License and Collaboration Agreement, dated September 25, 2018, by and among the Company, Novartis Pharma AG and other parties thereto

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

This LICENSE AND COLLABORATION AGREEMENT (this “Agreement”) is made as of September 25, 2018 (the “Effective Date”), by and between Novartis Pharma AG, a company (Aktiengesellschaft) organized and existing under the laws of Switzerland, having its principal place of business at Lichtstrasse 35, 4056 Basel, Switzerland (“Novartis”), Cellular Biomedicine Group, Inc., a corporation organized and existing under the laws of Delaware, having its principal place of business at 19925 Stevens Creek Blvd., Suite 100, Cupertino, California 95014, USA (“CBMG Parent”), Cellular Biomedicine Group HK Ltd., a company organized and existing under the laws of the Hong Kong Special Administrative Region of the People’s Republic of China, whose registered office is at Unit 402, 4th Floor, Fairmont House, No 8, Cotton Tree Drive, Admiralty, Hong Kong (“CBMG HK”), Cellular Biomedicine Group (Wuxi) Ltd. (西比曼生物科技（无锡）有限公司), a company organized and existing under the laws of the PRC whose legal address is located at 1699 Huishan Boulevard, Room 1103, Huishan High Tech Park, Wuxi, China (“CBMG Wuxi”), Cellular Biomedicine Group Ltd. (Shanghai) Ltd. (西比曼生物科技（上海）有限公司), a company organized and existing under the laws of the PRC whose legal address is located at 333 Guiping Road, Building No.1 F6, Xuhui District, Shanghai, China (“CBMG Shanghai”), and Shanghai Cellular Biopharmaceutical Group Ltd. (上海赛比曼生物科技有限公司), a company organized and existing under the laws of the PRC, whose legal address is located at 85 Faladi Road, Building No.3, China (Shanghai) Pilot Free Trade Zone, Shanghai, China (“Shanghai Cellular”) (CBMG HK, CBMG Wuxi, CBMG Shanghai, and Shanghai Cellular, collectively, the “CBMG Subsidiaries”) (the CBMG Subsidiaries, together with CBMG Parent, “CBMG”). Novartis, CBMG Parent, and CBMG Subsidiaries are each referred to individually as a “Party” and, collectively, as the “Parties.”

WHEREAS, CBMG and Novartis desire to enter into a collaboration under which CBMG will become Novartis’s collaboration partner and manufacturer of the Product in the Territory (as such terms are defined below);

WHEREAS, CBMG will manufacture and supply the Product in the Territory for use by Novartis, its Affiliates, and its designees in the Territory, on the terms and conditions set forth in this Agreement and the Ancillary Agreements (as such terms are defined below);

WHEREAS, concurrently with the execution and delivery of this Agreement, CBMG and Novartis are entering into that certain Share Purchase Agreement, pursuant to which Novartis will purchase from CBMG Parent, and CBMG Parent will sell to Novartis, a certain number of shares of CBMG’s common stock, par value $.001 per share (the “Share Purchase Agreement”); and

WHEREAS, subject to the terms of this Agreement, each Party is relying on the other Party with regard to its satisfaction of all legal, regulatory, contractual, and other obligations, and each Party will act independently in accordance with this Agreement and all Applicable Laws.

NOW, THEREFORE, in consideration of the foregoing, the representations, warranties, obligations, and agreements set forth in this Agreement, and other good and valuable consideration, the adequacy and receipt of which hereby are acknowledged, and intending to be legally bound hereby, the Parties hereby agree as follows:

 

 

  When used in this Agreement, except as otherwise expressly provided herein, the following terms shall have the meanings set forth or referenced below.

“Accounting Standards” means, with respect to Novartis, IFRS and, with respect to CBMG, GAAP, in each case, as generally and consistently applied throughout such Party’s organization. Each Party shall promptly notify the other Party in the event that it changes the Accounting Standards pursuant to which its records are maintained, it being understood that each Party may only use internationally recognized accounting principles (e.g., IFRS, GAAP, etc.).

“Action” means any action, suit, arbitration, or other proceeding, whether civil, criminal, or administrative, at law or in equity by or before any Governmental Entity.

“Additional Indication” means any Indication other than the Initial Indications.

“Additional Indication Clinical Development Costs” means Clinical Development Costs incurred by or on behalf of the Parties in connection with the Development of the Product for an Additional Indication in the Territory.

“Affiliate” means, with respect to a Person, any other Person that controls, is controlled by, or is under common control with such Person. For purposes of this Agreement, a Person will be deemed to control another Person if it owns or controls, directly or indirectly, more than fifty percent (50%) of the Equity Securities of such other Person entitled to vote in the election of directors (or, in the case that such other Person is not a corporation, for the election of the corresponding managing authority), or otherwise has the power to direct the management and policies of such other Person (including any PRC domestic capital companies not controlled through ownership of Equity Securities but through contracts under a VIE structure). 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 fifty percent (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.

“Agreement” has the meaning set forth in the first paragraph of this Agreement.

“Alliance Manager” has the meaning set forth in Section 3.1.

“Ancillary Agreements” means the Manufacturing and Supply Agreement, the Share Purchase Agreement, the Pharmacovigilance Agreement, and any other agreements entered into by Novartis and CBMG or their respective Affiliates in connection with this Agreement.

 

 

 

“Anti-Corruption Laws” has the meaning set forth in the definition of “Applicable Law.”

“Applicable Law” means, individually and collectively, any federal, state, local, national, and supra-national laws, treaties, statutes, ordinances, rules, and regulations, including any rules, regulations, guidance, guidelines, circulars, officially announced policies of any Governmental Entity(ies), and requirements of any national securities exchange or securities listing organization having the binding effect of law, including: (a) those in effect in the Territory (“Applicable PRC Law”); (b) cGCP, cGLP, and cGMP; and (c) those concerning bribery, corruption, or illegal payments and gratuities, including the United States Foreign Corrupt Practices Act, the Hong Kong Prevention of Bribery Ordinance, the UK Bribery Act 2010, the PRC Criminal Law, the PRC Unfair Competition Law, the Interim Regulations on Prohibition of Commercial Bribery issued by the SAIC, and any Applicable PRC Laws similar to any of the foregoing (“Anti-Corruption Laws”).

“Applicable PRC Law” has the meaning set forth in the definition of “Applicable Law.”

“Acquirer” means, collectively, the Third Party referenced in the definition of Change of Control and such Third Party’s Affiliates, other than the applicable Party in the definition of Change of Control and such Party’s Affiliates, determined immediately prior to the closing of such Change of Control or the entry into a definitive agreement providing for a transaction or series of transactions that would constitute a Change of Control, as applicable.

“Aggregate Deferral Amount” has the meaning set forth in Section 5.5(c)(i)(B).

“Arbitrators” has the meaning set forth in Section 18.12(a).

“Audited Party” has the meaning set forth in Section 10.5.

“Auditing Party” has the meaning set forth in Section 10.5.

“Auditor” has the meaning set forth in Section 10.5.

“Business Day” means a day other than a Saturday, Sunday, or a bank or other public holiday in Basel, Switzerland, New York, New York, or Shanghai, PRC.

“Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1, and October 1, except that the first (1st) Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first (1st) to occur of January 1, April 1, July 1, or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term.

“Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first (1st) Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs, and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.

 

 

 

“CAPAs” has the meaning set forth in Section 7.2.

“CBMG” has the meaning set forth in the first paragraph of this Agreement.

“CBMG HK” has the meaning set forth in the first paragraph of this Agreement.

“CBMG Background Intellectual Property” means any and all Patent Rights, Know-How, and other intellectual property rights: (a) in existence and Controlled by CBMG or its Affiliates as of the Effective Date; or (b) that arise outside of activities under this Agreement and the Ancillary Agreements and are Controlled by CBMG or its Affiliates after the Effective Date.

“CBMG Collaboration Technology” means: (a) any and all Know-How, compounds, data, derivatives, designs, developments, discoveries, enhancements, inventions, materials, modifications, molecules, new uses, processes, products, research results, sequences, techniques, writings, or other technology rights, whether or not patentable, in each case, that are invented, conceived, reduced to practice, or otherwise developed in the course of activities under this Agreement or any Ancillary Agreement solely by or on behalf of CBMG; and (b) any and all Patent Rights and other intellectual property rights in any of the foregoing.

“CBMG Indemnitees” has the meaning set forth in Section 16.1.

“CBMG Know-How” means any Know-How Controlled by CBMG or any of its Affiliates as of the Effective Date or thereafter during the Term or the term of any Ancillary Agreement, as applicable (including with respect to any CBMG Collaboration Technology and CBMG’s interest in any Joint Collaboration Technology) which is: (a) necessary or useful for the Development, Manufacture, or Commercialization of the Product; or (b) related to CBMG’s serum-free medium or viral vectors.

“CBMG Other CART” means any CART therapy owned or controlled by CBMG other than any CART therapy targeting CD-19.

“CBMG Parent” has the meaning set forth in the first paragraph of this Agreement.

“CBMG Patents” means any Patent Rights Controlled by CBMG or any of its Affiliates as of the Effective Date or thereafter during the Term or the term of any Ancillary Agreement, as applicable (including with respect to any CBMG Collaboration Technology and CBMG’s interest in any Joint Collaboration Technology) which include claims that are: (a) necessary or useful for the Development, Manufacture, or Commercialization of the Product; or (b) related to CBMG’s serum-free medium or viral vectors, including the Patent Rights identified on Exhibit A.

