RESEARCH COLLABORATION AGREEMENT
Exhibit 10.13
RESEARCH COLLABORATION AGREEMENT
This RESEARCH COLLABORATION AGREEMENT (the “Agreement”) is effective as of December 21, 2021 (the “Effective Date”) by and between Aarvik Therapeutics, Inc., a company incorporated in Delaware, having a place of business at 00000 Xxxxxxxxx Xxxxx, Xxxxxxx, XX 00000 (“Aarvik”), and ArriVent Biopharma, Inc., a company incorporated in Delaware, with offices located at 00 Xxxxxx Xxxx. Xxxxx 000, Xxxxxxx Xxxxxx, XX 00000-0000 (“ArriVent”). ArriVent and Aarvik are referred to herein individually, as a “Party” or, collectively, as “Parties.”
The following capitalized terms shall have the meanings given in this Article 1 when used in this Agreement:
1.1 “Aarvik Indemnitees” has the meaning set forth in Section 10.2.
1.2 “Aarvik IP” shall mean Aarvik Know-How and Aarvik Patents.
1.3 “Aarvik Know-How” shall mean all Know-How owned or Controlled by Aarvik or any of its Affiliates as of the Effective Date or during the Term that is necessary or useful for the Research, Development, Manufacture, or Commercialization of any Compound or Product in the Field. For clarity, Aarvik Know-How shall include all Know-How licensed to Aarvik or any of its Affiliates under the Existing In-License Agreements.
1.4 “Aarvik Patents” shall mean all Patents owned or Controlled by Aarvik or any of its Affiliates as of the Effective Date or during the Term that are necessary or useful for the Research, Development, Manufacture, use or Commercialization of any Compound or Product in the Field. For clarity, Aarvik Patents shall include all Patents, if any, licensed to Aarvik or any of its Affiliates under the Existing In-License Agreements.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
1.5 “Accounting Standards” shall mean with respect to a Person, as applicable (a) generally accepted accounting principles as practiced in the United States, (b) the International Financial Reporting Standards issued by the International Financial Reporting Standards Foundation and the International Accounting Standards Board, or (c) applicable accounting standards followed by such Person, in each case, consistently applied.
1.6 “ADCs” means an antibody drug conjugate comprising one or more antibody(ies) (or fragment(s) thereof) that binds to one or more Target(s) and is conjugated to a [***]. “[***]” means [***]: (a) [***]; (b) [***]; or (c) [***].
1.7 “Affiliate” shall mean, with respect to either Party, any Person controlling, controlled by or under common control with such Party, for so long as such control exists. For purposes of this definition only, “control” shall mean (a) direct or indirect ownership of fifty percent (50%) or more (or, if less than fifty percent (50%), the maximum ownership interest permitted by Applicable Law) of the stock or shares having the right to vote for the election of directors of such corporate entity or (b) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of voting securities, by contract or otherwise.
1.8 “Alliance Manager” has the meaning set forth in Section 2.2.
1.9 “Applicable Laws” shall mean the applicable provisions of any and all national, supranational, regional, state and local laws, treaties, statutes, rules, regulations, administrative codes, guidance, ordinances, judgments, decrees, directives, injunctions, orders, permits (including Marketing Approvals) of or from any court, arbitrator, mediator, Regulatory Authority or governmental agency or authority having jurisdiction over or related to the subject item including all anti-corruption laws.
1.10 “ArriVent Indemnitees” has the meaning set forth in Section 10.1.
1.11 “Biologics Act” has the meaning set forth in Section 7.5.
1.12 “Biosimilar Product” shall mean [***].
1.13 “Business Day” shall mean any day other than a Saturday, Sunday or any other day on which commercial banks in either Pennsylvania or California, the United States or the Cayman Islands are required by law to remain closed.
1.14 “Calendar Quarter” shall mean each successive period of three calendar months ending on March 31, June 30, September 30 and December 31, provided that the first Calendar Quarter of the Term shall begin on the Effective Date and end on the first to occur of March 31, June 30, September 30 or December 31 thereafter.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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1.15 “Calendar Year” shall mean the respective periods of twelve (12) months commencing on January 1 and ending on December 31.
1.16 “Collaboration” shall mean the Research collaboration between the Parties in accordance with the applicable SOWs during the Research Term. When used as a verb, “Collaborate” shall mean to engage in Collaboration.
1.17 “Collaboration Compound” shall mean any ADC that is generated within the Collaboration Program, as well as the antibodies incorporated in the ADC.
1.18 “Collaboration IP” shall mean, [***].
1.19 “Collaboration Patents” has the meaning set forth in Section 7.2.2.
1.20 “Collaboration Program” shall mean the Collaboration with respect to a pair of Targets, subject to the applicable SOWs, with the goal to identify at least one ADC showing meaningful binding activities against such pair of Targets that is suitable for further development by ArriVent beyond the Collaboration.
1.21 “Commercialization” shall mean, with respect to a particular Product, any and all processes and activities conducted to establish and maintain sales for such Product (including with respect to reimbursement and patient access), including offering for sale, detailing, selling (including launch), marketing (including education and advertising activities), promoting, storing, transporting, distributing, and importing such Product, but shall exclude Development and Manufacturing of such Product. “Commercialize” and “Commercializing” shall have their correlative meanings.
1.22 “Commercially Reasonable Efforts” shall mean, with respect to a Party, the level of efforts and resources (measured as of the time that such efforts and resources are required to be used under this Agreement) that are commonly used by a company in the industry of a similar size and similar profile as such Party to research, Develop, Manufacture or Commercialize, as the case may be, a product owned by such company or to which it has rights, which product is at a similar stage in its development or product life and is of a similar market and profitability potential to the Product and taking into account all relevant factors, including the intellectual property protection of the product, product labeling or anticipated labeling, market potential, financial return, medical and clinical considerations, regulatory environments and competitive market conditions, market exclusivity, and other technical legal, scientific, medical or commercial factors that such a company would reasonably deem to be relevant. With respect to a particular Product, Commercially Reasonable Efforts shall be determined on a country-by-country basis for such Product, and it is anticipated that the level of effort will be different for different markets, and will change over time, reflecting changes in the status of the Product and the market(s) involved.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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1.23 “Compound” shall mean [***].
1.24 “Confidential Information” has the meaning set forth in Section 8.1.
1.25 “Control” shall mean, with respect to particular Know-How or a particular Patent, possession by the Party granting the applicable right, license or sublicense to the other Party as provided herein of the power and authority, whether arising by ownership, license, or other authorization, to disclose and deliver the particular Know-How to the other Party, and to grant and authorize under such Know-How or Patent the right, license or sublicense, as applicable, of the scope granted to such other Party in this Agreement without giving rise to a violation of the terms of any agreement or other arrangement with any Third Party. “Controlled” shall have its correlative meanings.
1.26 “Cover” shall mean, with respect to any subject matter, the make or have made, manufacture or have manufactured, use, sale, offer for sale, importation, exportation or other Exploitation of such subject matter would infringe a claim of a Patent at the relevant time. “Covered” or “Covering” shall have their correlative meanings.
1.27 “Data Package” shall mean the data package containing such data and other contents as required in the applicable SOW.
