Royalty Reduction for Biosimilar Product Sample Clauses

Royalty Reduction for Biosimilar Product. If, on a Licensed Product-by-Licensed Product and country-by-country and Calendar Quarter-by-Calendar Quarter basis, (i) [***]; or (ii) [***]; then the royalties payable with respect to Per Licensed Product Annual Net Sales of such Licensed Product pursuant to Section 5.3.1 in such country during such Calendar Quarter shall be reduced to [***], of the royalties otherwise payable pursuant to Section 5.3.1. [***].
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Royalty Reduction for Biosimilar Product. If, on a Licensed Product-by-Licensed Product and country-by-country and Calendar Quarter-by-Calendar Quarter basis: (i) Biosimilar Product(s) (in the aggregate) have a market share of greater than [**] percent ([**]%) but less than or equal to [**] percent ([**]%); or (ii) Biosimilar Product(s) (in the aggregate) have a market share of more than [**] percent ([**]%); then the royalties payable with respect to Annual Product Net Sales of such Licensed Product pursuant to Section 6.2.1 in such country during such Calendar Quarter shall be reduced to [**] percent ([**]%) if subsection (i) applies, or [**] percent ([**]%) if subsection (ii) applies, respectively, of the royalties otherwise payable pursuant to Section 6.2.1. Market share shall be based on the aggregate market in such country of such Licensed Product and the Biosimilar Product(s) (based on the number of units of such Licensed Product and such Biosimilar Product(s) in the aggregate sold in such country, as reported by a well-known reporting service agreed between the Parties acting reasonably (e.g., IQVIA)).

Related to Royalty Reduction for Biosimilar Product

  • Combination Product The term “

  • 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.

  • 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.

  • 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.

  • 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 [***].

  • SOURCE CODE ESCROW FOR LICENSED PRODUCT If Source Code or Source Code escrow is offered by either Contractor or Product manufacturer or developer to any other commercial customers, Contractor shall either: (i) provide Licensee with the Source Code for the Product; or (ii) place the Source Code in a third party escrow arrangement with a designated escrow agent who shall be named and identified to the State, and who shall be directed to release the deposited Source Code in accordance with a standard escrow agreement acceptable to the State; or (iii) will certify to the State that the Product manufacturer/developer has named the State, acting by and through the Authorized User, and the Licensee, as a named beneficiary of an established escrow arrangement with its designated escrow agent who shall be named and identified to the State and Licensee, and who shall be directed to release the deposited Source Code in accordance with the terms of escrow. Source Code, as well as any corrections or enhancements to such source code, shall be updated for each new release of the Product in the same manner as provided above and such updating of escrow shall be certified to the State in writing. Contractor shall identify the escrow agent upon commencement of the Contract term and shall certify annually that the escrow remains in effect in compliance with the terms of this clause. The State may release the Source Code to Licensees under this Contract who have licensed Product or obtained services, who may use such copy of the Source Code to maintain the Product.

  • 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.

  • 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.

  • Royalty Reductions (a) In the event that, during the Royalty Term for a Licensed Product and a country, (i) at the time of the First Commercial Sale of such Licensed Product in such country there is no Valid Claim that is infringed by the sale of such Licensed Product in such country for so long as there is no such Valid Claim, or (ii) if any such Valid Claim did exist as of such First Commercial Sale or thereafter but such Valid Claim has expired or otherwise no longer meets the definition of Valid Claim, then for any royalty payments made during the period when the condition set forth in (i) or (ii) exists with respect to such Licensed Product and such country, the royalties payable with respect to Net Sales of such Licensed Product sold by Jazz, its Affiliates and its Sublicensees in such country shall be reduced by [***] of the royalties otherwise owed to Codiak pursuant to this Section 8.10. In addition, if in any country in the Territory during the Royalty Term for a Licensed Product for such country, a Biosimilar/Generic Product is sold in such country and, according to a reasonable information source or reasonable proxy mutually agreed by the Parties, the units sold of all Biosimilar/Generic Products, collectively, exceed [***] or more of the unit sales of such Licensed Product in such country, then thereafter, the royalties payable with respect to Net Sales of such Licensed Product sold by Jazz, its Affiliates and its Sublicensees in such country shall be reduced by [***] of the royalties otherwise owed to Codiak pursuant to this Section 8.10. The reductions provided for by this Section 8.10.2(a) shall be calculated using the methodology outlined in Exhibit D. (b) Codiak will be responsible for all payment obligations owing to Third Parties under licenses to which Codiak or any of its Affiliates is a party as of the Effective Date or thereafter as set forth in Section 3.3. Other than any licenses or similar rights obtained by Jazz from a Third Party as contemplated in Section 3.3.5(b), if (i) the Exploitation of Licensed Compounds or Licensed Products as contemplated hereunder, including, for clarity, the use of any Agreed Included Codiak Platform Addition in connection with such Exploitation, would infringe or misappropriate any intellectual property that is owned or Controlled by a Third Party, and (ii) Jazz decides to obtain a license or other similar rights from such Third Party in order to avoid such infringement or misappropriation, then [***] of any payments made to such Third Party in connection with obtaining and maintaining such licenses may be deducted from the royalties otherwise payable by Jazz to Codiak hereunder; provided that in no event shall the aggregate royalties payable by Jazz to Codiak for any Calendar Quarter be reduced as a result of such deduction by more than [***] of the royalty that would otherwise have been due under Section 8.10.1, as such royalty amount is determined prior to the application of any reductions provided in this Section 8.10.2. If Jazz is unable to deduct the full amount of the payments to Third Parties contemplated by this Section 8.10.2(b) for a Calendar Quarter, Jazz will be entitled to carry forward such amounts and deduct them in future Calendar Quarters until such time as Jazz has been able to fully deduct such amounts from the royalties payable under Section 8.10.1. Notwithstanding the foregoing, in the case of payments due to a Third Party on sales in the Shared Territory for a Licensed Product for which Codiak exercised its Development and Commercialization Option, no deduction under this Section 8.10.2(b) shall be permitted but Jazz may include such payments in Allowable Expenses.

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

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