Document:

Third Amendment to the Exclusive License and Collaboration Agreement

 Exhibit 10.1 

EXECUTION COPY 

THIRD AMENDMENT 

TO 

EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT 

This Third Amendment (this “Amendment”) to the Exclusive License and Collaboration Agreement effective as of
October 16, 2006 (“Original Agreement,” as amended by that certain First Amendment effective as of October 16, 2008 (“First Amendment”) and that certain Second Amendment effective as of October 16,
2009 (“Second Amendment”) (the Original Agreement, as amended by the First Amendment and the Second Amendment, the “Agreement”) is made effective as of April 30, 2010 (the “Third Amendment Effective
Date”) and entered into by and between Hoffmann-La Roche Inc., a New Jersey corporation located at 340 Kingsland Street, Nutley, New Jersey 07110 (“Roche Nutley”), and F.Hoffmann-La Roche Ltd, a Swiss
corporation, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”; Roche Nutley and Roche Basel are collectively referred to as “Roche”), on the one hand, and InterMune,
Inc., a Delaware corporation with its principal place of business at 3280 Bayshore Boulevard, Brisbane, California 94005 (“InterMune”), on the other hand. 

WHEREAS, InterMune and Roche wish to enter into this Amendment to the Agreement to (i) further extend the Research Program
Term (and consequently the [*]) for an additional amount of time set forth herein; (ii) extend the date by which Roche is to provide to InterMune a definitive Development Budget for the First DAA Program (as defined below); (iii) provide
for the sharing by [*] of certain [*] and [*] associated with the First DAA Program; (iv) [*] the royalty payable by Roche for Net Sales in the ROW Territory for any Product containing ITMN-191 as the Licensed Compound; (v) provide
InterMune with [*]; and (vi) provide for a mechanism to determine the appropriate sharing of costs and expenses associated with possible future Co-Funded Development of Licensed Compounds under a Follow-on DAA Program (as defined below). 

 NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for good
and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Roche and InterMune hereby agree as follows: 
  

	1.	Any capitalized term not otherwise defined herein shall have the meaning ascribed to it in the Agreement. 

 

	2.	The Parties acknowledge and agree that the Research Program Term (as previously extended by the First Amendment and the Second Amendment) expired on [*] under the
existing terms and conditions of the Agreement. The Parties hereby agree to extend further the Research Program Term from [*] until [*] (the “Extended Research Program Term”). As a result of this Amendment, the definition of
“Research Program Term” for purposes of the Agreement shall include the Extended Research Program Term, with the express exception of Section 12.2 of the Agreement. The Parties agree that the [*] provided for in the Agreement (as
previously extended by the First Amendment and the Second Amendment) shall [*]. 

  

	[*] =	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS. 

	3.	The Parties shall work together to modify the Research Plan, as appropriate, to specify the ongoing activities of the Research Program during the Extended Research
Program Term consistent with the guidelines set forth in Schedule 1.1 attached to this Amendment (“Schedule 1.1”). For purposes of the Extended Research Program Term, the definition of “Research Program” under the
Agreement, as amended by the First Amendment, the Second Amendment and this Amendment, shall include those activities contemplated in the revised Research Plan. 

 

	4.	The Parties acknowledge and agree that as of the Third Amendment Effective Date, pursuant to the Second Amendment, Roche is currently funding [*] ([*]) InterMune FTEs
assigned to the Research Program. The Parties hereby agree that Roche shall continue to fund [*] percent ([*]%) of the Research Program activities as follows: 

 

	 	1.4.1	From and after [*] until [*], Roche shall continue to fund [*] ([*]) InterMune FTEs assigned to the Research Program at an FTE rate equal to CHF [*] ([*]). As also
provided in the First Amendment, on a Calendar Quarter basis, InterMune shall invoice Roche for the actual FTEs used, not to exceed [*] ([*]) FTEs, at the FTE rate set forth herein that were incurred during the relevant Calendar Quarter and payment
for each invoice shall be made by Roche to InterMune at the same time cash settlement is made between the Parties based on the Reconciliation Statement process described in Section 1.6 of Exhibit A attached to the Agreement.

