Document:

Exhibit 10.2

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

THIRD AMENDMENT TO API MANUFACTURING AND SUPPLY AGREEMENT

 

This Third Amendment (this “Third Amendment”) dated as of the 10th day of September, 2012 (the “Third Amendment Date”), is made by and between Biocon Limited (“Biocon”) and Optimer Pharmaceuticals, Inc. (“Optimer”).

 

WHEREAS, the parties have entered into that certain API Manufacturing and Supply Agreement dated May 18, 2010, pursuant to which Biocon agreed to manufacture and supply quantities of Product to Optimer in the Territory (the “Agreement”); and

 

WHEREAS, Biocon and Optimer desire to amend the Agreement so that Biocon may improve the manufacturing process of the Product.

 

NOW, THEREFORE, the parties agree as follows:

 

1.                                      All capitalized terms used in this Third Amendment and not otherwise defined herein shall have the meanings given to them in the Agreement.

 

2.                                      Section 9.8 is hereby added to the Agreement as follows:

 

Biocon agrees to conduct the activities set forth in the process improvement plan attached to this Agreement as Schedule 9.8, as such plan may be amended by the parties from time to time in accordance with this Agreement (each a “Process Improvement Activity” and collectively the “Process Improvement Activities”).  Biocon will perform the Process Improvement Activities in a timely, workmanlike manner, with professional diligence and skill consistent with industry standards, and in accordance with the terms of Schedule 9.8, the applicable Protocol (as defined below) and this Agreement.  Biocon will ensure that all persons performing any Process Imprivement Activities are properly qualified and experienced to perform the same.  Upon Optimer’s request, Biocon may remove from any Process Improvement Activity any person that Optimer determines to be unsuitable, unqualified or otherwise objectionable.  Biocon will comply with all Applicable Laws in the course of performing the Process Improvement Activities.

 

(a)         Upon initiation of each Process Improvement Activity, Biocon shall give written notice to Optimer.  Each Process Improvement Activity will be conducted in accordance with a protocol developed by and agreed to by both Biocon and Optimer (a “Protocol”).  Each Protocol shall also set forth the number of FTEs (as defined below) to be used in performing the applicable Process Improvement Activity and the timeframe in which Biocon expects in good faith to complete the applicable Process Improvement Activity. Biocon shall not modify a Protocol in any way (including by adding additional FTEs) prior to obtaining Optimer’s consent in writing in the form of a Protocol amendment.  Biocon shall provide written progress reports for all Process Improvement Activities being conducted on a quarterly basis.  Within after completion or termination of a Process Improvement Activity or termination of this Agreement, whichever occurs first, Biocon shall provide to Optimer a detailed written report of work performed and results achieved (the “Final Report”). Without prejudice to Section 14 of this Agreement, any Intellectual Property Rights generated in connection with any Process Improvement Activity shall be jointly owned by Biocon and Optimer.  Biocon and Optimer shall equally bear the cost and expenses with respect to registration and maintenance of such Intellectual Property Rights.

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

(b)         The parties agree that in order to determine whether any process improvement has occurred, a Batch size of [...***...] per Batch of [...***...] and a Batch size of [...***...] per Batch of [...***...] shall be used.  The achievement of a process improvement will be determined by an increase in yield or a decrease in the raw material used or throughput or cycle time per Batch of [...***...].  The yield of [...***...] Batches [...***...] will be monitored to confirm the achievement of a process improvement (“Confirmation Batches”).  Upon written confirmation by Optimer of a process improvement, the price of the Confirmation Batches will be adjusted to reflect the cost savings set forth in Section 9.8 (h) of this Agreement and a credit will be given by Biocon to Optimer.

 

(c)          Optimer in its sole discretion shall determine whether a process improvement shall be incorporated into the Product or used in connection with manufacturing the Product.  Biocon warrants that any Product incorporating any process improvement shall be manufactured by Biocon in accordance with the Product Warranties set forth in Section 11.3 of this Agreement.  Optimer shall only purchase Product from Biocon incorporating a process improvement that has Regulatory Approval for making a commercial-grade Product.  In the event Optimer wishes to purchase Product from Biocon incorporating a process improvement that does not have Regulatory Approval for making a commercial-grade Product (e.g., development or clinical Product), the Parties shall determine on a case-by-case basis the terms of such transaction.  For clarity, Optimer shall have no obligation to purchase Product from Biocon incorporating a process improvement that does not have Regulatory Approval for making a commercial-grade Product.