1.28 “Development” or “Develop” shall mean, any preclinical, clinical, non-clinical activity directed to obtaining or maintaining Regulatory Approval of a Compound or Product, including all preclinical studies, toxicology testing, chemistry, manufacturing and control (CMC), clinical trials, statistical analysis and report writing, all related regulatory activities, the preparation and submission of such regulatory filings (including INDs and XXXx), regulatory affairs with respect to the foregoing and all other activities reasonably necessary or useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining a Regulatory Approval for a Compound or Product. When used as a verb, “Develop” shall mean to engage in Development. For clarity, “Development” shall include Phase IV studies or any other clinical trial commenced after Regulatory Approval.
1.29 “Executive Officers” means the Chief Executive Officer of ArriVent and Chief Executive Officer of Aarvik or their respective designees.
1.30 “Exploit” or “Exploitation” shall mean to make, have made, import, export, use, have used, sell, have sold, offer for sale, have offered for sale, or otherwise exploit, including to Research, Develop, Commercialize, register, modify, enhance, improve, manufacture, have manufactured, hold, keep (whether for disposal or otherwise), or otherwise dispose of “Existing In-License Agreements” shall mean any and all agreements between Aarvik or any of its Affiliates, on the one hand, and any Third Party, on the other hand, existing as of the Effective Date or during the Term pursuant to which Aarvik in-licenses any Patents or Know-How that are included as part of the Aarvik Patents or Aarvik Know-How.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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1.31 “Existing In-License Agreements” shall mean any and all agreements between Aarvik or any of its Affiliates, on the one hand, and any Third Party, on the other hand, existing as of the Effective Date or during the Term pursuant to which Aarvik in-licenses any Patents or Know-How that are included as part of the Aarvik Patents or Aarvik Know-How.
1.32 “FDA” shall mean the United States Food and Drug Administration, or any successor agency thereto.
1.33 “Field” shall mean [***].
1.34 “First Commercial Sale” shall mean, with respect to a Product, post-Regulatory Approval, the first sale, transfer or disposition for value of such Product in the Territory.
1.35 “Full Report” has the meaning set forth in Section 3.7.6.
1.36 “Governmental Authority” means any court, tribunal, arbitrator, Regulatory Authority, agency, commission, department, ministry, official or other instrumentality of the United States or other country, or any supra-national organization, or any foreign or domestic, state, county, city or other political subdivision.
1.37 “IND” shall mean an investigational new drug application, investigational medicinal product dossier, clinical study application, clinical trial application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
1.38 “Indemnify” has the meaning set forth in Section 10.1.
1.39 “Initial Transfer” has the meaning set forth in Section 5.3.
1.40 “Intellectual Property Rights” shall mean rights in Patents and Know-How and other intellectual property.
1.41 “JRC” has the meaning set forth in Section 2.2.
1.42 “Know-How” shall mean any and all know how, information comprising or embodied by (a) ideas, discoveries, inventions (including data or descriptions contained in unpublished patent applications), improvements or trade secrets, (b) research and development data, such as medicinal chemistry data, preclinical data, pharmacology data, chemistry data (including analytical, product characterization, manufacturing, and stability data), toxicology data, clinical data (including investigator reports (both preliminary and final), statistical analyses, expert opinions and reports, safety and other electronic databases), quality control data and stability data, dosage regimens, product specifications, study designs and protocols, assays and biological methodology, (c) databases, practices, techniques, specifications, formulations, formulae, knowledge, (d) techniques, methods, processes, manufacturing information, (e) materials, cell lines, reagents and compositions of matter, including chemical or biological materials, in each case, whether patentable or not. Know-How shall not include any of the foregoing to the extent it is described or claimed in any published Patent.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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1.43 “Losses” has the meaning set forth in Section 10.1.
1.44 “MAA” (Marketing Approval Application) shall mean a Biologics License Application or similar application or submission filed with or submitted to any Regulatory Authority to obtain permission to initiate marketing and sales of a Product in the Field.
1.45 “Major Market Country” shall mean any of the following: [***].
1.46 “Manufacture” or “Manufacturing” shall mean all operations involved in the pre-clinical, clinical, and commercial manufacturing, quality control testing (including in-process, release and stability testing, if applicable), storage, releasing and packaging the Compound(s) and Product(s), including vector construction, cell line development, master cell bank generation, test method development and stability testing, toxicology, formulation and delivery system development, process development and optimization, clinical Compound and Product supply, manufacturing scale-up, development-stage manufacturing, quality assurance/quality control procedure development and performance with respect to clinical materials.
1.47 “Marketing Approval” shall mean, with respect to a Product in a particular jurisdiction, all approvals, licenses, registrations or authorizations necessary for the Commercialization of such Product in such jurisdiction, including only where mandatory for Commercialization of such Product, approval of labeling, price, reimbursement and manufacturing.
1.48 “Net Sales” shall mean gross sales of a Product as received by ArriVent, its Affiliates or its Sublicensees from a Third Party within the Territory under the applicable Accounting Standards, and less (a) all allowances for discounts, rebates and charge-backs, (b) credits or allowances granted upon claims, rejections, exchanges or returns of Products, (c) distribution, warehousing, transportation, importation, freight, postage, special packaging, shipping and insurance charges paid for delivery of Products, (d) the portion of any management or administrative fees paid during the relevant time period to government payor health care programs or pharmaceutical benefit managers for such government payor health care programs that relate specifically to sales of such Product, (e) taxes, duties or other governmental charges levied on or measured by the billing amount when included in billing, as adjusted for rebates and refunds, and (f) other reductions or specifically identifiable amounts deducted for reasons similar to those listed above, in each case, in accordance with the applicable Accounting Standards, as consistently applied. Adjustments may be made to the calculation of net sales as required by changes in the Accounting Standards as necessary in the future, or as appropriate to reflect changes to the accounting rules brought about by merger, take-over or law. Without limiting the generality of the foregoing, sales, transfers, or dispositions of Product for charitable, named-patient, promotional (including samples), non-clinical, clinical, or regulatory purposes shall be excluded from Net Sales, as shall sales or transfers of Product among ArriVent and its Affiliates or licensees or sublicensees.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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In the event that a Product is sold in any country in the form of a Combination Product, Net Sales of such Combination Product shall be adjusted by multiplying actual Net Sales of such Combination Product in such country (calculated pursuant to the foregoing definition of “Net Sales”) [***]. “Combination Product” means a Product that is comprised of or contains a Compound as an active ingredient together with one (1) or more other active ingredients or delivery systems and is sold together.
1.49 [***].
1.50 [***].
1.51 [***].
1.52 “NMPA” shall mean the National Medical Product Administration of the People’s Republic of China, or any successor agency thereto.
1.53 “Option” has the meaning set forth in Section 3.9.
1.54 “Option Period” has the meaning set forth in Section 3.9.
1.55 “Patentability and FTO Analysis” has the meaning set forth in Section 3.2.3.
1.56 “Patents” shall mean all patents and patent applications in any country in the world, including any continuations, continuations-in-part, divisionals, provisionals or any substitute applications, any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any patent term extension in the United States or supplemental protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all non-United States counterparts of any of the foregoing.
1.57 “Person” shall mean any individual, corporation, partnership, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof
1.58 “Phase 1 Clinical Trial” shall mean a clinical development program in any country that generally provides for the first introduction into humans of a pharmaceutical product candidate with the primary purpose of which is preliminary determination of safety, metabolism and pharmacokinetic properties and clinical pharmacology of such pharmaceutical product candidate in healthy patients, or otherwise generally consistent with U.S. 21 C.F.R. §312.21(a).
