Common use of Information and Reporting Clause in Contracts

Information and Reporting. Fibrocell will keep Intrexon informed about Fibrocell’s efforts to develop and Commercialize Fibrocell Products and Improved Products, including reasonable and accurate summaries of Fibrocell’s (and its Affiliates’ and, if applicable, (sub)licensees’) development plans (as updated), including preclinical, clinical and regulatory plans, marketing plans (as updated), progress towards meeting the goals and milestones in such plans and explanations of any material deviations, significant developments in the development and/or Commercialization of the Fibrocell Products and Improved Products, including initiation or completion of a clinical trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, clinical safety event, receipt of Regulatory Approval, or commercial launch, and manufacturing and pricing information, including data evidencing current COGS for any Existing Products. As set forth in Section 3.8 above, Fibrocell shall also provide to Intrexon copies of all final preclinical protocols and reports, final clinical protocols and reports, and regulatory correspondence and filings generated by Fibrocell as soon as practical after they become available. Intrexon will keep Fibrocell informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Fibrocell Products and Improved Products (and Intrexon Materials relevant thereto) and otherwise perform its manufacturing responsibilities under Section 4.6 and (b) to undertake discovery-stage research for the Fibroblast Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accord with Section 4.2 above, such disclosures by Fibrocell and Intrexon will be made in the course of JSC meetings at least once every six (6) months while Fibrocell Products and Improved Products are being developed or Commercialized anywhere in the world, and shall be reflected in the minutes of such meetings.

Appears in 3 contracts

Samples: Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.), Exclusive Channel Collaboration Agreement (Fibrocell Science, Inc.), Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.)

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Information and Reporting. Fibrocell will keep Intrexon informed about Fibrocell’s efforts to develop and Commercialize Fibrocell Products and Improved Products, including reasonable and accurate summaries of Fibrocell’s (and its Affiliates’ and, if applicable, (sub)licensees’) development plans (as updated), including preclinical, clinical and regulatory plans, marketing plans (as updated), progress towards meeting the goals and milestones in such plans and explanations of any material deviations, significant developments in the development and/or Commercialization of the Fibrocell Products and Improved Products, including initiation or completion of a clinical trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, clinical safety event, receipt of Regulatory Approval, or commercial launch, and manufacturing and pricing information, including data evidencing current COGS for any Existing Products. As set forth in Section 3.8 above, Fibrocell shall also provide to Intrexon copies of all final preclinical protocols and reports, final clinical protocols and reports, and regulatory correspondence and filings generated by Fibrocell as soon as practical after they become available. Intrexon will keep Fibrocell informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Fibrocell Products and Improved Products (and Intrexon Materials relevant thereto) Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. and otherwise perform its manufacturing responsibilities under Section 4.6 and (b) to undertake discovery-stage research for the Fibroblast Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accord with Section 4.2 above, such disclosures by Fibrocell and Intrexon will be made in the course of JSC meetings at least once every six (6) months while Fibrocell Products and Improved Products are being developed or Commercialized anywhere in the world, and shall be reflected in the minutes of such meetings.

Appears in 2 contracts

Samples: Exclusive Channel Collaboration Agreement (Intrexon Corp), Exclusive Channel Collaboration Agreement (Intrexon Corp)

Information and Reporting. Fibrocell AquaBounty will keep Intrexon informed about FibrocellAquaBounty’s efforts to develop and Commercialize Fibrocell Products and Improved AquaBounty Products, including reasonable and accurate summaries of FibrocellAquaBounty’s (and its Affiliates’ and, if applicable, (sub)licensees’) development plans (as updated), including preclinical, clinical and regulatory plans, marketing plans (as updated), progress towards meeting the goals and milestones in such plans and explanations of any material deviations, significant developments in the development and/or Commercialization of the Fibrocell Products and Improved AquaBounty Products, including initiation or completion of a clinical regulatory trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, clinical product safety event, receipt of Regulatory Approval, or commercial launch, and manufacturing costs and pricing information, including data evidencing current COGS for any Existing Products. As set forth in Section 3.8 3.7 above, Fibrocell AquaBounty shall also provide Intrexon access to Intrexon copies of all final preclinical protocols and reports, final clinical regulatory trial protocols and reports, and regulatory correspondence and filings generated by Fibrocell AquaBounty as soon as practical after they become available. Intrexon will keep Fibrocell AquaBounty informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Fibrocell Products and Improved AquaBounty Products (and Intrexon Materials relevant thereto) and otherwise perform its manufacturing responsibilities under Section 4.6 and (b) to undertake discovery-stage research for the Fibroblast Aquaculture Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accord accordance with Section 4.2 above, such disclosures by Fibrocell AquaBounty and Intrexon will be coordinated by the JSC and made in the course of connection with JSC meetings at least once every six (6) months while Fibrocell Products and Improved AquaBounty Products are being developed or Commercialized anywhere in the world, and shall be reflected in the minutes of such meetings.

Appears in 2 contracts

Samples: Exclusive Channel Collaboration Agreement (AquaBounty Technologies, Inc.), Exclusive Channel Collaboration Agreement (AquaBounty Technologies, Inc.)

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Information and Reporting. Fibrocell Histogenics will keep Intrexon informed about Fibrocell’s Histogenics’ efforts to develop and Commercialize Fibrocell Products and Improved Collaboration Products, including reasonable and accurate summaries of Fibrocell’s Histogenics’ (and its Affiliates’ and, if applicable, (sub)licensees’) development plans (as updated)) for Collaboration Products, including preclinical, clinical and regulatory plans, marketing plans (as updated), progress towards meeting the goals and milestones in such plans **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CONFIDENTIAL TREATMENT REQUESTED CONFIDENTIAL and explanations of any material deviations, significant developments in the development and/or Commercialization of the Fibrocell Products and Improved Collaboration Products, including initiation or completion of a clinical regulatory trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, clinical product safety event, receipt of Regulatory Approvalregulatory approval, or commercial launch, and manufacturing costs and pricing information, including data evidencing current COGS for any Existing Products. As set forth in Section 3.8 above, Fibrocell Histogenics shall also provide to Intrexon copies of all final preclinical protocols and reports, final clinical protocols regulatory documents and reports, and regulatory correspondence and filings generated by Fibrocell Histogenics, to the extent that they relate specifically to Intrexon Materials that are or express ingredients for Collaboration Products, as soon as practical after they become availablefollowing receipt of Intrexon’s written request for such materials. Intrexon will keep Fibrocell Histogenics informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Fibrocell Products and Improved Products (and Intrexon Materials relevant thereto) and otherwise perform its manufacturing responsibilities under Section 4.6 and (b) to undertake discovery-stage research for the Fibroblast Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accord with Section 4.2 aboveJSC, such disclosures by Fibrocell Histogenics and Intrexon will be coordinated by the JSC and made in the course of connection with JSC meetings at least once every six (6) months while Fibrocell Products and Improved Collaboration Products are being developed or Commercialized anywhere in the world, and shall be reflected in the minutes of such meetings.

Appears in 1 contract

Samples: Exclusive Channel Collaboration Agreement (Histogenics Corp)

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