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RESEARCH AND DEVELOPMENT AGREEMENT

Research and Development Agreement

RESEARCH AND DEVELOPMENT AGREEMENT | Document Parties: OXIGENE INC | Symphony GP, LLC | SYMPHONY ViDA HOLDINGS LLC You are currently viewing:
This Research and Development Agreement involves

OXIGENE INC | Symphony GP, LLC | SYMPHONY ViDA HOLDINGS LLC

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Title: RESEARCH AND DEVELOPMENT AGREEMENT
Governing Law: New York     Date: 3/30/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

RESEARCH AND DEVELOPMENT AGREEMENT, Parties: oxigene inc , symphony gp  llc , symphony vida holdings llc
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Exhibit 10.57

EXECUTION COPY

 

RESEARCH AND DEVELOPMENT AGREEMENT

between

OXiGENE, INC.

and

SYMPHONY ViDA HOLDINGS LLC

 

Dated as of October 1, 2008

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 


 

TABLE OF CONTENTS

 

 

 

 

 

 

 

Page

1. [Intentionally Omitted]

 

 

1

 

 

 

 

 

 

2. Overview of Development

 

 

1

 

 

 

 

 

 

3. Development Committee

 

 

2

 

 

 

 

 

 

4. Development Plan and Development Budget

 

 

2

 

4.1 Generally

 

 

2

 

4.2 Amendments

 

 

3

 

 

 

 

 

 

5. Regulatory Matters

 

 

4

 

5.1 FDA Sponsor

 

 

4

 

5.2 Correspondence

 

 

4

 

5.3 Inspections and Meetings

 

 

5

 

 

 

 

 

 

6. The Company’s Obligations

 

 

5

 

6.1 Generally

 

 

5

 

6.2 Subcontracting

 

 

6

 

6.3 Reports and Correspondence

 

 

7

 

6.4 Staffing

 

 

8

 

6.5 QA Audit

 

 

8

 

6.6 Financial Audit

 

 

8

 

6.7 Insurance

 

 

9

 

 

 

 

 

 

7. Holdings’ Obligations

 

 

9

 

7.1 Generally

 

 

9

 

7.2 Subcontracting

 

 

9

 

7.3 Insurance

 

 

10

 

7.4 Staffing

 

 

10

 

7.5 Inspection and Audit

 

 

10

 

 

 

 

 

 

8. Funding and Payments

 

 

10

 

8.1 Use of Proceeds

 

 

10

 

8.2 Reimbursement

 

 

10

 

8.3 Budget Allocation and Deviations

 

 

11

 

8.4 Employee Benefits

 

 

11

 

 

 

 

 

 

9. Covenants

 

 

12

 

9.1 Mutual Covenants

 

 

12

 

 

 

 

 

 

10. Confidentiality

 

 

13

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

i


 

 

 

 

 

 

 

 

Page

11. Discontinuation Option

 

 

13

 

 

 

 

 

 

12. Representations and Warranties

 

 

14

 

12.1 Company Representations and Warranties

 

 

14

 

12.2 Holdings Representations and Warranties

 

 

16

 

 

 

 

 

 

13. Relationship Between the Company and Holdings

 

 

17

 

 

 

 

 

 

14. Change of Control

 

 

18

 

 

 

 

 

 

15. No Restrictions; Indemnification

 

 

18

 

15.1 No Restrictions

 

 

18

 

15.2 Indemnification

 

 

18

 

 

 

 

 

 

16. Limitation of Liabilities

 

 

22

 

16.1 Between the Parties

 

 

22

 

 

 

 

 

 

17. Term and Termination

 

 

22

 

17.1 Term

 

 

22

 

17.2 Termination for Company’s Breach

 

 

22

 

17.3 Termination for Holdings’ Breach

 

 

23

 

17.4 Termination of License Agreement

 

 

23

 

17.5 Survival

 

 

23

 

 

 

 

 

 

18. Miscellaneous

 

 

23

 

18.1 No Petition

 

 

23

 

18.2 Notices

 

 

24

 

18.3 Governing Law; Consent to Jurisdiction and Service of Process

 

 

25

 

18.4 Waiver of Jury Trial

 

 

25

 

18.5 Entire Agreement

 

 

26

 

18.6 Amendment; Successors; Assignment; Counterparts

 

 

26

 

18.7 Severability

 

 

26

 

Annex A — Certain Definitions
Annex B — Development Committee Charter
Annex C — Payment Terms

Schedule 6.2 — Subcontracting Agreements
Schedule 6.4 — Key Personnel
Schedule 12.1(f) — Material Disclosed Contracts

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

ii


 

RESEARCH AND DEVELOPMENT AGREEMENT

     This RESEARCH AND DEVELOPMENT AGREEMENT (this “ Agreement ”) is entered into as of October 1, 2008 (the “ Closing Date ”) by and between OXiGENE, INC., a Delaware corporation (the “ Company ”) and SYMPHONY ViDA HOLDINGS LLC, a Delaware limited liability company (“ Holdings ”) (each of the Company and Holdings being a “ Party ,” and collectively, the “ Parties ”). Capitalized terms used herein and not defined herein shall have the meanings assigned to such terms in Annex A attached hereto.

PRELIMINARY STATEMENT

     In the Technology License Agreement, the Company grants Holdings an exclusive license to the Programs. Holdings wishes for the Company to continue to develop such Programs. Holdings and the Company desire to establish, and agree on the responsibilities of, a Development Committee to oversee such development. The Company and Holdings further desire to comply with and perform certain agreements and obligations related thereto.

     The Parties hereto agree as follows:

     1.  [Intentionally Omitted] .

     2.  Overview of Development .

               (a) The Parties shall develop the Programs in a collaborative and efficient manner as set forth in this Article 2 . Representatives of the Parties shall engage in joint decision-making for the Programs as set forth in Articles 3 and 4 hereof. Holdings shall have overall responsibility for all matters set forth in the Development Plan (pursuant to Article 7 hereof), and shall engage the Company (pursuant to Article 6 hereof), and such independent contractors and agents as the Company may retain (which contractors include entities retained by the Company prior to the Closing Date pursuant to the Subcontracting Agreements set forth on Schedule 6.2 ), to act on behalf of Holdings and carry out the duties set forth therein and herein.

