Full Press Release Details
EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT
Connect Biopharma HongKong Limited
Simcere Pharmaceutical Co., Ltd.
| 1. | DEFINITIONS | 3 |
| 2. | LICENSE | 12 |
| 3. | GOVERNANCE | 15 |
| 4. | DEVELOPMENT AND REGULATORY MATTERS | 18 |
| 5. | COMMERCIALIZATION | 23 |
| 6. | MANUFACTURE AND SUPPLY | 25 |
| 7. | PAYMENTS | 26 |
| 8. | COMPLIANCE WITH LAWS | 30 |
| 9. | INTELLECTUAL PROPERTY | 32 |
| 10. | CONFIDENTIALITY | 37 |
| 11. | REPRESENTATIONS AND WARRANTIES, COVENANTS | 40 |
| 12. | BOOKS AND RECORDS; AUDIT RIGHTS | 44 |
| 13. | TERM; TERMINATION | 45 |
| 14. | INDEMNIFICATION; INSURANCE | 52 |
| 15. | DISPUTE RESOLUTION | 54 |
| 16. | MISCELLANEOUS PROVISIONS | 56 |
EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT
Whereas, Licensor is in Control (as defined below) of certain intellectual property and other rights related to the Licensed Compound (as defined below).
Whereas, Licensee agrees to obtain from Licensor an exclusive license under such intellectual property and other rights to Exploit the Licensed Compound in the Field (as defined below) in the Territory (as defined below).
Now Therefore, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:
The following capitalized terms shall have the meanings indicated for purposes of this Agreement.
1.1. Accounting Standards shall mean (a) the International Financial Reporting Standards ( IFRS ) as promulgated by the IFRS Foundation or its successor organization, or (b) any other accounting standards that are agreed by both Parties in good faith.
1.2. Affiliate shall mean, as to any entity, any Person which directly or indirectly controls, is controlled by, or is under common control with such entity. For purposes of the preceding definition, control in this Section shall mean beneficial ownership of fifty percent (50%) or more of the outstanding shares, stock or securities of such entity, the ability otherwise to elect a majority of the board of directors of such entity, the power to direct or cause the direction of the management and policies of such entity, or other managing authority over such entity.
1.3. Applicable Laws shall mean the applicable provisions of any and all national, supranational, regional, state and local laws, treaties, statutes, rules, regulations, administrative codes, guidance, ordinances, judgments, decrees, directives, injunctions, orders, permits (including regulatory approvals), and regulatory requirements, of or from any court, arbitrator, Regulatory Authority or other governmental agency or authority having jurisdiction over or related to the subject activity or item, as they may be in effect from time to time.
1.4. Applicable Territory shall mean (a) with respect to Licensee, the Territory, and (b) with respect to Licensor, the rest of the world.
1.5. Biologics License Application or BLA shall mean a request submitted to the Regulatory Authority in the Territory for permission to market a biologic product in the Territory under the Applicable Laws.
1.6. Biosimilar shall mean, with respect to a Licensed Product in a Region, any biologic product that: (a) has received all necessary approvals including Regulatory Approvals from the applicable Regulatory Authority in such Region for being marketed and sold as a biologic product; (b) is Manufactured and Commercialized by a Third Party that is not any Permitted Sublicensee of Licensee, provided that such Third Party does not purchase or acquire such product in a chain of distribution that included any of Licensee, its Affiliates or their Permitted Sublicensees; and (c) is approved as a biosimilar to the Licensed Product in terms of safety, quality and efficacy for use in such Region by the applicable Regulatory Authority pursuant to the then-current Regulatory Approval processes and standards governing Regulatory Approvals of biosimilars in such Region.
1.7. Business Day shall mean a day other than Saturday, Sunday or any day that banks in New York, the United States or Shanghai, China are required or permitted to be closed.
1.8. Calendar Quarter shall mean each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1; provided that (a) the first Calendar Quarter hereunder shall be deemed to commence upon the Effective Date and (b) the final Calendar Quarter hereunder shall be deemed to expire upon the effective date of the expiration or termination of this Agreement.
1.9. Calendar Semi-annual Period shall mean each successive period of six (6) calendar months commencing on January 1 and July 1; provided that (a) the first Calendar Semi-annual Period hereunder shall be deemed to commence upon the Effective Date and (b) the final Calendar Semi-annual Period hereunder shall be deemed to expire upon the effective date of the expiration or termination of this Agreement.