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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1.59 “Phase 2 Clinical Trial” shall mean a clinical study of an investigational product in subjects with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, pharmacokinetics, pharmacodynamics, and dose finding information as described in 21 C.F.R. 312.21(b), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States, including a clinical study that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Clinical Trial.
1.60 “Phase 3 Clinical Trial” shall mean a clinical study of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States.
1.61 “Product” shall mean any formulation containing a Compound as an active ingredient, including all methods, forms, presentations, dosage strengths, dosage forms and formulations thereof, for administration by any method of delivery.
1.62 “Publications” has the meaning set forth in Section 8.5.1.
1.63 “Registration Trial” means a human clinical trial anywhere in the world that is a clinical trial or study that intends to provide the ultimate evidence and data that a Regulatory Authority uses to decide whether or not to approve a potential new medicine. For clarity, a Phase 2 or 2(b) Clinical Trial that satisfies the requirements of 21 CFR §312.21 (c) or its equivalent prescribed by the Regulatory Authority in the applicable country or regulatory jurisdiction other than the United States where the clinical trial takes place shall be considered a Registration Trial.
1.64 “Regulatory Approval” shall mean all approvals (including any applicable mandatory governmental price and reimbursement approvals and other Marketing Approvals), licenses, registrations, and authorizations of any federal, national, multinational, state, provincial or local Regulatory Authority, department, bureau and other governmental entity that are necessary for the marketing and sale of a product in a country or group of countries.
1.65 “Regulatory Authority” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the discovery, Development, Manufacturing, Commercialization or other use or exploitation (including the granting of Marketing Approvals) of any Product in any jurisdiction, including the FDA, Pharmaceuticals and Medical Devices Agency (PMDA), Medicines and Healthcare Products Regulatory Agency (MHRA), European Medicines Agency (EMA), and the NMPA.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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1.66 “Representatives” means, with respect to any Person, such Person’s directors, officers, managers, employees, counsel, accountants, financial advisors, lenders and other agents and representatives.
1.67 “Research” means activities related to the design, discovery, identification, synthesis and characterization of Compounds within the Collaboration Program. “Researching” shall have a correlative meaning.
1.68 “Research Term” has the meaning set forth in Section 3.1.
1.69 “Royalty Term” has the meaning set forth in Section 6.5.2.
1.70 “SOWs” has the meaning set forth in Section 3.1. An agreed form of SOW is appended hereto as Exhibit D.
1.71 “Sublicensee” of a Party shall mean any Third Party to whom such Party has directly or indirectly granted a sublicense under all or any portion of the license granted to such Party under this Agreement.
1.72 “Target” shall mean the biological target of a pharmacologically active drug compound or epitopes of such biological target.
1.73 “Target Pair” shall mean, with respect to compounds being developed under the Collaboration Program, the two (2) Targets that such compound binds. The Target Pair mutually agreed upon by the Parties as of the Effective Date is set forth on Exhibit A.
1.74 “Term” has the meaning set forth in Section 11.1.
1.75 “Territory” shall mean [***].
1.76 “Third Party” shall mean any Person other than Aarvik, ArriVent or their respective Affiliates.
1.77 “Third-Party Claim” has the meaning set forth in Section 10.1.
1.78 “US Dollars” or “US$” or “$” shall mean United States dollars, the lawful currency of the United States.
1.79 “Valid Claim” shall mean a claim contained in (a) an issued and unexpired Patent, which claim has not been found to be unpatentable, invalid, revocable or unenforceable by a decision of a court or other authority of competent jurisdiction in the subject country, which decision is unappealable or unappealed within the time allowed for appeal, and has not been admitted to be invalid or unenforceable through abandonment, reissue, disclaimer or otherwise; or (b) a pending patent application that has been filed in good faith and that has not been cancelled, withdrawn, or abandoned and has not been pending for more than [***] ([***]) years from the earliest priority date.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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1.80 “Work Item” shall mean each of the [***] ([***]) components of the Collaboration Program as set forth in Exhibit B.
ARTICLE 2
OVERVIEW; GOVERNANCE
2.3.1 monitoring activities under each SOW;
2.3.2 forming any subcommittee as it or the Parties deem appropriate or necessary, deciding the scope of responsibilities of any subcommittee, supervising the subcommittees and resolving issues and disputes submitted by any subcommittee;
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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2.3.3 reviewing and recommending any amendments to any SOW (including the proposed research activities and budgets);
2.3.4 periodic review of the overall goals and strategy of the Collaboration;
2.3.5 providing strategic direction to Aarvik’s activities under the Collaboration to ensure the delivery of Compounds suitable for further preclinical development;
2.3.6 reviewing the relevant Data Package(s);
2.3.7 discussing the suitability of any Compounds for Development;
2.3.8 reviewing and implementing patenting and Intellectual Property Right protection strategies on Compounds and other Collaboration IP;
2.3.9 discussing any patentability or freedom-to-operate issue about the Compound(s);
2.3.10 facilitating access to and the exchange of information between the Parties related to the Collaboration activities, including monitoring and approving the exchange of relevant information and data between the Parties as required for the performance of any SOW;
2.3.11 discussing certain payments described in Section 6.2.2 and 6.2.3 below; and
2.3.12 such other responsibilities as may be assigned to the JRC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
2.4.1 Each Party’s representatives of the JRC shall have collectively one (1) vote. All decisions of the JRC shall be made whenever possible by unanimous vote.
2.4.2 Notwithstanding the foregoing, XxxxXxxx shall have the final decision-making authority with respect any “go/no-go” decision pertaining to the Collaboration Program.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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ARTICLE 3
RESEARCH COLLABORATION
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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3.4.1 Aarvik shall (i) prepare a draft SOW for each of the [***] ([***]) Work Items consistent with the terms set forth on Exhibit B and Exhibit D hereto; (ii) submit the [***] to ArriVent for approval no later than [***] ([***]) days before the anticipated commencement date of the [***]; (iii) submit the [***] to ArriVent for approval no later than [***] ([***]) days before the anticipated commencement date of the [***]; and (iv) submit the [***] to ArriVent for approval no later than [***] ([***]) days before the anticipated commencement date of the [***]. Each SOW shall set forth, with respect to the Collaboration Program, (a) agreed activities to be performed by or on behalf of Aarvik; (b) the content of the applicable Data Package, materials and other deliverables to be delivered to ArriVent; (c) timeline for completion of each activity set forth in the SOW; and (d) such other information and/or materials that may be reasonably required by ArriVent.
3.4.2 During the Research Term, any updates or amendments to a SOW must be mutually agreed upon in writing by XxxxXxxx and Aarvik. Any such updated and amended SOW will reflect any changes to, re-prioritization of studies within, reallocation of resources with respect to, or additions to, respectively, the then-current SOW. Once approved by the Parties, the amended SOW will become effective for the applicable period on the date approved by the Parties (or such other date as the Parties will specify). Any amended SOW approved by the Parties will supersede, respectively, the previous SOW for the applicable period.
3.4.3 During the Research Term, Aarvik shall provide prompt written notice to ArriVent if at any time it believes that it may or is actually running more than [***] ([***]) days ahead or behind the timeline approved by XXX.
