Pre-Launch Commercialization definition

Pre-Launch Commercialization means, with respect to a pharmaceutical product, any and all processes and activities conducted to prepare for the successful commercial launch of such product, [ * * *].
Sample 1

Examples of Pre-Launch Commercialization in a sentence

  • Rather, the Pre-Launch Commercialization Expenses shall be distributed evenly between the [***], such that each of the [***] shall include [***] of the total Pre-Launch Commercialization Expenses.

  • Notwithstanding the foregoing in this Section 8.8, the first (1st) Quarterly N.A. Profit Report shall not contain all Pre-Launch Commercialization Expenses.

  • Although that might sound pretty simple, a good security policy encompasses many different topics and spells out in detail allowable actions that users can take as well as penalties that are imposed if inappropriate behavior occurs.

  • When approved by the applicable Regional Operating Committee (or in the case of a dispute by the Regional Operating Committee, the JEC), such separate Pre-Launch Commercialization Plan and Budget for such country shall be considered to be (i) part of the overall Pre‑Launch Commercialization Plan and Budget and overall Annual Commercialization Plan and Budget and (ii) an Approved Plan.

  • Sandoz shall have the opportunity to review the Pre-Launch Commercialization Activities and Pre-Launch Commercialization Costs and to determine which deliverables, marketing materials and other products resulting from such Pre-Launch Commercialization Activities would be useful to Sandoz in fulfilling its obligations, and exercising its rights, under this Agreement; provided, however, that [*****].

  • Such Pre-Launch Commercialization Plan and Budget for a country shall be consistent with the Pre-Launch Commercialization Plan and Budget with respect to the Region in which such country is included and approved by the applicable Regional Operating Committee.

  • Within [*****] of receipt of an invoice from Anacor for any such Pre-Launch Commercialization Costs incurred by Anacor that Sandoz agrees to reimburse pursuant to this Section 6.5, Sandoz shall reimburse Anacor for such costs.

  • The application is certified by the applicant and submitted to the University no earlier than the day of application and no later than the day of the end of receiving applications for admission.

  • The record must be examined in order to determine the significance of the missing portion.

  • The plan for the Pre-Launch Commercialization of Product for the Field in the Licensed Territory (as may be updated from time to time pursuant to Section 6.1(e), the “Pre-Launch Plan”) shall be [ * * *] of the Effective Date.

Related to Pre-Launch Commercialization

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Commercialization Plan has the meaning set forth in Section 6.2.

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

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Development Plan has the meaning set forth in Section 3.2.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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.

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • 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 III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • 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.

  • Launch means the intentional ignition of the first-stage motor(s) of the Launch Vehicle intended to place or try to place a Launch Vehicle (which may or may not include any Transfer Vehicle, Payload or crew) from Earth:

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Licensed Territory means worldwide.

  • Licensed Compound means [***].

  • 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.