Conduct of Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package were and, if still pending, are being conducted in compliance with all applicable current Good Laboratory Practices and Good Clinical Practices in all material respects. The descriptions of the studies, tests and preclinical and clinical trials, including the related results and regulatory status, contained in the General Disclosure Package are accurate in all material respects. Except as described in the General Disclosure Package, the Company has not received any notices, correspondence or other communication from the FDA or other governmental agency requiring the termination or suspension of any clinical trials conducted by, or on behalf of, the Company or in which the Company has participated.
Conduct of Clinical Trials. All clinical studies conducted by or on behalf of the Company that are material to the Company, taken as a whole, are described in the General Disclosure Package. To the Company’s knowledge, after reasonable inquiry, the clinical studies conducted by or on behalf of the Company that are described in the General Disclosure Package or the results of which are referred to in the General Disclosure Package were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to clinical studies from which data will be submitted to support marketing approval. The descriptions in the General Disclosure Package of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study, the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the General Disclosure Package or the results of which are referred to in the General Disclosure Package. Except as disclosed in the General Disclosure Package, the Company has not received any written notices or statements from the United States Food and Drug Administration (the “FDA”), the European Medicines Agency (“EMEA”) or any other governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical studies that are described in the General Disclosure Package or the results of which are referred to in the General Disclosure Package.
Conduct of Clinical Trials. 5.3.1 Novartis may conduct the activities set forth in any development plan with respect to a Dose Ranging Clinical Trial, a Drug-Drug Interaction Study or an HCV Combination Clinical Trial involving an Idenix HCV Product described in Section 5.2 (and any ancillary activities reasonably related thereto), and Novartis shall be solely responsible for such activities and all costs and expenses associated therewith; provided, that (a) if permitted by applicable Law, at Novartis’ election, a separate IND may be filed by Novartis to conduct such study(ies) or if not so permitted or Novartis does not so elect, Novartis shall be entitled to rely on and reference any IND held by Idenix or its Affiliates with respect to the applicable Idenix HCV Product and only for the purposes of conducting the relevant study(ies); (b) without limiting the foregoing clause (a), Idenix hereby grants Novartis a right of reference to its regulatory filings made in connection with the applicable Idenix HCV Product, solely for purposes of Novartis’ regulatory filings in connection with such study(ies) and the Development, Manufacture and/or Commercialization of any Novartis HCV Product which is the subject of such study(ies), and Idenix agrees to use Commercially Reasonable Efforts to assist Novartis, at Novartis’ reasonable request and expense, with respect to such regulatory filings; (c) Idenix, at its sole expense, shall provide Novartis with analytical support in any Drug-Drug Interaction Study(ies) of the relevant Idenix HCV Product with the relevant Novartis HCV Product; (d) Idenix shall provide Novartis with copies of the investigator brochure for such Idenix HCV Product; (e) Idenix shall promptly, on request, provide Novartis with copies of all correspondence with Regulatory Authorities (other than (i) commercially sensitive information, (ii) trade secrets and (iii) other information which is not applicable or relevant to the use of the relevant Idenix HCV Product) relating to such Idenix HCV Product; (f) Idenix shall promptly, upon request, provide Novartis with relevant data from prior clinical trials involving the relevant Idenix HCV Product (other than (i) commercially sensitive information, (ii) trade secrets and (iii) other information which is not applicable or relevant to the use of such Idenix HCV Product), including reports sent to any data and safety monitoring board; (g) Idenix shall otherwise use Commercially Reasonable Efforts to assist Novartis, at Novartis’ reas...
Conduct of Clinical Trials. Bio-Management, its licensees or sublicensees shall use its best efforts to conduct, as soon as commercially practicable, such human clinical trials as are necessary or desirable to obtain all regulatory approvals to develop and commercialize in the U.S. each Product for which an IND has been filed.