 

(d)         Optimer and Biocon will [...***...] the FTE costs toward conducting the Process Improvement Activities, which will not exceed [...***...] per year per FTE (the “Service Fees”), pro-rated for any partial year of services.  “FTE” shall mean the equivalent of the work time of a full-time employee of Biocon solely assigned to conducting the Process Improvement Activities. With respect to the Service Fees payable by Optimer to Biocon, Optimer will bear and pay any taxes applicable in the USA and Biocon will bear and pay any taxes applicable in India.  The Service Fees will be reviewed by the parties on an annual basis.  Optimer’s share of the Service Fees which it does not dispute in good faith shall be payable on a quarterly basis within thirty (30) days of Optimer’s receipt of the relevant invoice submitted by Biocon, which invoice shall detail the number of FTEs performing Process Improvement Activities during such quarter and to which Process Improvement Activities each FTE was assigned during such quarter.  Biocon shall submit invoices to Optimer at the beginning of each quarter.

 

(e)          Optimer shall pay Biocon for any additional quality testing and documentation (e.g., protocols or reports) needed in the event Regulatory Approval is required for a process improvement. Such payment shall be made by Optimer within thirty (30) days of Optimer’s receipt of the relevant invoice from Biocon.

 

(f)           Optimer and Biocon will [...***...] the costs and all incidental expenses incurred toward procuring raw materials and other incidental expenses (e.g., movement of equipment, or raw materials between Biocon facilities or to a third party service provider facility or storage charges) and any third party services as may be required to complete any Process Improvement Activity; provided that unless such costs are set forth and budgeted in the applicable Protocol, Biocon shall not incur such costs without Optimer’s prior written consent. Biocon shall submit invoices to Optimer at the beginning of each quarter for the raw materials and consumables procured in the previous quarter and Optimer shall pay all such invoices within thirty (30) days of Optimer’s receipt of the relevant invoice submitted by Biocon. Payment terms with respect to any third party services shall be communicated to Optimer as appropriate.

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

(g)          Optimer will be responsible for the costs and all incidental expenses toward procuring any special new equipment that may be required to complete any Process Improvement Activity; provided that unless such costs are set forth and budgeted in the applicable Protocol, Biocon shall not incur such costs without Optimer’s prior written consent.  Any equipment procured by Biocon and paid for by Optimer pursuant to this Section 9.8(g) shall be owned exclusively by Optimer and Biocon shall cause any such equipment to be dedicated solely to the performance of Biocon’s obligations under this Agreement and shall ensure that such equipment is not subject to any lien, pledge, security interest or other encumbrances, without prior written approval from Optimer.

 

(h)         The parties agree that any results of the Process Improvement Activities which are implemented and result in costs savings shall be shared between Optimer and Biocon [...***...] respectively until the [...***...] of Product before any other discounts to Optimer (e.g., volume or currency)  is adjusted to [...***...].  After adjustment of the price of the Product to [...***...], any results of the Process Improvement Activities which are implemented and result in cost savings shall be shared by Optimer and Biocon [...***...] respectively.

 

(i)             The parties agree that for purposes of Section 13, any results, information or materials generated during the performance of the Process Improvement Activities shall be the Confidential Information of both parties.

 

(j)            For purposes of clarification, the parties agree that Biocon’s performance of the Process Improvement Activities shall be activities and work conducted under this Agreement on manufacturing processes of the API.

 

(k)         Either party may terminate any or all Process Improvement Activities at any time with or without cause.  Following the effective date of such termination, Biocon shall cease performing any such terminated Process Improvement Activities, and Optimer will pay Biocon all undisputed Service Fees for Process Improvement Activities conducted.  Within 30 days of the termination of any Process Improvement Activity, upon Optimer’s request, Biocon will return at Optimer’s cost to Optimer all equipment provided by Optimer or fully funded by Optimer under this Section 9.8.

 

3.             Schedule 9.8 attached hereto is hereby added as a schedule to the Agreement and may be amended from time to time pursuant to the terms of the Agreement.

 

4.             Each party hereby represents and warrants to the other that it has the corporate power and authority to enter into this Third Amendment and this Third Amendment constitutes a legal, valid and binding obligation, enforceable against such party in accordance with its terms.

 

5.             This Third Amendment may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument.  Each party may execute this Third Amendment by facsimile transmission or in AdobeTM Portable Document Format (PDF) sent by electronic mail.  Facsimile or PDF signatures of authorized signatories of the parties will be deemed to be original signatures, will be valid and binding, and, upon delivery, will constitute due execution of this Third Amendment.

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

6.             This Third Amendment shall be effective upon the date first set forth above.

 

7.             Other than as set forth in this Third Amendment, all of the terms and conditions of the Agreement will continue in full force and effect.

