Clinical Development. Licensee will have sole responsibility for and sole decision making over the clinical development of any Product arising from the Research Program in the Field. Notwithstanding the foregoing, if Licensee wishes to conduct clinical development of a Development Candidate at Penn and Penn has the clinical expertise, interest and ability to run such a trial as assessed at Penn’s sole discretion, such a study will be conducted under a separate Clinical Trial Agreement to be negotiated by the Parties prior to initiation of such study. Such separate clinical trial agreement will include a detailed clinical development plan, including costs and time lines for conducting the Clinical Trial.
Clinical Development. Copies of the following items that are Controlled by NOVARTIS, its Affiliates or the University of Minnesota (in the case of the University of Minnesota, in NOVARTIS’ possession) in each case below, solely as they relate to the HemOnc IND and the IMD IND:
Clinical Development. (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.
Clinical Development. Licensee will have sole responsibility for and sole decision making over the clinical development of the Licensed Products arising from the Research Program or otherwise developed by or on behalf of Licensee or any of its Sublicensees, in each case, in the Field.
Clinical Development. GSK shall be solely responsible for, and shall use Commercially Reasonable Efforts to conduct and fund [***] of the clinical development of the Compound and any Backup Compound and the development and manufacture of all Products for the Atopic Dermatitis Indication and the Psoriasis Indication in (i) the Ex-China Territory after the First Closing and (ii) if the Second Closing occurs in accordance with this Agreement, the China Territory after the Second Closing. GSK shall, not less than once every [***], provide to Welichem a written report in summary form describing the efforts, and results of its efforts, to develop the Compound in accordance with the Development Plan. Such written report shall include a summary of any material changes made to the Development Plan.
Clinical Development. DISTRIBUTOR shall not initiate, sponsor or support any structured data collection schemes involving any Product, including but not limited to:
Clinical Development. AEVI will develop a clinical development strategy for the Field in the Territory. Each Development Plan will be consistent with such clinical development strategy. AEVI will conduct clinical Development for Licensed Product in the Field in the Territory as necessary for preparing and submitting Regulatory Approval Applications in Field in the Territory.
Clinical Development. Except as disclosed in the Registration Statement and the Prospectus, none of the Company’s product candidates have received marketing approval from any Applicable Regulatory Authority. All clinical and pre-clinical studies and trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, to the Company’s knowledge, being conducted in all material respects in accordance with all applicable Health Care Laws of the Applicable Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions in the Registration Statement and the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; the Company has no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus; the Company has not received any written notices, correspondence or other communications from the Applicable Regulatory Authorities or any other governmental entity requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, no investigational new drug application or comparable submission filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA or any other Applicable Regulatory Authority. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial. To the Company’s knowledge, none of...
Clinical Development. During the term of this Agreement, Medtronic shall have overall control and responsibility, at its sole expense and discretion, for the clinical and regulatory development of Medtronic Licensed Products in the Field, including without limitation all human clinical trials involving the Medtronic Licensed Products in the Field and
Clinical Development. Subject to the terms of this Agreement, Cara shall be responsible for: (a) conducting all clinical development and other studies that is needed in order to obtain or maintain Regulatory Approvals of the Licensed Products in the United States reasonably in accordance with the development timeline in the Exhibition C established by Cara, and (b) providing CKD with all the Regulatory Documents submitted to FDA and needed in order to obtain Regulatory Approvals of Licensed Products in the Territory. Cara shall use Commercially Reasonable Efforts to conduct such development and studies. CKD shall be responsible for conducting all additional clinical development and other studies in the Territory on Licensed Products that is needed in order to obtain or maintain Regulatory Approvals of Licensed Products in the Territory, to the extent that such additional clinical trial(s) are needed in order to obtain Regulatory Approval of Licensed Products on the basis of CKD’s strategy of development and commercialization in the Territory. In this case, CKD shall conduct all such clinical trials and other studies on Licensed Product strictly in accordance with a clinical plan and study protocols reviewed and approved by Cara. CKD shall keep Cara fully informed of the progress of all such work and trials on Licensed Product conducted by or on behalf of CKD, and shall disclose all data, results and other Information generated, made or identified in any such work or trials. Cara shall have the full rights to use (and to license its other licensees to use) all such Information for all purposes relating to research, development and/or Commercialization of Licensed Products outside the Territory except upon termination of this Agreement pursuant to Section 11.2(c). To facilitate the foregoing, CKD will provide Cara accurate and complete English translations, at CKD’s costs and expenses for translation, of a summary of all such plans and protocols, and all Information generated in such work or trials. Pursuant to the disclosures under Section 3.1 above, Cara shall keep CKD reasonably informed of the progress and results of Cara’s development work on Licensed Product, to the extent needed by CKD for its obtaining or maintaining Regulatory Approval in the Territory, and shall disclose all data made from such trials to the extent needed by CKD for such Regulatory Approval. CKD shall have the rights to use such Licensed Know-How as permitted in Section 2.1.
