Clinical Transfer Price definition

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

  • If Gilead does not dispute the Clinical Manufacturing Cost as calculated by Cubist, then [*] any difference between the Clinical Transfer Price and the Clinical Manufacturing Cost shall, within [*] after the end of such [*], pay [*] by wire transfer of immediately available funds to an account designated by such other Party.

  • Hence, semantic interoperability may be seen as an expeditious way to facilitate data interpretation.

  • Cubist's notice as to the Clinical Transfer Price and Transfer Price it proposes shall include [*] upon which [*], and shall include a [*].

  • Cubist's notice as to the Clinical Transfer Price and Transfer Price it proposes shall include [ ]* upon which [ ]*, and shall include a [ ]*.

  • 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 [***].

  • If Gilead does not dispute the Clinical Manufacturing Cost as calculated by Cubist, then [ ]* any difference between the Clinical Transfer Price and the Clinical Manufacturing Cost shall, within [ ]* after the end of such [ ]*, pay [ ]* by wire transfer of immediately available funds to an account designated by such other Party.

  • 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.


More Definitions of Clinical Transfer Price

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 [***].
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Clinical Transfer Price means the supply price calculated as set forth in the Clinical Supply Agreement.
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Related to Clinical Transfer Price

  • Transfer Price has the meaning set forth in Section 2.01.

  • Alternative nicotine product means any noncombustible product containing nicotine that is intended for human consumption, whether chewed, absorbed, dissolved, or ingested by any other means. "Alternative nicotine product" does not include any nicotine vapor product, tobacco product, or product regulated as a drug or device by the U.S. Food and Drug Administration (FDA) under Chapter V (21

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • House dust mite product means a product whose label, packaging, or accompanying literature states that the product is suitable for use against house dust mites, but does not indicate that the product is suitable for use against ants, cockroaches, or other household crawling arthropods.

  • Net Sales Price means the gross sales price to retailers of all Licensed Products sold under this Agreement or, with respect to Licensed Products that are not sold directly or indirectly to retailers, other ultimate consumers (as in the case of accommodation sales by Licensee to its employees or sales by Licensee in its own shops), less trade discounts, merchandise returns, sales tax (if separately identified and charged) and markdowns and/or chargebacks which, in accordance with generally accepted accounting principles, would normally be treated as deductions from gross sales, and which, in any event, do not include any chargebacks or the like for advertising, fixture or retail shop costs or contributions. Notwithstanding the foregoing, Licensor hereby waives its right to (i) receive royalties hereunder for, or (ii) include within the calculation of Net Sales Price for the purpose of calculating the Annual Advertising Obligation as set forth in paragraph 4.6 hereof, sales of units of Licensed Products sold at a discount of [OMITTED; MATERIAL FILED SEPARATELY WITH SECURITIES AND EXCHANGE COMMISSION] or more off the regular wholesale price ("Discounted Units"), provided that such waiver shall only apply to the extent that the aggregate Net Sales Price of Discounted Units for any year does not exceed [OMITTED; MATERIAL FILED SEPARATELY WITH SECURITIES AND EXCHANGE COMMISSION] of the Net Sales Price of all units of Licensed Products other than Discounted Units sold in such year. No other deductions shall be taken. Any merchandise returns shall be credited in the quarter in which the returns are actually made. For purposes of this Agreement, affiliates of Licensee shall mean all persons and business entities, whether corporations, partnerships, joint ventures or otherwise, which now or hereafter control, or are owned or controlled, directly or indirectly by Licensee, or are under common control with Licensee. It is the intention of the parties that royalties will be based on the bona fide wholesale prices at which Licensee sells Licensed Products to independent retailers in arms' length transactions. In the event Licensee shall sell Licensed Products to its affiliates, royalties shall be calculated on the basis of such a bona fide wholesale price irrespective of Licensee's internal accounting treatment of such sale unless such products are sold by its affiliates directly to the end-user consumer, in which case royalties shall be calculated on the basis of the price paid by the end-user consumer, less applicable taxes. Licensee shall identify separately in the statements provided to Licensor pursuant to paragraph 7 hereof, all sales to affiliates. At least once annually and no later than 90 days after the close of Licensee's fiscal year, Licensee shall furnish to Licensor a statement of the Net Sales Price of all Licensed Products sold during the year just ended, which shall be certified by the independent auditor for Licensee as correct and in accordance with the terms of this Agreement.

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • Combination Products means COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products and Quad Product.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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).

  • Supply Price has the meaning set forth in Section 6.2.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • 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.

  • Signaling Transfer Point (“STP”) means a signaling point that performs message routing functions and provides information for the routing of messages between signaling points within or between CCIS networks. A STP transmits, receives and processes CCIS messages.

  • Contract Sales Price means the total consideration received by the Company for the sale of an Investment.

  • 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, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Gross Sales Price with respect to each sale of Shares sold pursuant to this Agreement shall be the gross sales price per share of such Shares.

  • 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 has the meaning set forth in Section 7.2.1.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Basket Componenti means the respective share as specified in § 1 of the Product and Underlying Data.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.