“CBMG Production Costs” has the meaning set forth on Schedule 9.1(e).

“CBMG Shanghai” has the meaning set forth in the first paragraph of this Agreement.

“CBMG Subsidiaries” has the meaning set forth in the first paragraph of this Agreement.

 

 

 

“CBMG Technology” means the CBMG Know-How and the CBMG Patents.

“CBMG Technology Tech Transfer Plan” has the meaning set forth in Section 15.3(a).

“CBMG Trade Secrets” has the meaning set forth in Section 12.5(a).

“CBMG Wuxi” has the meaning set forth in the first paragraph of this Agreement.

“CDA” means that certain Confidentiality Agreement, by and between Novartis and CBMG Parent, dated December 4, 2017.

“cGCP” means the then-current ethical, scientific, and quality standards required by the FDA for designing, conducting, recording, and reporting trials that involve the participation of human subjects, as set forth in FDA regulations in 21 C.F.R. Parts 11, 50, 54, 56, and 312 and related FDA guidance documents, by the International Conference on Harmonization E6: Good Clinical Practices Consolidated Guideline, and as otherwise required by the SAMR, including those set out in, or issued pursuant to, the Drug Operation Quality Administrative Standards issued by the SAMR.

“cGLP” means the then-current good laboratory practices as required by the FDA under 21 C.F.R. Part 58 and all applicable FDA rules, regulations, orders, and guidances, and the requirements with respect to current good laboratory practices prescribed by the European Community, the OECD (Organization for Economic Cooperation and Development Council) and the ICH Guidelines, or as otherwise required by the SAMR, including those set out in, or issued pursuant to, the Non-Clinical Drug Research Quality Administrative Standards issued by the SAMR.

“cGMP” means the then-current good manufacturing practices as required by the FDA under 21 C.F.R. Parts 210 and 211 and all applicable FDA rules, regulations, orders, and guidances, and the requirements with respect to current good manufacturing practices prescribed by the European Community under provisions of The Rules Governing Medicinal Products in the European Community, Volume 4, Good Manufacturing Practices, Guidelines on Good Manufacturing Practices specific to Advanced Therapy Medicinal Products, or as otherwise required by the SAMR, including under the Quality Administrative Standard for Drug Manufacturing, any requirements issued pursuant to the Regulation of Drug Manufacturing Administrative Procedures issued by the SAMR, or the appendix thereto for biochemical drugs.

“Change of Control” means, with respect to a Party: (a) a merger or consolidation of such Party or its parent company with a Third Party that results in the voting securities of such Party or its parent company outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity or the parent company of the surviving entity immediately after such merger or consolidation; (b) a transaction or series of related transactions pursuant to which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of more than fifty percent (50%) of the combined voting power of the outstanding securities of such Party or its parent company; or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s and its controlled Affiliates’ assets.

 

 

“Claim” means any action, cause of action, claim, demand, proceeding, suit, or judgment brought by a Third Party.

“Clinical Development” means any and all pre-clinical and clinical drug or biologic development activities conducted before or after obtaining Regulatory Approval that are reasonably related to or which lead to the development, preparation, and submission of data and information to a Regulatory Authority for the purpose of obtaining, supporting, or expanding Regulatory Approval or to the appropriate body for obtaining, supporting, or expanding pricing approval, including all activities related to pharmacokinetic profiling, design, and conduct of Clinical Studies, regulatory affairs, statistical analysis, report writing, and regulatory filing creation and submission (including the services of outside advisors and consultants in connection therewith). “Clinical Development” does not include Technical Development.

“Clinical Development Budget” means the budget for the Parties’ Clinical Development of the Product, which budget is included in the Clinical Development Plan.

“Clinical Development Costs” means the direct costs incurred by or on behalf of a Party or its Affiliates during the Term and pursuant to this Agreement for the Clinical Development of the Product, calculated as the sum of: [***].

“Clinical Development Plan” means the Clinical Development plan, including the Clinical Development Budget, attached as Exhibit B and any amendments thereto, as in effect from time to time in accordance with this Agreement, outlining the goals, activities, timelines, deliverables, allocation of responsibilities between the Parties, and the commitment of resources by the respective Parties with respect to the Clinical Development of the Product for purposes of obtaining Regulatory Approval in the PRC.

“Clinical Study” means a study in humans to obtain information regarding a product which is authorized by the SAMR, the FDA, or other applicable Regulatory Authority, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging, or efficacy of the product.

“Collaboration Payment Term” has the meaning set forth in Section 9.1(b).

“Collaboration Technology” means, collectively, the CBMG Collaboration Technology, the Novartis Collaboration Technology, and the Joint Collaboration Technology.

“Combination Product” has the meaning set forth in the definition of “Net Sales.”

“Commercialize” means to market, promote, distribute, import, export, offer to sell, or sell a pharmaceutical or biological product or conduct other commercialization activities, and “Commercialization” means marketing, promoting, distributing, importing, exporting, offering for sale, selling, or other commercialization activities with respect to a pharmaceutical or biological product.

 

 

“Competing Infringement” has the meaning set forth in Section 11.3(a).

“Competing Product” means any CART therapy targeting CD-19 other than the Product.

“Confidential Information” means any and all confidential or proprietary information and data and all other scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial, and commercial information or data, whether communicated in writing or orally or by any other method, which is or has been provided by or on behalf of one (1) Party to the other Party or its designee in connection with this Agreement. “Confidential Information” includes the following, which are transferred, disclosed, or made available by the disclosing Party: confidential and proprietary technical and commercial information, Know-How, amino acid and nucleic acid sequences, biochemical, cell-based, and animal assays, animal models, dosages, dosage schedules, drawings, specifications, models, or designs relating to development, manufacture, production, registration, promotion, distribution, marketing, performance, or sale(s); experimental, manufacturing, process, analytical, packaging, product, warehousing, quality control, and quality assurance and marketing specifications, standards, procedures, processes, methods, instructions, and techniques, samples, prototypes, formulae, writings of any kind, opinions, or otherwise unwritten data or in the form of computer software or computer programs; biological, chemical, or physical materials provided under this Agreement; and reports provided under this Agreement.

“Contract” means any written contract, agreement, or commitment.

“Control” or “Controlled” means, with respect to any Patent Rights, Know-How, or other intellectual property right, the possession, legal authority, or right (whether by ownership, license, or sublicense, other than by a license, sublicense, or other right granted (but not assignment) pursuant to this Agreement) by a Party of the ability to assign or grant to the other Party the licenses, sublicenses, or rights to access and use or disclose such Patent Rights, Know-How, or other intellectual property right as provided for in this Agreement, without paying any consideration to any Third Party (now or in the future) or violating the terms of any agreement or other arrangement with any Third Party in existence as of the time such Party would be required hereunder to grant such license, sublicense, or rights of access and use.

“Cover,” “Covering,” or “Covered” means, with respect to the Product, that, but for a license granted to a Person under a claim included in a Patent Right, the Development, Manufacture, or Commercialization of the Product by such Person would infringe, or contribute to or induce the infringement of, such claim, or with respect to a patent application, as if such claim was contained in an issued patent.

“Data Protection Laws” means any Applicable Law concerning the protection or processing or both of personal data, including the PRC Constitution, People’s Republic of China General Principles of Civil Law effective January 1, 1987, Opinions of the Supreme People’s Court on Several Issues Concerning the Implementation of the People’s Republic of China General Principles of Civil Law (Trial) effective January 26, 1988, People’s Republic of China Regulations on Employment Services and Employment Management (effective January 1, 2008), People’s Republic of China Tortious Liability Law (effective July 1, 2010), Regulating the Internet Information Service Market Order Several Provisions (effective March 15, 2012), Decision of the Standing Committee of the National People’s Congress on the Strengthening of the Protection of Network Information (effective December 28, 2012), Information Security Technology Guidelines on Personal Information Protection within Information Systems for Public and Commercial Services (effective February 1, 2013), Protection of Personal Information of Telecommunications and Internet Users Provisions (effective September 1, 2013), Amendments to the Consumer Protection Law (effective March 15, 2014), Amendments to the People’s Republic of China Criminal Law (9th set of amendments) (effective November 1, 2015), People’s Republic of China Cyber Security Law (effective June 1, 2017), People’s Republic of China General Provisions of Civil Law (effective October 1, 2017), and other Applicable Laws relating to data protection and privacy.

 

 

“Deferral Amount” has the meaning set forth in Section 5.5(c)(i)(B).

“Deferral Election” has the meaning set forth in Section 5.5(c)(i)(B).

“Develop” or “Development” means Clinical Development or Technical Development, as the context requires.

“Development Budget” means the Clinical Development Budget or the Technical Development Budget, as the context requires.

“Development Costs” means Clinical Development Costs or Technical Development Costs, as the context requires.

“Development Plan” means the Clinical Development Plan or the Technical Development Plan, as the context requires.

“Dispute” has the meaning set forth in Section 18.12(a).

“DLBCL” means diffuse large B-cell lymphoma.

“Effective Date” has the meaning set forth in the first paragraph of this Agreement.

