US Launch definition

US Launch means Launch in the US.
US Launch means the date of the first sale of the PRODUCT by SIRION in the TERRITORY.
US Launch. U.S. Launch means the time when Sandoz, its Affiliates or distributors achieve the First Commercial Sale of the Product in the U.S. Territory. 1. 100. “U.S. Territory”. U.S. Territory shall mean the fifty states of the United States of America, the District of Columbia and all territories and possessions of the United States of America and any other location where the FDA has jurisdiction over medicinal products intended for human use.

Examples of US Launch in a sentence

  • Within * after the expiration of each Contract Quarter Wyeth shall provide to Biomatrix an updated * supply forecast (the "Supply Forecast") and the * shall be consistent with the firm purchase orders previously delivered pursuant to Section 7, provided that commencing in * after the U.S. Launch Date Biomatrix's obligation to supply Products under the Supply Forecasts shall not increase * The Supply Forecast shall supersede the Long Range Forecast for any applicable period.

  • For example, if Final Legal Clearance occurs midway between the [**] and [**] anniversary of U.S. Launch, the first two (2) Commercial Milestone Payments shall be due 45 days after the end of the Post-Launch Quarter in which Final Legal Clearance occurs.

  • The sum of the Profit/Royalty payable to Momenta (as calculated in the previous column) for all Quarters from U.S. Launch through the [**] Quarter of the [**] Post-Launch Year ($[**]) is divided by the sum of the Profits for the Product over the same period ($[**]) to yield [**]%.

  • Ardelyx’s participation in the Promotion Activities shall, at a minimum, include (i) [***] (for clarity, such Detail efforts to include those performed by Ardelyx, in the event it exercises the Co-Promote Option) with respect to the relevant Co-Promote Products in the U.S. Territory as set forth in the US Commercialization Plan and the US Launch Plan prepared by Sanofi, and (ii) Other Promotional Activities and may constitute, at Ardelyx’s election, [***], as determined in the Co-Promote Agreement.

  • Commercially Reasonable Efforts to provide the first draft of the US Commercialization Plan and the US Launch Plan as soon as reasonably practicable following the Filing of the first Drug Approval Application for a Licensed Product in the Territory, and shall, in any event, provide such first plan to Ardelyx no later than six (6) months after the Filing of the first Drug Approval Application for a Licensed Product in the Territory.

  • The measures established in this Annex apply in the event the U.S. Launch Base Security Authority or other appropriate U.S. authority is provided or otherwise receives RESTREINT UE/EU RESTRICTED information under this agreement.

  • In respect of each calendar month following the U.S. Launch Date, Company shall pay to the Applicable Affiliate, on a calendar monthly basis in respect of each calendar month during the Term, the greater of (i) the Service Fees due pursuant to section 6.01 below attributable to the exploitation of SONY BMG Materials in the United States, or (ii) a minimum revenue guarantee (the “Revenue Guarantee”) of Fifty Thousand United States Dollars (US$50,000) per calendar month.

  • As used herein, "U.S. Launch Date" is the date of the non-beta commercial launch of the Video Service via any Approved Distribution Channel in the United States.

  • Such access shall be allowed exclusively for investigative purposes and after prior authorisation by the European Commission as conveyed by the ESA LSO to the U.S. Launch Base Security Authority.

  • The U.S. Launch Base Security Authority, in coordination with the Launch Service Provider, ESA LSO and other applicable organisations, shall investigate any Security Incident reported by the ESA LSO.