CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. CO-DEVELOPMENT AND LICENSE AGREEMENT Between Zhejiang...

Exhibit 10.6

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

CO-DEVELOPMENT AND LICENSE AGREEMENT

Between

Zhejiang Medical Corporation

and

AMBRX, INC.

Dated as of June 14, 2013 

CO-DEVELOPMENT AND LICENSE AGREEMENT

This CO-DEVELOPMENT AND LICENSE AGREEMENT (this “Agreement”), effective as of June 14, 2013 (the “Effective Date”), is between AMBRX, Inc., a Delaware Corporation having the principal business address at ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇ for and on behalf of itself and its Affiliates (together with its Affiliates, “AMBRX”), and , Zhejiang Medicine Co., Ltd., a company duly organized and existing under the laws of the People’s Republic of China and having the principal business address at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇ District, Hangzhou, Zhejiang, P.R. China, for and on behalf of itself and its Affiliates (together with its Affiliates, “ZMC”). AMBRX and ZMC may each be referred to herein individually as a “Party” or, collectively, as the “Parties.”

RECITALS

WHEREAS, Ambrx owns and/or controls Ambrx Background Technology (as hereinafter defined) and has rights to Licensed Intellectual Property Rights as hereinafter defined) with respect to αHer2-ADC Program (as hereinafter defined);

WHEREAS, ZMC is a pharmaceutical company engaged in research, development, and commercialization of pharmaceutical products, including the human therapeutic products in the Territory (as hereinafter defined);

WHEREAS, ZMC desires to obtain an exclusive license under the Ambrx Existing Patent Rights in the Territory upon the terms and conditions set forth herein, and Ambrx desires to grant such a license, in order for ZMC to develop, make, use, sell, offer for sale the Licensed Products (as hereinafter defined) for the prevention or treatment of human diseases and human conditions in the Territory;

WHEREAS, ZMC desires to obtain assistance from AMBRX and AMBRX desires to offer such assistance to ZMC to develop αHer2-ADC Program to the Licensed Products in the Territory under the world-class standards and complete phase I human clinical trials outside the Territory and build a cGMP manufacturing facility to produce the Licensed Product for commercialization in the Territory and/or αHer2-ADC API or αHer2-ADC Product (as hereinafter defined) outside the Territory.

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

ARTICLE 1 

DEFINITIONS

As used in this Agreement, the following terms shall have those meanings set forth in this Article 1 unless the context dictates otherwise.

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3  

Controlled by or licensed to Ambrx as of the Effective Date which is related to αHer2-ADC as shown in Exhibit X.

4  

5  

herein without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be required hereunder to grant the other Party such access or license or sublicense.

6  

Third Parties working on behalf of ZMC, on the one hand, with one or more employees or Third Parties working on behalf of AMBRX, on the other hand, in connection with the development of Licensed Products or in the course of engaging in αHer2-ADC Program, as well as any and all Patents covering the same.

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based on Phase I Clinical Data, excluding FTEs, reimbursements and deductions as defined in 1.40(II)(a)-(i); and

(II) to ZMC, the gross invoice price (not including value added taxes, sales taxes, or similar taxes) of Licensed Product sold by ZMC or its Affiliate to the first Third Party in which ZMC has no equity interest after deducting, if not previously deducted, from the amount invoiced or received:

Any individual items that are estimated and deducted in calculating Net Sales shall be periodically (but at least on a calendar quarter basis) trued up and adjusted by ZMC consistent with its customary practices and in accordance with China GAAP. Any deductions subsequently reversed shall be included in Net Sales for the royalty period in which such deductions are reversed. The calculation of Net Sales hereunder shall be in accordance with China GAAP and ZMC’ and/or its Affiliates’ customary accounting policies, applied consistently across periods, and

(a)  Transfer or sale of a Licensed Product within ZMC, between ZMC and an Affiliate, or between ZMC and a non-Affiliate Third Party in which ZMC has equity interest shall not be considered a sale, commercial use or disposition for the purpose of the foregoing paragraphs;

(b)  in the event that ZMC has to transfer or sell any Licensed Product to a non-Affiliate Third Party in which ZMC has equity interest, ZMC and AMBRX shall

8  

jointly discuss and determine the value of Net Sales; and

(c) in the event that ZMC receives consideration for any Licensed Products in the case of transactions not at arm’s length with a non-Affiliate of ZMC, Net Sales will be calculated based on the fair market value of such consideration or transaction, assuming an arm’s length transaction made in the ordinary course of business.

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Sale of the Licensed Product and continue until the expiration of the later of: (i) the last-to-expire Valid Patent Claim that would be infringed by the manufacture, use or sale of Licensed Product in the Territory; or (ii) the period of twenty (20) years following the First Commercial Sale of such Licensed Product in Territory.

ARTICLE 2 

LICENSE; DEVELOPMENT AND COMMERCIALIZATION

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AMBRX hereby grants to ZMC an exclusive right and license in the Field throughout the Territory, with the right to grant sublicenses subject to Section 2.7.1, under AMBRX Know-How to develop, have developed, use, manufacture, have manufactured, sell, offer for sale and have sold Licensed Products.

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mutually approved jurisdiction outside the Territory pursuant to Section 2.2.

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substantially entire rights and interests granted herein to a Third Party unless Parties negotiate in good faith to reach an agreement prior to such sublicense, and 2) shall not unreasonably withhold such consent if ZMC enters such sublicense for the purpose of distributing or supplying Licensed Products in the Territory or otherwise expressed approved herein or by the Joint Steering Committee.

ARTICLE 3 

JOINT STEERING COMMITTEE

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designated by ZMC thereafter. The initial chairperson is designated on Exhibit 5. Each Party shall be free to replace its representative members with new appointees who have authority to act on behalf of such Party on the Joint Steering Committee, on written notice to the other Party.

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by the Chairman of ZMC and the CEO of AMBRX or by their designated representative. If no such decision is made then the chairperson of the Joint Steering Committee shall make a final decision in good faith, provided however, in the event such decision is relevant to activities outside Territory or cGMP compliance, such decision shall be made by a member designated by AMBRX.

ARTICLE 4 

DEVELOPMENT AND COMMERCIALIZATION

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Program, under the guidance and supervision of the Joint Steering Committee, to evaluate αHer2-ADC Candidate(s) provided by AMBRX and select αHer2-ADC API or αHer2-ADC Product therefrom for development and commercialization.

provided, however, that, upon request by ZMC, ZMC shall present to the Joint Steering Committee and AMBRX, revisions to the milestones described in clauses 4.1.1 through 4.1.3 above, or in the designated time periods, with supporting evidence of technical difficulties or delays in financing, clinical

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studies, or regulatory processes that AMBRX shall deem appropriate at its sole discretion.

ARTICLE 5 

SUPPORT AND ASSISTANCE

ARTICLE 6 

MONETARY OBLIGATIONS, REPORTS AND AUDITS

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***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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Quarter showing the gross and Net Sales of all Licensed Products subject to royalty payments sold by ZMC and its Affiliates in the Territory during the reporting period and the royalties payable under this Agreement. Reports shall be due on the forty-fifth (45th) day following the close of each Calendar Quarter. Royalties shown to have accrued by each royalty report shall be due and payable on the date such royalty report is due. ZMC and its Affiliates shall keep complete and accurate records in sufficient detail to enable the royalties payable hereunder to be determined.

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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accounting firm shall be equally shared by AMBRX and ZMC.

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payments made by ZMC to AMBRX under the Agreement to the bank accounts designated by AMBRX outside China, and AMBRX will provide reasonable assistance if necessary.

