed, but not including any marks that include, in whole or part, any corporate name or logo of Company), Company shall assign (or, if applicable, cause its Affiliate to assign) to BMS all of Company’s (and such Affiliate’s) right, title and interest in and to any registered or unregistered trademark, trademark application, trade name or internet domain name in each terminated country.

 

13.4.9              Company shall grant and hereby grants to BMS an exclusive, royalty-bearing (as set forth in Section 13.4.10), non-transferable (except as provided in Section 15.5) license, with the right to grant sublicenses, under (a) any Patent Rights owned or Controlled by Company or its Affiliates as at the effective date of termination and (b) all Patent Rights owned or Controlled by Company or its Affiliates after the date of such termination claiming any invention conceived or reduced to practice by or on behalf of Company during the term of this Agreement, in each case of (a) and (b) to the extent covering the composition of matter, use, or manufacture of BMS Reversion Products (solely to the extent actually practiced in connection with the BMS Reversion Products as of such termination effective date) and that, in each case of (a) and (b), are necessary to develop, manufacture or commercialize BMS Reversion Products. Nothing hereunder is intended to prevent Company from granting licenses under any Patent Rights owned or Controlled by Company or its Affiliates as at the effective date of termination and (b) all Patent Rights owned or Controlled by Company or its Affiliates after the date of such termination claiming any invention conceived or reduced to practice by or on behalf of Company during the term of this Agreement to the extent that the Patent Rights also cover products and/or compounds other than BMS Reversion Products or their use or manufacture.

 

13.4.10                   Company shall provide to BMS all data generated during the term of this Agreement necessary for the development and/or commercialization of the relevant BMS Reversion Products and assign (or, if applicable, cause its Affiliate to assign) to BMS all of Company’s (and such Affiliate’s) entire right, title and interest in and to all such data, subject to BMS’ reimbursement of Company’s actual costs incurred in transferring such items, and preparing and making such items in connection with such transfer (without duplicating any amounts reimbursed pursuant to Sections 13.4.2 and 13.4.7).

 

13.4.11                   Neither Party shall be relieved of any obligation that accrued prior to the effective date of such termination.

 

13.4.12                   BMS shall not owe any other compensation to Company for the research, Development and Commercialization of any BMS Reversion Product in the event of any such termination of the Agreement by BMS.

 

13.4.13                   Any costs and expenses incurred by Company in connection with the assignments and transfers made by Company under this Section 13.4 shall be borne by Company unless BMS terminates this Agreement under Section 13.2.1, in which case such costs and expenses shall be reimbursed by BMS.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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13.4.14                   It is understood and agreed that BMS shall be entitled to specific performance as a remedy to enforce the provisions of this Section 13.4, in addition to any other remedy to which it may be entitled by applicable Law.

 

13.4.15                   If Company has the capability in place as of the date of such termination to commercially manufacture and supply to BMS all or part of BMS’ requirements of the applicable BMS Reversion Products for use and sale in the Territory, if BMS so elects in its sole discretion, Company shall supply to BMS for a period not to exceed [* * *] (with the period of time being within the sole discretion of BMS) as much of BMS’ requirements of such BMS Reversion Products as possible for use and sale in the Territory, at a price equal to [* * *] of Company’s documented fully-burdened manufacturing cost (determined in accordance with GAAP) for such BMS Reversion Products, under terms and conditions as may be mutually agreed between the Parties. In the event that Company has, prior to the date of such termination, engaged a Third Party to manufacture and supply any BMS Reversion Products, Company shall use reasonable efforts, at BMS’ sole cost and expense, to assist in the transfer of such supply arrangements to BMS. In the event that BMS terminates this Agreement under Section 13.2, Company shall supply BMS’ requirements of all such BMS Reversion Products in quantities manufactured for and supplied to Company by such Third Party for a period not to exceed [* * *] (with the period of time being within the sole discretion of BMS) as much of BMS’ requirements of such BMS Reversion Products as possible (not to exceed amounts needed by Company for Development and/or Commercialization by Company); provided however, if there are restrictions in the agreement between Company and such Third Party governing the manufacture and supply of such BMS Reversion Products that would preclude the period from being up to [* * *], then such period shall be up to as long a time as permitted under such agreement. Where Company has engaged a Third Party to manufacture and supply any BMS Reversion Products to Company and BMS elects to have Company supply any portion of BMS’ requirements of such BMS Reversion Products, then Company shall supply such BMS Reversion Products at a price equal to [* * *] of the cost paid by Company to such Third Party plus Company’s shipping, handling, including other reasonable costs associated with providing such BMS Reversion Products to BMS.

