CO-DEVELOPMENT AND LICENSE AGREEMENT among NOVOCODEX BIOPHARMACEUTICALS LTD. and AMBRX, INC. Dated as of 22 October, 2019
Exhibit 10.9
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
among
NOVOCODEX BIOPHARMACEUTICALS LTD.
and
AMBRX, INC.
Dated as of 22 October, 2019
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This CO-DEVELOPMENT AND LICENSE AGREEMENT (this βAgreementβ), effective as of 22 October, 2019 (the βEffective Dateβ), is between, Ambrx, Inc., a Delaware corporation having its principal business address at 00000 Xxxxx Xxxxxx Xxxxx Xxxx, Xx Xxxxx, Xxxxxxxxxx 00000, XXX, for and on behalf of itself and its Affiliates (together with its Affiliates, βAmbrxβ), and NovoCodex Biopharmaceuticals Ltd., a company registered under the laws of the Peopleβs Republic of China, with its registered address in Shaoxing, China, for and on behalf of itself and its Affiliates (together with its Affiliates, βNovocodexβ). Novocodex currently is majority owned by Zhejiang Medicine Co. Ltd., a company registered with address in Shaoxing, China. Ambrx and Novocodex may each be referred to herein individually as a βPartyβ or, collectively, as the βParties.β
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 the Program (as hereinafter defined);
WHEREAS, Novocodex 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, Novocodex 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 Novocodex, 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; and
WHEREAS, Novocodex desires to obtain assistance from Ambrx and Ambrx desires to offer such assistance to Novocodex to develop the Program and the Licensed Products in the Territory under world-class standards.
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
As used in this Agreement, the following terms shall have those meanings set forth in this ARTICLE 1 unless the context dictates otherwise.
1.1 | βAnti-CD70-ADCβ shall mean an Antibody Drug Conjugate (ADC) which is capable of binding primarily to CD70 and being conjugated to one cytotoxic payload. For clarity, Anti-CD70-ADC includes ADC that has been conjugated to one cytotoxic payload. |
1.2 | βARX305β shall mean the Anti-CD70-ADC with the structure depicted in Exhibit 1.1, also known as ARX305. |
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1.3 | βAffiliateβ shall mean, with respect to any Person, any other Person that directly or indirectly controls, is controlled by, or is under common control with such Person. A Person shall be deemed to control another Person if such Person possesses the power to direct or cause the direction of the management, business and policies of such Person, whether through the ownership of fifty percent (50%) or more of the voting securities of such Person by voting agreement, by contract or otherwise. |
1.4 | βAmbrx Background Technologyβ shall mean Know-How and Ambrx Patent Rights, including inventions, discoveries, improvements, processes, methods, protocols, formulas, compositions, data, inventions, know-how and/or trade secrets, patentable or otherwise, which are owned and/or Controlled by Ambrx or any of its Affiliates as of the Effective Date or during the Term of this Agreement. |
1.5 | βAmbrx Existing Patent Rightsβ shall mean all Patent Rights in the Territory owned or Controlled by or licensed to Ambrx as of the Effective Date which is related to ARX305 as shown in Exhibit 1.5. |
1.6 | βAmbrx Improvementsβ shall mean all Patent Rights and Know-How first (i) conceived, (ii) developed, (iii) reduced to practice or (iv) shown to have utility by one or more employees or Third Parties working on behalf of Ambrx, in connection with the development of Licensed Products or in the course of engaging in the Program during the Term of this Agreement without involvement of any employees from Novocodex. |
1.7 | βAmbrx Know-Howβ shall mean all Confidential Information & Materials, technical knowledge, materials, cells or cell lines, software, trade secrets, Know-How, process technology and other knowledge, information, or technology in possession of Ambrx and its Affiliate, as of the Effective Date and during the Royalty Term, concerning subject matter relating to Licensed Products and which are necessary for the development, manufacture, use or sale of Licensed Products in the Field in the Territory. |
1.8 | βAmbrx Patent Rightsβ shall mean any Patent Rights Controlled or owned by Ambrx as of the Effective Date or during the Term of this Agreement in addition to Ambrx Existing Patent Rights. |
1.9 | βAntibodyβ or βAntibodiesβ shall mean a full length antibody which is a βYβ-shaped protein consisting of four polypeptide chains: two identical heavy chains and two identical light chains connected by disulfide bonds, capable of binding to an antigen, whether polyclonal, monoclonal, human, humanized, chimeric, murine, synthetic or from any other source. |
1.10 | βAntibody Drug Conjugateβ or βADCβ shall mean an Antibody which 1) has undergone modification through [***], 2) provides one or more specific site(s) in the amino acid sequence of the Antibody suitable for conjugation, and 3) is suitable and capable of [***]. |
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For clarity, ADC includes an Antibody that has been conjugated, linked or attached to one or more cytotoxic payload(s) via one or more specific site(s).