  

	 	B.	From and after [*] until [*], Roche shall [*], which use shall be consistent with the Research Plan and the guidelines set forth in Schedule 1.1. Furthermore, as also
provided in the First Amendment, the Parties agree that the JRC shall continually review, discuss and monitor the use of various Third Party vendors and the incurrence of costs from such use. On a Calendar Quarter basis, InterMune shall provide to
Roche copies of all invoices received by such Third Party vendors to evidence such actual costs incurred during the relevant Calendar Quarter and [*]. 

  

	 	C.	Notwithstanding subsections (A) and (b) of this Section 4, the Parties acknowledge that, as of the Third Amendment Effective Date, InterMune has invoiced
Roche for the [*] and the [*] in an aggregate amount of US$[*]. 

  

	5.	In the event InterMune undergoes and closes a Change of Control transaction at any time during the Extended Research Program Term, the Extended Research Program Term
and the [*] shall automatically terminate upon the closing of such Change of Control transaction. However, Roche’s obligation [*] of termination of the Extended Research Program Term shall survive such early termination and Roche will [*] as a
result of the Research Program. 

  

	6.	Roche shall have the right to credit [*] percent ([*]%) of all amounts paid by Roche to InterMune to fund the Research Program during the Extended Research Program
Term, including those amounts set forth in Section 4 A., B., and C. (US $[*]) of this Amendment. against any Licensed Compound Payment(s) otherwise due and payable to InterMune pursuant to Section 5.3.3 of the Agreement in connection with
the designation by Roche of additional Licensed Compounds. 

  

	[*] =	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS. 

	7.	The period of time during which Roche has the right to add or substitute Licensed Compounds pursuant to Sections 5.3.3 and 5.3.2 of the Agreement shall be extended for
a period of [*] ([*]) months following the expiration of the Extended Research Program Term. 

  

	8.	By way of background, as a subpart of the Co-Funded Development of ITMN-191, the Parties are engaging in the Development of ITMN-191 [*] (the “First DAA
Program”). The Parties acknowledge that during the 2009 Calendar Year Roche and InterMune have shared in the [*] and [*] incurred in the First DAA Program on an [*] percent ([*]%) basis for [*] and [*] percent ([*]%) basis for [*]. The
Agreement currently provides that Roche shall provide to InterMune no later than [*] a definitive Development Budget for the First DAA Program. 

  

	9.	With respect to such First DAA Program, Roche shall provide to InterMune no later than [*] a definitive First DAA Program Development Budget (prepared in the same good
faith, commercially reasonable manner as the Co-Funded Development Plan is prepared in accordance with Section 4.3.7(a)(iii) of the Agreement and substantially consistent with the Parties’ understanding of the First DAA Program as of the
Third Amendment Effective Date) (“Finalized First DAA Program Development Budget”). From and after [*] and until [*], Roche and InterMune shall share in the [*] and [*] incurred in the First DAA Program Development during [*] on a
[*] ([*]%) basis for [*] and [*] percent ([*]%) basis for [*]; provided, however, that any variances to the Preliminary STAT-C Development Budget will be handled in the same manner as that set forth in Section 1.3 of Exhibit A attached
to the Agreement. 

  

	10.	From and after the delivery of the Finalized First DAA Program Development Budget and until such time as InterMune exercises [*] (as set forth in Section 13 of
this Amendment and [*] of the Agreement) (an “[*]”): (a) [*], Roche and InterMune shall share [*] or [*] incurred in the First DAA Program Development portion of the ITMN-191 Co-Funded Development Plan on a [*] percent ([*]%)
basis for [*] and [*] percent ([*]%) basis for [*]; and (b) for each [*], Roche and InterMune shall share [*] or [*] incurred in the First DAA Program Development portion of the ITMN-191 Co-Funded Development Plan on a [*] percent ([*]%) basis
for [*] and [*] percent ([*]%) basis for [*]; provided, however, that in each of (a) and (b) above, [*] shall bear [*] or [*] incurred in the First DAA Program Development that exceeds [*] percent ([*]%) in total of the Finalized
First DAA Program Development Budget presented by Roche to InterMune hereunder. 

