Clinical Activities. For each R&D Project, Clinical activities-related costs shall be borne as follows:
Clinical Activities. The Licensed Technology is provided by Hythiam to Group and, by extension, Group Personnel and Group Physicians as additional points of information and not, in whole or in part, as medical advice, diagnosis or treatment recommendations. The Parties acknowledge and agree that Hythiam in performing its obligations under this Agreement is providing access to technology and technology services only and will not be delivering patient care and will not be sponsoring or performing human subjects research. Group, as between the Parties, and Group Physicians, as appropriate consistent with Laws, control and are fully responsible for any and all patient care, Continuing Care or research activity delivered by Group, Group Personnel or Group Physicians using the Licensed Technology. Group Personnel and Group Physicians shall at all times exercise their independent professional judgment when treating patients, providing Continuing Care, referring to other providers or performing research using the Licensed Technology.
Clinical Activities. Licensee will use Commercially Reasonable Efforts to continue, or support the continuation of, the clinical activities of, or on behalf of, MSK or its Affiliate with respect to any Licensed Product that are ongoing as of the Effective Date. The Parties agree that (i) clinical study protocols #95-024 and 11-130 under [ * ] will be conducted by MSK pursuant to the Clinical Trial Agreement(s) entered into by the Parties concurrently with this Agreement, and (ii) that the clinical study protocols listed on Exhibit G will be conducted by MSK pursuant to one or more Investigator Sponsored Trial Agreement(s) entered into by the Parties concurrently with this Agreement. All data and results of all clinical trials on Licensed Products conducted by or on behalf of MSK or its Affiliate at any time prior to or during the Term are included in the Licensed Tangible Materials and Licensed Know-How and are licensed exclusively to Licensee under this Agreement.
Clinical Activities. The Licensed Technology is provided by Hythiam to Hospital and/or to any Hospital Personnel or Staff Physicians as additional points of information and not, in whole or in part, as medical advice, diagnosis or treatment recommendations. The Parties acknowledge and agree that Hythiam in performing its obligations under this Agreement is providing access to technology and technology services only and will not be delivering patient care and will not be sponsoring or performing human subjects research. Hospital, as between the Parties, and/or Staff Physicians, as appropriate consistent with applicable Law, control and are fully responsible for any and all patient care, Aftercare and/or research activity delivered by Hospital, Hospital Personnel, or Staff Physicians using the Licensed Technology. Hospital Personnel and Staff Physicians shall at all times exercise their independent medical judgments when treating patients, providing Aftercare, referring to other providers, or performing research using the Licensed Technology.
Clinical Activities. The Licensed Technology is provided by Manager to PC and/or to any Medical Contractor as additional points of information and not, in whole or in part, as medical advice, diagnosis or treatment recommendations. The Parties acknowledge and agree that Manager in performing its obligations under this Agreement is providing access to technology and management and support services only and will not be delivering patient care and will not be sponsoring or performing human subjects research. PC , as between the Parties, and/or Medical Contractors, as appropriate consistent with applicable Law, control and are fully responsible for any and all patient care, Aftercare and/or research activity delivered by PC or Medical Contractors using the Licensed Technology. PC and Medical Contractors shall at all times exercise their independent medical judgments when treating patients, providing Aftercare, referring to other providers, or performing research using the Licensed Technology.
Clinical Activities. Dara shall be solely responsible for conducting, at its sole expense, the pediatric study required by the FDA under the Pediatric Research Equity Act as specifically detailed in the NDA approval. Onxeo shall provide such reasonable assistance and cooperation as may be required in order to assist Dara in the fulfillment of the foregoing and shall not seek reimbursement of any out-of-pocket costs it incurs in connection therewith. Onxeo shall provide any necessary clinical trial supplies of the Product at the prices set forth in the Supply Agreement, and Dara shall reimburse Onxeo for the out-of-pocket cost Onxeo actually incurs of any and all required modifications thereto (e.g., modified labeling or packing) , with such costs being billed as pass-through costs without markup.
Clinical Activities. Until the end of the [****], Maxygen shall not commence clinical development of any E Compound except for the Initial Indications.
Clinical Activities. Beginning on the day immediately after the Transition Completion Date, the parties agree that Inamed shall assume primary responsibility for the performance of Clinical Activities relating to the development of Hylaform, including without limitation, the Clinical Activities described in Part A-1 of Exhibit A attached hereto. Notwithstanding the assumption by Inamed of primary responsibility for the Hylaform Clinical Activities, Genzyme may exercise certain rights and perform certain activities as described in Part A-2 of Exhibit A attached hereto, and Inamed agrees to support Genzyme's exercise of those rights and activities. The parties confirm the following with respect to the Hylaform Clinical Activities:
Clinical Activities. Section 1: Duties and Rights of Inamed General • General supervision and management of all Clinical Activities in compliance with applicable regulatory requirements • By means of the Committee and the Managers, seek in a timely manner and consider in good faith the advice of Genzyme regarding all Clinical Activities • Provide to Genzyme original copies of documents and materials received, generated or used by Inamed in conducting the Clinical Activities; provided, that the parties shall mutually determine the method and timing for such delivery and reasonable exceptions to such delivery requirement to avoid undue burden for either party • Track all Development Costs incurred and paid to third parties in connection with Clinical Activities, and provide Genzyme periodically with reports regarding the same • Perform Clinical Activities substantially in accordance with GCPs and the clinical trial protocol, and consult with Genzyme in advance regarding implementation of deviations from GCPs and the clinical trial protocol • Upon written request to Genzyme, receive from Genzyme copies of all third party invoices and related back-up materials to the invoices submitted to Genzyme pursuant to the Clinical Agreements Clinical Trial • General supervision and management of all clinical activities • Management of the relationship with Celeris, Xxxxxxxx, CRL-Medinet, SRL and other vendors involved in the clinical trial; provided, that a (i) a material amendment to any contract with any vendor, or (ii) a notice of breach or a notice of termination of any contractual relationship with any vendor may not be made or issued without the prior consent of Genzyme • Management of the relationship with all investigators and related medical personnel • Remittance of all payments to vendors and investigators • Supervision of patient enrollment • Oversight of clinical site monitoring • Management (but not responsibility) of the accountability and disposition of supplies of Hylaform at the clinical trial sites in accordance with Genzyme standard operating procedures ("SOPs") • Review of all protocol deviations and protocol interpretation issues, and consult with Genzyme regarding findings relating to protocol deviations and the rationale for protocol interpretations • Consult with Genzyme regarding the outcomes of audits and other examinations of the Clinical Activities, and collaborate on resolving issues that could have an effect on Genzyme's ability to meet its regulatory obligati...
Clinical Activities. Mallinckrodt shall be responsible for obtaining all FDA and foreign equivalent approvals and conducting any activities related thereto, including but not limited to pre-clinical and clinical trials, for any indication of ALBUNEX or OPTISON, at its sole expense and as deemed technically and commercially appropriate in Mallinckrodt's sole judgment.
