Data Exchange and Use. In addition to its adverse event and safety data reporting obligations set forth in Section 4.4, each Party will promptly provide the other Party, through the JSC (or, based on the time sensitivity or urgency of such data and results, directly between representatives of the Parties outside of the JSC), with copies of all data and results and all supporting documentation (e.g., protocols, Investigator’s Brochures, case report forms, analysis plans, and all in English language) (collectively, “Clinical Data and Documentation”) (a) Controlled by such Party or its Affiliates (or Sublicensees, in the case of TGTX) (b) owned by, or licensed to, Precision’s licensees, to the extent Controlled by Precision, in each case, (a) or (b), that are generated by or on behalf of such Party or its Affiliates (or its licensees or Sublicensees, as applicable) in the Development of each Licensed Product, including in the Development of the existing Licensed Product under the Precision-Imugene License Agreement. TGTX will have the right to use and reference such data and results provided by Precision for the purpose of performing Development activities under this Agreement, obtaining, supporting, and maintaining Regulatory Approvals and any Reimbursement Approval, as applicable, of Licensed Products in the Licensed Field in the Territory, without additional consideration. Precision and its Affiliates and licensees will have the right to use and reference such data and results provided by TGTX for the purpose of Developing the Licensed Product (but, during the Term, only outside the Licensed Field) or any other products based on ARCUS Technology, and obtaining, supporting, and maintaining Regulatory Approvals or any Reimbursement Approvals, as applicable, of any such product, without additional consideration. For clarity, Precision shall not clinically Develop the Licensed Product in the Licensed Field in the Territory during the Term. [***].
Appears in 2 contracts
Samples: License Agreement (Precision Biosciences Inc), License Agreement (Tg Therapeutics, Inc.)
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations set forth in pursuant to Section 4.46.4, each Party will shall promptly (but in any event no later than [***] from the other Party’s request) provide the other Party, through the JSC (or, based on the time sensitivity or urgency of such data and results, directly between representatives of the Parties outside of the JSC), Party with copies of all data and results results, including all Clinical Data, and all supporting documentation (e.g., e.g. protocols, Investigator’s Brochures, case report formsCRFs, analysis plans, and all in English language) (collectively, “Clinical Data and Documentation”)
(a) Controlled by such Party or its Affiliates (or Sublicensees, in the case of TGTX) (b) owned by, or licensed to, Precision’s licensees, to the extent Controlled by Precision, in each case, (a) or (b), that are generated by or on behalf of such Party or its Affiliates or (or its licensees or Sublicenseessub)licensees (including, as with respect to Zymeworks, the Ex-Territory Partner), if applicable) , in the Development of each Licensed ProductProducts; provided that Jazz shall only be required to provide Zymeworks such data, results and documentation to the extent it is reasonably necessary or useful for Zymeworks or its Affiliate or (sub)licensees’ (including the Ex-Territory Partner’s) Development or Commercialization of the Licensed Products in the Field outside the Territory[***]; and provided further that Zymeworks will provide any other such data, results or documentation Controlled by Zymeworks or its Affiliates that is requested by Jazz and reasonably necessary or useful for the Development or Commercialization of the existing Licensed Product under Products in the Precision-Imugene License AgreementField in the Territory[***]. TGTX will Jazz shall have the right to use and reference such data and results provided by Precision Zymeworks, pursuant to the licenses granted under Section 2.1, including for the purpose of performing Development activities under this Agreementfiling Patent Rights covering Jazz Collaboration IP and Joint Collaboration IP, obtaining, supporting, obtaining and maintaining Regulatory Approvals Approval and any Reimbursement Approvalpricing or reimbursement approvals, as applicable, of Licensed Products in the Licensed Field in the Territory, without additional consideration. Precision Zymeworks and its Affiliates and licensees will designees shall have the right to use and reference such data and results provided by TGTX Jazz, without additional