COLLABORATION AND LICENSE AGREEMENT
Exhibit 10.3
COLLABORATION AND LICENSE AGREEMENT
by and between
Kiniksa Pharmaceuticals (UK), Ltd.
and
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Dated as of February 21, 2022
[**] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(a)(6)
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10)(iv). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
CONFIDENTIAL
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TABLE OF CONTENTS
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Schedules
Schedule 1.58Existing In-Licenses
Schedule 1.106Kiniksa Patent Rights
Schedule 2.2.3Preapproved Subcontractors
Schedule 5.2Territory Development Plan
Schedule 5.3Global Development Plan
Schedule 11.7.1(a) Kiniksa Press Release
Schedule 11.7.1(b) Partner Press Release
Schedule 12.3 Partner Disclosures
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COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (this “Agreement”) is made as of February 21, 2022 (the “Effective Date”) by and between Kiniksa Pharmaceuticals (UK), Ltd., a United Kingdom corporation (“Kiniksa”), having a place of business at Third Floor, 00 Xxx Xxxx Xxxxxx, Xxxxxx, Xxxxxx Xxxxxxx, X0X 0XX, and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd (“Partner”), having a place of business at Xx. 000 Xxxxxxxxx Xxxx, XxxxXxx Xxxxxxxx, Xxxxxxxx Xxxx, Xxxxxxxxx Province, People’s Republic of China. Kiniksa and Partner are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”
Recitals
WHEREAS, Kiniksa, including its Affiliates, is a biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need, including mavrilimumab;
WHEREAS, Kiniksa Controls certain Know-How and Patent Rights relating to such product;
WHEREAS, Partner is a pharmaceutical company engaged in the research, development, and commercialization of pharmaceutical and biologic products in the greater China region; and
WHEREAS, Partner wishes to obtain from Kiniksa an exclusive license to perform Clinical Development of, perform Medical Affairs for, and Commercialize the Licensed Product in the Territory and a non-exclusive license to Manufacture, and to have Manufactured, the Licensed Product in the Territory, and Kiniksa is willing to grant such licenses to Partner, as such terms are defined herein and all in accordance with the terms and conditions set forth herein.
Agreement
NOW, THEREFORE, the Parties hereby agree as follows:
Unless specifically set forth to the contrary herein, the following terms will have the respective meanings set forth below, whether used in the singular or plural:
1.1“Accounting Standards” means GAAP or IFRS (as applicable to a Party).
1.2“Acquired Party” has the meaning set forth in Section 2.7.3 (Business Combinations).
1.3“Affiliate” means, with respect to a Person, any other Person that controls, is controlled by, or is under common control with such Person. For the purpose of this definition only, “control” (including, with correlative meaning, the terms “controlled by” and “under the common control”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of any Person, whether by the ownership of more than 50% of the voting security of such Person, by contract or otherwise. The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than 50%, and that in such case such lower percentage will be substituted in the preceding sentence; provided that such foreign investor has the power to direct the management and policies of such entity. Notwithstanding the foregoing, neither Xxxxx Brothers Advisors nor any other financial investor (excluding a financial investor that is the
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investment entity of a pharmaceutical or biotechnology company), nor any funds affiliated with Xxxxx Brothers Advisors or entities controlled by Xxxxx Brothers Advisors or any other financial advisor (excluding a financial investor that is the investment entity of a pharmaceutical or biotechnology company) will be considered an Affiliate of Kiniksa.
1.4“Agreement” has the meaning set forth in the Preamble.
1.6“Anti-Corruption Laws” means all local or other laws prohibiting or regulating public or private-sector corruption, bribery, kickbacks, speed or facilitation payments, ethical business conduct, money laundering, embezzlement, political contributions, gifts, gratuities, expenses, entertainment, hospitalities, agency relationships, commissions, lobbying, books and records, and financial controls, including the United States Foreign Corrupt Practices Act, the U.S. Travel Act, the UK Xxxxxxx Xxx 0000, and other anti-corruption laws, in each case, as amended.
1.7“Applicable Law” means collectively all laws, rules, regulations, ordinances, decrees, judicial and administrative orders (and any license, franchise, permit, or similar right granted under any of the foregoing), and any policies and other requirements of any applicable Governmental Authority that govern or otherwise apply to a Party, including all Anti-Corruption Laws.
1.8“Approved Labeling” means, with respect to the Licensed Product: (a) the Regulatory Authority-approved full prescribing information for the Licensed Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for the Licensed Product.
1.9“Assigned Collaboration Know-How” means any Collaboration Know-How developed or invented by Representatives of Partner or its Affiliates or its or their licensees (other than Kiniksa), Sublicensees, or Subcontractors, or any Persons contractually required to assign or license such Collaboration Know-How to Partner or any Affiliate of Partner, whether alone or jointly with others (including jointly with Kiniksa), that (a) is directed to (i) [***] (ii) [***] or (iii) [***]
1.10“Assigned Collaboration Patent Rights” means all Collaboration Patent Rights that Cover Assigned Collaboration Know-How.
1.11“Assigned Collaboration Technology” means the Assigned Collaboration Know-How and the Assigned Collaboration Patent Rights.
1.12“Biosimilar Competition” means, with respect to a Biosimilar Product in a country or region in the Territory and particular Calendar Quarter following the Biosimilar Launch Quarter for such Biosimilar Product in such country or region, the decrease in the Net Sales in such country or region for the Licensed Product during the applicable Calendar Quarter, as compared to the average quarterly Net Sales of the Licensed Product in such country or region during the four Calendar Quarters immediately preceding such Biosimilar Launch Quarter.
1.13“Biosimilar Launch Quarter” means, with respect to a Biosimilar Product to the Licensed Product in a country or region in the Territory, the Calendar Quarter in which the First Commercial Sale of the applicable Biosimilar Product in such country or region occurred following the receipt of all necessary Regulatory Approvals from the applicable Regulatory Authorities in such country or region to market and sell such Biosimilar Product as a therapeutic product for one or more Indication included in the Approved Labeling for the Licensed Product in such country or region.
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1.14“Biosimilar Product” means, with respect to the Licensed Product in a particular country or region, after receipt of Regulatory Approval of the Licensed Product in such country or region, any other therapeutic drug product designated for human use that [***]
1.15“Breach Notification” has the meaning set forth in Section 15.2.2 (Termination for Material Breach).
1.16“Business Day” means a day other than a Saturday, Sunday, or a day on which banking institutions in Boston, Massachusetts, Beijing, China, or Hong Kong are required by Applicable Law to remain closed.
1.17“Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30, and December 31.
1.19“cGMP” means all current Good Manufacturing Practices and regulations applicable to the Manufacture of the Licensed Product that are promulgated by any applicable Regulatory Authority having jurisdiction over the Manufacture of the Licensed Product, including, as applicable, as promulgated under and in accordance with (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the International Conference on Harmonization’s Q7 Guideline, and (d) the equivalent Applicable Law in any relevant country or region, each as may be amended and applicable from time to time.
1.20“Change of Control” means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such Party, or if the percentage ownership of such Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than 50% of the total voting power of all of the then outstanding voting securities of such Party; (b) any merger, consolidation, recapitalization, or reorganization of such Party is consummated that would result in shareholders or equity holders of such Party immediately prior to such transaction owning 50% or less of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; (c) the shareholders or equity holders of such Party approve any plan of complete liquidation of such Party, or an agreement for the sale or disposition by such Party of all or substantially all of such Party’s assets, in each case, through one or more related transactions, other than to an Affiliate or pursuant to one or more related transactions that would result in shareholders or equity holders of such Party immediately prior to such transaction owning more than 50% of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; or (d) the sale or transfer to any Third Party, in one or more related transactions, of all or substantially all of such Party’s consolidated assets taken as a whole.
1.21“Clinical Development” has the meaning set forth in Section 1.48 (Development).
1.22“Clinical Supply Agreement” has the meaning set forth in Section 7.1.1 (Development Supply).
1.23“Clinical Trial” means any clinical trial in humans that is conducted in accordance with cGCP and is designed to generate data (a) under an IND, (b) to address a commitment or requirement under a Regulatory Approval or Reimbursement Approval (as applicable), or (c) to support an expansion of an Indication.
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1.25“Collaboration Know-How” means any Know-How developed or invented during the Term by Representatives of a Party or its Affiliates or its or their licensees, Sublicensees, or Subcontractors, or any Persons contractually required to assign or license such Know-How to a Party or any Affiliate of a Party, whether alone or jointly with Representatives of the other Party or its Affiliates or its or their licensees, Sublicensees, or Subcontractors, or any Persons contractually required to assign or license such Know-How to the other Party or any Affiliate of the other Party, in each case, in the performance of activities under this Agreement.
1.26“Collaboration Patent Right” means any Patent Right that (a) has a priority date after the Effective Date and (b) Covers any invention included in the Collaboration Know-How.
1.27“Collaboration Technology” means Collaboration Know-How and Collaboration Patent Rights.
1.28“Commercial Supply Agreement” has the meaning set forth in Section 7.1.2 (Commercial Supply).
1.29“Commercialization” means with respect to any product, any and all activities directed to the marketing, promotion, distribution, pricing, reimbursement, import, export, offering for sale, and sale of such product and interacting with Regulatory Authorities following receipt of Regulatory Approval in the applicable country or region for such product regarding the foregoing, including seeking and maintaining any required Reimbursement Approval, but excluding any activities directed to Manufacturing, Development, or Medical Affairs. “Commercialize,” “Commercializing,” and “Commercialized” will be construed accordingly.
1.30“Commercialization Plan” means, with respect to the Licensed Product, the written high-level strategic and tactical plans for the Commercialization activities for the Licensed Product to be conducted in the Territory that will be prepared and updated by or on behalf of Partner as provided in Section 9.2 (Commercialization Plan), and will include for the Licensed Product in each country or region in the Territory: (a) the general strategies for promoting, marketing, and distributing the Licensed Product, (b) pre-launch Commercialization activities and the expected date of First Commercial Sale, (c) the nature of promotional activities anticipated, (d) non-binding summary-level market and sales forecasts for the Licensed Product, (e) non-binding projection of Net Sales for the Licensed Product, (f) plans regarding distribution and supply chain management, and (g) reimbursement and pricing information.
1.31“Commercially Reasonable Efforts” means, with respect to the Exploitation of the Licensed Product by Partner, [***].
1.32“Competitive Activities” has the meaning set forth in Section 2.7.1 (Partner Exclusivity).
1.33“Competitive Infringement” has the meaning set forth in Section 14.4.2(a)(ii) (Kiniksa First Right).
1.34“Competitive Product” means any product, other than the Licensed Product, that [***].
1.35“Confidential Information” means, subject to Section 11.3 (Exemptions), (a) Know-How and any technical, scientific, trade, research, manufacturing, business, financial, marketing, product, supplier, intellectual property, and other non-public or proprietary data or information (including unpublished patent applications) that may be disclosed by one Party or its Affiliates to the other Party or its
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Affiliates pursuant to this Agreement (including information disclosed prior to the Effective Date pursuant to the Confidentiality Disclosure Agreement), regardless of whether such information is specifically marked or designated as confidential and regardless of whether such information is in written, oral, electronic, or other form, and (b) the terms of this Agreement.
1.36“Confidentiality Disclosure Agreement” means the Confidentiality Disclosure Agreement by and between the Parties dated March 8, 2021 (as amended from time to time).
1.37“Continuing Know-How Transfer” has the meaning set forth in Section 4.3 (Continuing Know-How Transfer).
1.38“Control” or “Controlled” means the possession by a Party (whether by ownership, license, or otherwise other than pursuant to this Agreement) of, (a) with respect to any tangible Know-How, the legal authority or right to physical possession of such tangible Know-How, with the right to provide such tangible Know-How to the other Party on the terms set forth herein, (b) with respect to Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible Know-How, or other intellectual property rights, the legal authority or right to grant a license, sublicense, access, or right to use (as applicable) to the other Party under such Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible Know-How, or other intellectual property rights on the terms set forth herein, in each case ((a) and (b)), without breaching or otherwise violating the terms of any arrangement or agreement with a Third Party in existence as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such access, right to use, license, or sublicense and without being required to make any payment to any Third Party or incurring any payment obligations under any such arrangement or agreement, other than payment obligations pursuant to Third Party IP Agreements in accordance with Section 2.6 (Third Party In-Licenses) or if Kiniksa determines, in its sole discretion, that Partner need not be responsible for any costs associated with the grant of a sublicense thereunder, and (c) with respect to any product, the legal authority or right to grant an exclusive license or sublicense under Patent Rights that Cover such product or Know-How that relates to such product. Notwithstanding the foregoing, a Party and its Affiliates will not be deemed to “Control” any of the foregoing (a) – (c) that, (i) prior to the consummation of a Change of Control of such Party, is owned or in-licensed by a Third Party that becomes an Affiliate of such acquired Party (or that merges or consolidates with such Party) after the Effective Date as a result of such Change of Control and (ii) was not, at the time of such Change of Control already Controlled by such Party undergoing such Change of Control.
1.39“Controlling Party” has the meaning set forth in Section 14.4.2(a)(v) (Step-In Rights).
1.40“Cover” means, with respect to a particular subject matter at issue and a relevant Patent Right, that the manufacture, use, sale, offer for sale, or importation of such subject matter would fall within the scope of one or more claims in such Patent Right.
1.41“CPI” means (a) with respect to Kiniksa, the Consumer Price Index-Urban Wage Earners and Clerical Workers, U.S. City Average, All Items 1982-84=100, published by the United States Department of Labor, Bureau of Labor Statistics (or its successor equivalent index), in the United States and (b) with respect to Partner, the consumer price index for Beijing as published by The National Bureau of Statistics of China.
1.42“CREATE Act” has the meaning set forth in Section 14.2 (CREATE Act).
1.43“CRO” means a contract research organization.
1.44“CSO” means a contract sales organization.
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1.45“Debarred/Excluded” means any Person becoming debarred or suspended under 21 U.S.C. §335(a) or (b), the subject of a conviction described in Section 306 of the FD&C Act, excluded, or having previously been excluded, from a federal or governmental health care program, debarred from federal contracting, convicted of or pled nolo contendere to any felony, or to any federal or state legal violation (including misdemeanors) relating to prescription drug products or fraud, the subject to OFAC sanctions or on the OFAC list of specially designated nationals, or the subject of any similar sanction of any Governmental Authority in the Territory.
1.46“Deficient Site” has the meaning set forth in Section 5.8.2 (Deficient Sublicensees or Sites and Replacement).
1.47“Deficient Sublicensee” has the meaning set forth in Section 5.8.2 (Deficient Sublicensees or Sites and Replacement).
1.48“Development” means, with respect to any product, any and all internal and external research, development and regulatory activities regarding such product, including (a) research, process development, non-clinical testing, toxicology, non-clinical activities, GLP toxicology and other preclinical studies (the conduct of those development activities described in the foregoing clause (a), “Pre-Clinical Development”) and (b) Clinical Trials, preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization to conduct Clinical Trials and to obtain, support, or maintain Regulatory Approval of such product (such as post-marketing approval studies and observational studies for an indication, if required by any Regulatory Authority in any country in the Territory to support or maintain Regulatory Approval for a product in such indication in such country) (the conduct of Clinical Trials and the conduct of those regulatory activities described in the foregoing clause (b), to the extent related to the conduct of Clinical Trials, “Clinical Development”) but in each case of (a) and (b) excluding any activities directed to Manufacturing, Medical Affairs, or Commercialization. Development will include research, development, and regulatory activities for additional presentations or indications for a product after receipt of Regulatory Approval of such product, including Clinical Trials commenced following receipt of Regulatory Approval or any Clinical Trial to be conducted after receipt of Regulatory Approval that was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved indication (such as post-marketing approval studies and observational studies, if required by any Regulatory Authority in any country in the Territory to support or maintain Regulatory Approval for a product in such country). “Develop,” “Developing,” and “Developed” will be construed accordingly.
1.49“Development Milestone Events” has the meaning set forth in Section 10.2.1 (Development Milestone Events and Payments).
1.50“Development Milestone Payments” has the meaning set forth in Section 10.2.1 (Development Milestone Events and Payments).
1.51“Disclosing Party” has the meaning set forth in Section 11.1.1 (Duty of Confidence).
1.52“Dispute” has the meaning set forth in Section 16.1 (Dispute Resolution; General).
1.54“Effective Date” has the meaning set forth in the Preamble.
1.55“Ex-Territory Infringement” has the meaning set forth in Section 14.4.1 (Patent Enforcement; Notice).
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1.56“Examined Party” has the meaning set forth in Section 10.11 (Financial Records and Audits).
1.57“Executive Officers” has the meaning set forth in Section 3.6.3 (Decisions of the JSC).
1.58“Existing In-Licenses” means any agreement between Kiniksa (or any of its Affiliates) and any Third Party entered into prior to the Effective Date under which such Third Party grants Kiniksa (or any of its Affiliates) a license to any of the Kiniksa Technology that is sublicensed to Partner hereunder as of the Effective Date. The Existing In-Licenses as of the Effective Date are set forth on Schedule 1.58 (Existing In-Licenses).
1.59“Exploit” means to make, have made, use, import, export, offer to sell, sell, Develop, Manufacture, perform Medical Affairs activities for, Commercialize, or otherwise exploit. “Exploitation” will be construed accordingly.
1.60“FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).
1.61“FDA” means the United States Food and Drug Administration or any successor entity thereto having essentially the same function.
1.62“Field” means all human diagnostic, prophylactic, and therapeutic uses, subject to any restrictions or limitations in any Third Party IP Agreement.
1.63“First Commercial Sale” means, with respect to the Licensed Product or Biosimilar Product (as applicable) in any country or region, the first sale of the Licensed Product or Biosimilar Product (as applicable) to a Third Party for distribution, use, or consumption in such country or region after receipt of Regulatory Approval for the Licensed Product in such country or region. First Commercial Sale excludes any sale or other distribution of the Licensed Product for use in a Clinical Trial or other Development activity or for compassionate or named-patient use, in each case, sold at or below cost of goods sold.
1.65“FTE” means the equivalent of the work of one duly qualified employee of a Party full time for one year (consisting of a total of [***] hours per year) carrying out Development, Manufacturing, Medical Affairs activities, or other scientific or technical work under this Agreement. Overtime and work on weekends, holidays, and the like, in each case, will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution. The portion of an FTE billable by a Party for one individual during a given accounting period will be determined by dividing the number of hours worked directly by such individual on the work to be conducted under this Agreement during such accounting period and the number of FTE hours applicable for such accounting period based on [***] working hours per Calendar Year.
1.66“FTE Rate” means the amount for an FTE per Calendar Year, which for the Calendar Year ending on December 31, 2022 will be (a) with respect to Kiniksa, $[***] per FTE; and (b) with respect to Partner, $[***] per FTE, in each case, pro-rated for the period beginning on the Effective Date and ending on December 31, 2022. Beginning on January 1, 2023 and on January 1 of each subsequent Calendar Year during the Term, each FTE Rate is subject to annual adjustment by the percentage increase or decrease in the applicable CPI comparing the levels of the applicable CPI as of December 31 of the two most recently completed Calendar Years.
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1.67“Fully Burdened Manufacturing Cost” means, with respect to the Licensed Product, in each case, supplied by or on behalf of the applicable Party or its Affiliates to the other Party or its Affiliates hereunder:
(a)if and to the extent the Licensed Product (or any precursor or intermediate thereof), as applicable, is Manufactured by a Third Party manufacturer, [***]; or
(b)if and to the extent the Licensed Product (or any precursor or intermediate thereof), as applicable, is Manufactured by a Party or its Affiliate, [***]. Such fully burdened costs will be calculated in accordance with applicable Accounting Standards, consistently applied.