ARTICLE 7 

INTELLECTUAL PROPERTY

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file and maintain said Patent Rights in said elected country. Further, if, pursuant to Section 7.2.2, ZMC elects not to file in a particular country outside Territory and Ambrx elects to file and maintain Patent Rights on such ZMC Improvements, then AMBRX shall pay 100% of the costs to file and maintain said Patent Rights in the elected country(ies). For clarity, AMBRX shall be responsible for prosecuting and maintaining AMBRX Existing Patent Rights and AMBRX Patent Rights in and outside the Territory at its own expense.

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In the event ZMC exercises its right to ▇▇▇ pursuant to this Section 7.3.2, it shall first reimburse itself out of any sums recovered in such suit or in settlement thereof for all costs and expenses of every kind and character, including reasonable attorneys’ fees, necessarily incurred in the prosecution of any such suit. If, after such reimbursement, any funds shall remain from said recovery, then AMBRX shall receive an amount equal to [***] of such funds and the remaining [***] of such funds shall be retained by ZMC.

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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promptly notify AMBRX in writing and AMBRX may elect, upon written notice to ZMC within thirty (30) days after AMBRX receives notice of the commencement of such action, to take over the defense of the invalidity and/or unenforceability aspect of the action solely.

ARTICLE 8 

CONFIDENTIALITY & PUBLICATIONS

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extent that it can be established by the receiving Party by competent proof that such information: (i) is, or hereafter becomes, generally available to the public other than by reason of any default by the receiving Party with respect to its confidentiality obligations hereunder; (ii) was already known to the receiving Party at the time of disclosure by the disclosing Party; (iii) was lawfully disclosed to the receiving Party by a Third Party not in default of any confidentiality obligation to the disclosing Party; or (iv) is independently developed by or for the receiving Party without reference to or reliance upon the information furnished by the disclosing Party.

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Article 7 above. Upon expiration of such one hundred and twenty (120) days, the publishing Party shall be free to proceed with the publication or presentation. If the reviewing Party requests modifications to the publication or presentation, the publishing Party shall edit such publication to prevent disclosure of trade secret or proprietary business information prior to submission of the publication or presentation.

ARTICLE 9 

REPRESENTATIONS AND WARRANTIES

Each Party represents and warrants to the other Party the following as of the Effective Date:

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corporate actions of such Party. This Agreement has been duly executed by such Party. This Agreement and any other documents contemplated hereby constitute valid and legally binding obligations of such Party enforceable against it in accordance with their respective terms, except to the extent that enforcement of the rights and remedies created thereby is subject to bankruptcy, insolvency, reorganization, moratorium and other similar laws of general application affecting the rights and remedies of creditors.

AMBRX represents and warrants to ZMC the following as of the Effective Date:

9.3 REPRESENTATIONS BY ZMC. ZMC represents, warrants and covenants to AMBRX that:

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authorizations of regulatory authorities or other governmental authorities that cannot be obtained before the Effective Date, will be obtained within sixty (60) days after the Effective Date.

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31  

ARTICLE 10 

INDEMNIFICATION & INSURANCE

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consent of the Indemnified Party, which the Indemnifying Party may provide in its sole discretion. The Indemnified Party shall not settle or compromise any such claim without the prior written consent of the Indemnifying Party, not to be unreasonably withheld.

ARTICLE 11

TERM & TERMINATION

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(v)  admitted in writing its inability to pay all or substantially all of its debts as they become due, or (vi) taken corporate action for the purpose of effecting any of the foregoing; or

(iii)  the winding-up or liquidation of such other Party; and, in each case, such proceeding or petition shall have continued undismissed for sixty (60) days, or an order or decree approving or ordering any of the foregoing shall have continued unstayed, unappealed and in effect for thirty (30) days.

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provided however, ZMC shall not assert against AMBRX, its Affiliates or sublicensees any claims for infringement of the reverted rights in the event AMRBX and/or its Affiliate and/or sublicensees continue to make, develop, manufacture, have manufactured, sell, offer for sale and have sold Licensed Products; and (iii) any existing agreements that contain a Sublicense shall terminate to the extent of such Sublicense; provided, however, that, for each sublicensee, upon termination of the Sublicense agreement with such sublicensee, if the sublicensee is not then in breach of its Sublicense agreement with ZMC such that ZMC would have the right to terminate such Sublicense, such sublicensee shall have the right to seek a license from AMBRX at AMBRX’s sole discretion.

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to, incorporate and use all documents and other materials filed by or on behalf of ZMC and its Affiliates with any Regulatory Authority in furtherance of applications for Marketing Authorization in the Territory or outside Territory with respect to Licensed Product. AMBRX shall be entitled to freely and exclusively use and to grant others the right to use all such materials and documents delivered pursuant to this Section 11.5.4

ARTICLE 12 

LIMITATIONS OF LIABILITY

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EVEN IF AN AUTHORIZED REPRESENTATIVE OF SUCH PARTY IS ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME.

ARTICLE 13

DISPUTE RESOUTION

ARTICLE 14 

MISCELLANEOUS

Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent that such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, potentially including, embargoes, war, acts of war (whether war be declared or not), acts of terrorism, insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of God, or acts, omissions or delays in acting by any governmental authority or the other Party. The affected Party shall notify the other Party of such force majeure circumstances as soon as

37  

reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.

Except as provided in this Section 14.2, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the consent of the other Party. Notwithstanding the foregoing, either Party may, without the other Party’s consent, assign this Agreement and its rights and obligations hereunder in whole or in part to an Affiliate; provided, however, that the assigning party must notify the other party at least twenty (20) days prior to completion of any such assignment. Further, each party may assign this Agreement to any assignee of all or substantially all of such Party’s business or in the event of such Party’s merger, consolidation or similar transaction. Any permitted assignee shall assume all obligations of its assignor under this Agreement. This Agreement is binding upon the permitted successors and assigns of the Parties. Any attempted assignment not in accordance with this Section 14.2 shall be void

If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their good faith efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.

All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by internationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

With a copy to:

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With a copy to:

or to such other address(es) as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered, if personally delivered or sent by facsimile on a business day (or if delivered or sent on a non-business day, then on the next business day); (b) on the business day after dispatch, if sent by internationally-recognized overnight courier; or (c) on the fifth (5th) business day following the date of mailing, if sent by mail.

This Agreement shall be governed by and construed in accordance with the laws of the People’s Republic of China, without reference to any rules of conflict of laws or renvoi. The United Nations Convention on the Sale of Goods shall not apply to this Agreement.

This Agreement together with the Schedules hereto contains the entire understanding of the Parties with respect to the subject matter hereof, including the research program and the licenses granted hereunder. Any other express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, with regard to the subject matter hereof, including the research program and/or the licenses granted hereunder, are superseded by the terms of this Agreement. The Schedules to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto.

The captions to the several Articles and Sections and subsections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof. Any reference in this Agreement to an Article, Section, subsection, paragraph, clause, or Schedule or Exhibit shall be deemed to be a reference to an Article, Section, subsection, paragraph, clause, or Schedule or Exhibit, of or to, as the case may be, this Agreement, unless otherwise indicated. Unless the context of this Agreement otherwise requires, (a) words of any gender include each other gender, (b) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear, (c) words using the singular shall include the plural, and vice versa, (d) whenever any provision of this

39  

Agreement uses the term “including” (or “includes” or words of similar import), such term shall not be limiting and such term shall be deemed to mean “including without limitation” (or “includes without limitation”), (e) the word “or” shall not be construed as exclusive, and (f) references to any Articles or Sections include Sections and subsections that are part of the reference Article or section (e.g., a section numbered “Section 2.2.1” would be part of “Section 2.2.”, and references to “Article 2” or “Section 2.2.” would refer to material contained in the subsection described as “Section 2.2.2”).