Conduct of Clinical Trials. All preclinical and clinical studies conducted by or on behalf of the Company or any Subsidiary that are material to the Company and its Subsidiaries, taken as a whole, are described in the Registration Statement, the General Disclosure Package and the Prospectus. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company and any Subsidiary that are described in the Registration Statement, the General Disclosure Package or the Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the General Disclosure Package and the Prospectus of the results of such studies do not contain any misstatement of a material fact or omit to state any material facts necessary to make such descriptions not misleading and fairly present the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company or any Subsidiary that are described in the Registration Statement, the General Disclosure Package or the Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Prospectus. Except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the United States Food and Drug Administration (the “FDA”), the European Medicines Agency (“EMEA”) or any other governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the General Disclosure Package or the Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Prospectus.
Conduct of Clinical Trials. All clinical studies conducted by or on behalf of the Company or any Subsidiary that are material to the Company and the Subsidiaries, taken as a whole, are described in the Prospectus. To the Company’s knowledge, after reasonable inquiry, the clinical studies conducted by or on behalf of the Company or any Subsidiary that are described in the Prospectus or the results of which are referred to in the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to clinical studies from which data will be submitted to support marketing approval. The descriptions in the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study, the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company or any Subsidiary that are described in the Prospectus or the results of which are referred to in the Prospectus. Except as disclosed in the Prospectus, the Company has not received any written notices or statements from the United States Food and Drug Administration (the “FDA”), the European Medicines Agency (“EMEA”) or any other governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical studies that are described in the Prospectus or the results of which are referred to in the Prospectus.
Conduct of Clinical Trials. Sanofi shall act as the sponsor of any clinical trial conducted pursuant to the Development Plan, provided that Sanofi shall consider in good faith whether to use Biontech’s resources in regions where such internal resources are available [***] and whether in certain circumstances Biontech shall be the co-sponsor or sponsor of selected clinical trials. The Party acting as sponsor (or co-sponsor, as applicable) shall ensure that any such clinical trial (for which it is sponsor (or co-sponsor, as applicable)) is performed in accordance with this Agreement, the applicable protocol and Applicable Law, and the other Party shall provide such Party with any assistance as reasonably requested by such Party, in order for such Party to fulfil its obligations as sponsor (or co-sponsor) of such clinical trial. Each Party shall mention or list the other Party as collaborator (e.g. “in collaboration with BioNTech RNA Pharmaceuticals GmbH” or “in collaboration with Sanofi”, as applicable)) (and the other Party hereby agrees to such mention or listing) in the relevant clinical trial databases and registers (e.
Conduct of Clinical Trials. 14.1.1 STOCOSIL shall be responsible for conducting and funding, in its sole direction, all Phase III Clinical Trials for the Product and/or Optional Product in the Territory.
14.1.2 Unless otherwise agreed by the Parties or required by Applicable Law, STOCOSIL shall own all data and reports related to Clinical Studies in the Territory. All data, database information and safety reports from such Clinical Trials in the Territory for the Product and/or Optional Product shall be centralised and held by STOCOSIL with copies of such data, information or reports provided to DAEWOONG to the extent required as contemplated in this Agreement or the Development Plan to support application for Marketing Authorization outside of the Territory.
Conduct of Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus, to the actual knowledge of the Company, were and, if still pending, are being conducted in compliance with all applicable current good laboratory practices and good clinical practices in all material respects. The descriptions of the studies, tests and preclinical and clinical trials, including the related results and regulatory status, contained in the General Disclosure Package or the Final Prospectus are accurate in all material respects. The Company has not received any written notices, correspondence or other communication from the FDA or other governmental agency requiring the termination or suspension of any clinical trials conducted by, or on behalf of, the Company or in which the Company has participated.
Conduct of Clinical Trials. MRK shall have the sole discretion as to whether to conduct any Clinical Trials with respect to the Drug required for a Project. MRK shall be solely responsible for the cost of such Clinical Trials.