  

	11.	All the terms and conditions contained in Section 4.3.7(a)(iii) of the Agreement with respect to [*] or [*] incurred in connection with all other aspects of the
ITMN-191 Co-Funded Development Plan remain unchanged and in full force and effect, including but not limited to [*] obligation to bear [*] or [*] that exceed [*] percent ([*]%) in total of the initial ITMN-191 Co-Funded Development Budget presented
by Roche to InterMune thereunder. In terms of the guiding principles for capturing, reporting and consolidating the Development Expenses and Other Out of Pocket Costs for the First DAA Program, the Parties agree that the same principles set forth in
the Agreement, including, but not limited to Exhibit A thereto, shall apply and that the budget contained in the Preliminary STAT-C Development Budget and, when applicable, the Finalized First DAA Program Development Budget shall be deemed a part of
the Co-Funded Development Budget for such purposes. 

  

	[*] =	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS. 

	12.	The royalties payable by Roche to InterMune for Net Sales in the ROW Territory for any Product containing ITMN-191 as the Licensed Compound (a “191
Product”) shall be [*] by [*] percent ([*]%) for the applicable Royalty Period. For clarity, the royalties otherwise payable by Roche to InterMune under the Agreement for any other Product remain unchanged and in full force and effect.

  

	13.	In addition to the [*] which InterMune shall retain under [*] of the Agreement, InterMune shall have a period of [*] ([*]) days following receipt of the Finalized First
DAA Program Development Budget to elect to exercise [*] with respect to [*]). In the event InterMune elects not to exercise the [*], InterMune shall have a right to elect to exercise its Opt-Out rights with respect to any ITMN-191 Development,
including but not limited to, the First DAA Program, one time in each Calendar Year thereafter, by providing notice to Roche between September 15 and November 15 of such Calendar Year (the “Subsequent 191 Opt-Out” and
together with the [*], the “[*]”). 

 In the event InterMune elects to exercise its [*], InterMune
may do so by providing to Roche a written notice of its intent to exercise its [*] during the time periods set forth in the immediately preceding paragraph, which [*] shall be effective upon such written notice. Should InterMune elect to exercise
such [*], such [*] shall be subject to the same consequences as those consequences set forth in [*] of the Agreement. For purposes of clarity, notwithstanding anything to the contrary contained in the Agreement, (i) such [*] shall be in
addition to the [*] with respect to [*] provided for in [*] of the Agreement; (ii) in the event InterMune exercises its [*] with respect to [*] under [*] of the Agreement, InterMune shall be deemed to have also [*]; and (iii) in the event
InterMune exercises its [*], InterMune shall be deemed to have also [*] of any further [*] (including, but not limited to, [*]) with the same consequences set forth in [*] of the Agreement. 

For all intent and purposes of the Agreement, the definition of [*] is hereby amended to also include the exercise by [*] right provided
in this Section 13 of this Amendment. 
  

	14.	The Parties also hereby acknowledge and agree that they may engage in the Development of [*]) [*] consisting of such Licensed Compound and [*] (each, a
“Follow-on DAA Program”). Section 4.3.7(a)(iii) shall apply with respect to the timing of any notice related to Co-Funded Development (including the applicable Co-Funded Development Budget) for such Follow-on DAA Program;
provided, that the Parties will allocate related [*] ([*] in a [*] (including the [*]) included in such [*] for which Roche has [*]. For example, if a Licensed Compound is being Developed as a [*] for which Roche has [*], then InterMune would
be responsible for [*] of the [*] ([*]) or if a Licensed Compound is being Developed as a [*] for which Roche has [*], then InterMune would be responsible for [*] of the [*] ([*]). If Roche has [*], then the Parties shall discuss in good faith the
appropriate allocation of [*] ([*] and taking into account relevant considerations, including but not limited to the [*] and the [*]). 

  

	[*] =	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS. 

	15.	Except as specifically modified and amended by this Amendment, the Agreement remains unchanged and in full effect between the Parties. 

 

	16.	This Amendment may be signed by the parties in counterparts, which signatures, taken as a whole, shall constitute a single effective agreement.

 [Signature Page Follows] 

 

	[*] =	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS. 

 IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Third Amendment Effective
Date. 
  

									
	HOFFMANN-LA ROCHE INC.	  		  	INTERMUNE, INC.
					