consideration, for the purpose of Developing Developing, manufacturing and Commercializing Licensed Products in accordance with the Licensed Product (butlicenses granted under Section 2.4, during the Termincluding filing Patent Rights covering Zymeworks Collaboration IP, only outside the Licensed Field) or any other products based on ARCUS TechnologyJoint Collaboration IP and Zanidatamab Collaboration IP, and obtaining, supporting, obtaining and maintaining Regulatory Approvals Approval and any pricing or any Reimbursement Approvalsreimbursement approvals, as applicable, of any such product, without additional considerationLicensed Products outside of the Territory. For clarity, Precision any such data or results that are Inventions will be owned in accordance with Section 14.1 and subject to the licenses, rights and obligations set forth herein. The Parties shall not clinically Develop adhere to the Licensed Product terms and conditions of the Data Processing Addendum, which is attached hereto as Exhibit 5.9 and incorporated by reference, in the Licensed Field in the Territory during the Term. [***]relation to data protection.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Zymeworks Inc.), License and Collaboration Agreement (Jazz Pharmaceuticals PLC)
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations set forth in Section 4.4, each Party will (a) Crinetics shall (i)(A) promptly provide the other Party, through the JSC (or, based on the time sensitivity or urgency of such data and results, directly between representatives of the Parties outside of the JSC), SKK with copies of any and all data and results of Clinical Trials and all non-clinical studies, including safety information, and their reasonable supporting documentation (e.g., e.g. protocols, Investigator’s Brochures, case report forms, analysis plansplans and communications with the Regulatory Authorities (both the communication in writing and minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority) and, to the extent requested by SKK and required to verify the data and results of such Clinical Trials, raw data supporting such data and results) generated or collected by Crinetics or its Affiliates, and (B) use Commercially Reasonable Efforts to provide SKK with copies of any and all data and results of Clinical Trials and non-clinical studies, including safety information, and their reasonable supporting documentation (e.g. protocols, case report forms and analysis plans), with the raw data supporting the documentation, that are generated outside the Territory by its or its Affiliates’ Licensees, in English languageeach case (A) and (collectivelyB), “in the development of Licensed Product for the Field, and (ii) at any time upon reasonable notice to Crinetics, and during regular business hours, afford SKK (if mutually agreed) or an independent Third Party an opportunity to inspect and audit the result of Clinical Data Trials and Documentation”)
(a) Controlled non-clinical studies conducted by such Party Crinetics or its Affiliates (or Sublicenseesas SKK deems reasonably necessary for obtaining a Regulatory Approval for Licensed Product in the Field in the Territory, in each case (i) and (ii), free of charge to the case extent Controlled by Crinetics, provided that any reasonable out-of-pocket costs incurred by Crinetics to accommodate any related requests from SKK shall be reimbursed by SKK, the extent and scope of TGTXthe inspection or audit shall be mutually agreed, Crinetics shall have the right to require that any such inspector or auditor (other than any Regulatory Authority) (b) owned bybe bound by reasonable obligations of confidentiality, non-disclosure and non-use prior to commencement of such activities, and any inspections or licensed to, Precision’s licenseesaudits of Third Parties shall be limited to Crinetics’ rights to conduct such inspections and audits and subject to coordination with any inspection or audit of such Third Party that is being or may be conducted by Crinetics. Crinetics shall provide SKK with copies of any data and results generated or collected by Crinetics or its Affiliates in the development of Licensed Product for outside the Field, to the extent Controlled by PrecisionCrinetics, in each caseonly upon mutual agreement of the Parties. Crinetics shall not provide, (a) nor shall Crinetics be required to provide, SKK with any personal information of the individuals that are subjects of any Clinical Trial of Licensed Product, except to the extent required for Crinetics or SKK, or any of their Affiliates or (sub)licensees to comply with Applicable Law or for patient safety.