1.69“GCP” or “cGCP” means all applicable current good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice E6 (the “GCP Guideline”) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2013) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards), and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Law in each country or region in the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.
1.70“Global Brand Elements” has the meaning set forth in Section 14.9.1 (Global Brand Elements).
1.71“Global Brand Strategy” has the meaning set forth in Section 9.2 (Commercialization Plan).
1.72“Global Clinical Trial” means a Clinical Trial for the Licensed Product the data from which is intended to be used to obtain or support Regulatory Approval both inside and outside of the Territory.
1.73“Global Development Plan” has the meaning set forth in Section 5.3 (Global Development Plan).
1.74“GLP” or “cGLP” means all applicable good laboratory practice standards, including, as applicable, as set forth in the then-current good laboratory practice standards promulgated or endorsed by the U.S. Food and Drug Administration, as defined in 21 C.F.R. Part 58, and the equivalent Applicable Law in each country or region in the Territory, each as may be amended and applicable from time to time.
1.75“Governmental Authority” means any federal, national, state, provincial, or local government, or political subdivision thereof, or any multinational organization or any authority, agency, regulatory body, or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, or any court or tribunal (or any department, bureau or division of any of the foregoing, or any governmental arbitrator or arbitral body). Governmental Authorities
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include all Regulatory Authorities.
1.76“ICC Rules” has the meaning set forth in Section 16.4 (Arbitration).
1.77“IDL” has the meaning set forth in Section 1.119 (Marketing Authorization Application).
1.78“IFRS” means International Financial Reporting Standards, consistently applied.
1.79“IND” means an Investigational New Drug application required pursuant to 21 C.F.R. Part 312 required to commence human clinical trials in the U.S. or, to the extent required in any country or region in the Territory, any equivalent application in such country or region, and including all supplements or amendments that may be filed with respect to the foregoing.
1.80“Indemnified Party” has the meaning set forth in Section 13.3 (Indemnification Procedure).
1.81“Indemnifying Party” has the meaning set forth in Section 13.3 (Indemnification Procedure).
1.82“Indication” means a separate and distinct disease, disorder, or medical condition that the Licensed Product is intended to treat, prevent, cure, or ameliorate in the indication section of the Approved Labeling for the Licensed Product, or that is the subject of a Clinical Trial and where it is intended that the data and results of such Clinical Trial (if successful) will be used to support a Regulatory Submission and Regulatory Approval that is intended to result in distinct labeling in the indication section of the Approved Labeling relevant to usage of the Licensed Product in such disease, disorder, or medical condition that is separate and distinct from another disease, disorder, or medical condition.
1.83“Initial Know-How Transfer” has the meaning set forth in Section 4.1 (Initial Know-How Transfer).
1.84“Initiate” means, with respect to a Clinical Trial, the first patient, first visit in such Clinical Trial.
1.85“Invoiced Sales” has the meaning set forth in Section 1.128 (Net Sales).
1.86“JDC” has the meaning set forth in Section 3.3.1 (Formation and Purpose of the JDC).
1.87“JMC” has the meaning set forth in Section 3.4.1 (Formation and Purpose of the JMC).
1.88“Joint Collaboration Know-How” means all Collaboration Know-How, other than Assigned Collaboration Know-How, developed or invented jointly by Representatives of a Party or its Affiliates or its or their licensees, Sublicensees, or Subcontractors, or any Persons contractually required to assign or license such Collaboration Know-How to such Party or any Affiliate of such Party, on the one hand, and Representatives of the other Party or its Affiliates or its or their licensees, Sublicensees, or Subcontractors, or any Persons contractually required to assign or license such Collaboration Know-How to such Party or any Affiliate of such Party, on the other hand.
1.89“Joint Collaboration Patent Rights” means all Collaboration Patent Rights that Cover Joint Collaboration Know-How.
1.90“Joint Collaboration Technology” means the Joint Collaboration Know-How and the
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Joint Collaboration Patent Rights.
1.92“JSC Chairperson” has the meaning set forth in Section 3.2.1 (Formation and Purpose of JSC).
1.93“Key Country” has the meaning set forth in Section 6.2.3 (Review of Regulatory Submissions).
1.95“Kiniksa Collaboration Know-How” means any Collaboration Know-How developed or invented solely by Representatives of Kiniksa or its Affiliates or its or their licensees (other than Partner), Sublicensees (other than Partner), or Subcontractors, or any Persons contractually required to assign or license such Collaboration Know-How to Kiniksa or any Affiliate of Kiniksa, but expressly excluding Kiniksa Manufacturing Know-How.
1.96“Kiniksa Collaboration Patent Rights” means any Patent Rights that Cover any Kiniksa Collaboration Know-How.
1.97“Kiniksa Collaboration Technology” means the Kiniksa Collaboration Know-How and the Kiniksa Collaboration Patent Rights.
1.98“Kiniksa Identified Rights” has the meaning set forth in Section 2.6.1 (Kiniksa Identified Rights).
1.99“Kiniksa Indemnitee(s)” has the meaning set forth in Section 13.1 (Indemnification; By Partner).
1.100“Kiniksa Know-How” means any Know-How that is Controlled by Kiniksa or any of its Affiliates as of the Effective Date or during the Term (including Kiniksa Collaboration Know-How and Kiniksa’s interest in the Joint Collaboration Know-How), and [***] to perform Clinical Development, Pre-Clinical Development (solely to the extent permitted in accordance with Section 5.2.2 (Pre-Clinical Development)), or Medical Affairs with respect to, or Commercialize the Licensed Product in the Territory in the Field, but expressly excluding Kiniksa Manufacturing Know-How.
1.101“Kiniksa Manufacturing Know-How” means any Know-How that is Controlled by Kiniksa or any of its Affiliates as of the Effective Date or during the Term (including Kiniksa Collaboration Know-How), and is necessary for the Manufacturing of the Licensed Product in the Territory in the Field.
1.102“Kiniksa Manufacturing Patent Rights” means any Patent Rights that are Controlled by Kiniksa or any of its Affiliates as of the Effective Date or during the Term (including Kiniksa Collaboration Patent Rights), and are necessary for the Manufacturing of the Licensed Product in the Territory in the Field.
1.103“Kiniksa Manufacturing Technology” means all Kiniksa Manufacturing Know-How and Kiniksa Manufacturing Patent Rights.
1.104“Kiniksa P&L Process and Specifications” has the meaning set forth in Section 4.1 (Initial Know-How Transfer).
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1.105“Kiniksa Patent Right Infringement” has the meaning set forth in Section 14.4.1 (Patent Enforcement; Notice).
1.106“Kiniksa Patent Rights” means any Patent Right that (a) is Controlled by Kiniksa or any of its Affiliates as of the Effective Date or during the Term (including Kiniksa Collaboration Patent Rights and Joint Collaboration Patent Rights), and (b) is [***] (or, with respect to patent applications, would be [***] if such patent applications were to issue as patents) to perform Clinical Development or Pre-Clinical Development (solely to the extent permitted in accordance with Section 5.2.2 (Pre-Clinical Development)) or Medical Affairs with respect to, or Commercialize, the Licensed Product in the Territory in the Field (including any such Patent Right that Covers a composition of matter (e.g., a drug formulation) of the Licensed Product), but expressly excluding Kiniksa Manufacturing Patent Rights. Schedule 1.106 (Kiniksa Patent Rights) sets forth the Kiniksa Patent Rights that are owned or exclusively licensed by Kiniksa or its Affiliates as of the Effective Date in the Territory.
1.107“Kiniksa Process and Specifications” has the meaning set forth in Section 7.2.4 (Process and Specifications).
1.108“Kiniksa Technology” means the Kiniksa Know-How and Kiniksa Patent Rights.
1.109“Know-How” mean any and all proprietary technical, scientific, or other information, data (including physical, chemical, biological, toxicological, pharmacological, clinical and veterinary data), test results, knowledge, know-how, techniques, practices, processes, discoveries, inventions, specifications, strategies, plans, dosage regimens, drug formulations, control assays, product specifications, analytical and quality control data, marketing, pricing, distribution cost and sales data or descriptions, designs (including study designs), trade secrets, Regulatory Submissions, and other technology, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or otherwise protected by trade secret law, in each case, that is not in the public domain or otherwise generally known.
1.110“Knowledge” means the actual knowledge, without any inquiry, investigation, or obligation to conduct any freedom to operate analysis, of (a) with respect to Kiniksa, the Chief Intellectual Property Officer, the Chief Medical Officer, and the Chief Operating Officer, in each case, of Kiniksa or its Affiliates; and (b) with respect to Partner, the Chief Medical Officer, the Chief Business Officer, and the General Counsel.
1.111“Licensed Product” means any product Controlled by Kiniksa or its Affiliates comprised of or that contains mavrilimumab, a human monoclonal antibody targeting granulocyte macrophage colony-stimulating factor receptor alpha (GM-CSFRα).
1.112“Listing Patent Rights” has the meaning set forth in Section 14.6 (Patent Listings).
1.113“Local Manufacturing Approval” has the meaning set forth in Section 6.2.1(a) (Local Manufacturing).
1.114“Losses” means damages, debts, obligations, and other liabilities, losses, claims, taxes, interest obligations, deficiencies, judgments, assessments, fines, fees, penalties, or expenses (including amounts paid in settlement, interest, court costs, costs of investigators, reasonable fees and expenses of attorneys, accountants, financial advisors, consultants, and other experts, and other expenses of litigation).
1.115“Manufacture” means with respect to any product, any and all activities directed to manufacturing, processing, packaging, labeling, filling, finishing, assembly, quality assurance, quality
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control, testing, and release, shipping, supply, or storage of such product (or any components or process steps involving such product), as the case may be, including qualification, validation, and scale-up, preclinical, clinical, and commercial manufacture and analytic development, product characterization, and stability testing, but excluding any activities directed to Development, Medical Affairs, or Commercialization. “Manufacturing” and “Manufactured” will be construed accordingly.
1.116“Manufacturing License” has the meaning set forth in Section 2.1.2 (Manufacturing License).
1.117“Manufacturing Technology Transfer” means the transfer of the Kiniksa Manufacturing Know-How related to the Licensed Product in accordance with the Manufacturing Technology Transfer Plan for the Licensed Product, which includes the provision of any technical assistance to enable the applicable steps of the Manufacture of the Licensed Product to be transferred to those CMOs selected by Partner or, if determined by the JSC in accordance with Section 4.2 (Manufacturing Technology Transfer), to Partner.
1.118“Manufacturing Technology Transfer Plan” means, for each Licensed Product, the plan for the transfer to Partner of the Kiniksa Manufacturing Know-How for the Licensed Product, which plan, among other things, will set forth for the Licensed Product the scope of Manufacturing activities that will be transferred to Partner, the scope of the Kiniksa Manufacturing Know-How that will be necessary for the conduct of such activities, and the work plan and timeline for such transfer, in each case, determined in accordance with Section 4.2 (Manufacturing Technology Transfer).
1.119“Marketing Authorization Application” or “MAA” means any new drug application, biologics license application, or other marketing authorization application, in each case, filed with the applicable Regulatory Authority in a country or other regulatory jurisdiction, which application is required to commercially market or sell a pharmaceutical or biologic product in such country or jurisdiction (and any amendments thereto). In the context of imported drugs in the PRC, MAA is also known as the Import Drug License (“IDL”) application.
1.120“Marketing Authorization Holder” has the meaning set forth in Section 6.2.1(b) (Other Regulatory Approvals).
1.121“Material Adverse Impact” means, with respect to any matter, that such matter could (a) have a materially adverse impact on the Development or Commercialization of the Licensed Product outside of the Territory (including any concern related to quality, safety, toxicity, or side effects), or (b) be inconsistent with Kiniksa’s global regulatory strategy or Global Development Plan for the Licensed Product.
1.122“Material Subcontractor” has the meaning set forth in Section 2.2.3 (Right to Subcontract).
1.123“Mavrilimumab Agreement” means the License Agreement between MedImmune, Limited and Kiniksa Pharmaceuticals, Ltd. effective as of December 21, 2017, as amended by Amendment No. 1 effective as of July 9, 2020 and as the same may be amended in accordance with the terms of this Agreement.
1.124“Medical Affairs” means activities conducted by a Party’s medical affairs department (or, if a Party does not have a medical affairs department, the equivalent function thereof), including communications with key opinion leaders and clinical or scientific thought leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), activities performed
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in connection with patient registries, and other medical programs and communications, including educational grants, research grants (including those related to investigator-initiated studies), and charitable donations to the extent related to medical affairs and not to other activities that involve the promotion, marketing, sale, or other Commercialization of the Licensed Product and are not conducted by a Party’s medical affairs (or equivalent) department. Medical Affairs excludes any activities directed to Manufacturing, Development, or Commercialization.
1.125“Medical Affairs Plan” means, with respect to the Licensed Product, the written high-level strategic and tactical plans for the Medical Affairs activities for the Licensed Product to be conducted in the Territory that will be prepared and updated by Partner as provided in Section 8.1 (Medical Affairs Plan).
1.126“Milestone Events” has the meaning set forth in Section 10.2.3(a) (Notification of Milestone Events).
1.127“Milestone Payments” has the meaning set forth in Section 10.2.3(a) (Notification of Milestone Events).
1.128“Net Sales” means with respect to the Licensed Product for any period, the gross amounts invoiced by Partner or its Affiliates to Third Parties or Sublicensees for sales of the Licensed Product in the Territory (the “Invoiced Sales”) less the following deductions:
| (a) | [***]; |
| (b) | [***]; |
| (c) | [***]; |
| (d) | [***]; and |
| (e) | [***]. |
For the avoidance of doubt, (a) in the case of any sale or other disposal of the Licensed Product between or among Partner and its Affiliates for resale, invoiced sales and Net Sales will be calculated only on the amount invoiced on the first arm’s length sale thereafter to a Third Party; and (b) Net Sales will not be imputed to transfers of Licensed Product (i) without consideration or for nominal consideration for use in any Clinical Trials reasonably necessary to comply with any Applicable Law or regulation or any request by a Regulatory Authority in the Territory, (ii) for any bona fide charitable, compassionate use or indigent patient, or other similar program purpose where the Licensed Product is sold at or below cost of goods sold, or (iii) in commercially reasonable quantities as samples for promotional purposes.
Subject to the above, Net Sales will be calculated in accordance with the standard internal policies and procedures of Partner, its Affiliates or its or their Sublicensees, which must be in accordance with U.S. GAAP or, if applicable, IFRS.
1.129“New Development” has the meaning set forth in Section 5.4 (New Development by Partner).
1.130“New Development Activities” has the meaning set forth in Section 5.4 (New Development by Partner).
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1.131“New Development Proposal” has the meaning set forth in Section 5.4 (New Development by Partner).
1.132“New Kiniksa In-Licensed Rights” has the meaning set forth in Section 2.6.3 (Third Party In-Licenses).
1.133“New Territory-Specific Development Activities” has the meaning set forth in Section 5.4 (New Development by Partner).
1.134“New Third Party IP Agreement” has the meaning set forth in Section 2.6.3 (Third Party In-Licenses).
1.135“NMPA” means the National Medical Products Administration of the People’s Republic of China, and local counterparts thereto, and any successor agency or authority thereto having substantially the same function.
1.136“OFAC” means the Office of Foreign Assets Control of the United States Department of the Treasury or any successor agency thereto.
1.137“Ongoing Global Clinical Trial” means any Global Clinical Trial for the Licensed Product that is ongoing as of the Effective Date or Initiated within [***] months following the Effective Date.
1.138“Partner” has the meaning set forth in the Preamble.
1.139“Partner Collaboration Know-How” means Collaboration Know-How, other than Assigned Collaboration Know-How, developed or invented solely by Representatives of Partner or its Affiliates or its or their licensees (other than Kiniksa), Sublicensees, or Subcontractors, or any Persons contractually required to assign or license such Collaboration Know-How to Partner or any Affiliate of Partner.
1.140“Partner Collaboration Patent Rights” means any Collaboration Patent Right that Covers Partner Collaboration Know-How.
1.141“Partner Collaboration Technology” means the Partner Collaboration Know-How and Partner Collaboration Patent Rights.
1.142“Partner Identified Rights” has the meaning set forth in Section 2.6.2 (Partner Identified Rights).
1.143“Partner Indemnitee(s)” has the meaning set forth in Section 13.2 (Indemnification; By Kiniksa).
1.144“Partner Know-How” means all Know-How that is Controlled by Partner or any of its Affiliates as of the Effective Date or during the Term, and [***] to Exploit the Licensed Product, including Partner Collaboration Know-How and Partner’s interest in the Joint Collaboration Know-How.
1.145“Partner Patent Rights” means all Patent Rights that are Controlled by Partner or any of its Affiliates as of the Effective Date or during the Term, and [***] (or, with respect to patent applications, would be [***] if such patent applications were to issue as patents) to Exploit the Licensed Product, including all Partner Collaboration Patent Rights and Partner’s interest in the Joint Collaboration Patent
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Rights.
1.146“Partner Process and Specifications” has the meaning set forth in Section 7.2.4 (Process and Specifications).
1.147“Partner Technology” means Partner Know-How and Partner Patent Rights.
1.148“Party” or “Parties” has the meaning set forth in the Preamble.
1.149“Patent Challenge” has the meaning set forth in Section 15.2.3 (Termination for Patent Challenge).
1.150“Patent Prosecution” means activities directed to (a) preparing, filing, and prosecuting applications (of all types) for any Patent Right, (b) maintaining any Patent Right, and (c) deciding whether to abandon or maintain any Patent Right.
1.151“Patent Rights” means any and all (a) patents, patent applications, and utility models in any country or jurisdiction, including provisional applications, priority applications, and international applications, (b) patent applications filed either from such patents or patent applications or from a patent application claiming priority from any of these, including divisionals, provisionals, continuations, and continuations-in-part, (c) patents that have issued or in the future issue from the foregoing patent applications, (d) substitutions, renewals, registrations, confirmations, revalidations, reissues, and re-examinations of the foregoing patents or patent applications, and (e) extensions, restorations, supplemental protection certificates, and the like based on any of the foregoing patents or patent applications.
1.152“Patent Term Adjustment” has the meaning set forth in Section 14.7 (Patent Term Extensions).
1.153“Patent Term Extension” has the meaning set forth in Section 14.7 (Patent Term Extensions).
1.154“Paying Party” has the meaning set forth in Section 10.12.2 (Tax Cooperation).
1.155“Person” means any corporation, limited or general partnership, limited liability company, joint venture, joint stock company, trust, unincorporated association, governmental body, authority, bureau, or agency, or any other entity or body, or an individual.
1.156“Phase III Clinical Trial” means a clinical trial in humans in a manner that is generally consistent with 21 C.F.R. § 312.21(c), as amended (or its successor regulation), or, with respect to any other country or region, the equivalent of such a clinical trial in such other country or region.
1.157“Pivotal Clinical Trial” means any (a) Phase III Clinical Trial, or (b) other Clinical Trial of a pharmaceutical or biologic product on a sufficient number of patients, the results of which, together with prior data and information concerning such product, are sufficient, without any additional Clinical Trial to meet the evidentiary standard for demonstrating the safety, purity, efficacy, and potency of such active substance of such product established by a Regulatory Authority in any particular jurisdiction and that is intended to support the filing of an MAA with a Regulatory Authority in such jurisdiction. Notwithstanding any provision to the contrary set forth in this Agreement, treatment of patients as part of an expanded access program, compassionate sales or use program (including named patient program or single patient program), or an indigent program, in each case, will not be included in determining whether or not a Clinical Trial is a Pivotal Clinical Trial.