	BY:	  	  
	  		  	BY:	  	  

	NAME:	  	  
	  		  	NAME:	  	  

	TITLE:	  	  
	  		  	TITLE:	  	  

	DATE:	  	  
	  		  	DATE:	  	  

				
	F.HOFFMANN-LA ROCHE LTD	  		  		  	
					
	BY:	  	  
	  		  		  	
	NAME:	  	  
	  		  		  	
	TITLE:	  	  
	  		  		  	
	DATE:	  	  
	  		  		  	
					
	BY:	  	  
	  		  		  	
	NAME:	  	  
	  		  		  	
	TITLE:	  	  
	  		  		  	
	DATE:	  	  
	  		  		  	

  

	[*] =	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS. 

 SCHEDULE 1.1 

GUIDELINES FOR EXTENSION OF RESEARCH PROGRAM 

InterMune and Roche will continue to collaborate on the discovery and preclinical development of [*]. 

The primary purpose of the extension of the Research Program is to nominate and develop [**]. The Parties anticipate that during the extension period,
InterMune will disclose in more detail InterMune Know-How to Roche concerning [*], the use of which by Roche shall be expressly subject to the scope of the license grants by InterMune to Roche under the Agreement. 

 

			
	Estimated FTE
	 	  	01/10 – 06/10
	 Synthetic chemistry
	  	[*]
	 Computational chemistry/Roche functional area liaison
	  	[*]
	 CRO manager/Lead medicinal chemist/Roche functional area
liaison
	  	[*]
	 Compound screening/Kinetic characterization/mutant enzyme
activity
	  	[*]
	 Biochemistry management/Roche functional area liaison
	  	[*]
	 Compound screening/Antiviral activity characterization (clearance,
synergy)
	  	[*]
	 Biology management/Roche functional area liaison
	  	[*]
	 	 
	 Toxicology
	  	[*]
	 Formulation
	  	[*]
	 Bioanalytics
	  	[*]
	 ADME
	  	[*]
	 DMPK management/Roche functional area liaison
	  	[*]
	
Total  
	  	[*]

 

	[*] =	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS. 

			
	**Estimated pass through cost (US$ in thousands)
	 	  	01/10 – 06/10
	 Synthetic chemistry
	  	[*]
	 Structural Biology
	  	[*]
	 PK
	  	[*]
	 Protein Production
	  	[*]
	 License Fees
	  	[*]
	Total	  	[*]

	**	Current good faith estimate only. Actual costs may differ. 

  

	[*]=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.Amendment No. 1 to Emtricitabine Manufacturing Supply Agreement

 Exhibit 10.68 

EMTRICITABINE MANUFACTURING SUPPLY AGREEMENT 

AMENDMENT NO. 1 

THIS AMENDMENT (the “Amendment No. 1”) to the Emtricitabine Manufacturing Supply Agreement is entered into as of
April 30, 2010, by and between Evonik Degussa GmbH (formerly known as Degussa AG), a German limited liability company (“Evonik”) and Gilead Sciences Limited, an Irish limited company (“GSL”). 

WHEREAS Evonik and GSL entered into the Emtricitabine Manufacturing Supply Agreement dated as of June 6, 2006 (the
“Agreement”); and 
 WHEREAS the Parties hereto wish to amend the Agreement in accordance with
Section 30 thereof and agree upon certain additional terms set forth in this Amendment No. 1. 
 NOW,
THEREFORE, in consideration of the mutual covenants herein contained and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows: 

1. Amendment to Preamble. The first and second Recitals of the Preamble are hereby deleted in their entirety and replaced
with the following: 
 WHEREAS, Evonik is a manufacturer of active pharmaceutical ingredients with expertise in cGMP
manufacturing, and GSL and its designees manufacture and market pharmaceutical products for human use, including, but not limited to, emtricitabine 200 mg, known as Emtriva (“Finished Product”); 

WHERAS, Evonik and GSL desire to establish mutually agreeable terms for the commercial supply of bulk emtricitabine
(“FTC” or “API”) by Evonik to GSL for use in the manufacture of Finished Product; 
 2.
Amendment to Section 2. Section 2 is hereby deleted in its entirety and replaced with the following: 
  

	 	2	TERM: The term of this Agreement shall begin as of the Effective Date, and shall remain in effect until December 31, 2014 (“Term”), unless
earlier terminated by either Party according to Section 12 “Termination” of this Agreement. 