1.10. Calendar Year shall mean (a) for the first calendar year, the period commencing on the Effective Date and ending on December 31, 2023, (b) for each successive period, beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31, and (c) for the calendar year in which this Agreement expires or is terminated, the period beginning on January 1 of such calendar year and ending on the effective date of the expiration or termination of this Agreement.
1.11. Clinical Study means a human clinical study conducted on sufficient numbers of human subjects that is designed to (a) establish that a pharmaceutical product is reasonably safe for continued testing, (b) investigate the safety and efficacy of the pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range to be prescribed or (c) support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product. Without limiting the foregoing, Clinical Studies include any Phase I clinical trial, Phase II clinical trial, Phase III clinical trial, or Phase IV clinical trial (as well as bioequivalence (BE) test as
applicable in the PRC) conducted by or on behalf of one or both Parties in connection with this Agreement.
1.12. COGs means the fully-burdened manufacturing, auditable costs in USD or RMB, as determined in accordance with IFRS, of Manufacturing and supplying the Licensed Compound or any Licensed Product(s) in either drug substance and finished drug product form ready for use, as applicable for non-clinical studies and Clinical Studies purposes and Commercial purposes.
1.13. Commercialize or Commercialization shall mean to market, promote, advertise, exhibit, distribute (including storage for distribution or inventory), detail, sell (including to offer for sale or contract to sell) or otherwise commercially Exploit (including to conduct pricing and reimbursement activities) a pharmaceutical or biological compound or product, or to conduct any activities directed to any of the foregoing (including importing and exporting activities in connection therewith). For the avoidance of doubt, the term Commercialize or Commercialization shall exclude any activities related to Development, Manufacture, or the [***].
1.14. Commercially Reasonable Efforts shall mean, with respect to a Party, [***]
1.15. Confidential Information shall mean, subject to the terms and conditions herein, any confidential or proprietary information, and any other information relating to any research project, document, work in process, development, scientific, engineering, manufacturing, marketing or business plan, financial or personnel matter relating to a Party or any of its Affiliates, or any of its present or future products, sales, suppliers, customers, employees, investors or business disclosed, shared, or made available under this Agreement by a Party or any of its Affiliates, whether in oral, written, graphic or electronic form. Without limiting the generality of the foregoing, the Parties agree that the financial terms of this Agreement, the Parties' communication hereunder, the Technology Transfer Plan, the Development Plan and the Commercialization Plan will be considered each Party's Confidential Information.
1.16. Control , with respect to a Party, shall mean the possession of such Party of the ability to grant a license, sublicense, a right to access, a right to use, or other right (as applicable) to the other Party without (a) violating the terms of any agreement or other arrangement with any Third Party or (b) incurring any financial or other obligation to any Third Party by the other Party.
1.17. Current Cell Line shall mean the cell line as set forth in Exhibit F.
1.18. Develop or Development shall mean to conduct any non-clinical or clinical drug research or development activities, whether before or after the Regulatory Approval, including drug metabolism and pharmacokinetics, translational research, toxicology, pharmacology, test method development and stability testing, process and packaging development and improvement, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, conduct of clinical trials, regulatory affairs, the preparation and submission of regulatory filings, clinical trial regulatory activities, or any other activities directed towards obtaining or maintaining the Regulatory Approval of any pharmaceutical or biological compound or product. Development
includes use and importation of the relevant compound or product to conduct such development activities. Development does not include Commercialization activities.
1.19. Exploit or Exploitation shall mean, with respect to any pharmaceutical or biological compound or product, to Develop, Manufacture, have Manufactured, use, Commercialize, import, export, obtain and maintain the Regulatory Approvals and applicable pricing or reimbursement approvals.
1.20. Field shall mean all human diseases, symptoms, conditions, or other indications.
1.21. First Commercial Sale shall mean, with respect to any Licensed Product, the first sale for economic value for end use or consumption of such Licensed Product by Licensee to an independent or unaffiliated Third Party in a jurisdiction after the applicable Regulatory Authorities of such jurisdiction have granted the Regulatory Approvals of such Licensed Product. For clarity, the sale of a Licensed Product at nominal cost for indigent or similar public support or compassionate use programs shall not, in any case, be considered as a First Commercial Sale of such Licensed Product. [***]
1.22. Force Majeure Event shall mean an event beyond the reasonable control of the applicable Party, which may include act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, pandemic, fire, earthquake, flood, storm or like catastrophe, action or inaction of any governmental authority, or any other event similar to those enumerated above.