 

13.4.16                   Nothing in this Section 13.4 shall be deemed to limit any remedy to which either Party may be entitled by applicable Law.

 

13.5                        Effect of Termination by Company for Breach by BMS. Upon termination of this Agreement by Company pursuant to Section 13.3.2:

 

13.5.1              All rights and licenses granted to Company in Article 2 shall terminate, all rights of Company under the BMS Patent Rights and BMS Know-How shall revert to BMS, and Company and its Affiliates shall cease all use of the BMS Patent Rights, the BMS Know-How and the Transferred Materials, and shall return to BMS all unused portions of the Transferred Materials.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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13.5.2              All amounts due or payable to BMS that were accrued, or that arise out of acts or events occurring, prior to the effective date of termination or expiration shall remain due and payable; but (except as otherwise expressly provided herein) no additional amounts shall be payable based on events occurring after the effective date of termination or expiration.

 

13.5.3              BMS shall have the right to retain all amounts previously paid to BMS by Company.

 

13.5.4              Should Company have any inventory of any Licensed Product approved and allocated prior to termination for sale in a terminated country, Company shall have [* * *] thereafter in which to dispose of such inventory (subject to the payment to BMS of any royalties due hereunder thereon).

 

13.5.5              Neither Party shall be relieved of any obligation that accrued prior to the effective date of such termination or expiration.

 

13.5.6              Nothing in this Section 13.5 shall be deemed to limit any remedy to which Company may be entitled by applicable Law.

 

13.6                        Effect of Expiration of this Agreement. Upon expiration of this Agreement:

 

13.6.1              All amounts due or payable to BMS that were accrued, or that arise out of acts or events occurring, prior to the effective date of expiration shall remain due and payable; but (except as otherwise expressly provided herein) no additional amounts shall be payable based on events occurring after the effective date of expiration.

 

13.6.2              BMS shall have the right to retain all amounts previously paid to BMS by Company.

 

13.6.3              Neither Party shall be relieved of any obligation that accrued prior to the effective date of expiration.

 

13.6.4              The license with respect to BMS Patent Rights and BMS Know-How granted under Section 2.1 shall remain in effect and shall be fully paid-up.

 

13.7                        Scope of Termination. Termination of this Agreement shall be as to all countries in the Territory and all Licensed Compounds and all Licensed Products.

 

13.8                        Survival. The following provisions shall survive termination or expiration of this Agreement, as well as any other provisions which by their nature are intended to survive termination: Article 1 (as applicable), Section 4.1, Sections 8.5 through 8.10 (for three (3) years after the end of the Calendar Year in which this Agreement was terminated), Section 9.5, Section 10.1, Section 10.4 (with respect to an action, suit or proceeding commenced prior to termination), Section 10.8, Article 11, Article 12, whichever one of Sections 13.4 and 13.5 applies, this Section 13.8, Section 13.9, Article 14 and Article 15.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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13.9                        Bankruptcy. The Parties agree that in the event a Party becomes a debtor under Title 11 of the U.S. Code (“Title 11”), this Agreement shall be deemed to be, for purposes of Section 365(n) of Title 11, a license to rights to “intellectual property” as defined therein. Each Party as a licensee hereunder shall have the rights and elections as specified in Title 11. Any agreements supplemental hereto shall be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of Title 11.

 

13.10                 No Limitation of Remedies. Except as herein expressly provided, notwithstanding anything to the contrary in this Agreement, except as otherwise set forth in this Agreement, termination or expiration of this Agreement shall not relieve the Parties of any liability or obligation which accrued hereunder prior to the effective date of such termination or expiration nor prejudice either Party’s right to obtain performance of any obligation. Each Party shall be free, pursuant to Article 14, to seek (without restriction as to the number of times it may seek) damages, costs and remedies that may be available under applicable Law or in equity and shall be entitled to offset the amount of any damages and costs obtained in a final determination under Article 14 of monetary damages or costs (as permitted by this Agreement) against the other Party against any amounts otherwise due to such other Party under this Agreement.

 

ARTICLE 14

 

DISPUTE RESOLUTION

 

14.1                        Resolution by Senior Executives. Except as provided in Sections 8.7 and 14.3, in the event of any dispute between the Parties in connection with this Agreement, the construction hereof, or the rights, duties or liabilities of either Party hereunder, including any disagreement as to whether there has been a material breach of this Agreement pursuant to Sections 13.2.2, 13.2.3, or 13.3.2, the Parties shall first attempt in good faith to resolve such dispute by negotiation and consultation between themselves. In the event that such dispute is not resolved on an informal basis within ten (10) Business Days, either Party may, by written notice to the other Party, refer the dispute to (i) the Chief Executive Officer of Company and (ii) if a scientific matter, the Executive Vice President & Chief Scientific Officer of BMS or, if a commercial matter, the Executive Vice President and Chief Commercial Officer of BMS for attempted resolution by good faith negotiation within thirty (30) days after such notice is received; provided, however, such executive officers of Company and BMS may each designate a senior manager to whom such dispute is delegated instead for such attempted resolution.