It is expressly agreed that Ambrx and ZMC shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency. Neither Ambrx nor ZMC shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

The waiver by either Party hereto of any right hereunder, or of any failure of the other Party to perform, or of any breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach by or failure of such other Party, whether of a similar nature or otherwise.

No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.

In the event that any notice or other action or omission is required to be taken by a Party under this Agreement on a day that is not a business day then such notice or other action or omission shall be deemed to be required to be taken on the next occurring business day.

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This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. For purposes hereof, a scanned copy of this Agreement, including the signature pages hereto, will be deemed to be an original.

ZMC shall be responsible for any and all PRC related regulatory approvals, registrations and/or filings in connection with performance of this Agreement, including without limitation registering this Agreement with competent commission of commerce and providing registration certificate to Ambrx within sixty (60) days after execution of this Agreement. Before ZMC’s filing or submission of any reports or other documents with any PRC governmental authority or securities exchange, it shall provide copies of any such reports or documents to be filed or submitted to Ambrx for its prior consents; after regulatory approvals, registrations and/or filings are completed, ZMC shall provide a copy of relevant certificates to Ambrx immediately.

Notwithstanding anything to the contrary contained herein, all obligations of Ambrx and ZMC are subject to prior compliance with the export regulations of the United States and any other relevant country and such other laws and regulations in effect in the United States and/or any other relevant country as may be applicable, and to obtaining all necessary approvals required by the applicable agencies of the governments of the United States and any other relevant countries. Ambrx and ZMC shall cooperate with each other and shall provide assistance to the other as reasonably necessary to obtain any required approvals.

Each Party will execute, acknowledge and deliver such further instruments, and to do all such other ministerial, administrative or similar acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

The provisions of this Agreement are for the exclusive benefit of the Parties, and no other person or entity shall have any right or claim against any Party by reason of these provisions or be entitled to enforce any of these provisions against any Party.

Except as otherwise specifically provided in this Agreement, each Party (and its Affiliates) shall bear its own costs and expenses in connection with entering into this Agreement and the consummation of the transactions and performance of its obligations contemplated hereby.

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ZMC shall have the right to extend the rights, licenses, immunities and obligations granted in this Agreement to one or more of its Affiliates. All applicable terms and provisions of this Agreement shall apply to any such Affiliate to which this Agreement has been extended to the same extent as such terms and provisions apply to ZMC. ZMC shall remain fully liable for any acts or omissions of such Affiliates.

The official text of this Agreement is in the English language as written and spoken in the United States of America. Any text or version of this Agreement in another language, even if such text or version is made by translation or prepared by or executed by one or both of the Parties for a Party’s convenience shall not be binding and shall have no force or effect. Without limiting the foregoing, in the event of any conflict or inconsistency between the English text of this Agreement and any text or version of this Agreement in another language, the English text of this Agreement will prevail.

[Remainder of this page is left intentionally blank]

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IN WITNESS WHEREOF, the Parties have executed this Co-development and License Agreement as of the Effective Date in HuangPu District, Shanghai, People’s Republic of China.

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Exhibit 1

Protein Sequence of HER2

[***]

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Exhibit 2

AMBRX Existing Patent Rights

[***]

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Exhibit 3

ZMC-WUXI Service Agreement

DEVELOPMENT, MANUFACTURING, AND TESTING TERMS AND CONDITIONS

This Development, Manufacturing and Testing Terms and Conditions together with any Technology Development Contracts attached hereto is made and entered into as of Jun 14_, 2013 (Effective Date) by and between WuXi AppTec Biopharmaceuticals Co., Ltd., a company organized under the laws of PR.China, having a principal place of business at ▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ and its affiliates. (collectively, “WuXi”) and Zhejiang Medicine Co Ltd, a company organized under the laws of PR China having a principle place of business at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (“Customer”). Customer and WuXi are referred to herein individually as a “Party” and collectively as the “Parties”.

The Parties agree as follows:

1. Definitions

1.1 Defined Terms. The following terms (whether or not underscored) when used in this Agreement, shall, except where the context otherwise requires, have the following meanings:

1.1.1 “Affiliate” means any company, partnership or other entity which directly or indirectly controls, is controlled by or is under common control with the relevant Party to this Agreement. “Control” means the ownership of at least fifty per cent (50%) of the equity of the entity or the legal power to direct the general management and policies of the entity.

1.1.2 “Agreement” means these Terms and Conditions together with an applicable Technology Development

Contract.

1.1.3 “Batch” means the total Product obtained from one bioreactor run and associated purification using the Process and carried out in accordance with cGMP or non cGMP if so identified in the Technology Development Contract.

1.1.4 “Cell Line” means the cell line used to produce Product, particulars of which are set out in Technology Development Contracts.

1.1.5 “Certificate of Analysis” means a certificate of analysis as to testing of Specifications of any Product in form and substance agreed to by WuXi and Customer.

1.1.6 “cGMP” means current Good Manufacturing Practices and General Biologics Products Standards as promulgated under the US Federal Food Drug and Cosmetic Act at 21 CFR (Chapters 210, 211, 600 and 610), the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC and ICH Guidance Q7A (Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. WuXi’s operational quality standards are defined in internal GMP policy documents.

1.1.7 “cGMP Product” means Product which may be required under Technology Development Contracts to be manufactured in accordance with cGMP.

1.1.8 “Customer” means Zhejiang Medicine Co Ltd and its successors and assigns.

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1.1.9 “Customer Information” means all technical and other information from time to time supplied by Customer to WuXi, which at the time of supply by Customer is not (i) already in the public domain or (ii) already known by WuXi at the time of disclosure as established by written records.

1.1.10 “Customer Know-How” means all technical and other information relating to the Product or the Process known to Customer from time to time other than WuXi Know-How and information in the public domain.

1.1.11 “Customer Materials” means the materials supplied by Customer to WuXi and identified as such in Technology Development Contracts hereto.

1.1.12 “Customer Patent Rights” means all patents and patent applications of any kind throughout the world that are necessary or useful in performance of the Services, or related to the Products or the Process, which from time to time Customer is the owner of or is entitled to use.

1.1.13 “Deliver”, “Delivered” or “Delivery” has the meaning ascribed to it by Section 5.1.

1.1.14. “Price” means the price specified in Technology Development Contracts for the Services.

1.1.15 “Process” means the process for the production of the Product from the Cell Line, including any improvements or modifications thereto from time to time.

1.1.16 “Product” means all or any part of the product manufactured (including any sample thereof), particulars of which are set out in Technology Development Contracts and includes all derivatives thereof.

1.1.17 “Quality Agreement” means the quality agreement between the Parties. The Quality Agreement is attached as Appendix X and hereby incorporated into this Agreement and all related Technology Development Contracts by reference.

1.1.18 “Services” means all or any part of the services that are the subject of the Agreement, particulars including but not limited to specifications, cost, quantity, and delivery dates of which are set out in Technology Development Contracts.

1.1.19 “Specification” means the specification for Product or Services, as applicable, particulars of which are set out in Technology Development Contracts.

1.1.20 “Terms of Payment” means the terms of payment specified in Technology Development Contracts.

1.1.21 “Testing Laboratories” means any third party instructed to carry out tests on the Cell Line or the Product. All proposed third party laboratories (or for that matter, any other Parties to which WuXi subcontracts work on Customer Cell Line or Product) shall be subject to prior review and approval by Customer.

1.1.22 “Technology Development Contract” means any such appendix to this Agreement specifying Services, as agreed to in writing by the Parties from time to time during the Term of this Agreement. Approved Technology Development Contract(s) shall be attached to this Agreement and shall, when approved in writing signed by both Parties, be deemed an integral part hereof. Technology Development Contract(s) may be updated from time to time by mutual written agreement of the Parties.