1.23. FTE means the equivalent of the work of one appropriately qualified individual working on a full-time basis in performing work in connection with this Agreement for a [] period (consisting of at least a total of [] of dedicated effort related to scientific, technical or operational work (excluding administrative services).
1.24. FTE Rate means a rate of (a) [] (b) [] (c) [] and (d) []
1.25. Good Clinical Practices or GCP shall mean the then-current standards, practices and procedures promulgated or endorsed by the FDA, the NMPA or other applicable Regulatory Authority, for designing, conducting, recording, analyzing and reporting clinical trials that involve the participation of human subjects, as may be amended from time to time. For clarity, with respect to Licensee, the term Good Clinical Practices or GCP shall mean such then-current standards, practices and procedures promulgated or endorsed by the NMPA or other applicable Regulatory Authority in the corresponding region, for designing, conducting, recording, analyzing and reporting clinical trials that involve the participation of human subjects, as such standards, practices and procedures may be amended from time to time.
1.26. Good Laboratory Practices or GLP shall mean the then-current good laboratory practice standards promulgated or endorsed by the FDA, the NMPA or other applicable Regulatory Authority, for nonclinical laboratory studies that support or are intended to support applications to conduct research on human subjects or to obtain any regulatory approval, as may be amended from time to time. For clarity, with respect to Licensee, the term Good Laboratory Practices or GLP shall mean such then-current good laboratory practice standards promulgated or endorsed by the NMPA or other applicable Regulatory Authority in the corresponding region, for nonclinical laboratory
studies that support or are intended to support applications to conduct research on human subjects or to obtain any regulatory approval, as such standards may be amended from time to time.
1.27. Good Manufacturing Practices or GMP shall mean the then current good Manufacturing Practice standards promulgated or endorsed by the FDA, the NMPA or other applicable Regulatory Authority for manufacturing of pharmaceutical or biological products, as may be amended from time to time. For clarity, with respect to Licensee, the term Good Manufacturing Practices or GMP shall mean such then-current good manufacturing practice standards promulgated or endorsed by the NMPA or other applicable Regulatory Authority in the corresponding region for manufacturing of pharmaceutical or biological products, as such standards may be amended from time to time.
1.28. Improvements shall mean any writing, invention, discovery, development, modification, technology or know-how with respect to the Licensed Compound and/or any Licensed Product, whether or not patentable, that is conceived, reduced to practice, discovered, Developed or otherwise created at any time, (a) as a result of the conduct of the activities contemplated by this Agreement, or (b) using, benefiting from, incorporating, referencing, based on, or deriving from any Licensed Patents, Licensed Know-How, and/or Confidential Information of Licensor, whether by or on behalf of either Party or jointly by both Parties, including, without limitation, in each case through Affiliates, Permitted Sublicensees, or Subcontractors or with any other Third Parties, which is necessary or reasonably useful for the Exploitation of such Licensed Compound or Licensed Product, including, without limitation, any enhancement in the efficiency, operation, manufacture, cost of manufacture, ingredients, preparation, presentation, formulation, mean of delivery or dosage, use, or methods of use or packaging of such Licensed Compound or Licensed Product, any discovery or Development of any new or expanded indications for such Licensed Compound or Licensed Product, and/or any discovery or Development that improves the stability, safety or efficacy of such Licensed Compound or Licensed Product. For the avoidance of doubt, the term Improvements shall also include any writing, invention, discovery, development, modification, technology or know-how with respect to the Licensed Compound and/or any Licensed Product that (x) are reduced to practice, discovered, Developed or otherwise created at any time by Licensor outside of any activities contemplated by this Agreement as long as (y) satisfy the definition as provided herein.
1.29. Knowledge , with respect to any representation or warranty or other statement in this Agreement qualified by knowledge of a Party, [***].
1.30. Licensed Compound shall mean CBP-201 with the chemical structure as set forth in Exhibit A and [***]
1.31. Licensed Know-How shall mean all know-how, including scientific, technical, regulatory, commercial, or other information, results, or data, related to the Licensed Compound and/or any Licensed Product, owned or Controlled by Licensor or its Affiliates as of the Effective Date, or becomes owned or Controlled by Licensor or its Affiliates (including jointly with Licensee or its Affiliates) during the Term, that is necessary or reasonably useful for Licensee to Develop, Manufacture, and Commercialize the Licensed Compound and/or any Licensed Product, solely in the Field, in each case within the Territory, including the know-how set forth in Exhibit B,
which if needed will be updated annually by Licensor (excluding any such know-how already known to or co-owned by Licensee). For clarity, with respect to jointly owned know-how, the term Licensed Know-How shall only apply to Licensor's title, right, or interest and shall exclude the Licensee's (or its Affiliates') title, right, or interest in or to such Jointly owned know-how.
