Development Records and Reports. Each Party shall maintain or cause to be maintained complete and accurate records (in the form of technical notebooks and/or electronic files where appropriate) of all work conducted by it or on its behalf under the Development Plan and all Information resulting from such work, including in the case of FibroGen, records of whether Development Costs are borne or reimbursed by Astellas under the Astellas EU Agreement. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the Development Plan in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Such records shall be retained by such Party for at least five (5) years after the term of this Agreement or such longer period as may be required by applicable laws. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times and to obtain access to originals to the extent needed for patent or regulatory purposes or for other legal proceedings. Each Party shall provide the JDC with regular reports, at least annually, detailing its Development activities under the Development Plan and the results of such activities.
Development Records and Reports. GSK shall maintain complete, current and accurate records of all development activities conducted by it hereunder, and all data and other Know-How resulting from such activities in accordance with the principles set forth in Section 3.5(b) and 3.6. Upon expiration of the JSC Term, at Liquidia’s request, which request shall not be made more frequently than annually until such earlier time as GSK either files the first NDA for a particular Research Product or ceases development of a particular Research Product, GSK shall provide Liquidia with written reports summarizing the material activities of GSK with respect to the development of such Research Product in the Territory, to enable Liquidia to determine GSK’s compliance with its diligence obligations hereunder; provided, that GSK shall not be required to provide any confidential or proprietary information regarding any GSK Material, whether owned by GSK or licensed to GSK by a Third Party. If Liquidia has any questions with respect to the information set forth in any report provided by GSK under this Section 6.3, then Liquidia shall direct such questions to GSK’s Alliance Manager and GSK shall make reasonably available to Liquidia appropriate technical or scientific personnel who are knowledgeable about the development activities conducted by GSK with respect to the Research Products that are the subject of the report, to respond to such questions in a timely manner, via teleconference, in person or such other mode of communication as the Parties may mutually agree, subject always to the proviso set forth in the preceding sentence. Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Development Records and Reports. Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all Information resulting from such activities. Such records shall accurately and completely reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes.
Development Records and Reports. Each Party shall maintain complete and accurate records (in the form of technical notebooks and/or electronic files where appropriate) of all work conducted by it under the Development Plan and all Information resulting from such work. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the Development Plan in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times and upon reasonable notice, and to obtain access to originals to the extent needed for patent or regulatory purposes or for other legal proceedings. Each Party shall provide the Development Committee with regular reports detailing its respective research and development activities under the Development Plan and the results of such activities.
Development Records and Reports. Each Party shall maintain complete, current and accurate records of the Studies and other development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. fully and properly reflect all work done and results achieved in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all Studies in formal written study reports according to Applicable Laws and national and international (e.g., ICH, GCP, GLP, and GMP) guidelines. Each Party shall maintain such records in a professional manner in compliance with all Applicable Laws and regulations and no Party shall destroy any such records without the other Party’s consent. Each Party shall provide the JCC with regular reports detailing its activities under the Development Plan and the results of such activities at each regularly scheduled JCC meeting. The Parties shall discuss the status, progress and results of each Party’s activities under the Development Plan at such JCC meetings.
Development Records and Reports. Each Party shall maintain or cause to be maintained complete and accurate records (in the form of technical notebooks and/or electronic files where appropriate) of all work conducted by it or on its behalf under the Development Plan and all Information resulting from such work. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the Development Plan in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Such records shall be retained by such Party for at least five (5) years after the term of this Agreement or such longer period as may be required by applicable laws. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times and to obtain access to originals to the extent needed for patent or regulatory purposes or for other legal proceedings. Each Party shall provide the China Committee with quarterly reports detailing its Development activities under the Development Plan and the results of such activities.
Development Records and Reports. Reneo shall maintain complete and accurate customary records (in the form of technical notebooks or electronic files where appropriate) of all Development activities related to any Compound or Licensed Product conducted by it or any of its Affiliates or Sublicensees, as applicable, under this Agreement and all Information resulting from such work. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the Development activities related to any Compound or Licensed Product in sufficient detail and in good scientific manner appropriate for applicable patent and regulatory purposes. Upon the expiry of each consecutive [***] month period during the Term until First Commercial Sale of a Licensed Product, Reneo shall provide vTv with a written report summarizing its Development activities related to any Compound or Licensed Product conducted by Reneo or any of its Affiliates or Sublicensees, as applicable, under this Agreement and the results of such activities, and shall be reasonably available for at least one (1) meeting (which may be held in person or by videoconference or teleconference) to discuss each such written report. Any information or report provided by Reneo to vTv pursuant to this Section 4.6 shall be deemed to be Reneo’s Confidential Information and subject to the provisions of Article 6.
Development Records and Reports. Lumena shall maintain complete and accurate customary records (in the form of technical notebooks and/or electronic files where appropriate) of all Development activities conducted by it or its Affiliates or sublicensees, as applicable, under this Agreement and all Information resulting from such work. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the Development activities in sufficient detail and in good scientific manner appropriate for applicable patent and regulatory purposes. Upon the expiry of each consecutive [...***...] period during the Term, Lumena shall provide Sanofi with a written report summarizing its Development activities conducted by Lumena or its Affiliates or sublicensees, as applicable, under this Agreement and the results of such activities. Any information or report provided by Lumena to Sanofi pursuant to this Section 4.6 shall be deemed to be Lumena’s Confidential Information and subject to the provisions of Article 7.
Development Records and Reports. Mirum shall maintain complete and accurate records (in the form of technical notebooks or electronic files where appropriate) of all Development activities conducted by it or its Affiliates or their respective sublicensees, as applicable, under this Agreement and all Information resulting from such work. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the Development activities in sufficient detail and in good scientific manner appropriate for applicable patent and regulatory purposes. […***…] prior to the expiry of each consecutive […***…] period during the Term, Mirum shall provide Shire with a written report summarizing its Development activities conducted by Mirum or its Affiliates or their respective sublicensees, as applicable, under this Agreement and the results of such activities. Any information or report provided by Mirum to Shire pursuant to this Section 5.2(c) shall be deemed to be Mirum’s Confidential Information and subject to the provisions of Article 7.
Development Records and Reports. Artiva shall maintain complete and accurate customary records (in the form of technical notebooks or electronic files where appropriate) of all development activities conducted by it or its Affiliates or Sublicensees, as applicable, under this Agreement and all Information resulting from such work. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the development activities in sufficient detail and in good scientific manner appropriate for applicable patent and regulatory purposes. Upon the expiry of each consecutive [***] period during the Term until First Commercial Sale of a Licensed Product, Artiva shall provide GCLC (through the JDC) with an update of development activities conducted by Artiva or its Affiliates or Sublicensees, as applicable, with respect to Exercised Selected Products. Any information or report provided by Artiva to GCLC pursuant to this Section 7.3 shall be Artiva’s Confidential Information and subject to the provisions of Article 9.