               (b) With respect to the Programs, the Company shall be responsible for the execution of all non-clinical and clinical development, all regulatory activities, all scientific and technical services associated with such development (including manufacturing), and all patent work, including all related matters set forth in the Development Plan for such Programs.

               (c) Nothing in Section 2(b) shall in any way limit the authority of the Development Committee (as defined below) or the Holdings’ managing member (the “ Manager ”) hereunder, and the engagements and delegations set forth

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 


 

therein shall be subject to the terms and conditions of this Agreement, and the satisfactory performance by the Company of its obligations pursuant hereto and thereto. The allocations of responsibility described in this Article 2 shall remain subject to further modification in accordance with the terms and conditions of this Agreement.

     3.  Development Committee . The Parties shall establish and maintain a committee (the “ Development Committee ”) to oversee the development of the Programs (including the continued development and refinement of the Development Plan and the Development Budget). The Development Committee shall be established, operated and governed in accordance with the policies and procedures set forth in Annex B hereto (the “ Development Committee Charter ”). The Development Committee Charter may be amended only with the unanimous approval of the Development Committee Members and the consent of Holdings and the Company. In no event shall the Development Committee have the power to amend the terms of any Operative Document.

     4.  Development Plan and Development Budget .

          4.1 Generally .

               (a) The Parties shall agree to a Development Plan and a Development Budget following the Closing Date, and which shall be further developed and refined from time to time in accordance herewith. The Development Plan shall consist of detailed provisions governing all research, non-clinical, clinical, development, manufacturing, scientific, technical, regulatory and patent work to be performed under the Operative Documents. Following the Closing Date, the Development Committee shall, on an ongoing basis, develop the Development Plan to include, without limitation, (i) an outline of the plan for the clinical development of each Program; and (ii) outlines of non-clinical activities, key regulatory and quality activities, and CMC activities for each Program. The Development Budget shall consist of two (2) components: (x) a development budget for each Program covered by the Development Plan (the “ Program Specific Budget Component ”), and (y) a budget for the cross program management and administrative functions of Holdings (the “ Cross Program Budget Component ”). The development budgets for each Program in the Program Specific Budget Component covered by the Development Plan shall be further divided into budget spreadsheets summarizing (1) anticipated costs of engaging third party service providers and the scope of work to be performed by such third parties; and (2) the number of FTEs to be dedicated to the Programs (by function and work responsibilities, on a Program-by-Program basis).

               (b) Prior to the initiation of any Activity pursuant to the Development Plan, funds sufficient to pay all of the estimated costs and expenses for work to be performed in relation to such Activity until completion of such Activity, must be available, either as committed by Holdings or committed by the Company. If such

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

2


 

funds are committed by the Company, the Company shall (i) make such commitment in writing; and (ii) be obligated to provide such committed funds until completion of the related Activity, and such obligation shall survive beyond the expiration or termination of the Purchase Option or any of the Operative Documents; provided , that following the expiration or termination of the Purchase Option or any of the Operative Documents, if any changes in the scope or nature of the related Activity increase the cost of the completion of such Activity, the Company shall not be obligated to make additional funds available.

          4.2 Amendments .

               (a) All amendments of, and all material deviations from, the Development Plan and Development Budget shall be made in accordance with the procedures described in this Article 4 and in the Development Committee Charter, including obtaining the approval of Holdings, as may be required by the Development Committee Charter.

               (b) The Development Committee shall review the Development Plan and Development Budget in their entirety on a semi-annual basis to determine whether any changes are required, and shall comply with all procedures required to amend the Development Plan or Development Budget to implement such changes. Furthermore, following the Closing Date, the Development Committee shall, on an ongoing basis, continue to develop the Development Plan, including, without limitation, as set forth in Section 4.1 and in response to requests, proposals or reports from the Company to the Development Committee.

               (c) A Program, or a Product within a Program, may only be discontinued in the event that either (i) the Parties mutually agree to discontinue such Program or Product based on (A) a Medical Discontinuation Event, or (B) scientific evidence (regardless of whether such evidence is generated by a Party or a third party) that the likelihood of success for a particular Program or Product is not sufficient to warrant further development (a “ Scientific Discontinuation Event ”) that arises in the course of developing such Program or Product; or (ii) Holdings resolves to discontinue such Program or Product. The Development Committee shall promptly thereafter amend the Development Plan and Development Budget to reflect such discontinuation.

               (d) The Development Plan shall never be amended in any manner that would require the Company or Holdings to perform any assignments or tasks in a manner that would violate any applicable law or regulation. In the event of a change in any applicable law or regulation, the Development Committee shall consider amending the Development Plan to enable the Company or Holdings (or any Person acting on behalf of the Company or Holdings), as the case may be, to comply fully with such law or regulation. If such amendment is not approved, the affected Party shall be excused from performing any activity specified herein or in the Development Plan that would violate or result in a violation of any applicable law or regulation.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

3


 

     5.  Regulatory Matters .

          5.1 FDA Sponsor . Notwithstanding any governance provision contained herein or in any Operative Document, the Parties agree that, unless and until the expiration or termination of the purchase option (the “ Purchase Option ”) to be granted to the Company pursuant to an agreement among Holdings, the Company and such other party as may be required, the term of which has been agreed between the Parties, and which agreement shall provide for the Company to purchase the rights to the Programs from Holdings (the “ Purchase Option Agreement ”) without the Company’s exercise of the Purchase Option, the Company shall be the FDA sponsor, and shall serve the equivalent role with respect to any Regulatory Authority outside of the United States, for the Programs, except any Programs which were the subject of a Discontinuation Option that was not exercised by the Company (the “ FDA Sponsor ”). As the FDA Sponsor, the Company shall have the responsibility and the authority to act as the sponsor and make those decisions and take all actions reasonably necessary to assure compliance with all regulatory requirements. The Company agrees to be bound by, and perform all obligations set forth in, 21 C.F.R. § 312 and any and all similar obligations imposed by a foreign Regulatory Authority related to the Company’s role as the FDA Sponsor. Notwithstanding anything to the contrary in Article 4 or the Development Committee Charter, the Company, in its capacity as FDA Sponsor, may discontinue or modify any Program without the approval of the Development Committee or Holdings in the event such actions are: (a) attributable to an event that is reportable to the FDA or corresponding Regulatory Authority outside of the United States; and (b) reasonably necessary to avoid the imposition of criminal or civil liability; provided , however , that to the extent commercially reasonable, the Company shall (i) pursuant to Section 5.2 , advise and consult with the Development Committee prior to taking such action and (ii) forward a copy of all regulatory correspondence relevant to such discontinuation or modification to the Manager.

