Clinical Activities. For each R&D Project, Clinical activities-related costs shall be borne as follows:
4.4.2.1. All expenses (internal and external costs) incurred by the Parties in the performance of R&D Project clinical activities shall be exclusively borne by GenSight;
4.4.2.2. GenSight shall bear all costs (internal and external) for the manufacture of all GMP batches of Product other than any GMP preclinical toxicology batch(es), and the initial GMP batch for Phase 1 studies manufactured by Genethon, at Genethon’s costs, as contemplated above. The Parties shall negotiate diligently and in good faith a specific contract, under commercially reasonable terms, to cover the manufacture of these GMP batches of Product which shall, among other things, specify the price thereof.
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. 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:
(1) Inamed (in the name of Inamed or its Affiliates) shall be responsible for the overall management of the Hylaform clinical trial, including supervision of any third party contract research organizations, investigators and site monitors;
(2) Inamed shall be responsible for the management and analysis of data resulting from the Hylaform clinical trial, including supervision of a third party reviewers, biostatisticians and other persons participating in the organization and analysis of the clinical trial; and
(3) Inamed shall be responsible for the drafting of the final clinical study report for the Hylaform trial and for the delivery to Genzyme of other information generated from the clinical trial that is necessary or useful to complete the Filings.
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 Original Effective Date. The Parties agree that 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. 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. Until the end of the [****], Maxygen shall not commence clinical development of any E Compound except for the Initial Indications.
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. The Executive may provide clinical patient care in a manner that requires less of a time commitment than the five hours per week that the Executive previously provided during his prior tenure as President and Chief Operating Officer of the Company.