3.5 Subcontractor; Research Staffing.
3.5.1 Aarvik may contract or delegate any portion of its obligations hereunder to its Affiliates or subcontractors; provided that Aarvik shall keep ArriVent informed through the JRC of each subcontract entered into therewith, specifying the name of the contract service provider. Aarvik is responsible for the compliance of its Affiliates and subcontractors with the terms and conditions of this Agreement, and any act or omission of an Affiliate or subcontractor that would be a material breach of this Agreement if performed by Aarvik will be deemed to be a material breach by Aarvik under this Agreement. For clarity, the performance of any obligations of Aarvik by its Affiliates or subcontractors will not diminish, reduce or eliminate any obligation of Aarvik under this Agreement.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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3.5.2 Throughout the Research Term, for the Collaboration Program, Aarvik shall assign, and shall cause its Affiliates and subcontractors involved to assign, reasonably sufficient qualified scientist and other resources to perform the work set forth in the SOWs, with the mixture of skills and levels of such scientists to be appropriate to accomplish the scientific objectives of the Collaboration Program. Aarvik shall be solely responsible for managing the performance of its subcontractors. Aarvik shall cooperate with ArriVent in periodically reviewing the performance of the personnel and shall promptly remedy any concerns to ArriVent’s reasonable satisfaction. Xxxxxx shall promptly select a qualified replacement should any personnel resign or become otherwise unavailable. Before commencing work under this Agreement and any SOW, all Aarvik, its Affiliates and subcontractors personnel must be subject to binding written agreements that are consistent with the terms of this Agreement, including research records (Section 3.6), confidentiality (Article 8) and inventor assignment obligation (Section 7.1.3).
3.7.1 Aarvik shall carry out the activities of each Work Item and deliver the required Data Package and/or deliverables in accordance with the applicable SOW. Without limiting the generality of the foregoing, Aarvik shall, in accordance with the applicable SOWs and the timeline approved by JRC, apply the Aarvik IP to (i) design and synthesize Collaboration Compounds, and (ii) by itself or through subcontractor(s), [***]. During the Research Term, if any Party identifies any Third Party Patent or Know-How that is necessary or reasonably useful for any activity under the SOWs but has not been included in the Aarvik IP, then such Party shall immediately inform the other Party and the Parties shall discuss in good faith the need of obtaining a license from such Third Party.
3.7.2 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver the Data Packages and all other deliverables required under the [***], as well as the results of the Patentability and FTO Analysis as described in Section 3.2.3, to ArriVent. ArriVent shall have the sole discretion to decide whether or not to advance any Collaboration Compound and which Collaboration Compound(s) will be advanced for further studies beyond the [***]. ArriVent shall inform Xxxxxx of its decision in writing. If XxxxXxxx decides to advance the Collaboration Program to [***], ArriVent shall make the payment for the [***] pursuant to Section 6.2.1.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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3.7.3 If, upon completion of the [***] for the Collaboration Program, XxxxXxxx decides not to advance the Collaboration Program to [***], ArriVent may terminate the Collaboration Program. If XxxxXxxx decides to advance the Collaboration Program to [***], ArriVent shall make the payment for the [***] pursuant to Section 6.2.1.
3.7.4 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver all Data Packages and deliverables required under the [***] to ArriVent. ArriVent shall have the sole discretion to decide whether or not to advance any Collaboration Compound and which Collaboration Compound(s) will be advanced for further studies beyond the [***]. ArriVent shall inform Xxxxxx of its decision in writing.
3.7.5 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver all Data Packages and deliverables required under the [***] to ArriVent.
3.7.6 Within [***] ([***]) days after completion of the [***], Aarvik shall deliver to ArriVent a full report on all key results and findings of the Collaboration Program, and such other data, results and information as ArriVent may deem necessary for it to determine whether or not to exercise the Option (the “Full Report”).
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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ARTICLE 4
DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION
4.2 Development Key Milestones.
4.2.1 Subject to terms and conditions hereof, ArriVent will use Commercially Reasonable Efforts to (a) file an IND with respect to a Product within twenty-four (24) months after completion of the Initial Transfer; and (b) initiate a Phase 2 Clinical Trial within (24) months after completion of a Phase 1 Clinical Trial or a Phase 2b Clinical Trial within twenty-four (24) months after completion of a combined Phase 1/2 a Clinical Trial (the “Key Milestones”). Subject to Aarvik’s prior written consent (not to be unreasonably withheld, conditioned or delayed), any of the foregoing timelines may be extended for scientific, technical or regulatory reason, force majeure event as set forth in Section 13.6, reason not attributable to ArriVent or any other relevant reason (whether or not the same kind of reason as or similar to those aforementioned). The Parties hereby agree that ArriVent will not be deemed to be in breach of its obligations under this Section 4.2 to the extent it is prevented from or delayed in using Commercially Reasonable Efforts to perform an activity as a result of the acts or omissions of Aarvik, including Aarvik’s breach of any of its obligations under this Agreement or failure to timely perform its obligations under this Agreement. If XxxxXxxx fails to timely achieve a Development Key Milestone as a result of Aarvik’s failure to timely perform any of its obligations under this Agreement, then the deadlines for the applicable Key Milestones will be extended to commensurate with the delay caused by Aarvik. For the purposes of this Agreement, a clinical trial is deemed to be completed upon generation of a clinical study report (CSR) for such clinical trial.
4.2.2 If ArriVent fails to use Commercially Reasonable Efforts to achieve the Key Milestones for the Target Pair in accordance with the timeline, as may be extended, ArriVent will assign back to Aarvik the right to the Collaboration IP related to the Target Pair that Aarvik assigned to ArriVent pursuant to Section 7.1.2(b), following which Aarvik will solely own such Collaboration IP related to the Target Pair. Notwithstanding anything to the contrary contained in this Agreement, such assignment will be Xxxxxx’s sole and exclusive remedy for any failure of ArriVent to use Commercially Reasonable Efforts to achieve the Key Milestones.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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ARTICLE 5
LICENSES AND EXCLUSIVITY
5.1 Licenses from Aarvik to ArriVent. Aarvik hereby grants to ArriVent, effective as of the date on which ArriVent exercises the Option, an exclusive (even as to Aarvik), sub-licensable license under the Aarvik IP for the Research, Development, Manufacture, use, Commercialization or other Exploitation of the ADCs related to the Target Pair in the Field in the Territory. Such license shall apply to no other use or purpose by ArriVent or its Sublicensees. Notwithstanding anything in this Agreement to the contrary, but subject to the restrictions set forth in Section 5.4 below, Aarvik shall be entitled to freely use all payloads and linker-payloads utilized in connection with the Products for any and all other purposes.
(a) before the end of the Option Period or ArriVent’s exercise of the Option for the Collaboration Program (whichever the earlier), Aarvik shall not, and shall cause its Affiliates not to, directly or indirectly, by itself or with, through or in collaboration with any Third Party, whether through license, assignment, joint venture, investment or otherwise (including via any arrangement or series of arrangements with a Third Party), Research, Develop, use, Manufacture or Commercialize (i) any ADC against the Target Pair of the Collaboration Program, or any product containing such ADC, or (ii) [***], or any product containing such ADC, in each case of (i) and (ii), other than pursuant to this Agreement; and
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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(b) in the event that ArriVent exercises the Option with respect to the Collaboration Program pursuant to Section 3.9, before the end of the Term, Aarvik shall not, and shall cause its Affiliates not to, directly or indirectly, by itself or with, through or in collaboration with any Third Party, whether through license, assignment, joint venture, investment or otherwise (including via any arrangement or series of arrangements with a Third Party), Research, Develop, use, Manufacture or Commercialize (i) any ADC against the Target Pair of the Collaboration Program, or any product containing such ADC, or (ii) [***], or any product containing such ADC.