1.11 | βApplicable Lawsβ shall mean the applicable laws of any jurisdiction which are applicable to any of the Parties or their respective Affiliates in carrying out activities hereunder or to which any of the Parties or their respective Affiliates in carrying out the activities hereunder is subject by law or by agreement, and shall include all statutes, enactments, acts of legislature, laws, ordinances, rules, regulations, notifications, guidelines, policies, directions, directives and orders of any statutory authority, tribunal, board, or court or any central or state government or local authority or other governmental entity in such jurisdictions. |
1.12 | βCalendar Quarterβ shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31. |
1.13 | βCalendar Yearβ shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31. |
1.14 | βCD70β shall mean the protein encoded by the CD70 (Cluster of Differentiation 70, Entrez Gene: 970) gene which is known to be a cytokine in the tumor necrosis factor (TNF) ligand family. |
1.15 | βcGMPβ or βCurrent Good Manufacturing Practiceβ shall mean the applicable then-current standards for manufacturing of pharmaceuticals or biologicals, as set forth in the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301, as amended from time to time, together with any similar standards of good manufacturing practice as required by the FDA and other relevant Regulatory Authority. |
1.16 | βChina GAAPβ shall mean Generally Accepted Accounting Principles for the Peopleβs Republic of China. |
1.17 | βCommercially Reasonable Effortsβ shall mean, with respect to the efforts to be expended by a Party with respect to any objective, [***]. |
1.18 | βConfidential Information & Materialsβ shall mean any and all proprietary and/or confidential information, materials, and data, including all scientific, pre-clinical, clinical, |
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regulatory, process, formulation, manufacturing, marketing, financial and commercial information or data, compounds, cells, cell lines, whether communicated in writing or orally or by any other method, which are provided by one Party to the other Party prior to or during the Term of this Agreement. |
1.19 | βControlβ, βControlsβ or βControlled byβ shall mean with respect to any Patent Rights, Know-How, Confidential Information & Materials, or other intellectual property assets or other items or rights, as applicable, the possession of (whether by ownership or license or other right, other than pursuant to a license under this Agreement), or the ability of a Party to grant access to, or a license or sublicense of, such item or right as provided for herein without violating the terms of any agreement and without additional payments 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. |
1.20 | βCovered Byβ shall mean, with respect to Patent Rights: materials, products and services developed, manufactured, used, sold or provided by Novocodex, which but for the License, would infringe a Valid Claim of such Patent Rights in the Territory in which such products or services are developed, used, manufactured, sold or provided by Novocodex, respectively. |
1.21 | βEffective Dateβ shall mean the date first set forth above. |
1.22 | βFDAβ shall mean the United States Food and Drug Administration, or any successor thereto. |
1.23 | βFieldβ shall mean all human indications and uses, such as diagnosis, prevention, and treatment of human diseases and conditions associated with anti-CD70. For clarity, the Field is for human use only and excludes all non-human indications and uses. |
1.24 | βFirst Commercial Saleβ shall mean, with respect to Licensed Product, the first sale to the general public of such Licensed Product in the Territory after all required marketing and pricing approvals have been granted, or otherwise permitted, by the governing health authority of Territory such as NMPA. βFirst Commercial Saleβ shall not include the provision of any Licensed Product for use in clinical trials or for compassionate use, in each case, if such use is not compensated, prior to the receipt of necessary Marketing Authorization. |
1.25 | βFull Time Equivalentβ or βFTEβ shall mean a dedicated full-time employee or contractor of Ambrx, as the case may be, or in the case of less than a full-time dedicated person, a full-time, equivalent person year, each based upon the total of one thousand six hundred eighty (1680) hours per year of work on activities hereunder. |
1.26 | βFTE Rateβ means the yearly rate at which Novocodex will fund Ambrx FTEs for labor and services. |
1.27 | βGeneric/Biosimilar Competitionβ shall mean the sale of products containing ARX305 in the Territory by a Third Party. |
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1.28 | βGlobal Development Planβ means the plan setting forth the pre-clinical, clinical, manufacturing and regulatory activities and timelines relating to the development of Licensed Products in the Field. An initial draft of the Global Development Plan is set forth on Exhibit 1.28. |
1.29 | βJoint Development Technologyβ or βJoint Improvementsβ shall mean all inventions and Know-How first (i) conceived, (ii) developed, (iii) reduced to practice or (iv) shown to have utility by, on one hand, one or more employees or Third Parties working on behalf of Novocodex, 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 the Program, as well as any and all Patent Rights covering the same. |
1.30 | βJoint Steering Committeeβ shall mean the entity organized and acting pursuant to ARTICLE 3. |
1.31 | βKnow-Howβ shall mean unpatented technical and other information or materials which are not in the public domain including information comprising or relating to discoveries, inventions, data, designs, formulae, methods, models, assays, research plans, procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development or Anti-CD70-ADC Program), cells or cell lines (including cells or cell lines producing Anti-CD70 Antibody or Anti-CD70 ADC), processes (including manufacturing processes, specifications and techniques), laboratory records, chemical, pharmacological, toxicological, clinical, analytical and quality control data, trial data, case report forms, data analyses, reports or summaries and information contained in submissions to and information from ethical committees and regulatory authorities. Know-How includes rights protecting Know-How. The fact that an item is known to the public shall not be taken to exclude the possibility that a compilation including the item, and/or a development relating to the item, is (and remains) not known to the public. |
1.32 | βLicenseβ shall mean all of the rights granted by Ambrx to Novocodex by this Agreement under the Licensed Intellectual Property Rights pursuant to Sections 2.1.1 and 2.1.2. |
1.33 | βLicensed Intellectual Property Rightsβ shall mean (a) Ambrx Know-How; and (b) Ambrx Existing Patent Rights. |
1.34 | βLicensed Productβ shall mean any pharmaceutical product containing ARX305 as an active pharmaceutical ingredient, that meets any of the following criteria: (i) the development, use, manufacture or sale of such product is or will be Covered By a Valid Claim of any Ambrx Existing Patent Rights and/or Ambrx Patent Rights; or (ii) such product (a) is not described in clause (i) above and (b) is developed, manufactured, sold or provided using Ambrx Know-How. |
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1.35 | βMarketing Authorizationβ shall mean all approvals from NMPA necessary to market and sell a Licensed Product in the Territory or a Regulatory Authority in a corresponding jurisdiction outside the Territory. |
1.36 | βNet Salesβ shall mean: |
(I) to Ambrx, the βfor profitβ licensing revenue Ambrx received from a Third Party by transferring, assigning or licensing Phase I Clinical Data to such Third Party, [***]; and
(II) to Novocodex, the gross invoice price (not including value added taxes, sales taxes, or similar taxes) of Licensed Product sold by Novocodex or its Affiliate or sublicensee to the first Third Party in which Novocodex or its Affiliate or sublicensee has no equity interest after deducting, if not previously deducted, from the amount invoiced or received:
(a) | [***]; |
(b) | [***]; |
(c) | [***]; |
(d) | [***]; |
(e) | [***]; |
(f) | [***]; and |
(g) | [***]; |
(h) | [***]; and |
(i) | [***]. |
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 Novocodex 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. In no event shall the total amount of deductions
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made in accordance with Items 1.36(II)(e) through (i) above during any period exceed [***]% of the gross invoice price for such period. The calculation of Net Sales hereunder shall be in accordance with China GAAP and Novocodexβs and/or its Affiliatesβ customary accounting policies, applied consistently across periods, and
(1) Transfer or sale of a Licensed Product within Novocodex, between Novocodex and an Affiliate, or between Novocodex and a non-Affiliate Third Party in which Novocodex has equity interest shall not be considered a sale, commercial use or disposition for the purpose of the foregoing paragraphs;
(2) in the event that Novocodex has to transfer or sell any Licensed Product to a non-Affiliate Third Party in which Novocodex has equity interest, Novocodex and Ambrx shall jointly discuss and determine the value of Net Sales; and
(3) in the event that Novocodex receives consideration for any Licensed Products in the case of transactions not at armβs length with a non-Affiliate of Novocodex, Net Sales will be calculated [***].