1.32. Licensed Patents shall mean all patent rights, including rights to patents, patent applications, divisions, continuations, or continuations-in-part, and if any, reissues, reexams, extensions, renewals or restorations of any of the foregoing by existing or future extension, renewal or restoration mechanisms, including supplementary protection certificate, patent term adjustment, patent term extensions or the equivalent thereof etc., owned or Controlled by Licensor or its Affiliates as of the Effective Date, or becomes owned or Controlled by Licensor or its Affiliates (including jointly with Licensee or its Affiliates) during the Term, that (a) contain one or more claims that cover any Licensed Know-How (including any Licensed Know-How related to formulation, composition, manufacture and/or use of the Licensed Compound and/or any Licensed Product with or without device) and/or (b) are necessary or reasonably useful for Licensee to Develop, Manufacture, and Commercialize the Licensed Compound and/or any Licensed Product, solely in the Field, in each case within the Territory, including the patents set forth in Exhibit B, which will be updated annually by Licensor (excluding any such patent rights already known to or co-owned by Licensee). For clarity, with respect to a Jointly owned patent or patent application, the term Licensed Patent shall only apply to Licensor's title, right, or interest and shall exclude the Licensee's (or its Affiliates') title, right, or interest in or to such Jointly owned patent or patent application.
1.33. Licensed Product shall mean one or more pharmaceutical products containing a Licensed Compound as the sole active ingredient or in combination with one or more other active ingredients, each in any formulation, dosage form, or mode of administration.
1.34. Licensed Product Trademarks shall mean the Trademark(s) used or anticipated to be used by a Party or its Affiliates or Permitted Sublicensees (in the case of Licensee) for the Exploitation of the Licensed Compound or a Licensed Product in such Party's Applicable Territory, and any registrations thereof or any pending applications relating thereto.
1.35. Licensed Technology shall mean the Licensed Patents and the Licensed Know-How.
1.36. Manufacture or Manufacturing shall mean to conduct or have conducted any activities directed to producing, making, scaling up, processing, filling, finishing, packaging, labeling, quality assurance testing and release, post-marketing validation testing, shipping, and storage at manufacturing facilities of any pharmaceutical or biological compound or product, or any component thereof (including production of drug substance and drug product, in bulk form, whether for Development or Commercialization).
1.37. Net Sales shall mean with respect to any Licensed Product during any period, the tax excluded gross amount billed by Licensee, its Affiliates, and/or their Permitted Sublicensees for sale (excluding sales for use in Clinical Trials or other scientific testing
or any compassionate use programs or any donations) of such Licensed Product to independent or unaffiliated Third Parties during such period, less the following deductions, to the extent actually incurred, allowed or paid with respect to such sale by the Licensee, its Affiliates, and/or their Permitted Sublicensees, in each case, calculated in compliance with the applicable Accounting Standards on a consistent basis:
1.38. NMPA shall mean the National Medical Products Administration in China, including its internal institutions such as the Center for Drug Evaluation (CDE), or any successor agency with a similar scope of responsibility regarding the regulation of human pharmaceutical and biological products in China.
1.39. NRDL shall mean the National Reimbursement Drug List in China.
1.40. New Cell Line shall mean the cell line as set forth in Exhibit G.
1.41. Official shall mean any official, employee, or representative of, or any other person acting in an official capacity for or on behalf of, any (i) national, federal, state, provincial, or local government, including any entity owned or controlled thereby, (ii) political party, party official, or political candidate, or (iii) public international organization.
1.42. Patent shall mean any patent right, including any patent, patent application, division, continuations, or continuations-in-part, and if any, reissue, reexam, extension, renewal or restoration of any of the foregoing by existing or future extension, renewal or restoration mechanisms, including supplementary protection certificate, patent term adjustment, patent term extensions or the equivalent thereof etc.
1.43. Person shall mean any individual, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture, unincorporated organization or association, or governmental authority.
1.44. Mainland China shall mean the People's Republic of China (for the purpose of this Agreement, excluding Hong Kong, Macau and Taiwan).
