Generic Product Reduction Sample Clauses

Generic Product Reduction. This Section 5.7.2 will apply solely to royalties payable under Section 5.5. Notwithstanding the foregoing provisions of Section 5.5 (as applicable), if, in a particular Calendar Year, one or more Third Parties is or are selling a Generic Product in the Field in a country in the Territory and the sales of all such Generic Products in the Field in such country represent at least [*] of the total units of a Product and related Generic Products sold in the Field during the Royalty Term in such Calendar Year in such country, then in such case the royalty rates attributable to the Net Sales of such Product in the Field in such country during the Royalty Term shall thereafter be reduced (a) by [*] of the amount otherwise payable under Section 5.5.1, and (b) to [*] with respect to the royalties payable under Section 5.5.3, as applicable. For purposes of the foregoing, “Generic Product” means with respect to a Product, a non-proprietary product: (A) with the same active ingredient(s) and administration route as the Product; (B) that has obtained Marketing Approval from the applicable Regulatory Authority solely by means of a procedure for establishing equivalence to the Product, without the conduct of any human clinical efficacy trials; and (C) is legally marketed in such country by or under the authority of an entity other than Oncothyreon, its Affiliates or Sublicensees (including affiliates and sublicensees of its Sublicensees).
Sample 1
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Generic Product Reduction. This Section 10.6.2 will apply solely to royalties payable under Section 10.4. Notwithstanding the foregoing provisions of Section 10.4 (as applicable), if, in a particular Calendar Year, one or more Third Parties is or are selling a Generic Product in the Field in a country in the Territory other than the United States and the sales of all such Generic Products in the Field in such country represent at least [*] of the total units of a Product and related Generic Products sold in the Field during the Royalty Term in such Calendar Year in such country, then in such case the royalty rates attributable to the Net Sales of such Product in the Field in such country during the Royalty Term shall thereafter be reduced by [*] of the amount otherwise payable under Section 10.4, as applicable. For purposes of the foregoing, “Generic Product” means any Product that is not developed, the subject of regulatory approval obtained, manufactured, offered for sale, sold or used, by or under the authority of the Selling Party.
Sample 1Sample 2
Generic Product Reduction. Subject to Section 8.3.3(e) (Cumulative Reductions Floor), on a Licensed Product-by-Licensed Product basis, if during any Calendar Quarter, there is Loss of Market Exclusivity for such Licensed Product in the Territory, then the transfer price rate applicable to Net Sales of such Licensed Product in the Territory in such Calendar Quarter will be reduced by [***] of the applicable transfer price rate that would otherwise be owed on such Net Sales of such Licensed Product in the Territory under Section 8.3 (Transfer Price Rates). Torii will promptly notify BioCryst of the occurrence of Loss of Market Exclusivity, which notice will specify the applicable Generic Products and Indication.
Sample 1
Generic Product Reduction. On a [***] basis, during any period in a country in which sales of a Generic Product are equal to or greater than [***] of the volume of its corresponding branded Product in such country in the Territory (the volume as measured by prescriptions or other similar information available in such country), the royalty rates set forth in Section 7.4.3 (that is, the percentage calculated pursuant to clause (i) of Section 7.4.3) with respect to Net Sales for such Product in such country for such Calendar Quarter shall be reduced by [***] of the portion of such royalty rates that is not allocated to the consideration for Aerie’s commercial supply of such Product to Santen payable pursuant to Section 3.1.2 after the application of any deduction pursuant to Section 7.4.4(a), if any. For example purposes only, if such royalty rate [***], and after [***] such royalty rate would be [***], then such rate [***] under this Section 7.4.4(b).
Sample 1
Generic Product Reduction. Notwithstanding the foregoing provisions of Section 6.5, if, in a particular calendar year, one or more Third Parties is or are selling Generic Product in the Field in a country in the Territory during the Royalty Term and the sales of all such Generic Products in the Field in such country represent [***] sold in the Field during the Royalty Term in such calendar year in such country, then in such case the royalty rates attributable to the Net Sales of such Product in the Field in such country during the Royalty Term shall thereafter [***] of the amount otherwise payable under Section 6.5. For purposes of the foregoing, “Generic Product” means any Product that is not developed, the subject of regulatory approval obtained, manufactured, offered for sale, sold or used, by or under the authority of Amgen or its Sublicensee but that obtains Marketing Approval through an abbreviated regulatory pathway for generic products.
Sample 1
Generic Product Reduction. Net Sales of a Licensed Product in a country shall be reduced by [***] if, following the first sale of a Generic Product with respect to such Licensed Product in such country, the Net Sales in such country of such Licensed Product in any Calendar Quarter are [***] of the average Net Sales of such Licensed Product in such country averaged over the [***] Calendar Quarters immediately prior to the first sale of such Generic Product in such country. If such reduction takes effect, it will apply for each Calendar Quarter thereafter in which the Net Sales of such Licensed Product in such country remain [***] of the average Net Sales of such Licensed Product in such country averaged over the [***] Calendar Quarters immediately prior to the first sale of such Generic Product in such country; provided that such reduction to Net Sales of such Licensed Product in such country shall become permanent beginning on the first Calendar Quarter after such reduction has been in effect for the immediately preceding [***] consecutive Calendar Quarters; further provided that the terms of this Section 8.4(a)(ii) shall not apply to reduce Net Sales of a Licensed Product in a country if such Net Sales have already been reduced pursuant to terms of Section 8.4(a)(i).
Sample 1

Related to Generic Product Reduction

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Combination Product The term “

  • Product Quality (a) Tesoro warrants that all Products delivered under this Agreement or any Purchaser Order shall meet the latest applicable pipeline specifications for that Product upon receipt at the applicable Terminal and contain no deleterious substances or concentrations of any contaminants that may make it or its components commercially unacceptable in general industry application. Tesoro shall not deliver to any of the Terminals any Products which: (a) would in any way be injurious to any of the Terminals; (b) would render any of the Terminals unfit for the proper storage of similar Products; (c) would contaminate or otherwise downgrade the quality of the Products stored in commingled storage; (d) may not be lawfully stored at the Terminals; or (e) otherwise do not meet applicable Product specifications for such Product that are customary in the location of the Terminal. If, however, there are Products that do not have such applicable specifications, the specifications shall be mutually agreed upon by the Parties. Should Tesoro's commingled Products not meet or exceed the minimum quality standards set forth in this Agreement or any applicable Purchase Order, Tesoro shall be liable for all loss, damage and cost incurred thereby, including damage to Products of third parties commingled with Tesoro's unfit Products.

  • Royalty Reduction If Licensed Product is royalty-bearing only on account of Section 4.3(b)(ii), then the royalty rates set forth in Section 4.3(a) with respect to Net Sales attributable to Licensed Product will be reduced by [***].

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.

  • Product The term “

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

  • Product Changes IDSI reserves the right to make design and other modifications in the Equipment at any time but shall not be obligated to implement such modifications in Equipment that has previously been delivered.

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