          5.2 Correspondence . Each Party hereto acknowledges that the Company, in its capacity as FDA Sponsor, shall be the Party responding to any regulatory correspondence or inquiry regarding, or which would reasonably be expected to affect, any of the Programs. The Company shall, within [ * ] ([ * ]) hours: (a) notify at least one (1) Development Committee Member designated by Holdings of any FDA or other governmental or regulatory correspondence, inspection or inquiry regarding or reasonably expected to impact any of the Programs; and (b) forward to the Development Committee copies of any correspondence sent to or received from any regulatory or governmental agency, including, but not limited to, Form FD-483 notices and FDA refusal to file, action or warning letters, even if they do not specifically mention Holdings. To the extent practicable, the Company shall consult with the Development Committee prior to responding to any such regulatory correspondence or inquiry, but the Company shall not be obligated to do so if such action would require a delay beyond any time period permitted by applicable law or regulations. During the Company’s consultation with the Development Committee, the Company and the Development

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

4


 

Committee shall discuss and agree upon issues including, but not limited to, overall regulatory strategy and goals and objectives. Subject to the following sentence, Holdings shall not have any right to initiate any regulatory correspondence with respect to the Programs. In the event that Holdings receives a request or notification from a Governmental Authority with respect to the Programs, Holdings shall: (i) notify the Company within [ * ] ([ * ]) hours of receipt of such request or communication and (ii) to the extent practicable, submit any proposed response to the Company for review and approval; provided , that such approval shall not be unreasonably withheld and shall not prevent the Holdings from complying with any legal requirements or acting to avoid any civil or criminal liability.

          5.3 Inspections and Meetings . Each Party agrees that, during an inspection by the FDA or other Regulatory Authority concerning the Programs, it will not disclose to such agency any information and materials that are not, in the reasonable judgment of the disclosing Party, required to be disclosed to such agency without first obtaining the consent of the other Party, which consent shall not be unreasonably withheld or delayed, except to the extent that such Party may be required by law to disclose such information and materials. The Company shall be the Party responsible for arranging and participating in any meetings with any Regulatory Authority concerning any of the Programs. To the extent practicable, the Company shall consult with the Development Committee prior to any such meetings and provide to the Development Committee for review all relevant correspondence to date. During the Company’s consultation with the Development Committee, the Company and the Development Committee shall discuss and agree upon issues including, but not limited to, overall regulatory strategy, proposed agendas, goals and objectives, preparation and attendees. The Company shall provide prompt and reasonable prior notice of any such meetings to at least one (1) of the Development Committee Members designated by Holdings, and shall, upon a request from Holdings, and to the extent reasonably possible, facilitate the attendance of at least one (1) of the Development Committee Members designated by Holdings at any such meeting reasonably anticipated to pertain in a material way to a Program. Following any meeting that pertains to a Program, but that was not attended for any reason by at least one (1) of the Development Committee Members designated by Holdings, the Company shall provide at least one (1) of the Development Committee Members designated by Holdings with an oral summary of that portion of the meeting relevant to such Program within [ * ] ([ * ]) hours of such meeting and a written summary of that portion within [ * ] ([ * ]) Business Days of such meeting.

     6.  The Company’s Obligations .

          6.1 Generally

               (a) The Company shall have primary responsibility for the implementation of the Development Plan. Without limiting the foregoing, the Company shall specifically be responsible for (i) performing all non-clinical and clinical

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

5


 

development for the Programs in accordance with the Development Plan, (ii) manufacturing of, or arranging for third parties to manufacture, Clinical Trial Materials for the Programs, and carrying out the quality assurance therefor, in each case in accordance with the Development Plan, and (iii) executing all other matters set forth in the Development Plan that are delegated to the Company by Holdings pursuant to the Development Plan (collectively, the “ Company Obligations ”).

               (b) The Company agrees that it will work diligently and use commercially reasonable efforts to discharge the Company Obligations in a good scientific manner and in accordance with the Development Plan, the Development Budget, and the terms of this Agreement.

          6.2 Subcontracting . All agreements between the Company and third parties (including without limitation clinical research organizations and contract manufacturers) for such third parties to perform any Company Obligations (each such third party, a “ Company Subcontractor ” and each such agreement, a “ Subcontracting Agreement ”) entered into by the Company prior to the Closing Date (except for those master service agreements executed prior to the Closing Date that, only through the subsequent addition of a new work order, change order, project or the like after the Closing Date, become Subcontracting Agreements) and listed on Schedule 6.2 hereto, shall be deemed to be acceptable to the Parties in all respects. Following the Closing Date, the Company shall obtain approval of the Development Committee prior to entering into any Subcontracting Agreement, issuing new work orders against existing Subcontracting Agreements, or amending or terminating any Subcontracting Agreement, which approval shall not unreasonably be withheld. The Development Committee may, in its discretion, approve standard forms of Subcontracting Agreements with respect to which the Company may enter into pursuant to such standing authority granted by the Development Committee from time to time, as such authority may be modified or terminated by the Development Committee in its discretion. The Company shall provide the Development Committee with a copy of each draft Subcontracting Agreement (other than those using standard forms and entered into in accordance with the preceding sentence). The Development Committee, or its designee(s), shall have [ * ] ([ * ]) Business Days to approve or reject the terms of such draft Subcontracting Agreement; provided that during such [ * ] ([ * ]) Business Day period the Company shall make appropriate representatives available to the Development Committee to discuss such Subcontracting Agreement in good faith and reasonable detail and shall provide any information as may be reasonably requested by the Development Committee or any member thereof. Only approval of the terms of such draft Subcontracting Agreement by the Development Committee will entitle the Company to reimbursement by Holdings for such Subcontracting Agreement. The terms of such draft Subcontracting Agreement shall be deemed to have been approved if not objected to by any Development Committee Member within the [ * ] ([ * ]) Business Day period. The terms of any such Subcontracting Agreements shall be deemed the Confidential Information of the Company and be subject to the rights and obligations set forth in the Confidentiality

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

6


 

Agreement. The Company shall monitor the performance of its Company Subcontractors and shall promptly notify the Development Committee with respect to any Company Subcontractor performance issues that may have a material adverse effect on the Programs. The Company shall deliver a copy of each Subcontracting Agreement within [ * ] Business Days after it is executed by all parties thereto. The Development Committee shall have the authority to direct the Company to terminate any Subcontracting Agreement pursuant to the terms thereof.