(b)) SKK shall provide Crinetics with copies of any and all data and results of Clinical Trials and non-clinical studies, that are generated including safety information, and their reasonable supporting documentation (e.g. protocols, case report forms and analysis plans and, to the extent requested by or on behalf Crinetics and required to verify the data and results of such Party Clinical Trials, raw data supporting such data and results) generated or collected in the Territory by SKK or its Affiliates (or its licensees or Sublicensees“SKK’s Data”), as applicable) in the Development of each Licensed Product, including in the Development of the existing Licensed Product under the PrecisionProduct, in each case free of charge, provided that any reasonable out-Imugene License Agreement. TGTX will have the right of-pocket costs incurred by SKK to use and reference such data and results provided accommodate any related requests from Crinetics shall be reimbursed by Precision for the purpose of performing Development activities under this Agreement, obtaining, supporting, and maintaining Regulatory Approvals and any Reimbursement Approval, as applicable, of Licensed Products in the Licensed Field in the Territory, without additional consideration. Precision and its Affiliates and licensees will have the right to use and reference such data and results provided by TGTX for the purpose of Developing the Licensed Product (but, during the Term, only outside the Licensed Field) or any other products based on ARCUS Technology, and obtaining, supporting, and maintaining Regulatory Approvals or any Reimbursement Approvals, as applicable, of any such product, without additional consideration. For clarity, Precision shall not clinically Develop the Licensed Product in the Licensed Field in the Territory during the TermCrinetics. [***]. SKK shall not provide, nor shall SKK be required to provide, Crinetics with any personal information of the individuals that are subjects of any Clinical Trial of Licensed Product, except to the extent required for Crinetics or SKK, or any of their Affiliates or (sub)licensees to comply with Applicable Law or for patient safety.
(c) Any information or documents exchanged in accordance with Section 4.1 or this Section 4.3 will be provided in its original language in electronic format unless otherwise agreed by the Parties, along with English translation if such translation already exists or an English summary thereof to be provided within thirty (30) days of the other Party’s request (which may be extended upon mutual agreement of the Parties which agreement shall not be unreasonably withheld by either Party) if such translation does not exist. Such transfers shall be performed in accordance with Applicable Laws, including those with respect to electronic records transfer, privacy and personal information. The receiving Party shall be solely responsible for additional translation of such information for its or its licensees’ use. All title to and ownership of the original information provided by a Party, including copyrights or any other intellectual property rights to any data or information contained in any documentation provided by such Party, shall solely belong to such Party. The receiving Party shall obtain prior written consent from the disclosing Party for any use of translated information by a Sublicensee (with respect to SKK) or use by a Licensee (with respect to Crinetics), provided that no such consent shall be required of any Licensee of Crinetics if such Licensee has been authorized to use SKK’s Data.
Appears in 1 contract
Samples: License Agreement (Crinetics Pharmaceuticals, Inc.)
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations set forth in Section 4.46.6 (Adverse Events Reporting), each Party will promptly [***] provide the other Party, through the JSC (or, based on the time sensitivity or urgency of such data and results, directly between representatives of the Parties outside of the JSC)JDC, with copies of all data and results and all supporting documentation (e.g., protocols, Investigator’s Brochures, case report forms, analysis plans, and all in English language) (collectively, “Clinical Data and Documentation”)
(a) Controlled by such Party or its Affiliates (or Sublicensees, in the case of TGTX) (b) owned by, or licensed to, Precision’s licensees, to the extent Controlled by Precision, in each case, (a) or (b), that are generated by or on behalf of such Party or its Affiliates (or its licensees or Affiliates, Sublicensees, as or Subcontractors, if applicable) , in the Development of each Licensed Product, including all data and results (or on whose behalf such data and results are generated) in the Development course of conducting such non-clinical or preclinical studies or Clinical Trials for any Licensed Product. Such data, results, and supporting documentation provided by a Party pursuant to this Section 5.11 (Data Exchange and Use) will be the existing Licensed Product under Confidential Information of such Party, and such Party will be the Precision-Imugene License AgreementDisclosing Party with respect thereto, in each case, subject to the terms of Article 11 (Confidentiality; Publication). TGTX Partner will not have the right to use and reference such data and results provided by Precision ImmunoGen, including ImmunoGen