1.45. Product Data shall mean any and all data relating to or arising out of the Development, Improvement or Manufacture of the Licensed Compound or any Licensed Product that is necessary or reasonably useful for the Exploitation of the Licensed Compound or any Licensed Product in the Field, including data collected or
resulting from pre-clinical studies or clinical trials, CMC data, other non-clinical data, other clinical data, other Developmental data, other manufacturing records and information, and supporting documentation (e.g., protocols, format of case report forms, analysis plans) relating to pre-clinical studies, clinical trials or other Developmental, or Manufacturing activities with respect to the Licensed Compound or any Licensed Product.
1.46. Region shall mean each of the Mainland China, the Hong Kong Special Administrative Region (Hong Kong), the Macau Special Administrative Region (Macau), and Taiwan.
1.47. Regulatory Approvals shall mean all approvals, licenses, or permits necessary for the Development, Manufacture, and Commercialization of any Licensed Product in the applicable country or jurisdiction, which may include satisfaction of all applicable regulatory and notification requirements.
1.48. Regulatory Authority shall mean any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity whose review, approval or authorization is necessary for the Development, Manufacture, and/or Commercialization of a Licensed Product.
1.49. Regulatory Documents shall mean any filing, application or submission with any Regulatory Authority, together with authorizations, approvals or clearances arising from the foregoing, including clinical trial applications, BLAs and Regulatory Approvals or their equivalents in any jurisdiction, and all written notification, written correspondence or written communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to the Licensed Compound or any Licensed Product.
1.50. Royalty Term shall mean the period commencing on the date of First Commercial Sale of a Licensed Product in the Territory and continue until the later of (a) twelve (12) years following the First Commercial Sale of such Licensed Product in the Territory, (b) the expiration of the last-to-expire Valid Claim of the Licensed Patents that have been granted or are pending as of the Effective Date, or (c) the expiration of the last-to-expire regulatory exclusivity for such Licensed Product in the Territory (for clarity, such regulatory exclusivity shall not be considered for the Royalty Term as long as any Biosimilar is launched in the Territory).
1.51. Subcontractor shall mean each of the contract research organizations (CROs), contract manufacturing organizations (CMOs), distributors or other Third Parties that either Party or any of its Affiliates or Permitted Sublicensees engages to perform activities related to the Development, Commercialization and Manufacture of the Licensed Compound or any Licensed Product.
1.52. Territory shall mean all of the Regions (as defined above).
1.53. Third Party shall mean any Person other than Licensor or Licensee, or an Affiliate of Licensor or Licensee.
1.54. Valid Claim shall mean [***] an unexpired claim of an issued patent within the Licensed Patents which has not been found to be unpatentable, invalid or unenforceable
by a court or other authority in the applicable country or jurisdiction, from which decision no appeal is taken or can be taken; [***]
2.1. License Grant. Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee, during the Term of this Agreement, an exclusive (subject to this Section 2.1 and Section 13.1), royalty-bearing, non-transferable (except in accordance with Section 16.6), sub-licensable (subject to Section 2.2 and through multiple tiers) license under the Licensed Technology to Develop, have Developed, Manufacture, have Manufactured, Commercialize, have Commercialized, otherwise Exploit, and otherwise have Exploited the Licensed Compound and/or any Licensed Product in the Field in the Territory (the License ). For the avoidance of doubt, the License granted to Licensee under this Agreement shall not refrain Licensor (including through Affiliates, Subcontractors, or other Third Parties) from conducting and completing Development and Manufacture activities for the Licensed Compound or any Licensed Product in the Territory (i) solely to fulfill Licensor's obligations under this Agreement, including, without limitation, with respect to (x) completing the ongoing CBP-201 China pivotal clinical trial in Atopic Dermatitis (AD) in the Territory (https://clinicaltrials.gov/ct2/show/NCT05017480) (the Pivotal Trial ), (y) completing clinical trials for CBP-201-CN003 (NMPA Clinical Trial Registration No. CTR20231224) and CBP-201-CN004 (NMPA Clinical Trial Registration No. CTR20231708), and (z) conducting and completing any other activities assigned to Licensor as provided in the Technology Transfer Plan, the Development Plan, and the Commercialization Plan, each of which (x), (y), and (z) shall be conducted and completed in accordance with this Agreement, or (ii) to support Development, Manufacture, and/or Commercialization of the Licensed Compound or any Licensed Product outside the Territory, including, without limitation, with respect to seeking any Regulatory Approvals of such Licensed Compound or Licensed Product outside the Territory, which, for clarification, the License granted to Licensee under this Agreement shall exclude Licensor from Commercializing or having Commercialized the Licensed Compound and/or any Licensed Product in the Field in the Territory.
