Clinical Transfer Price definition

Clinical Transfer Price is defined in Section 10.3.
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Clinical Transfer Price shall have the meaning assigned such term in Section 7.2.
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Clinical Transfer Price has the meaning set forth in Section 5.1.
Sample 1

Examples of Clinical Transfer Price in a sentence

  • Prior to the First Commercial Sale, RPI will manufacture Exogenous Ribozymes for the requirements of Schering for (i) research purposes as ordered by Schering at a price equal to [ ] ("Research Transfer Price") [ ] (ii) clinical purposes as ordered by Schering at a price equal to [ ] per vial ("Clinical Transfer Price").

  • The Clinical Transfer Price shall be deemed to include the final form of the product and final packaging as described in the IND.

  • The R&D Budget shall specify the estimated costs and expenses of Development (including external and internal, and notably CMC development costs) for the relevant Collaboration Product in each Calendar Year of the corresponding R&D Term, including the Clinical Transfer Price and all Logistics Costs.

  • As soon as practicable following the execution of this Agreement, the Parties will enter into a clinical supply agreement (the “Clinical Supply Agreement”), substantially in the form attached as Schedule 6.2.1 of this Agreement (with such changes as the Parties may mutually agree to), pursuant to which CymaBay will supply Kaken’s and its Related Parties’ clinical requirements of [***] for the Licensed Products for the Kaken Territory for the Field of Use at the Clinical Transfer Price [***] and at [***].


More Definitions of Clinical Transfer Price

Clinical Transfer Price means the supply price calculated as set forth in the Clinical Supply Agreement.
Sample 1
Clinical Transfer Price means, with respect to each Collaboration Product the price agreed by the Parties and set forth in the Clinical Supply Agreement. For the avoidance of doubt, the Clinical Transfer Price shall include [***] as well as [***] and/or [***], and the [***]; and shall exclude [***] and [***].
Sample 1

Related to Clinical Transfer Price

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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 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 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.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Major Market Country means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.