          6.3 Reports and Correspondence . The Company shall keep the Development Committee informed of its activities under the Development Plan through regular reports, as set forth in this Section 6.3 . At each Scheduled Meeting of the Development Committee, or according to a schedule agreed to by the Development Committee, the Company shall, to the extent reasonably required by the Development Committee, provide a summary of the Company’s activities and developments with respect to the Programs for the period following the most recent preceding scheduled summary report. Such summary report shall include the following types of information in a format and frequency as determined by the Development Committee: (i) updates regarding (A) patient enrollment, adverse events or serious adverse events (to the extent the Company has been notified of such adverse events), any added or terminated clinical trial sites, any significant Protocol deviations, the results of any interim analyses, statistical reports, updated Investigator Brochures or final clinical study reports or any new Protocols, Protocol amendments or studies synopses being drafted, all to the extent relating to the Development Plan; and (B) CMC status, non-clinical program status, regulatory and quality program status, communications with regulatory agencies, results of meetings of the Company’s standing or ad hoc clinical advisors, safety monitoring boards or other similar oversight bodies (if and when formed) for a particular Program, and results of meetings with consultants for the Programs, all to the extent related to the Company Obligations; (ii) a copy of each standard clinical study progress report for the Programs received by the Company during the preceding period from any of the clinical research organizations engaged by the Company pursuant to any Subcontracting Agreements and a copy of any final preclinical study reports for such Programs; (iii) a financial report, in a format agreed upon by the Development Committee, itemizing actual spending under the Development Plan as well as any variation from planned spending; (iv) copies of all Subcontracting Agreements executed since the previous Development Committee Meeting; and (v) such other information as the Development Committee may reasonably request. The Company shall notify at least one (1) of the Development Committee Members designated by Holdings as soon as possible, but no later than within [ * ] ([ * ]) hours of the occurrence of any event that has, or could reasonably be expected to have, in the Company’s judgment in light of the circumstances existing at the time, a material effect on the Development Plan or the Development Budget and shall keep the Development Committee regularly updated and informed with respect to any such event.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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          6.4 Staffing . The Company shall use commercially reasonable efforts to provide such sufficient and competent staff and Personnel (including, without limitation, such employees or agents of, or independent contractors retained by, the Company) that have the skill and expertise necessary to perform the Company Obligations. The Company shall notify Holdings in advance, if practicable, and in any event promptly thereafter, of any change in Key Personnel involved in the Programs.

          6.5 QA Audit . During the Term, the Company will permit Holdings’ representatives (such representatives (i) to be identified by Holdings in advance and reasonably acceptable to the Company and (ii) to enter into a confidentiality agreement with the Company) to examine and audit, during regular business hours, the work performed by the Company hereunder and the Company facilities at which such work is conducted to determine that the Company Obligations are being conducted in accordance with the terms of the Agreement, the Development Plan and the Development Budget (“ QA Audits ”). Holdings shall give the Company reasonable advance notice of such QA Audits specifying the scope of the audit. If a particular QA Audit reveals a material deficiency in the Company’s quality assurance procedures, then the Company will be responsible for all costs of such QA Audit, including Holdings’ reasonable costs associated with such QA Audit, the work to be re-performed and the costs or expenses associated with curing such material deficiencies. Holdings and the Company shall meet to discuss the results of the QA Audit and, if required, jointly agree upon any actions that will be required as a result of such QA Audit including defining material deficiencies to be addressed. The Company shall make commercially reasonable efforts to reconcile all such deficiencies found by Holdings during such QA Audit.

          6.6 Financial Audit . During the Term, the Company will permit Holdings’ representatives (such representatives (i) to be identified by Holdings in advance and reasonably acceptable to the Company and (ii) to enter into a confidentiality agreement with the Company), to verify the Company’s invoices, other receipts, and FTE records that are related to the Company’s performance of the work under the Programs (“ Financial Audits ”), which review shall be conducted during regular business hours and will take place no more than once per year, unless otherwise agreed to by the Parties. Holdings shall give the Company reasonable advance notice of such Financial Audits specifying the scope of the audit, which shall not include work that has previously undergone Financial Audits. Holdings shall reimburse the Company for its time associated with Financial Audits; provided , however , that should a particular Financial Audit reveal an overstatement of costs and expenses in the reports submitted by the Company to Holdings for reimbursement purposes during the period covered by such Financial Audit that exceeds [ * ]% in the aggregate, then the Company will be responsible for all costs of such Financial Audit, including Holdings’ reasonable costs associated therewith. Holdings and the Company shall meet to discuss the results of the Financial Audit and, if required, jointly agree upon any actions that will be required as a result of such Financial Audit including defining material discrepancies to be addressed. The Company shall make commercially reasonable efforts to reconcile all such

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

8


 

discrepancies found by Holdings during such Financial Audit. In addition, the Company shall, during regular business hours, cooperate with, and promptly respond to, inquiries from Holdings Auditors, if Holdings Auditors shall reasonably conclude that they require additional information or clarification regarding any invoices, other receipts or FTE records submitted by the Company.