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1.1.23 “WuXi” means WuXi AppTec Biopharmaceutical Co Ltd, and its successors and assigns.

1.1.24 “WuXi Know-How” means all technical and other information and materials, ideas, concepts, methods, procedures, designs, documents, data, inventions, discoveries and works of authorship (in each case, whether or not patentable) known to WuXi from time to time other than confidential Customer Information and information in the public domain.

1.1.25 “WuXi Patent Rights” means all patents and patent applications of any kind throughout the world relating to WuXi Know-How or to the Process which from time to time WuXi is the owner of or is entitled to use

1.2 Use of Definitions. Unless the context requires otherwise, words and phrases defined in any other part of the Agreement shall bear the same meanings in these Standard Terms and Conditions, references to the singular number include the plural and vice versa, references to Technology Development Contracts are references to Technology Development Contracts to the Agreement, and references to Sections are references to sections of these Standard Terms and Conditions.

1.3 Conflicting Definitions. In the event of a conflict between a term in any executed Technology Development Contract or any supplemental or additional term agreed to in writing from time to time between the parties and these Standard Terms and Conditions, any Technology Development Contract and any supplemental or additional term agreed to in writing after the date hereof shall prevail.

2. Applicability of Terms and Conditions

These Terms and Conditions will not be effective until it (or a counterpart of it) has been signed on behalf of both Parties. Customer and WuXi must complete and execute a Technology Development Contract before Services are provided. Each Technology Development Contract will include information relating to the specific Services agreed to by the Parties and price for Services. Once signed, a Technology Development Contract becomes a part of the Agreement, although the terms in a Technology Development Contract will govern only Services described in that Technology Development Contract. A Technology Development Contract will not change any term in the Agreement. In the event of any inconsistency between the Agreement and any Technology Development Contract, the Agreement will prevail unless the Technology Development Contract Specifies. No variation of or addition to the Agreement or any part thereof shall be effective unless in writing and signed on behalf of both Parties. Notwithstanding the above, the Parties hereby confirm that amendments to the Specification shall be effective if reduced to writing and signed by the quality and/or regulatory representative of both Parties, which quality and/or regulatory representative shall be nominated from time to time by each Party. Any such amendments to Specifications must also reflect, in writing, any corresponding changes to the timing of the Services and any changes to the Pricing detailed in the applicable Technology Development Contract.

3. Representations and Warranties

3.1.1 The Services will be performed in accordance with the Terms and Conditions of this Agreement;

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3.1.2 It will use reasonable endeavors to keep the Cell Line and/or the Customer Materials and/or the Customer Know-How secure and safe from loss and damage in such manner as WuXi stores its own material of similar nature;

3.1.3 It will not part with possession of the Cell Line and/or the Customer Materials or the Product, save for the purpose of tests at any third party Testing Laboratories that may be required and only with Customer’s written permission; and

3.1.4 It will use only Testing Laboratories bound to obligations of confidence substantially similar to those obligations of confidence imposed on WuXi under these Standard Terms and Conditions.

3.1.5 Subject to Section 13, unencumbered title to Product will be conveyed to Customer upon Delivery;

3.1.6 As of the date of this Agreement, to the best of WuXi’s knowledge without independent investigation, the WuXi Patent Rights and the WuXi Know-How are owned by WuXi or WuXi is otherwise entitled to use them for the purposes of providing Services under this Agreement and during the term of this Agreement WuXi shall not do or cause anything to be done which would adversely affect their ownership or entitlement to use the same for those purposes. WuXi will notify Customer in writing immediately if it receives or is notified of a claim from a third party that the use by WuXi of the WuXi Know-How or the WuXi Patents Rights for Services infringes any intellectual property rights vested in such third party;

3.1.7 WuXi has the necessary corporate authorizations to enter into this Agreement;

3.1.8 WuXi has all necessary licenses from Life Technologies to use their host cell/vector system to develop a Cell Line. WuXi has the right to grant Customer a royalty-free sublicense to use the Cell Line for development and commercial production upon payment of [***] to Life Technologies.

3.1.9 To the best of WuXi’s knowledge, no taxes are payable to P.R.China in connection with the Services or production and Delivery of Product.

3.2 DISCLAIMER. SECTION 3.1 IS IN LIEU OF ALL CONDITIONS, WARRANTIES AND STATEMENTS IN RESPECT OF THE SERVICES AND/OR THE PRODUCT WHETHER EXPRESSED OR IMPLIED BY STATUTE, CUSTOM OF THE TRADE OR OTHERWISE (INCLUDING BUT WITHOUT LIMITATION ANY SUCH CONDITION, WARRANTY OR STATEMENT RELATING TO THE DESCRIPTION OR QUALITY OF THE PRODUCT, ITS FITNESS OR SUITABILITY FOR A  PARTICULAR PURPOSE OR USE UNDER ANY CONDITIONS WHETHER OR NOT KNOWN TO WUXI APPTEC) AND ANY SUCH CONDITION, WARRANTY OR STATEMENT IS HEREBY EXCLUDED AND DISCLAIMED.

3.3 Representations and Warranties of Customer. Customer represents and warrants to WuXi that:

3.3.1 Customer shall supply to WuXi the Customer Information, together with full details of any hazards relating to the Cell Line (if applicable) and/or the Customer Materials, their storage and use. Upon review of this Customer Information, the Cell

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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Line and/or the Customer Materials and/or the Customer Know-How will be provided to WuXi at WuXi’s reasonable request. The Cell Line and/or the Customer Materials and/or the Customer Information and/or the Customer Know-How supplied to WuXi will remain the property of Customer.

3.3.2 Customer hereby grants WuXi the non-exclusive right to use the Cell Line, the Customer Materials, the Customer Know-How and the Customer Information for the purpose of the Agreement. WuXi hereby undertakes not to use the Cell Line, the Customer Materials, the Customer Know-How or the Customer Information (or any part thereof) for any other purpose.

3.3.3 Customer has the necessary corporate authority to enter into this Agreement;

3.3.4 To Customer’s knowledge without independent investigation, as of the date of this Agreement, Customer has the right to supply the Cell Line (if applicable), the other Customer Materials and the Customer Information to WuXi and the necessary rights to license or permit WuXi to use the same for the purpose of the Services; and Customer shall not do or cause anything to be done which would adversely affect their ownership or entitlement to use the same for those purposes;

3.3.5 To Customer’s knowledge and belief without independent investigation, as of the date of this Agreement, the use by WuXi of the Cell Line, other Customer Materials, Customer Information and Customer Patent Rights for the Services (including without limitation the manufacture of the Product) will not infringe in China any intellectual property rights of any third party; and Customer shall not do or cause anything to be done which would adversely affect such use;

3.3.6 Customer will promptly notify WuXi in writing if it receives or is notified of a claim from a third party that the Cell Line, other Customer Materials, Customer Information or the Customer Patent Rights or that the-use by WuXi thereof for the provision of the Services infringes any intellectual property rights of such third party;

4. Provision of the Services

4.1 Services. WuXi acknowledges and agrees that Customer commissioned WuXi to perform the Services, and all rights, title, interests and benefits in and to the Customer Property, including all inventions therein, vest absolutely and exclusively in Customer from the moment of their creation or development. WuXi shall carry out the Services as provided in applicable Technology Development Contracts and shall use reasonable efforts to achieve the estimated time schedule thereto or as agreed to by the Parties. Customer shall have the right to be present during manufacturing of Product, and the right to conduct periodic routine GMP compliance audits or “for cause” audits of WuXi’s manufacturing facility.

4.2 Specification. Specifications will be agreed to by the Parties prior to initiation of a manufacturing run or other Services, as appropriate.

