Commercially Launched definition

Commercially Launched means, with respect to each Licensed Product in each country, the first bona fide commercial sale of a Licensed Product in a country by or under authority of NewLink, its Affiliates or Sublicensees, including without limitation, any offer for sale or sale made by NewLink, its Affiliates or Sublicensees to a Third Party pursuant to a written agreement.
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Commercially Launched means a commercial launch of a particular Product, which shall at a minimum require at least commercial scale sales, marketing and promotional activities using Commercially Reasonable Efforts.
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Commercially Launched shall have its correlative meaning.
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Examples of Commercially Launched in a sentence

  • Roche shall use Commercially Reasonable Efforts to file submissions for reimbursement approval in each country where it intends to, or has, Commercially Launched a Product.

  • Following the First Commercial Launch of Licensed Product, NEWLINK shall pay to CIHS a minimum annual royalty as follows: Prior to December 31 of the calendar year in which the first Licensed Product is Commercially Launched, NEWLINK shall pay to CIHS [*] (“Initial Payment”).

  • FMI or its Affiliates shall use Commercially Reasonable Efforts to prepare, or have prepared for it, all regulatory filings and Regulatory Approvals for all Products (other than F1CDx) that are required to be submitted in each country of the Territory where Roche intends to Commercially Launch such Product or has Commercially Launched such Product.

  • For purposes of calculating Royalty Term under this Section 4.3(e), the “First Product” shall mean with respect to (i) all the Products containing TRC105 in a given country, the first Product containing TRC105 that is Commercially Launched in such country, and (ii) all the Products containing Alternate Compound in a given country, the first Product containing Alternate Compound that is Commercially Launched in such country.

  • FMI or its Affiliates shall use Commercially Reasonable Efforts to prepare, or have prepared for it, all regulatory filings and Regulatory Approvals for all Products that are required to be submitted in each country of the Territory where Roche intends to Commercially Launch a Product or has Commercially Launched a Product.

  • Roche shall ensure that F1CDx is Commercially Launched in each country or region in the Territory: (a) by the target date set forth in the F1CDx Initial Launch Plan or (b) in the absence of a launch target date as set forth in the F1CDx Initial Launch Plan, within […***…] following the Parties’ agreement that all required Regulatory Approvals have been received in such market (either of clause (a) or (b), the “Initial Launch Requirement”).

  • Roche will be responsible for Commercially Launching each Product in a given country in the Territory for which FMI has delivered a launch notice, and will ensure such Product remains Commercially Launched in such country in the Territory.

  • After commercial crew and cargo flights to the ISS, Other Commercially Launched Satellites, which is predominantly government satellites launched commercially, is the second largest market, comprising 21 percent of the launch market.

  • Roche will ensure that any Subsequent Claim Filings, and any updates to F1CDx in a Non-Regulated Market (“Non-Regulated Updates”), are Commercially Launched in such market in the time period mutually agreed to by the Parties.

  • If during the Royalty Term with respect to a Product in a country within the Spectrum Territory, a Biosimilar Product is Commercially Launched, Spectrum shall pay no royalties to Hanmi for Net Sales of the Product in such country during the remaining Royalty Term.

Related to Commercially Launched

  • Commercially Useful Function means responsibility for the execution of a distinct element of the work of the contract, which is carried out by actually performing, managing, and supervising the work involved, evidencing the responsibilities and risks of a business owner such as negotiating the terms of (sub)contracts, taking on a financial risk commensurate with the contract or its subcontract, responsibility for acquiring the appropriate lines of credit and/or loans, or fulfilling responsibilities as a joint venture partner as described in the joint venture agreement.

  • 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:

  • Commercially available means that the choice between domestic and imported products is unrestricted and depends only on commercial considerations.

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

  • Commercially Reasonable Efforts means efforts which are reasonably within the contemplation of the Parties at the time of executing this Agreement and which do not require the performing Party to expend any funds other than expenditures which are customary and reasonable in transactions of the kind and nature contemplated by this Agreement in order for the performing Party to satisfy its obligations hereunder.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

  • Contractor Commercially Sensitive Information means the information listed in the Contractor Commercial Sensitive Information Annex to the Contract being information notified by the Contractor to the Authority which is acknowledged by the Authority as being commercially sensitive information.

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

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Commercially Sensitive Information means the Information (i) listed in the Commercially Sensitive Information Schedule; or (ii) notified to the Authority in writing (prior to the commencement of this Contract) which has been clearly marked as Commercially Sensitive Information comprised of information:

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

  • Commercially Reasonable or “Commercially Reasonable Efforts” means, with respect to any action required to be made, attempted or taken by a Party under this Agreement, the level of effort in light of the facts known to such Party at the time a decision is made that: (a) can reasonably be expected to accomplish the desired action without a material increase in costs incurred by such Party; (b) is consistent with Prudent Industry Practices; and (c) takes into consideration the amount of advance notice required to take such action, the duration and type of action and the competitive environment in which such action occurs.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Commercial Software means Software developed or regularly used that: (i) has been sold, leased, or licensed to the general public; (ii) has been offered for sale, lease, or license to the general public; (iii) has not been offered, sold, leased, or licensed to the public but will be available for commercial sale, lease, or license in time to satisfy the delivery requirements of this Contract; or (iv) satisfies a criterion expressed in (i), (ii), or (iii) above and would require only minor modifications to meet the requirements of this Contract.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Launch Date has the meaning specified therefor in Section 2.02(b) of this Agreement.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • 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.

  • Deadly weapon means any weapon, whether loaded or unloaded, from which a shot may be discharged, or a switchblade knife, gravity knife, billy, blackjack, bludgeon, or metal knuckles.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Marijuana-infused products means products that contain marijuana or marijuana extracts and are intended for human use. The term "marijuana-infused products" does not include useable marijuana.