Fixed Dose Combination Product Sample Clauses

Fixed Dose Combination Product. With respect to Fixed Dose Combination Products, on a Fixed Dose Combination Product-by-Fixed Dose Combination Product and country-by-country basis during the Royalty Term applicable to such Fixed Dose Combination Product and such country, Lilly shall pay Licensee a [***] royalty on Net Sales of such Fixed Dose Combination Product.
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Fixed Dose Combination Product. If Lilly decides, in its sole discretion, to pursue the Development or Commercialization of a Fixed Dose Combination Product, the Parties shall discuss in good faith and enter into a mutually acceptable supply agreement (the “Supply Agreement”) to govern the supply of Commercialization Product and the Compound used in such Commercialization Product and a related quality agreement (the “Quality Agreement”) to govern the responsibilities and procedures associated with record retention, complaint handling, quality-specific audit rights, specifications, key contacts and other quality-related matters. Additionally, Lilly shall have the right to audit all nodes of Licensee’s supply chain, including Third Party manufacturing sites, prior to entering into, and during the term of, the Supply Agreement. Lilly shall have sole responsibility for the Manufacture of any Lilly Target Molecules prescribed for use in Lilly Product. To the extent that Lilly notifies Licensee in writing that it desires to establish an alternative source of supply for Fixed-Dose Combination Products: (a) to the extent that the Fixed-Dose Combination Product includes a Commercialization Product, Lilly shall be permitted to establish such alternative source of supply of a finished dosage form containing the applicable Compound (but not the Compound itself), and (b) to the extent that the Fixed-Dose Combination Product does not include a Commercialization Product, Lilly shall be permitted to establish such alternative source of supply for the Compound and the finished dosage form containing the Compound; provided, that notwithstanding clauses (a) and (b) if Lilly reasonably determines based on its audit of Licensee’s supply chain discussed above that there are quality issues with the Compound, Lilly shall be permitted to establish an alternative source of supply for the Compound and the finished dosage form containing the Compound for any Fixed-Dose Combination Product.
Fixed Dose Combination Product. Seagen may perform pre-clinical research on a RC48 Fixed Dose Combination Product [ * ] for the RC48 Fixed Dose Combination Product, [ * ]. When Seagen is ready to [ * ] with respect to an RC48 Fixed Dose Combination Product, Seagen shall [ * ] so notify RemeGen in writing and provide a package containing [ * ]. RemeGen shall have [ * ] to review such package. At the end of the [ * ] period, the Parties shall [ * ] in good faith over a [ * ] period commercially reasonable [ * ] terms [ * ] for such RC48 Fixed Dose Combination Product, which [ * ] terms shall be [ * ]; provided that if RemeGen notifies Seagen within such [ * ] period that it does not wish to clinically Develop and Commercialize the RC48 Fixed Dose Combination Product in the RemeGen Territory, then [ * ]. If the Parties do not agree within such [ * ] period (as may be extended by agreement of the Parties) on the [ * ] terms for such RC48 Fixed Dose Combination Product, then the matter [ * ]. For clarity, (i) Seagen’s right to Develop and Commercialize any RC48 Fixed Dose Combination Product is expressly conditioned on the [ * ] terms for such RC48 Fixed Dose Combination Product having been determined in accordance with this Section 2.7(d), (ii) without limiting the foregoing clause (i), Seagen agrees to [ * ], and (iii) [ * ]. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

Related to Fixed Dose Combination Product

  • Combination 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.

  • 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.

  • Fixed Kilowatt Rate Product If Clearview Energy would like to propose a change to a fixed kilowatt rate product, you will be notified by the process described in Change of Terms. Fixed price products may change due to new or modified federal, state or local laws; or regulatory actions that impose new or modified fees. 2b. Month-to-month Variable Kilowatt Rate Product – Month-to-month variable kilowatt rate products are subject to change without notice at Clearview Energy’s discretion outside of any applicable promotion. If applicable, the Monthly Base Charge may also fluctuate outside of any applicable promotion. All pricing can be viewed at xxx.XxxxxxxxxXxxxxx.xxx.

  • Net Sales 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.

  • Competing Products The provisions of Section 21 are set forth on attached Exhibit H and are incorporated in this Section 21 by this reference.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Product Sales Subject to Sections 10.3(c) and 10.3(d), Licensee agrees that it will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination Product, TDF Product and TDF Combination Product for use in the Field and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, and (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in the countries of the EVG-Quad Territory.‌ (i) Licensee agrees that during the period in which the Patents are valid and enforceable (on a Product-by-Product basis) it will prohibit its Distributors from selling Product (A) to any other wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field. (ii) Licensee agrees that it will not administer the TAF Quad to humans, or sell the TAF Quad until Gilead has obtained marketing approval for the TAF Quad from the FDA. Licensee agrees that it will not administer EVG to humans, or sell Products containing EVG until Gilead has obtained marketing approval for an EVG Product from the FDA. Licensee agrees that it will not administer COBI to humans, or sell Products containing COBI until Gilead has obtained marketing approval for a COBI Product from the FDA. Licensee agrees that it will not administer TAF to humans, or sell Products containing TAF until Gilead has obtained marketing approval for a TAF Product from the FDA. If Gilead obtains marketing approval from the FDA for any Quad Product or a Combination Product containing TAF, COBI or EVG (“Approved Combination Product”) prior to obtaining marketing approval for a TAF Product, EVG Product or COBI Product from the FDA, then Licensee will be allowed to administer such Quad Product or such Approved Combination Product to humans, and sell such Quad Product or such Approved Combination Product from and after the date of such marketing approval from the FDA, but will not (A) administer to humans or sell Combination Products containing EVG other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for an EVG Product, or (B) administer to humans or sell Combination Products containing COBI other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a COBI Product or (C) administer to humans or sell Combination Products containing TAF other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a TAF Product.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

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