Reduction in Royalty for Generic Products Sample Clauses

Reduction in Royalty for Generic Products. Subject to Section 6.4.4 below, in the event that one or more Generic Product(s) (defined below) are sold in a country and such Generic Product(s) account for at least ***% of the aggregate unit sales of such Generic Product(s) and the Licensed Product in such country, the applicable patent royalty rates set forth in Section 6.4.1(a) and/or (b) above shall be reduced by *** percent (***%) for such Licensed Product sold in such country. The term “Generic Product” means: (i) with respect to a Licensed Product comprising a Compound sold in a country and approved for a particular indication, an AB-rated Generic Product that: (A) is owned by a Third Party that has not obtained the rights to such product as a sublicensee or distributor of GSK or any of its Affiliates; (B) contains as an active ingredient the same Licensed Product (or salt, metabolite, prodrug or other physical form thereof, or equivalent as determined by the relevant regulatory authority) as contained in such Licensed Product; and (C) is approved for use in the same country as such Licensed Product pursuant to 21 U.S.C. 355(b)(2), an abbreviated new drug application, a separate NDA (excluding any NDA owned by GSK or any of its Affiliates), compendia listing, or other drug approval application (excluding any NDA owned by GSK or any of its Affiliates), including any and all foreign equivalents of the foregoing; and (ii) with respect to a Licensed Product comprising a Biologic, a product that: (A) is owned by a Third Party that has not obtained the rights to such product as a sublicensee or distributor of GSK or any of its Affiliates; (B) contains as an active ingredient the same biologic (i.e., identical relevant amino acid sequence) as contained in such Licensed Product; and (C) is approved for use in the same country as such Licensed Product.
Sample 1Sample 2See All (4)
AutoNDA by SimpleDocs

Related to Reduction in Royalty for Generic Products

  • Net Sales 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.

  • Combination Product The term “

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Sublicense Fees Licensee will pay Sublicense Fees indicated in Section 3.1(e) of the Patent & Technology License Agreement on or before the Quarterly Payment Deadline for the Contract Quarter.

  • AUDIT OF LICENSED PRODUCT USAGE Contractor shall have the right to periodically audit, no more than annually, at Contractor’s expense, use of licensed Product at any site where a copy of the Product resides provided that: (i) Contractor gives Licensee(s) at least thirty (30) days advance written notice, (ii) such audit is conducted during such party’s normal business hours, (iii) the audit is conducted by an independent auditor chosen on mutual agreement of the parties. Contractor shall recommend a minimum of three (3) auditing/accounting firms from which the Licensee will select one (1). In no case shall the Business Software Alliance (BSA), Software Publishers Association (SPA), Software and Industry Information Association (SIIA) or Federation Against Software Theft (FAST) be used directly or indirectly to conduct audits, or be recommended by Contractor; (iv) Contractor and Licensee are each entitled to designate a representative who shall be entitled to participate, and who shall mutually agree on audit format, and simultaneously review all information obtained by the audit. Such representatives also shall be entitled to copies of all reports, data or information obtained from the audit; and (v) if the audit shows that such party is not in compliance, Licensee shall be required to purchase additional licenses or capacities necessary to bring it into compliance and shall pay for the unlicensed capacity at the NYS Net Price in effect at time of audit, or if none, then at the Contractor’s U.S. Commercial list price. Once such additional licenses or capacities are purchased, Licensee shall be deemed to have been in compliance retroactively, and Licensee shall have no further liability of any kind for the unauthorized use of the software.

  • Earned Royalties In partial consideration of the License and subject to Sections 3.7 and 3.8, Company will pay to Penn: (i) a graduated royalty as set forth in the table below based upon worldwide annual Net Sales made by Company and its Affiliates (but not sublicensees) of any Designated Compound Sold for use in the Field of Use while covered in the country of Sale of expected use by a Valid Claim of the Assigned BMS Patents that is licensed to Company under the License (but no other Licensed Product): <$500 million [CONFIDENTIAL TREATMENT REQUESTED] /*/% >$500 million but <$750 million [CONFIDENTIAL TREATMENT REQUESTED] /*/% >$750 million but <$1 billion [CONFIDENTIAL TREATMENT REQUESTED] /*/% >$1 billion [CONFIDENTIAL TREATMENT REQUESTED] /*/% [CONFIDENTIAL TREATMENT REQUESTED] /*/ PATENT LICENSE AGREEMENT (ii) a royalty of [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) of Net Sales made by Company and its Affiliates (but not sublicensees) for all Licensed Products that qualify as “Licensed Products” hereunder based on clause (b) of that definition and Sold while covered in the country of Sale of expected use by a Valid Claim of the Penn Existing Patents or Penn New Patents; provided that, notwithstanding any credits provided for in Section 3.7 but subject in all events to Section 3.8, royalties payable by Company for such Net Sales for such Licensed Products shall not be less than [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%). Only one royalty shall be due hereunder on the Sale of the same unit of Licensed Product. If a royalty accrues to a Sale of a Licensed Product under both clause (i) and (ii) above, then the higher rate of clause (i) shall apply. Only one royalty shall be due hereunder on the Sale of a Licensed Product even if the manufacture, use, sale, offer for sale or importation of such Licensed Product infringes more than one Valid Claim of the Penn Patent Rights.

  • Additional Products Upon satisfying the minimum order requirements above, Enrolled Affiliate may order Additional Products.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!