 3.
Amendment to Section 3(b). The second sentence of Section 3(b) is hereby amended by deleting the proviso that reads, “provided, however, GSL shall have [*].” 

4. Amendment to Section 10. Section 10 is hereby deleted in its entirety and replaced with the following: 

 

	 	10	 QUANTITY AND PRICE: Subject to adjustment as provided in this Agreement, GSL will pay to Evonik the [*] Selling Price (as hereinafter
defined) derived from the applicable base selling price per kilogram FTC as set forth in Exhibit A of this Amendment No. 1 (the 

 

 [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 

	 	 
“Base Selling Price”). The baseline for all adjustments of the Base Selling Price and the quantities is [*]. The Parties agree (i) to conduct [*] review
of the then-current Base Selling Price each [*] and re-establish the Base Selling Price and [*] Selling Price on [*] for the [*] and (ii) to discuss any adjustments that may be required to the then current Base
Selling Price applicable to orders in [*], in accordance with, and subject to, the following provisions and adjustments (which adjustments may occur at any time during [*]): 

 

	 	a)	Adjustment during [*] due to Changes in Cost of Standard Raw Materials. 

 

	 	(1)	If, at any time during [*], the aggregate cost (including, but not limited to, [*]) of all raw materials to be purchased by Evonik (not including Key Raw
Materials (as hereinafter defined)) for the manufacture of FTC (collectively “Standard Raw Materials”) in Euro per kilogram of FTC (“Current Aggregate Standard Raw Material Cost”) is projected by Evonik to increase
or decrease during [*] by more than [*] percent ([*]%) of the aggregate cost (including, but not limited to, [*]) in Euro per kilogram of FTC upon which the then-applicable Base Selling Price was based (“Baseline
Aggregate Standard Raw Material Cost”) then, in each case, Evonik shall inform GSL in due course in writing of such increase or decrease above or below the Baseline Aggregate Standard Raw Material Cost (“Evonik Standard Raw Material
Cost Notice”) and the Parties shall in due course discuss such increase or decrease in accordance with subsections (a)(2) and (a)(3) below. 

  

	 	(2)	If, at any time during [*], the Current Aggregate Standard Raw Material Cost are projected by Evonik to decrease by more than [*] percent ([*]%) of
the Baseline Aggregate Standard Raw Material Cost, the Parties shall review and agree upon appropriate adjustments so as to [*] of the Baseline Aggregate Standard Raw Material Cost. 

 

	 	(3)	If, at any time during [*], the Current Aggregate Standard Raw Material Cost are projected by Evonik to increase by more than [*] percent ([*]%) of
the Baseline Aggregate Standard Raw Material Cost, GSL shall, within a period of [*] ([*]) business days after receipt of the Evonik Standard Raw Material Cost Notice (“Standard Raw Material Response Period”), either:

 (i) [*]; or 

(ii) provide Evonik in a signed writing alternatives to [*]. 

If GSL provides Evonik with alternatives pursuant to (ii) above, then the Parties shall [*] within [*] ([*])
business days after the expiration of the Standard Raw Material Response Period (the “SRM Alternative Period”). As part of such discussions, Evonik shall estimate, and GSL will agree upon, [*] (collectively, the
“Estimated SRM Alternative Costs”). If the actual costs of 
  

 2 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 

 
implementing and operating the selected alternatives (the “Actual SRM Alternative Costs”) [*]. If the Actual SRM Alternative Costs are [*]. 

If, during the SRM Alternative Period, the Parties [*]. 

For clarity, from the time that Evonik first projects a [*]% increase or decrease in Current Aggregate Standard Raw Material Cost
under (a)(1) above until the earlier of [*]; provided, however, that Evonik may [*]. After the expiration of the earliest of (A), (B), (C) or (D) above Evonik may [*]. 

 

	 	(4)	The adjustments to be made pursuant to subsection (2) and (3), respectively, may be realized, at GSL’s choice, [*]. 

 

	 	b)	Adjustment during [*] due to Changes in Cost of Key Raw Materials. 