5.6 [***].
5.6.1 Payments to [***]. After ArriVent exercises the Option with respect to the Collaboration Program pursuant to Section 3.9, in addition to the costs for the manufacture and supply of the applicable materials (if any) to be paid to [***], ArriVent shall be solely responsible to [***] for, and shall promptly discharge, the royalty of [***]% of the annual net sales of the Products under section 2.2(c) of the [***] (if applicable).
5.6.2 [***]. Aarvik hereby represents, warrants and covenants that Aarvik is entitled to exercise the [***] with respect to the Collaboration Program. Aarvik hereby assigns the [***] with respect to the Collaboration Program to ArriVent (it being understood that Aarvik shall no longer have the right to exercise the [***] with respect to the Collaboration Program and ArriVent may exercise the [***] with respect to the Collaboration Program by serving a written notice to [***] directly at any time). For clarity, such option shall not apply to any program other than the Collaboration Program hereunder, and any exercise of such option shall not preclude Aarvik from exercising any option with [***] for any program other than the Collaboration Program or utilizing payload and linkers used in the Collaboration Program for any program other than the Collaboration Program. ArriVent hereby covenants that it will not exercise the [***] with respect to the Collaboration Program unless and until it exercises the Option with respect to the Collaboration Program in accordance with Section 3.9 of this Agreement. Upon ArriVent’s exercise of the [***] with respect to the Collaboration Program pursuant to section 2.2(c) of the [***], Aarvik shall (and/or cause [***] to, as the case may be) (a) immediately transfer all Manufacturing Know-How related to the Collaboration Program directly to ArriVent or its designee(s), and (b) enter into a manufacturing technology transfer agreement with ArriVent, pursuant to which Aarvik and/or [***] (as the case may be) shall provide, at ArriVent’s cost, such support and assistance as ArriVent may request, in each of (a) and (b) above, in order for ArriVent or its designee(s) to Manufacture the relevant Compounds and Products in substantially the same manner as [***] Manufactures such Compounds and Products.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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5.6.3 Supply for Registration Trial or Commercial Use. Aarvik shall ensure that if ArriVent exercises the [***] with respect to the Collaboration Program, ArriVent shall have the right to Manufacture, or have Manufactured by any of its Affiliate or any Third Party, any and all Compounds (including any component thereof) and Products within the Collaboration Program for commercial use or for use in any Phase 3 Clinical Trial or Registration Trial (whether or not denominated a “Phase 3” clinical trial under applicable regulations).
5.6.4 Manufacturing Criteria. Aarvik represents, warrants and covenants that if [***] fails to demonstrate that it has met all the Manufacturing Criteria (as defined in the [***] Agreement) and such other terms to be defined in a Quality agreement between ArriVent and [***] in advance with respect to any of the Compounds or Products within the Collaboration Program no later than [***] ([***]) months prior to the date on which ArriVent intends to file the first IND with respect to the Collaboration Program to any Regulatory Authority: (a) the license granted to ArriVent under Section 5.1 of this Agreement shall automatically include all Manufacturing rights with respect to the ADCs (including any component thereof) related to the Target Pair of the Collaboration Program; (b) following ArriVent’s exercise of the Option for the Collaboration Program pursuant to Section 3.9 of this Agreement, ArriVent shall have the right to Manufacture, or have Manufactured by any of its Affiliate or any Third Party, any and all Compounds (including any component thereof), Products and other materials within the Collaboration Program for any purpose; and (c) ArriVent shall not be required to pay [***] the royalty of [***]% of the annual net sales of the Products under section 2.2(c) of the [***]. In addition, if [***] fails to demonstrate that it has met all the Manufacturing Criteria as described above, then following ArriVent’s exercise of the Option for the Collaboration Program pursuant to Section 3.9 of this Agreement, Aarvik shall (and/or shall cause [***] to, as the case may be) immediately transfer all Manufacturing Know-How related to the Collaboration Program and enter into a manufacturing technology transfer agreement in accordance with the last sentence of Section 5.6.2 of this Agreement. Xxxxxx further agrees and covenants that it will share fully and timely with ArriVent all information related to whether [***] has satisfied the Manufacturing Criteria. In the event ArriVent does not agree that [***] has satisfied the Manufacturing Criteria, Aarvik shall cause [***] to agree to select a third party arbitrator that is approved by XxxxXxxx to decide on whether [***] has satisfied the Manufacturing Criteria. If [***] has satisfied the Manufacturing Criteria with respect to the Compounds and Products within the Collaboration Program before [***] ([***]) months prior to the date on which ArriVent intends to file the first IND with respect to the Collaboration Program to any Regulatory Authority, ArriVent will purchase such Compounds or Products manufactured by [***] for use in any Phase 1 Clinical Trial or Phase 2 Clinical Trial (as long as such Phase 2 Clinical Trial is not a Registration Trial).
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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5.6.5 Materials Supplied by [***]. Aarvik hereby agrees that XxxxXxxx may enter into agreement(s) with [***] directly in connection with the Manufacture and supply, quality and other matters of any materials to be Manufactured by or on behalf of [***] and supplied to ArriVent.
6.2.1 Aarvik may not invoice ArriVent and ArriVent will not be required to pay the research fee for the [***] (US$[***] x [***]% = US$[***]) for the Collaboration Program until ArriVent informs Aarvik in writing that it decides to proceed to the [***] in accordance with Section 3.7.2 or 3.7.3;
6.2.2 Subject to the rest of this Agreement (including Section 3.7.3), the total amount of research fees for [***] shall not exceed the amounts listed in Exhibit B (which assumes two lead antibodies are required to be used to generate the tetravalent antibody), plus [***]% overhead. If more than two lead antibodies are required to be used to generate the tetravalent antibody, then ArriVent will further pay to Aarvik the additional expenses actually incurred by Aarvik (plus [***]% overhead) to obtain such additional antibody(ies), provided that Aarvik shall submit to the JRC details regarding such additional costs for discussion in the JRC and for ArriVent’s approval. Subject to the rest of this Agreement (including Section 3.7.3), for each [***], ArriVent will pay to Aarvik the expenses (other than the costs as set forth in Section 6.2.3) actually incurred for such SOW, plus [***]% overhead, which shall not exceed the amount pre-approved by ArriVent prior to the commencement of such SOW pursuant to this Section 6.2.2. The research fee for each [***], as set forth in Exhibit B hereto is the estimated research fee calculated based on expected expenses for such SOW, plus [***]% overhead. In the event the actual expenses for a [***] are anticipated to exceed the applicable amount set forth on Exhibit B hereto, then Aarvik shall (when submitting the applicable SOW to ArriVent pursuant to Section 3.4.1 above) submit to the JRC details regarding such additional costs for discussion in the JRC and for ArriVent’s approval prior and as a condition to commencement of work under such SOW. No later than [***] ([***]) days after completion of each [***], Aarvik will provide ArriVent with a report setting forth in reasonable detail all expenses actually incurred by Aarvik for such SOW, and all documented evidence (including Third Party invoices related thereto). In the event that the sum of all expenses actually incurred by Aarvik for such [***] plus [***]% overhead is less than the amount of research fee ArriVent paid for such SOW prior to the commencement thereof, then such overpayment will be credited against future research fees payable by ArriVent to Aarvik for the subsequent SOWs, or, if no further research fees are to be paid to Aarvik under this Agreement, Aarvik shall promptly repay such overpayment; provided that, if Aarvik completes [***] and delivers all Data Packages and deliverables required thereunder in accordance with Section 3.7, the sum of all research fees payable by ArriVent under this Agreement will not be less than the sum of all estimated research fees as set forth in Exhibit B as of the Effective Date (i.e., US$[***]).