 

14.2                        Remedies. Except as provided in Sections 8.7 and 14.3, if any dispute between the Parties relating to or arising out this Agreement cannot be resolved in accordance with Section 14.1, each Party shall be free to pursue any or all available remedies at law or in equity, consistent with Section 15.8.

 

14.3                        Injunctive Relief. Notwithstanding anything in this Article 14, each Party shall have the right to seek injunctive or other equitable relief from a court of competent jurisdiction pursuant to Section 15.8 that may be necessary to avoid irreparable harm, maintain the status quo

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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or preserve the subject matter of the dispute, including any breach or threatened breach of Article 11.

 

ARTICLE 15

 

MISCELLANEOUS

 

15.1                        Right of First Negotiation. Upon delivery of the top-line data from the first Phase III Trial for the most advanced Licensed Product or Licensed Compound, Company shall provide written notice thereof to BMS, including a summary of all data generated by Company as of such time, including any filings with the FDA. Upon receipt of such notice, BMS will have the right to elect to exercise a right of first negotiation (“ROFN”) to regain the rights under the BMS Patent Rights and BMS Know-How, and take a license to any data, know-how, patent rights and other intellectual property rights generated by Company with respect to the Licensed Compounds, as they relate to such Licensed Product (either through a sublicense back to BMS or a buy-out of Company’s rights), for a period of [* * *] of the receipt of the notice by BMS. If BMS and Company, after using good faith efforts, are unable to execute a definitive agreement with respect to such transaction within such period, Company will have the right to enter into discussions with and execute any such Sublicense with respect to such Licensed Product in the Territory, subject to the applicable provisions of this Agreement relating to Sublicenses.

 

15.2                        Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable, 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 any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement with respect to such provision may be realized.

 

15.3                        Notices. Any notice required or permitted to be given by this Agreement shall be in writing and shall be delivered by hand or overnight courier with tracking capabilities or mailed postage prepaid by first class, registered or certified mail, return receipt requested or electronic means with proof of delivery and addressed as set forth below unless changed by notice so given:

 

If to Company:

 

Biohaven Pharmaceutical Holding Company Ltd.
 234 Church Street, Suite 304
 New Haven, Connecticut 06510
 Attention: Dr. Vladimir Coric, CEO
 Email: [* * *]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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With a copy to:
 Mr. Douglas Gray
 Locke Lord, LLP
 One Financial Plaza
 Providence, RI 02903
 Email: [* * *]

 

If to BMS:

 

Bristol-Myers Squibb Company
 P.O. Box 4000
 Route 206 & Province Line Road

Princeton, New Jersey 08543-4000
 Attention: Vice President, Business Development
 Email: [* * *]

 

With a copy to:

 

Bristol-Myers Squibb Company
 P.O. Box 4000
 Route 206 & Province Line Road
 Princeton, New Jersey 08543-4000
 Attention: Vice President & Assistant General Counsel, Business Development and Licensing

 

Any such notice shall be deemed delivered on the date received. A Party may add, delete, or change the person or address to whom notices should be sent at any time upon written notice delivered to the Party’s notices in accordance with this Section 15.2.

 

15.4                        Force Majeure. Neither Party shall be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to causes beyond its reasonable control, including acts of God, fires, earthquakes, strikes and labor disputes, acts of war, terrorism, civil unrest or intervention of any governmental authority (“Force Majeure”); provided, however, that the affected Party promptly notifies the other Party and further provided that the affected Party shall use Commercially Reasonable Efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance with the utmost dispatch whenever such causes are removed. When such circumstances arise, the Parties shall negotiate in good faith any modifications of the terms of this Agreement that may be necessary or appropriate in order to arrive at an equitable solution.

 

15.5                        Assignment.

 

15.5.1              BMS may, without Company’s consent, (x) assign, delegate or transfer some or all of its rights and obligations hereunder to any Affiliate of BMS, and (y) assign or

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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transfer, in connection with any transfer or assignment of all of the BMS Patent Rights and BMS Know-How, to any Third Party (including a successor in interest by reason of merger, consolidation or sale of substantially all of the assets of BMS to which this Agreement relates).