1.37 | βNMPAβ shall mean National Medical and Pharmaceutical Administration in the Peopleβs Republic of China, or any successor thereto. |
1.38 | βNovocodex Improvementsβ shall mean all Patent Rights and Know-How first (i) conceived, (ii) developed, (iii) reduced to practice or (iv) shown to have utility by one or more employees or Third Parties working on behalf of Novocodex, in connection with the development of Licensed Products or in the course of engaging in the Program without any involvement with employee(s) of Ambrx. |
1.39 | βPatent Rightsβ shall mean any and all rights under any of the following, whether existing now or in the future, and whether or not filed: (i) a United States, international or foreign patent, utility model, design registration, certificate of invention, patent of addition or substitution, or other governmental grant for the protection of inventions or industrial designs anywhere in the world, including any reissue, renewal, re-examination or extension thereof; and (ii) any application for any of the foregoing, including any international, provisional, divisional, continuation, continuation-in-part, or continued prosecution application. |
1.40 | βPersonβ shall mean any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government or any agency or political subdivision thereof. |
1.41 | βPhase I Clinical Dataβ shall mean data, information, or regulatory filings related to Phase I Clinical Trial in a country that would satisfy the requirements of 21 CFR 312.21(a), as may be amended, or the foreign equivalent thereof. |
1.42 | βPhase I Clinical Trialβ shall mean a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a), as may be amended, or the foreign equivalent thereof. |
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1.43 | βPhase II Clinical Trialβ shall mean a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(b), as may be amended, or the foreign equivalent thereof. |
1.44 | βPhase III Clinical Trialβ shall mean a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(c), as may be amended, or the foreign equivalent thereof. |
1.45 | βProgramβ shall mean development, preclinical and clinical activities directed by the Joint Steering Committee and undertaken by the Parties to develop ARX305 into a therapeutic product. |
1.46 | βRegulatory Authorityβ shall mean any applicable government regulatory authority involved in granting approvals for the manufacturing, marketing, reimbursement and/or pricing of the Licensed Product or ARX305 in the Territory or outside the Territory, including, in the Territory, NMPA, and in the United States, the FDA and any successor governmental authority having substantially the same function. |
1.47 | βRoyalty Termβ shall have the meaning set forth in Section 6.5. |
1.48 | βTerritoryβ shall mean all cities, zones, provinces, territories and other divisions or regions in and throughout the Peopleβs Republic of China. |
1.49 | βThird Partyβ shall mean a person or entity other than Ambrx, Novocodex or their Affiliates. |
1.50 | βValid Claimβ means: (a) a claim of an issued and unexpired patent within the Patent Rights that has not been (i) held permanently revoked, unenforceable, unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, (ii) rendered unenforceable through disclaimer or otherwise, (iii) abandoned or (iv) permanently lost through an interference or opposition proceeding without any right of appeal or review; or (b) a pending claim of a pending patent application within the Patent Rights that (i) has been asserted and continues to be prosecuted in good faith and (ii) has not been abandoned or finally rejected without the possibility of appeal or refiling. |
ARTICLE 2
LICENSE; DEVELOPMENT AND COMMERCIALIZATION
2.1 |
2.1.1 | Subject to terms and conditions of this Agreement, including the rights retained by Ambrx in Sections 2.1.3 & 2.1.4, Ambrx hereby grants to Novocodex an exclusive right and license in the Field throughout the Territory, with the right to grant sublicenses subject to Section 2.9.1, under Ambrx Existing Patent Rights to develop, have developed, |
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use, manufacture, have manufactured, sell, offer for sale and have sold Licensed Products during the Term of this Agreement. |
2.1.2 | Subject to terms and conditions of this Agreement, including the rights retained by Ambrx in Sections 2.1.3 & 2.1.4, Ambrx hereby grants to Novocodex an exclusive right and license in the Field throughout the Territory, with the right to grant sublicenses subject to Section 2.9.1, under Ambrx Know-How to develop, have developed, use, manufacture, have manufactured, sell, offer for sale and have sold Licensed Products during the Term of this Agreement. |
2.1.3 | Ambrx shall retain non-exclusive and sublicensable rights under the foregoing Licenses in Section 2.1.1 and 2.1.2 solely as are necessary to perform documented research activities in the Territory and Ambrx shall notify Novocodex in writing thirty (30) days in advance of such activities. |
2.1.4 | Ambrx shall retain all rights under Licensed Intellectual Property Rights unless otherwise specifically and expressly set forth in this Agreement. |
2.1.5 | Ambrx agrees that during the Term of this Agreement, it will not grant any exclusive right and license under Ambrx Existing Patent Rights to any Third Party to develop, have developed, use, manufacture, have manufactured, sell, offer for sale and have sold any product containing any Anti-CD70-ADC for use in the Field and in the Territory. |
2.2 |
2.3 | NON-EXCLUSIVE SUBLICENSE GRANT BY AMBRX. In the event that, during the term of this Agreement and after the Effective Date, Ambrx licenses from any Third Party rights in the Field to any Valid Claim of any issued patent or patent application issued to a Third Party that shall be necessary for Novocodexβs exercise of its rights pursuant to Section 2.1 herein (an βAmbrx Third Party Licenseβ) in the Territory, Ambrx shall promptly notify Novocodex of the terms of such Ambrx Third Party License and the rights covered by such license. Upon request by Novocodex, and to the extent not prohibited by such Ambrx Third Party License, Ambrx shall grant to Novocodex, and does hereby grant to Novocodex, a non-exclusive right and sublicense (if permitted by the Third Party) in the Field throughout the Territory, with the right to grant further sublicenses subject to Section 2.9.1, under the rights granted to Ambrx in the Ambrx Third Party License. Ambrx shall use reasonable efforts to secure the right to grant the sublicense under this Section in any Ambrx Third Party License. If Novocodex is required to pay certain royalty payment to such a Third Party under Ambrx Third Party License, Novocodex is entitled to offset such royalty payment pursuant to the terms in Section 6.7. |
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2.4 | NON-EXCLUSIVE LICENSE GRANT BY AMBRX. Ambrx hereby grants to Novocodex a non-exclusive, sub-licensable subject to Section 2.9.1, royalty-free right and license in the Territory, under Ambrxβs interest in the Ambrx Improvements, to use, develop and exploit Ambrx Improvements only for Licensed Products. |
2.5 |
2.6 |
2.7 |
2.8 | TRANSFER OR EXCLUSIVE LICENSE GRANT BY NOVOCODEX REGARDING PHASE I CLINICAL DATA. To the extent permissible by Applicable Law, Novocodex shall transfer and assign to Ambrx ownership of all preclinical, clinical, regulatory filings, and Phase I Clinical Data in any mutually approved jurisdiction outside the Territory, provided however, if such transfer and assignment is not legally permitted, Novocodex hereby grants to Ambrx an exclusive (even as to Novocodex), sub-licensable, transferable, perpetual, irrevocable, non-terminable, royalty-bearing right and license in the world outside the Territory, under Novocodexβs interest in information including regulatory filings and Phase I Clinical Data, to use, reference, develop and exploit such information by Ambrx, its Affiliate or a Third Party authorized by Ambrx. Novocodex shall make reasonable effort to perfect such transfer, assignment or exclusive license under this Section. |