2.2. Sublicensing. The License is sub-licensable; provided that Licensee shall not grant any sublicense to any Third Party under the License or otherwise transfer any rights under this Agreement (in each case, Sublicensing ) without Licensor's prior written consent. Any such permitted sublicense shall be in writing (any sublicensee of such permitted sublicense, a Permitted Sublicensee ) and shall not permit further sublicensing without Licensor's prior written consent. If the License is sublicensed to an Affiliate of Licensee, Licensee may grant sublicenses to such Affiliate without Licensor's prior written consent, provided that Licensee shall provide a written notice thereof to Licensor. Licensee shall remain directly responsible to Licensor for all of Licensee's obligations under this Agreement. Notwithstanding anything in this Agreement to the contrary, any such transaction involving Sublicensing (i) shall not conflict with any terms and conditions of this Agreement, (ii) shall not adversely affect and be subject to Licensor's rights under this Agreement, and (iii) shall not relieve Licensee from any of its obligations hereunder, including without limitation, any payment obligations under Article 7.
2.3. Performance by Affiliates and Subcontractors. Licensee may perform some but not all of its obligations under this Agreement through its Affiliates and Subcontractors; provided, however, that (i) Licensee shall promptly notify Licensor in writing of any contract research organizations (CROs) or contract manufacturing organizations
(CMOs) that become Subcontractors and cause its Affiliates and Subcontractors to comply with the terms and conditions of this Agreement for such performance and (ii) Licensee shall remain directly responsible to Licensor for all such obligations performed through its Affiliates and Subcontractors. Licensee shall ensure that any agreements with its Subcontractors regarding the performance of any obligations hereunder do not conflict with this Agreement. Subcontractors shall not be deemed Permitted Sublicensees for purposes of this Agreement notwithstanding such Subcontractor being granted a limited, non-exclusive license solely to perform services on Licensee, its Affiliates' or Permitted Sublicensees' behalf.
2.4. Technology Transfer. Subject to the compliance with Applicable Laws and to the extent not already provided, Licensor shall promptly use Commercially Reasonable Efforts to transfer to Licensee all Licensed Know-How pursuant to the Technology Transfer Plan as set forth in Exhibit E (the Technology Transfer Plan ) to the extent such transfer is necessary or reasonably useful for Licensee (a) to exercise its rights under the licenses granted in this Agreement or (b) to undertake activities assigned to it under the Development Plan or Commercialization Plan in this Agreement.
2.4.1. Delivery of Drug Substance and Drug Product. Within [] after the Effective Date, Licensor shall deliver to Licensee [] of the drug substance and [***] of the drug product for testing purposes.
2.4.2. Fees. Licensor shall provide free of charge assistance to Licensee for the activities specified in this Section 2.4; and any assistance exceeding what is specified in this Section 2.4 shall be charged to Licensee at Licensor' FTE Rates as defined herein. Licensee shall reimburse Licensor and its Affiliates for the out-of-pocket costs and expenses (including, without limitation, those charged by CMOs and other Subcontractors to support any technical assistance requested pursuant to this Section 2.4), provided that any such out-of-pocket costs or expenses shall be specifically pre-approved by Licensee.
2.5. No Implied Licenses. Except as explicitly set forth in this Agreement, Licensor shall not be deemed to grant to Licensee any license or other rights under any intellectual property rights (whether by implication, estoppel or otherwise).