Generated Data and any data that constitutes Product Invention Know-How, unless and until Partner bears its applicable share of the costs and expenses in accordance with Section 5.5 (New Development by ImmunoGen), in which case, Partner will have the exclusive right to use and reference such data and results for the purpose of performing Development activities in accordance with this Agreement (including under this Agreementany Global Development Plan and Territory Development Plan), and obtaining, supporting, and maintaining Local Manufacturing Approvals, Regulatory Approvals Approvals, and any Reimbursement Approval, as applicable, of the Licensed Products in the Licensed Field in the Territory, Territory without additional consideration. Precision ImmunoGen and its Affiliates and licensees designees will have the exclusive right to use and reference such data and results provided by TGTX Partner, including the Partner Generated Data, for the purpose of Developing the Licensed Product (but, during the Term, only outside the Licensed Field) or any other products based on ARCUS TechnologyProducts, and obtaining, supporting, and or maintaining Regulatory Approvals Approval or any Reimbursement ApprovalsApproval, as applicable, of any such productLicensed Product outside the Territory, without additional consideration. For clarity, Precision shall not clinically Develop the Licensed Product in the Licensed Field in the Territory during the Term. [***].
Appears in 1 contract
Samples: Collaboration and License Agreement (ImmunoGen, Inc.)
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations set forth in pursuant to Section 4.46.4, each Party will shall promptly (but in any event no later than [***] from the other Party’s request) provide the other Party, through the JSC (or, based on the time sensitivity or urgency of such data and results, directly between representatives of the Parties outside of the JSC), Party with copies of all data and results results, including all Clinical Data, and all supporting documentation (e.g., e.g. protocols, Investigator’s Brochures, case report formsCRFs, analysis plans, and all in English language) (collectively, “Clinical Data and Documentation”)
(a) Controlled by such Party or its Affiliates (or Sublicensees, in the case of TGTX) (b) owned by, or licensed to, Precision’s licensees, to the extent Controlled by Precision, in each case, (a) or (b), that are generated by or on behalf of such Party or its Affiliates or (or its licensees or Sublicenseessub)licensees (including, as with respect to Zymeworks, the Ex-Territory Partner), if applicable) , in the Development of each Licensed ProductProducts; provided that Jazz shall only be required to provide Zymeworks such data, results and documentation to the extent it is reasonably necessary or useful for Zymeworks or its Affiliate or (sub)licensees’ (including the Ex-Territory Partner’s) Development or Commercialization of the Licensed Products in the Field outside the Territory [***]; and provided further that Zymeworks will provide any other such data, results or documentation Controlled by Zymeworks or its Affiliates that is requested by Jazz and reasonably necessary or useful for the Development or Commercialization of the existing Licensed Product under Products in the Precision-Imugene License AgreementField in the Territory [***]. TGTX will Jazz shall have the right to use and reference such data and results provided by Precision Zymeworks, pursuant to the licenses granted under Section 2.1, including for the purpose of performing Development activities under this Agreementfiling Patent Rights covering Jazz Collaboration IP and Joint Collaboration IP, obtaining, supporting, obtaining and maintaining Regulatory Approvals Approval and any Reimbursement Approvalpricing or reimbursement approvals, as applicable, of Licensed Products in the Licensed Field in the Territory, without additional consideration. Precision Zymeworks and its Affiliates and licensees will designees shall have the right to use and reference such data and results provided by TGTX Jazz, without additional consideration, for the purpose of Developing Developing, manufacturing and Commercializing Licensed Products in accordance with the Licensed Product (butlicenses granted under Section 2.4, during the Termincluding filing Patent Rights covering Zymeworks Collaboration IP, only outside the Licensed Field) or any other products based on ARCUS TechnologyJoint Collaboration IP and Zanidatamab Collaboration IP, and obtaining, supporting, obtaining and maintaining Regulatory Approvals Approval and any pricing or any Reimbursement Approvalsreimbursement approvals, as applicable, of any such product, without additional considerationLicensed Products outside of the Territory. For clarity, Precision any such data or results that are Inventions will be owned in accordance with Section 14.1(a) and subject to the licenses, rights and obligations set forth herein. The Parties shall not clinically Develop adhere to the Licensed Product terms and conditions of the Data Processing Addendum dated as October 18, 2022, and entered into between the Parties in connection with the Licensed Field Original Agreement, which is attached hereto as Exhibit 5.8 and incorporated by reference, in the Territory during the Term. [***]relation to data protection.