2.9 |
2.9.1 | Any sublicense by Novocodex of the rights granted to Novocodex under this Agreement shall obtain written approval from the Joint Steering Committee first, and then Ambrxβs prior written consent (not unreasonably withheld or delayed), be consistent with the terms |
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of this Agreement, and include an obligation for the sublicensee to comply with the applicable obligations of the sublicensing Party set forth in this Agreement. Novocodex shall not grant any sublicense hereunder that would impose obligations on Ambrx greater than those obligations of Ambrx contained in this Agreement. Novocodex shall provide to Ambrx a copy of each sublicense hereunder, which shall permit verification by Ambrx of compliance with the provisions of this Agreement. Parties expressly agree that Ambrx 1) shall reasonably withhold the written consent if Novocodex sublicenses its 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 Novocodex 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. |
2.9.2 | With respect to any sublicense by one Party of the rights granted to said Party under this ARTICLE 2, said Party shall not grant any sublicense hereunder that would impose obligations on the other Party greater than those obligations of the other Party contained in this Agreement. |
2.10 |
ARTICLE 3
3.1 |
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3.2 |
3.3 |
3.4 |
3.4.1 | A quorum for a meeting of the Joint Steering Committee shall require the presence of at least two (2) Ambrx members (or designees) and at least two (2) Novocodex members (or designees) in person or by telephone. All decisions made or actions taken by the Joint Steering Committee shall be made unanimously by its members, with the Ambrx members present at a meeting cumulatively having one (1) vote and the Novocodex members present at a meeting cumulatively having one (1) vote. |
3.4.2 | In the event that unanimity cannot be reached by the Joint Steering Committee with respect to a matter that is a subject of its decision-making authority within thirty (30) days after the matter is first brought before the Joint Steering Committee, then the matter shall be decided unanimously by the Chairperson of Novocodex and the CEO of Ambrx or by their designated representatives. If the Chairperson of Novocodex and the CEO of Ambrx or their designated representatives cannot reach an unanimous decision within thirty (30) days after the matter is first brought to them, then [***] shall have the final decision making authority for [***]; provided that [***] final decisions do not obligate [***] to [***]. |
3.5 |
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Steering Committee at such meeting. The chairperson of the Joint Steering Committee shall be responsible for circulation of all draft and final minutes. Draft minutes shall be circulated to all members of the Joint Steering Committee sufficiently in advance of the next meeting to allow review and comment prior to the meeting. Minutes shall be approved or disapproved, and revised as necessary, at the next meeting. Final minutes shall be distributed to the members of the Joint Steering Committee. |
3.6 |
3.7 |
ARTICLE 4
DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION
4.1 |
4.2 |
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collaborative manner (which shall be attached hereto as Exhibit 1.28), which shall include, but not be limited to (i) the indication(s) to be developed, (ii) the proposed global development activities and allocation thereof between the Parties, (iii) the timeline and budget, (iv) manufacturing process development, (v) clinical supply arrangement, and (vi) the Phase I clinical activities and such other matters that the Parties may want to include (the βGlobal Development Planβ). Either Party may propose to the Joint Steering Committee and the other Party, revisions to the Global Development Plan, with supporting evidence, such as technical, clinical or regulatory reasons that underline the proposed revisions. The Joint Steering Committee may amend the Global Development Plan from time to time after the Effective Date, pursuant to the decision making mechanism as set forth in Section 3.4.2. |
4.3 | COLLABORATIONS UNDER THE GLOBAL DEVELOPMENT PLAN; FUNDING. |
4.3.1 | Up until the completion of the global Phase I Clinical Trials of the Licensed Product, the Parties shall collaborate in the development of the Licensed Product in accordance with the Global Development Plan, including budgets and timelines set forth in the Global Development Plan. Each Party shall use Commercially Reasonable Efforts to carry out the activities assigned to it under the Global Development Plan and in accordance with the world-class standards. Novocodex shall, among other things, be responsible for funding the preparation of IND filing package(s) suitable for filings in the US and the Territory. The Parties shall jointly be responsible for designing clinical trials and study protocols and overseeing the global Phase I Clinical Trial of the Licensed Product and the performance of other activities under the Global Development Plan, with the priority to complete the Phase I activities, including dose-escalation and indication explorations, inside the Territory first. |
4.3.2 | Novocodex shall be responsible for funding activities up to the end of the global Phase I Clinical Trial of the Licensed Product in accordance with the Global Development Plan and shall fund or reimburse Ambrx for development costs incurred or to be incurred by Ambrx prior to the completion of the global Phase I Clinical Trial of the Licensed Product, with the following exceptions: (i) with respect to Phase I Clinical Trial activities under the Global Development Plan conducted outside the Territory and clinical supply of drug substance for such Phase I Clinical Trial activities, Novocodex shall fund or reimburse Ambrx for up to $[***] in costs and expenses (the βCapβ), and (ii) in the event that costs and expenses for Phase I Clinical Trial activities under the Global Development Plan conducted outside the Territory are in excess of the Cap, Novocodex shall be responsible for [***]% and Ambrx shall be responsible for [***]% of the amount above the Cap (the βCost Shareβ). For the sake of clarity, [***]. Novocodex shall promptly, within thirty (30) days after the date of receipt of Ambrxβs invoices, fund or reimburse Ambrx the development costs incurred or to be |
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incurred by Ambrx prior to the completion of the global Phase I Clinical Trial of the Licensed Product. |
4.4 | OUTSIDE THE GLOBAL DEVELOPMENT PLAN. Other than rights and obligations set forth in the Global Development Plan, Novocodex shall be solely responsible for conducting and paying for all development and commercialization of the Licensed Products in or for the Territory, and Ambrx shall be solely responsible for conducting and paying for the development and commercialization of the Licensed Products outside the Territory. Subject to Section 3.4.2, Novocodex shall have decision making authority for (and an obligation to fund) additional activities not included in the Global Development Plan that Novocodex deems necessary or desirable for the Territory; provided that such additional activities would not reasonably likely to affect the development or commercialization of the Licensed Product outside the Territory or outside the Field. |
4.5 |
4.6 |