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1.158“PRC” means the People’s Republic of China, which, for purposes of this Agreement, does not include Hong Kong Special Administrative Region, Macau Special Administrative Region, or Taiwan.
1.159“Preapproved Subcontractor” means any Subcontractor to be engaged by Partner to perform its obligations or exercise its rights under this Agreement as further described in Section 2.2.3 (Right to Subcontract) and (a) identified as a Subcontractor in a Territory Development Plan or Global Development Plan that is approved by the JSC or (b) selected by Partner to Manufacture the Licensed Product in the Territory in accordance with Section 4.2 (Manufacturing Technology Transfer).
1.160“Pre-Clinical Development Plan” has the meaning set forth in Section 5.2.2 (Territory Pre-Clinical Development).
1.161“Product Marks” has the meaning set forth in Section 14.9.2 (Product Marks in the Territory).
1.162“Public Official” means (a) any officer, employee or representative of any regional, federal, state, provincial, county or municipal government or government department, agency or other division; (b) any officer, employee or representative of any commercial enterprise that is owned or controlled by a government, including any state-owned or controlled veterinary, laboratory or medical facility; (c) any officer, employee or representative of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank; and (d) any person acting in an official capacity for any government or government entity, enterprise, or organization identified above.
1.163“Publication” has the meaning set forth in Section 11.5 (Publications).
1.164“Receiving Party” has the meaning set forth in Section 11.1.1 (Duty of Confidence).
1.165“Recipient” has the meaning set forth in Section 10.12.2 (Tax Cooperation).
1.166“Regulatory Approval” means, with respect to a particular country or other regulatory jurisdiction, any approval of an MAA or other approval, product, or establishment license, registration, or authorization of any Regulatory Authority necessary for the commercial marketing or sale of a pharmaceutical or biologic product in such country or other regulatory jurisdiction, excluding, in each case, Reimbursement Approval.
1.167“Regulatory Authority” means any applicable Governmental Authority with jurisdiction or authority over the Development, Manufacture, Commercialization, or other Exploitation (including Regulatory Approval or Reimbursement Approval) of pharmaceutical or biologic products in a particular country or other regulatory jurisdiction, including the NMPA, and any corresponding national or regional regulatory authorities.
1.168“Regulatory Exclusivity” means any exclusive marketing rights or data protection or other exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical or biologic product in a particular country or other regulatory jurisdiction, but in all cases excluding Patent Rights.
1.169“Regulatory Submissions” means any filing, application, or submission with any Regulatory Authority in support of Developing, Manufacturing, or Commercializing a pharmaceutical or biologic product (including to obtain, support, or maintain Regulatory Approval from that Regulatory Authority) and any proposed Approved Labeling, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any substantive meetings, telephone conferences, or discussions with the relevant Regulatory Authority. Regulatory Submissions include all INDs, XXXx,
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and other applications for Regulatory Approval and their equivalents.
1.170“Reimbursement Approval” means an approval, agreement, determination, or other decision by the applicable Governmental Authority that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product will be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities in the Territory.
1.171“Replacement Site” has the meaning set forth in Section 5.8.2 (Deficient Sublicensees or Sites and Replacement).
1.172“Representative” means any employee, officer, contractor, consultant, or agent of a Party.
1.173“Required Pre-Clinical Development” has the meaning set forth in Section 5.2.2 (Territory Pre-Clinical Development).
1.174“Review Period” has the meaning set forth in Section 11.5 (Publications).
1.175“Royalty Patent Rights” means the Kiniksa Patent Rights and the Kiniksa Manufacturing Patent Rights.
1.176“Royalty Payments” has the meaning set forth in Section 10.3.1 (Royalty Rates).
1.177“Royalty Report” has the meaning set forth in Section 10.3.4 (Royalty Reports and Payments).
1.178“Royalty Term” has the meaning set forth in Section 10.3.2 (Royalty Term).
1.179“Safety Agreement” has the meaning set forth in Section 6.6.1 (Adverse Events Reporting; Safety Agreements).
1.180“Sales Milestone Events” has the meaning set forth in Section 10.2.2 (Sales Milestone Events and Payments).
1.181“Sales Milestone Payments” has the meaning set forth in Section 10.2.2 (Sales Milestone Events and Payments).
1.182“Selected Territory GCT Countries” has the meaning set forth in Section 5.3 (Global Development Plan).
1.183“Status Quo Item” has the meaning set forth in Section 3.7.2(a) (No Change; Status Quo).
1.184“Subcontractor” means (a) a Third Party contractor engaged by a Party to perform certain obligations or exercise certain rights of such Party under this Agreement on a fee-for-service basis (including CROs, CMOs, and CSOs), or (b) a Third Party Distributor. A Subcontractor of Partner may be deemed a Sublicensee for purposes of this Agreement if such Subcontractor requires a sublicense under the rights granted to Partner in Section 2.1 (License Grants to Partner) to perform the applicable activities for which they were engaged.
1.185“Sublicensee” means any Person (a) with respect to Partner, to whom Partner grants a sublicense of, or other authorization or permission granted under, the rights granted to Partner in Section 2.1 (License Grants to Partner), including any Subcontractor (to the extent such Subcontractor requires a sublicense under the rights granted to Partner in Section 2.1 (License Grants to Partner) to perform the
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applicable activities for which they were engaged), and (b) with respect to Kiniksa, to whom Kiniksa grants a sublicense of, or other authorization or permission granted under, the rights granted to Kiniksa in Section 2.3 (License Grant to Kiniksa).
1.186“Subsidiary” means, with respect to a Party, any Person that is controlled by such Party. For the purpose of this definition only, “control” (including, with correlative meaning, the terms “controlled by” and “under the common control”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of any Person, whether by the ownership of more than 50% of the voting security of such Person, by contract or otherwise. The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than 50%, and that in such case such lower percentage will be substituted in the preceding sentence; provided that such foreign investor has the power to direct the management and policies of such entity.
1.187“Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including any interest thereon), including value add, sales, excise or similar taxes (“VAT”).
1.188“Technology Transfer” has the meaning set forth in Section 4.3 (Continuing Know-How Transfer).
1.189“Term” has the meaning set forth in Section 15.1 (Term).
1.190“Territory” means, subject to Section 15.2.4 (Termination in [***]), Asia Pacific Region (the People’s Republic of China, Hong Kong SAR, Macao SAR, Taiwan Region, South Korea, Indonesia, Singapore, The Philippines, Thailand, Australia, Bangladesh, Bhutan, Brunei, Burma, Cambodia, India, Laos, Malaysia, Maldives, Mongolia, Nepal, New Zealand, Sri Lanka, and Vietnam).
1.191“Territory Development” has the meaning set forth in Section 5.1 (Development Diligence and Responsibilities).
1.192“Territory Development Plan” has the meaning set forth in Section 5.2.1 (Territory Clinical Development).
1.193“Territory Sponsor” means, with respect to a Territory-Specific Clinical Trial or a Global Clinical Trial for the Licensed Product to be conducted at sites in the Territory, the Party that holds the IND from the applicable Regulatory Authority in the Territory for such Clinical Trial in its name.
1.194“Territory-Specific Clinical Trial” means a Clinical Trial for the Licensed Product, the data from which at the time of commencement of such Clinical Trial is intended to be used to obtain Regulatory Approval in the Territory but not to obtain Regulatory Approval outside of the Territory.
1.196“Third Party Claims” means collectively, any and all Third Party demands, claims, actions, suits, and proceedings (whether criminal or civil, in contract, tort, or otherwise).
1.197“Third Party Distributor” means any Third Party that purchases Licensed Product from Partner or its Affiliates or Sublicensees, takes title to the Licensed Product, and distributes the Licensed Product directly to customers, but does not Develop, Manufacture, or otherwise Commercialize the Licensed Product and does not make any upfront, milestone, royalty, profit-share, or other payment to
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Partner or its Affiliates or Sublicensees, other than payment for the purchase of Licensed Product for resale.
1.198“Third Party IP Agreements” has the meaning set forth in Section 2.6.3 (Third Party In-Licenses).
1.199“United States” or “U.S.” means the United States of America and its territories and possessions.
1.200“Valid Claim” means, with respect to a particular country or region, (a) a claim of an issued and unexpired patent (as may be extended through supplementary protection certificate or patent term extension or the like) that, in such country or region, has not been revoked, held invalid, or unenforceable by a patent office or other Governmental Authority of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period) and that has not been disclaimed, denied, or admitted to be invalid or unenforceable through reissue, re-examination, or disclaimer or otherwise; or (b) a pending claim of an unissued, pending patent application in such country or region that has not been pending for more than [***] years since the date of the first response on the merits received from the relevant patent office regarding such application, provided that such [***] year period will be tolled for the duration of any adverse proceeding (e.g., Third Party oppositions or any appeal of an adverse determination against the Valid Claim) with respect to the patent application at issue.
1.201“VAT” has the meaning set forth in Section 1.187 (Tax).
| 2.1. | License Grants to Partner. |
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| accordance with Section 3.2.4(f) (JSC Roles and Responsibilities) and, if Partner is to Manufacture the Licensed Product itself, transferred in accordance with the Manufacturing Technology Transfer Plan for the Licensed Product, solely for sale and use of the Licensed Product in the Field in the Territory (such license under the foregoing clause (b), the “Manufacturing License”). |
| 2.1.3. | Pre-Existing Third Party Rights. In addition to the other terms and conditions of this Agreement, the licenses granted hereunder are subject to the terms of (a) all New Third Party IP Agreements (and amendments thereto) as further described in, and solely to the extent such New Third Party IP Agreements (and amendments thereto) are entered into in accordance with, Section 2.5.2 (Third Party IP Agreement Amendments) and Section 2.6.3 (Third Party In-Licenses) and (b) the Mavrilimumab Agreement. |
| 2.2. | Sublicensing and Subcontractors. |
| 2.2.1. | Right to Sublicense. Subject to the terms of this Agreement, Partner will have the right to grant sublicenses of the rights granted under Section 2.1 (License Grants to Partner): |
| (a) | to (i) Preapproved Subcontractors (to the extent such Preapproved Subcontractors require a sublicense under the rights granted to Partner in Section 2.1 (License Grants to Partner) to perform the applicable activities for which they were engaged) and, (ii) subject to Kiniksa’s prior written consent, not to be unreasonably withheld, conditioned, or delayed, to other Subcontractors (to the extent such other Subcontractors require a sublicense under the rights granted to Partner in Section 2.1 (License Grants to Partner) to perform the applicable activities for which they were engaged); |
| (b) | subject to Kiniksa’s prior written approval, not to be unreasonably withheld, conditioned, or delayed, to (i) Partner’s Subsidiaries or (ii) other Third Parties that are not Subcontractors; |
in each case ((a) and (b)), for the sole purpose of performing Partner’s obligations and exercising Partner’s rights with respect to the Clinical Development, Pre-Clinical Development (to the extent permitted in accordance with Section 5.2.2 (Territory Pre-Clinical Development)), Manufacture, performance of Medical Affairs activities with respect to, or Commercialization of the Licensed Product in accordance with this Agreement. [***] Each Sublicensee will hold its rights contingent on the rights licensed to Partner under the terms of this Agreement and may not grant any further sublicenses of its rights to any Third Party. Any termination of the licenses granted to Partner under Section 2.1 (License Grants to Partner) as a result of a termination of this Agreement will cause the Sublicensees to automatically lose the same rights under any sublicense.
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| version of the agreement between Partner and any such Third Party in English for Kiniksa to review and determine whether to approve. Each sublicense to a Third Party (including any Preapproved Subcontractor or other Subcontractor, in each case, that requires a sublicense under the rights granted to Partner in Section 2.1 (License Grants to Partner) to perform the applicable activities for which they were engaged) will be granted under a written agreement that is consistent with and subject to the terms of this Agreement, to the extent required pursuant to the terms of any Third Party IP Agreement that has been approved in writing by Kiniksa, and that: |
| (a) | contains the requirements set forth under Section 2.2.4 (Terms of Sublicenses and Subcontracts with Third Parties); |
| (b) | requires each such Sublicensee to comply with the terms of this Agreement that are applicable to such Sublicensee (including the Milestone Event and Royalty Payment reporting obligations set forth under Section 10.2 (Milestone Payments) and Section 10.3 (Royalty Payments to Kiniksa), the record keeping and audit requirements set forth under Section 5.8 (Clinical Trial Audit Rights), Section 10.11 (Financial Records and Audits), and the intellectual property provisions set forth in Article 14 (Intellectual Property)); |
| (c) | requires that each such Sublicensee performs the activities that they are sublicensed or engaged to perform (as applicable) in accordance with the terms of all Third Party IP Agreements, cGLP, cGMP, and cGCP, as applicable, and otherwise in compliance with Applicable Law; |
| (d) | includes Kiniksa as an intended third party beneficiary under the sublicense with the right to enforce the applicable terms of such sublicense; |
| (e) | precludes the granting of further sublicenses without the prior written consent of Kiniksa, not to be unreasonably withheld, conditioned, or delayed; |
| (f) | prohibits such Third Party from engaging in, independently or for or with any other Third Party, any Exploitation of any Competitive Product in the Territory; and |
| (g) | is subject in all respects to any applicable Third Party IP Agreement under which Kiniksa is granted any right that will be sublicensed under such proposed sublicense. |
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| preceding clauses (a) or (b), a “Material Subcontractor”) to perform its obligations or exercise its rights under this Agreement related to the Clinical Development, Manufacture, Pre-Clinical Development (solely to the extent permitted in accordance with Section 5.2.2 (Territory Pre-Clinical Development)), performance of Medical Affairs with respect to, or Commercialization of the Licensed Product, then at least [***] days before engaging any such Subcontractor, Partner will provide to the JSC, for review and discussion, written notice identifying Partner’s intention to engage such Subcontractor, the purpose of engaging such Subcontractor, and the identity of such Subcontractor. The Parties agree that Partner’s engagement of Material Subcontractors that do not require a sublicense do not require the approval of the JSC, and if the JSC does not provide to Partner comments with respect to the engagement of any such proposed Material Subcontractors prior to the end of such [***] day period, then Partner may so engage such Material Subcontractors. |
| 2.2.5. | Notice of Sublicenses. Partner will provide Kiniksa with a true and complete copy of each agreement between Partner and any Sublicensee no later than [***] days after the execution thereof, provided that, to the extent permitted under any Third Party IP Agreement, Partner may redact any financial terms contained therein that are not necessary for Kiniksa to determine the scope of the rights granted under such sublicense. If any such agreement between Partner and any Sublicensee is not in English, then Partner will also provide to Kiniksa an English translation thereof, at Partner’s expense, no later than [***] days following the execution thereof. |
| 2.2.6. | Partner Audits of Sublicensees and Subcontractors. Partner will provide Kiniksa with copies of any quality oversight or audit reports from audits that Partner (or its agent) has conducted on any Sublicensees or other Material Subcontractors engaged by Partner to perform its obligations or exercise its rights under this Agreement to the extent such reports are relevant to such Sublicensees’ or other Subcontractors’ performance of such obligations or exercise of such rights no later than [***] Business Days after receiving or preparing, as applicable, any such report. Partner will provide to Kiniksa all quality oversight or audit reports from audits that Partner (or its agent) conducts, and, if any such report is not in English, a summary in English of any such report. Solely to the extent that Kiniksa is required to submit such quality oversight or audit reports to a Regulatory Authority. Partner will reimburse Kiniksa for any translation expenses reasonably incurred by Kiniksa to obtain English translation thereof by translators selected by Kiniksa. |
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| 2.2.7. | Responsibility for Sublicensees and Subcontractors. Notwithstanding any sublicense or subcontracting, Partner will remain primarily liable to Kiniksa for the performance of all of its obligations under, and Partner’s and its Sublicensees’ and other Subcontractors’ compliance with all provisions of, this Agreement. Partner will be fully responsible and liable for any breach of the terms of this Agreement by any of its Sublicensees or other Subcontractors to the same extent as if Partner itself has committed any such breach, and Partner will promptly terminate the sublicense or subcontract, as applicable, with any Sublicensee or other Subcontractor if such Sublicensee or Subcontractor is in material breach of this Agreement and does not cure such breach in a timely manner in accordance with the terms of this Agreement. |
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| 2.5. | Third Party IP Agreements. |
| 2.6. | Third Party In-Licenses. |
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| a Third Party (whether by acquisition or license) that may be necessary to Exploit the Licensed Product in the Field in the Territory (other than through a Change of Control of Kiniksa or any of its Affiliates or as a result of the acquisition by Kiniksa or any of its Affiliates of a Third Party by merger, acquisition, or similar transaction or series of related transactions) and for which Kiniksa intends Partner to share amounts due in consideration of a grant under such Know-How and Patent Rights (such Know-How and Patent Rights, “Kiniksa Identified Rights”), then Kiniksa will notify Partner in writing of such Kiniksa Identified Rights and Section 2.6.3 (Third Party In-Licenses) will apply. |
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| 2.7. | Exclusivity Covenants. |
| 2.7.2. | Kiniksa Exclusivity. Unless otherwise agreed in writing by the Parties or as expressly provided by the terms of this Agreement, during the Term, Kiniksa will not, and will ensure that its Affiliates do not, conduct, license, participate in, or fund, directly or indirectly, independently or for or with any Third Party, any Competitive Activities. |
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| 2.7.4. | Acquisition of a Competitive Product. Neither Party nor its Subsidiaries (with respect to Partner) or its Affiliates (with respect to Kiniksa) will be in breach of the restrictions set forth in this Section 2.7 (Exclusivity Covenants) if such Party or any of its Subsidiaries (with respect to Partner) or its Affiliates (with respect to Kiniksa) acquires a Competitive Product that is being Exploited in the Territory through an acquisition of, or a merger with, the whole or substantially the whole of a business or assets of another Person, so long as such Party (or its Affiliate) (a) enters into a definitive agreement with a Third Party to divest (whether by exclusive out-license or otherwise) such Competitive Product throughout the Territory within [***] months after the closing of such acquisition or merger or (b) terminates the further Exploitation of such Competitive Product throughout the Territory within [***] days after the closing of such acquisition or merger, and, until the completion of such divestiture or termination, (i) no Kiniksa Technology, Kiniksa Manufacturing Technology, or Partner Technology is used by or on behalf of such Party or its Affiliates in connection with any subsequent Exploitation of such Competitive Products in the Territory, and (ii) such Party and its Affiliates institute commercially reasonable technical and administrative safeguards to ensure the requirements set forth in the foregoing clause (i) are met, including by creating “firewalls” between the personnel Exploiting such Competitive Products and the personnel teams charged with Exploiting the Licensed Product or having access to data from activities performed under this Agreement or Confidential Information of the Parties. |
| 3.2. | Joint Steering Committee. |
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| any meeting by another person designated by the absent representative. A representative of Kiniksa will chair the JSC (“JSC Chairperson”) until the first anniversary of the Effective Date. Thereafter, a Partner representative will become the JSC Chairperson for the next [***] months of the Term and then the role of JSC Chairperson will rotate between the Parties every [***] months during the Term. Each Party’s representatives on the JSC will inform and coordinate within their respective organization to enable each Party to fulfill its obligations as agreed upon between the Parties under this Agreement, including within the time frames set forth hereunder. |
| 3.2.2. | Meeting Agendas. Each Party will disclose to the other Party the proposed agenda items along with appropriate information at least [***] Business Days in advance of each meeting of the JSC; provided that under exigent circumstances requiring JSC input, a Party may provide its agenda items to the other Party within a shorter period of time in advance of a meeting, or may propose that there not be a specific agenda for a particular meeting, so long as such other Party consents to such later addition of such agenda items or the absence of a specific agenda for such JSC meeting. |