4.3 Time Limitations. Due to the unpredictable nature of discovery services, technical transfer, Cell Line development, process development, process scale-up, assay development, formulation and other related Services, the time schedule set down for the performance of these Services is estimated only. Upon completion or near completion of these Services the project teams will work to finalize the pilot and cGMP manufacturing schedules.

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4.4 Quality. Responsibility for quality assurance and quality control of Products shall be allocated between Customer and WuXi as set forth in the Quality Agreement and in WuXi standard operating procedures.

5. Delivery, Transportation of Product

5.1 Delivery. Product will be delivered Ex Works WuXi premises in Wuxi at the address set forth in the first paragraph of this Agreement, which means (a) WuXi places Product at the disposal of Customer at WuXi’s premises not cleared for export and not loaded onto any collecting vehicle and (b) risk and title to Product pass to Customer upon delivery (“Deliver,” “Delivery,” or “Delivered,” as appropriate). Subject to Section 5.2, WuXi shall deliver to Customer the Certificate of Analysis, the Certificate of Compliance (with GMP), and BSE/TSE Certification for each Batch of Product not later than the date of Delivery. Transportation of Product, whether or not under any arrangements made by WuXi on behalf of Customer, shall be made at the sole risk and expense of Customer.

5.2 Delivery Without Certificate of Analysis. At Customer’s request, WuXi will Deliver Product in quarantine prior to delivery of the Certificate of Analysis. Such request shall be accompanied by Customer’s written acknowledgement that the Product has been Delivered without the transmittal to Customer of a Certificate of Analysis, that accordingly the Product cannot be administered to humans until transmittal of the Certificate of Analysis, and that Customer nevertheless accepts full risk of loss, title and ownership of the Product. The Delivery of Product in quarantine will be subject to such testing requirements as WuXi may reasonably require, and the forty-five (45) day period referred to in Section 5.8 will run from Delivery in quarantine by Customer of the Product.

5.3 Packaging and Labeling. Unless otherwise agreed, WuXi shall package and label Product for Delivery in accordance with its standard operating procedures and in accordance with required shipping conditions. It shall be the responsibility of Customer to inform WuXi in writing in advance of any special packaging and labeling requirements for Product. All additional costs and expenses of whatever nature incurred by WuXi in complying with such special requirements must be agreed to in advance in writing and will be charged to Customer in addition to the Price.

5.4 Insurance. If requested in writing by Customer, WuXi will (acting as agent for Customer) arrange for insurance of Product while held by WuXi after Delivery (awaiting transportation) for a maximum of fourteen (14) days on terms equivalent to those under which WuXi insures product prior to Delivery. Third party expenses incurred by WuXi in arranging such insurance must be agreed to in advance in writing and will be charged to Customer in addition to the Price.

5.5 Transportation. If requested in writing by Customer, WuXi will (acting as agent of Customer for such purpose) arrange the transportation of Product from WuXi’s premises to the destination indicated by Customer together with insurance coverage for Product in transit at its invoiced value. All additional costs and expenses of whatever nature incurred by WuXi in arranging such transportation and insurance must be agreed to in advance in writing and will be charged to Customer in addition to the Price.

5.6 Additional Cost. Any other additional cost and expenses for this project need to be approved in writing by both parties including both the contractor and the contractee.

5.7 Acceptance of Delivery. Where WuXi has made arrangements for the transportation of Product, Customer shall diligently examine the Product as soon as practicable after receipt. Notice of all claims (time being of the essence) arising out of:

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5.7.1 Visible damage to or total or partial loss of Product in transit will be given in writing to WuXi and the carrier within five (5) working days of receipt by Customer; or

5.7.2 Non-delivery will be given in writing to WuXi within ten (10) days after the receipt by Customer of WuXi’s dispatch notice.

5.8 Damage Claims. Customer shall make damaged Product and associated packaging materials available for inspection and shall comply with the reasonable requirements of any insurance policy covering the Product, for which notification has been given by WuXi to Customer. WuXi shall offer Customer all reasonable assistance in pursuing any claims arising out of the transportation of Product.

6. Non-Conforming Product or Tests.

6.1 Non-Conforming Product. Within thirty (30) days following Delivery of Product and copies of the relevant production batch records in English, including copies of the CoA, CoC, and BSE/TSE certification provided at Delivery, Customer shall determine whether the Product conforms to the Specifications and has been manufactured in material accordance with such batch records. If Customer determines that the Product fails to meet Specification, or was not produced in material accordance with the batch records Customer shall give WuXi written notice within such 30 day period and shall return such Product to WuXi’s premises, at WuXi’s expense, for further analysis. In the absence of such written notice, Product shall be deemed to have been accepted by Customer as meeting Specification and Customer has waived its right to revoke acceptance. If Customer reasonably demonstrates to WuXi that Product returned to WuXi fails to meet Specification or was not manufactured in material accordance with the batch records and that such failure is due to the negligence of WuXi and not due in whole or in part to the inherent property of the Product or Process, or acts or omissions of Customer or any third party after Delivery, WuXi shall at its option either refund that part of the Price that relates to the production of such non-conforming Product, or initiate a manufacturing run within sixty (60) calendar days from the date it was determined that the Product was non-conforming to replace such Product at its own cost and expense.

6.2 Non-Conforming Test. If, within fourteen (14) calendar days of receiving a result from a test conducted by WuXi, Customer notifies WuXi in writing that the result is unexpected, WuXi will initiate a laboratory investigation of the result. The Customer and WuXi will agree on an appropriate course of action pending the results of the laboratory investigation. If WuXi observes an Out Of Specification (OOS) result it will notify Customer as soon as reasonable but in any case within two (2) working days of learning of such result. Customer and WuXi will agree on the appropriate course of action to investigate the OOS result. If WuXi determines that an unexpected, or OOS result is due to the inherent condition of the sample matrix, or to the act, omission, direction, or negligence of Customer or any third party outside of WuXi’s control, Customer shall be liable to WuXi for the Price of the Services performed, including any additional testing or retests, and materials, reagents, expenses consumed, employed, or specially obtained during the course of the laboratory investigation. If the unexpected or OOS result was caused by a combination of the inherent property of the sample matrix or the act, omission, direction, or negligence of Customer or any third party outside of WuXi’s control and WuXi error, or a reasonable determination of cause cannot be ascertained, Customer shall be liable for 50% of the Price of the Services performed, including any additional testing or retests, and 50% of the cost of any materials or reagents specially obtained by WuXi during the course of the laboratory investigation. Customer is not liable to WuXi for unexpected, or OOS results due to WuXi error and WuXi shall provide a refund of any payments made by Customer for the Services giving rise to the unexpected or OOS results. Should Customer request a repeat or retest of such non-conforming Services Customer shall be liable for the Price of a successful repeat or retest of such non-conforming Services.

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7. Records

Records of Services are available for Customer review at the WuXi facility where the Services were performed. WuXi will retain Batch, laboratory and other technical records (“Records”) of Services for the longer of ten (10) years or for the minimum period required by applicable law and consistent with FDA, EMA, or other relevant Competent Authority regulations and guidance relating to the manufacture or testing of products intended to support an application for regulatory approval. Technology Development Contracts shall include copies of protocols, test methods, method qualification/validation reports. To the extent that raw data from Services or descriptions of any of WuXi’s protocols, test methods, or SOPs are not included in the Customer-approved protocol Technology Development Contract, or Report pertaining to any particular Service and are required by a competent regulatory authority, WuXi will upon written request by Customer provide a copy of such raw data or relevant portions of such protocols, test methods, or SOPs to be used solely for purposes of such regulatory submission under the provisions of Confidentiality in accordance with Section 10. In the event WuXi proposes to dispose of Records WuXi shall provide Customer written notice thereof. If within thirty (30) days after such notice Customer requests any Records, WuXi shall provide to Customer at Customer’s expense such Records rather than disposing thereof. WuXi may, however, retain copies of any Records as are reasonably necessary for regulatory or insurance purposes, subject to WuXi’s obligation of confidentiality.