4.7 | COMMERCIALIZATION. Novocodex (itself and through its Affiliates and sublicensees, as applicable) shall be solely responsible, at its own expense, for marketing, selling, offering for sale, distributing, promoting and otherwise commercializing Licensed Product in the Field in the Territory. |
4.8 |
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manufacturing and commercialization activities with respect to ARX305 and Licensed Product in the Field in the Territory in compliance with this Agreement, all Applicable Laws and world-class standards, including cGMP, good scientific and clinical practices under the Applicable Laws of the country in which such activities are conducted. |
ARTICLE 5
5.1 |
5.2 |
ARTICLE 6
MONETARY OBLIGATIONS, REPORTS AND AUDITS
6.1 |
6.2 | FOLLOW-UP PAYMENTS. As set forth in the following table, Novocodex shall make the following payments (the βFollow-up Paymentsβ) to Ambrx upon achievement of each of the events set forth in the tables below (the βFollow-up Eventsβ) by Novocodex or its Affiliates or sublicensees. Each Follow-up Payment shall be payable by Novocodex to Ambrx within thirty (30) days after the achievement of the corresponding Follow-up Event and receipt of invoice from Ambrx with respect to the Licensed Product. Such payments shall be non-refundable and non-creditable and not subject to set-off. |
Follow-up Event |
Follow-up Payment |
|||
[***] |
[ | ***] |
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[***] |
[ | ***] | ||
[***] |
[ | ***] |
6.3 |
6.3.1 | [***] ([***]%) of such Net Sales in the Territory in each Calendar Year up to and including Net Sales of [***] ($[***]); |
6.3.2 | [***] ([***]%) of such Net Sales in the Territory in each Calendar Year for the portion of such Net Sales exceeding of [***] ($[***]) up to and including of [***] ($[***]); and |
6.3.3 | [***] ([***]%) of such Net Sales in the Territory in each Calendar Year for the portion of such Net Sales exceeding [***] ($[***]). |
6.4 | KNOW-HOW ROYALTY. Notwithstanding the provisions of Section 6.3 above, in the event and after the manufacture, use or sale of Licensed Products by Novocodex or its Affiliates would not infringe a Valid Claim of the Ambrx Existing Patent Rights, or the Ambrx Existing Patent Rights covering the Licensed Products are deemed invalid or have expired, the Net Sales of such Licensed Products in the Territory shall remain the same during the Royalty Term in determining the applicable royalty rate according to Section 6.3, provided however, the Net Sales of such Licensed Products shall be [***] if Generic Competition exists. |
6.5 |
6.6 |
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6.6.1 | [***] ([***]%) of such Net Sales if Ambrx or its Affiliate(s) transfers or licenses Phase I Clinical Data without making additional efforts as defined in Sections 6.6.2 to 6.6.4; |
6.6.2 | [***] ([***]%) of such Net Sales if Ambrx or its Affiliate(s) transfers or licenses Phase I Clinical Data after Ambrx initiates Phase II Clinical Trial outside the Territory; |
6.6.3 | [***] ([***]%) of such Net Sales if Ambrx or its Affiliate(s) transfers or licenses Phase I Clinical Data after Ambrx initiates Phase III Clinical Trial outside the Territory; and |
6.6.4 | [***] ([***]%) of such Net Sales if Ambrx or its Affiliate(s) commercializes and sells a Licensed Product outside the Territory, the Marketing Authorization of such Licensed Product is based on Phase I Clinical Data. |
6.7 | THIRD PARTY ROYALTY SET-OFF. If Novocodex under Ambrx Third Party License is required to pay royalty that is necessary for Novocodexβs exercise of its rights hereunder in Territory pursuant to Section 2.3 or obtain a license from a Third Party due to infringement action under Section 7.4, it may offset any royalty payments actually paid by Novocodex to such Third Party due thereunder with respect to sales of Licensed Products against the royalty payments that are due to Ambrx; provided that in no event shall the royalty payments to Ambrx with respect to such Licensed Products be reduced by more than [***] ([***]%) of the amount otherwise due. |
6.8 |
6.9 |
6.10 |
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installments. Novocodex shall make the payment to Ambrx within thirty (30) days after receipt of invoice from Ambrx at the beginning of each Calendar Quarter. |
6.11 |
6.12 |
6.12.1 |
6.12.2 |
6.12.3 |
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6.12.4 |
6.12.5 |
6.13 |
6.14 |
6.15 |
ARTICLE 7
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7.1 |
7.2 | FILING, PROSECUTION AND MAINTENANCE OF PATENTS FOR JOINT DEVELOPMENT TECHNOLOGY. |
7.2.1 | JOINT DEVELOPMENT TECHNOLOGY. Ambrx shall have the first right to file patent applications for Joint Development Technology (in the name of both Novocodex and Ambrx) and thereafter prosecute and maintain Patent Rights for such Joint Development Technology. In the event that Ambrx files such patent applications and thereafter prosecutes and maintains Patent Rights for such Joint Development Technology, Novocodex shall execute such documents and perform such ministerial acts, at Novocodexβs expense, as may be reasonably necessary for Ambrx to continue such prosecution or maintenance of Patent Rights claiming such Joint Development Technology. Ambrx shall, in its sole discretion, have a right to choose external counsel to assist in the procurement and maintenance of such Joint Development Technology; provided that Ambrxβs choice of counsel will not present a conflict of interest for Novocodex. With respect to a given Joint Development Technology, Ambrx may elect not to file or may elect not to file in a particular country and if so, Ambrx shall notify Novocodex and Novocodex shall have the right to file such patent applications for such Joint Development Technology (in the name of both Novocodex and Ambrx) and thereafter prosecute and maintain Patent Rights for such Joint Development Technology. In the event that Novocodex files such patent applications and thereafter prosecutes and maintains Patent Rights for such Joint Development Technology, Ambrx shall execute such documents and perform such ministerial acts, at Ambrxβs expense, as may be reasonably necessary for Novocodex to continue such prosecution or maintenance of Patent Rights claiming such Joint Development Technology. Novocodex shall, in its sole discretion, have a right to choose external counsel to assist in the procurement and maintenance of such Joint Development Technology; provided that Novocodexβs choice of counsel will not present a conflict of interest for Ambrx. |
7.2.2 | NOVOCODEX IMPROVEMENTS. Novocodex shall have the first right, at its sole cost and expense, to file patent applications for Novocodex Improvement and thereafter prosecute and maintain Patent Rights for such Novocodex Improvements. With respect to a given Novocodex Improvement, Novocodex may elect not to file or may elect not to file in a particular country outside the Territory and if so, Novocodex shall notify Ambrx and Ambrx shall have the right but not the obligation to file such patent applications for such Novocodex Improvement and thereafter prosecute and maintain Patent Rights for such Novocodex Improvement. In such event, Novocodex shall execute such documents and perform such ministerial acts, at Ambrxβs expense, as may be reasonably necessary for Ambrx to continue such prosecution or maintenance of Patent Rights claiming such Novocodex Improvements outside the Territory. |
7.2.3 | REVIEW AND CONSULTATION. In each case in connection with the foregoing with respect to Joint Development Technology and Novocodex Improvement, as applicable, |