Appears in 1 contract
Samples: License and Collaboration Agreement (Zymeworks Inc.)
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations set forth in pursuant to Section 4.46.4, each Party will shall promptly (but in any event no later than […***…] from the other Party’s request) provide the other Party, through the JSC (or, based on the time sensitivity or urgency of such data and results, directly between representatives of the Parties outside of the JSC), Party with copies of all data and results results, including all Clinical Data, and all supporting documentation (e.g., e.g. protocols, Investigator’s Brochures, case report formsCRFs, analysis plans, and all in English language) (collectively, “Clinical Data and Documentation”)
(a) Controlled by such Party or its Affiliates (or Sublicensees, in the case of TGTX) (b) owned by, or licensed to, Precision’s licensees, to the extent Controlled by Precision, in each case, (a) or (b), that are generated by or on behalf of such Party or its Affiliates (or its licensees or Sublicenseessublicensees, as if applicable) , in the Development of each Licensed ProductProducts; provided that Zymeworks shall only be required to provide BeiGene such data, results and documentation to the extent it comprises Zymeworks Know-How and is reasonably necessary or useful for BeiGene’s Development or Commercialization of the Licensed Products in the Field in the Territory, including any such data, results and documentation that are reasonably requested by BeiGene or that are necessary to support filings for Regulatory Approval for the Licensed Product in the Development of the existing Licensed Product under the Precision-Imugene License AgreementTerritory. TGTX will BeiGene shall have the right to use and reference such data and results provided by Precision Zymeworks, without additional consideration, for the purpose of performing Development activities under this Agreement, obtaining, supporting, obtaining and maintaining Regulatory Approvals Approval and any Reimbursement Approvalpricing or reimbursement approvals, as applicable, of Licensed Products in the Licensed Field in the Territory, without additional consideration. Precision Zymeworks and its Affiliates and licensees will designees shall have the right to use and reference such data and results provided by TGTX BeiGene, without additional consideration, for the purpose of Developing Developing, manufacturing and Commercializing Licensed Products in accordance with the Licensed Product (butlicenses granted under Section 2.4, during the Term, only outside the Licensed Field) or any other products based on ARCUS Technology, filing Patent Rights covering Zymeworks’ Inventions and obtaining, supporting, ZW49 Collaboration IP and obtaining and maintaining Regulatory Approvals Approval and any pricing or any Reimbursement Approvalsreimbursement approvals, as applicable, of any such product, without additional considerationLicensed Products outside the Field in the Territory or outside of the Territory. For clarity, Precision shall not clinically Develop any such data or results that are Inventions will be owned in accordance with Section 14.1 and subject to the Licensed Product in the Licensed Field in the Territory during the Term. [***].licenses, rights and obligations set forth herein.53
Appears in 1 contract
Samples: License and Collaboration Agreement (Zymeworks Inc.)