| 3.2.3. | Meetings. The JSC will hold meetings at such times as it elects to do so, but will meet no less frequently than quarterly, unless otherwise agreed by the Parties. All meetings will be conducted in English. The JSC may meet in person or by means of teleconference, Internet conference, videoconference, or other similar communication method; provided that, if practicable or permissible in light of travel restrictions due to the COVID-19 pandemic or any other reason, at least one meeting each Calendar Year will be conducted in person at a location selected alternatively by Kiniksa and Partner or such other location as the Parties may agree. Each Party will be responsible for all of its own costs and expenses of participating in any JSC meeting. The Alliance Managers will jointly prepare and circulate minutes for each JSC meeting within [***] Business Days after each such meeting and will ensure that such minutes are reviewed and approved by their respective companies within [***] days thereafter. |
| 3.2.4. | JSC Roles and Responsibilities. The responsibilities of the JSC will be to: |
| (a) | provide a forum for the discussion of the Parties’ activities under this Agreement; |
| (b) | review and discuss matters that Kiniksa believes may have a Material Adverse Impact on the Licensed Product; |
| (c) | review and discuss Partner’s engagement of Subcontractors that are not Preapproved Subcontractors, as described in Section 2.2.3 (Right to Subcontract); |
| (d) | establish and oversee the JDC and JMC and settle any disputes that arise within the JDC or JMC, as described in Section 3.6.2 (Resolution of JDC and JMC Disputes); |
| (e) | oversee the implementation of, and the coordination between the Parties of activities to be performed under, the Clinical Supply Agreement, the Commercial Supply Agreement, the Safety Agreements, and any other written agreement between the Parties with respect to the subject matter hereof; |
| (f) | determine the appropriate time to perform the Manufacturing Technology Transfer for the Licensed Product, which in all cases will be conducted with sufficient time |
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| (g) | if the Manufacturing Technology Transfer for the Licensed Product will be to Partner (and not one or more CMOs), review, discuss, and determine whether to approve (i) the Manufacturing Technology Transfer Plan for the Licensed Product and (ii) any change in the scope of Manufacturing activities to be transferred to Partner if agreed by the JSC in connection with the Manufacturing Technology Transfer for the Licensed Product, each as described in Section 4.2 (Manufacturing Technology Transfer); |
| (h) | review, discuss, and determine whether to approve any updates to the Territory Development Plan for the Licensed Product, in each case, as described in Section 5.2.1 (Territory Clinical Development); |
| (i) | [***]; |
| (j) | review, discuss, and determine whether to approve any material updates to, the Global Development Plan for the Licensed Product with respect to activities to be conducted by Partner in the Territory, including Partner’s participation in the conduct of any Global Clinical Trial, each as described in Section 5.3 (Global Development Plan); |
| (k) | review and discuss if Partner will be the Territory Sponsor for Global Clinical Trials to be conducted under the Global Development Plan (as set forth therein), as described in Section 5.3 (Global Development Plan); provided that Partner will have the right, following such review and discussion, to make such determination; |
| (l) | review, discuss, and determine whether to add any countries in the Territory as Selected Territory GCT Countries for a given Global Clinical Trial to be conducted under the Global Development Plan, as described in Section 5.3 (Global Development Plan); |
| (m) | determine the total number of patients to be enrolled in the Territory for a given Global Clinical Trial, as contemplated in the applicable protocol for such Global Clinical Trial, as described in Section 5.3 (Global Development Plan); |
| (n) | review, discuss, and determine whether to approve any New Development Proposal, and review, discuss, and determine whether to approve any New Territory-Specific Development Activities, in each case, as described in Section 5.4 (New Development by Partner); |
| (o) | discuss the status, progress, and results of the Parties’ respective Development activities, as described in Section 5.10 (Development Reports); |
| (p) | review, discuss, and determine whether to approve the regulatory strategy for receipt of Regulatory Approval in each country or region in the Territory, as described in Section 6.1 (Regulatory Strategy); |
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| (q) | review and discuss Partner’s plan for undertaking additional regulatory activities for the Licensed Product delegated by Kiniksa or the JSC to Partner, as described in Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals); |
| (r) | review and discuss the transfer of the Manufacturing of the Licensed Product (or any component thereof) in the Territory to one or more CMOs in the Territory selected by Partner, as described in Section 6.2.1(a) (Local Manufacturing); |
| (s) | review, discuss, and determine whether to permit Partner to Manufacture the Licensed Product in the Territory itself, instead of through one or more CMOs selected by Partner, as described in Section 6.2.1(a) (Local Manufacturing); |
| (t) | review, discuss, and determine whether to approve Partner’s plan for undertaking any activities and interactions relating to obtaining and maintaining Local Manufacturing Approvals for the Licensed Product in the Territory, as described in Section 6.2.1(a) (Local Manufacturing); |
| (u) | review, discuss, and determine whether to approve any Regulatory Submissions that are in the name of Kiniksa, as described in Section 6.2.3 (Review of Regulatory Submissions); |
| (v) | facilitate the Parties’ review and updating of Partner Process and Specifications and develop a plan for remediation of any deficiencies or limitations with respect to such Partner Process and Specifications, as described in Section 7.2.4 (Process and Specifications); |
| (w) | review, discuss, and determine whether to approve Medical Affairs Plans for the Territory and any updates thereto for the Licensed Product, as described in Section 8.1 (Medical Affairs Plan); |
| (x) | review, discuss, and determine whether to approve the Commercialization Plan for the Territory and any updates thereto for the Licensed Product, as described in Section 9.2 (Commercialization Plan); |
| (y) | review, discuss, and determine whether to approve any brand strategy for the Licensed Product that is specific to the Territory (or any country or region therein) and that is inconsistent with the Global Brand Strategy for the Licensed Product, as described in Section 9.2 (Commercialization Plan); |
| (z) | review, discuss, and determine whether to approve the use of any Product Xxxx for the Licensed Product in the Territory that deviates from Kiniksa’s Global Brand Elements, as described in Section 14.9.2 (Product Marks in the Territory); and |
| (aa) | perform such other functions as expressly set forth in this Agreement or allocated to the JSC by the Parties’ written agreement. |
| 3.3. | Joint Development Committee. |
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| Development of the Licensed Product in the Field in the Territory, which will be a subcommittee of the JSC and will have the responsibilities set forth in this Article 3 (Governance). The JDC will dissolve upon completion of all Development activities with respect to the Licensed Product in the Territory. The JDC will hold meetings at such times as it elects to do so, but will meet no less frequently than quarterly, unless otherwise agreed by the Parties. All meetings will be conducted in English. The JDC may meet in person or by means of teleconference, Internet conference, videoconference, or other similar communication method. Each Party will be responsible for all of its own costs and expenses of participating in any JDC meeting. |
| 3.3.2. | Membership of the JDC. Each Party will designate up to three representatives with appropriate knowledge and expertise to serve as members of the JDC. The JDC will be co-chaired by one of the representatives of each Party. Each Party may replace its JDC representatives and co-chairpersons at any time upon written notice to the other Party. The Alliance Manager of each Party (or his or her designee) will attend each meeting of the JDC as a non-voting participant. |
| 3.3.3. | JDC Roles and Responsibilities. The responsibilities of the JDC will be to: |
| (a) | serve as a forum of information exchange and coordinate for Continuing Know-How Transfer as described in Section 4.3 (Continuing Know-How Transfer); |
| (b) | review, discuss, and submit to the JSC to further review, discuss, and determine whether to approve any updates to the Territory Development Plan, as described in Section 5.2.1 (Territory Clinical Development); |
| (c) | review, discuss, and submit to the JSC to further review, discuss, and determine whether to approve each Territory Pre-Clinical Development Plan, as described in Section 5.2.2 (Territory Pre-Clinical Development); |
| (d) | review, discuss, and submit to the JSC to further review, discuss, and determine whether to approve any updates to the Global Development Plan that include activities to be conducted by Partner in the Territory, including by participating in the conduct of any Global Clinical Trial, as described in Section 5.3 (Global Development Plan); |
| (e) | update the Territory Development Plan to reflect the JSC’s decision regarding the conduct of Territory-specific New Development Activities, as described in Section 5.4 (New Development by Partner); |
| (f) | discuss and develop the regulatory strategy for receipt of approval from the NMPA with respect to the conduct of the applicable Clinical Trials in the Territory, and submit the same to the JSC to further review, discuss, and determine whether to approve, as described in Section 6.1 (Regulatory Strategy); |
| (g) | review, discuss, and submit to the JSC to further review, discuss, and determine whether to approve Regulatory Submissions in each country or region in the Territory for the Licensed Product, as described in Section 6.2.3 (Review of Regulatory Submissions); and |
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| (h) | develop, review, and discuss an initial draft of the Medical Affairs Plans for the Licensed Product in the Territory and propose any update thereto, and submit the same to the JSC to further review, discuss, and determine whether to approve, as described in Section 8.1 (Medical Affairs Plan). |
| 3.4. | Joint Manufacturing Committee. |
| 3.4.2. | Membership of the JMC. Each Party will designate up to three representatives with appropriate knowledge and expertise to serve as members of the JMC. The JMC will be co-chaired by one of the representatives of each Party. Each Party may replace its JMC representatives and co-chairpersons at any time upon written notice to the other Party. The Alliance Manager of each Party (or his or her designee) will attend each meeting of the JMC as a non-voting participant. |
| 3.4.3. | JMC Roles and Responsibilities. The responsibilities of the JMC will be to: |
| (a) | review and discuss the Manufacturing Technology Transfer Plan for the Licensed Product, and submit the same to the JSC to further review, discuss, and determine whether to approve, as described in Section 4.2 (Manufacturing Technology Transfer); and |
| (b) | perform such other functions expressly allocated to the JMC in this Agreement or by the written agreement of the Parties. |
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| competitively sensitive information that is reasonably likely to be discussed at such meeting (i.e., a consultant that also provides services to a Third Party with a Competitive Product), then such Third Party will not be permitted to participate in such meeting (or the portion thereof during which such competitively sensitive information is reasonably likely to be discussed). |
| 3.6. | Decision-Making. |
| 3.7. | Resolution of JSC Disputes. |
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| use good faith efforts to resolve any such matter so referred to them as soon as practicable, and any final decision that the Executive Officers agree to in writing will be conclusive and binding on the Parties. |
| (b) | Partner Final Decision-Making Authority. Partner will have final decision-making authority over matters that are not Status Quo Items and that are (i) [***], (ii) [***], and (iii) [***]. |
| (c) | Kiniksa Final Decision-Making Authority. Kiniksa will have final decision-making authority with respect to all matters related to (i) [***], (ii) [***], (iii) [***], (iv) [***], and (v) [***]. |
| 3.7.3. | Limitations on Decision-Making. Notwithstanding any provision to the contrary set forth in this Agreement, without the other Party’s prior written consent, neither Party (in the exercise of a Party’s final decision-making authority), the JSC, the JDC, the JMC, nor a Party’s Executive Officer, in each case, may make a decision that could reasonably be expected to (a) require the other Party to take any action that such other Party reasonably believes would (i) require such other Party to violate any Applicable Law, the requirements of any Regulatory Authority, or any agreement with any Third Party entered into by such other Party (including any Third Party IP Agreement) or (ii) require such other Party to infringe or misappropriate any intellectual property rights of any Third Party or (b) conflict with, amend, interpret, modify, or waive compliance under this Agreement, the Clinical Supply Agreement, the Commercial Supply Agreement, the Safety Agreement, or any other agreement between the Parties related to the subject matter set forth herein. Following a determination by the JSC (A) that Partner should itself assume responsibility for the Manufacture of the Licensed Product (or any component thereof) in the Territory, or (B) the time at which to conduct the Manufacturing Technology Transfer for the Licensed Product to those CMOs selected by Partner (or, if agreed by the JSC to Partner), the JSC will not have the authority to reverse or revoke such determination unless otherwise agreed in writing by the Parties. |
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| to the other terms of this Agreement and consistent with the terms of Section 3.7 (Resolution of JSC Disputes). |
| 4.2. | Manufacturing Technology Transfer. |
| 4.2.1. | Timing of Transfer. At a time to be agreed by the JSC, which will in any event be conducted with sufficient time so that Partner can be the Marketing Authorization Holder for the Licensed Product throughout the Territory Kiniksa will perform (or cause one or more applicable Third Parties (including any CMO engaged by Kiniksa to Manufacture the Licensed Product) to perform) a Manufacturing Technology Transfer for the Licensed Product to those CMOs selected by Partner or, if agreed by the JSC, to Partner, which transfer, if to Partner and not to a CMO, will be conducted in accordance with the Manufacturing Technology Transfer Plan for the Licensed Product. Notwithstanding the foregoing, if a Manufacturing Technology Transfer is not required for Partner to be the Marketing Authorization Holder for the Licensed Product throughout the Territory, then at Partner’s election, Kiniksa will supply Licensed Product to Partner under the terms of the Commercial Supply Agreement until such time as the Commercial Supply Agreement expires or is otherwise earlier terminated by the Parties. |
| 4.2.2. | Transferred Steps. Unless otherwise agreed by the JSC, the Manufacturing Technology Transfer for the Licensed Product will contemplate the transfer to the applicable CMOs, or, if approved by the JSC, to Partner, of all activities necessary to Manufacture the Licensed Product (or components thereof) for use in the Field in the Territory in accordance with this Agreement. |
| 4.2.3. | Transfer to Partner. If the JSC determines that Partner will itself (and not through one or more CMOs) Manufacture the Licensed Product, then, in addition to the Kiniksa Know-How provided to Partner pursuant to the Initial Know-How Transfer, the Parties will develop a draft Manufacturing Technology Transfer Plan for the Licensed Product that contemplates the transfer to Partner of the relevant Kiniksa Manufacturing Know-How for the Licensed Product in the Territory in accordance with Section 6.2.1(a) (Local Manufacturing). In such case, the Parties will develop a draft Manufacturing Technology |
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| Transfer Plan at a time to be agreed by the JSC, which will in any event be with sufficient time so that Partner can be the Marketing Authorization Holder for the Licensed Product throughout the Territory or, if a Manufacturing Technology Transfer is not required for Partner to be the Marketing Authorization Holder for the Licensed Product throughout the Territory, no later than the date of submission of the first MAA for the Licensed Product in the PRC. The Parties will provide such initial draft of the Manufacturing Technology Transfer Plan to the JMC for review and discussion, and the JMC will provide such draft to the JSC to review, discuss, and determine whether to approve, which the JSC will do no later than [***] days following the JMC’s provision of such draft to the JSC. If the JSC determines that Partner will itself Manufacture the Licensed Product, then following the approval of the Manufacturing Technology Transfer Plan for the Licensed Product, the Parties will use reasonable efforts to complete the Manufacturing Technology Transfer for the Licensed Product on a timely basis and in accordance with the terms of such Manufacturing Technology Transfer Plan. |
| 4.2.4. | Manufacturing Technology Transfer Costs. Subject to Section 4.4 (Technology Transfer Costs), Partner will be solely responsible for any and all costs and expenses relating to the Manufacturing Technology Transfer for the Licensed Product, whether to those CMOs selected by Partner or, if agreed by the JSC, to Partner, including any costs imposed by any CMO engaged by Kiniksa for the Manufacture of the Licensed Product relating to the transfer to those CMOs selected by Partner to Manufacture the Licensed Product for use by Partner in the Territory (or to Partner, if approved by the JSC). |
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| (a) internal costs (at the FTE Rate) of such consultation and assistance for the Licensed Product and (b) all out-of-pocket costs, in each case ((a) and (b)), reasonably incurred by or on behalf of Kiniksa in connection with such assistance for the Initial Know-How Transfer, and the Manufacturing Technology Transfer, and the Continuing Know-How Transfer within [***] days after receiving Kiniksa’s invoice therefor. |
| 5.2. | Territory Development Plan. |
| 5.2.2. | Territory Pre-Clinical Development. In connection with the Clinical Development of the Licensed Product pursuant to a given Territory Development Plan, Partner may |
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| identify, on a country-by-country or region-by-region basis, certain Pre-Clinical Development that is required in order to obtain Regulatory Approval of the Licensed Product in such country or region (“Required Pre-Clinical Development”). [***] If the JSC approves a Pre-Clinical Development Plan, then Kiniksa will have [***] days following the date of such approval by the JSC to determine whether it will either perform or permit Partner to perform such Required Pre-Clinical Development in accordance with the Pre-Clinical Development Plan. If Kiniksa elects to perform such Required Pre-Clinical Development, then Kiniksa will (a) provide to Partner a budget for such Pre-Clinical Development, to be included under the Pre-Clinical Development Plan, (b) use reasonable efforts to perform the Required Pre-Clinical Development in accordance with the applicable Pre-Clinical Development Plan (including the budget therein), and (c) deliver all results therefrom to Partner in accordance with Section 4.3 (Continuing Know-How Transfer) or as otherwise specified in the Pre-Clinical Development Plan. Partner will reimburse Kiniksa for its documented costs and expenses incurred performing such Required Pre-Clinical Development. If Kiniksa elects not to perform the Required Pre-Clinical Development as set forth in the applicable Pre-Clinical Development Plan, or fails to notify Partner of its decision within such [***] day time period, then (i) Partner will have the right to perform, at its cost and expense, the Required Pre-Clinical Development in accordance with the applicable Pre-Clinical Development Plan, and (ii) only in such case, will Partner have the right to practice under the non-exclusive license under the Kiniksa Technology granted pursuant to Section 2.1 (Licenses Granted to Partner) solely with respect to the performance of the Pre-Clinical Development in accordance with the applicable Pre-Clinical Development Plan. |
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| Global Clinical Trial will be conducted (the countries in the Territory in which the Global Clinical Trial will be conducted, the “Selected Territory GCT Countries”) and, unless Applicable Law prevents the conduct of such Global Clinical Trial in the PRC, the Selected Territory GCT Countries will include the PRC, |
| (b) | if the PRC is a Selected Territory GCT Country, then the protocol for such Global Clinical Trial will contemplate the enrollment of a sufficient number of patients in the PRC to support the submission of an MAA for the Licensed Product in the applicable Indication in the PRC, and |
| (c) | unless otherwise agreed by the JSC, the Global Development Plan will not require Partner to enroll more than [***]% of the total number of patients contemplated in the applicable protocol for such Global Clinical Trial (and nothing set forth herein will require Kiniksa to otherwise increase the total number of patients contemplated in the applicable protocol for such Global Clinical Trial). |
Kiniksa will not approach any other Third Party to serve as the Territory Sponsor for any Global Clinical Trial in the Territory without first offering such opportunity to Partner. The Global Development Plan and each update thereto will include: (i) an outline of all major Development activities for the Licensed Product to be conducted worldwide by Kiniksa, and (ii) for those Global Clinical Trials in which Partner agrees to participate and serve as Territory Sponsor in accordance with the terms set forth in this Agreement, details and estimated timelines of the Clinical Development activities to be conducted in the Selected Territory GCT Countries and assigned to Partner to support Global Clinical Trials or other global Development for the Licensed Product, which activities will, unless otherwise agreed to by Partner, be designed to support the filing of the Marketing Authorization Applications within the Territory for the Licensed Product. From time to time, Kiniksa may make and implement updates to the then-current Global Development Plan for the Licensed Product, including to contemplate the conduct of the Development of the Licensed Product for a New Development. Solely to the extent such amendments (A) are material (in cost, time, and scope), and (B) include activities to be conducted by Partner in the Territory, Kiniksa or the JDC (as applicable) will submit such proposed updates to the JSC to review, discuss, and determine whether to approve.