 

15.5.2              Company may assign or transfer all of its rights and obligations hereunder without BMS’s consent to a successor in interest by reason of merger, consolidation or sale of substantially all of the assets of Company related to the Licensed Compounds or Licensed Products (and so long as such assignment or transfer includes, without limitation, all Approvals, all manufacturing assets relating to this Agreement, and all rights and obligations under this Agreement); provided, however, that such successor in interest shall have agreed prior to such assignment or transfer to be bound by the terms of this Agreement in a writing provided to BMS and no such assignment shall relieve the Company of any obligations or liability accrued prior to the date of assignment except as may be agreed to in writing by BMS.

 

15.5.3              Subject to the foregoing, this Agreement shall inure to the benefit of, and be binding on, the Parties’ permitted successors and assigns. Any assignment or transfer in violation of the foregoing shall be null and void and wholly invalid, the assignee or transferee in any such assignment or transfer shall acquire no rights whatsoever, and the non-assigning, non-transferring Party shall not recognize, nor shall it be required to recognize, such assignment or transfer.

 

15.5.4              In the event that BMS assigns, delegates or otherwise transfers this Agreement, in whole or in part, to an Affiliate of BMS, BMS hereby agrees to be jointly and severally liable with any such Affiliates for the actions of such Affiliates and for any and all amounts that become due and payable hereunder to Company. In the event that Company assigns or otherwise transfers or assigns this Agreement to an Affiliate of Company, Company hereby agrees to be jointly and severally liable with any such Affiliates for the actions of such Affiliates and for any and all amounts that become due and payable hereunder to BMS. If Company transfers or assigns this Agreement, and such transfer or assignment has an adverse tax consequence to BMS, then Company shall make additional payments BMS under this Agreement to provide BMS the payments that would have been due to BMS had such transfer or assignment not occurred.

 

15.5.5              Notwithstanding anything to the contrary in this Agreement, in the event of any such transfer or assignment to a Third Party (including a successor in interest by reason of merger, consolidation or sale of assets permitted), the intellectual property rights of the acquiring party (if other than one of the Parties) or the acquired Party (if acquired by a Party or its Affiliates) shall not be included in the technology licensed to the other Party hereunder to the extent (x) held by such Party that is acquired or is acquiring a Third Party prior to such transaction, or (y) such technology is developed thereafter outside the scope of activities conducted with respect to the Licensed Compounds or Licensed Products.

 

15.6                        Further Assurances. Each Party agrees to do and perform all such further acts and things and shall execute and deliver such other agreements, certificates, instruments and

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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documents necessary or that the other Party may deem advisable in order to carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.

 

15.7                        Waivers and Modifications. The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification, release or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by each of the Parties.

 

15.8                        Choice of Law. This Agreement shall be governed by, enforced, and shall be construed in accordance with the laws of the State of New York without regard to its conflicts of law provisions (other than section 5-1401 of the New York General Obligations Law).

 

15.9                        Jurisdiction. Each Party irrevocably submits to the exclusive jurisdiction of (i) the Supreme Court of the State of New York, New York County, and (ii) the United States District Court for the Southern District of New York, for the purposes of any suit, action or other proceeding arising out of this Agreement or out of any transaction contemplated hereby. Each Party agrees to commence any such action, suit or proceeding either in the United States District Court for the Southern District of New York or if such suit, action or other proceeding may not be brought in such court for jurisdictional reasons, in the Supreme Court of the State of New York, New York County. Each Party irrevocably and unconditionally waives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement or the transactions contemplated hereby in (i) the Supreme Court of the State of New York, New York County or (ii) the United States District Court for the Southern District of New York, and hereby and thereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.

 

15.10                 Publicity. Each Party agrees not to issue any press release or other public statement disclosing other information relating to this Agreement or the transactions contemplated hereby without the prior written consent of the other Party, such consent not to be unreasonably withheld, delayed or conditioned, provided, however, that any disclosure which is required by Law or the rules of a securities exchange, as reasonably advised by the disclosing Party’s outside counsel, and provided, further, that Company may from time to time issue public statements relating to the ongoing Development and/or Commercialization of Licensed Compounds and/or Licensed Products (excluding disclosure of the financial terms of this Agreement) pursuant to this Agreement without the prior written consent of BMS. The Parties agree that any such required disclosure shall not contain confidential business or technical information and, if disclosure of confidential business or technical information is required by Law, the Parties shall use appropriate diligent efforts to minimize such disclosure and obtain confidential treatment for any such information which is disclosed to a governmental agency. Each Party agrees to provide to the other Party a copy of any public announcement regarding this

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Agreement or the subject matter thereof as soon as reasonably practicable under the circumstances prior to its scheduled release. Except under extraordinary circumstances, each Party shall provide the other with an advance copy of any such announcement at least five (5) business days prior to its scheduled release. Each Party shall have the right to expeditiously review and recommend changes to any such announcement and, except as otherwise required by Law, the Party whose announcement has been reviewed shall remove any information the reviewing Party reasonably deems to be inappropriate for disclosure. The contents of any announcement or similar publicity which has been reviewed and approved by the reviewing Party can be re-released by either Party without a requirement for re-approval.