2.6. Diligence. Licensee shall use Commercially Reasonable Efforts to apply for Regulatory Approvals for the Licensed Compound and/or a Licensed Product, as applicable, in the Field in the Territory and to conduct clinical trials, other Development work, and Manufacture and Commercialization activities. Without limiting the foregoing, Licensee shall use Commercially Reasonable Efforts to proceed in accordance with the Development Plan and the Commercialization Plan (each, as defined below), including, without limitation, to use Commercially Reasonable Efforts to allocate sufficient time, effort, equipment and facilities, and sufficient personnel with required skills and experience, to conduct such clinical trials, other Development work, and Manufacture and Commercialization activities, and to explore new indications as mutually agreed upon by the Parties. For any other indication in the Field, Licensee shall use Commercially Reasonable Efforts to develop a Development Plan and conduct Development work in accordance with such Development Plan. [] and (b) []
2.7. No Competitive Products. During the Term, without either Party's prior written consent, the other Party or its Affiliates or Permitted Sublicensee shall not engage, alone or in conjunction with any Third Party, in the Development or Commercialization of a Competitive Product in the Territory. For the avoidance of doubt, subject to the conditions and terms of the Agreement, either Party (including through Affiliates, subcontractors, or other Third Parties) has the right to conduct and complete development and manufacture activities for a Competitive Product in the Territory to support development and manufacture, including regulatory approvals, of such Competitive Product outside the Territory. Competitive Product shall mean [***] For the avoidance of doubt, notwithstanding anything in this Agreement to the contrary, this Agreement does not convey to Licensee or its Affiliates or Permitted Sublicensee any license or right to, and Licensee and its Affiliates and Permitted Sublicensee shall not use, any Licensed Technology or any other intellectual property of Licensor in connection with any Competitive Product.
3.1. Joint Steering Committee
3.1.1. Establishment and Responsibilities. Promptly following the Effective Date, but in no event later than [***] after the Effective Date, the Parties will form a joint steering committee (the JSC ) to provide oversight and to facilitate information sharing between the Parties with respect to the activities of the Parties under this Agreement. In addition to its overall responsibility to provide oversight and to facilitate information sharing between the Parties with respect to the activities of the Parties under this Agreement, the JSC will:
3.1.1.1. coordinate and share information with respect to the Development, Manufacturing and Commercialization of the Licensed Compound or any Licensed Product (x) in the Territory by Licensee, its Affiliates or Permitted Sublicensees, or their Subcontractors and (y) in and outside the Territory by Licensor, its Affiliates, licensees (including sublicensees), or Subcontractors;
3.1.1.2. coordinate and oversee activities relating to conducting clinical trials and seeking Regulatory Approvals for the Licensed Compound or any Licensed Product, including, for instance, but not limited to (i) reviewing the Development Plan and any amendments thereto, (ii) reviewing and discussing any matters related to obtaining and maintaining the Regulatory Approvals for the Licensed Compound or any Licensed Product in the Field, (iii) coordinate and share information with respect to the Development activities, and all necessarily filing and registration activities for the Regulatory Approvals of the Licensed Compound or any Licensed Product;
3.1.1.3. attempt to resolve in the first instance all matters between the Parties that are in dispute; and
3.1.1.4. have such other responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
3.1.2. Membership. The JSC will consist of an equal number of representatives for each Party, with up to [] representatives appointed by each Party. A Party may change any of its representatives on the JSC at any time with a new person (with appropriate expertise to replace the outgoing member) by giving written notice to the other Party; provided, however, that, without limiting the generality of the foregoing, a key objective with respect to membership in the JSC will be preserving continuity. The JSC shall be co-chaired by one designated representative of each Party. The co-chairpersons shall be responsible for calling meetings, preparing and issuing minutes of each such meeting [] thereafter, and preparing and circulating an agenda for the upcoming meeting; provided that the co-chairpersons shall consider including any agenda items proposed by either Party no less than [***] prior to the JSC meeting, for which the agenda is prepared
and circulated. One member of the JSC shall serve as secretary of the JSC at each JSC meeting, and the secretary shall alternate from meeting to meeting between a Licensee JSC member and a Licensor JSC member.
3.1.3. Meetings. The JSC shall hold at least [] per []; provided, that the JSC shall meet more or less frequently as Licensee and Licensor mutually agree. Meetings of the JSC shall be effective only if at least one (1) representative of each Party is present or participating. The JSC may meet either in person at such locations as the Parties may agree or by audio or video teleconference. Other representatives of each Party involved with the Licensed Compound or Licensed Product may attend meetings as non-voting participants, subject to the confidentiality provisions set forth in Article 10. Additional meetings of the JSC may also be held with the consent of each Party, including to resolve disputes, disagreements or deadlocks in any Subcommittees or as otherwise required under this Agreement, and neither Party shall unreasonably withhold its consent to hold such additional meetings.
