Common use of Information and Reporting Clause in Contracts

Information and Reporting. AquaBounty will keep Intrexon informed about AquaBounty’s efforts to develop and Commercialize AquaBounty Products, including reasonable and accurate summaries of AquaBounty’s (and its Affiliates’ and, if applicable, (sub)licensees’) development plans (as updated), including 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 AquaBounty Products, including initiation or completion of a regulatory trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, product safety event, receipt of Regulatory Approval, or commercial launch, and manufacturing costs and pricing information. As set forth in Section 3.7 above, AquaBounty shall also provide Intrexon access to all final regulatory trial protocols and reports, and regulatory correspondence and filings generated by AquaBounty as soon as practical after they become available. Intrexon will keep AquaBounty informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for AquaBounty Products (and Intrexon Materials relevant thereto) and (b) to undertake discovery-stage research for the Aquaculture Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accordance with Section 4.2 above, such disclosures by AquaBounty and Intrexon will be coordinated by the JSC and made in connection with JSC meetings at least once every six (6) months while AquaBounty 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, Exclusive Channel Collaboration Agreement (AquaBounty Technologies, Inc.), Exclusive Channel Collaboration Agreement (AquaBounty Technologies, Inc.)

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Information and Reporting. AquaBounty Fibrocell will keep Intrexon informed about AquaBountyFibrocell’s efforts to develop and Commercialize AquaBounty Fibrocell Products and Improved Products, including reasonable and accurate summaries of AquaBountyFibrocell’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 AquaBounty Fibrocell Products and Improved Products, including initiation or completion of a regulatory clinical trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, product clinical 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 3.7 3.8 above, AquaBounty Fibrocell shall also provide to Intrexon access to copies of all final regulatory trial preclinical protocols and reports, final clinical protocols and reports, and regulatory correspondence and filings generated by AquaBounty Fibrocell as soon as practical after they become available. Intrexon will keep AquaBounty Fibrocell informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for AquaBounty 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 Aquaculture Fibroblast Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accordance accord with Section 4.2 above, such disclosures by AquaBounty Fibrocell and Intrexon will be coordinated by the JSC and made in connection with the course of JSC meetings at least once every six (6) months while AquaBounty 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 (Castle Creek Biosciences, Inc.), Exclusive Channel Collaboration Agreement (Fibrocell Science, Inc.)

Information and Reporting. AquaBounty Oragenics will keep Intrexon informed about AquaBounty’s Oragenics’ efforts to develop and Commercialize AquaBounty Oragenics Products, including reasonable and accurate summaries of AquaBounty’s Oragenics’ (and its Affiliates’ and, if applicable, (sub)licensees’) global development plans (as updated), including preclinical, clinical and regulatory plans, global marketing plans (as updated), progress towards meeting the goals and milestones in such plans and explanations of any material deviations, and significant developments in the development and/or Commercialization of the AquaBounty Oragenics Products, including initiation or completion of a regulatory clinical trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, clinical or product safety event, receipt of Regulatory Approval, regulatory approval or commercial launch, and manufacturing costs and pricing information. As set forth in Section 3.7 3.8 above, AquaBounty Oragenics shall also provide to Intrexon access to copies of all final regulatory trial preclinical protocols and reports, final clinical protocols and reports, and regulatory correspondence and filings generated by AquaBounty Oragenics as soon as practical after they become available. Intrexon will keep AquaBounty Oragenics informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for AquaBounty Oragenics 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 Aquaculture Probiotics Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accordance accord with Section 4.2 above, such disclosures by AquaBounty Oragenics and Intrexon will be coordinated by the JSC and made in connection with JSC meetings at least once every six (6) months while AquaBounty Oragenics 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 (Oragenics Inc)