  

	 	(1)	If, at any time, during [*], the aggregate cost (including, but not limited to, [*]) of [*] to be purchased by Evonik for the production of
FTC (collectively “Key Raw Materials”) in Euros per kilogram of FTC (“Current Aggregate Key Raw Material Cost”) is projected by Evonik to increase or decrease during [*] above or below the aggregate cost
(including, but not limited to, [*]) in Euros per kilogram of FTC upon which the then-applicable Base Selling Price was based (“Baseline Aggregate Key Raw Material Cost”), then, in each case, Evonik shall inform GSL in
writing of such increase or decrease above or below the Baseline Aggregate Key Raw Material Cost (“Evonik Key Raw Material Cost Notice”) and the Parties shall in due course discuss such increase or decrease in accordance with
subsections (b)(2) and (b)(3) below. For purposes of determining the Current Aggregate Key Raw Material Cost, Evonik will [*] 

  

	 	(2)	If, at any time during [*], the Current Aggregate Key Raw Material Cost is projected to decrease below the Baseline Aggregate Key Raw Material Cost, the
Parties shall [*]. 

  

	 	(3)	If, at any time during [*], the Current Aggregate Key Raw Material Cost are projected to increase above the Baseline Aggregate Key Raw Material Cost, GSL
shall, within a period of [*] ([*]) business days after receipt of the Evonik Key Raw Material Cost Notice (“Key Raw Material Response Period”), either: 

(i) [*]; or 

(ii) provide Evonik in a signed writing alternatives to [*]. 

If GSL provides Evonik with alternatives pursuant to (ii) above, then the Parties shall [*] within [*] ([*])
business days after the expiration of the Key Raw Material Response Period (the “KRM Alternative Period”). As part of such discussions, Evonik shall 

 

 3 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 

 
estimate, and GSL will agree upon, [*] (collectively, the “Estimated KRM Alternative Costs”). If the actual costs of implementing the selected alternatives (the “Actual
KRM Alternative Costs”) [*]. If the Actual KRM Alternative Costs are [*]. 
 If, during the KRM Alternative
Period, the Parties [*]. 
 For clarity, from the time that Evonik first projects an increase or decrease in Current
Aggregate Key Raw Material Cost under (a)(1) above until the earlier of [*]; provided, however, that [*]. After the expiration of the earliest of (A), (B), (C) or (D) above Evonik may [*]. 

 

	 	(4)	The adjustments to be made pursuant to subsection (2) and (3), respectively, may be realized, at GSL’s choice, [*]. 

 

	 	(5)	For [*], the USD values of the Key Raw Materials will be converted to Euro applying the Standard Exchange Rate (as defined in Section 11 d). However,
for [*] the USD values of the Key Raw Materials will be converted to Euro applying the exchange rate as reported in the Wall Street Journal as of the date of the Evonik Key Raw Material Cost Notice, for inclusion in the Base Selling Price
calculation for [*]. 

  

	 	c)	Adjustment for [*] due to Changes in Cost of Standard Raw Materials and/or Key Raw Materials. 

 

	 	(1)	At the [*] review of the then current Base Selling Price on [*], Evonik will propose adjustments to the Baseline Aggregate Standard Raw Material
Cost for the following [*] based on changes to the aggregate costs (including, but not limited to, [*]) of the Standard Raw Materials per kilogram of FTC that had been experienced in [*] and/or on projections of pricing from
vendors of Standard Raw Materials for [*]. 

  

	 	(2)	No later than [*] prior to the [*] review on [*], GSL will provide Evonik, in writing, the aggregate cost in USD (including, but not limited
to, [*]) for [*] per kilogram of each Key Raw Material. Such cost in USD per kilogram of each Key Raw Material will be converted into the aggregate cost in Euros (including, but not limited to, [*]) per kilogram of Key Raw
Material applying the Standard Exchange Rate. Then, such amounts will be converted to the aggregate cost (including, but not limited to, [*]) of Key Raw Materials in Euros per kilogram of FTC for the [*], using the specific consumption
figures stated in Annex B. 

 At the [*] review of the then current Base Selling Price on [*],
Evonik will propose adjustments to the Baseline Aggregate Key Raw Material Cost for [*] based on the changes to the aggregate 

 

 4 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 

 
costs (including, but not limited to, [*]) of the Key Raw Materials per kilogram of FTC for [*] in Euros per kilogram of FTC. 

