Information and Reporting. Synthetic will keep Intrexon informed about Synthetic’s efforts to develop and commercialize Synthetic Products, including reasonable and accurate summaries of Synthetic’s (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 Synthetic 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. As set forth in Section 3.8 above, Synthetic 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 Synthetic as soon 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. as practical after they become available. Intrexon will keep Synthetic informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Synthetic 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 Anti-Infectives Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein, such disclosures by Synthetic and Intrexon will be made in the course of JSC meetings at least once every six (6) months while Synthetic 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. Synthetic will keep Intrexon informed about Synthetic’s efforts to develop and commercialize Synthetic Commercialize Collaboration Products, including reasonable and accurate summaries of Synthetic’s (and its Affiliates’ and, if applicable, (sub)licensees’) global development plans (as updated)) for Collaboration Products, 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 Synthetic Collaboration 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 Approvalregulatory approval, or commercial launch. As set forth in Section 3.8 above, Synthetic 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 Synthetic as soon as practical after they become available. Intrexon will keep Synthetic informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Collaboration 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 Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein, such disclosures by Synthetic and Intrexon will be coordinated by the JSC and made in connection with JSC meetings at least once every six (6) months while Collaboration 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. as practical after they become available. Intrexon will keep Synthetic informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Synthetic 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 Anti-Infectives Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein, such disclosures by Synthetic and Intrexon will be made in the course of JSC meetings at least once every six (6) months while Synthetic 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 (Synthetic Biologics, Inc.)
Information and Reporting. Synthetic BioLife will keep Intrexon informed about SyntheticBioLife’s efforts to develop and and, upon successful execution by BioLife of its option under Section 5.1, commercialize Synthetic BioLife Products, including reasonable and accurate summaries of SyntheticPortions 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. BioLife’s (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 Synthetic BioLife 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. As set forth in Section 3.8 above, Synthetic BioLife 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 Synthetic BioLife as soon 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. as practical after they become available. Intrexon will keep Synthetic BioLife informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Synthetic BioLife 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 Anti-Infectives SMA Therapeutics Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein, such disclosures by Synthetic BioLife and Intrexon will be made in the course of JSC meetings at least once every six (6) months while Synthetic BioLife 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 Research Collaboration Agreement (Intrexon Corp)
Information and Reporting. Synthetic Oragenics will keep Intrexon informed about Synthetic’s Oragenics’ efforts to develop and commercialize Synthetic Oragenics Products, including reasonable and accurate summaries of Synthetic’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 Synthetic Oragenics 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. As set forth in Section 3.8 above, Synthetic Oragenics 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 Synthetic Oragenics as soon 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. as practical after they become available. Intrexon will keep Synthetic Oragenics informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Synthetic 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 Anti-Infectives Lantibiotics Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein, such disclosures by Synthetic Oragenics and Intrexon will be made in the course of JSC meetings at least once every six (6) months while Synthetic Oragenics Products are being developed or commercialized anywhere in the world, and shall be reflected in the minutes of such meetings.
Appears in 1 contract
Information and Reporting. Synthetic Oragenics will keep Intrexon EGI informed about Synthetic’s Oragenics’ efforts to develop and commercialize Synthetic Oragenics Products, including reasonable and accurate summaries of Synthetic’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 Synthetic Oragenics 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. As set forth in Section 3.8 above, Synthetic Oragenics shall also provide to Intrexon EGI copies of all final preclinical protocols and reports, final clinical protocols and reports, and regulatory correspondence and filings generated by Synthetic Oragenics as soon 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. as practical after they become available. Intrexon EGI will keep Synthetic Oragenics informed about IntrexonEGI’s efforts (a) to establish manufacturing capabilities and facilities for Synthetic Oragenics Products (and Intrexon EGI Materials relevant thereto) and otherwise perform its manufacturing responsibilities under Section 4.6 and (b) to undertake discovery-stage research for the Anti-Infectives Lantibiotics Program with respect to the Intrexon EGI Channel Technology and Intrexon EGI Materials. Unless otherwise provided herein, such disclosures by Synthetic Oragenics and Intrexon EGI will be made in the course of JSC meetings at least once every six (6) months while Synthetic Oragenics 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 (Oragenics Inc)
Information and Reporting. Synthetic will keep Intrexon informed about Synthetic’s efforts to develop and commercialize Synthetic Products, including reasonable and accurate summaries of Synthetic’s (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 Synthetic 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. As set forth in Section 3.8 above, Synthetic 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 Synthetic as soon 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. as practical after they become available. Intrexon will keep Synthetic informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Synthetic 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 Anti-Infectives Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein, such disclosures by Synthetic and Intrexon will be made in the course of JSC meetings at least once every six (6) months while Synthetic 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: Collaboration Agreement (Synthetic Biologics, Inc.)
Information and Reporting. Synthetic Fibrocell will keep Intrexon informed about SyntheticFibrocell’s efforts to develop and commercialize Synthetic Commercialize Collaboration Products, including reasonable and accurate summaries of SyntheticFibrocell’s (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 Commercialization of the Synthetic Collaboration 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 Approvalregulatory approval, or commercial launch, and manufacturing and pricing information. As set forth in Section 3.8 above, Synthetic 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 Synthetic Fibrocell as soon 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. as practical after they become available. Intrexon will keep Synthetic Fibrocell informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Synthetic Collaboration 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 Anti-Infectives Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided hereinherein or directed by the JSC in accordance with Section 4.2 above, such disclosures by Synthetic Fibrocell and Intrexon will be made in the course of JSC meetings at least once every six (6) months while Synthetic Collaboration Products are being developed or commercialized Commercialized anywhere in the world, and shall be reflected in the minutes of such meetings.
Appears in 1 contract
Samples: Channel Collaboration Agreement (Fibrocell Science, Inc.)