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the filing Party (a) shall keep the non-filing Party advised of the status of the actual and prospective patent filings; (b) upon the non-filing Partyβs written request, shall provide advance copies of any papers related to the filing, prosecution and maintenance of such patent filings; (c) shall give the non-filing Party an opportunity to review the text of the application before filing and shall consult with the non-filing Party with respect thereto; (d) shall give the non-filing Party an opportunity to review and comment on any documents relating to such patent filings that will be filed in any patent office at least twenty (20) days before such filing and give due consideration to such substantive, non-cumulative comments; (e) shall supply the non-filing Party with a copy of the application as-filed, together with notice of its filing date and serial number; and (f) shall promptly give notice to the non-filing Party of the grant, lapse, revocation, surrender, invalidation or abandonment of any Patent Rights claiming Joint Development Technology and Novocodex Improvement, as applicable) for which it is responsible for the filing, prosecution or maintenance hereunder (provided that the filing Party shall give at least thirty (30) days prior written notice to the non-filing Party of any desire to cease prosecution and/or maintenance of such Patent Rights). |
7.2.4 | COSTS. The Parties shall [***] costs of filing patent applications and procuring and maintaining Patent Rights in the United States, Japan, China, Brazil, and with the European Patent Office (including but not limited to all National Phase filing costs and fees) for such Joint Development Technology; Ambrx shall be responsible for [***] of filing patent applications and procuring and maintaining Patent Rights for such Joint Development Technology in all other jurisdictions outside the Territory, provided however, if, pursuant to Section 7.2.1, Ambrx elects not to file in a particular country in such other jurisdictions and Novocodex elects to file in such particular country for such Joint Development Technology, then Novocodex shall pay [***]% of the costs to file and maintain said Patent Rights in said elected country. Further, if, pursuant to Section 7.2.2, Novocodex elects not to file in a particular country outside the Territory and Ambrx elects to file and maintain Patent Rights on such Novocodex Improvements, then Ambrx shall pay [***]% 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 [***]. |
7.3 |
7.3.1 |
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7.3.2 |
7.3.3 |
24
and prosecute any legal action(s) relating to Licensed Intellectual Property Rights or Ambrx Background Technology outside the Territory at its own expense. |
7.3.4 |
7.3.5 |
7.4 |
7.4.1 |
7.4.2 |
7.4.3 |
ARTICLE 8
CONFIDENTIALITY & PUBLICATIONS
8.1 |
25
and for ten (10) years thereafter, each Party and its Affiliates, if any (collectively, a βreceiving Partyβ), shall use their best efforts to keep Confidential Information & Materials completely confidential, shall not publish or otherwise disclose to any Third Party and shall not use for any purpose other than the performance of this Agreement both the financial terms of this Agreement and any information furnished to it by the other Party or its Affiliates, if any (collectively, a βdisclosing Partyβ) (and shall ensure that its and its Affiliatesβ respective directors, officers, employees or agents do likewise), except to the 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. |
8.2 |
8.3 |
26
delay submission or presentation for a period of one hundred and twenty (120) days to enable patent applications protecting each Partyβs rights in such information to be filed in accordance with 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. |
8.4 |
8.5 |
ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 |
9.1.1 |
9.1.2 |
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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. |
9.1.3 | NON-CONTRAVENTION. The execution, delivery and performance by such Party of this Agreement and any other agreements and instruments contemplated hereunder will not (i) in any material respect violate any statute, regulation, judgment, order, decree or other restriction of any governmental authority to which such Party is subject, (ii) violate any provision of the corporate charter, by-laws or other organizational documents of such Party, or (iii) constitute a material violation or breach by such Party of any provision of any material contract, agreement or instrument to which such Party is a party or to which such Party may be subject although not a party. |
9.2 |
9.2.1 | to Ambrxβs knowledge, the Licensed Intellectual Property Rights exist and are not invalid or unenforceable, in whole or in part; |
9.2.2 | it has not previously (i) assigned, transferred, conveyed or otherwise encumbered its right, title and/or interest in Licensed Intellectual Property Rights related to ARX305 in the Field in the Territory, or (ii) granted any rights to any Third Parties, in either case that would conflict with the rights granted to Novocodex hereunder; |
9.2.3 | to Ambrxβs knowledge, it is the sole and exclusive owner or sole and exclusive licensee of Licensed Intellectual Property Rights related to ARX305 in the Territory, |
9.2.4 | to Ambrxβs knowledge, there are no claims, judgments or settlements against or owed by Ambrx and, no pending or threatened claims or litigation relating to Licensed Intellectual Property Rights in the Territory. |
9.3 | REPRESENTATIONS BY NOVOCODEX. Novocodex represents, warrants and covenants to Ambrx that: |
9.3.1 | All necessary consents, approvals and authorizations of all regulatory authorities and other governmental authorities and other persons or entities required to be obtained by Novocodex in order to enter into this Agreement have been obtained or, with respect to such consents, approvals and 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. |
9.3.2 | Novocodex, its Affiliates, and its and their respective principals, owners, officers, directors, employees, agents, consultants, and joint venture partners, and any other party acting on behalf of Novocodex (collectively as βNovocodex Representativesβ), have not and shall not offer, promise, provide, or accept any item of value (broadly meaning any monetary payment, such as fees or commissions, or nonmonetary benefit, such as employment opportunities, gifts, travel or entertainment), directly or indirectly, to or from any person in exchange for a business advantage; |
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9.3.3 | All Novocodex Representatives shall abide by all applicable anti-bribery and corruption laws, including the United States Foreign Corrupt Practices Act of 1977 and any other international or local laws of a similar nature or having similar effect now existing or to be enacted in the future; |
9.3.4 | No principal, owner, officer, director, employee or agent of Novocodex or its Affiliates is currently a βGovernment Official,β defined as: (a) an officer, agent or employee of a government; or (b) a candidate for government or political office. |
9.3.5 | No Government Official who is closely related to a Novocodex Representative has been or will be, directly or indirectly, involved in influencing, obtaining, or retaining business on behalf of Novocodex or fulfilling Novocodexβs obligations to Ambrx under this Agreement; |
9.3.6 | No Novocodex Representative (i) is listed on the Office of Foreign Assets Controlβs (βOFACβ) βSpecially Designated National and Blocked Person Listβ (βSDN Listβ) or otherwise subject to any sanction administered by OFAC (βU.S. Economic Sanctionsβ); (ii) is owned, controlled by or acting on behalf of, directly or indirectly, any person, entity, or government listed on the SDN List or otherwise subject to any U.S. Economic Sanction; (iii) has made sales to, contracted with, or otherwise engaged in any dealing or transaction with or for the benefit of any person, entity, or government listed on the SDN List or otherwise subject to any U.S. Economic Sanction during the previous five years; or (iv) has used, directly or indirectly, any corporate funds to contribute to or finance the activities of any person, entity, or government listed on the SDN List or otherwise subject to any U.S. Economic Sanction. |