 

	 	(3)	The Parties will review and agree upon appropriate adjustments to the Base Selling Price for [*] based on projected changes to the (i) Baseline
Aggregate Standard Raw Material Cost and (ii) the Baseline Aggregate Key Raw Material Cost. The re-established Base Selling Price, Baseline Aggregate Standard Raw Material Cost and the Baseline Aggregate Key Raw Material Cost (i) will
apply to [*], provided however that the re-established Base Selling Price will be subject to further adjustment pursuant to Section 11 d), and (ii) when active, will be subject to the provisions and adjustments listed in
Section 10 a) and Section 10 b). 

 d) Adjustment Due to Use of Alternative Raw Material Sources.
If Evonik or GSL identify alternative sources of or arrangements for raw materials, in each case that [*], the Base Selling Price shall be [*]. 

e) Adjustment Due to Yield Improvements. If there are decreases in FTC Variable Costs (as defined in Exhibit A) due to a yield
improvement, the Base Selling Price shall [*]. 
 f) Adjustment Due to Reduction in Fixed Costs. If there are
decreases in fixed costs due to process improvements identified by Evonik and/or GSL, in any such case that reduce the API manufacturing cost by [*] percent ([*]%) or more, GSL will have the right to [*]. In addition, after
implementation of such process improvements, GSL will determine in due course whether [(i) the Minimum Quantities shall be [*] and the Base Selling Price shall be [*] by an amount equal to [*] or (ii) the Base Selling Price
and the Minimum Quantities shall [*], in each case of (i) and (ii), such that there will be [*] to the Minimum Contribution in the [*]. 

g) Minimum Contribution. For clarity, if (i) any or all instances of the adjustments to the Base Selling Price result in
[*]. For further clarity, in no event shall the [*]. 
 h) Improvement. The effects of any improvements
introduced after the date of this Amendment No. 1 shall be governed by Sections 10(d), (e) or (f), as applicable. 
  

	 	5.	Amendment of Section 11 d). Section 11 d) is hereby deleted in its entirety and replaced with the following: 

d) Exchange Rate: On [*] and [*] thereafter, during the duration of this Agreement, the Parties will adjust the Base Selling Price
as determined pursuant to Section 10 for [*] to reflect any changes in the Euro/U.S. Dollar exchange rate so that the Parties share equally any economic benefit or detriment as a result of currency fluctuations from the agreed upon exchange
rate of 0.748279 Euro/U.S. Dollar (“Standard Exchange 
  

 5 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 

 
Rate”). The adjustment shall be made in accordance with the following formula and shall become effective as of [*]: 

[*] 
 6.
Amendment to Section 28. The third paragraph of Section 28 is hereby deleted in its entirety and replaced with the following: 
  

							
	If to Evonik:	  		  	With a copy to:
			
	Evonik Degussa GmbH	  		  	Evonik Services GmbH
	Business Line Exclusive Synthesis	  	Legal Services
	and Amino Acids	  	Weissfrauenstr. 9
	Rodenbacher Chaussee 4	  	60287 Frankfurt
	63457 Hanau-Wolfgang	  		  		  	

							
				
	Attention:	 	[*]	  	    Attention:	 	[*]
		 	[*]	  		 	[*]
	Facsimile:	 	[*]	  	    Facsimile:	 	[*]

 7. Amendment of Exhibits A,
B and C. Exhibits A and B are hereby deleted in their entirety and replaced with Exhibits A and B attached to this Amendment. Exhibits C is hereby deleted in its entirety. 

8. Substitution of FTC and Competitive Pricing Clause. For clarity, the Parties expressly agree that (i) GSL may not
substitute another active pharmaceutical ingredient for all or part of the Minimum Quantity of FTC to be supplied under the Agreement and (ii) the Competitive Pricing Clause set forth in the former Section 10(f) of the original Agreement
is deleted in its entirety and shall have no further force or effect. 
 9. Release. In exchange for the
agreements the Parties have reached in this Amendment No. 1, Evonik hereby releases, acquits and forever discharges GSL and its current and former officers, directors, agents, employees, affiliates, subsidiaries, successors or assigns
(collectively, “Released Parties”) from any and all causes of action, demands, claims, damages, losses, liabilities, liens or other rights of any nature (whether known or unknown) (“Claims”) that Evonik had, has or
may have against the Released Parties arising out of, connected with, relating or incidental to Evonik’s procurement of materials and any other costs whatsoever related to this Agreement incurred by Evonik, in each case on or prior to
[*]. For purposes of clarity, the foregoing release is solely by Evonik in favor of GSL and GSL is not releasing, acquitting nor forever discharging Evonik, its current and former officers, directors, agents, employees, affiliates,
subsidiaries, successors or assigns from any Claims GSL had, has or may have against such persons arising out of, connected with, relating or incidental to the Agreement. 