 

8.             The parties agree that Section 19 of the Agreement shall apply to this Third Amendment.

 

[SIGNATURE PAGE TO FOLLOW]

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

IN WITNESS WHEREOF, the parties have caused this Third Amendment to be executed by their duly authorized representatives as of the Third Amendment Date.

 

 

	
Optimer   Pharmaceuticals, Inc.
    	
 
    	
Biocon   Limited
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By: 
    	
/s/   Bridget Noe
    	
 
    	
By:
    	
/s/   Rakesh Bamzai
    
	
Name:
    	
 Bridget Noe
    	
 
    	
Name:
    	
Rakesh   Bamzai
    
	
Title: 
    	
Senior   Corporate Counsel
    	
 
    	
Title: 
    	
President   – Marketing
    
									

 

 

	
 
    	
Biocon   Limited
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:  
    	
/s/   Murali Krishnan K.N.
    
	
 
    	
Name: 
    	
Murali Krishnan K.N.
    
	
 
    	
Title:
    	
President   – Group Finance
    
				

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Schedule 9.8

 

[...***...]Exhibit 10.1

 

General Version

 

FORM OF NON-QUALIFIED STOCK OPTION AWARD AGREEMENT

 

THIS NON-QUALIFIED STOCK OPTION AWARD AGREEMENT (this “Agreement”) is made as of the       th day of                 , 2012, between DYNEGY INC., a Delaware corporation (“Dynegy”), and all of its Affiliates (collectively, the “Company”), and                 (“Employee”).  A copy of the Dynegy Inc. 2012 Long Term Incentive Plan (the “Plan”) is annexed to this Agreement and shall be deemed a part of this Agreement as if fully set forth herein.  Unless the context otherwise requires, all terms that are not defined herein but which are defined in the Plan shall have the same meaning given to them in the Plan when used herein.

 

1.             The Grant.  The Compensation and Human Resources Committee of the Board of Directors (the “Committee”) granted to Employee on               , 2012 (“Effective Date”), as a matter of separate inducement and not in lieu of any salary or other compensation for Employee’s services, the right and option to purchase (the “Option”), in accordance with the terms and conditions set forth in the Plan and in this Agreement, an aggregate number of shares (the “Shares”) of common stock of Dynegy, $0.01 par value per share (the “Common Stock”), at a price of $                       per share (the “Exercise Price”).  Employee acknowledges receipt of a copy of the Plan, and agrees that the Option shall be subject to all of the terms and provisions of the Plan, including future amendments thereto, if any, pursuant to the terms thereof, and to all of the terms and conditions of this Agreement.  The Option shall not be treated as an incentive stock option within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”).  The Exercise Price is, in the judgment of the Committee, not less than one hundred percent (100%) of the Fair Market Value of a share of the Common Stock on the Effective Date.

 

2.             Exercise.  Subject to the provisions, limitations and other relevant provisions of the Plan and of this Agreement, and the earlier expiration of the Option as herein provided, Employee may exercise the Option to purchase some or all of the Shares as follows:

 

(a)           The Option shall become exercisable in three cumulative equal annual installments as follows:

 

(i)            on the first anniversary of the Effective Date, the right to purchase one-third of the aggregate number of Shares shall become exercisable without further action by the Committee;

 

(ii)           on the second anniversary of the Effective Date, the right to purchase an additional one-third of the aggregate number of  Shares shall become exercisable without further action by the Committee; and

 

(iii)          on the third anniversary of the Effective Date, the right to purchase the remaining one-third of the aggregate number of Shares shall become exercisable without further action by the Committee.

 

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(b)           Notwithstanding any other provision of this Agreement, the unexercised portion of the Option, if any, will automatically and without notice terminate and become null and void upon the expiration of ten (10) years from the Effective Date of the Option.

 

(c)           Any exercise by Employee of the Option, or portion thereof, shall be conducted by delivery of an irrevocable notice of exercise to the Company or its designee as provided in the Plan.  In no event shall Employee be entitled to exercise the Option for less than a whole Share.

