Pivotal Clinical Trials definition

Pivotal Clinical Trials means clinical trials which when completed will have demonstrated that the Product(s) (i) is safe and efficacious, (ii) has an established dose, (iii) has an established route of administration and (iv) has a treatment schedule in the target population, all sufficient for the purpose of supporting a Drug Approval Application.

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Pivotal Clinical Trials means that portion of the clinical development program that provides for the expanded controlled, pivotal Phase III (or foreign equivalent) human clinical trials, performed after preliminary evidence suggesting effectiveness of a Product has been obtained, which are intended to gather the additional information about the effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of such Product and to provide adequate basis for labeling, in accordance with the appropriate governmental and institutional regulatory authorities.

Pivotal Clinical Trials means clinical trials which when completed will have demonstrated that the Ribozyme Product(s) and Non-Ribozyme Product(s) (i) are safe and efficacious, (ii) have an established dose, (iii) have an established route of administration and (iv) have a treatment schedule in the target population, all sufficient for the purpose of supporting a Drug Approval Application.

Examples of Pivotal Clinical Trials in a sentence

Unless otherwise agreed by the Parties, Pivotal Clinical Trial(s) conducted pursuant to each Development Plan shall be designed so that such Pivotal Clinical Trial(s), to the extent reasonably possible, satisfy regulatory requirements in both the United States and Europe.
The potential supply of Cas9 mRNA Constructs required for use by CRISPR its Affiliates and Sublicensees for Pivotal Clinical Trials and Commercial supply and a technology transfer in the event CureVac will not supply such Cas9 mRNA Constructs is set forth in the Manufacturing Services Agreement.
If, during the Term of this Agreement, Centocor requests in writing that ImmunoGen supply it with Clinical Materials in connection with the conduct of Pivotal Clinical Trials, ImmunoGen will supply Centocor with such Clinical Materials only to the extent ImmunoGen has the capability to do so at the time of Centocor’s request.
In this case, if LICENSOR is not appointed by TG for Manufacturing and supply of LFB R603, TG shall pay to LICENSOR the extra-royalty under section 7.3.4 For the sake of clarity, if LICENSOR provides, directly or indirectly, the supply of LFB R603 for Pivotal Clinical Trials, LICENSOR or its Affiliates shall have the exclusive right and responsibility to provide Manufacturing services to TG and Manufacture and supply LFB R603 as required for the Commercialization in the Territory.
Each Grantor shall, if so requested by the Collateral Agent, furnish to the Collateral Agent upon reasonable request, statements and schedules further identifying and describing the Collateral and such other reports in connection with the Collateral as the Collateral Agent may reasonably request, all in reasonable detail.
Unless otherwise agreed by the Parties, with respect to a Shared Development Program, Pivotal Clinical Trial(s) conducted pursuant to each Development Plan shall be designed so that such Pivotal Clinical Trial(s), to the extent reasonably possible, satisfy regulatory requirements in both the United States and Europe.
SDI shall finish doing so for each Licensed Product prior to Avigen commencing any Pivotal Clinical Trial(s) of such Licensed Product that Avigen may undertake.
Currently (as of the Commencement Date), Pivotal Clinical Trials of an IR Product are expected to commence no earlier than [*] However, these dates are not binding.
If the Project Representatives agree to the filing of a protocol for a Pivotal Clinical Trial of the Product for a non- hematologic indication, Genzyme shall fund all commercially reasonable Development Costs relating to Pivotal Clinical Trials and NDA filing for that indication.
Avigen may require updates to the Specifications for each Licensed Product prior to Avigen’s Pivotal Clinical Trials of each Licensed Product or prior to NDA submission or in response to an FDA requirement to approve the NDA.

More Definitions of Pivotal Clinical Trials

Pivotal Clinical Trials means adequate and well-controlled clinical trials (as defined in 21 C.F.R. § 314.126, as amended from time to time, or corresponding regulations in jurisdictions other than the United States) that are designed to demonstrate the effectiveness of a Product in certain indications necessary for obtaining Regulatory Approval, including clinical trials which: (a) prove substantial evidence of effectiveness; (b) prospectively evaluate an important safety endpoint; or (c) have the ability to generate product labeling that defines an appropriate patient population and provides adequate information to enable safe and effective use of the Product. For the avoidance of doubt, a Phase III Clinical Trial shall always be deemed to be a Pivotal Clinical Trial.

Pivotal Clinical Trials means the final or pivotal phase of human ----------------------- clinical trials of a drug or biologic product required by the FDA and intended to serve as the basis for an NDA or PLA filing.