9.3.7 | Novocodex and its Affiliates (i) are in compliance in all material respects with all Applicable Laws relating to anti-money laundering, and (ii) are not and have not been part of any proceedings (nor is any such proceeding pending or threatened) with respect to any such laws. |
9.3.8 | Both the Ambrx Existing Patent Rights and the Ambrx Know-How are permitted to be imported into China under PRC law, and none of it falls within the PRC categories for technologies that are restricted or prohibited from being imported. |
9.3.9 | Novocodex and its Affiliates will use the Ambrx Existing Patent Rights and Ambrx Know-How solely for the purpose of the development, use, manufacture or sale of the Licensed Products in Territory strictly in accordance with the terms of this Agreement and not for any other purpose. |
9.3.10 | Novocodex and its Affiliates shall invest sufficient resources and funds and use Commercially Reasonable Efforts to achieve Novocodex Follow-up Events so as to develop and commercialize Licensed Product in the Territory and obtain Phase I Clinical Data outside the Territory. |
ARTICLE 10
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10.1 |
10.2 |
10.3 |
10.4 |
30
10.4.1 |
10.4.2 |
10.4.3 |
ARTICLE 11
11.1 |
11.2 |
11.3 |
11.4 |
11.4.1 | Such other Party materially defaults with respect to any of its material obligations under this Agreement and does not cure such default within sixty (60) days after the receipt of a notice from the non-breaching Party specifying the nature of, and requiring the remedy of, such default (or, if such default cannot be cured within such sixty (60)-day period, if |
31
the breaching Party does not commence and diligently continue actions to cure same during such sixty (60)-day period); |
11.4.2 | The other Party shall have: (i) voluntarily commenced any proceeding or filed any petition seeking relief under the bankruptcy, insolvency or other similar laws of any jurisdiction, (ii) applied for, or consented to, the appointment of a receiver, trustee, custodian, sequestrator, conciliator, administrator or similar official for it or for all or substantially all of its property, (iii) filed an answer admitting the material allegations of a petition filed against or in respect of it in any such proceeding, (iv) made a general assignment for the benefit of creditors of all or substantially all of its assets, (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 |
11.4.3 | An involuntary proceeding shall have been commenced, or any involuntary petition shall have been filed, in a court of competent jurisdiction seeking: (i) relief in respect of the other Party, or of its property, under the bankruptcy, insolvency or similar laws of any jurisdiction, (ii) the appointment of a receiver, trustee, custodian, sequestrator, conciliator, administrator or similar official for such other Party or for all or substantially all of its property, 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. |
11.5 |
11.5.1 |
i. | Upon termination of this Agreement by Ambrx pursuant to Section 11.4 or by Novocodex pursuant to Section 11.3, (i) the rights and licenses granted to Novocodex under Sections 2.1, 2.2, 2.3, and 2.4 shall terminate, all rights therein or under will revert to Ambrx and neither Novocodex nor its Affiliates may make, develop, manufacture, have manufactured, sell, offer for sale and have sold Licensed Products in the Territory; (ii) the rights and licenses granted to Ambrx under Sections 2.6 and 2.7 will revert back to Novocodex, provided however, Novocodex shall not assert against Ambrx, its Affiliates or sublicensees any claims for infringement of the reverted rights in the event Ambrx 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 termination is not caused by any action or inaction of the sublicensee, such sublicensee shall have the right to seek a license from Ambrx at Ambrxβs sole discretion. |
ii. | Upon termination of this Agreement by Novocodex pursuant to Section 11.4, (i) the rights and licenses granted to Novocodex under Sections 2.1, 2.2, 2.3 and 2.4 shall terminate, all rights therein or under will revert to Ambrx and neither |
32
Novocodex nor its Affiliates may make any further develop, manufacture, have manufactured, sell, offer for sale and have sold Licensed Products in the Territory; and (ii) rights and licenses granted to Ambrx under Sections 2.6 and 2.7 will revert to Novocodex. |
11.5.2 |
11.5.3 |
11.5.4 |
11.5.5 |
11.6 |
11.6.1 | Termination or expiration of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to such termination or expiration. Such termination or expiration shall not relieve either Party from obligations which are expressly indicated to survive termination or expiration of this Agreement. The rights of the Parties upon termination described in this Agreement shall not be exclusive of any other rights or claims at law or in equity that either Party may have against the other arising out of this Agreement. |
33
11.6.2 |
ARTICLE 12
12.1 |
12.2 |
12.3 |
ARTICLE 13
13.1 |
34
of this Agreement (a βDisputeβ) will be referred to the Executive Officers (or such Executive Officerβs designee with decision-making authority) for attempted resolution. In the event such executives are unable to resolve such Dispute within 30 days after the initial written request, then, upon the written demand of either Party, the Dispute shall be subject to arbitration, as provided in Section 13.2, except as expressly set forth in 13.2. |
13.2 | ARBITRATION. Any Dispute that cannot be resolved pursuant to Section 13.1 will be referred to and finally resolved by arbitration in accordance with the International Chamber of Commerce (the βRulesβ) by the Hong Kong International Arbitration Centre (βHKIACβ), by an arbitral tribunal composed of three (3) arbitrators, with each Party appointing one (1) arbitrator and the third arbitrator to be selected by mutual agreement of the two (2) arbitrators appointed by the Parties. The foregoing arbitration proceedings may be commenced by either Party by notice to the other Party. All arbitration proceedings will be conducted in the English language. The allocation of expenses of the arbitration, including reasonable attorneyβs fees, will be determined by the arbitrators, or, in the absence of such determination, each Party will pay its own expenses. All rulings by the arbitrators will be final. |
13.3 |
ARTICLE 14
14.1 |
14.2 |
35
the foregoing, either Party may, without the other Partyβs 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 Partyβs business to a successor in interest in connection with the transfer or sale of all or substantially all of its business or assets to which this Agreement relates, or in the event of such Partyβs 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. |
14.3 |
14.4 |
If to Ambrx, to: | Ambrx, Inc. | |||
00000 Xxxxx Xxxxxx Xxxxx Xxxx | ||||
Xx Xxxxx, XX 00000 | ||||
Attn: Office of General Counsel | ||||
Facsimile No.: | ||||
With a copy to: | ||||
Xxxxxxx Procter LLP | ||||
One Exchange Square | ||||
Suite 2801, 0 Xxxxxxxxx Xxxxx | ||||
Xxxxxxx, Xxxx Xxxx | ||||
Attn: Wenseng βXxxxxβ Pan, Esq. | ||||
Facsimile No.: | ||||
If to Novocodex, to: | NovoCodex Biopharmaceuticals Ltd., | |||
000 Xxxxxx Xxxx, Xxxxxxxxxxxxxx, Xxxxxxxx, Xxxxxxxx 000000, the Peopleβs Republic of China | ||||
Attn: Zhenlan Hu | ||||
Facsimile No.: |
36
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.