Information and Reporting. AquaBounty Soligenix will keep Intrexon informed about AquaBountySoligenix’s efforts to develop and Commercialize AquaBounty Soligenix Products, including reasonable and accurate summaries of AquaBountySoligenix’s (and its Affiliates’ and, if applicable, (sub)licensees’) development plans (as updated), including 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 AquaBounty Soligenix Products, including initiation or completion of a regulatory trialRegulatory Trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, product Soligenix Product adverse safety eventevents, receipt of Regulatory Approval, or commercial launch, and manufacturing costs and pricing information. As set forth in Section 3.7 above, AquaBounty Soligenix shall also provide to Intrexon access to copies of all final regulatory trial Regulatory Trial protocols and reports, and regulatory correspondence and filings generated by AquaBounty Soligenix as soon as practical after they become available. Intrexon will keep AquaBounty Soligenix informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for AquaBounty Soligenix 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 Aquaculture Melioidosis Program with respect to the Intrexon 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. Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accordance accord with Section 4.2 above, such disclosures by AquaBounty Soligenix and Intrexon will be coordinated by the JSC and made in connection with JSC meetings at least once every six (6) months while AquaBounty Soligenix 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. AquaBounty will keep Intrexon informed about AquaBounty’s efforts to develop and Commercialize AquaBounty Products, including reasonable and accurate summaries of AquaBounty’s (and its Affiliates’ and, if applicable, (sub)licensees’) development plans (as updated), including 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 AquaBounty Products, including initiation or completion of a regulatory trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, product safety event, receipt of Regulatory Approval, or commercial launch, and manufacturing costs and pricing information. As set forth in Section 3.7 above, AquaBounty shall also provide Intrexon access to all final regulatory trial protocols and reports, and regulatory correspondence and filings generated by AquaBounty as soon as practical after they become available. Intrexon will keep AquaBounty informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for AquaBounty Products (and Intrexon Materials relevant thereto) and (b) to undertake discovery-stage research for the Aquaculture Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accordance with Section 4.2 above, such disclosures by AquaBounty and Intrexon will be coordinated by the JSC and made in connection with JSC meetings at least once every six (6) months while AquaBounty Products are being developed or Commercialized anywhere in the world, and shall be reflected in the minutes of such meetings. 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.

Appears in 2 contracts

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

Information and Reporting. AquaBounty Oragenics will keep Intrexon informed about AquaBounty’s Oragenics’ efforts to develop and Commercialize AquaBounty Oragenics Products, including reasonable and accurate summaries of AquaBounty’s Oragenics’ (and its Affiliates’ and, if applicable, (sub)licensees’) global development plans (as updated), including preclinical, clinical and regulatory plans, global marketing plans (as updated), progress towards meeting the goals and milestones in such plans and explanations of any material deviations, and significant developments in the development and/or Commercialization of the AquaBounty Oragenics Products, including initiation or completion of a regulatory clinical trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, clinical or product safety event, receipt of Regulatory Approval, regulatory approval or commercial launch, and manufacturing costs and pricing information. As set forth in Section 3.7 3.8 above, AquaBounty Oragenics shall also provide to Intrexon access to copies of all final regulatory trial preclinical protocols and reports, final clinical protocols and reports, and regulatory correspondence and filings generated by AquaBounty Oragenics as soon as practical after they become available. Intrexon will keep AquaBounty Oragenics informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for AquaBounty Oragenics 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 Aquaculture Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accordance accord with Section 4.2 above, such disclosures by AquaBounty Oragenics and Intrexon will be coordinated by the JSC and made in connection with JSC meetings at least once every six (6) months while AquaBounty Oragenics 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 (Oragenics Inc), Exclusive Channel Collaboration Agreement (Oragenics Inc)

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

Information and Reporting. AquaBounty Soligenix will keep Intrexon informed about AquaBountySoligenix’s efforts to develop and Commercialize AquaBounty Soligenix Products, including reasonable and accurate summaries of AquaBountySoligenix’s (and its Affiliates’ and, if applicable, (sub)licensees’) development plans (as updated), including 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 AquaBounty Soligenix Products, including initiation or completion of a regulatory trialRegulatory Trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, product Soligenix Product adverse safety eventevents, receipt of Regulatory Approval, or commercial launch, and manufacturing costs and pricing information. As set forth in Section 3.7 above, AquaBounty Soligenix shall also provide to Intrexon access to copies of all final regulatory trial Regulatory Trial protocols and reports, and regulatory correspondence and filings generated by AquaBounty Soligenix as soon as practical after they become available. Intrexon will keep AquaBounty Soligenix informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for AquaBounty Soligenix 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 Aquaculture Melioidosis Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accordance accord with Section 4.2 above, such disclosures by AquaBounty Soligenix and Intrexon will be coordinated by the JSC and made in connection with JSC meetings at least once every six (6) months while AquaBounty Soligenix Products are being developed or Commercialized anywhere in the world, and shall be reflected in the minutes of such meetings. 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.

Appears in 1 contract

Samples: Exclusive Channel Collaboration Agreement (Soligenix, Inc.)

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