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| be measured, and the statistical design and powering (the “New Development Activities”), as well as a proposed timeline and budget and an analysis of the business opportunity and revenue potential anticipated to result from such New Development Activities. The JSC will review, discuss, and determine whether to approve a New Development Proposal within [***] days after receipt thereof from Partner. Upon such an approval, (a) the New Development Activities set forth in such New Development Proposal will be “New Territory-Specific Development Activities” for purposes of this Agreement, and (b) the JDC will update the Territory Development Plan for the Licensed Product to include such New Territory-Specific Development Activities for those countries or regions in the Territory agreed by the JSC, including the proposed timelines, in each case, for such New Development Activities set forth in such New Development Proposal (as may be amended by the JSC upon such approval). Any New Territory-Specific Development Activities included in a Territory Development Plan pursuant to this 5.4 (New Development by Partner) will be Development activities for all purposes under this Agreement. |
| 5.5. | New Development by Kiniksa. If Kiniksa proposes any Global Clinical Trials for the Licensed Product for any New Development, then: |
| (a) | Partner will not be obligated to implement such Global Clinical Trials in any such country or region in the Territory or perform any activities in connection therewith, and |
| (b) | notwithstanding any provision to the contrary set forth in this Agreement (including the terms of Section 2.1 (License Grants to Partner)), unless Partner subsequently elects to (and does) reimburse Kiniksa for the costs and expenses of such Global Clinical Trials for the Licensed Product in accordance with Section 5.5.3(b) (Reimbursement at a Premium), Partner will not have any rights with respect to any data or results generated in such Global Clinical Trials for such New Development, including pursuant to Section 5.11 (Data Exchange and Use) or Section 6.5 (Right of Reference) except as necessary for Partner to comply with Applicable Law or safety reporting requirements to applicable Regulatory Authorities in the Territory, and |
| (c) | Kiniksa will have the right to conduct such Global Clinical Trials for the Licensed Product for such New Development globally (including in the Territory), at Kiniksa’s cost and expense. |
Notwithstanding any provision to the contrary set forth in this Agreement, if Partner agrees to act as Territory Sponsor or regulatory agent throughout the Selected Territory GCT Countries for a given Global Clinical Trial, but is prevented by Applicable Law from participating in such Global Clinical Trial for such New Development in the PRC and instead conducts a Pivotal Clinical Trial within the PRC with respect to such New Development for the submission of a MAA for the PRC with respect to such New Development, then (i) the foregoing restriction on access to data or results generated in such Global Clinical Trials for such New Development, including pursuant to Section 5.11 (Data Exchange and
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Use), and (ii) the obligation to reimburse a percentage of the costs and expenses of such Global Clinical Trial in order to obtain access to such data and results, pursuant to Section 5.5.3 (Partner Sharing of Development Costs and Data Access), will not apply and such data and results will be included within Partner’s right of reference pursuant to Section 6.5 (Right of Reference).
| 5.5.2. | Partner Assistance. If Partner (either itself or through its Affiliate) elects to serve as the Territory Sponsor or regulatory agent in the Territory for, and enroll and treat patients in, any such Global Clinical Trials for a New Development, then such Partner activities will be added to the Global Development Plan and submitted to the JSC for approval in accordance with Section 5.3 (Global Development Plan). |
| 5.5.3. | Partner Sharing of Development Costs and Data Access. |
| (b) | Reimbursement at a Premium. If Partner (either itself or through its Affiliate) either: |
| (i) | elects to serve as the Territory Sponsor or regulatory agent in all Selected Territory GCT Countries, but does not bear [***]% of the costs and expenses incurred by or on behalf of the Parties in the conduct of such Global Clinical Trial in all such Selected Territory GCT Countries, any other Development costs or expenses associated therewith, and the Fully Burdened Manufacturing Cost of the Licensed Product used for such Global Clinical Trial as set forth above in Section 5.5.3(a) (Ongoing Reimbursement) or |
| (ii) | does not elect to serve as the Territory Sponsor or regulatory agent in all Selected Territory GCT Countries for any such Global Clinical Trials and to bear [***]% of the costs and expenses incurred by or on behalf of the Parties in the conduct of such Global Clinical Trials in all such Selected Territory GCT Countries, any other Development costs or expenses associated therewith, and the Fully Burdened Manufacturing Cost of the Licensed Product used for such Global Clinical Trial as set forth above in Section 5.5.3(a) (Ongoing Reimbursement), then, in each case ((i) and (ii)), if Partner wishes to be granted rights with respect to any data or |
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| results generated in such Global Clinical Trial for the Licensed Product for such New Development for the Territory, including pursuant to Section 5.11 (Data Exchange and Use) or Section 6.5 (Right of Reference), then unless otherwise agreed by the Parties, upon the receipt of the first Regulatory Approval for the Licensed Product for such New Development in the U.S. or any country or region in the Territory, Partner must: |
| (A) | reimburse Kiniksa, in case (ii), for [***]% of all costs and expenses incurred by or on behalf of Kiniksa in the conduct of such Global Clinical Trial for the Licensed Product, including the Fully Burdened Manufacturing Cost of the Licensed Product used for such Global Clinical Trial, and reimburse Kiniksa, in case (i), for [***]% of all costs and expenses of such Global Clinical Trial solely in the Selected Territory GCT Countries for the Licensed Product and any other Development costs or expenses associated therewith, including the Fully Burdened Manufacturing Cost of the Licensed Product used for such Global Clinical Trial and other Development activities for the Selected Territory GCT Countries, which costs and expenses are incurred by or on behalf of Kiniksa as a result of Partner’s failure to bear such costs in accordance with Section 5.5.3(a) (Ongoing Reimbursement), plus, in each case ((i) and (ii)), a [***]% xxxx-up with respect to all such costs and expenses, and |
| (B) | pay to Kiniksa any Development Milestone Payment that would have been payable with respect to such Global Clinical Trial pursuant to Section 10.2.1 (Development Milestone Events and Payments) had Partner participated in such Global Clinical Trial. |
| 5.6. | Standard of Conduct. |
| 5.6.1. | General Obligations. Partner will perform, and will cause its Affiliates, Sublicensees, and Subcontractors to perform, all Development activities for the Licensed Product in a timely and professional manner, and in compliance with the Territory Development Plan, Global Development Plan, or Pre-Clinical Development Plan, as applicable, and all |
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| Applicable Law, including as applicable cGLP, cGCP, and cGMP. In addition, each Party will conduct its obligations with respect to any Global Clinical Trial under a Global Development Plan, Pre-Clinical Development Plan, or (with respect to Partner) Territory-Specific Clinical Trial under a Territory Development Plan (as applicable) in strict adherence with the study design set forth in the applicable protocol therefor and as set forth in such Global Development Plan or such Territory Development Plan, each as may be amended from time to time, and will comply with each statistical analysis plan implemented by the other Party (as applicable) in connection therewith. |
| 5.6.2. | Global Development. Kiniksa agrees that if Kiniksa or its Affiliates fail to perform one or more Global Clinical Trials as set forth in any Global Development Plan in accordance with the study design set forth in the protocol(s) therefor, then, to the extent that, as a direct result of such failure, Partner is unable to complete its obligations under the Global Development Plan (if Partner is participating as Territory Sponsor) or any Territory Development Plan, Partner will not be in breach of its diligence obligations under Section 5.1 (Development Diligence and Responsibilities) with respect to such failure to perform its obligations under the Global Development Plan or Territory Development Plan, as applicable, as a result of Kiniksa’s failure to perform. |
| 5.7. | Responsibility for Development Costs. |
| 5.8. | Clinical Trial Audit Rights. |
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| Replacement Site will be compliant in all respects with Applicable Law and Kiniksa’s Global Clinical Trial standards provided by Kiniksa from time to time during the Term. In addition, if any audit of any Sublicensee conducted pursuant to Section 5.8.1 (Conduct of Audits) identifies that any Sublicensee (including any contract research organizations or other subcontractors engaged to perform activities under the Global Development Plan or Territory Development Plan) is not performing its activities in accordance with the terms of the Third Party IP Agreements, this Agreement, the Global Development Plan or Territory Development Plan, cGLP, cGMP, or cGCP, as applicable, and Applicable Law or do not meet Kiniksa’s Global Clinical Trial standards provided by Kiniksa in accordance with Section 5.8.1 (Conduct of Audits), or that any deficiencies identified as a result of any such audit related to any such Sublicensee’s performance may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from Partner’s conduct of any such Global Clinical Trial or Territory-Specific Clinical Trial (as applicable) (each, a “Deficient Sublicensee”), then Partner will promptly (a) require such Deficient Sublicensee to remediate such deficiencies in a timely manner or (b) remove such Deficient Sublicensee from performing further activities under the Global Development Plan or Territory Development Plan and replace such Deficient Sublicensee with a new Sublicensee engaged in accordance with Section 2.2 (Sublicensing and Subcontractors) to perform the applicable Development activities at Partner’s sole cost and expense unless such deficiencies can be promptly remedied to Kiniksa’s reasonable satisfaction in a timely manner. If the Deficient Sublicensee is unable to mitigate the deficiencies in a timely manner or Partner is unable to mitigate the deficiencies or replace any Deficient Site with a Replacement Site or Deficient Sublicensee with a replacement Sublicensee (as applicable), as applicable, or, in Kiniksa’s reasonable discretion, the Deficient Sublicensee or Partner, as applicable, is unable to mitigate the deficiencies or replace any Deficient Site or Deficient Sublicensee, as applicable, in a timely manner so as not to jeopardize the Parties’ ability to meet the timelines for Regulatory Submissions set forth in the Territory Development Plan, then, in each case, Kiniksa may (i) replace such Deficient Site with one or more Replacement Sites outside of the Territory, or (ii) with respect to a Deficient Sublicensee, perform itself or have performed by any Third Party engaged by Kiniksa in its sole discretion, the applicable Development activities, and in each case ((i) and (ii)), Partner will be responsible for all costs and expenses incurred by or on behalf of Kiniksa in connection with the engagement of any such Replacement Site or replacement Sublicensee. Kiniksa will invoice Partner quarterly for the foregoing costs incurred by or on behalf of Kiniksa in such Calendar Quarter, and Partner will pay the amount invoiced within [***] days after the date of any such invoice. |
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| expenses reasonably incurred by Kiniksa to obtain translation thereof by translators selected by Kiniksa. |
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| protocols, Investigator’s Brochures, case report forms, and analysis plans, all in English language) Controlled by such Party that are generated by or on behalf of such Party or its Affiliates, Sublicensees, or Subcontractors, if applicable, in the Development of the Licensed Product, including all data and results (or on whose behalf such data and results are generated) in the course of conducting such non-clinical or preclinical studies or Clinical Trials for the Licensed Product. Such data, results, and supporting documentation provided by a Party pursuant to this Section 5.11 (Data Exchange and Use) will be the Confidential Information of such Party, and such Party will be the Disclosing Party with respect thereto, in each case, subject to the terms of Article 11 (Confidentiality; Publication). Partner will not have the right to use or reference such data and results provided by Kiniksa or any data that constitutes Assigned Collaboration Know-How, unless and until Partner bears its applicable share of the costs and expenses in accordance with Section 5.5 (New Development by Kiniksa), in which case, Partner will have the exclusive right to use and reference such data and results for the purpose of performing Development activities in accordance with this Agreement (including under any Global Development Plan and Territory Development Plan), and obtaining, supporting, and maintaining Local Manufacturing Approvals, Regulatory Approvals, and any Reimbursement Approval, as applicable, of the Licensed Product in the Territory without additional consideration. Kiniksa and its designees will have the exclusive right to use and reference such data and results provided by Partner, for the purpose of Developing the Licensed Product, and obtaining, supporting, or maintaining Regulatory Approval or any Reimbursement Approval, as applicable, of the Licensed Product outside the Territory, without additional consideration. |
| 6.2. | Partner’s Responsibilities. |
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| authorizations necessary for the applicable CMOs (or Partner, if agreed by the JSC) to Manufacture the Licensed Product (or any component thereof) in the Territory (including after validation and qualification of such CMOs’ applicable facilities in the Territory) (“Local Manufacturing Approval”), Partner or one of its Affiliates will be responsible for all regulatory activities and interactions with Regulatory Authorities in the Territory leading up to and including obtaining (to the extent not already obtained) and thereafter maintaining Local Manufacturing Approvals for such locally-Manufactured Licensed Product (or any component thereof) in the Territory in Partner’s or its Affiliate’s own name in accordance with the applicable regulatory strategy approved by the JSC. Prior to undertaking any such activities and interactions relating to obtaining and maintaining Local Manufacturing Approvals in the Territory, whether prior to or after the date of receipt of such Local Manufacturing Approvals for the Licensed Product (or any component thereof), Partner will submit a reasonably detailed plan for undertaking the same to the JSC to review, discuss, and determine whether to approve. |
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| (or its designee) will lead any such meeting or discussion and Kiniksa or its designee will have the right, but not the obligation, to attend and participate in any such meeting or discussion unless prohibited or restricted by Applicable Law or Regulatory Authority. Notwithstanding the foregoing, if any such meeting or discussion with a Regulatory Authority concerns the Licensed Product for which Kiniksa is the Marketing Authorization Holder from such Regulatory Authority at such time, then Kiniksa or its designee will have the further right, but not obligation, to lead such meeting or discussion. At Kiniksa’s request, Kiniksa may participate in any preparations of Partner or its Affiliates or Sublicensees for any such meeting or discussion. If Kiniksa elects not to attend such meeting or discussion, then Partner will provide to Kiniksa a written summary thereof in English promptly following such meeting or discussion, as well as any minutes prepared by Partner or, to the extent available, formal minutes generated by the Regulatory Authority. |
| 6.2.5. | Partner Responsibility for Costs and Expenses. Irrespective of which Party is the Marketing Authorization Holder for the Licensed Product in the Territory, Partner will be responsible for all costs and expenses incurred in connection with the performance of all regulatory activities leading up to and including obtaining and thereafter maintaining, Local Manufacturing Approvals, Regulatory Approvals, and any Reimbursement Approvals, as applicable, for the Licensed Product from Regulatory Authorities in the Territory. |
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| Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product in the Field in the Territory. Kiniksa may use such right of reference to Partner’s Regulatory Submissions, if any, solely to seek, obtain, support, and maintain Regulatory Approval and any Reimbursement Approvals for the Licensed Product outside of the Territory. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 6.5 (Right of Reference). Each Party will take such actions as may be reasonably requested by the other Party to give effect to the intent of this Section 6.5 (Right of Reference) and to give the other Party the benefit of the granting Party’s Regulatory Submissions in the other Party’s territory as provided herein. Such actions may include providing to the other Party copies of correspondence and communications received from the applicable Regulatory Authorities related to such Party’s application for Regulatory Approval of the Licensed Product in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Product outside of the Territory (if Kiniksa is the Party seeking Regulatory Approval). |
| 6.6. | Adverse Events Reporting. |
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| Business Days after receipt of such notice (or, if action is taken without notice, within [***] Business Days of Partner becoming aware of such action). Partner will have the final decision-making authority with respect to such responses and will incorporate Kiniksa’s reasonable comments to any such responses, provided that if Kiniksa is then the Marketing Authorization Holder for the Licensed Product, then Kiniksa will have final decision-making authority with respect to such responses. The costs and expenses of any regulatory action in the Territory [***]. Each Party will keep the other Party informed, as soon as possible, but no later than [***] after notification of any action by, or notification or other information that it receives (directly or indirectly) from, any Regulatory Authority, Third Party, or other Governmental Authority that: |
| 6.8.1. | raises any material concerns regarding the safety or efficacy of the Licensed Product; |
| 6.8.2. | indicates or suggests a potential investigation or formal inquiry by any Regulatory Authority in connection with the Exploitation of the Licensed Product; or |
| 6.8.3. | is reasonably likely to lead to a recall or market withdrawal of the Licensed Product anywhere in the Territory. |
| 7.1. | Supply by Kiniksa. |
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| the “Commercial Supply Agreement”), for the supply to Partner of the Licensed Product pursuant to which Partner will purchase from Kiniksa all of its requirements of drug product for the Licensed Product necessary for Partner to fulfill its obligations under this Agreement related to the Commercialization of the Licensed Product in the Territory. The terms of the Commercial Supply Agreement will include product warranties and terms related to labeling, safety stock provisions, failure to supply, audit, shortage allocation, delivery, acceptance and rejection, limitations of liability, and other customary terms, that, in each case, are consistent with the terms of any agreement between Kiniksa and any Third Party Manufacturing the Licensed Product. Notwithstanding any provision to the contrary set forth in this Agreement, the term of the Commercial Supply Agreement will expire no later than [***] years after the commencement of the Manufacturing Technology Transfer for the Licensed Product and following expiration of the Commercial Supply Agreement, Kiniksa will have no obligation to supply to Partner drug product for the Licensed Product for Partner to fulfill its obligations under this Agreement related to the Commercialization of the Licensed Product in the Territory. Pursuant to and in accordance with the Commercial Supply Agreement for the Licensed Product in the Territory, Kiniksa will use reasonable efforts to supply to Partner pursuant to this Section 7.1.2 (Commercial Supply) the Licensed Product at a transfer price equal to [***]. Upon its receipt of a purchase order from Partner for the Licensed Product under the Commercial Supply Agreement, Kiniksa will invoice Partner for the Licensed Product and, subject to the terms of the Commercial Supply Agreement, Partner will pay the undisputed invoiced amounts within [***] days after the date of the invoice. |
| 7.1.3. | Shipment and Delivery. Delivery of all Licensed Product supplied by Kiniksa under the Clinical Supply Agreement or Commercial Supply Agreement will take place [***] (Incoterms 2020) at the applicable port of import. Kiniksa will be responsible for obtaining all licenses or other authorizations for the exportation of Licensed Product. Partner will be responsible for obtaining all licenses or other authorizations for the importation of Licensed Product into the Territory, and Kiniksa will use reasonable efforts to provide to Partner any documentation in Kiniksa’s Control that is required with respect to the importation of the Licensed Product into the Territory. Partner will also be responsible for all quality control and quality assurance, release, storage, customs clearance, and distribution of the Licensed Product in the Territory, at Partner’s cost and expense. |
| 7.2. | Supply by Partner. |
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| 7.2.3. | Supply of Licensed Product. Subject to Section 7.2.2 (Restriction on Manufacturing by Partner), following the date of receipt of Local Manufacturing Approvals for the Licensed Product (or any component thereof) pursuant to Section 4.2 (Manufacturing Technology Transfer), Partner will, solely through those CMOs selected by Partner to Manufacture the Licensed Product in the Territory for use by Partner in the Territory (or, if approved by the JSC, by Partner itself), Manufacture Licensed Product (or any component thereof) in the Territory solely for clinical or commercial use in the Territory by or on behalf of Partner or its Affiliates and, if Partner is to itself Manufacture the Licensed Product, as set forth in the Manufacturing Technology Transfer Plan for the Licensed Product approved by the JSC, except with respect to any supply of Licensed Product (or any component thereof) for use by Kiniksa, at Partner’s sole cost and expense. Partner will ensure that the Manufacturing process with respect to all locally-Manufactured Licensed Product (or any component thereof) will at all times be in accordance with the Partner Process and Specifications for the Licensed Product approved by Kiniksa pursuant to Section 7.2.4 (Process and Specifications) and cGMP and cGCP guidelines, and in compliance with Applicable Law. In addition, following the date of receipt of Local Manufacturing Approvals, at Kiniksa’s request, those CMOs selected by Partner (or, if the JSC determines that Partner will have the right to Manufacture the Licensed Product, Partner) will serve as a second source of supply of the Licensed Product (or any component thereof) for use by Kiniksa. Following any such request by Kiniksa, the Parties will enter into a separate written agreement pursuant to which Partner (through its CMOs, or, if the JSC determines that Partner will have the right to Manufacture the Licensed Product, Partner itself) would supply such locally-Manufactured Licensed Product to Kiniksa at a price equal to Partner’s Fully Burdened Manufacturing Cost and upon such other customary terms to be agreed to by the Parties, including product warranties and terms related to labeling, safety stock provisions, failure to supply, audit, shortage allocation, delivery, acceptance and rejection, limitations of liability, and other customary terms, that, in each case, are consistent with the terms of any agreement between Partner and any Third Party Manufacturing the Licensed Product. |
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| 7.2.5. | Manufacturing by Partner. Subject to the terms of this Agreement, including Section 7.2.4 (Process and Specifications), following completion of the Manufacturing Technology Transfer to the applicable CMOs to, or, if the JSC determines that Partner will itself Manufacture the Licensed Product, to Partner, Partner will have the right to make day-to-day operational decisions solely relating to the Manufacture by such CMOs (or, if approved by the JSC, Partner) of the Licensed Product in the Territory. |
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| performing such activities. Thereafter, from time to time, but at least annually, the JDC will propose updates to the Medical Affairs Plan for the Licensed Product to reflect changes in such plans, including to account for relevant factors that may influence such plan and the Medical Affairs activities set forth therein and provide each such update to the JSC to review, discuss, and determine whether to approve. To the extent relevant to the conduct of Medical Affairs activities for the Licensed Product in the Territory by Partner in accordance with the Medical Affairs Plan, the Parties will discuss, through the JSC, Kiniksa’s Medical Affairs activities outside of the Territory, including medical publications, real world study data, symposium, and conference presentations. |
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| in response to changes in the marketplace, relative commercial success of the Licensed Product, and other relevant factors that may influence such plan and the Commercialization activities set forth therein and provide each such update to the JSC to review, discuss, and determine whether to approve. The Commercialization Plan (including each update thereto) must be consistent with Kiniksa’s global brand strategy and global key messaging for the Licensed Product (each, a “Global Brand Strategy”), as provided to Partner by Kiniksa from time to time during the Term. |
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| Development Plan or Territory Development Plan, or except in connection with a Manufacturing Technology Transfer pursuant to Article 7 (Manufacturing). |
| 10.2. | Milestone Payments. |
Table 10.2.1 Development Milestones | |
Development Milestone Events | Development Milestone Payment (in U.S. Dollars) |
Initiation of first Territory-Specific Clinical Trial that is a Phase III Clinical Trial for each Indication for the Licensed Product | $[***] |
Initiation of first Global Clinical Trial that is a Phase III Clinical Trial in each Indication for the Licensed Product in which Partner has agreed to participate in accordance with this Agreement | $[***] |
Receipt of Regulatory Approval from the NMPA for the Licensed Product in the first Indication | $[***] |
Receipt of Regulatory Approval from the NMPA for the Licensed Product in the second Indication | $[***] |
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Table 10.2.2 Sales Milestones | |||
| Sales Milestone Event | Sales Milestone Payment (in U.S. Dollars) | |
1. | First Calendar Year in which annual Net Sales of the Licensed Product in the Territory equal or exceed $[***] USD | $[***] | |
2. | First Calendar Year in which annual Net Sales of the Licensed Product in the Territory equal or exceed $[***] USD | $[***] | |
3. | First Calendar Year in which annual Net Sales of the Licensed Product in the Territory equal or exceed $[***] USD | $[***] | |
4. | First Calendar Year in which annual Net Sales of the Licensed Product in the Territory equal or exceed $[***] USD | $[***] | |
5. | First Calendar Year in which annual Net Sales of the Licensed Product in the Territory equal or exceed $[***] USD | $[***] | |
6. | First Calendar Year in which annual Net Sales of the Licensed Product in the Territory equal or exceed $[***] USD | $[***] | |
7. | First Calendar Year in which annual Net Sales of the Licensed Product in the Territory equal or exceed $[***] USD | $[***] | |
8. | First Calendar Year in which annual Net Sales of the Licensed Product in the Territory equal or exceed $[***] USD | $[***] | |
| 10.2.3. | Milestone Conditions. |
| 10.3. | Royalty Payments to Kiniksa. |
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Table 10.3.1 Royalty Payments | |
Portion of Aggregate Calendar Year Net Sales of the Licensed Product in the Territory (in U.S. Dollars) | Royalty Rate |
Greater than $[***] and less than $[***] | [***]% |
Greater than or equal to $[***] and less than $[***] | [***]% |
Greater than or equal to $[***] and less than $[***] | [***]% |
Greater than or equal to $[***] | [***]% |
For example, [***]Royalty Term. Partner will pay to Kiniksa the Royalty Payments on a country-by-country or region-by-region basis, as applicable, until the later of: (a) the [***] anniversary of the date of the First Commercial Sale of the Licensed Product in such country or region in the Territory; (b) the date of expiration of the last-to-expire Valid Claim of a Royalty Patent Right Covering the Licensed Product in such country or region; and (c) the expiration of all Regulatory Exclusivity for the Licensed Product in such country or region (“Royalty Term”).