          6.7 Insurance . The Company shall carry and maintain throughout the Term (i) clinical trial liability insurance (including errors and omissions coverage and product coverage), at the Company’s sole expense, with limits of at least $[ * ] per occurrence, and (ii) property and casualty insurance covering Products and other Company assets used in executing the Development Plan in amounts customarily carried by business entities with a size and risk profile similar to the Company, at the Company’s sole expense, with limits of at least $[ * ]. Holdings shall be named as an additional insured on all clinical trial liability insurance. Upon Holdings’ request, the Company shall instruct its insurance carrier(s) to promptly furnish to Holdings certificates reflecting such coverage and a representation indicating that such coverage shall not be canceled or otherwise terminated during the Term without [ * ] ([ * ]) days’ prior written notice to Holdings. Notwithstanding anything to the contrary herein, this Section 6.7 shall survive for a period of [ * ] ([ * ]) years following termination or expiration of this Agreement.

     7.  Holdings’ Obligations .

          7.1 Generally . Holdings shall have overall responsibility for all matters set forth in the Development Plan, and shall be responsible for (i) executing or delegating its management and administration responsibilities; and (ii) executing or delegating the development activities set forth in the Development Plan. Holdings shall, and shall instruct all Persons whom it engages pursuant to Article 2 hereof to, perform its obligations hereunder and under the Development Plan in good faith and in accordance with the applicable provisions of the Development Plan and the Development Budget, and the terms of this Agreement.

          7.2 Subcontracting . Holdings is subcontracting, and will in the future subcontract, certain of its responsibilities under the Development Plan to the Company (pursuant hereto), and to other vendors and service providers (pursuant to subcontracting agreements to be approved by the Development Committee); provided , that Holdings shall remain responsible for the performance of its obligations hereunder notwithstanding any such arrangement. Each subcontracting agreement entered into by Holdings shall include a provision permitting assignment at any time of the subcontracting agreement from Holdings to the Company without the subcontractor’s consent; provided that Holdings may not assign its obligations under any such subcontracting agreement to the Company without the Company’s prior written consent.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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          7.3 Insurance . Holdings shall maintain insurance with creditworthy insurance companies against such risks and in such amounts as are usually maintained or insured against by other companies of established repute engaged in the same or a similar business.

          7.4 Staffing . Holdings shall use commercially reasonable efforts to provide, or cause to be provided on its behalf, sufficient and competent staff and Personnel that have the skill and expertise necessary to perform Holdings’ obligations under this Agreement, the Development Plan and the Development Budget, including, but not limited to, carrying out its clinical development duties in accordance with this Agreement, the Development Plan and the Development Budget.

          7.5 Inspection and Audit . Holdings shall permit each of the Company, Investors and each Symphony Fund and their duly authorized representatives at all reasonable business hours to inspect and audit (1) Holdings’ books, records and other reasonably requested materials and (2) any and all properties of Holdings, and it shall provide to each of the Company, Investors and each Symphony Fund all books, records and other materials related to any meeting of Manager or Shareholders and to permit the Company, Investors and each Symphony Fund to make copies or extracts therefrom; provided , that each aforementioned party may conduct one such inspection or audit in each calendar year without cost to such party, and that any party conducting additional inspections or audits shall reimburse the Manager for its reasonable costs and expenses in facilitating such additional inspections or audits unless such additional inspections or audits were performed to determine whether previously identified material deficiencies have been addressed. Holdings and the party conducting such inspection or audit, or such party’s representative, shall meet to discuss the results of such inspection or audit and, if required, jointly agree upon any actions that will be required as a result of such inspection or audit including defining material discrepancies to be addressed. Holdings shall make commercially reasonable efforts to reconcile all such discrepancies found by the Company, Investors or any Symphony Fund during such inspection or audit.

     8.  Funding and Payments .

          8.1 Use of Proceeds . Holdings shall use any and all proceeds received by Holdings from Investors and the Symphony Funds for the development of the Programs.

          8.2 Reimbursement . Holdings shall compensate the Company for its Development Plan-associated activities and services, including, without limitation, its research, clinical and manufacturing services and any other activities delegated to and by the Company in accordance with this Agreement. Such compensation shall be made in accordance with the provisions of this Article 8 and the payment terms to be agreed between the Parties (the “ Payment Terms ”) attached hereto as Annex C , the terms of which are hereby adopted and incorporated herein; provided that the Company shall be

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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directly responsible for compensation and reimbursement of the Company Subcontractors, it being understood that the cost shall be passed through to Holdings. With respect to costs for travel, unless the Development Committee provides the Company with prior approval, all the Company personnel shall adhere to the Company’s travel policy.

          8.3 Budget Allocation and Deviations . The Company shall have the discretion to incur out-of-pocket fees, expenses and costs and allocate its resources in a manner consistent with the Development Plan and the Development Budget. If the Company reasonably anticipates that the actual cost for any particular Activity will cause that portion of the Development Budget allocated over any [ * ] ([ * ]) month period to be exceeded by $[ * ] or more (or such greater amount as Manager may subsequently determine), then the Company may request that the Development Committee amend the Development Budget, either at its next Scheduled Meeting or at an Ad Hoc Meeting, to reflect such cost increase. The Company shall be fully reimbursed, pursuant to Section 8.2 , for all out-of-pocket amounts incurred with respect to an Activity performed pursuant to the Development Plan, as such Development Plan may be modified upon approval of the Development Committee, provided that, without the approval of the Development Committee, the Company shall not be reimbursed for expenditures that exceed the amounts set forth in the Development Budget by the criteria set forth in the second sentence of this Section 8.3 . If the Development Committee denies a request made by the Company pursuant to this Section 8.3 to amend the Development Budget, then the Company shall no longer be obligated to perform such incremental activity that is expected to give rise to such additional expenditures.