“Equity Securities” means, with respect to any Person that is a legal entity, any and all shares of capital stock, membership interests, units, profits interests, ownership interests, equity interests, registered capital, and other equity securities of such Person, and any right, warrant, option, call, commitment, conversion privilege, preemptive right or other right to acquire any of the foregoing, or security convertible into, exchangeable or exercisable for any of the foregoing, or any Contract providing for the acquisition of any of the foregoing.

“FDA” means the United States Food and Drug Administration, any successor entity thereto in the United States, or any equivalent entity outside of the United States, as applicable.

 

 

“FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act.

“Field” means the treatment, prevention, or diagnosis of all indications in humans.

“Finance Officers” has the meaning set forth in Section 5.5(c).

“First Commercial Sale” means the first commercial sale in an arms’-length transaction of the Product to a Third Party by Novartis or any of its Affiliates in the Territory following receipt of applicable Regulatory Approval of the Product. For clarity, “First Commercial Sale” shall not include any distribution or other sale solely for patient assistance, named patient use, compassionate use, or test marketing programs, or non-registrational studies or similar programs or studies where the Product is supplied without charge or at the actual Manufacturing cost thereof (without allocation of indirect costs or any markup).

“FTE” means a full-time scientific equivalent person (i.e., one (1) fully-dedicated or multiple partially-dedicated employees aggregating to one (1) full-time employee employed or contracted by Novartis or CBMG, or their respective Affiliates, as applicable) based upon a total of [***] working hours per year (taking into account normal vacations, sick days and holidays at the Party they are employed and not being considered working days), undertaken in connection with the conduct of Development in accordance with the Development Plan. For clarity: (a) personnel who directly support Development activities (including data managers and clinical planning managers) shall constitute FTEs; and (b) personnel who do not directly support Development activities (including support functions such as managerial, financial, legal, or business development) shall not constitute FTEs.

“FTE Costs” means the product of: (a) the actual number of FTEs utilized in the Development of the Product in accordance with the Development Plan (including the Development Budget) after the Effective Date, as documented by the applicable Party using a reliable time tracking system; and (b) the FTE Rate.

“FTE Rate” means: (a) with respect to FTEs in the U.S., Switzerland, and the European Union (including, for the avoidance of doubt, the United Kingdom), the rate of [***] during Calendar Year 2018, such amount to be adjusted as of January 1, 2019 and annually thereafter by the percentage increase or decrease, if any, in the Consumer Price Index for All Urban Consumers (CPI-U) for the U.S. City Average, 1982-84 = 100, calculated by the Bureau of Labor Statistics of the U.S. and available at https://www.bls.gov/regions/new-england/data/consumerpriceindex_us_table.htm; and (b) with respect to FTEs in the PRC, the rate of [***] during Calendar Year 2018, such amount to be adjusted as of January 1, 2019 and annually thereafter by the percentage increase or decrease, if any, in the China Consumer Price Index – Health Cares, as reported by the National Bureau of Statistics of China and available at http://data.stats.gov.cn/english/easyquery.htm?cn=A01. For the avoidance of doubt, such rate is intended to cover the cost of salaries, benefits, infrastructure costs, travel, general laboratory or office supplies, postage, insurance, training, and all other general expenses and overhead items. Notwithstanding the foregoing, for any Calendar Year during the Term that is less than a full year, the above referenced rate shall be proportionately reduced to reflect such portion of FTEs for such full Calendar Year.

 

 

“GAAP” means generally accepted accounting principles as practiced in the United States, as consistently applied.

“Generic Version” means, with respect to the Product, a product (including a “biogeneric,” “follow-on biologic,” “follow-on biological medicine or product,” “similar biological medicine or product,” or “biosimilar product”) that is determined by the applicable Regulatory Authority or by Applicable Law to be “similar,” “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” to the Product.

“Governmental Entity” means any federal, state, local or foreign government, regulatory, legislative, or administrative body, or any agency, bureau, board, commission, court, department, tribunal, or other instrumentality thereof, including any Regulatory Authority.

“Healthcare Laws” means all Applicable Laws (including Applicable PRC Laws) that govern the research, development, testing, manufacture, handling, packaging, labeling, storage, promotion, marketing, sales, distribution, import, export, or any other use with respect to any product or product candidate, including the FD&C Act; the Public Health Service Act; the federal False Claims Act; the federal Anti-Kickback Statute; the Civil Monetary Penalty Statute; the Stark Law; the Health Insurance Portability and Accountability Act of 1996 (HIPAA); Physicians Payments Sunshine Act (Title XI of Social Security Act); the Medicare Program (Title XVIII of the Social Security Act); the Medicaid Program (Title XIX of the Social Security Act); Federal Sentencing Guidelines for Organizations; the Health Information Technology for Economic and Clinical Health Act (HITECH); the Clinical Laboratories Improvement Act (CLIA); all regulations promulgated or enforced thereunder; and analogous Applicable Law to the foregoing in any jurisdiction.

“ICC” has the meaning set forth in Section 18.12(b).

“IFRS” means International Financial Reporting Standards, the set of accounting standards and interpretations as promulgated by the International Standards Accounting Board and as they may be updated for time to time, as consistently applied.

“IND” means an investigational new drug application, clinical trial application, or similar application or submission for approval to conduct Clinical Studies filed with or submitted to a Regulatory Authority in the Territory in conformance with the requirements of such Regulatory Authority, and any amendments thereto.

“Indemnification Claim Notice” has the meaning set forth in Section 16.3(b).

“Indemnified Party” has the meaning set forth in Section 16.3(b).

“Indemnifying Party” has the meaning set forth in Section 16.3(b).

 

 

“Indemnitee” means a CBMG Indemnitee or a Novartis Indemnitee, as the context requires.

“Indication” means a disease or pathological condition for which clinical results for such disease or condition and a separate MAA or a supplement (or other addition) to an existing MAA is required for the purpose of obtaining Regulatory Approval in the Territory.

“Initial Indications” means DLBCL and pALL.

“Initial Indication Clinical Development Costs” means Clinical Development Costs incurred by or on behalf of the Parties in connection with the Development of the Product for an Initial Indication in the Territory.

“Initial Term” has the meaning set forth in Section 13.1.

“Insolvency Event” means, in relation to either Party or an Affiliate thereof, as the case may be, any one (1) of the following: (a) that Party is the subject of voluntary or involuntary bankruptcy proceedings instituted on behalf of or against such Party (except for involuntary bankruptcy proceedings which are dismissed within sixty (60) days, or withdrawn or terminated prior to the declaration of insolvency of such Party); (b) an administrator, administrative receiver, receiver and manager, interim receiver, custodian, sequestrator, or similar officer is appointed in respect of that Party (collectively, the “Receiver”) and that Party has not caused the underlying action or the Receiver to be dismissed within sixty (60) days after the Receiver’s appointment; (c) the board of directors or shareholders’ meeting of such Party has passed a resolution to wind up or deregister that Party (or other through a process whereby the business is terminated and assets of such Party are distributed amongst the creditors, equityholders, or investors), or such a resolution shall have been passed, other than a resolution for the solvent reconstruction or reorganization of that Party; (d) a resolution shall have been passed by that Party or that Party’s directors or shareholders to make an application for an administration order or to appoint an administrator, liquidation committee, group, or similar body or Person; (e) that Party makes a general assignment, composition, or arrangement with or for the benefit of all or the majority of that Party’s creditors, or makes, suspends, or threatens to suspend making payments to all or the majority of that Party’s creditors; (f) any distress, execution, sequestration, or other similar process being levied or enforced upon or sued upon against the property or assets of that Party that is not discharged within seven (7) days; (g) that Party cannot repay debts that have fallen due, or its assets are insufficient to pay all of its debts, or it manifestly lacks the ability to repay its debts; or (h) in the case of any Person in the PRC, a Governmental Entity cancels or withdraws any Permit needed for that Party or its Affiliate to operate, or orders the dissolution of such Party or its Affiliate as a result of, or in connection with, any non-compliance with Applicable PRC Law.

“JOC Co-Chairs” has the meaning set forth in Section 3.2(b).

“Joint Collaboration Technology” means: (a) any and all Know-How, compounds, data, derivatives, designs, developments, discoveries, enhancements, inventions, materials, modifications, molecules, new uses, processes, products, research results, sequences, techniques, writings, or other technology rights, whether or not patentable, in each case, that are invented, conceived, reduced to practice, or otherwise developed in the course of activities under this Agreement or any Ancillary Agreement jointly by or on behalf of both Parties; and (b) any and all Patent Rights and other intellectual property rights in any of the foregoing.

 

 

“Joint Oversight Committee” or “JOC” means the committee established under Section 3.2.

“Know-How” means all commercial, technical, scientific, and other know-how and information, biochemical, cellular, and animal assays, animal models, trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical, and analytical, preclinical, clinical, safety, Manufacturing, and quality control data and know-how, including regulatory data, study designs, and protocols), and materials, in all cases, in written, electronic, or any other form now known or hereafter developed.

“Knowledge” means, with respect to CBMG, the actual knowledge of those Persons listed in Exhibit C after due inquiry.

“Look-Back Date” has the meaning set forth in Section 15.1(e).

“Loss of Market Share” means, with respect the Product in the Territory, that: (a) [***] Generic Versions of the Product has been sold by any Third Party in the Territory; (b) the Net Sales of the Product in any Calendar Quarter are less than [***] as compared with the Net Sales of the Product in the corresponding Calendar Quarter in the immediately preceding Calendar Year (e.g., the fourth (4th) Calendar Quarter of Calendar Year 2018 as compared to the fourth (4th) Calendar Quarter of Calendar Year 2017); or (c) the sale of the Product in the Territory is not Covered by a Valid Claim in the Territory.