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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6.2.3 In addition to the research fees set forth in Section 6.2.2, ArriVent shall reimburse Aarvik for any costs actually incurred by Aarvik to procure such amount of [***] (as defined in the [***]) (e.g., materials, shipping and handling, etc.) as Aarvik will actually use in performing the activities under the applicable SOWs; provided that Aarvik shall provide ArriVent with an estimate of such costs for ArriVent’s approval prior to procuring such materials from [***], and the total reimbursement amount under this Section 6.2.3 shall not exceed the amount pre-approved by XxxxXxxx.
6.4 Milestone Payments by XxxxXxxx.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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Milestone Events | Milestone
Payments (in US Dollars) |
1. [***] | $[***] |
2. [***] | $[***] |
3. [***] | $[***] |
Total milestone payments for the Target Pair | $[***] |
Milestone Events | Milestone
Payments (in US Dollars) |
1. The aggregate amount of annual Net Sales of a Product in the Field worldwide first exceeds [***] US Dollars (US$[***]) | $[***] |
2. The aggregate amount of annual Net Sales of a Product in the Field worldwide first exceeds [***] US Dollars (US$[***]) | $[***] |
3. The aggregate amount of annual Net Sales of a Product in the Field worldwide first exceeds [***] US Dollars (US$[***]) | $[***] |
Total milestone payment per Product | $[***] |
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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6.5 Royalty Payments by XxxxXxxx.
Net Sales of Product | Royalty Rate |
1. The portion of annual Net Sales of a Product equal to or greater than US$[***] but less than US$[***] | [***]% |
2. The portion of annual Net Sales of a Product equal to or greater than US$[***] but less than US$[***] | [***]% |
3. The portion of annual Net Sales of a Product equal to or greater than US$[***] | [***]% |
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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6.6 Financial Records and Audit Rights.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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ARTICLE 7
INTELLECTUAL PROPERTY
7.1 Inventorship; Ownership; Collaboration Compounds.
(b) Assignment of Collaboration IP to ArriVent. Effective as of the date on which ArriVent exercises the Option for the Collaboration Program, Aarvik shall assign, for itself and on behalf of its Affiliates, and hereby assigns to ArriVent all their right, title and interest in and to the Collaboration IP with respect to the Collaboration Program.
(c) If XxxxXxxx fails to exercise the Option for the Collaboration Program before the expiration of the Option Period, then Aarvik may grant any Third Party a license under the applicable Collaboration IP for the development and/or commercialization of any compound or product.
(d) If ArriVent fails to use Commercially Reasonable Efforts to achieve the applicable Key Milestones after its exercise of the Option for the Collaboration Program and, as a result, Aarvik regains its ownership interest in such Collaboration IP in accordance with Section 4.2.2, then Aarvik may grant any Third Party a license under such Collaboration IP for the development and/or commercialization of any compound or product.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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7.2 Patent Prosecution and Maintenance.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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ARTICLE 8
CONFIDENTIALITY
8.1.1 is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party;
8.1.2 can be demonstrated by documentation or other competent proof to have been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information;
8.1.3 is subsequently received by the receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information;
8.1.4 has been published by a Third Party or otherwise enters the public domain through no fault of the receiving Party in breach of this Agreement; or
8.1.5 has been independently developed or acquired by the receiving Party or any of its Affiliates without the aid, application or use of the disclosing Party’s Confidential Information.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
8.2.1 made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for an approval or authorization of a Product; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information to the extent practicable and consistent with Applicable Law;
8.2.2 made by or on behalf of the receiving Party in response to a valid order of a Governmental Authority of competent jurisdiction or, if in the reasonable opinion of the receiving Party’s legal counsel, such disclosure is otherwise required by Applicable Law (including, for clarity, any disclosure required by Applicable Law on xxxxxxxxxxxxxx.xxx or disclosure required by reason of filing with securities regulators); provided, however, that the receiving Party shall first have given notice to the disclosing Party and given the disclosing Party (a) a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of any such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued and (b) a right to review and comment upon such disclosure, which comments shall be considered in good faith by the receiving Party; and provided further that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;
8.2.3 made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining, enforcing or defending a Patent pursuant to the terms of this Agreement in a manner not inconsistent with Article 7; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available;
8.2.4 made by the receiving Party or its Affiliates, Sublicensees or subcontractors to its or their attorneys, auditors, advisors, consultants or contractors; provided, however, that such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Article 8 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [***] ([***]) years from the date of disclosure);
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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8.2.5 made by or on behalf of the receiving Party where such disclosure is required by a Regulatory Authority (including in filings with the Securities and Exchange Commission or other agency) of certain material developments or material information generated under this Agreement, or the terms of this Agreement, and agrees that each Party may make such disclosures as required by Applicable Law; provided that, to the extent permitted, the Party seeking such disclosure first provides the other Party a copy of the proposed disclosure; and provided, further, that the receiving Party shall afford to the other Party an opportunity to review and comment, which period shall be no less than [***] ([***]) Business Days, including to propose redactions to the terms of this Agreement, and the receiving Party shall accept any reasonable comments so provided; or
8.2.6 made by the receiving Party to potential or actual investors, acquirors, collaborators, business partners, licensees/Sublicensees, legal or financial advisors; provided, however, that such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Article 8 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [***] ([***]) years from the date of disclosure).
8.5.1 Aarvik shall not, without the prior written consent of XxxxXxxx, publish any papers or make any oral presentations or otherwise disclose publicly or to any collaborator (such papers, oral presentations and disclosures, including abstracts of any of the foregoing, “Publications”): (a) any Confidential Information of ArriVent, (b) any information related to any Target, Compound or Product of the Collaboration Program before the expiration of the Option Period therefor, or (c) the results of or any other information regarding activities pursuant to the Collaboration of the Collaboration Program before the expiration of the Option Period therefor, in each case, except as required by Applicable Law, in which case Section 8.2.2 shall apply.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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8.5.2 Subject to Section 8.5.3, (a) Aarvik may make Publications relating specifically and exclusively to the Aarvik’s proprietary ADC drug discovery platform (excluding the information set forth in Section 8.5.1); (b) ArriVent may, in its discretion, make Publications regarding any Target, Compound, Product or any activities pursuant to the Collaboration after ArriVent exercises the Option for the Collaboration Program (excluding information specifically and exclusively to Aarvik’s proprietary ADC drug discovery platform), provided that Aarvik’s advance review and written approval shall be required with respect to publications of any data generated within the Collaboration (i.e., data generated prior to ArriVent’s exercise of the Option for the Collaboration Program); and (c) if ArriVent elects not to exercise the Option, Aarvik may, in its discretion, make Publications regarding any Target, Compound or any activities pursuant to the Collaboration of the Collaboration Program after the expiration of the Option Period.