| 10.3.2. | Royalty Reductions. |
| (b) | Biosimilar Product Reduction. Subject to Section 10.3.3(d) (Cumulative Reductions Floor), on a country-by-country or region-by-region basis, as |
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| applicable, if during any Calendar Quarter, there is Biosimilar Competition for the Licensed Product in such country or region, then the Net Sales of the Licensed Product in such country or region in such Calendar Quarter will be reduced by the applicable percentage set forth in Table 10.3.3(b), in each Calendar Quarter in which the Biosimilar Competition continues during the Royalty Term for the Licensed Product in such country or region. Partner will promptly notify Kiniksa of the occurrence of Biosimilar Competition, which notice will specify the applicable Biosimilar Products, Indication, and country or region in the Territory. |
Table 10.3.3(b) – BIOSIMILAR PRODUCT ROYALTY REDUCTION RATES | |
Percentage Decline in Aggregate Calendar Year Net Sales of the Licensed Product in the Territory Due to Biosimilar Competition | Net Sales Reduction |
Greater than [***]% but less than [***]% | [***]% |
Greater than [***]% | [***]% |
| (e) | No Duplicative Royalties. In no event will the sale of the Licensed Product in a given country in the Territory give rise to more than one Royalty Payment due to Kiniksa, including any instance where the Licensed Product is Covered by more than one Royalty Patent Right in such country. |
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| 10.6. | No Refunds. Except as expressly provided herein, all payments under this Agreement will be irrevocable, non-refundable, and non-creditable. |
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| 10.12. | Taxes. |
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| deduction or withholding been required to be made on such amount and (ii) no other Taxes been imposed on any additional amounts payable to Kiniksa. Each Royalty Report will show the amounts of Taxes due and paid by Partner with respect to payments made by Partner to Kiniksa during such Calendar Quarter. The amount of the invoice provided by Kiniksa to Partner must include the withholding income tax amount paid by Partner and the amount actually received by Kiniksa, even if Kiniksa only receives the net amount payable in accordance with this Agreement. |
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| 11.1. | Duty of Confidence. Subject to the other provisions of this Article 11 (Confidentiality; Publication): |
| 11.1.2. | the Receiving Party will treat all Confidential Information provided by the Disclosing Party at a minimum, with the same degree of care as the Receiving Party uses for its own similar information, but in no event less than a reasonable degree of care; |
| 11.1.3. | the Receiving Party may only use any Confidential Information of the Disclosing Party for the purposes of performing its obligations or exercising its rights under this Agreement; |
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| obligations set forth in this Agreement. Each Party will remain responsible for any failure by its Affiliates, licensees, and Sublicensees, and its and its Affiliates’, licensees’, and Sublicensees’ respective employees, directors, officers, agents, contractors, consultants, attorneys, accountants, banks, investors, and advisors, in each case, to treat such Confidential Information as required under this Section 11.1 (Duty of Confidence) (as if such Affiliates, licensees, Sublicensees, employees, directors, officers, agents, contractors, consultants, attorneys, accountants, banks, investors, and advisors were Parties directly bound to the requirements of this Section 11.1 (Duty of Confidence)); and |
| 11.1.5. | each Party will promptly notify the other Party of any misuse or unauthorized disclosure of the other Party’s Confidential Information. |
| 11.3.2. | is generally available to the public before its receipt from the Disclosing Party; |
No combination of features or disclosures will be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.
| 11.4. | Authorized Disclosures. |
| 11.4.1. | Permitted Circumstances. Notwithstanding the obligations set forth in Section 11.1 (Duty of Confidence), a Party may disclose the other Party’s Confidential Information |
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| (including this Agreement and only the specifically relevant terms herein) to the extent such disclosure is reasonably necessary in the following situations: |
| (a) | disclosure to comply with the terms of any Third Party IP Agreement; |
| (b) | (i) the Patent Prosecution or enforcement of Kiniksa Patent Rights, Kiniksa Manufacturing Patent Rights, or Partner Collaboration Patent Rights, in each case, as contemplated by this Agreement; or (ii) in connection with regulatory filings and other filings with Governmental Authorities (including Regulatory Authorities), as necessary for the Exploitation of the Licensed Product; |
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| (e) | disclosure pursuant to Section 6.8 (Notice of Regulatory Action), Section 11.6 (Publication and Listing of Clinical Trials), and Section 11.7 (Publicity; Use of Name). |
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| will require its Affiliates and Sublicensees to comply with the obligations of this Section 11.5 (Publications) as if they were Partner, and Partner will be liable for any non-compliance of such Persons. |
| 11.7. | Publicity; Use of Names. |
| 11.7.2. | Disclosures by the Parties. |
| (b) | Notwithstanding any provision to the contrary set forth in this Agreement, Partner its designees may publicly disclose (in written, oral, or other form): (a) the achievement of Milestone Events under this Agreement (including the amount, payment, and timing of any such Milestone Event); (b) with Kiniksa’s prior written approval, the commencement, completion, material data, or key results of any Global Clinical Trials as it relates to the Territory or Territory-Specific Clinical Trials for the Licensed Product conducted under this Agreement; (c) with Kiniksa’s prior written approval, any other information relating to any Global Clinical Trial as it relates to the Territory, including the commencement, completion, material data, or key results; and (d) the receipt of Regulatory |
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| Approval or Reimbursement Approval within the Territory for the Licensed Product. |
| 11.7.4. | Repeated Disclosures. The Parties agree that after (a) the issuance of a disclosure or press release made in accordance with Section 11.7.1 (Press Release) or Section 11.4 (Authorized Disclosures), (b) the use of the other Party’s name or logo by a Party in presentations, its website, collateral materials, or corporate overviews to describe the collaboration relationship in accordance with Section 11.7.3 (Use of Names), or (c) use of the other Party’s name or logo by a Party in any taglines of press releases issued pursuant to Section 11.7.1 (Press Release) or Section 11.4 (Authorized Disclosures), in each case ((a) – (c)), the disclosing Party may make subsequent public disclosures reiterating such information without having to obtain the other Party’s prior consent and approval so long as the information in such press release, other public announcement, or other materials remains true, correct, and the most current information with respect to the subject matters set forth therein. Similarly, after a Publication has been made available to the public, each Party may post such Publication or a link to it on its corporate website (or any website managed by such Party in connection with a Clinical Trial for the Licensed Product, as appropriate) without the prior written consent of the other Party, so long as the information in such Publication remains true, correct, and the most current information with respect to the subject matters set forth therein. Notwithstanding any provision to the contrary set forth in this Agreement, neither Party will use the other Party’s corporate name in such manner that the distinctiveness, reputation, and validity of any trademarks and corporate or trade names of such other Party will not be impaired, and consistent with best practices used by such other Party for its other collaborators. |
| 12.1. | Representations and Warranties of Each Party. Each Party represents and warrants to the other Party as of the Effective Date as follows: |
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| 12.1.1. | It (a) is a corporation or limited company duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization; (b) has the full right, power and authority to enter into this Agreement and to perform its obligations hereunder, including the legal right to grant the licenses granted by it hereunder in accordance with the terms of this Agreement; and (c) has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder. |
| 12.1.2. | It has not been Debarred/Excluded and no proceeding that could result it in being Debarred/Excluded is pending, and neither it nor any of its Affiliates has used, in any capacity in the performance of obligations relating to the Licensed Product, any employee, Subcontractor, consultant, agent, representative, or other Person who has been Debarred/Excluded. |
| 12.1.3. | All consents, approvals, and authorizations from all Governmental Authorities or other Third Parties required to be obtained by such Party in connection with this Agreement have been obtained. |
| 12.2. | Representations and Warranties of Kiniksa. Kiniksa represents and warrants to Partner as of the Effective Date as follows: |
| 12.2.4. | There are no pending or, to Kiniksa’s Knowledge, threatened, adverse actions, suits, or proceedings against Kiniksa or any of its Affiliates or to Kiniksa’s Knowledge, any of its licensees, sublicensees or licensors involving the Kiniksa Technology or Kiniksa Manufacturing Technology (including, to Kiniksa’s Knowledge, any action to invalidate Kiniksa Patent Rights). |
| 12.2.5. | To Kiniksa’s Knowledge, Kiniksa has not withheld from Partner any information with respect to the Kiniksa Technology that, in Kiniksa’s reasonable determination, would materially adversely affect the Development, Manufacture, or Commercialization of the Licensed Product in the Territory as contemplated under this Agreement. To Kiniksa’s |
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| Knowledge, (a) true, complete, and correct copies of all portions of Regulatory Documentation that is material for the Licensed Product in the Territory; and (b) all material adverse written information with respect to the safety of the Licensed Product have been provided or made available to Partner prior to the Effective Date. To Kiniksa’s Knowledge, the information provided by Kiniksa to Partner regarding the Kiniksa Technology is accurate, true, and correct in all material respects. |
| 12.2.6. | To Kiniksa’s Knowledge, neither Kiniksa nor any of its Affiliates have employed nor used a contractor or consultant that has employed any Person Debarred/Excluded, or any Person that is the subject of an investigation or proceeding that could result in such Person being Debarred/Excluded, in any capacity in connection with this Agreement. |
| 12.2.7. | There are no legal claims, judgments, or settlements against or owed by Kiniksa or any of its Affiliates, or pending or, to Kiniksa’s Knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, or Anti-Corruption Law violations. |
| 12.2.8. | Schedule 1.58 (Existing In-Licenses) sets forth all Existing In-Licenses as of the Effective Date, redacted copies of which have been provided to Partner prior to the date hereof. Except for the redactions in such copies, Kiniksa has provided Partner with true, complete and correct copies of all Existing In-Licenses. Other than the Existing In-Licenses, there are no agreements between Kiniksa and any Third Party pursuant to which Kiniksa Controls any Kiniksa Technology licensed to Partner under this Agreement. |
| 12.2.9. | Each Existing In-License is a valid binding agreement, enforceable in accordance with its terms and neither Kiniksa nor any counterparty to any Existing In-Licenses has in writing alleged or threatened that the other party has breached an Existing In-License (which has not been cured) or, to Kiniksa’s Knowledge, threatened in writing to terminate an Existing In-License. |
| 12.2.10. | To its Knowledge, neither Kiniksa nor any of its Affiliates, or its or their directors, officers, employees, distributors, agents, representatives, sales intermediaries, or other Third Parties acting on behalf of Kiniksa or any of its Affiliates: |
| (a) | has taken any action in violation of any applicable Anti-Corruption Laws; or |
| (b) | has corruptly offered, paid, given, promised to pay or give, or authorized the payment or gift of anything of value, directly or indirectly, to any Public Official, for the purposes of: |
| (i) | influencing any act or decision of any Public Official in his or her official capacity; |
| (ii) | inducing such Public Official to do or omit to do any act in violation of his or her lawful duty; |
| (iii) | securing any improper advantage; or |
| (iv) | inducing such Public Official to use his or her influence with a government, governmental entity, or commercial enterprise owned or controlled by any government (including state-owned or controlled |
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| veterinary, laboratory or medical facilities) in obtaining or retaining any business whatsoever. |
| 12.3. | Representations and Warranties of Partner. Partner represents and warrants to Kiniksa as of the Effective Date as follows: |
| 12.3.1. | No Partner Technology exists as of the Effective Date. |
| 12.3.2. | There are no Partner Patent Rights owned by or exclusively licensed to Partner or any of its Affiliates. |
| 12.3.3. | There are no legal claims, judgments, or settlements against or owed by Partner or any of its Affiliates, or pending or, to Partner’s Knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, or Anti-Corruption Law violations. |
| 12.3.6. | To its Knowledge, neither Partner nor any of its Affiliates, or its or their directors, officers, employees, distributors, agents, representatives, sales intermediaries, or other Third Parties acting on behalf of Partner or any of its Affiliates: |
| (a) | has taken any action in violation of any applicable Anti-Corruption Laws; or |
| (b) | has corruptly offered, paid, given, promised to pay or give, or authorized the payment or gift of anything of value, directly or indirectly, to any Public Official, for the purposes of: |
| (i) | influencing any act or decision of any Public Official in his or her official capacity; |
| (ii) | inducing such Public Official to do or omit to do any act in violation of his or her lawful duty; |
| (iii) | securing any improper advantage; or |
| (iv) | inducing such Public Official to use his or her influence with a government, governmental entity, or commercial enterprise owned or controlled by any government (including state-owned or controlled veterinary, laboratory or medical facilities) in obtaining or retaining any business whatsoever. |
| 12.3.7. | Except as otherwise disclosed on Schedule 12.3 (Partner Disclosures), none of the officers, directors, or employees of Partner or of any of its Affiliates or agents acting on behalf of |
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| Partner or any of its Affiliates, in each case, that are employed or reside outside the United States, is a Public Official. |
| 12.4. | Covenants of Partner. Partner covenants to Kiniksa that: |
| 12.4.1. | Partner will conduct all Clinical Development activities for the Licensed Product solely in accordance with, and will not conduct any Clinical Development activities other than as set forth in, the applicable Territory Development Plan or Global Development Plan. Partner will conduct all Medical Affairs and Commercialization activities for the Licensed Product solely in accordance with, and will not conduct any Medical Affairs or Commercialization activities other than as set forth in, the applicable Medical Affairs Plan or Commercialization Plan, respectively. |
| 12.4.2. | Partner will only engage Clinical Trial sites under a Global Development Plan or a Territory Development Plan that conduct all Clinical Trials in compliance with Applicable Law, including cGCP and the GCP guidelines and that are approved by the applicable Regulatory Authority in the country or region in the Territory in which such Clinical Trial site is located. |
| 12.4.3. | Partner will permit, or will cause any of its applicable Affiliates, Sublicensees, or Subcontractors to permit, Kiniksa, its Affiliates, or Representatives to visit and inspect, no more than [***] per Calendar Year any of Partner’s or its Affiliates’, Sublicensees’, or Subcontractors’ facilities that perform Pre-Clinical Development, Manufacturing, Medical Affairs, or Commercialization of the Licensed Product (or any component thereof) upon Kiniksa’s request during normal business hours and upon no less than [***] days’ prior notice and at Kiniksa’s sole cost; provided that all such inspections will be conducted in accordance with Partner’s and its Affiliates’, Sublicensees’ or Subcontractors confidentiality requirements and on-site policies (as applicable), in each, to the extent communicated to Kiniksa in writing in advance. |
| 12.5. | Covenants of Kiniksa and Partner. |
| 12.5.2. | Compliance with Applicable Law. In the course of performing its obligations or exercising its rights under this Agreement, each Party will comply with all Applicable Law, including, as applicable, cGMP, cGCP, and cGLP, and will not employ or engage, and if so employed and engaged, will thereafter terminate any Person who has been Debarred/Excluded, or is the subject of any proceedings that could result in such Person being Debarred/Excluded. |
| 12.5.3. | Compliance with Anti-Corruption Laws. Notwithstanding any provision to the contrary set forth in this Agreement, each Party agrees as follows: |
| (a) | It will not, in the performance of this Agreement, perform any actions that are prohibited by any Anti-Corruption Laws that may be applicable to one or both Parties. |
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| (b) | It will not, in the performance of this Agreement, directly or indirectly, make any payment, or offer or transfer anything of value, or agree or promise to make any payment or offer or transfer anything of value, to a government official or government employee, to any political party or any candidate for political office or to any other Third Party with the purpose of influencing decisions related to either Party or its business in a manner that would violate applicable Anti-Corruption Laws. |
| (c) | It will not, directly or indirectly, solicit, receive, or agree to accept any payment of money or anything else of value in violation of the Anti-Corruption Laws. |
| (d) | It will comply with the Anti-Corruption Laws and will not take any action that will, or would reasonably be expected to, cause the other Party or its Affiliates or licensors to be in violation of any such laws. |
| (e) | It will, no later than [***] days following the end of each Calendar Year, verify in writing that to its Knowledge, there have been no violations of Anti-Corruption Laws by it or its Affiliates or Sublicensees, or persons employed by or Subcontractors used by it or its Affiliates or Sublicensees in the performance of this Agreement, or will provide details of any exception to the foregoing. |
| (f) | It will maintain records (financial and otherwise) and supporting documentation related to the subject matter of this Section 12.5.3 (Compliance with Anti-Corruption Laws) in order to document or verify compliance with the provisions of this Section 12.5.3 (Compliance with Anti-Corruption Laws), and upon request of other Party upon reasonable advance notice, will provide the other Party or its representative with access to such records for purposes of verifying compliance with the provisions of this Section 12.5.3 (Compliance with Anti-Corruption Laws). |
