Additional Clinical Trial definition

Additional Clinical Trial has the meaning set forth in Section 3.2.2(c).
View Source
Additional Clinical Trial means a controlled clinical trial of a Product in human patients to generate safety, efficacy or clinical immunogenicity data to demonstrate that such Product is highly similar to its Reference Product and to demonstrate safety, purity, and potency of such Product, in the proposed therapeutic indication, which information is sufficient to support the filing for Regulatory Approval under Section 351(k) of the PHS Act, or corresponding laws or their implementing regulations in other countries within the Territory. For clarity, an Additional Clinical Trial may be conducted using a single dose or regimen or multiple doses or regimens, as appropriate, and such Additional Clinical Trial may be conducted at multiple centers. The Additional Clinical Trial shall be designed to be a pivotal study or, when appropriate outside the United States, a Phase 3 clinical trial, for such Product.
View Source
Additional Clinical Trial means a controlled clinical trial of a Product in human patients to generate safety, efficacy or clinical immunogenicity data to demonstrate that such Product is highly similar to its Reference Product and to demonstrate safety, purity, and potency of such Product, in the proposed therapeutic indication, which information is sufficient to support the filing for Regulatory Approval under Section 351(k) of the PHS Act, or corresponding laws or their implementing regulations in other countries within the Territory. For clarity, an Additional Clinical Trial may be conducted using a single dose or regimen or multiple doses or regimens, as appropriate, and such Additional Clinical Trial may be conducted at multiple centers. The Additional Clinical Trial shall be designed to be a pivotal study or, when appropriate outside the United States, a Phase 3 clinical trial, for such Product. Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.
View Source

Examples of Additional Clinical Trial in a sentence

  • Notwithstanding the foregoing, in no event will Purchaser use a price quoted by AAI DS to solicit competitive bids for Additional Clinical Trial Services.

  • If a Party elects to terminate the Agreement with respect to a Product at any time following the first dosing in humans in an Additional Clinical Trial for such Product, such Party shall provide [***] prior written notice to the other Party.

  • Notwithstanding the foregoing, because the details, timing and conditions of any Additional Clinical Trial cannot be predicted, Corautus shall not be obligated to Recipient as a clinical site for, and Recipient shall not be obligated to participate as a clinical site in any Additional Clinical Trial.

  • 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.

  • If Novartis intended to use its supply or manufacture Licensed Compound and/or Licensed Product for such Additional Clinical Trial, BeiGene and Novartis will enter into a clinical trial collaboration agreement (a “CTCA”) on terms substantially similar to the CTCSA (other than supply by ▇▇▇▇▇▇▇) in a form to be negotiated by the Parties in good faith within […***…] after the execution of this Agreement.

  • If a Party elects to terminate the Agreement with respect to a Product at any time following the first dosing in humans in an Additional Clinical Trial for such Product, such Party shall provide [***] ([***]) [***] prior written notice to the other Party.

  • For a period of five years from the Effective Date, the Parties agree that they will cooperate in good faith to provide CSEMC with the opportunity to be a primary clinical site in any Additional Clinical Trial, subject to applicable law and reasonable qualifications.

  • For clarity, Global Additional Development does not include any Additional Clinical Trial or other Development that is required solely by a Regulatory Authority or Applicable Laws for obtaining Regulatory Approval in one Party’s territory and is not required by Regulatory Authorities or Applicable Laws for obtaining Regulatory Approvals both within and outside the Territory.

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

  • Notwithstanding the foregoing, because the details, timing and conditions of any Additional Clinical Trial cannot be predicted, Corautus shall not be obligated to CSEMC as a clinical site for, and CSEMC shall not be obligated to participate as a clinical site in any Additional Clinical Trial.