8.5.3 At least [***] ([***]) days prior to publishing any Publication, the publishing Party shall provide the other Party with a draft copy thereof for its review. The publishing Party shall consider in good faith any comments provided by the other Party during such [***] ([***])-day period. In addition, the publishing Party shall, at the other Party’s reasonable request, remove therefrom any Confidential Information of the other Party. The contribution of each Party shall be noted in all publications or presentations by acknowledgment or co-authorship, whichever is appropriate.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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ARTICLE 9
REPRESENTATIONS, WARRANTIES AND COVENANTS
9.1.1 it is duly organized and validly existing under the Applicable Laws of the jurisdiction of its incorporation, and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
9.1.2 it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate action;
9.1.3 this Agreement is legally binding upon it and enforceable in accordance with its terms. To the Party’s knowledge, the execution, delivery and performance of this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material Applicable Law;
9.1.4 it is not aware of any action, suit or inquiry or investigation instituted by any Person which questions or threatens the validity of this Agreement; and
9.1.5 in the performance of its obligations under this Agreement, it shall comply and shall cause its and its Affiliates’ employees and contractors to comply with all Applicable Laws, rules and regulations, including all export control, anti-corruption and anti-bribery laws and regulations, and shall not cause such other Party’s Indemnitees to be in violation of any Applicable Laws or otherwise cause any reputational harm to such other Party.
9.2.1 Aarvik Controls the Aarvik IP, and no Third Party has any right, interest or claim in or to such rights that would limit the rights granted to ArriVent under this Agreement;
9.2.2 Aarvik IP includes all Patents and Know-How licensed to Aarvik or any of its Affiliates under the Existing In-License Agreements;
9.2.3 except Aarvik IP, Aarvik or its Affiliates do not own or Control any further Patents or Know-How that is necessary or useful for the research, Development, Manufacture, use or Commercialization of any Compound or Product in the Field;
9.2.4 Aarvik is the sole and exclusive owner or licensee of the entire right, title and interest in the Aarvik IP and such Aarvik IP are free of any encumbrance, lien, or claim of ownership by any Third Party;
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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9.2.5 Aarvik is entitled to grant the licenses pursuant to Section 5.1 and assign to ArriVent the right, title and interest in the Collaboration IP pursuant to Section 7.1.2(b) and it has not granted, and shall not grant during the Term, any Third Party rights and has not taken, and shall not take during the Term, any other action which would be inconsistent or interfere with ArriVent’s rights hereunder;
9.2.6 to the extent any Aarvik IP are in-licensed, Aarvik has not received any notice alleging that it is in material breach of any term of such in-license agreement, and covenants, during the Term, that it (a) shall use Commercially Reasonable Efforts not to commit any acts or permit the occurrence of any omissions that would cause a material breach or the termination of any in-license agreement, and (b) shall not amend or otherwise modify or permit to be amended or modified any in-license agreement in such a manner as could materially adversely affect XxxxXxxx’s rights hereunder;
9.2.7 there is no legal action by any Third Party (and Aarvik is not aware of any grounds therefor), and Aarvik and its Affiliates have not received any written claim or demand, alleging that (a) any Intellectual Property Rights of a Third Party would be infringed by the Compounds, the Products, or the use of Aarvik IP under this Agreement; or (b) any Intellectual Property Rights licensed by Aarvik to ArriVent under this Agreement are not valid or subsisting;
9.2.8 to the best of Aarvik’s knowledge and its Affiliates, no Third Party is infringing or misappropriating any Aarvik IP;
9.2.9 there are no settled, pending or threatened Third Party opposition or interference proceedings, nor any litigation or claim with respect to the Aarvik Patents;
9.2.10 Aarvik and its Affiliates have, to the extent any of them have disclosed Aarvik Know-How to a Third Party, done so pursuant to non-disclosure or confidentiality agreements and have otherwise taken commercially reasonable measures consistent with industry practices to protect the secrecy, confidentiality and value of Aarvik Know-How, and to Aarvik’s knowledge, there has not been any misappropriation of Aarvik Know-How by any Third Party;
9.2.11 it has obtained or shall obtain written agreements from each of its employees, consultants and contractors who perform Collaboration and other activities pursuant to this Agreement, which agreements shall obligate such persons to obligations of confidentiality and non-use and to assign Inventions in a manner consistent with the provisions of this Agreement;
9.2.12 neither it nor any of its or its Affiliates’ employees or agents performing under this Agreement has ever been, or is currently: (a) debarred under 21 U.S.C. § 335a or by any Regulatory Authority; (b) excluded, debarred, suspended, or otherwise ineligible to participate in federal health care programs or in federal procurement or non-procurement programs; (c) listed on the FDA’s Disqualified and Restricted Lists for clinical investigators; or (d) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible. Aarvik further covenants that if, during the Term of this Agreement, it becomes aware that it or any of its or its Affiliates’ employees or agents performing under this Agreement is the subject of any investigation or proceeding that could lead to it becoming a debarred entity or individual, an excluded entity or individual or a convicted entity or individual, it will promptly notify ArriVent. This provision will survive termination or expiration of this Agreement; and
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9.2.13 (a) except for [***], neither Aarvik nor any of its Affiliates, on the one hand, is party to an agreement with any Third Party, on the other hand, pursuant to which Aarvik or its Affiliate has (i) in-licensed any Patents or Know-How that are included as part of the Aarvik IP or (ii) agreed to provisions that would require ArriVent to undertake or observe any restrictions or obligations with respect to the Research, Development, Manufacture, use, Commercialization or other Exploitation of the ADCs related to any Target Pair in the Field in the Territory; (b) the [***] is in full force and effect and has not been amended, modified or waived; and (c) a redacted copy of the fully executed [***] has been provided to ArriVent prior to the Effective Date and the redacted provisions thereunder are irrelevant to and unnecessary for ArriVent to ascertain ArriVent’s rights and obligations under this Agreement or the [***] as a sublicensee thereunder. Aarvik hereby covenants not to enter into any amendment to the [***] that might affect ArriVent’s rights or obligations under this Agreement or the [***] in any respect and it will provide ArriVent with a copy of any amendment to the [***] within [***] ([***]) days after execution thereof; provided that Aarvik may redact the provisions in the amendment that are irrelevant to or unnecessary for ArriVent to ascertain its rights and obligations under this Agreement or the [***].
ARTICLE 10
INDEMNIFICATION
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ARTICLE 11
TERM AND TERMINATION
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11.6 Limitations on Termination Remedy.
11.6.1 Notwithstanding anything herein to the contrary, in the event that this Agreement is terminated with respect to a Target Pair, Compound or Product pursuant to (a) Section 11.2 for a jurisdiction or (b) Section 11.3 to the extent the material breach affects only a specific jurisdiction, then this Agreement may only be terminated for such Target Pair, Compound or Product in such jurisdiction.
11.6.2 For avoidance of doubt, any termination under this Article 11 with respect to a particular Target Pair, Compound or Product or jurisdiction shall have no effect on and shall not in any way limit the licenses granted under this Agreement for any other Target Pair, Compound or Product or any other jurisdiction.