14.5 | APPLICABLE LAW. This Agreement shall be governed by and construed in accordance with the laws of the Hong Kong Special Administrative Region, 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. All disputes arising from or in connection with this Agreement shall be submitted for arbitration in accordance with the UNCITRAL Arbitration Rules in accordance with the HKIAC Procedures for the Administration of International Arbitration in force at the date of this Agreement. The place of arbitration shall be in Hong Kong at Hong Kong International Arbitration Centre. |
14.6 |
14.7 |
37
14.8 |
14.9 |
14.10 |
14.11 |
14.12 |
14.13 |
14.14 |
14.15 |
38
of the governments of the United States and any other relevant countries. Ambrx and Novocodex shall cooperate with each other and shall provide assistance to the other as reasonably necessary to obtain any required approvals. |
14.16 |
14.17 |
14.18 |
14.19 |
14.20 |
[Remainder of this page is left intentionally blank]
39
IN WITNESS WHEREOF, the Parties have executed this Co-Development and License Agreement as of the Effective Date.
NOVOCODEX BIOPHARMACEUTICALS LTD. | ||
By: ηΎεοΌ | /s/ Xxxxxx Xxxxx | |
Name: ε§ε : | Xxxxxx Xxxxx | |
Title: θδ½οΌ |
AMBRX, INC. | ||
By: ηΎεοΌ | /s/ Xxxx Xxxx | |
Name: ε§ε : | Xxxx Xxxx | |
Title: θδ½οΌ | CEO |
40
Exhibits
Exhibit 1.1: Structure of ARX305
[***]
[***]AS269
[***]
[***]
[***]
Exhibit 1.5: List of Ambrx Existing Patent Rights
[See attached]
Exhibit 1.28: Global Development Plan
To be adopted by the JSC within 60 days after the Effective Date.
Exhibit 3.1: Initial Members of Joint Steering Committee
Ambrx | NovoCodex | |
Xxxxx Xxxxx | Gang Xia | |
Xxxx Xxxxxxxx | Xxxxxxx Xxxxx | |
Xxxxx Xxx | Xxxxxxxx Xxx |
Exhibit 8.4: Draft Joint Press Release
Ambrx and NovoCodex form Second Collaboration to Develop and
Commercialize Ambrxβs Antibody Drug Conjugates
SAN DIEGO and SHANGHAI, October 22, 2019 /PRNewswire/ β Ambrx and NovoCodex Biopharmaceuticals Ltd., (NovoCodex), a majority owned company of Zhejiang Medicine Co Ltd., today announced that they have formed a second collaboration to develop and commercialize Ambrxβs internally developed site-specific antibody drug conjugates (ADCs). Under the agreement, Ambrx and NovoCodex will join forces to continue the development of ARX305, an Ambrx enabled ADC for the treatment of CD70 positive cancers.
Under the terms of the agreement, NovoCodex is responsible for developing and commercializing ARX305 in China while Ambrx is responsible for developing and commercializing ARX305 outside of China. NovoCodex will fund global development activities to the end of Phase 1 clinical trials and pay Ambrx an undisclosed upfront payment, development milestones, and a double digit royalty on product sales in China. NovoCodex is also eligible to share in undisclosed portion of ARX305 product sales outside of China.
βWe are excited to initiate our second collaboration with NovoCodex following our successful collaboration with ARX788, which is currently in Phase 1 clinical trials for HER2 positive breast and gastric cancers. ARX305 is a natural extension to the first collaboration with the inclusion of another Ambrx enabled ADC that is intended to treat CD70 positive cancers such as Renal Cell Carcinoma and Multiple Myeloma. Further, we continue to align ourselves with Chinaβs leading pharmaceutical companiesβ said Xxxx Xxxx, Ph.D., Chief Executive Officer of Ambrx. βARX305, which is expected to start Phase 1 clinical trials in early 2021, allows Ambrx to expand its ADC pipeline into multiple cancer types while gaining access to the China market through our partnership with NovoCodex.β
Chunbo Li, Chairman of Zhejiang Medicine, commented, βThe smooth progress of our first ZMC-Ambrx collaborated ADC project, ARX788, proves that Ambrxβ technology is one of the best methods to make an ADC drug. The new alliance with Ambrx on ARX305 will strengthen our leading position on ADC research, and hopefully will bring new treatment to related cancer patients.β
About Ambrx
Ambrx Inc. is a clinical stage biopharmaceutical company using an expanded genetic code to create first- and/or best-in-class biotherapeutics, including antibody drug conjugates (ADC), immunomodulating proteins, bispecific antibodies and other therapeutic proteins with improved pharmacologic properties. Leveraging the Ambrx proprietary technology platforms, Ambrx has collaborations with Xxxxxxx-Xxxxx Squibb, Astellas, BeiGene, Elanco and ZMC, with drug products generated using Ambrx technology in different stages of clinical trials. Ambrx is advancing a robust portfolio of product candidates that are optimized for efficacy, safety and ease of use in multiple therapeutic areas. For additional information, visit xxx.xxxxx.xxx
About ARX305
CD70 is highly expressed in multiple solid and liquid tumors such as Renal Cell Carcinoma, Multiple Myeloma, Non-Hodgkinβs Lymphoma, AML, and etc. ARX305 is a best-in-class anti-CD70 ADC that was precision-engineered using Ambrx proprietary antibody and clinically validated drug payload. Strong in vitro and in vivo efficacy have been demonstrated in multiple tumor cells and models. It is expected to deliver a direct killing to CD70-overexpressing tumor and improvement of the immune suppression in the tumor microenvironment.
About NovoCodex
NovoCodex is a majority owned company of Zhejiang Medicine Co., Ltd. (stock code: SH.600216), mainly committed to the research and development of biological products. The companyβs laboratory has experience and capabilities in genetic engineering, cell culture, toxin synthesis, conjugation, formulation & filling, preclinical study and clinical study. ARX788 project has been successfully advanced to the later stage of phase 1 clinical trial in China. The company is building a protein drug development platform with the insertion of unnatural amino acids as the core technology to develop a variety of long-acting protein drugs. For additional information, visit xxxx://xxx.xxxxxxxxx.xx/.