All the original lab notes will be in Chinese to meet Chinese regulatory requirements. All technical reports and regulatory dossiers will be in both Chinese and English.

For the time specified in 5, 6, and 7, one party can ask for extension once upon written request from the other party. Only a single extension is allowed.

8. Price and Terms of Payment

8.1 Price. Customer shall pay the Price in accordance with the Price detailed in Technology Development Contracts attached hereto.

8.2 Payment. Payment will be made in accordance with Technology Development Contracts attached hereto. Unless otherwise indicated in a Technology Development Contract, all Prices and charges are exclusive of any applicable taxes, levies, duties and fees of whatever nature imposed by or under the authority of any government or public authority, which shall be paid by Customer (other than taxes on WuXi’s income). Payment must be made within thirty (30) days of receipt by Customer of a correct invoice. Payment shall be made without deduction, deferment, set-off, lien or counterclaim of any nature. Payment shall be made in RMB by wire transfer to a Chinese bank account designated by WuXi. For uncontrollable reasons such as natural disasters, war, government control and bank errors that lead to payment delay, the client will notify WuXi and make corrections in a reasonable timeframe.

8.3 No Additional Cost. WuXi acknowledges that it is duly compensated for all actions through being entrusted by Customer with the performance of the Services under this Agreement, and WuXi agrees that it shall not be entitled to any additional fees, costs, reimbursement or other charges, unless otherwise agreed by the Parties in writing. WuXi represents and warrants to Customer that all its employees, agents, consultants, and contractors who have contributed and will contribute to the Services have been and will be, as the case may be, properly remunerated, compensated and awarded for their contributions. WuXi agrees that this Agreement does not create an employment relationship between Customer and any of WuXi employees, agents, consultants, or contractors, notwithstanding any agreements that a WuXi employee, agent, consultant, or contractor may sign with Customer and/or WuXi from time to time. It is WuXi’s sole responsibility to compensate its

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employees, agents, consultants, and contractors as prescribed by applicable Chinese laws. Customer shall have no liability or responsibility for compensating any of WuXi employees, agents, consultants, or contractors for any invention.

9. Indemnification and Limitation of Liability

9.1 WuXi Indemnity. WuXi shall indemnify and hold Customer harmless against all claims, actions, costs, expenses (including court costs and reasonable attorney’s fees) or other liabilities (collectively, “Losses”) whatsoever to, from or in favor of third parties, to the extent such Losses are in respect of WuXi’s material breach of any of the terms and conditions of this Agreement, or the negligence or wrongful action of WuXi or any of its employees or agents in the provision of Services under this Agreement.

9.2 Customer Indemnity. Customer shall indemnify and hold WuXi harmless against all claims, actions, costs, expenses (including court costs and reasonable attorney’s fees) or other liabilities whatsoever to, from or in favor of third parties, in respect of

9.2.1 Customer’s storage, research, development, manufacture, distribution, use, sales or other disposition by Customer, or any distributor, collaborator, customer, sublicense, representative or agent of Customer, of the Product or other test materials or any other substances upon which the Services of WuXi were performed; or

9.2.2 any claim that the use, sale, marketing, or distribution of the Product by Customer or WuXi’s use of Customer-supplied information or materials violates any third party’s intellectual property or proprietary rights; or

9.2.3 any negligent or willful act, omission, or breach of Customer in connection with this Agreement.

9.3 Limitation. Except for the above indemnification obligations, neither Party shall be liable for any penalties, liquidated, special, consequential, incidental or indirect damages arising out of or in connection with this Agreement (or the termination hereof), including, without limitation, loss of profits or anticipated sales to the fullest extent permitted by law, and the total liability, in the aggregate, of either Party and its agents to the other Party and anyone claiming by or through the other Party, for any and all claims, losses, costs or damages, including without limitation, attorneys’ fees and costs and expert-witness fees and costs of any nature whatsoever or claims expenses resulting from or in any way related to this Agreement from any cause or causes shall not exceed the fees paid or owed under this Agreement for the portion of the Services under which such liability arises. Except as otherwise provided, it is intended that this limitation apply to any and all liability or cause of action however alleged or arising, including without limitation, negligence, professional errors and omissions, breach of contract, unless otherwise prohibited by law. For the avoidance of doubt, the foregoing shall not limit either Party’s ability to obtain equitable relief of any type.

9.4 Further Limitation. The obligation of WuXi under Section 9.1 and Customer under Section 9.2 is limited to one-hundred thousand dollars ($100,000) per event, except that this limitation will not apply with respect to any indemnifiable claim arising out of or relating to gross negligence, fraud or willful misconduct by the indemnifying Party under this Agreement. Except for claims arising under indemnities contained herein, any claim must be brought by either Party within one (1) year from the completion of Services under which such claim arises or such claim will be forever barred.

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9.5 Limitation Exception. Nothing contained in these Standard Terms and Conditions shall purport to exclude or restrict any liability for death or personal injury resulting directly from gross negligence by a Party in carrying out their obligations in breach of the terms of this Agreement.

9.6 Waiver of Claims. WuXi represents only that it will use reasonable care in the provision of Services. WuXi makes no representation or warranty, and Customer expressly waives all claims against WuXi and its Affiliates, and any of its respective agents or employees, arising out of or in connection with any claims relating to the stability, efficacy, safety, or toxicity of the Product developed, formulated, packaged, or manufactured in accordance with the agreed upon Services.

9.7 For each party that is involved in legal or administrative procedures due to this agreement, the other party shall provide reasonable support.

9.8 Survival. The obligations of WuXi and Customer and under this Section 9 shall survive the termination or expiration of this Agreement.

10. Confidentiality

10.1 Confidential Information. The Parties will exchange proprietary and confidential information during the term of this Agreement, including without limitation, the existence and terms of this Agreement. The Parties will identify, in writing, such information as confidential and/or proprietary. Notwithstanding the foregoing, Customer Confidential Information will also include Customer Information, Customer Materials, and Customer Know-How, and WuXi Confidential Information will include WuXi Know-How, study designs, pricing information, and test protocols. Customer acknowledges that WuXi Confidential Information and WuXi AppTec acknowledges that Customer Confidential Information, with which it is supplied by the other pursuant to the Agreement is supplied subject to Sections 10.5 and 10.6 in circumstances imparting an obligation of confidence. Each Party agrees to keep the other Party’s confidential information secret and confidential and to respect the other’s proprietary rights therein and not at any time for any reason whatsoever to disclose or permit the other party’s confidential information to be disclosed to any third party save as expressly provided herein. Processes, formulations, SOPs, assays and test results developed by WuXi AppTec in the course of providing the Services and specific to Customer Process and Product is the Confidential Information of Customer.

10.2 Obligations of Confidentiality. Customer and WuXi AppTec shall each cause all their respective employees, consultants, contractors and persons for whom it is responsible having access to WuXi AppTec Confidential Information or Customer Confidential Information to be subject to the same obligations of confidence as Customer and WuXi pursuant to Sections 10.1 and 10.3 and shall be bound by confidentiality agreements in support of such obligations. WuXi and Customer each undertake not to disclose or permit to be disclosed to any third party, or otherwise make use of or permit to be made use of (a) any trade secrets or confidential information relating to the technology, business affairs or finances of the other, any subsidiary, holding company or subsidiary or any such holding company of the other, or of any suppliers, agents, distributors, licensees or other customers of the other which comes into its possession under this Agreement, or (b) the commercial terms of this Agreement; except to the extent that the same is required to be disclosed pursuant to subpoena, court order, judicial process or otherwise by law, provided the receiving party provides prompt notice to the disclosing Party of such requirement in order to give the disclosing party an opportunity to timely seek a protective order or other appropriate judicial relief. In the event the disclosing Party is unable to obtain a protective order or other appropriate judicial relief, the receiving party shall disclose only that portion of the disclosing Party’s confidential information which is legally required to be disclosed, and that the disclosing party shall be given an opportunity to review the confidential information prior to its disclosure.