“Losses” means any and all liability, damage, loss, cost, or expense of any nature (including reasonable attorneys’ fees and litigation expenses).

“MAA” means an application for the authorization to market the Product in the Territory, as defined by Applicable Law and regulations and filed with the applicable Regulatory Authority.

“Manufacture” or “Manufacturing” means all activities related to the manufacture of a pharmaceutical or biological product, including manufacturing supplies, for Development or Commercialization, packaging, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance and quality control activities related to manufacturing and release of product, ongoing stability tests, storage, shipment, and regulatory activities related to any of the foregoing.

 

 

“Manufacturing and Supply Agreement” means a manufacturing and supply agreement to be entered into after the Effective Date that contains the terms and conditions set forth on Exhibit E.

“Margin” has the meaning set forth in Section 9.1(e).

“MOFCOM” means the Ministry of Commerce of the PRC and its local authorized bodies.

“MOST” means the Ministry of Science and Technology of the PRC and its local authorized bodies.

“Net Sales” means the net sales recorded by Novartis or any of its Affiliates or sublicensees, excluding distributors and wholesalers, for any Product sold to Third Parties other than sublicensees in the Territory as determined in accordance with Novartis’s Accounting Standards as consistently applied, less a deduction of [***] for direct expenses related to the sales of the Product, distribution and warehousing expenses, and uncollectible amounts on previously-sold products.

[***]

             [***]

 “Novartis” has the meaning set forth in the first paragraph of this Agreement.

“Novartis Background Intellectual Property” means any and all Patent Rights, Know-How, and other intellectual property rights: (a) in existence and Controlled by Novartis or its Affiliates as of the Effective Date; or (b) that arise outside of activities under this Agreement and the Ancillary Agreements and are Controlled by Novartis or its Affiliates after the Effective Date.

“Novartis Collaboration Technology” means: (a) any and all Know-How, compounds, data, derivatives, designs, developments, discoveries, enhancements, inventions, materials, modifications, molecules, new uses, processes, products, research results, sequences, techniques, writings, or other technology rights, whether or not patentable, in each case, that are invented, conceived, reduced to practice, or otherwise developed in the course of activities under this Agreement or any Ancillary Agreement solely by or on behalf of Novartis; and (b) any and all Patent Rights and other intellectual property rights in any of the foregoing.

“Novartis Data Protection and Information Security Requirements” means the requirements set forth on Schedule 15.4(c).

 

 

“Novartis Indemnitees” has the meaning set forth in Section 16.2.

“Novartis Know-How” means any Know-How Controlled by Novartis or any of its Affiliates as of the Effective Date or thereafter during the Term or the term of any Ancillary Agreement, as applicable, that is necessary for the Development or Manufacture of the Product.

“Novartis Patents” means any Patent Rights Controlled by Novartis or any of its Affiliates as of the Effective Date or thereafter during the Term or the term of any Ancillary Agreement, as applicable, which include claims that are necessary for the Development or Manufacture of the Product.

“Novartis Technology” means the Novartis Know-How and the Novartis Patents.

“Novartis Third Party Agreements” means any agreement between Novartis or an Affiliate thereof, on the one hand, and a Third Party, on the other hand, which is set forth on Schedule 2.6(b).

“Novartis Trade Secrets” has the meaning set forth in Section 12.5(a).

“Order” means any order, injunction, ruling, writ, judgment, or decree of any Governmental Entity.

“Other Development Expenses” means any expenses incurred for clinical materials, analytical services, or other items, in each case, to the extent provided in the Development Plan.

“Out-of-Pocket Costs” means direct expenses, other than Other Development Expenses, paid or payable to Third Parties which are specifically identifiable and incurred by a Party or its Affiliates for the Development of the Product in accordance with the Development Plan; provided, that such expenses shall have been recorded as income statement items in accordance with such Party’s Accounting Standards and shall not include: (a) any expenses relating to management, human resources, or finance personnel; or (b) any pre-paid amounts, capital expenditures (including amortization thereof), or items intended to be covered by the FTE Rate.

“pALL” means pediatric acute lymphoblastic leukemia.

“Party” or “Parties” has the meaning set forth in the first paragraph of this Agreement.

“Patent Extensions” has the meaning set forth in Section 11.7.

“Patent Rights” means all patents and patent applications and all substitutions, divisions, continuations, and continuations-in-part, any patent issued with respect to any such patent applications, any reissue, reexamination, utility models, or designs, renewal, or extension (including any supplementary protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all counterparts thereof.

 

 

“Permit” means all clearances, orders, declarations, approvals, authorizations, qualifications, registrations, filings, certifications, consents, licenses, waivers, and permits required by any Governmental Entity(ies) or under Applicable Law.

“Person” means any natural person, corporation, unincorporated organization, partnership, association, sole proprietorship, joint stock company, joint venture, limited liability company, trust, government, or Regulatory Authority, or any other similar entity.

“Pharmacovigilance Agreement” has the meaning set forth in Section 8.2.

“PRC” means the People’s Republic of China, excluding the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and Taiwan.

“Product” means Novartis’s proprietary CD-19 targeting CART therapy, generically known as tisagenlecleucel.

“Product Marks” has the meaning set forth in Section 11.6.

“Product Price” has the meaning set forth in Section 9.1(e).

“Product Tech Transfer Plan” has the meaning set forth in Section 15.3(a).

“Prohibited Fund” has the meaning set forth in Section 15.1(h)(iv).

“Prohibited Payment” has the meaning set forth in Section 15.1(h)(ii).

“Prosecution and Maintenance” or “Prosecute and Maintain” means, with respect to a Patent Right, the preparation, filing, prosecution, and maintenance of such Patent Right, and re-examinations, reissues, and appeals with respect to such Patent Right, together with the initiation or defense of interferences, oppositions, or other similar proceedings with respect to the particular Patent Right, and any appeals therefrom. For clarity, “Prosecution and Maintenance” or “Prosecute and Maintain” shall not include any other enforcement actions taken with respect to a Patent Right.

“Quality Audit” has the meaning set forth in Section 7.2.

“Receiver” has the meaning set forth in the definition of “Insolvency Event.”

“Regulatory Approval” means, with respect to the Product in the Territory, all approvals, registrations, licenses, or authorizations from a Regulatory Authority in the Territory that are necessary to market and sell the Product in the Territory.

“Registration Authority” has the meaning set forth in Section 15.3(b).

“Regulatory Documentation” means all: (a) documentation comprising Regulatory Filings, marketing authorizations, Regulatory Approvals, or other Permits for any product or product candidate of CBMG or its Affiliates (or, after the Effective Date, the Product), and including pre-clinical and clinical data and information, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.F.R. Part 314.420 and any non-U.S. equivalents), and any other reports, records, regulatory correspondence, and other materials relating to Development or Regulatory Approval for any product or product candidate of CBMG or its Affiliates (or, after the Effective Date, the Product), or required to manufacture or commercialize any product or product candidate of CBMG or its Affiliates (or, after the Effective Date, the Product), including any information that relates to pharmacology, toxicology, chemistry, manufacturing, and controls data, batch records, safety, and efficacy, and any safety database; and (b) material correspondence and other filings relating to any product or product candidate of CBMG or its Affiliates (or, after the Effective Date, the Product) submitted to or received from any Governmental Entity (including minutes and official contact reports relating to any communications with any Governmental Entity) and relevant supporting documents submitted to or received from Governmental Entities with respect thereto, including all regulatory drug lists, final versions of advertising and promotion documents, adverse event files and complaint files.

 

 

“Regulatory Filings” means any submission to a Regulatory Authority of any appropriate regulatory application (including any IND or MAA), including any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

“Regulatory Requirements” has the meaning set forth in Section 15.1(g)(i).

“Relevant Affiliate” means, as to either of the Parties, and as the context requires, any Affiliate of such Party that is intended to be a signatory to any of the Ancillary Agreements.

“Renewal Term” has the meaning set forth in Section 13.1.

“Representatives” means, as to any Person, such Person’s or its Affiliates’ officers, managers, directors, employees, agents, and advisors (including attorneys, accountants, and financial advisors).

“Required PRC Approvals” means all Permits required for the performance of the Parties’ obligations under this Agreement and the Ancillary Agreements under Applicable PRC Law set forth on Exhibit D.

“Restricted Activities” has the meaning set forth in Section 2.5(b)(ii).

“ROFN Activities” has the meaning set forth in Section 2.5(b)(ii).

“ROFN Notice” has the meaning set forth in Section 2.5(b)(ii).

“Rules” has the meaning set forth in Section 18.12(b).

“SAFE” means the State Administration of Foreign Exchange of the PRC and its local authorized bodies.

 

 

“SAIC” means the former State Administration of Industry and Commerce, now part of SAMR.

“Sales & Collaboration Payment Report” means a written report showing each of: (a) the Net Sales of the Product in the Territory during the reporting period by Novartis and its Affiliates and sublicensees; and (b) the collaboration payments payable, in USD, which shall have accrued under this Agreement with respect to such Net Sales.