 

15.11                 Relationship of the Parties. Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute BMS and Company as partners, agents or joint venturers. Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party.

 

15.12                 Headings. Headings and captions are for convenience only and are not be used in the interpretation of this Agreement.

 

15.13                 Entire Agreement. This Agreement constitutes the entire agreement between the Parties as to the subject matter of this Agreement, and supersedes and merges all prior negotiations, representations, agreements and understandings regarding the same.

 

15.14                 Counterparts; Electronic Delivery. This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument. Signatures to this Agreement transmitted by email in “portable document format” (“.pdf”), or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement shall have the same effect as physical delivery of the paper document bearing original signature.

 

15.15                 Performance by Affiliates. Each Party recognizes that the other Party may perform some or all of its obligations under this Agreement through Affiliates to the extent permitted under this Agreement; provided, however, that such other Party shall remain responsible for the performance by its Affiliates as if such obligations were performed by such other Party.

 

15.16                 Exports. Company agrees not to export or re-export, directly or indirectly, any information, technical data, the direct product of such data, samples or equipment received or generated under this Agreement in violation of any applicable export control Laws.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

15.17                 Interpretation.

 

15.17.1                   Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

 

15.17.2                   The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”. The word “will” shall be construed to have the same meaning and effect as the word “shall”. The word “any” shall mean “any and all” unless otherwise clearly indicated by context.

 

15.17.3                   Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument or other document herein shall 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 or therein), (b) any reference to any Laws herein shall be construed as referring to such Laws as from time to time enacted, repealed or amended, (c) any reference herein to any Person shall be construed to include the Person’s successors and assigns, (d) the words “herein”, “hereof’ and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (e) all references herein to Articles, Sections or Appendices, unless otherwise specifically provided, shall be construed to refer to Articles, Sections and Appendices of this Agreement; and (f) the term “and/or” in a sentence shall be construed such that the phrase “X and/or Y” means “X or Y, or both X and Y”.

 

15.17.4                   This Agreement should be interpreted in its entirety and the fact that certain provisions of this Agreement may be cross-referenced in a Section shall not be deemed or construed to limit the application of other provisions of this Agreement to such Section and vice versa.

 

* * *

 

[SIGNATURE PAGE FOLLOWS]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized officers.

 

	
 
    	
 
    	
BIOHAVEN PHARMACEUTICAL HOLDING   COMPANY LTD
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
By:
    	
/s/   Vlad Coric, M.D.
    
	
 
    	
 
    	
 
    	
(Signature)
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
Name:
    	
Vlad   Coric, M.D.
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
Title:
    	
CEO
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
Date:
    	
July 8,   2016
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
BRISTOL-MYERS SQUIBB COMPANY
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
By:
    	
/s/   Graham R. Brazier
    
	
 
    	
 
    	
 
    	
(Signature)
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
Name:
    	
Graham   R. Brazier
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
Title:
    	
Vice   President, Business Development
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
Date:
    	
July 8,   2016
    

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix 1a

 

BMS Patent Rights covering the Lead Compounds

 

	
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Filing Number
    	
 
    	
Filing
   Date
    	
 
    	
Grant Number
    	
 
    	
Grant
   Date
    	
 
    	
Expiry
   Date
    	
 
    	
Status
    
	
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix 1b

 

BMS Patent Rights other than those covering the Lead Compounds

 

	
Docket Number
    	
 
    	
Country
    	
 
    	
Filing
   Number
    	
 
    	
Filing
   Date
    	
 
    	
Publication
    	
 
    	
Publication
   Number
    	
 
    	
Grant
   Number
    	
 
    	
Grant Date
    
	
[* * *]
    	
 
    	
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix 2

 

Initial Development Plan

 

[* * *]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix 3

 

Lead Compounds

 

[* * *]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix 4

 

Transferred Materials to be provided by BMS

 

[* * *]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix 5
  Documentation to be provided

 

[* * *]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix 6

 

[* * *]

 

Exhibit A to Appendix 6

See attached.

 

Exhibit B to Appendix 6

See attached.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

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