10. Miscellaneous. 
  

	 	(a)	 Effect on the Agreement. The Agreement shall continue in full force and effect as amended by this Amendment No. 1 and this Amendment
No. 1, together with the Agreement, constitutes the entire agreement of the Parties with respect to the matters set forth 

 

 6 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 

	 	 
herein and there are no other agreements, commitments or understandings among the Parties with respect to the matters set forth herein. In the event of any conflict or inconsistency between the
provisions of this Amendment No. 1 and the provisions of the Agreement, the provisions of this Amendment No. 1 shall govern and control. Each and every other term, condition, covenant, representation, warranty and provision set forth in
the Agreement shall remain in full force and effect in accordance with the terms of the Agreement. From and after the date hereof, all references in the Agreement to the “Agreement” shall be deemed to mean the Agreement as amended by this
Amendment No. 1. 

  

	 	(b)	Counterparts. This Amendment No. 1 may be executed in any number of counterparts, each of which will be deemed an original, but all of which together will
constitute one and the same instrument. 

  

	 	(c)	Defined Terms. Capitalized terms used but not defined herein shall have the meaning ascribed to them in the Agreement. 

 

 7 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 

 IN WITNESS WHEREOF, the Parties have signed this Amendment No. 1 as of the date
first set out above. 
 GILEAD SCIENCES LIMITED 
  

			
	By:	 	 /s/ John Milligan

	Name:	 	John F. Milligan, Ph.D.
	Title:	 	President

 EVONIK DEGUSSA GMBH 

 

									
	By:	 	 /s/ Reiner Beste
	  		 	By:	 	 /s/ Klaus Stingl

	Name:	 	Reiner Beste	  		 	Name:	 	Klaus Stingl
	Title:	 	Head of Business Unit Health and Nutrition	  		 	Title:	 	Head of KCA NAITA + Asia Exclusive Synthesis

  

 8 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 

 Exhibit A 

Minimum Contribution and API Quantities 

The table below sets forth GSL’s minimum contribution obligations for the stated calendar years for Evonik’s manufacturing emtricitabine (FTC)
for commercial use to be delivered pursuant to a delivery schedule agreed upon by Evonik and GSL (for any such year as set forth in the table below, the “Minimum Contribution”) as well as, subject to the adjustment pursuant to the
Agreement, (i) the minimum quantity of FTC to be purchased by GSL and delivered by Evonik, respectively, and (ii) the Base Selling Price per kilogram of FTC. Base Selling Price per unit was determined by adding [*], as described in
Exhibit B, to [*] as described in the table below. 
  

									
	 Calendar

Year
	 	 Minimum

Contribution
	 	 Minimum Quantity

of FTC to be

Purchased by GSL

and to be Delivered

By Evonik
	 	 Minimum

Contribution per

kilogram
	 	 Base Selling

Price per

kilogram

	2010	 	[*]	 	[*]	 	[*]	 	[*]
	2011	 	[*]	 	[*]	 	[*]	 	[*]
	2012	 	[*]	 	[*]	 	[*]	 	[*]
	2013	 	[*]	 	[*]	 	[*]	 	[*]
	2014	 	[*]	 	[*]	 	[*]	 	[*]

 GSL is obligated to order no less
than, and Evonik shall not be obligated to deliver more than, such quantities of FTC in the years 2010 through 2014 so that the Minimum Contribution indicated in the table above is achieved. 

* * * * * 
  

 9 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 

 Exhibit B 

[*] Costs for 2010 

[*] are as attached and conform with the process outlined in the Contractor’s Manual. 

See Attachment 
  

 10 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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