          8.4 Employee Benefits . Holdings shall not be responsible for providing or paying any benefits (including, but not limited to, unemployment, disability, insurance, or medical, and any pension or profit sharing plans) to the Company or to any employees of the Company or any persons retained or used by the Company to perform activities pursuant to the Development Plan, including independent contractors, Subcontractors and agents (collectively, “ Company Personnel ”). As to the Company or any Company Personnel, Holdings shall not be responsible for: (a) any federal, state or local income tax withholding; (b) Federal Insurance Contributions Act contributions; (c) contributions to state disability funds or liability funds or similar withholdings; (d) payment of any overtime wages; (e) workers’ compensation; or (f) compliance with any laws, rules or regulations governing employees. The Company agrees that, as between Holdings and the Company, the Company is and will continue to be responsible for: (i) all matters relating to the payment of compensation and provision of benefits to Company Personnel; and (ii) compliance with all applicable laws, rules and regulations governing the Company’s employees. The Company acknowledges that the Company is not entitled to reimbursement with respect to any amounts related to the services of Company Personnel in excess of the fully burdened FTE rates in accordance with Annex C attached hereto, and Holdings acknowledges that the FTE rates used as the basis for reimbursing the Company for the services of Company Personnel include the Company’s

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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costs associated with providing such benefits and fulfilling such responsibilities. Such FTE rates also cover all direct and indirect, cash and non-cash compensation paid to or on behalf of said employee or other individual performing duties customarily performed by an employee; all payroll related taxes and costs; all fringe benefits and perquisites; all overhead and support provided by the Company for said employee, including but not limited to facility, office, laboratory and equipment costs, training and education, and general corporate management, supervision, executive and administrative functions and activities; and quality assurance and other functions and activities benefiting the Company or multiple departments, projects or employees within the Company.

     9.  Covenants .

          9.1 Mutual Covenants . Each of the Company and Holdings covenants and agrees that, with respect to the Programs and any other rights and obligations set forth in the Operative Documents, it shall:

               (a) perform all of its obligations pursuant to this Agreement in material compliance with: (i) all applicable federal and state laws, statutes, rules, regulations and orders (including all applicable approval and qualification requirements thereunder), including, without limitation, the Federal Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto; (ii) all applicable good clinical practices and guidelines; (iii) all applicable standard operating procedures; (iv) all applicable Protocols; and (v) the provisions of this Agreement;

               (b) keep complete, proper and separate books of record and account, including a record of all costs and expenses incurred, all charges made, all credits made and received, and all income derived in connection with the operation of its business, all in accordance with GAAP;

               (c) not employ (or, to the best of its Knowledge, shall not use any contractor or consultant who is or that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of any other Regulatory Authority), or, to the best of its Knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of any other Regulatory Authority), in the conduct of the Programs;

               (d) promptly deliver to the other, upon receipt thereof, notice of all actions, suits, investigations, litigation and proceedings before any Governmental Authority, which would reasonably be expected to affect such Party’s ability to perform its obligations under this Agreement;

               (e) upon its acquiring Knowledge of (i) any breach by it of any representation, warranty, covenant or any other term or condition of this Agreement or (ii) any other event or development, in each case that is, or is reasonably expected to be, materially adverse to the other Party with respect to any Program, such

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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Party shall promptly notify the other Party in writing within [ * ] ([ * ]) Business Days of acquiring such Knowledge; provided , that the failure to provide such notice shall not impair or otherwise be deemed a waiver of any rights any Party may have arising from such breach, event or development and that notice under this Section 9.1(e) shall not be deemed an admission by the Party providing such notice of any breach of any of the Operative Documents; and

               (f) with reasonable promptness, deliver to the other Party such data and information relating to the ability of such Party to perform its obligations hereunder as from time to time may be reasonably requested by the other Party (subject to the maintenance of the confidentiality of any such information by the receiving Party). For the avoidance of doubt, this Section 9.1(f) includes the Company’s obligations to provide financial and other necessary information in respect of such Programs to Holdings to enable Holdings to fulfill its obligations to the Company under Section 5(d) of the Purchase Option Agreement.

     10.  Confidentiality . It is understood that during the course of this Agreement each of the Parties shall be bound by the terms of the Confidentiality Agreement.

     11.  Discontinuation Option .

               (a) A Program may only be discontinued in accordance with Section 4.2(c) . In the event of such a Program discontinuation during the Term, (i) Holdings shall so notify the Company promptly and in writing of such discontinuation, and (ii) the Company shall have the right and option (a “ Discontinuation Option ”), exercisable for [ * ] ([ * ]) days after receipt of such written notice from Holdings of such discontinuation, to buy back all rights of Holdings to such discontinued Program, the Products being developed in such discontinued Program, and the Licensed Intellectual Property related to such discontinued Program for a price (payable by wire transfer to Holdings) that is [ * ]% of the sum of (x) the funds expended on such discontinued Program and (y) a share of all non-Program-specific expenditures that is in the same proportion to the total of all non-Program-specific expenditures as the amount in clause (x)  of this sentence is to the aggregate of all Program-specific expenditures (such sum, the “ Discontinuation Price ”), to be reasonably determined between the Parties, or, if the Parties are unable to come to a resolution within [ * ] ([ * ]) days after receipt of such written notice from Holdings of such discontinuation, to be determined in accordance with Section 11(b) hereof; provided , that if the Ophthalmology Program is discontinued, the Discontinuation Price with respect to such Program shall be reduced by [ * ]% of the purchase price paid by Holdings in consideration for the purchase of all Non-IV Shares pursuant to the Stock and Warrant Purchase Agreement. If the Discontinuation Price is determined in accordance with Section 11(b) , then the [ * ] ([ * ]) day period for the Company’s exercise of a Discontinuation Option shall be extended by the time needed

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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for such determination so that the Company has at least [ * ] ([ * ]) days after such determination to decide whether it wishes to exercise a Discontinuation Option.

               (b) If the Company and Holdings cannot agree on the Discontinuation Price within [ * ] ([ * ]) days after receipt of such written notice from Holdings of such discontinuation, then at the Company’s request, the Chief Executive Officer of the Company and the Manager shall make good faith efforts to resolve the disagreement(s) regarding the calculation of the Discontinuation Price. If the Chief Executive Officer of the Company and the Manager do not agree on the Discontinuation Price within [ * ] ([ * ]) days after the Company’s request, then the Parties shall jointly select a nationally recognized expert to resolve any remaining disagreements regarding calculation of the Discontinuation Price. The Parties shall use their respective commercially reasonable efforts to cause such expert to make its determination of the Discontinuation Price within [ * ] ([ * ]) days of accepting its selection. The expert’s determination of the Discontinuation Price shall, absent manifest error, be (i) binding and conclusive and (ii) the Discontinuation Price at which a Discontinuation Option may be exercised by the Company. All costs and expenses of the expert shall be shared equally between the Company and Holdings. Notwithstanding the foregoing, in any case, each Party shall be responsible for the payment of its respective costs and expenses, including any attorneys’ fees.