11.7.1 The Parties intend to take advantage of the protections of Section 365(n) (or any successor provision) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction to the maximum extent permitted by Applicable Law. All rights and licenses granted under or pursuant to this Agreement, but only to the extent they constitute licenses of a right to “intellectual property” as defined in Section 101 of the U.S. Bankruptcy Code or in any analogous provisions in any other country or jurisdiction (as the case may be) shall be deemed to be “intellectual property” for the purposes of Section 365(n) or any analogous provisions in any other country or jurisdiction (as the case may be). The Parties shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, including the right to obtain the intellectual property from another entity.
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11.7.2 In the event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the Party that is not subject to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropriate) all such intellectual property (including all embodiments of such intellectual property), which, if not already in the non-subject Party’s possession, shall be promptly delivered to it upon the non-subject Party’s written request (i) upon commencement of a bankruptcy proceeding, unless the Party subject to such proceeding continues to perform all of its obligations under this Agreement, or (ii) if not delivered pursuant to clause (i) above because the subject Party continues to perform, upon the rejection of this Agreement by or on behalf of the subject Party.
11.7.3 Unless and until the subject Party rejects this Agreement, the subject Party shall perform this Agreement or provide the intellectual property (including all embodiments of such intellectual property) to the non-subject Party, and shall not interfere with the rights of the non-subject Party to such intellectual property, including the right to obtain the intellectual property from another entity.
11.7.4 The Parties acknowledge and agree that payments made under Section 6.2, 6.3 or 6.4 are not intended to be and shall not (i) constitute royalties within the meaning of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction or (ii) relate to licenses of intellectual property hereunder.
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ARTICLE 12
DISPUTE RESOLUTION
12.3 Arbitration. Any dispute, controversy or claim arising under, out of or relating to this contract and any subsequent amendments of this contract, including, without limitation, its formation, validity, binding effect, interpretation, performance, breach or termination, as well as non-contractual claims, shall be referred to and finally determined by arbitration in accordance with the Rules of Arbitration of the International Chamber of Commerce. The arbitral tribunal shall consist of three arbitrators. The place of arbitration shall be New York, the United States. The language to be used in the arbitral proceedings shall be English.
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ARTICLE 13
MISCELLANEOUS
13.1 Governing Law. This Agreement (and any claims or disputes arising out of or related thereto or to the transactions contemplated thereby or to the inducement of any party to enter therein, whether for breach of contract, tortious conduct, or otherwise, and whether predicated on common law, statute, or otherwise) shall in all respects be governed by and construed in accordance with the laws of the State of New York, including all matters of construction, validity and performance, in each case without reference to any conflict of law rules that might lead to the application of the laws of any other jurisdiction.
If to Aarvik, addressed to: | Aarvik
Therapeutics, Inc. Attention: Xxxxxx Xxxxx Xxxxxxxx, CEO Address: 00000 Xxxxxxxxx Xxxxx Xxxxxxx, XX 00000 Facsimile: |
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With a copy to: | Fox
Rothschild LLP Attention: Xxxxxxxx Xxxxxx, Esq. 000 Xxxxxxxxxxxx Xxxxx, Xxxxx 000 Xxxxx, XX 00000-0000 Telephone: [***] Facsimile: [***] | |
If to ArriVent, addressed to | ArriVent
Biopharma, Inc. Attention: Xxxxxxxx Xxx Address: 00 Xxxxxx Xxxx Xxxxx 000 Xxxxxxx Xxxxxx, XX 00000-0000 Telephone: Facsimile: | |
With copies to: | ArriVent Biopharma, Inc.
Xxxxxxx
Procter (Hong Kong) LLP |
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IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their duly authorized representatives as of the Effective Date.
AARVIK THERAPEUTICS, INC. | ARRIVENT BIOPHARMA, INC. | |||||
By: | /s/Xxxxxx Xxxxx Xxxxxxxx, Ph.D. | By: | /s/ Xxxxxxxx Xxx, Ph.D. | |||
Name: | Xxxxxx Xxxxx Xxxxxxxx, Ph.D. | Name: | Xxxxxxxx Xxx, Ph.D. | |||
Title: | Co-founder, President & CEO | Title: | CEO and Chairman |
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EXHIBIT A
TARGET PAIR
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EXHIBIT B
SUMMARY OF WORK ITEMS AND RESEARCH EXPENSES
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EXHIBIT C
JOINT RESEARCH COMMITTEE MEMBERS
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EXHIBIT D
STATEMENT OF WORK (SOW)
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AMENDMENT NO. 1 TO RESEARCH COLLABORATION AGREEMENT
THIS AMENDMENT NO. 1 TO RESEARCH COLLABORATION AGREEMENT (this “Amendment”) is effective as of June 30, 2023 (the “Effective Date”) by and between Aarvik Therapeutics, Inc., a company incorporated in Delaware, having a place of business at 00000 Xxxxxxxxx Xxxxx, Xxxxxxx, XX 00000 (“Aarvik”), and ArriVent Biopharma, Inc., a company incorporated in Delaware, with offices located at 00 Xxxxxx Xxxx., Xxxxx 000, Xxxxxxx Xxxxxx, XX 00000-0000 (“ArriVent”). XxxxXxxx and Aarvik are referred to herein individually as a “Party” or, collectively, as the “Parties.”
WHEREAS, Aarvik and XxxxXxxx are parties to that certain Research Collaboration Agreement dated December 21, 2021 (the “Agreement”); and
1. Incorporation of Background; Capitalized Terms. The “Background” provisions set forth above, together with the defined terms therein, are incorporated herein by reference. Capitalized terms not otherwise defined herein shall have the meanings given to such terms in the Agreement.
2. Amendment. Exhibit B to the Agreement is hereby amended and restated in its entirety as set forth on Exhibit B attached hereto.
3. Amendments to Section 6.2. The amounts of the research fees set forth in Sections 6.2.1, 6.2.2 and 6.2.3 of the Agreement are hereby amended to be consistent with the applicable amounts as set forth in Exhibit B attached hereto. For purposes of clarity, all other terms and conditions set forth in Sections 6.2.1, 6.2.2 and 6.2.3 of the Agreement shall remain unchanged and in full force and effect.
4. No Other Amendments. All provisions of the Agreement not expressly amended by this Amendment shall remain in full force and effect, and are ratified and confirmed.
5. Counterparts. This Amendment may be executed in counterparts, each of which shall be deemed an original and all of which, taken together, shall constitute one and the same instrument. An electronic or faxed signed copy of this Amendment shall have the same force and effect as an original signed copy.
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6. Governing Law. This Amendment shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, without giving effect to principles of conflicts of law.
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IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their duly authorized representatives as of the Effective Date.
AARVIK THERAPEUTICS, INC. | ARRIVENT BIOPHARMA, INC. | |||
By: | /s/ Xxxxxx Xxxxx Xxxxxxxx | By: | /s/ Xxxxxx Xxxxxxx | |
Name: | Xxxxxx Xxxxx Xxxxxxxx | Name: | Xxxxxx Xxxxxxx | |
Title: | President & CEO | Title: | CMO and President |
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EXHIBIT B
SUMMARY OF WORK ITEMS AND RESEARCH EXPENSES
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