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10.3 Limitations. The obligations of confidentiality referred to in this Section 10 shall not extend to any information which:

10.3.1 Is or becomes generally available to the public otherwise than by reason of a breach by the recipient Party of the provisions of this Section 10;

10.3.2 Is known to the receiving Party and is at its free disposal prior to its receipt from the disclosing Party, as established by written records;

10.3.3 Is subsequently disclosed to the receiving Party without being made subject to an obligation of confidence by a third party, as established by written records;

10.3.4 Is required to be disclosed by WuXi or Customer under any statutory, regulatory or similar legislative requirement, or is incorporated into a regulatory submission, subject to the imposition of obligations of confidentiality wherever possible in that relation; or

10.3.5 Is developed by any servant or agent of the recipient Party without access to or use or knowledge of the information by the disclosing party, as established by written records.

10.4 Remedies. Without prejudice to any other rights and remedies that the Parties may have, the Parties agree that the confidential information is valuable and that damages may not be an adequate remedy for any breach of the provisions of Sections 10.1, 10.2, or 10.3. The Parties agree that the relevant party will be entitled to seek the remedies of an injunction and other equitable relief for any actual or threatened breach by the other Party.

10.5 WuXi Confidential Information. Customer acknowledges that Customer shall not at any time have any right, title, license or interest in or to WuXi Confidential Information the WuXi Patent Rights or any other intellectual property rights relating to the Services which are vested in WuXi or to which WuXi is otherwise entitled.

10.6 Customer Confidential Information. WuXi acknowledges that save as provided herein WuXi shall not at any time have any right, title, license or interest in or to the Customer Confidential Information, Customer Patent Rights, Customer Know-How, or any other intellectual property rights vested in Customer or to which Customer is entitled.

10.7 Survival. The obligations of WuXi and Customer under this Section 10 shall survive the termination or expiration of this Agreement.

11. Term and Termination

11.1 Term. This Agreement will expire on the later of (a) two (2) years from the Effective Date or (b) the completion of all Services under the last Technology Development Contract executed by the Parties prior to the second anniversary of the Effective Date. The Agreement may be extended by mutual agreement of the Parties or earlier terminated in accordance with Section 11.2. or 11.3.

11.2 Termination without Cause.

11.2.1 Customer may in its sole discretion terminate this Agreement at any time for any reason or no reason by giving not less than thirty (30) days notice in writing to WuXi. In the event of termination pursuant to this Section 10.2.1 Customer shall pay WuXi for Services performed up to the date of termination. In addition, Customer shall reimburse WuXi for expenses incurred or irrevocably committed to third parties in accordance with this Agreement

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and the Price for any cell banks, toxicology studies, or manufacturing Batches that are in-progress or that has an initiation date scheduled within forty-five (45) days of the receipt of notice of termination.

11.2.2 WuXi may in its sole discretion terminate this Agreement or any Technology Development Contract at any time for any reason or no reason by giving not less than one hundred eighty (180) days notice in writing to Customer. During such notice period, WuXi shall continue and complete all work in progress and both Parties shall remain liable to each other for their respective obligations under this Agreement. In the event of termination pursuant to this Section 11.2.2 Customer shall pay WuXi for Services performed and for expenses incurred or irrevocably committed to third parties.

11.3 Termination for Cause. WuXi and Customer may each terminate the Agreement forthwith by notice in writing to the other upon the occurrence of any of the following events:

11.3.1 If the other commits a material breach of the Agreement which in the case of a breach capable of remedy is not remedied to the reasonable satisfaction of the non-breaching Party within forty-five (45) days of the receipt by the other of written notice identifying the breach and requiring its remedy; or

11.3.2 Any party may terminate this Agreement at any time by giving notice in writing to the other Party, if the other Party files a petition of any type as to its bankruptcy, is declared bankrupt, becomes insolvent, makes an assignment for the benefit of creditors, goes into liquidation or receivership, otherwise loses legal control of its business or ceases to carry on its business.

11.4 Rights and Obligations upon Termination. Upon the termination of the Agreement for whatever reason:

11.4.1 Subject to Section 7, WuXi shall promptly return to Customer all Customer Know-How, Customer Information and shall dispose of or return to Customer the Customer Materials (and where supplied by Customer the Cell Line) and any materials therefrom, as directed by Customer;

11.4.2 Customer shall promptly return to WuXi all WuXi Know-How and WuXi Confidential Information it has received from WuXi;

11.4.3 Subject to the terms of Section 13, Customer shall not thereafter use or exploit WuXi Confidential Information, the WuXi Patent Rights or the WuXi Know-How in any way whatsoever;

11.4.4 WuXi shall not thereafter use or exploit the Customer Patent Rights, Customer Know-How or the Customer Information in any way whatsoever;

11.4.5 WuXi and Customer shall do all such acts and things and shall sign and execute all such deeds and documents as the other may reasonably require to evidence compliance with this Section 11.4.

12. Force Majeure

12.1 Force Majeure Rights. If either Party is prevented or delayed in the performance of any of its obligations under the Agreement by Force Majeure such Party shall give written notice thereof to the other Party specifying the matters constituting Force Majeure together with such evidence as reasonably can give and specifying the period for which it is

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estimated that such prevention or delay will continue, the Party claiming Force Majeure shall be excused from the performance or the punctual performance of such obligations as the case may be from the date of such notice for so long as such cause of prevention or delay shall continue. Notwithstanding the foregoing, if the Party claiming Force Majeure estimates that the delay will exceed 30 days, or if the delay has, in fact, exceeded 30 days, the other Party may terminate this Agreement for cause as set forth in Section 9.3, including an additional 30 days notice to remedy the breach.

12.2 Force Majeure Definition. The expression “Force Majeure” shall be deemed to include any cause affecting the performance by either Party of the Agreement arising from or attributable to acts, events, acts of God, omissions or accidents beyond the reasonable control of the Party claiming the Force Majeure.

13. Inventions. WuXi hereby assigns to Customer all right, title, and interest in all inventions, improvements, designs, formulas, methods, processes and writings, whether or not copyrightable or patentable that embodies Customer Materials and Customer Know-How provided hereunder and discovered solely as a result of using such Customer Materials and Customer Know-How (collectively, the “Inventions”). WuXi agrees, upon Customer’s request and at Customer’s expense, to do all things reasonably necessary to obtain patents or copyrights on any Inventions discovered exclusively as a result of performing Services and to execute any documents necessary to formalize the afore-mentioned assignments. Notwithstanding the foregoing, Customer acknowledges that WuXi possesses certain inventions, processes, know-how, trade secrets, other intellectual property and assets, including but not limited to, discovery methods, production methods, test methods, viral clearance methods and expertise, controls, procedures, computer technical expertise and software which have been independently developed by WuXi (collectively, the “WuXi Property”). Customer and WuXi agree that any WuXi Property or improvements thereto which are used, improved, modified or developed by WuXi under or during the term of this Agreement, are the product of WuXi’s technical expertise possessed and developed by WuXi prior to or during the performance of this Agreement and are the sole and exclusive property of WuXi regardless if such WuXi Property or improvements thereto are incorporated or embedded in any Inventions or Deliverable generated or due hereunder, except that Customer is granted a non-exclusive, world-wide, royalty-free license, sublicensable in conjunction with a license to Customer Know-How and Customer Patent Rights, to portions of WuXi Property or improvements that are incorporated or embedded in Deliverables to the extent reasonably necessary to allow full lawful use of the Deliverables that incorporate it. Protocols, methods, controls, SOPs, Specifications, or documents (other than Customer data, reports, and documents specific to Customer Process and Product) that are produced by WuXi for Services (collectively, “Service Instruments”) are furnished solely with respect to Services, and WuXi will retain all common law, statutory, ownership, and other reserved rights in such Service Instruments. The assignment of inventions and other intellectual property rights shall include the right to apply for patent and the right to have patent granted in the name of Customer (or its designee). Customer shall have sole discretion in the preparation, filing, prosecution, maintenance, and enforcement of patents arising from Inventions. WuXi agrees to cooperate with Customer during the preparation, filing, prosecution, issuance and maintenance of patents and patent applications covering Inventions by promptly executing papers and providing assistance, information and records as needed, in a timely manner.

