Initial Commercial Sale definition

Initial Commercial Sale means the first commercial sale of a Product *
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Initial Commercial Sale means the first sale for use or consumption by the general public of the Licensed Product by Licensee or its Affiliates or Sublicensee 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.
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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).
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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.

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

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

  • 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).

  • 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).

  • Pursuant to the Representative Agreement, McGovern is entitled to receive a fee of three percent (3%) of "Net Revenues” received by the Company 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).

  • Section 5.1 Buffer Stock Beginning on the date that is [****] months prior to the anticipated date of the Initial Commercial Sale, Immtech shall have available (including as a result of Product Manufactured by any Second Source Facility, as defined below) a buffer stock of Product for supply to BioAlliance (the “Buffer Stock”), as determined by mutual agreement of the parties.

  • Subject to the foregoing, each Party shall have in place prior to the Initial Commercial Sale product liability insurance coverage in an amount of not less than *** million US dollars ($***) per occurrence, and Alfacell shall have a maximum self-insured retention or deductible of *** US dollars ($***) with respect thereto.

  • In addition, and without limiting PAR’s obligations under Section 2.2 or this Section 5.3, PAR shall consummate the Initial Commercial Sale in the United States within nine (9) months after receipt of Regulatory Approval from the FDA for the Licensed Product.


More Definitions of Initial Commercial Sale

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.
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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:
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Initial Commercial Sale means the first sale of the Product by BioAlliance or its Affiliate in the Territory following Regulatory Approval of the Product in the Territory.
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Initial Commercial Sale means the first commercial sale by Abbott, or any Abbott Affiliate of Product to any third party customer.
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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 the first sale for use or consumption of any Licensed Product in a country after all required Regulatory Approvals for commercial sale of such Licensed Product have been obtained in such country.

  • Commencement of Commercial Production means the first occurrence of Commercial Production in an Area.

  • Commercial Launch means on a country-by-country basis, the first sale of a Product to a Third Party following Regulatory Approval of the Product in such country.

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

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

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • 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, 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 I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Date of Commercial Operation or “COD” means

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

  • 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 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to 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 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.

  • 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 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.

  • 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 each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.