               (c) Upon the exercise of a Discontinuation Option for a Program, such Program shall no longer be a Program and the Products being developed in such Program shall no longer be Products for purposes of the Operative Documents, except to the extent the Operative Documents deal with the rights of the Company and the obligations of Holdings following exercise of a Discontinuation Option..

     12.  Representations and Warranties .

          12.1 Company Representations and Warranties . The Company hereby represents and warrants to Holdings that, as of the Closing Date:

               (a)  Organization . The Company is a corporation, duly organized, validly existing and in good standing under the laws of the State of Delaware.

               (b)  Authority and Validity . The Company has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement and the Technology License Agreement and to consummate the transactions contemplated thereby. The execution, delivery and performance by the Company of this Agreement and the Technology License Agreement and the consummation of the transactions contemplated thereby have been duly and validly authorized by all necessary action required on the part of the Company, and no other proceedings on the part of the Company are necessary to authorize this Agreement or the Technology License Agreement or for the Company to perform its obligations under this Agreement or the Technology License Agreement. This Agreement and the Technology

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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License Agreement constitute the lawful, valid and legally binding obligations of the Company, enforceable in accordance with their terms, except as the same may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the enforcement of creditors’ rights generally and general equitable principles regardless of whether such enforceability is considered in a proceeding at law or in equity.

               (c)  No Violation or Conflict . The execution, delivery and performance of this Agreement and the Technology License Agreement and the transactions contemplated thereby do not and will not (i) violate, conflict with or result in the breach of any provision of the Organizational Documents of the Company, (ii) conflict with or violate any law or Governmental Order applicable to the Company or any of its assets, properties or businesses, or (iii) conflict with, result in any breach of, constitute a default (or event that with the giving of notice or lapse of time, or both, would become a default) under, require any consent under, or give to others any rights of termination, amendment, acceleration, suspension, revocation or cancellation of, or result in the creation of any Encumbrance on any of the assets or properties of the Company, pursuant to, any note, bond, mortgage or indenture, contract, agreement, lease, sublease, license, permit, franchise or other instrument or arrangement to which the Company is a party except, in the case of clauses (ii)  and (iii) , to the extent that such conflicts, breaches, defaults or other matters would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on the Company or a material adverse effect on the Programs.

               (d)  Governmental Consents and Approvals . The execution, delivery and performance of this Agreement and the Technology License Agreement by the Company do not, and the consummation of the transactions contemplated thereby do not and will not, require any Governmental Approval which has not already been obtained, effected or provided, except with respect to which the failure to so obtain, effect or provide would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on the Company or a material adverse effect on the Programs.

               (e)  Litigation . Except as disclosed on the most recently filed Form 10-K filing of the Company, there are no actions by or against the Company pending before any Governmental Authority or, to the Knowledge of the Company, threatened to be brought by or before any Governmental Authority, that would, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on the Company. There are no pending or, to the Knowledge of the Company, threatened actions, to which the Company is a party (or is threatened to be named as a party) to set aside, restrain, enjoin or prevent the execution, delivery or performance of this Agreement or the Operative Documents or the consummation of the transactions contemplated hereby or thereby by any party hereto or thereto. The Company is not subject to any Governmental Order (nor, to the Knowledge of the Company, is there any

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

15


 

such Governmental Order threatened to be imposed by any Governmental Authority) that would, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on the Company or a material adverse effect on the Programs.

               (f)  No Contracts . Except as disclosed on Schedule 12.1(f) hereto, there are no material contracts between the Company and any third party (other than licenses of intellectual property that are in turn licensed to Holdings under the Technology License Agreement), including contractors, manufacturers or suppliers, used with or otherwise necessary for the Programs, and all such contracts are assignable to Holdings. Except as disclosed on Schedule 12.1(f) hereto, each such contract is assignable to Holdings without the prior consent of the applicable third party, or the absence of such contract (due to the inability or impracticability of assigning such contract to Holdings following a termination of this Agreement without the exercise of the Purchase Option) would not have a material adverse effect on any of the Programs or on Holdings’ rights under the Technology License Agreement.

               (g)  Information . All information provided or otherwise made available by the Company or its representatives in connection with the Programs and the underlying intellectual property, this Agreement, the Operative Documents and the transactions contemplated thereby, when taken as a whole, is complete and correct in all material respects and does not contain any untrue statement of material fact or omit to state a material fact necessary to make the statements contained therein, in light of the circumstances under which such statements are made, not misleading.

          12.2 Holdings Representations and Warranties . Holdings hereby represents and warrants to the Company that, as of the Closing Date:

               (a)  Organization . Holdings is a limited liability company, duly organized, validly existing and in good standing under the laws of the State of Delaware.

               (b)  Authority and Validity . Holdings has all requisite limited liability company power and authority to execute, deliver and perform its obligations under this Agreement and the Technology License Agreement and to consummate the transactions contemplated thereby. The execution, delivery and performance by Holdings of this Agreement and the Technology License Agreement and the consummation of the transactions contemplated thereby have been duly and validly authorized by all necessary action required on the part of Holdings, and no other proceedings on the part of Holdings are necessary to authorize this Agreement or the Technology License Agreement or for Holdings to perform its obligations under this Agreement or the Technology License Agreement. This Agreement and the Technology License Agreement constitute the lawful, valid and legally binding obligations of Holdings, enforceable in accordance with its terms, except as the same may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

16


 

the enforcement of creditors’ rights generally and general equitable principles regardless of whether such enforceability is considered in a proceeding at law or in equity.

               (c)  No Violation or Conflict . The execution, delivery and performance of this Agreement and the Technology License Agreement and the transactions contemplated thereby do not and will not (i) violate, conflict with or result in the breach of any provision of the Organizational Documents of Holdings, (ii) conflict with or violate any law or Governmental Order applicable to Holdings or any of its assets, properties or businesses, or (iii) conflict with, result in any breach of, constitute a default (or event that with the giving of notice or lapse of time, or both, would become a default) under, require any consent under, or give to others any rights of termination, amendment, acceleration, suspension, revocation or cancellation of, or result in the creation of any Encumbrance on any of the assets or properties of Holdings, pursuant to any note, bond, mortgage or indenture, contract, agreement, lease, sublease, license, permit, franchise or other instrument or arrangement to which Holdings is a party except, in the case of clauses (ii)  and (iii) , to the extent that such conflicts, breaches, defaults or other matters would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on Holdings.