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations set forth in pursuant to Section 4.46.4 and except to the extent excluded pursuant to Sections 5.5(b) and 5.5(c), each Party will shall promptly (but in any event no later than [* * *] from the other Party’s request) provide the other Party, through the JSC (or, based on the time sensitivity or urgency of such data and results, directly between representatives of the Parties outside of the JSC), Party with copies of all data and results results, including all Clinical Data and all supporting documentation (e.g., protocols, Investigator’s Brochures, case report formsCRFs, analysis plans, and all in English language) (collectively, “Clinical Data and Documentation”)
(a) Controlled by such Party or its Affiliates (or Sublicensees, in the case of TGTX) (b) owned by, or licensed to, Precision’s licensees, to the extent Controlled by Precision, in each case, (a) or (b), that are generated by or on behalf of such Party or its Affiliates (or its licensees or Sublicenseessublicensees, as if applicable) , in the Development of each Licensed ProductProducts; provided that AssemblyBio shall only be required to provide BeiGene such data, results and documentation to the extent it comprises AssemblyBio Know-How and is necessary or reasonably useful for BeiGene’s Development or Commercialization of the Licensed Products in the Field in the Territory, including any such data, results and documentation that are reasonably requested by BeiGene or that are necessary to support filings for Regulatory Approval for a Licensed Product in the Development of the existing Licensed Product under the Precision-Imugene License AgreementTerritory. TGTX will AssemblyBio agrees to use Commercially Reasonable Efforts to [* * *]. BeiGene shall have the right to use and reference such data and results provided by Precision AssemblyBio, without additional consideration, for the purpose of performing Development activities under this Agreement, obtaining, supporting, obtaining and maintaining Regulatory Approvals and any Pricing and Reimbursement ApprovalApprovals, as applicable, of Licensed Products in the Licensed Field in the Territory, without additional consideration. Precision AssemblyBio and its Affiliates and licensees will designees shall have the right to use and reference such data and results provided by TGTX BeiGene, without additional consideration, for the purpose of Developing (a) Developing, Manufacturing and Commercializing Licensed Products in accordance with the Licensed Product licenses granted under Section 2.4, (butb) filing Patent Rights covering AssemblyBio’s Inventions and Product-Specific IP, during the Term, only outside the Licensed Field(c) or any other products based on ARCUS Technology, and obtaining, supporting, obtaining and maintaining Regulatory Approvals or Approval and any Pricing and Reimbursement Approvals, as applicable, of Licensed Products outside the Field in the Territory or outside of the Territory, and (d) seeking, obtaining and maintaining a Clinical Trials Application for any such product, without additional considerationLicensed Product in the Field in the Territory in accordance with AssemblyBio’s retained rights under Section 2.3. For clarity, Precision shall not clinically Develop any such data or results that are Inventions will be owned in accordance with Section 14.1 and subject to the Licensed Product in the Licensed Field in the Territory during the Term. [***]licenses, rights and obligations set forth herein.
Appears in 1 contract
Samples: Collaboration Agreement (Assembly Biosciences, Inc.)
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations set forth in pursuant to Section 4.46.5, each Party will shall promptly provide the other Party, through the JSC (or, based on the time sensitivity or urgency of such data and results, directly between representatives of the Parties outside of the JSC), Party with copies of all data and results and all supporting documentation (e.g., e.g. protocols, Investigator’s Brochures, case report formsCRFs, analysis plans, and all in English language) (collectively, “Clinical Data and Documentation”)
(a) Controlled controlled by such Party or its Affiliates (or Sublicensees, in the case of TGTX) (b) owned by, or licensed to, Precision’s licensees, to the extent Controlled by Precision, in each case, (a) or (b), that are generated by or on behalf of such Party or its Affiliates (or its licensees or Sublicenseessublicensees, as if applicable) , in the Development of each Licensed ProductProducts; provided that NVCR shall only be required to provide Zai such data, including results and documentation to the extent it comprises NVCR Know-How and is reasonably necessary or useful for Zai’s Development and Commercialization of the Licensed Products in the Development of Field and in the existing Licensed Product under the Precision-Imugene License AgreementTerritory. TGTX will Zai shall have the right to use and reference such data and results provided by Precision NVCR, without additional consideration, for the purpose of performing Development activities under this Agreement, obtaining, supporting, obtaining and maintaining Regulatory Approvals Approval and any Reimbursement Approvalpricing or reimbursement approvals, as applicable, of Licensed Products in the Licensed Field and in the Territory, without additional consideration. Precision NVCR and its Affiliates and licensees will designees shall have the right to use and reference such data and results provided by TGTX Zai, without additional CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 20 consideration, for the purpose of Developing the Licensed Product (but, during the Term, only outside the Licensed Field) or any other products based on ARCUS Technology, and obtaining, supporting, obtaining and maintaining Regulatory Approvals Approval and any pricing or any Reimbursement Approvalsreimbursement approvals, as applicable, of any such product, without additional consideration. For clarity, Precision shall not clinically Develop Licensed Products outside the Licensed Product in Field or the Licensed Field in the Territory during the Term. [***]Territory.