“SAMR” means the State Administration of Market Regulation, the Chinese regulatory body in which the former China Food and Drug Administration and SAIC functions have been merged following a restructuring, and, where the context permits, including a reference to the new State Drug Administration, and their local authorized bodies.

“Senior Officers” means, with respect to Novartis, CEO, Oncology Business Unit or his/her designee and, with respect to CBMG, CEO or his/her designee.

“Shanghai Cellular” has the meaning set forth in the first paragraph of this Agreement.

“Share Purchase Agreement” has the meaning set forth in the Recitals.

“Tech Transfer Work Plans” means the CBMG Technology Tech Transfer Plan and the Product Tech Transfer Plan.

“Technical Development” means any and all technical and Manufacturing-related activities, including test method development and stability testing, assay development, process development, formulation development, quality assurance and quality control development, validation and other testing, packaging development, as well as record-keeping, data and database development, management, storage, and retention activities relating to any of the foregoing.

“Technical Development Budget” means the budget for the Parties’ Technical Development of the Product, which budget is included in the Technical Development Plan.

“Technical Development Costs” means the direct costs incurred by or on behalf of a Party or its Affiliates during the Term and pursuant to this Agreement for the Technical Development of the Product, calculated as the sum of: [***].

“Technical Development Plan” means the Technical Development plan, including the Technical Development Budget, to be agreed to by the Parties following the Effective Date and as in effect from time to time in accordance with this Agreement, outlining the goals, activities, timelines, deliverables, allocation of responsibilities between the Parties, and the commitment of resources by the respective Parties with respect to the Technical Development of the Product.

“Term” has the meaning set forth in Section 13.1.

“Territory” means the PRC.

 

 

“Third Party” means any Person other than a Party or an Affiliate of a Party.

“Third Party Infringement” has the meaning set forth in Section 11.4(a).

“Transactions” means the transactions contemplated by this Agreement and the Ancillary Agreements.

“United States” means the United States of America, its territories, and its possessions.

“USD” means the lawful currency of the United States.

“Valid Claim” means a claim of an issued patent Controlled by Novartis or its Affiliates that has not expired or been revoked or held invalid or unenforceable by a patent office, court, or other governmental agency of competent jurisdiction in the Territory in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period).

“VIE” means Variable Interest Entity.

.

Except as otherwise expressly provided in this Agreement, under no circumstances will a Party or any of its Affiliates, as a result of this Agreement, obtain any ownership interest, license, or other right in or to any Patent Rights, Know-How, or other intellectual property rights of the other Party, including tangible or intangible items owned, controlled, or developed by the other Party, or provided by the other Party to the receiving Party at any time, in each case, pursuant to this Agreement.

 

 

.o the extent that any license grant by Novartis to CBMG under the Novartis Technology pursuant to Section 2.1 constitutes the grant of a sublicense to CBMG of certain Novartis Technology that is not owned by Novartis or any of its Affiliates, but that is in-licensed by Novartis or any such Affiliate from a Third Party licensor pursuant to a Novartis Third Party Agreement, then:

 

 

Within thirty (30) days following the Effective Date, each Party will appoint (and notify the other Party in writing with respect to the identity of) a senior representative having a general understanding of pharmaceutical and biological Development, Manufacture, and Commercialization issues to act as its alliance manager under this Agreement (each, an “Alliance Manager”). The Alliance Managers will serve as the lead contact point between the Parties for the purpose of providing the other Party with information on the progress of Development, Manufacture, and Commercialization of the Product and will be primarily responsible for: (a) facilitating the flow of information and otherwise promoting communication, coordination, and collaboration between the Parties; (b) providing single-point communication for seeking consensus both internally within the respective Party’s organization and together regarding key strategy and planning issues, as appropriate, including facilitating review of external corporate communications; and (c) raising cross-Party or cross-functional disputes in a timely manner. Each Party may replace its Alliance Manager by written notice to the other Party.

  The JOC shall hold its initial meeting no later than sixty (60) days after the Effective Date and shall thereafter meet at least once per Calendar Quarter during the Term unless the Parties mutually agree in writing to a different frequency. No later than five (5) Business Days prior to any meeting of the JOC (or such shorter time period as the Parties may agree), the Alliance Managers will prepare and circulate an agenda for such meeting; provided, however, that either Party may propose additional topics to be included on such agenda, either prior to or in the course of such meeting. Either Party may also call a special meeting of the JOC (in person or by audio or video teleconference) by providing at least ten (10) Business Days’ prior written notice to the other Party if such Party reasonably believes that a significant matter must be addressed prior to the next scheduled meeting, in which event such Party will work with the JOC Co-Chairs and the Alliance Managers of both Parties to provide the representatives of the JOC no later than three (3) Business Days prior to the special meeting with an agenda for the meeting and materials reasonably adequate to enable an informed discussion on the matters to be considered. The JOC may meet in person or by audio or video teleconference; provided, that at least one (1) meeting per Calendar Year will be in person unless the Parties mutually agree in writing to waive such requirement. In-person JOC meetings will be held at locations alternately selected by CBMG and by Novartis. Each Party will bear the expenses of its respective JOC representatives’ participation in JOC meetings. Meetings of the JOC will be effective only if at least one (1) representative of each Party is present or participating in such meeting. The JOC Co-Chairs or their designees will send draft meeting documentation to each representative of the JOC for review and approval within ten (10) Business Days after each JOC meeting. Such documentation will be officially endorsed by the JOC at the next JOC meeting, including reflecting any differences noted by the Parties, and will be signed by the Alliance Managers.

The JOC may, at any time it deems necessary or appropriate, establish additional joint committees and delegate such of its responsibilities as it determines appropriate to such joint committees.

  As soon as reasonably practicable after the Effective Date and on a continuing basis during the Term, each Party shall, without additional consideration, disclose to the other Party copies of any Know-How: (a) in its Control; (b) in existence as of the Effective Date or which arises in the course of its performance of this Agreement; and (c) which is necessary for the other Party to exercise its rights or fulfill its obligations under this Agreement, including to perform the activities assigned to it under the Development Plan and, where the other Party is Novartis, its activities in connection with the Commercialization of the Product.

 

 

From time to time during the Term, at the request of a Party, the other Party shall, without additional consideration, provide reasonable assistance to the requesting Party or its Affiliates in connection with understanding and using such Party’s Know-How for purposes consistent with licenses and rights granted to the requesting Party under this Agreement.

As between the Parties, Novartis shall control and be responsible in its sole discretion for the Development of the Product in the Territory. CBMG shall be responsible for conducting certain Development activities in support of Novartis’s Development efforts, as set forth in the Development Plan.

CBMG shall perform the Development activities assigned to it under the Development Plan.

As between the Parties, Novartis shall be solely responsible in its sole discretion for regulatory activities under this Agreement, including: (a) determining the regulatory plans and strategies for the Product; (b) making all Regulatory Filings with respect to the Product, except for those that are required to be made by CBMG or its Affiliates under Applicable Law, in which case Novartis shall have the right to review and provide its written approval prior to the submission of such Regulatory Filings to the SAMR or other relevant Regulatory Authority; (c) obtaining and maintaining all Regulatory Approvals for the Product, except for those which are required to be obtained by CBMG or its Affiliates under Applicable Law, in which case Novartis shall have the right to review and give its written approval prior to the submission of any application for such Regulatory Approvals to the SAMR or other relevant Regulatory Authority; and (d) conducting all meetings with Regulatory Authorities in connection with the Development and Regulatory Approval of the Product, in each case ((a) through (d)), in the Territory. Any such activities may be performed by Novartis, its Affiliates, or its designees.

CBMG shall cooperate with and support Novartis in connection with Novartis’s activities pursuant to Section 6.1 to the extent reasonably requested by Novartis from time to time. For the avoidance of doubt, such cooperation and support shall include the provision to Novartis of local market access and related support and advice.

All Regulatory Documentation generated under this Agreement shall be owned by and held in the name of Novartis or its designee, and any such Regulatory Documentation issued in the name of CBMG or its Affiliates shall promptly be assigned by CBMG to Novartis or its designee to the extent permitted by Applicable Law or, in the event assignment is not permitted under Applicable Law, held in trust for, or for the sole benefit of, Novartis or its designee.

Novartis shall have the exclusive right to correspond or communicate with Regulatory Authorities regarding the Product in the Territory and other regulatory matters under this Agreement. Unless required by Applicable Law, CBMG and its Affiliates, sublicensees, and subcontractors shall not correspond or communicate with any Regulatory Authority regarding the Product or any other regulatory matters under this Agreement without first obtaining, in each case, Novartis’s prior written consent; provided, that, upon Novartis’s request, CBMG or its Affiliates shall attend any meeting with a Regulatory Authority in the Territory regarding the Product or any other regulatory matters under this Agreement. If CBMG or its Affiliates, sublicensees, or subcontractors receives any correspondence or other communication from a Regulatory Authority in the Territory regarding the Product or any other regulatory matter under this Agreement, CBMG shall provide Novartis with access to or copies of all such material written or electronic correspondence promptly after its receipt for Novartis’s review and comment, and shall incorporate any and all of Novartis’s comments thereto.

Novartis (or its Affiliate) and CBMG shall negotiate and enter into the Manufacturing and Supply Agreement within ninety (90) days after the Effective Date.

