Additional Clinical Trials definition

Additional Clinical Trials means Phase II, Phase III or any other human clinical trial testing the safety and efficacy of the Biological Materials for the treatment of peripheral artery disease.
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Additional Clinical Trials means clinical trials which are not required to obtain or maintain Regulatory Approval in any country in the Territory and that are solely for the benefit of one or more countries or regions outside the Territory, including any clinical trials or studies that are required to be conducted by the European Medicines Agency, or any successor thereto, and are not required by the FDA.
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Additional Clinical Trials means Phase II, Phase III or any other human clinical trial testing the safety and efficacy of the Biological Materials for the treatment of a peripheral neuropathy.
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Examples of Additional Clinical Trials in a sentence

  • Mylan will be primarily responsible, in collaboration with Momenta, for managing execution, and contracting with Third Parties (other than Third Parties for supply of Product) for the conduct, of Additional Clinical Trial(s) of the Products (other than M834).

  • Momenta will be primarily responsible, in collaboration with Mylan, for managing execution, and contracting with Third Parties (other than Third Parties for supply of Product) for the conduct, of pre-clinical Development Activities, Initial Clinical Trials and Additional Clinical Trial(s) for M834 and for pre-clinical Development Activities and Initial Clinical Trials for the other Products.

  • Recipient undertakes and shall ensure that similar publication and presentation procedures will be established for any Additional Clinical Trials.

  • Corautus shall permit Recipient to state in its marketing and similar materials that Recipient is Corautus’ premier clinical site in such Additional Clinical Trials if Recipient is actively participating in such Additional Clinical Trial as an investigator.

  • CSEMC will not sponsor or participate in Additional Clinical Trials other than those sponsored by CORAUTUS for so long as this Agreement is in effect.

  • On the Condition Date, the Borrower shall have paid to the Purchaser all reasonable costs, fees and expenses (including, without limitation, legal fees and expenses) payable to the Purchaser to the extent then due.

  • BCG Material for Clinical Trials During the Supply Period, PMC shall supply the BCG Material in the quantities and according to the terms set forth in Sections 2(a)(i), (ii), (iii) and (iv); provided, however, that with respect to the quantities and terms set forth in Section 2(a)(iii) and (iv), PMC shall only be required to use reasonable commercial efforts to make available to Recipient such BCG Material as may be requested for the Additional Clinical Trials.

  • In support of the Additional Clinical Trials sponsored by CORAUTUS and for the purpose of seeking Approval, CSEMC shall permit CORAUTUS to use, access and reference the CSEMC Research Study Data, and CSEMC will promptly advise the FDA in writing of such rights of reference and access when requested by CORAUTUS.

  • Status of Recipient ImClone and Merck are conducting the SILV▇ ▇▇▇al and any Additional Clinical Trials together, and will receive supplies of the BCG Material together or independently for the sole purpose of conducting the SILV▇ ▇▇▇al and the Additional Clinical Trials (the SILV▇ ▇▇▇al and the Additional Clinical Trials are collectively referred to herein as the "CLINICAL TRIALS").

  • ImClone and Merck are interested in securing a supply of the BCG Material to be administered with BEC2 in the ▇▇▇▇▇ Trial and any such Additional Clinical Trials, and PMC is willing to supply the BCG Material to ImClone and Merck on the terms set forth herein.

Related to Additional Clinical Trials

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase 1 Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial in humans of the safety of such product in healthy volunteers or a limited patient population, or human clinical studies directed toward understanding the mechanisms or metabolism of the product. A Phase 1 Clinical Trial shall be deemed initiated upon the dosing of the first subject or patient.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.