Appears in 1 contract
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations set forth in pursuant to Section 4.46.4, each Party will shall promptly (but in any event no later than […***…] from the other Party’s request) provide the other Party, through the JSC (or, based on the time sensitivity or urgency of such data and results, directly between representatives of the Parties outside of the JSC), Party with copies of all data and results results, including all Clinical Data, and all supporting documentation (e.g., e.g. protocols, Investigator’s Brochures, case report formsCRFs, analysis plans, and all in English language) (collectively, “Clinical Data and Documentation”)
(a) Controlled by such Party or its Affiliates (or Sublicensees, in the case of TGTX) (b) owned by, or licensed to, Precision’s licensees, to the extent Controlled by Precision, in each case, (a) or (b), that are generated by or on behalf of such Party or its Affiliates (or its licensees or Sublicenseessublicensees, as if applicable) , in the Development of each Licensed ProductProducts […***…]; provided that Zymeworks shall only be required to provide BeiGene such data, results and documentation to the extent it comprises Zymeworks Know-How and is reasonably necessary or useful for BeiGene’s Development or Commercialization of the Licensed Products in the Field in the Territory, including any such data, results and documentation that are reasonably requested by BeiGene or that are necessary to support filings for Regulatory Approval for the Licensed Product in the Development of the existing Licensed Product under the Precision-Imugene License AgreementTerritory. TGTX will BeiGene shall have the right to use and reference such data and results provided by Precision Zymeworks, without additional consideration, for the purpose of performing Development activities under this Agreement, obtaining, supporting, obtaining and maintaining Regulatory Approvals Approval and any Reimbursement Approvalpricing or reimbursement approvals, as applicable, of Licensed Products in the Licensed Field in the Territory, without additional consideration. Precision 48 Competitive Information – Discovery Information and Commercially Sensitive Terms. 49 Competitive Information – Commercially Sensitive Terms. 50 Competitive Information – Commercially Sensitive Terms. 51 Competitive Information – Discovery Information and Commercially Sensitive Terms. Zymeworks and its Affiliates and licensees will designees shall have the right to use and reference such data and results provided by TGTX BeiGene, without additional consideration, for the purpose of Developing Developing, manufacturing and Commercializing Licensed Products in accordance with the Licensed Product (butlicenses granted under Section 2.4, during the Term, only outside the Licensed Field) or any other products based on ARCUS Technology, filing Patent Rights covering Zymeworks’ Inventions and obtaining, supporting, ZW25 Collaboration IP and obtaining and maintaining Regulatory Approvals Approval and any pricing or any Reimbursement Approvalsreimbursement approvals, as applicable, of any such product, without additional considerationLicensed Products outside the Field in the Territory or outside of the Territory. For clarity, Precision shall not clinically Develop any such data or results that are Inventions will be owned in accordance with Section 14.1 and subject to the Licensed Product in the Licensed Field in the Territory during the Term. [***].licenses, rights and obligations set forth herein.52
Appears in 1 contract
Samples: License and Collaboration Agreement (Zymeworks Inc.)