14. Mediation, Arbitration, Governing Law, Jurisdiction, and Enforceability

14.1 Mediation. In the event of any dispute, controversy or claim arising out of or relating to this Agreement, or the breach, termination or invalidity thereof, each Party shall by written notice to the other have the right to have such dispute referred to the senior management of WuXi and Customer for attempted resolution by good faith negotiations within forty-five (45) days after such notice is received. If such senior management are unable to resolve such dispute within the forty-five (45) day period, and before arbitration is initiated, the

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Parties shall participate in a mediation that will last no less than eight (8) hours unless the dispute is resolved before such time. Notwithstanding the requirement for the Parties to submit to mediation for a minimum of eight (8) hours, neither party will be required to participate in mediation for longer than sixteen (16) hours. Any mediation will take place a mutually agreeable venue, and will be officiated by a mutually agreeable mediator identified and engaged by the Parties, the cost and fees for whom shall be borne equally by the Parties. In the event the Parties’ efforts to reach an amicable resolution through mediation or other informal means are unsuccessful, either party may invoke the provisions of Section 14.2. Any settlement reached by the Parties under this Section shall not be binding until reduced to writing and signed by the above-specified management of WuXi and Customer. When reduced to writing, such agreement shall supersede all other agreements, written or oral, to the extent such agreements specifically pertain to the matters so settled.

14.2 Arbitration. In the event of the failure to reach a resolution pursuant to Section 14.1, any dispute, controversy or claim arising out of or relating to this Agreement, or the breach, termination or invalidity thereof, shall be finally settled by binding arbitration in accordance with the complex rules of the Commercial Arbitration Rules of the Shanghai Arbitration Association in effect on the date of this Agreement. The place of arbitration will be Shanghai China and the Parties shall share equally filing fees, arbitrator fees or other costs of such proceedings, except that each Party shall bear its own attorney’s fees, and other out-of-pocket arbitration expenses, unless the arbitrators decides otherwise.

14.3 Governing Law and Jurisdiction. The construction, validity and performance of the Agreement shall be governed by the laws of the State of California, without regard to its conflict of laws provisions.

14.4 Waiver. No failure or delay on the part of either WuXi or Customer to exercise or enforce any rights conferred on it by the Agreement shall be construed or operate as a waiver thereof nor shall any single or partial exercise of any right, power or privilege or further exercise thereof operate so as to bar the exercise or enforcement thereof at any time or times thereafter.

14.5 Severability. The illegality or invalidity of any provision (or any part thereof) of the Agreement or these Standard Terms and Conditions shall not affect the legality, validity or enforceability of the remainder of its provisions or the other parts of such provision as the case may be. The Parties shall replace the illegal or invalid provision with a legal and valid provision that as closely as possible reflects the intent and economic effect of the illegal or invalid provision.

14.6 Agreement Language This agreement has both Chinese and English versions. If there is discrepancy, the Chinese version overrules.

15. Miscellaneous

15.1 Assignment. Neither Party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other which consent shall not be unreasonably withheld or delayed, save that either Party shall be entitled without the prior written consent of the other Party to assign, transfer, charge, sub-contract, deal with or in any other manner make over the benefit and/or burden of this Agreement to an Affiliate or to any company with which such assigning Party may merge or to any company to which such assigning Party may transfer its assets and undertakings.

15.2 Press Releases. The text of any press release or other communication to be published by or in the media concerning the subject matter of the Agreement shall require the prior written approval of WuXi and Customer.

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15.3 Entire Agreement. The Agreement, the Technology Development Contracts attached hereto embody the entire understanding of WuXi and Customer and there are no promises, terms, conditions or obligations, oral or written, expressed on implied, other than those contained in the Agreement. The terms of the Agreement shall supersede all previous agreements (if any) which may exist or have existed between WuXi and Customer relating to the Services. In the event the Parties desire to enter into a Commercial Manufacturing Agreement with each other, such Commercial Manufacturing Agreement shall be on separate terms and conditions from this Agreement.

15.4 No Third Party Beneficiaries. The Parties to this Agreement do not intend that any terms hereof should be enforceable by any person who is not a Party to this Agreement.

15.5 Counterparts. This Agreement may be executed in two or more counterparts, and each such counterpart shall be deemed an original thereof.

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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by its duly authorized representatives as of the Effective Date.

Appendix

[See Attached]

QUALITY AGREEMENT
by and between

Zhejiang Medicine Co. Ltd 

(“ZMC”)
and

WuXi AppTec Biopharmaceuticals Co Ltd. (“WuXi”)

Purpose

This Quality Agreement defines the quality responsibilities of the Parties and their respective affiliates or approved contractors with respect to the services provided by WuXi to ZMC regarding the development, cGMP manufacture, labeling, packaging, testing, release, shipment, and storage of the ZMC materials itemized in Exhibit A to this Agreement (“Products”).

The allocation of quality responsibilities is summarized in Exhibit B to this Agreement.

This Quality Agreement may be amended from time to time and additional details concerning quality requirements may be provided in addenda in writing signed by the parties to this Quality Agreement. By signing below, the parties acknowledge and agree to the provisions of this Quality Agreement.

Effective Date:

Table of contents

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6.1  Any subcontracting related to manufacture and testing of Products requires the prior approval of ZMC, a contractual agreement between WuXi and the respective contractor, and qualification of the contractor by WuXi quality assurance. Upon request by ZMC, WuXi shall provide documentation of the qualification of the contractor for ZMC review.

7.1  WuXi will operate all equipment, systems, and facilities related to manufacturing, testing, packaging, and storage of Products according to WuXi’s written procedures.

7.2  WuXi shall perform equipment qualification, preventive maintenance, instrument calibration, computer system validation, and cleaning validation according to WuXi’s written procedures.

7.3 WuXi is responsible for maintaining records of equipment usage, cleaning and any maintenance/calibration performed.

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13.1 WuXi shall retain Reference/Reserve Samples for each lot of Products produced and released for further manufacturing use, or for use in toxicology and clinical studies for the longer of five (5) years after the lot’s expiration period or two (2) years after the completion (as determined by issuance of a non-clinical or clinical study report) of a non-clinical or clinical study conducted using the lot.

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13.2 Each Reference/Reserve Sample will consist of at least twice the quantity necessary to determine whether the Product meets its established Specifications, except for sterility and pyrogen testing.

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18.3.4 WuXi shall provide a list and/or copies of all documents directly related to Products shared with a Regulatory Authority during any inspection.

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22.1 The individuals listed in EXHIBIT C shall be the key points of contact between WuXi and ZMC relating to the rights and obligations of the Parties in this Quality Agreement. The responsible individuals, or their respective delegates, must be notified in official communications as required by this Quality Agreement.

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Exhibit A 

List of Products

[***]

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Exhibit B

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

EXHIBIT C

Responsible Persons and Contact Information