CBMG grants to Novartis, its Affiliates, and its designees, upon reasonable prior notice, the right to inspect CBMG’s production facilities to perform a quality audit in order to confirm CBMG’s compliance with cGMP, Novartis’s quality requirements, and Applicable Law (each, a “Quality Audit”). If Novartis reasonably believes (as a result of a condition which it observes during a Quality Audit or otherwise) that CBMG may not be in compliance with cGMP, Novartis’s quality requirements, or Applicable Law, then the Parties shall discuss and agree upon any appropriate corrective actions to address such non-compliance (collectively, the “CAPAs”), and CBMG shall promptly implement such CAPAs at its sole cost and expense.

 

.Novartis shall be solely responsible, at its cost and in its sole discretion, for the Commercialization of the Product in the Territory, including booking sales and pricing.

If required by Applicable Law, within a reasonable amount of time, not to exceed six (6) months following the Effective Date, the Parties shall agree upon and implement a procedure for the mutual exchange of safety information associated with the Product. The details of the operating procedures relating to the exchange shall be the subject of a mutually-agreed upon pharmacovigilance agreement (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall enable each Party to comply with its respective obligations under Applicable Law with regard to adverse event data collection, analysis, and reporting.

Novartis and CBMG each acknowledge and agree that nothing in this Agreement shall be construed as representing an estimate or projection of anticipated sales of the Product, and that the Net Sales levels set forth above or elsewhere in this Agreement or that have otherwise been discussed by the Parties are merely intended to define the collaboration payment obligations in the event such Net Sales levels are achieved. NEITHER NOVARTIS NOR CBMG MAKES ANY REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT EITHER PARTY OR ITS AFFILIATES OR SUBLICENSEES WILL BE ABLE TO SUCCESSFULLY DEVELOP OR COMMERCIALIZE THE PRODUCT OR, IF COMMERCIALIZED, THAT ANY PARTICULAR NET SALES LEVEL OF THE PRODUCT WILL BE ACHIEVED.

 

 

All payments under this Agreement shall be payable in USD. Notwithstanding the foregoing sentence, to the extent any Ancillary Agreement provides that payments under such Ancillary Agreement shall be payable in RMB, such payments shall be made in RMB. When conversion of payments is required to be undertaken by a Party, the USD or RMB equivalent (as applicable) shall be calculated using such Party’s then-current standard exchange rate methodology as consistently applied in its external reporting.

Each Party shall be responsible for all taxes, fees, duties, levies, or similar amounts imposed on its income, assets, capital, employment, personnel, and right or license to do business. Except as otherwise provided, each Party shall be responsible for its own sales tax, use tax, excise tax, value-added tax (VAT), goods and services tax (GST), consumption tax, and similar taxes based upon its own activities under this Agreement. Each Party shall use reasonable and legal efforts to reduce tax withholding, to the extent permitted by Applicable Law, on payments made pursuant to this Agreement. In the event any payments due under this Agreement are subject to withholding tax under Applicable Law, the paying Party shall deduct the respective amount from the applicable payment and pay the withholding tax to the relevant tax authority. The paying Party shall deliver within sixty (60) days to the other Party evidence of such payment. Each Party shall make all reasonable efforts to obtain relief or reduction of withholding tax under the applicable tax treaties, including the submission or issuance of requisite forms and information. Any such amount deducted and paid to the applicable tax authority shall be deemed fully paid to the other Party in satisfaction of the applicable payment obligation under this Agreement.

Each Party shall keep complete, true, and accurate books and records in accordance with its Accounting Standards in relation to this Agreement, including with respect to Development Costs, Net Sales, collaboration payments, and Product Price. Each Party will keep such books and records for at least three (3) years following the Calendar Year to which they pertain. Each Party (the “Auditing Party”) may, upon written request, cause an internationally-recognized independent accounting firm (the “Auditor”), which is reasonably acceptable to the other Party (the “Audited Party”), to inspect the relevant records of such Audited Party and its Affiliates to verify the payments made and amounts reported by the Audited Party and the related reports, statements, and books of accounts, as applicable. Before beginning its audit, the Auditor shall execute an undertaking acceptable to the Audited Party by which the Auditor shall agree to keep confidential all information made available to the Auditor during the audit. The Auditor shall have the right to disclose to the Auditing Party only its conclusions regarding any payments owed under this Agreement. Each Party and its Affiliates and sublicensees shall make their records available for inspection by the Auditor during regular business hours at such place or places where such records are customarily kept, upon receipt of reasonable advance notice from the Auditing Party. The records shall be reviewed solely to verify the accuracy of the Audited Party’s collaboration payments and other payment obligations and compliance with the financial terms of this Agreement. Such inspection right shall not be exercised more than once without cause in any Calendar Year and not more frequently than once without cause with respect to records covering any specific period of time. In addition, the Auditing Party shall only be entitled to audit the books and records of the Audited Party from the three (3) Calendar Years prior to the Calendar Year in which an audit request is made. The Auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with Applicable Law or judicial order. The Auditor shall provide its audit report and basis for any determination to the Audited Party at the time such report is provided to the Auditing Party before it is considered final. In the event that the final result of the inspection reveals an underpayment or an overpayment by either Party, the underpaid or overpaid amount shall be settled promptly. The Auditing Party shall pay for any audit, as well as its expenses associated with enforcing its rights with respect to any payments hereunder; provided, that, if an underpayment of amounts due or overpayment of amounts payable by the Auditing Party of more than twenty percent (20%) of the total payments due hereunder for the applicable year is discovered, the fees and expenses charged by the Auditor shall be paid by Audited Party.

 

 

.Any recovery received as a result of any action under Section 11.3 or Section 11.4 shall be allocated in the following order: (a) to reimburse the Party taking legal action for the costs and expenses (including attorneys’ and professional fees) incurred by such Party in connection with such action, to the extent not previously reimbursed; (b) to reimburse the Party not taking the lead in a legal action but which joins such legal action as provided herein, for the costs and expenses (including attorneys’ and professional fees) incurred by such Party in connection with such action, to the extent not previously reimbursed; and (c) the remainder of the recovery shall be retained by Novartis.

Novartis shall have the right (but not the obligation) to brand the Product using Novartis-related trademarks and any other trademarks and trade names it determines appropriate in its sole discretion for the Product, which may vary within the Territory (the “Product Marks”). Novartis shall own all rights in the Product Marks and shall register and maintain the Product Marks to the extent it determines reasonably necessary.

Upon Novartis’s request, CBMG shall cooperate in obtaining patent term restoration, supplemental protection certificates or their equivalents, and patent term extensions (collectively, “Patent Extensions”) with respect to the CBMG Patents, where applicable, at Novartis’s sole cost and expense. If the Parties agree on a Patent Extension for a CBMG Patent, CBMG shall provide all reasonable assistance requested by Novartis, including permitting Novartis to proceed with applications for such Patent Extensions in the name of CBMG, if deemed appropriate by Novartis, and executing documents and providing any relevant information and assistance to Novartis.

 

 

The obligations under this Article 12 shall not apply to any information to the extent that such information:

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the recipient Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the recipient Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the recipient Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the recipient Party, unless the combination and its principles are in the public domain or in the possession of the recipient Party.

 

The term of this Agreement will commence upon the Effective Date and shall continue, unless earlier terminated as permitted by this Agreement, until the ten (10)-year anniversary of the Effective Date (the “Initial Term”). Thereafter, this Agreement shall be automatically renewed for consecutive two (2)-year periods (each, a “Renewal Term”) (each Renewal Term, collectively with the Initial Term, the “Term”) unless terminated by Novartis by written notice to CBMG at least ninety (90) days prior to such automatic renewal.

Novartis may terminate this Agreement upon sixty (60) days’ prior written notice where any Applicable Law is enacted or any existing Applicable Law is amended, supplemented, or otherwise modified, or any Governmental Entity takes any action, including with respect to regulation of VIEs generally or CBMG’s VIE structure specifically, any Requisition of Scientific Data, or any requisition or seizure of any of CBMG’s or its Affiliates’ other assets (including CBMG’s or its Affiliates’ manufacturing facilities) which are material to its business, in each case, in a manner which Novartis, in its sole discretion, determines renders illegal or restricts or adversely affects any activity contemplated by this Agreement. During such sixty (60)-day period, neither Party shall be obligated to perform under this Agreement to the extent that it reasonably believes such performance would violate Applicable Law. For purposes hereof, “Requisition of Scientific Data” means any instance where a Governmental Entity in the PRC requires, pursuant to Article 24 thereof, scientific data as defined under the Scientific Data Management Procedures issued by the State Council General Office with effect from March 17, 2018 to be disclosed to any Governmental Entity in the PRC.

Novartis may terminate this Agreement upon sixty (60) days’ prior written notice where it determines in its sole discretion that a safety issue exists with respect to the Development, Manufacture, or Commercialization of the Product. In connection with such termination, CBMG shall provide all assistance reasonably requested by Novartis during such period as is reasonably required to identify, further characterize, and fully document such safety issue. During such sixty (60)-day period, Novartis shall not be required to undertake any Development, Manufacturing, or Commercialization activities or any other activities, in each case, which it believes would implicate a material safety issue.

Novartis may terminate this Agreement effective immediately where any Required PRC Approval which is necessary for the Development, Manufacture, or Commercialization of the Product for DLBCL is not obtained by the applicable Party(ies) within eighteen (18) months after the Effective Date.