 

3.             Termination of Employment.  The Option may be exercised only while Employee remains an employee of the Company and will terminate and cease to be exercisable upon Employee’s termination of employment with the Company, except that:

 

(a)           if Employee shall die while in the employ of the Company, the Option awarded hereunder shall immediately vest with respect to all of the remaining Shares and become fully exercisable without further action by the Committee, and Employee’s legal representative, or the person, if any, who acquired the Option by bequest or inheritance or by reason of the death of Employee, may exercise the Option, to the extent not previously exercised, in respect of any or all such Shares at any time up to and including the date three (3) years after the date of death, or the end of the option term, whichever is less, after which date the Option will automatically and without notice terminate and become null and void; and

 

(b)           if Employee is determined to be disabled (as defined in the Company’s long term disability program or plan in which Employee is a participant or, if Employee does not participate in any such plan, as defined in the Dynegy Inc. Long Term Disability Plan, as amended, or the successor plan thereto), the Option awarded hereunder shall immediately vest with respect to all of the remaining Shares and become fully exercisable without further action by the Committee, and Employee may exercise the Option, to the extent not previously exercised, in respect of any or all such Shares at any time up to and including the date three (3) years after the date of such determination, or the end of the option term, whichever is less, after which date the Option will automatically and without notice terminate and become null and void; and

 

(c)           if Employee’s employment with the Company terminates by reason of dismissal by the Company for Cause, then the Option, to the extent not previously exercised, will immediately, automatically and without notice or further action by the Committee, terminate and become null and void; and

 

(d)           if Employee’s employment with the Company terminates by reason of resignation by the Employee (except as otherwise provided in Section 3(f) or (g) below) and at a time when Employee was entitled to exercise the Option, Employee may exercise the Option, to the extent not previously exercised, with respect to any or all such number of Shares as to which the Option was exercisable as of the date of Employee’s termination of employment, at any time up to and including the date ninety (90) days after

 

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the date of termination by reason of such resignation, or the end of the option term, whichever is less, after which date the Option will automatically and without notice terminate and become null and void; and

 

(e)           if Employee’s employment with the Company terminates by reason of Involuntary Termination, as such term is defined below, the Option awarded hereunder shall immediately vest with respect to all remaining Shares and become fully exercisable without further action of the Committee, and Employee may exercise the Option, to the extent not previously exercised, at any time up to and including the date three (3) years after the date of such termination of employment, or the end of the option term, whichever is less, after which date the Option will automatically and without notice terminate and become null and void; and

 

(f)            if the Employee’s employment with the Company terminates as a result of an Involuntary Termination within six months following a Change in Control, the Option shall become fully vested and immediately exercisable in full on the effective date of the Change of Control, and such Option shall remain exercisable from such date for the lesser of: (A) five (5) years  from the date of such Change in Control; (B) the remaining period of time for exercise of the Option hereunder (irrespective of any mandatory exercise period specified herein that would otherwise be triggered by the termination of employment of such Employee); or (C) such period of time (which period of time may end as early as the consummation of a Change in Control) as the Committee may determine in connection with or in contemplation of a Change in Control in the exercise of its discretion under the Plan, with respect to which the Committee has the discretion to, among other things, require the surrender of stock options (which surrender may be in exchange for a cash payment, if applicable) and to cancel such stock options upon the consummation of a Change in Control; and

 

(g)           if the Employee’s employment with the Company terminates by reason of retirement following the date on which such Employee has (I) reached sixty (60) years of age and (II) completed at least ten (10) years of service as an employee of the Company, Employee may exercise the Option, to the extent not previously exercised, with respect to any or all such number of Shares as to which the Option was exercisable as of the date of Employee’s termination of employment and (1) the number of then unvested and unexercised Shares subject to the Agreement multiplied by (2) a fraction, the numerator of which shall be the number of calendar days which have lapsed since the later of the Effective Date or most recent anniversary thereof and the denominator of which shall be the number of calendar days from the later of the Effective Date or the most recent anniversary thereof until the third anniversary of the Effective Date, at any time up to and including the date ninety (90) days after the date of termination, or the end of the option term, whichever is less, after which date the Option will automatically and without notice terminate and become null and void.

 

(h)           For purposes of this Agreement:

 

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“Base Salary” shall mean the regular base salary of Employee but excluding all bonuses, expense reimbursements, benefits paid under any plan maintained by the Company and all equity awards of any type.

 

“Cause” shall have the same meaning as set forth in the Plan.

 

“Change in Control” shall have the same meaning as the term “Corporate Change” set forth in the Plan.

 

“Involuntary Termination” shall have the same meaning as specified in the Dynegy Inc. Executive Severance Pay Plan.

 

4.             Registration.  The Company intends to register the Shares for issuance under the Securities Act of 1933, as amended (the “Act”), and to keep such registration effective throughout the period the Option is exercisable.  In the absence of such effective registration or an available exemption from registration under the Act, issuance of the Shares will be delayed until registration of such shares is effective or an exemption from registration under the Act is available.  The Company intends to use its best efforts to ensure that no such delay will occur.  In the event exemption from registration under the Act is available upon an exercise of the Option, Employee (or the person permitted to exercise the Option in the event of Employee’s death or incapacity), if requested by the Company to do so, will execute and deliver to the Company, in writing, such agreements and other documents containing such provisions as the Company may require to assure compliance with applicable securities laws.