| (g) | It will promptly provide the other Party with written notice of the following events: (i) upon becoming aware of any breach or violation by the other Party of any covenant or undertaking set out in this Section 12.5.3 (Compliance with Anti-Corruption Laws); or (ii) upon receiving a formal notification that it is the target of a formal investigation by a Governmental Authority for a material Anti-Corruption Law violation or upon receipt of information from its Affiliates, agents, representatives, consultants, and Sublicensees, subcontractors hired in connection with the subject matter of this Agreement that any of them is the target of a formal investigation by a Governmental Authority for a material Anti-Corruption Law violation. |
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| REGULATIONS, OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER KIND OF WARRANTY WHETHER EXPRESS OR IMPLIED. |
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| provide the other Party with reasonable advanced written notice prior to the cancellation or non-renewal of, or material changes in, such insurance. Such insurance will not be construed to create a limit of Kiniksa’s or Partner’s liability with respect to its indemnification obligations under this Article 13 (Indemnification). |
| 14.1. | Inventions. |
| 14.1.4. | Practice Under and other Use of Joint Collaboration Technology. Subject to the rights granted under and the restrictions set forth in this Agreement (including Section 2.7 |
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| (Exclusivity Covenants)), neither Party will have any obligation to account to the other Party for profits, or to obtain any approval of the other Party to license, assign, or otherwise exploit any Joint Collaboration Technology by reason of joint ownership thereof, and each Party hereby waives any right it may have under the Applicable Law of any jurisdiction to require any such approval or accounting. To the extent any further consent is required to enable a Party to so license or exploit its interest in the Joint Collaboration Technology, the other Party hereby grants such consent. |
| 14.1.5. | Employee Assignment. Partner and its Affiliates and Sublicensees performing activities or exercising rights under this Agreement will enter into with each of their respective employees legally binding and sufficient agreements or employment policies providing for the payment by Partner or its Affiliate of any reward or remuneration required under Applicable Law in a particular country or region in the Territory in consideration for the development of inventions by such employees. Without limiting the generality of the foregoing, Partner and its Affiliates will, and will cause its Sublicensees to, enter into an agreement or employment policy with each of its employees performing activities under this Agreement that (a) compels prompt disclosure to Partner (or its Sublicensee, as applicable) of all Collaboration Technology discovered or developed, invented, or filed by such employee during any performance under this Agreement; (b) automatically assigns to Partner (or its Sublicensee, as applicable) all rights, title, and interests in and to all Collaboration Technology, and requires each employee to execute all documents and take such other actions as may be necessary to effectuate such assignment; (c) includes an invention and patent reward and remuneration policy providing for the payment by Partner of any reward or remuneration required under Applicable Law in such country or region in consideration for the development of inventions by such employees that is legally sufficient under Applicable Law in the applicable country or region in the Territory; and (d) includes a waiver of pre-emption rights under any Applicable Law in such country or region, including in the case of an employee in the PRC, Article 326 of the Contract Law of the PRC to the effect that the employee will confirm that he/she will not have any right or claim with respect to any Collaboration Technology derived from his/her work, except for the reward and remuneration he/she is entitled to under the invention and patent reward and remuneration policy. |
| 14.1.6. | Payments in Consideration of Assignments of Intellectual Property. |
| (a) | Payment by Kiniksa. In consideration of the assignment by Partner to Kiniksa of all Assigned Collaboration Technology, Kiniksa will pay to Partner a one-time payment of $[***] [***], which payment will be payment in-full for the assignment of all Assigned Collaboration Technology hereunder, regardless of how many patent applications are filed or patents are issued Covering the Assigned Collaboration Know-How. Kiniksa will notify Partner of Kiniksa’s filing of the first patent application claiming any Assigned Collaboration Know-How with respect to which an employee of Partner is an inventor. Promptly thereafter, Partner will invoice Kiniksa for the foregoing amount, and Kiniksa will pay the undisputed invoiced amounts within [***] days after the date of such invoice. The Parties expressly acknowledge that the foregoing amount is reasonable compensation paid in consideration of the assignments of Assigned Collaboration Technology contemplated under this Agreement and is sufficient to satisfy the requirements under Applicable Law in the Territory regarding amounts to be paid in consideration of the assignment of intellectual property rights by Persons domiciled in the PRC to Persons domiciled outside of the PRC. |
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| (b) | Reward and Remuneration Payments to Partner Employees. As between the Parties, Partner will be solely responsible for the payment of, and Partner will pay, any rewards and remuneration for inventions and technical achievements required by Applicable Law to be paid to its employees for the development or invention of any Collaboration Technology, regardless of the form of such payment (including, for example, as a royalty). Notwithstanding any provision to the contrary in this Agreement, no payment made by Partner pursuant to Section 14.1.3 (Assignment by Partner) as reward or remuneration for any employee invention may be used as a credit against, or may otherwise reduce, any payment owed by Partner to Kiniksa under this Agreement. |
| 14.3. | Patent Prosecution. |
| 14.3.1. | Kiniksa Patent Rights and Kiniksa Manufacturing Patent Rights. |
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| respective IP counsels, will discuss the strategy for the portfolio of Patent Rights Covering the Licensed Product in the Territory. |
| (d) | Manufacturing Patent Rights. Notwithstanding any provision to the contrary set forth in this Agreement, Kiniksa or its Affiliate will have the sole right to control the Patent Prosecution of the Kiniksa Manufacturing Patent Rights worldwide, including in the Territory at Kiniksa’s sole cost and expense. |
| 14.3.2. | Partner Collaboration Patent Rights. |
| (a) | Right to Prosecute. As between the Parties, Partner will have the right to control the Patent Prosecution of all Partner Collaboration Patent Rights throughout the world. Partner will be responsible for [***]% of the costs and expenses incurred with respect to the Patent Prosecution of such Patent Rights throughout the world. |
| (c) | Abandonment. If Partner decides that it is no longer interested in continuing the Patent Prosecution of a particular Partner Collaboration Patent Right during the Term, then, unless Partner has a strategic rationale for ceasing such Patent Prosecution, it will provide written notice to Kiniksa of such decision at least [***] days prior to the date on which such Patent Right will become abandoned. Kiniksa or its Affiliate may, upon written notice to Partner, cause Partner not to cease such Patent Prosecution of such Partner Collaboration Patent Right with respect to which Partner does not have a strategic rationale for the abandonment thereof. In |
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| such event, Kiniksa will be responsible for [***]% of the costs and expenses of the Patent Prosecution of such Patent Right. |
| 14.4. | Patent Enforcement. |
| 14.4.2. | Enforcement Rights. |
| (a) | First Right and Step-In for Kiniksa Patent Right Infringement. |
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| enforcement of the Partner Collaboration Patent Rights against such Competitive Infringement. |
| 14.4.3. | Cooperation. At the request of the Party bringing an action related to infringement of any Kiniksa Patent Right, Kiniksa Manufacturing Patent Right, or Partner Collaboration Patent Right in accordance with this Section 14.4 (Patent Enforcement) either inside or outside the Territory, the other Party will provide reasonable assistance reasonably requested by the enforcing Party in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery, and joining as a party to the action if required by Applicable Law to pursue such action. |
| 14.4.4. | Recoveries. Any recoveries resulting from an enforcement action relating to a Competitive Infringement in the Territory will be first applied against payment of each Party’s costs and expenses in connection therewith. Any such recoveries in excess of such costs and expenses will be split as follows: (a) [***]% will be paid to the Party initiating such suit, action, or proceeding and (b) [***]% will be paid to the non-initiating Party. |
| 14.5. | Infringement of Third Party Rights. |
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| Partner will promptly notify Kiniksa within [***] Business Days after receipt of such claim or assertion and will include in such notice a copy of any summons or complaint (or the equivalent thereof) received regarding the foregoing. Thereafter, the Parties will promptly meet to consider the claim or assertion and the appropriate course of action and may, if appropriate, agree on and enter into a “common interest agreement” wherein the Parties agree to their shared, mutual interest in the outcome of such potential dispute. The Parties will assert and not waive the joint defense privilege with respect to any communications between the Parties in connection with the defense of such claim or assertion. |
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| Parties are unable to agree on which Patent Rights to list by the time required as provided under clause (i) to (iv) above, subject to the above proviso, then Kiniksa will have the final decision-making right over whether the Party holding the MAA for the Licensed Product in the Territory will list any Kiniksa Patent Rights, Kiniksa Manufacturing Patent Rights, or Joint Collaboration Patent Rights, and Partner will have the final decision-making right over whether the Party holding the MAA for the Licensed Product in the Territory will list any issued patents included in the Partner Collaboration Patent Rights. The Party holding the MAA for the Licensed Product in the Territory will promptly, and in any event at least [***] days prior to the applicable deadline for listing under Applicable Laws, list the Listing Patent Rights in the applicable patent listing system in the applicable regions in the Territory provided, that, without limiting the foregoing, if the Party holding the MAA for the Licensed Product in the Territory has not listed the Listing Patent Rights in the patent listing system of an applicable region before [***] days prior to the deadline for listing in the applicable region, then the other Party may list the Listing Patent Rights at anytime when permitted by Applicable Laws by providing prior written notice to the Party holding the MAA for the Licensed Product in the Territory. The Party holding the MAA for the Licensed Product in the Territory will provide copies of all documentation to be filed in connection with any such listing of Listing Patent Rights to the other Party prior to filing thereof and will consider the other Party’s comments with respect to such documentation. The Party holding the MAA for the Licensed Product in the Territory will cooperate with the other Party to the extent reasonably requested by the other Party to effectuate the intent of this Section 14.6 (Patent Listings), including providing all documentation, certifications, and consents necessary to effectuate the foregoing and setting up an account to list patents on the applicable patent listing system, and granting the other Party access to and a right to use such account as reasonably necessary to effectuate the intent of this Section 14.6 (Patent Listings). Neither Party will list any patent in any patent listing system in a region in the Territory for the Licensed Product, except in accordance with this Section 14.6 (Patent Listings). |
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| documentation, certifications, and consents necessary to make and prosecute such application and obtain such Patent Term Extension or Patent Term Adjustment. |
| 14.9. | Product Trademarks. |
| 14.9.4. | Use and Quality. Partner agrees that it and its Affiliates and Sublicensees will Commercialize the Licensed Product in the Territory in a manner consistent with the Global Brand Elements and will: (a) ensure that all Licensed Product that are sold bearing the Product Marks and Global Brand Elements are of a high quality consistent with industry standards for global pharmaceutical and biologic therapeutic products; (b) ensure that each use of the Global Brand Elements and Product Marks by Partner and its Affiliates and Sublicensees is accompanied by an acknowledgment that such Global Brand Elements and Product Marks are owned by Kiniksa; (c) not use such Global Brand Elements or Product Marks in a way that might materially prejudice their distinctiveness or validity or the goodwill of Kiniksa therein and includes the trademark registration symbol ® or ™ as appropriate; (d) not use any trademarks or trade names so resembling any of such Global Brand Elements or Product Marks as to be likely to cause confusion or deception; and (e) place and display the Global Brand Elements and the Product Marks on and in connection |
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| with the Licensed Product in a way that acknowledges Kiniksa’s role in discovering the Licensed Product and that the Licensed Product is under license from Kiniksa. To the extent permitted by Applicable Law, Partner will include the words “Licensed from Kiniksa.” on all packaging and labeling for the Licensed Product and in relevant scientific, medical, and other Licensed Product-related communications to the extent such communications address the Development, Manufacture, performance of Medical Affairs, or Commercialization of such the Licensed Product, or such other similar text provided by Kiniksa and reasonably acceptable to Partner. |
| 15.2. | Termination. |
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| 15.2.7. | Full Force and Effect During Notice Period. This Agreement will remain in full force and effect until the expiration of the applicable termination notice period. |
| 15.3. | Effects of Termination. Upon the termination of this Agreement: |
| 15.3.1. | Partial Termination. In the event that this Agreement is terminated pursuant to Section 15.2.4 (Termination in [***]) with respect to only certain countries or regions in the Territory, then Section 15.3 (Effects of Termination), Section 15.4 (Survival), and Section 15.5 (Cumulative Remedies; Termination Not Sole Remedy) will apply solely with respect to the terminated countries or regions, and all other rights and obligations of the Parties under this Agreement will otherwise remain in full force and effect. |
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| license granted to Kiniksa will be royalty-bearing at a royalty rate to be agreed by the Parties upon termination of this Agreement. In addition, Partner will assign to Kiniksa any Third Party IP Agreement pursuant to which Partner then Controls any Partner Technology, if permitted under such Third Party IP Agreement (and will use reasonable efforts to seek any consent required from the applicable Third Party in connection with such an assignment). If such Third Party IP Agreement cannot be assigned to Kiniksa, then upon Kiniksa’s reasonable request, Partner will maintain such Third Party IP Agreement and Kiniksa will pay to Partner [***]% of all payments due to the applicable Third Party under any such Third Party IP Agreement in consideration of the sublicense to Kiniksa and Kiniksa’s Exploitation of such Partner Identified Rights. If Partner is unable to assign the Third Party IP Agreement pursuant to which Partner acquired rights to any Partner Identified Rights and is unable to sublicense any Partner Identified Rights to Kiniksa pursuant to this Section 15.3.2 (Effects of Termination; Licenses) without the consent of the Third Party, then Partner will, on request from Kiniksa (and at Kiniksa’s cost and expense), use reasonable efforts to procure such licenses with respect to Licensed Product on behalf of Kiniksa to the extent that it is able to do so, and Kiniksa will pay such fees and agree to be bound by the terms agreed between Partner and the Third Party licensor. |
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| Regulatory Approval. In addition, upon Kiniksa’s written request, Partner will, at its cost and expense, provide to Kiniksa copies of all substantive related documentation, including non-clinical, preclinical, and clinical data that are held by or reasonably available to Partner or its Affiliates or Sublicensees. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, provided that Kiniksa will assume all safety and safety database activities with respect to the Licensed Product no later than [***] days after the effective date of termination of this Agreement. |
| (a) | subject to Partner’s confidentiality obligations to Third Parties, provide to Kiniksa for its review unredacted copies of all clinical trial agreements, manufacturing and supply agreements, distribution agreements (to the extent assignable and not cancelled), and confidentiality and other agreements, in each case, relating to the Licensed Product and that are [***] for the Exploitation of the Licensed Product, and, following such review, upon Kiniksa’s request and solely to the extent permitted under the terms of such agreements, assign and transfer to Kiniksa or its designee all of Partner’s rights, title, and interests in and to any such agreements. If such agreement is not assignable, then Partner will cooperate with Kiniksa in all reasonable respects to secure the consent of the applicable Third Party to such assignment or to cause such Third Party to enter into a separate agreement with Kiniksa on terms substantially similar to those granted to Partner; |
| (b) | disclose to Kiniksa or its designee all data, information, documents, records, and materials related to the Licensed Product that are controlled by Partner or that Partner is able to obtain using reasonable efforts, and that embody the foregoing; and |
| (c) | assign and transfer to Kiniksa or its designee all of Partner’s rights, title, and interests in and to any promotional materials, training materials, medical education materials, packaging and labeling, and all other literature or other information related to the Licensed Product and copyrights and any registrations for the foregoing. |
Unless this Agreement is terminated by Partner pursuant to Section 15.2.2 (Termination for Material Breach) or Section 15.2.6 (Termination for Insolvency), Partner will bear the costs and expenses associated with the assignments set forth in this Section 15.3.5 (Assignment and Disclosure). To the extent that any agreement or other asset described in this Section 15.3.5 (Assignment and Disclosure) is not assignable by Partner, then such agreement or other asset will not be assigned, and upon the request of Kiniksa, Partner will take such steps as may be necessary to allow Kiniksa to obtain and to enjoy the benefits of such agreement or other asset, without additional payment therefor, in the form of a license or other right to the extent Partner has the right and ability to do so. For clarity, Kiniksa will have the right to request that Partner take any or all of the foregoing actions in whole or in part, or with respect to all or any portion of the assets set forth in this Section 15.3.5 (Assignment and Disclosure).