Novartis may terminate this Agreement effective immediately if any of the Ancillary Agreements is not executed within six (6) months after the Effective Date.

 

 

Novartis may terminate this Agreement effective immediately if: (a) Novartis reasonably believes (as a result of a condition which it observes during a Quality Audit or otherwise) that CBMG may not be in compliance with cGMP, Novartis’s quality requirements, or Applicable Law; and (b) CBMG fails to successfully implement the CAPAs, as determined in Novartis’s sole discretion, within sixty (60) days following the Parties’ agreement on such CAPAs in accordance with Section 7.2.

Novartis may terminate this Agreement effective immediately if the Tech Transfer Work Plans are not finalized within thirty (30) days after the Effective Date in accordance with Section 15.3(a).

Novartis may terminate this Agreement effective immediately upon the expiration or termination of any Ancillary Agreement.

Novartis may terminate this Agreement upon sixty (60) days’ prior written notice upon a Change of Control of CBMG or CBMG’s or any Affiliate’s entry into a definitive agreement providing for a transaction or series of transactions that would constitute a Change of Control of CBMG; provided, that, at the applicable time, the Acquirer: (a) is researching, developing, manufacturing, or commercializing any cell therapy or gene therapy product, service, or technology that Novartis determines competes with any cell therapy or gene therapy product, service, or technology of Novartis or any of its Affiliates; or (b) has not been, during the five (5) consecutive Calendar Years immediately preceding such time, in full compliance with all Regulatory Requirements and Novartis internal regulatory and compliance standards; or (c) is researching, developing, manufacturing, or commercializing a Competing Product; or (d) recorded greater than [***] in worldwide net sales during the prior twelve (12)-month period (in each case, (a) through (d), as determined in Novartis’s sole discretion).

Novartis may terminate this Agreement upon sixty (60) days’ prior written notice where Novartis determines, in its sole discretion, that a Third Party Controls a Patent Right which is necessary for the Development, Manufacture, or Commercialization of the Product in the Territory.

Novartis may terminate this Agreement upon sixty (60) days’ prior written notice where: (a) any Novartis Third Party Agreement is terminated; or (b) the scope or exclusivity of any license granted to Novartis under any Novartis Third Party Agreement is diminished.

Novartis may terminate this Agreement upon sixty (60) days’ prior written notice in the event of a Loss of Market Share.

Novartis may terminate this Agreement upon sixty (60) days’ prior written notice where Novartis determines, in its sole discretion, that the Commercialization of the Product in the Territory is not commercially viable.

 

 

Novartis may terminate this Agreement effective immediately where Novartis sells, assigns, transfers, conveys, licenses, or otherwise divests to a Third Party any material right in and to the Product in the Territory.

Novartis may terminate this Agreement effective immediately where Novartis ceases all material development, manufacture, and commercialization activities with respect to the Product in the Territory.

Either Party may terminate this Agreement upon written notice if an Insolvency Event occurs in relation to the other Party. If a Party becomes aware of the likely occurrence of any Insolvency Event in regard to that Party, it shall promptly so notify the other Party in sufficient time to give the other Party sufficient notice to protect its interests under this Agreement. Novartis may terminate this Agreement in the event CBMG rejects this Agreement under Section 365 of the United States Bankruptcy Code, 11 U.S.C. § 101 et seq.

Upon the expiration or termination of this Agreement for any reason, the following consequences shall apply:

In addition to any other provisions of this Agreement that are elsewhere expressly stated to survive, the provisions of Articles 1 (Definitions and Interpretation), 10 (Payment Terms and Reports), 14 (Effects of Expiration or Termination), 16 (Indemnification and Liability), and 18 (Miscellaneous) and Sections 2.2(b) (License Grants to Novartis), 2.3(a)(ii) (Sublicenses), 2.5(a) (Exclusivity), 5.5 (Development Costs), 11.1 (Ownership), 15.1 (Representations and Warranties by CBMG), 15.2 (Representations and Warranties by Novartis), and 15.5 (No Other Warranties) shall survive the expiration or termination of this Agreement for any reason, in accordance with their respective terms and conditions, and for the duration stated, and where no duration is stated, shall survive indefinitely. In addition, the provisions of Article 12 shall survive the termination or expiration of this Agreement for a period of ten (10) years.

Except as otherwise expressly provided herein, the expiration or termination of this Agreement for any reason shall not release either Party from any liability that, at the time of such expiration or termination, has already accrued to the other Party or that is attributable to a period of time prior to such expiration or termination, nor will any expiration or termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, or at law or in equity, with respect to breach of this Agreement prior to such expiration or termination.

Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies at law or in equity will remain available except as agreed to otherwise herein.

 

 

CBMG represents and warrants to Novartis, as of the Effective Date, as follows:

Novartis represents and warrants to CBMG, as of the Effective Date, as follows:

 

 

Novartis shall use good-faith efforts to provide reasonable assistance to CBMG in connection with the registration of this Agreement. CBMG shall: (1) obtain from the Registration Authority the “Technology Import Contract Registration Certificate” and the “Technology Export Contract Registration Certificate” in respect of this Agreement promptly following issuance thereof by the Registration Authority; and (2) provide copies of such certificates to Novartis promptly (but in no event later than five (5) Business Days) following CBMG’s receipt thereof.

EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 15: (A) NO REPRESENTATION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF CBMG OR NOVARTIS; AND (B) ALL OTHER CONDITIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED, INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. WITHOUT LIMITING THE FOREGOING, CBMG HEREBY ACKNOWLEDGES: (1) THAT THE PRODUCT CONSTITUTES A NOVEL THERAPY AND THE MANUFACTURING PROCESS FOR THE PRODUCT IS COMPLEX AND EXPERIMENTAL IN NATURE; (2) THAT NO REPRESENTATION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF NOVARTIS WITH RESPECT TO THE MANUFACTURE OF THE PRODUCT, INCLUDING BY NOVARTIS, CBMG, OR ANY OTHER PERSON; AND (3) THE MATTERS SET FORTH ON SCHEDULE 15.5.

CBMG shall indemnify and hold Novartis, its Affiliates, and its sublicensees, and their respective officers, directors, and employees (the “Novartis Indemnitees”) harmless from any and all Losses incurred by or imposed upon the Novartis Indemnitees or any of them in connection with any Claim, in each case, to the extent arising or resulting from:

provided, however, that CBMG shall not be obliged to so indemnify and hold harmless the Novartis Indemnitees for any Claims: (x) under Sections 16.2(a) through 16.2(c); or (y) to the extent that such Claims arise from the breach, negligence, or willful misconduct of Novartis or any Novartis Indemnitee.

Novartis shall indemnify and hold CBMG, its Affiliates, and its sublicensees, and their respective officers, directors, and employees (the “CBMG Indemnitees”) harmless from any and all Losses incurred by or imposed upon the CBMG Indemnitees or any of them in connection with any Claim, in each case, to the extent arising or resulting from:

provided, however, that Novartis shall not be obliged to so indemnify and hold harmless the CBMG Indemnitees for any Claims: (x) under Sections 16.1(a) through 16.1(c); or (y) to the extent that such Claims arise from the breach, negligence, or willful misconduct of CBMG or any CBMG Indemnitee.

NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY, OR OTHERWISE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES OR FOR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY, EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE: (A) INCURRED AS A RESULT OF A BREACH OF SECTION 2.5; (B) INCURRED AS A RESULT OF A BREACH OF ARTICLE 12; (C) INCURRED AS A RESULT OF A PARTY’S GROSS NEGLIGENCE, INTENTIONAL MISCONDUCT, OR FRAUD; OR (D) REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 16.

Neither Party excludes any liability for death or personal injury caused by its negligence or willful misconduct or that of its officers, directors, employees, agents, sublicensees, or subcontractors.

Neither Party shall use the name, symbol, trademark, trade name, or logo of the other Party or its Affiliates in any press release, publication, or other form of public disclosure without first obtaining, in each case, the prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned, or delayed), except for those disclosures for which consent has already been obtained. Notwithstanding the foregoing, Novartis shall be entitled to use the name of CBMG to the extent necessary or useful in connection with the Development or Commercialization of the Product.

CBMG agrees not to issue any press release or other public statement, whether oral or written, disclosing the existence of this Agreement, the terms of this Agreement, or any information relating to this Agreement without first obtaining, in each case, the prior written consent of Novartis, exercisable in its sole discretion. CBMG shall provide Novartis with any such proposed press release or other public statement no less than five (5) Business Days prior to the date on which CBMG proposes to issue (subject to obtaining Novartis’s prior written consent) such press release or other public statement.

Notwithstanding Section 17.1, Section 17.2, and Section 17.3, each Party may make any disclosures required of it to comply with any duty of disclosure it may have pursuant to Applicable Law or the requirements of any Governmental Entity or Regulatory Authority or pursuant to the rules of any recognized stock exchange. In the event of a disclosure required by Applicable Law, the requirements of any Governmental Entity or Regulatory Authority, or the rules of any recognized stock exchange, the Parties shall coordinate with each other with respect to the timing, form, and content of such required disclosure. If so requested by the other Party, the Party subject to such obligation shall use commercially reasonable efforts to obtain an order protecting to the maximum extent possible the confidentiality of such provisions of this Agreement as reasonably requested by the other Party. If the Parties are unable to agree on the form or content of any required disclosure, such disclosure shall be limited to the minimum required as determined by the disclosing Party in consultation with its legal counsel. Without limiting the foregoing, CBMG shall provide Novartis with each proposed filing by CBMG with the United States Securities and Exchange Commission (or any stock exchange, including Nasdaq, or any similar regulatory agency in any country other than the United States) describing the terms of this Agreement (including any filings of this Agreement) at least ten (10) Business Days prior to submission of such filing, and shall reasonably consider and in good faith incorporate any and all of Novartis’s comments relating to such filing, including the provisions of this Agreement for which confidential treatment should be sought.