3.1.4. Decision-Making. The JSC may make decisions with respect to any subject matter that is subject to its authority and functions as set forth in Section 3.1. [] If the JSC cannot reach consensus on a given matter within [] after such matter is brought to the JSC for resolution, such disagreement shall be referred to senior executives of the Parties for resolution. If the senior executives do not resolve such matter within [] days after such matter has been referred to them, then Licensee shall have the final decision making authority with respect to the Development, Manufacture and Commercialization of the Licensed Compound or any Licensed Product in the Territory; provided that []
3.2. Subcommittees. From time to time, the JSC may establish and delegate particular responsibilities to subcommittees (each, a Subcommittee ). Each Subcommittee will be constituted and operate as the Parties reasonably and mutually determine in writing (including by e-mail); provided that each Subcommittee shall have equal representation from each Party.
3.3. Limitation of Authority. The JSC and any Subcommittee each shall only have the authority assigned expressly to it in this Agreement, and shall not have any power to amend, modify or waive compliance with this Agreement or create obligations on the Parties additional to the obligations expressly contemplated in this Agreement. Each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the JSC and any Subcommittee unless such delegation or vesting is expressly provided for in this Agreement or the Parties expressly so agree in writing.
3.4. Information Sharing. Each Party shall keep the JSC reasonably informed as to the progress and activities in material aspects relating to the Development, Manufacturing and Commercialization of the Licensed Compound and/or any Licensed Product in such each Party's Applicable Territory, and shall keep the JSC fully and promptly informed with respect to regulatory matters and meetings with the Regulatory Authorities in such each Party's Applicable Territory, by way of written updates to the JSC or applicable Subcommittee in writing. In connection therewith, each Party shall use Commercially Reasonable Efforts to provide the other Party with such information regarding such progress and activities under the Development Plan, the Commercialization Plan, or
otherwise relating to the Licensed Compound and/or any Licensed Product upon the other Party's reasonable request (e.g., in reasonable frequency, reasonable format, reasonable quantity, and other reasonable conditions) in writing. For the avoidance of doubt, the progress and activities as provided in this Section 3.4 shall include, without limitation, those arising from or relating to [***]
3.5. Minutes of Committee Meetings. Definitive minutes of all meetings of the JSC or any Subcommittee shall be finalized no later than [***] after each meeting. The minutes shall be approved by each Party not later than the first order of business at the immediately succeeding meeting of JSC or any Subcommittee.
3.6. Expenses. Each Party shall be responsible for all of its own expenses incurred in connection with participating in the JSC meetings or any of the Subcommittee meetings.
3.7. Alliance Managers. Promptly following the Effective Date, each Party shall appoint and notify the other Party of the identity thereof in writing (including by e-mail), one (1) senior representative to act as its alliance manager under this Agreement (each, an Alliance Manager ). The Alliance Managers shall serve as the contact point between the Parties and will be primarily responsible for facilitating the flow of information and otherwise promoting communication, coordination and collaboration between the Parties.
4. DEVELOPMENT AND REGULATORY MATTERS
4.1. Development Obligations
4.1.1. As between the Parties, (i) Licensee shall be the marketing authorization holder (MAH) of any Licensed Product in the Field in the Territory; (ii) Licensee shall be the applicant, or entitled, at its sole discretion, to designate and modify the designation of applicants, for any clinical trials for the Licensed Compound and any Licensed Product in the Field in the Territory; (iii) Licensee shall, subject to the terms and conditions in this Section 4.1, be responsible for applying or procuring the application for any and all Regulatory Approvals of the Licensed Compound and any Licensed Product for any indications in the Field in the Territory, including, without limitation, any application to the NMPA for the BLA approval; (iv) upon Licensee's request in writing, Licensor shall transfer or procure the transfer of any clinical trials to Licensee or its designate (including, without limitation, the applicants thereof); and (v) Licensor will be responsible for, [], continuing and completing (x) the ongoing Pivotal Trial and (y) clinical trials for CBP-201-CN003 and CBP-201-CN004 with Licensee providing any reasonable assistance [] In addition to the trials or studies required for the BLA approval for the Licensed Product in the treatment of Atopic Dermatitis (AD) prior to the launch of the Licensed Product in the Territory and subject to the terms and conditions herein, Licensee shall, at its own costs and expenses, be solely responsible for any trial or study conducted in the Territory. Licensee shall register, or will cause the sponsor of any studies and clinical trials involving the Licensed Product to register (if Licensee is not the sponsor) such studies and clinical trials on, and report the results of such studies and clinical trials to, the appropriate registry or database as required by the Applicable Laws. For clarity, except as set forth in this Agreement, Licensee shall be solely responsible for any costs and expenses related to its pursuing any activities with respect to the Licensed Compound and any Licensed Product in the Field in the Territory.