| 15.3.6. | Regulatory Transfer Support. In furtherance of the assignment of Regulatory Submissions and Regulatory Approvals and other data pursuant to Section 15.3.4 |
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| (Regulatory Submissions and Regulatory Approvals) and Section 15.3.5 (Assignment and Disclosure), Partner will appoint Kiniksa as Partner’s or its Affiliate’s agent for all Licensed Product-related matters involving Regulatory Authorities until all Regulatory Approvals, Regulatory Submissions, and other governmental or regulatory filings that are not then in Kiniksa’s or its Affiliate’s name have been assigned to Kiniksa or its designee. In the event of failure to obtain such assignment, Partner hereby consents and grants to Kiniksa the right to access and reference (without any further action required on the part of Partner, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such item with respect to the Licensed Product. |
| 15.3.7. | Transfer of Prosecution and Maintenance Responsibilities. Partner will transfer to Kiniksa any and all responsibility for Patent Prosecution for the Kiniksa Patent Rights, including transferring all files related to the Patent Prosecution of such Kiniksa Patent Rights, and at the request of Kiniksa, Partner will make appropriate personnel available to Partner to answer such reasonable questions as Kiniksa may have in connection with such transfer of Patent Prosecution of such Patent Rights. |
| 15.3.8. | Know-How Transfer Support. In furtherance of the assignment of Know-How pursuant to Section 15.3.5 (Assignment and Disclosure), Partner will, for a period of [***] months from the effective date of termination of this Agreement, provide such reasonable consultation or other reasonable assistance as Kiniksa may reasonably request to assist Kiniksa in becoming familiar with such Know-How in order for Kiniksa to undertake further Exploitation of the Licensed Product at Kiniksa’s cost and expense at Partner’s FTE Rate. |
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| time after termination of this Agreement with respect to the Licensed Product until such transfer is completed. |
| 15.3.11. | Ongoing Clinical Trials. |
| (a) | Transfer to Kiniksa. If, as of the effective date of termination of this Agreement with respect to the Licensed Product, Partner or its Affiliates are conducting any Clinical Trials for the Licensed Product, then, at Kiniksa’s election on a Clinical Trial-by-Clinical Trial basis, Partner will fully cooperate, and will ensure that its Affiliates fully cooperate, with Kiniksa to transfer the conduct of such Clinical Trial to Kiniksa or its designees. If Kiniksa so elects, then Partner will continue to conduct such Clinical Trial, at Kiniksa’s cost, to enable such transfer to be completed without interruption of any such Clinical Trial (including the assignment of all related Regulatory Submissions and investigator and other agreements related to such Clinical Trials). Partner will provide such knowledge transfer and other training to Kiniksa or its designated Affiliate or Third Party as reasonably necessary for Kiniksa or such designated Affiliate or Third Party to continue such Clinical Trial for the Licensed Product. |
| (b) | Wind-Down. If Kiniksa does not elect to assume control of any such Clinical Trials for the Licensed Product, then Partner will, in accordance with accepted pharmaceutical industry norms and ethical practices, wind-down the conduct of any such Clinical Trial in an orderly manner. Except for Partner’s termination of this Agreement under Section 15.2.2 (Termination for Material Breach) or Section 15.2.6 (Termination for Insolvency), Partner will be responsible for any costs and expenses associated with such wind-down. |
| 15.3.14. | Termination by Partner for Kiniksa’s Breach or Insolvency. Notwithstanding any provision to the contrary in this Article 15 (Term and Termination), if Partner terminates |
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| this Agreement pursuant to Section 15.2.2 (Termination for Material Breach) or Section 15.2.6 (Termination for Insolvency), then Kiniksa will be responsible for the reasonable out-of-pocket costs incurred by Partner directly in connection with the performance of the activities set forth in this Section 15.3 (Effects of Termination). Partner will invoice Kiniksa [***] for the foregoing costs incurred by or on behalf of Partner in such Calendar Quarter, and Kiniksa will pay the undisputed invoiced amounts within [***] days after the date of any such invoice. |
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| 16.4. | Arbitration. If any Dispute that was subject to Section 16.4 (Negotiation; Escalation) remains [***] Business Days after such Dispute is referred to the Executive Officers, then either Party may at any time after such [***] Business Day period submit such Dispute to be settled by arbitration under the Rules of Arbitration of the International Chamber of Commerce (the “ICC Rules”), in accordance with the procedural rules of the ICC Rules in effect at the time of submission. The arbitration will be conducted before an arbitral tribunal composed of three arbitrators, the chairperson of whom will be appointed by the two party arbitrators, and all of whom will have previous judicial experience and experience with the life sciences industry. If, however, the aggregate award sought by the Parties is less than $[***] and equitable relief is not sought, then, unless otherwise agreed by the Parties a single arbitrator will be appointed by agreement of the parties, or, failing such agreement, in accordance ICC Rules. Unless otherwise agreed by the Parties, all such arbitration proceedings will be held in New York, New York, USA, provided that proceedings may be conducted by telephone conference call with the consent of the Parties and the arbitrator(s). All arbitration proceedings will be conducted in the English language. The arbitrator(s) will have no authority to award punitive damages. The allocation of expenses of the arbitration, including reasonable attorney’s fees, will be determined by the arbitrator(s), or, in the absence of such determination, each party will pay its own expenses. All arbitration proceedings must be completed within [***] days of the notice of commencement of arbitration proceedings. The parties hereby agree that the arbitrator(s) have authority to issue rulings and orders regarding all procedural and evidentiary matters that the arbitrator(s) deem reasonable and necessary with or without petition therefore by the Parties as well as the final ruling and judgment. Rulings will be issued by written order summarizing the arbitration proceedings no more than [***] days after the final submissions of the Parties. All rulings by the arbitrator(s) will be final and binding on the Parties. The provisions of this Section 16.5 (Arbitration) may be enforced and judgment on the award (including without limitation equitable remedies) granted in any arbitration hereunder may |
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| be entered in any court having jurisdiction over the award or any of the parties or any of their respective assets. |
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| INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 13.1 (INDEMNIFICATION; BY PARTNER) OR SECTION 13.2 (INDEMNIFICATION; BY KINIKSA), DAMAGES AVAILABLE TO EITHER PARTY FOR THE OTHER PARTY’S BREACH OF Article 11 (CONFIDENTIALITY; PUBLICATION), OR DAMAGES AVAILABLE TO EITHER PARTY FOR THE OTHER PARTY’S FRAUD, GROSS NEGLIGENCE, WILFUL MISCONDUCT, OR BREACH OF ITS OBLIGATIONS HEREUNDER RELATING TO SECTION 2.7 (EXCLUSIVITY COVENANTS) OR AMOUNTS OWED BY EITHER PARTY HEREUNDER (INCLUDING UNDER ARTICLE 10) (PAYMENTS), OR MISAPPROPRIATION OR INFRINGEMENT OF INTELLECTUAL PROPERTY OWNED OR CONTROLLED BY EITHER PARTY. |
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If to Kiniksa:
Kiniksa Pharmaceuticals (UK), Ltd.
Third Floor
00 Xxx Xxxx Xxxxxx
Xxxxxx, XX, X0X 0XX
Attention: Chief Commercial Officer
with a copy to:
Kiniksa Pharmaceuticals Corp.
000 Xxxxxx Xxx.
Xxxxxxxxx, XX 00000
Xxxxxx Xxxxxx
Attention: General Counsel
with a copy to (which will not constitute notice):
Ropes & Xxxx LLP
000 Xxxxxxxx Xxxxxx; Prudential Tower
Xxxxxx, XX 00000
Attention: Xxxxxx X. Xxxxxxx
Email: Xxxxxx.Xxxxxxx@xxxxxxxxx.xxx
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Xx.000, Xxxxxxxxx Xxxx
Xxxxxxxx, Xxxxxx’s Republic of China
Attention: [**]
with a copy to (which copy will not constitute notice):
Xxxxxxxxx Xxxxxxx LLP
0000 Xxxxxxxx Xxxx
Xxxxx 0000
Xxxxxxx, Xxxxxxx 00000
Attention: [**]
Email: [**]
or to such other address 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 will be deemed to have been given: (a) on the Business Day after dispatch if sent by internationally-recognized overnight courier; or (b) on the [***] Business Day after dispatch if sent by registered or certified mail, postage prepaid, return receipt requested.
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| action based upon, arising out of or related to any representation or warranty made in or in connection with this Agreement or as an inducement to enter into this Agreement), will be governed by, and enforced in accordance with, the internal laws of the State of New York, including its statutes of limitations without giving effect to the conflicts of law provisions thereunder. |
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| the undisputed amount invoiced within [***] days after the date of any such invoice. Kiniksa acknowledges and agrees that any and all translations provided by Partner under this Agreement will not be certified translations (unless agreed by the Parties). |
[Remainder of the Page Intentionally Left Blank; Signature Page Follows]
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IN WITNESS WHEREOF, the Parties intending to be bound have caused this License and Collaboration Agreement to be executed by their respective duly authorized representatives as of the Effective Date.
Kiniksa Pharmaceuticals (UK), Ltd.
By: /s/ Xxxx Xxxx
Name: Xxxx Xxxx
Title: Director
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
By: /s/ Xxxxx Xx
Name: Xxxxx Xx
Title: Chairman & CEO
[Signature Page to Collaboration and License Agreement]
Schedule 1.58
Existing In-Licenses
[***]
Schedule 1.106
Kiniksa Patent Rights
[***]
Schedule 2.2.3
Preapproved Subcontractors
Schedule 5.2
Territory Development Plan
[***]
Schedule 5.3
Global Development Plan
[***]
Schedule 11.7.1(a)
Kiniksa Press Release
Kiniksa Pharmaceuticals and Huadong Medicine Announce Strategic Collaboration
– Collaboration includes rights to develop and commercialize ARCALYST® and mavrilimumab in the Asia Pacific Region (excluding Japan) –
– Kiniksa to receive $22 million upfront; eligible to receive development and commercial milestone payments and tiered royalties –
XXXXXXXX, BERMUDA – February 22, 2022 – Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (Huadong Medicine), today announced a strategic collaboration to develop and commercialize Kiniksa’s ARCALYST® and mavrilimumab in the Asia Pacific Region.
“This collaboration aims to bring Kiniksa’s therapeutics to patients in the Asia Pacific Region suffering from severe autoimmune and inflammatory diseases. With extensive regional experience, proven development and regulatory execution, and deep relationships with a broad network of hospitals and clinics, Huadong Medicine is an ideal partner to help drive value,” said Xxxx X. Xxxxx, Chairman and Chief Executive Officer of Kiniksa. “The collaboration also provides non-dilutive capital, cost-sharing, and resources for clinical trials to accelerate our drug development and commercialization efforts.”
“Kiniksa is an emerging leader in the development of immune-modulating therapies, for which there is significant unmet need across the Asia Pacific Region,” said Xxxxx Xx, Chairman and CEO of Huadong Medicine. “In addition to ARCALYST, the first and only FDA-approved treatment for recurrent pericarditis, the compelling clinical data generated to-date for mavrilimumab provide foundational support for development
across a range of underserved diseases. We look forward to working closely with Kiniksa to leverage our clinical, regulatory, and commercial capabilities in the Asia Pacific Region.”
Under the terms of the collaboration, Kiniksa will receive $22 million upfront and is eligible to receive up to approximately $640 million in specified development, regulatory and sales-based milestones. Kiniksa is also eligible to receive tiered royalties ranging from the low-teens to the low-twenties on annual net sales. Huadong Medicine will obtain exclusive rights and responsibility for the development and commercialization of ARCALYST and mavrilimumab in the Asia Pacific Region including Xxxxxxx Xxxxx, Xxxxx Xxxxx, Xxxxxxxxx, and 18 other countries, but excluding Japan. Kiniksa will otherwise retain all existing development and commercialization rights for both assets.
Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s portfolio assets, ARCALYST, mavrilimumab, vixarelimab and KPL-404, are based on strong biologic rationale or validated mechanisms, target underserved conditions, and offer the potential for differentiation. These assets are designed to modulate immunological pathways across a spectrum of diseases. For more information, please visit xxx.xxxxxxx.xxx.
About ARCALYST
ARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. ARCALYST was discovered by Regeneron and is approved by the U.S. Food and Drug Administration (FDA) for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Xxxxxx-Xxxxx Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to ARCALYST for the treatment of pericarditis in 2020. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2020.
IMPORTANT SAFETY INFORMATION ABOUT ARCALYST
| ● | ARCALYST may affect your immune system and can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in patients taking ARCALYST. If you have any signs of an infection, call your doctor right away. Treatment with |
| ARCALYST should be stopped if you get a serious infection. You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection). |
| ● | While taking ARCALYST, do not take other medicines that block interleukin-1, such as Kineret® (anakinra), or medicines that block tumor necrosis factor, such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), as this may increase your risk of getting a serious infection. |
| ● | Talk with your doctor about your vaccine history. Ask your doctor whether you should receive any vaccines before you begin treatment with ARCALYST. |
| ● | Medicines that affect the immune system may increase the risk of getting cancer. |
| ● | Stop taking ARCALYST and call your doctor or get emergency care right away if you have any symptoms of an allergic reaction. |
| ● | Your doctor will do blood tests to check for changes in your blood cholesterol and triglycerides. |
| ● | Common side effects include injection-site reactions (which may include pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site), upper respiratory tract infections, joint and muscle aches, rash, ear infection, sore throat, and runny nose. |
For more information about ARCALYST, talk to your doctor and see the Product Information.
About Mavrilimumab
Mavrilimumab is an investigational fully human monoclonal antibody that blocks activity of granulocyte macrophage colony stimulating factor (GM-CSF) by specifically binding to the alpha subunit of the GM-CSF receptor (GM-CSFRα). Phase 2 clinical trials of mavrilimumab in rheumatoid arthritis and giant cell arteritis achieved their primary and secondary endpoints with statistical significance.
About Huadong Medicine
Huadong Medicine Co., Ltd. (SZ.000963) is a leading Chinese pharmaceutical company based in Hangzhou, China. Founded in 0000, Xxxxxxx Medicine has fully integrated R&D, manufacturing, distribution, sales, and marketing capabilities. Huadong Medicine's product portfolio and pipeline are specialized in oncology, immunology, nephrology, and diabetes. The company has 11,000 employees and one of the most extensive commercial coverage and marketing capabilities in China. 'Patient Centered, Science Driven' is Huadong Medicine's value. For additional information, please visit xxx.xxxxxxxxxxxxxx.xxx/xx.
Kiniksa Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding the multi-product collaboration between Kiniksa and Huadong Medicine, including anticipated milestone and royalty payments under the collaboration; expectations regarding Kiniksa’s ability to expand its programs for ARCALYST and mavrilimumab globally and in the licensed territory; and statements regarding Kiniksa’s efforts to bring multiple therapeutics to patients suffering from severe autoimmune and inflammatory diseases globally and in the licensed territory.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; inability to successfully execute on our commercial strategy for ARCALYST; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; our reliance on Regeneron as the sole manufacturer of ARCALYST; raw materials, important ancillary products and drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; the impact of the COVID-19
pandemic and measures taken in response to the pandemic on our business and operations as well as the business and operations of our manufacturers, CROs upon whom we rely to conduct our clinical trials, and other third parties with whom we conduct business or otherwise engage, including the FDA and other regulatory authorities; changes in our operating plan and funding requirements; and existing or new competition.
These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”), including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
ARCALYST® is a registered trademark of Regeneron Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.
Kiniksa Investor and Media Contact
Xxxxxx Xxxxx
(000) 000-0000
xxxxxx@xxxxxxx.xxx
Huadong Medicine Investor and Media Contact
Xx Xxxx
x00 000 0000 0000
xx@xxxxxxxxxxxxxx.xxx
Schedule 11.7.1(b)
Partner Press Release
-华东医药将获得ARCALYST®和Mavrilimumab在亚太区（不包括日本）的独家开发、注册和商业化权益。
-Kiniksa将获得2,200万美元的首付款，并获得开发、注册和销售里程碑付款及分级的销售额提成费。
中国杭州市，2022年2月22日，华东医药股份有限公司（SZ.000963）的全资子公司杭州中美华东制药有限公司（以下简称“华东医药”）与美国上市公司Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA)的全资子公司Kiniksa Pharmaceuticals (UK), Ltd.（以下简称“Kiniksa”），一家拥有多款调节免疫信号通路治疗自身免疫疾病药物的全球性生物公司，宣布签署战略合作协议。Kiniksa授予华东医药ARCALYST®和Mavrilimumab在亚太区的独家开发、注册和商业化权益。
华东医药董事长兼首席执行官吕梁表示：“Kiniksa是免疫调节疗法开发领域的新兴领导者，该治疗领域在亚太地区存在巨大未被满足的临床需求。ARCALYST®是目前第一款也是唯一一款FDA批准的用于治疗复发性心包炎的药物。此外，Mavrilimumab迄今为止产生的临床数据也为一系列难治疾病的治疗提供了基础支持。我们期待与Kiniksa密切合作，充分发挥华东医药在亚太地区的临床，注册和商业化能力。”
Kiniksa的董事长兼首席执行官Xxxx X. Xxxxx表示：“本次合作旨在将Kiniksa的治疗方法惠及整个亚太地区患有严重自身免疫和炎症疾病的患者。华东医药在亚太地区拥有丰富的区域经验，成熟的开发、注册能力，以及广泛的营销网络。华东医药是帮助ARCALYST®和Mavrilimumab在亚太区的实现最大价值的理想合作伙伴。本次合作提供的资金，成本分摊及其他资源，将有助于加快产品的临床开发和商业化。”
根据协议条款，Kiniksa 将获得2,200万美元的首付款，并有权在实现开发、注册及销售里程碑后，获得最高不超过6.4亿美元的里程碑付款，Kiniksa还将获得分级的两位数的净销售额提成费。华东医药将获得ARCALYST®和Mavrilimumab在亚太区（包括中国、韩国、澳大利亚和其他18个国家和地区，但不包括日本）的独家开发、注册和商业化权益。Kiniksa将保留许可产品在许可区域以外的开发和商业化权益。
关于华东医药
华东医药股份有限公司（SZ.000963）总部位于中国杭州，公司成立于1993年，具有完整的产品研发，生产，经销能力。产品管线主要专注于肿瘤，免疫，肾科以及糖尿病领域，覆盖中药、化学药、生物药、医疗器械等多个品类。2020年公司年收入超过 50 亿美元，拥有员工11,000余人，“以科研为基础,以患者为中心”是华东医药秉承的企业理念。xxxxxxxxxxxxxxxxx.xxxxxxxxxxxxxx.xxx
关于Kiniksa
Kiniksa是一家以满足患者临床需求为企业愿景，致力于发现、获取、开发和商业化调节免疫信号通路治疗药物的全球性生物制药公司。Kiniksa的4款产品ARCALYST®，
Mavrilimumab，Vixarelimab，KPL-404都基于坚实的生物学原理或经过验证的机制，用于调节一系列免疫疾病的免疫信号通路，具有实现差异化的巨大潜力。
xxxxxxxxxx.xxxxxxx.xxx
关于ARCALYST®
ARCALYST®是一种每周进行皮下注射给药的重组二聚体融合蛋白，可阻断白细胞介素-1α（IL-1α）和白细胞介素-1β（IL-1β）的信号传导。ARCALYST®最早由Regeneron研发，获得FDA批准用于治疗冷吡啉相关的周期性综合征（CAPS），包括家族性寒冷型自身炎症综合征和穆-韦二氏综合征，以及IL-1受体拮抗剂缺乏症（DIRA）。2019年，ARCALYST®获得FDA突破性疗法认定，用于治疗复发性心包炎。2020年，FDA授予ARCALYST®用于治疗心包炎的孤儿药认定。2020年，欧盟委员会授予ARCALYST®孤儿药认定，用于治疗特发性心包炎。
关于Mavrilimumab
Mavrilimumab是一种全人源单克隆抗体，可特异性结合粒细胞-巨噬细胞集落刺激因子受体α（GM-CSFRα），并抑制粒细胞-巨噬细胞集落刺激因子（GM-CSF）的信号传导。Mavrilimumab针对类风湿性关节炎和巨细胞动脉炎（GCA）的2期临床研究都达到了主要和次要终点，并具有统计学意义。
投资者关系及媒体
华东医药
x00 000 0000 0000
xx@xxxxxxxxxxxxxx.xxx
Kiniksa
Xxxxxx Xxxxx
(000) 000-0000
xxxxxx@xxxxxxx.xxx
Schedule 12.3
Partner Disclosures
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