 

Employee agrees that the Shares will not be sold or otherwise disposed of in any manner which would constitute a violation of any applicable federal or state securities laws.  Employee also agrees that (a) the certificates representing the Shares, if any, may bear such legend or legends as the Committee in its sole discretion deems appropriate in order to assure compliance with applicable securities laws and (b) the Company may refuse to register transfer of the Shares on the stock transfer records of the Company, and may give related instructions to its transfer agent, if any, to stop registration of such transfer, if such proposed transfer would in the opinion of counsel satisfactory to the Company constitute a violation of any applicable securities law.

 

5.             Employment Relationship.  For purposes of this Agreement, Employee shall be considered to be in the employment of the Company as long as Employee remains an employee of (a) the Company, (b) an Affiliate (as such term is defined in the Plan) or (c) a corporation (or a parent or subsidiary of such corporation) assuming or substituting a new option for the Option.  Any question as to whether and when there has been a termination of such employment, and the cause of such termination, shall be determined by the Committee in its sole discretion, and its determination shall be final and binding on all parties.

 

6.             Withholding Taxes.  By Employee’s acceptance hereof, Employee hereby (a) agrees to reimburse the Company or any Affiliate by which Employee is employed for any federal, state or local taxes required by any government to be withheld or otherwise deducted by such corporation in respect of Employee’s exercise of the Option, (b) authorize the Company or

 

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any Affiliate by which Employee is employed to withhold from any cash compensation paid to Employee or in Employee’s behalf, an amount sufficient to discharge any federal, state and local taxes imposed on the Company, or the Affiliate by which Employee is employed, and which otherwise has not been reimbursed by Employee, in respect of Employee’s exercise of the Option and (c) agrees that the corporation by which Employee is employed, may, in its discretion, hold the stock to which Employee is entitled upon exercise of the Option, as security for the payment of the aforementioned withholding tax liability, until cash sufficient to pay that liability has been accumulated, and may, in its discretion, effect such withholding by retaining Shares issuable upon the exercise of the Option having a Fair Market Value on the date of exercise which is equal to the amount to be withheld.

 

7.             Miscellaneous.

 

(a)           This grant is subject to all the terms, conditions, limitations and restrictions contained in the Plan.  In the event of any conflict or inconsistency between the terms hereof and the terms of the Plan, the terms of the Plan shall be controlling.  In the event of any conflict or inconsistency between the terms hereof and the terms of the Dynegy Inc. Executive Severance Pay Plan and Dynegy Inc. Change in Control Executive Severance Pay Plan, including any amendments or supplements thereto, the terms hereof shall be controlling.

 

(b)           This grant is not a contract of employment and the terms of Employee’s employment shall not be affected hereby or by any agreement referred to herein except to the extent specifically so provided herein or therein.  Nothing herein shall be construed to impose any obligation on the Company or on any Affiliate to continue Employee’s employment, and it shall not impose any obligation on Employee’s part to remain in the employ of the Company or of any Affiliate.

 

(c)           All references in this Agreement to any “corporation” shall include a corporation, a general partnership, a joint venture, a limited partnership, a business trust or any other lawful business entity.

 

(d)           Any notices or other communications provided for in this Agreement shall be sufficient if in writing. In the case of Employee, such notices or communications shall be effectively delivered when hand delivered to Employee at his or her principal place of employment or when sent by registered or certified mail to Employee at the last address Employee has filed with the Company. In the case of the Company, such notices or communications shall be effectively delivered when sent by registered or certified mail to the Company at its principal executive offices.

 

8.             Amendment.  This Agreement may not be amended except by an agreement in writing signed by each of the Company and Employee consenting to such amendment. Notwithstanding the preceding, if it is subsequently determined by the Committee, in its sole discretion, that the terms and conditions of this Agreement and/or the Plan are not compliant with Code Section 409A, or any Treasury regulations or Internal Revenue Service guidance

 

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promulgated thereunder, this Agreement and/or the Plan may be amended by the Company accordingly.

 

[Remainder of page intentionally left blank]

 

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IN WITNESS WHEREOF, the Company has caused this Agreement to be duly executed by an officer thereunto duly authorized, and Employee has agreed to and accepted the terms of this Agreement*, all as of the date first above written.

 

 

	
 
    	
DYNEGY   INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Name:
    
	
 
    	
 
    
	
 
    	
Title:
    

 

*Employee has agreed to and accepted the terms of this Agreement utilizing online grant acceptance capabilities with E*Trade Financial, the Company’s stock option administrator.

 

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