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. [***].
Data Exchange and Use. Upon the Effective Date, Allos shall provide Mundipharma with access, free of charge, to all Allos Know-How then in existence that constitutes pre-clinical or clinical data relating to the Product. For clarity, Allos does not have any obligation to disclose or provide access to any Information with respect to manufacture of the Product except in the event the license under Section 2.1(c) becomes effective and then only in accordance with Section 2.1(c) and the Supply Agreement. In addition to its adverse event and safety data reporting obligations pursuant to Section 5.7, each Party shall promptly provide the other Party with access to, at no additional charge:
(a) all safety, clinical and other development Information (including, if requested, raw data) associated with the conduct of the Shared Studies, as reasonably necessary or useful to support such other Party’s Development or Commercialization of the Product in the Field in accordance with this Agreement, including rights of access and reference to Regulatory Materials; and
(b) all safety Information (including, if requested, raw data) generated pursuant to any Incremental Study which the Non-Conducting Party is required by a Regulatory Authority in its territory to file with such Regulatory Authority to support safety disclosure requirements. The Non-Conducting Party shall have no rights to use any other Information arising from such Incremental Study in any filings with Regulatory Authorities in its territory (i.e., in the Allos Territory where Allos is the Non-Conducting Party and in the Licensed Territory where Mundipharma is the Non-Conducting Party) unless and until such Non-Conducting Party exercises its right, pursuant to Section 4.4(c)(v), to convert such Incremental Study to an Additional Study.
Data Exchange and Use. This Section 5.5 shall not apply to any pharmacovigilance data (which is addressed in Section 5.2). FivePrime and/or its Third-Party collaborator shall disclose to and permit HGS and/or its Third Party collaborator (if any) to use preclinical or clinical data, in the form final study reports, from trials or studies conducted by FivePrime and/or its Third-Party collaborator for the Compound in HGS’ regulatory filings in the Territory at no additional cost to HGS. Similarly, HGS and its Third Party collaborator (if any) shall disclose to and permit FivePrime and/or its Third-Party collaborator to use preclinical or clinical data, in the form final study reports, from trials or studies conducted by HGS for the Compound in regulatory filings outside of the Territory at no cost to FivePrime. All such final study reports provided by one Party or its Third Party collaborator (if any) to the other Party or such other Party’s Third Party collaborator (if any) shall be provided, to the extent reasonably available to the providing Party, in formats reasonably useable by the receiving Party for purposes of cross-filing with a Regulatory Authority (e.g., final study reports should be provided electronically in file formats that allow information to be reorganized or sorted).
Data Exchange and Use. This Section 7.5 shall not apply to any pharmacovigilance data (which is addressed in Section 7.2). Daewoong shall, and shall ensure that its Sublicensees will, provide Ampio with copies of all final submissions and correspondence to and from all Regulatory Authorities relating to the Products in the Field within seven (7) days of submission or receipt, as applicable, and shall, and shall ensure that its Sublicensees will, provide Ampio a summary of each significant submission (such as application for approval for clinical trials, Regulatory Approval and fast track or orphan drug designation, the protocol for clinical trials and any modifications thereof) in English as soon as practicable but in any event within ten (10) business days after such submission. Each Party shall permit the other Party to access, and shall provide the other Party with rights to reference and use in association with the Products in the Field, all of its, its Affiliates’, and its or their licensees’ and Sublicensees’ regulatory, preclinical and clinical data documentation, Regulatory Filings, and Regulatory Approvals with respect to the Products in the Field.
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations pursuant to Section 6.5, each Party shall promptly provide the other Party with copies of all data and results and all supporting documentation (e.g. protocols, CRFs, analysis plans) controlled by such Party that are generated by or on behalf of such Party or its Affiliates or sublicensees, if applicable, in the Development of Licensed Products; provided that NVCR shall only be required to provide Zai such data, 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 Field and in the Territory. Zai shall have the right to use and reference such data and results provided by NVCR, without additional consideration, for the purpose of obtaining and maintaining Regulatory Approval and any pricing or reimbursement approvals, as applicable, of Licensed Products in the Field and in the Territory. NVCR and its designees shall have the right to use and reference such data and results provided by Zai, without additional consideration, for the purpose of obtaining and maintaining Regulatory Approval and any pricing or reimbursement approvals, as applicable, of Licensed Products outside the Field or the Territory.
Data Exchange and Use. Without unreasonable delay after the Effective Date, ITI shall provide, upon Takeda’s reasonable request, Takeda with copies of or access to any data related to Compounds as specified by Takeda, to the extent such data is in existence as of the Effective Date and was not previously provided to Takeda. Each Party shall without Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Data Exchange and Use. This Section 6.5 shall not apply to any pharmacovigilance data (which is addressed in Section 6.2). BDI Pharmaceuticals shall provide Dyadic with copies of all final submissions and correspondence to and from all Regulatory Authorities within seven (7) days of submission or receipt, as applicable, and shall provide Dyadic a summary of each significant submission in English as soon as practicable but in any event within ten (10) business days after such submission. Each Party shall permit the other Party to access, and shall provide the other Party with rights to reference and use in association with the Product(s) in the Field, all of its, its Affiliates’, and its or their licensees’ and Sublicensees’ regulatory, preclinical and clinical data documentation when allowed by the applicable laws and regulations of the Territory, Regulatory Filings and Regulatory Approvals with respect to the Product(s) in the Field.
Data Exchange and Use. Each Party shall promptly permit the other Party to access, and shall provide the other Party with rights to reference and use in association with the Product in the Field for use in their respective Territories, all of its or its sublicensees’ regulatory, preclinical, and clinical data documentation, the Regulatory Filings, and the Regulatory Approvals with respect to the Product in the Field for use in their respective Territories.
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations pursuant to Section 5.5, each Party shall promptly provide the other Party with copies of all data and results and all supporting documentation (e.g. protocols, CRFs, analysis plans) generated from its Development of the Product. Subject to Section 4.5(d), Ji Xing shall have the right to use the data provided by Cytokinetics for the purpose of obtaining and maintaining Regulatory Approval for and Commercializing the Product in the Field in the Territory. Cytokinetics shall have the right to use the data provided by Ji Xing for the purpose of obtaining and maintaining Regulatory Approval for and Commercializing the Product outside the Territory.
Data Exchange and Use. In addition to its adverse event and safety data reporting obligations pursuant to Section 5.4, each Party shall promptly provide the other Party with copies of all data and results and all supporting documentation (e.g. protocols, CRFs, analysis plans) generated by or on behalf of such Party in the Development of the Licensed Products in accordance with Applicable Laws. Ahon shall have the right to use and reference such data and results provided by DiaMedica, without additional consideration, for the purpose of obtaining and maintaining Regulatory Approval of the Licensed Products in the Field in the Territory and other reasonable purposes under the Agreement. DiaMedica shall have the right to use and reference such data and results provided by Ahon, without additional consideration, for the purpose of obtaining and maintaining Regulatory Approval of the Licensed Products outside the Territory and outside the Field in the Territory and other reasonable purposes under the Agreement, except to the extent such use is prohibited by PRC law, and if DiaMedica uses such data and results for any purpose other than the Development, manufacture and Commercialization of the Licensed Product, DiaMedica shall give Ahon a prior notice in writing of the purposes of such use.