               (d)  Governmental Consents and Approvals . The execution, delivery and performance of this Agreement and the Technology License Agreement by Holdings do not, and the consummation of the transactions contemplated thereby do not and will not, require any Governmental Approval which has not already been obtained, effected or provided, except with respect to which the failure to so obtain, effect or provide would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on Holdings.

               (e)  Litigation . There are no actions by or against Holdings pending before any Governmental Authority or, to the Knowledge of Holdings, threatened to be brought, by or before any Governmental Authority that would, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on Holdings. There are no pending or, to the Knowledge of Holdings, threatened actions to which Holdings is a party (or is threatened to be named as a party) to set aside, restrain, enjoin or prevent the execution, delivery or performance of this Agreement or the consummation of the transactions contemplated hereby by any party hereto. Holdings is not subject to any Governmental Order (nor, to the knowledge of Holdings, is there any such Governmental Order threatened to be imposed by any Governmental Authority) that would, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on Holdings or a material adverse effect on the Programs.

     13.  Relationship Between the Company and Holdings . Nothing contained in this Agreement or any acts or omissions hereunder shall constitute or be construed so as to create any joint venture or partnership relationship between the Company and Holdings, and the Parties acknowledge and agree that the Company is

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

17


 

acting as an independent contractor in the performance of its obligations under this Agreement.

     14.  Change of Control . Holdings has the Change of Control Put Option described in Section 2A of the Purchase Option Agreement following a Change of Control with respect to the Company.

     15.  No Restrictions; Indemnification .

          15.1 No Restrictions . Nothing in this Agreement shall limit or restrict the right of any director, officer or employee of the Company or any director, officer, or employee of any of its subsidiaries or its Affiliates to engage in any other business or to devote his or her time and attention to the management or other aspects of any other business, whether of a similar or dissimilar nature, nor limit or restrict the right of the Company or any of its affiliates to engage in any other business or to render services of any kind to any other Person.

          15.2 Indemnification .

               (a) To the greatest extent permitted by applicable law, the Company shall indemnify and hold harmless Holdings and each of its respective Affiliates, officers, directors, employees, agents, members, managers, successors and assigns (each, a “ Symphony Indemnified Party ”), and Holdings shall indemnify and hold harmless the Company, and its Affiliates and each of their respective officers, directors, employees, agents (other than the Company Subcontractors), members, managers, successors and assigns (each, a “ Company Indemnified Party ”), from and against any and all claims, losses, costs, interest, awards, judgments, fees (including reasonable fees for attorneys and other professionals), court costs, liabilities, damages and expenses incurred by any Symphony Indemnified Party or Company Indemnified Party (irrespective of whether any such Indemnified Party is a party to the action for which indemnification hereunder is sought) (hereinafter, a “ Loss ”) to the extent resulting from, arising out of, or relating to any and all third party suits, claims, actions, proceedings or demands based upon:

               (i) in the case of the Company being the Indemnifying Party, (A) any breach of any representation or warranty made by the Company herein or in any other Operative Document, (B) any material misrepresentation or omission of facts in the public information of the Company filed with the SEC, (C) any breach of any covenant, agreement or obligation of the Company contained herein or in any other Operative Document, except to the extent such covenant, agreement or obligation relates to the Company’s performance under the Development Plan, (D) any gross negligence or willful misconduct of the Company (and not that of any Company Subcontractors) in connection with the Company’s performance of its obligations under this Agreement (including the Development Plan), (E) any action undertaken or

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

18


 

performed by or on behalf of the Company prior to, and including, the Closing Date that relates to the Programs or the Products, (F) any regulatory matters relating to the Company, its businesses or its assets, (G) any investigation or claim, including derivative claims, relating to the Company, its businesses or its assets, or (H) in the event the Company exercises a Discontinuation Option for a Program, any action undertaken and/or performed by or on behalf of the Company after the Discontinuation Option Closing Date and relating to the Product that was the subject of such Program (including the development, manufacture, use, handling, storage, sale or other disposition of such Product); in each case, except (1) with respect to Losses for which the Company is entitled to indemnification under this Article 15 or (2) to the extent such Loss arises from the gross negligence or willful misconduct of a Symphony Indemnified Party; and

               (ii) in the case of Holdings being the Indemnifying Party, (A) any breach of any representation or warranty made by Holdings herein or in any other Operative Document, (B) any breach of any covenant, agreement or obligation of Holdings contained herein or in any other Operative Document, (C) any and all activities undertaken or performed by or on behalf of the Parties under the Development Plan during the Term, (D) any gross negligence or willful misconduct of Holdings (and not that of its direct subcontractors) in connection with Holdings’ performance of its obligations under this Agreement, or (E) the development, manufacture, use, handling, storage, sale or other disposition of the Products (including in the course of conducting the Programs) during the Term (except with respect to the development, manufacture, use, handling, storage, sale or other disposition, after the Company’s exercise of a Discontinuation Option, of Products covered under Section 15.2(a)(i)(H)) ; in each case, except (1) with respect to Losses for which Holdings is entitled to indemnification under this Article 15 , or (2) Losses deemed to have arisen from the breach by the Company of any covenant, agreement or obligation under this Agreement that relates to the Company’s performance under the Development Plan, as determined by a court, arbitrator or pursuant to a settlement agreement, or (3) to the extent such Loss arises from the gross negligence or willful misconduct of a Company Indemnified Party.

     To the extent that the foregoing undertaking by the Company or Holdings may be unenforceable for any reason, such Party shall make the maximum contribution to the payment and satisfaction of any Loss that is permissible under applicable law.

     To the extent that the foregoing undertaking by the Company or Holdings may be duplicated by any other undertaking by the Company or Holdings in any other Operative Document, the Symphony Indemnified Parties or the Company Indemnified Parties, as the case may be, shall be entitled to only one recovery under the Operative Documents for the relevant Loss (and not entitled to any duplicative recovery for the same Loss).

Portions of this Exhibit were omitted and have been filed s


 
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