Except as otherwise specified in this Agreement, each of the Parties shall bear its own costs and expenses (including investment banking and legal fees and expenses) incurred in connection with this Agreement and the transactions contemplated hereby.

All notices, requests, consents, claims, demands, waivers, and other communications under this Agreement shall be in writing and shall be delivered personally or sent electronic transmission, by a nationally-recognized overnight courier service, or by registered or certified mail, postage and fees prepaid, to the intended recipient at such Party’s address shown below (or such other address as may be specified by such Party in a notice given in the manner provided in this Section 18.2). Such notice or other communication shall be deemed to have been duly given: (a) when delivered, if delivered personally (with written confirmation of receipt); (b) when sent, if sent by electronic mail (if confirmed by reply electronic mail that is not automated); provided, that any electronic mail sent at or after 5:00 p.m. prevailing Eastern Time shall be deemed to be sent at 9:00 a.m. prevailing Eastern Time on the following Business Day; (c) one (1) Business Day after being sent, if sent overnight by a nationally-recognized overnight courier service (with written proof of delivery); or (d) five (5) Business Days after being sent, if sent by registered or certified mail, return receipt requested, with postage and fees prepaid.

 

 

 

 

 

 

 

 

 

 

 

This Agreement (including the Exhibits and Schedules hereto) and the Ancillary Agreements constitute the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements and understandings between the Parties, both written and oral, with respect to such subject matter; provided, however, that this Agreement shall not supersede the terms and provisions of the CDA applicable to any period prior to the Effective Date.

If any term or provision of this Agreement or the application of any such term or provision to any Person or circumstance shall be held invalid, void, or unenforceable in any respect by a court of competent jurisdiction, the remainder of the terms and provisions of this Agreement shall remain in full force and effect and shall in no way be affected, impaired, or invalidated, so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to either Party. Upon such a determination, the Parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in an acceptable manner in order that the agreement of the Parties be consummated as originally contemplated to the fullest extent possible.

This Agreement and the rights and obligations hereunder are not assignable (by operation of law or otherwise) by CBMG unless such assignment is consented to in writing by Novartis. This Agreement and the rights and obligations hereunder are assignable (by operation of law or otherwise) by Novartis: (a) to any of its Affiliates, upon prior written notice to CBMG; and (b) to any Third Party, upon CBMG’s prior written consent, not to be unreasonably withheld, conditioned, or delayed. Subject to the foregoing, this Agreement and all the provisions hereof shall be binding upon and shall inure to the benefit of the Parties and their respective successors and permitted assigns. Notwithstanding the foregoing, no assignment shall relieve the assigning Party of any of its obligations hereunder. Any purported assignment in violation of this Section 18.5 shall be null and void.

The headings contained in this Agreement are inserted for convenience only and shall not be considered in interpreting or construing any of the provisions contained in this Agreement.

 

 

 

This Agreement may be amended, modified, or supplemented only by a written mutual agreement executed and delivered by each of the Parties. Except as otherwise provided in this Agreement, any provision of this Agreement may be waived by the Party entitled to the benefits thereof only by a written instrument signed by the Party granting such waiver. No failure or delay by either Party in exercising any right, power, or privilege under this Agreement shall operate as a waiver thereof, nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power, or privilege.

This Agreement is for the sole benefit of the Parties and their permitted successors and assigns, and nothing herein express or implied shall give or be construed to give to any Person, other than the Parties and such permitted successors and assigns, any legal or equitable rights hereunder, except with respect to Novartis Indemnitees and CBMG Indemnitees, who are Third Parties, solely with respect to Article 16.

The Parties hereby expressly recognize and acknowledge that immediate, extensive, and irreparable damage would result, no adequate remedy at law would exist, and damages would be difficult to determine in the event that any provision of this Agreement is not performed in accordance with its specific terms or otherwise breached. It is hereby agreed, notwithstanding the intent of the Parties to submit claims to arbitration in accordance with Section 18.12, that the Parties shall be entitled to specific performance of the terms hereof and immediate injunctive relief and other equitable relief, without the necessity of proving the inadequacy of money damages as a remedy, and the Parties further hereby agree to waive any requirement for the securing or posting of a bond in connection with the obtaining of such injunctive or other equitable relief. The Parties further agree not to assert that a remedy of injunctive relief, specific performance, or other equitable relief is unenforceable, invalid, contrary to law, or inequitable for any reason, nor to assert that a remedy of monetary damages would provide an adequate remedy. Such remedies, and any and all other remedies provided for in this Agreement, shall, however, be cumulative in nature and not exclusive and shall be in addition to any other remedies whatsoever which either Party may otherwise have. Each of the Parties hereby acknowledges that the existence of any other remedy contemplated by this Agreement does not diminish the availability of specific performance of the obligations hereunder or any other injunctive relief. Each of the Parties further acknowledges and agrees that injunctive relief or specific performance will not cause an undue hardship to such Party.

Each of Novartis and CBMG acknowledges that it has been represented by independent counsel of its choice throughout all negotiations that have preceded the execution of this Agreement and that it has executed the same with consent and upon the advice of said independent counsel. Each Party and its counsel cooperated in the drafting and preparation of this Agreement and the documents referred to herein, and any and all drafts relating thereto shall be deemed the work product of the Parties and may not be construed against either Party by reason of its preparation. Accordingly, any rule of Applicable Law or any legal decision that would require interpretation of any ambiguities in this Agreement against the Party that drafted it is of no application and is hereby expressly waived. The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intentions of the Parties and this Agreement.

This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware applicable to agreements made and to be performed entirely within such State, without regard to the conflict of laws principles of such State to the extent that the laws of another jurisdiction would be required thereby.

TO THE EXTENT NOT PROHIBITED BY APPLICABLE LAW THAT CANNOT BE WAIVED, THE PARTIES HEREBY WAIVE, AND COVENANT THAT THEY WILL NOT ASSERT (WHETHER AS PLAINTIFF, DEFENDANT, OR OTHERWISE), ANY RIGHT TO TRIAL BY JURY IN ANY ACTION ARISING IN WHOLE OR IN PART UNDER OR IN CONNECTION WITH THIS AGREEMENT OR ANY OF THE CONTEMPLATED TRANSACTIONS, WHETHER NOW EXISTING OR HEREAFTER ARISING, AND WHETHER SOUNDING IN CONTRACT, TORT, OR OTHERWISE. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT: (A) NO REPRESENTATIVE OF THE OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER; (B) EACH PARTY UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER; (C) EACH PARTY MAKES THIS WAIVER VOLUNTARILY; AND (D) EACH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 18.13. THE PARTIES AGREE THAT ANY OF THEM MAY FILE A COPY OF THIS PARAGRAPH WITH ANY COURT AS WRITTEN EVIDENCE OF THE KNOWING, VOLUNTARY, AND BARGAINED-FOR AGREEMENT AMONG THE PARTIES IRREVOCABLY TO WAIVE THEIR RIGHTS TO TRIAL BY JURY IN ANY PROCEEDING WHATSOEVER AMONG THEM RELATING TO THIS AGREEMENT OR ANY OF THE CONTEMPLATED TRANSACTIONS AND WILL INSTEAD BE TRIED IN A COURT OF COMPETENT JURISDICTION BY A JUDGE SITTING WITHOUT A JURY.

.CBMG acknowledges and accepts that Novartis may exercise its rights and perform its obligations under this Agreement either directly or through one (1) or more of its Affiliates. Novartis’s Affiliates shall have the benefit of all rights of Novartis under this Agreement, but not be subject to Novartis’s obligations, unless expressly provided under this Agreement or to the extent that an Affiliate is exercising a right hereunder, or in the case of a permitted assignment. Accordingly, “Novartis” shall be interpreted to mean “Novartis or its Affiliates” where necessary to give Novartis’s Affiliates the benefit of the rights provided to Novartis under this Agreement and the ability to perform its obligations under this Agreement; provided, that Novartis shall remain responsible for the acts and omissions, including financial liabilities, of its Affiliates.

This Agreement may be executed in any number of counterparts, each of which, when executed, shall be deemed to be an original and all of which together shall be deemed to be one (1) and the same instrument binding upon all of the Parties, notwithstanding the fact that both Parties are not signatory to the original or the same counterpart. For purposes of this Agreement, .PDF and other electronic signatures shall be deemed originals.

IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Novartis intends to seek agreement with CFDA that local clinical trial data are not required to support KYMRIAH registration in China, given final regulation issued on 10-July 2018 by China’s State Drug Administration accepting foreign clinical trial data towards new drug approvals, given that following conditions are met:

 

 

In event that CFDA will still require a local China study to support registration in each pursued indication, for reasons such as significant manufacturing process changes intended for commercial product not studied to date in clinical trial setting, or post-approval commitment(s), the following study proposals would be considered, subject to negotiation and alignment with CFDA: