Initial Commercial Sale definition

Initial Commercial Sale means the first commercial sale of a Product *
Sample 1Sample 2Sample 3
Initial Commercial Sale means the first sale for use or consumption by the general public of the Licensed Product by PAR or its Affiliates in the Territory following Regulatory Approval of the Licensed Product. Sales for clinical studies, compassionate use, named patient programs, sales under a treatment IND, test marketing, any nonregistrational studies, or any similar instance where the Licensed Product is supplied without charge shall not constitute an Initial Commercial Sale.
Sample 1Sample 2
Initial Commercial Sale means, with respect to a Product in any country in the world, the first sale, for use or consumption by the general public, of such Product in such country by a member of the Buyer Right Chain Group after the granting of Regulatory Approval of such Product in such country.
Sample 1Sample 2

Examples of Initial Commercial Sale in a sentence

  • In addition, such insurance coverage shall include product liability coverage in an amount not less than that commensurate with industry standards for similar products, to be in place prior to the Initial Commercial Sale and for the remainder of the Term.

  • In addition to the milestone payments set forth above in Section 6.2, following the Initial Commercial Sale of the Product, in respect of any Contract Year, Par shall pay to Alfacell an amount equal to (i) *** (amounts owed to Alfacell pursuant to this Section 6.3(a), the “Royalty”).

  • As a result, many students do not acquire information of transaction floors or the information does not meet requirements of vocational students.

  • Pursuant to the Representative Agreement, McGovern is entitled to receive a fee of three percent (3%) of “Net Revenues” received by the Company’s from sales of the Company’s Products in the People’s Republic of China for a period of four years from Initial Commercial Sale (which was September 1, 2017).

  • Par shall use Commercially Reasonable Efforts to achieve an Initial Commercial Sale within *** after Alfacell obtains Regulatory Approval for the Primary UMM Indication, Secondary UMM Indication and/or any Future Indication (as applicable).

  • In addition, following the Initial Commercial Sale, Par shall (if it has not theretofore) employ or engage a sales training manager (such position may be filled by an employee or a consultant experienced in oncology) and a reimbursement specialist (who shall be knowledgeable about Part B).

  • Par shall utilize proactive and continuous Product Commercialization efforts (which may be subject to factors that are beyond the reasonable control of Par) by Par during the first *** after Initial Commercial Sale to advance the objectives and optimize the financial returns of both Parties under this Agreement (i.e., during such ***, Par shall not cease Commercializing, or engage in di minimis Commercialization of, the Product).

  • As of the Effective Date, Par intends on or before the Initial Commercial Sale to assign a dedicated product manager for Commercialization of the Product.

  • For Sale prior to Initial Commercial Sale - Prior to launch, the price of Substance shall be LJP's Fully Burdened Manufacturing Cost as specified in Appendix C, which will then be adjusted as specified in Section 8 of this Supply Agreement, Appendix G.

  • After the Initial Commercial Sale, the price of Substance sold for commercial sale anywhere in the Territory to Abboxx xx LJP shall be ***.


More Definitions of Initial Commercial Sale

Initial Commercial Sale means the first sale of the Product by Par or a Sub-distributor to a Third Party in the Field in the Territory following Regulatory Approval for the Primary UMM Indication, the Secondary UMM Indication or a Future Indication (whichever Indication is approved for the first Product sale in the Territory).
Sample 1Sample 2
Initial Commercial Sale means the first sale of the Product by Par or an Affiliate in the Territory following Regulatory Approval of the Product.
Sample 1
Initial Commercial Sale means the first commercial sale by Abbott, or any Abbott Affiliate of Product to any third party customer.
Sample 1
Initial Commercial Sale means the first commercial sale of a Product in the Field * Section 1.16 "Licensed Territory" and "Asian Licensed Territory" shall have the following meanings:
Sample 1

Related to Initial Commercial Sale

  • Commercial Sale means for a given product and country the sale for value of that product by a Party (or, as the case may be, by an Affiliate or permitted sublicensee of a Party), to a Third Party after regulatory approval (if necessary) has been obtained for such product in such country.

  • First Commercial Sale means, with respect to any Licensed Product, the first sale for use or consumption by the general public of such Licensed Product in any country in the Territory after Approval of such Licensed Product has been granted, or such marketing and sale is otherwise permitted, by the Regulatory Authority of such country.

  • Commencement of Commercial Production means: (i) if a mill is located on the Property, the last day of a period of 40 consecutive days in which, for not less than 30 days, the mill processed ore from the Property at 60% of its rated concentrating capacity; or (ii) if a mill is not located on the Property, the last day of a period of 30 consecutive days during which ore has been shipped from the Property on a reasonably regular basis for the purpose of earning revenues, but any period of time during which ore or concentrate is shipped from the Property for testing purposes, or during which milling operations are undertaken as initial tune-up, shall not be taken into account in determining the date of Commencement of Commercial Production;

  • Commercial Launch means the initial First Commercial Sale of a Product in the Territory.

  • Commercial Product means any such product as defined in FAR 2.101.

  • Offering Commencement Date means the first day of each Offering Period.

  • Commercial Production means the operation of the Property or any portion thereof as a producing mine and the production of mineral products therefrom (excluding bulk sampling, pilot plant or test operations);

  • Initial Sale is defined in the recitals of this Agreement.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • 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 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.

  • Date of Commercial Operation means the date on which the (nuclear or non-nuclear) power plant has successfully passed all performance and operational tests required by the end customer for commercial operation. In all other cases the warranty shall apply for twenty-four (24) months from delivery of the goods or performance of the services, or such longer period of time as customarily provided by Supplier, plus delays such as those due to non-conforming goods and services. The warranties shall apply to Buyer, its successors, assigns and the users of goods and services covered by this Order.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • 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.

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • 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 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 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.

  • 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).

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

  • 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.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Major Market Country means one or more of the following: Canada, France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom, and United States of America.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Development Milestone Event has the meaning set forth in Section 7.2.1.