Biosimilar Product Competition Sample Clauses

Biosimilar Product Competition. If, on a Licensed Product-by-Licensed Product, country-by-country and Calendar Quarter-by-Calendar Quarter basis, Biosimilar Product Competition is present with respect to such Licensed Product in such country during such Calendar Quarter, then the royalties payable with respect to such Licensed Product pursuant to Section 6.6.1 in such country during such Calendar Quarter shall be reduced to [**] percent ([**]%) of the amounts otherwise payable pursuant to Section 6.6.1, provided that, in no event shall such royalty payments, as adjusted by Section 6.4.1(e) and this Section 6.6.4, be [**] it being understood that if, for a full subsequent Calendar Quarter, there are no Biosimilar Products being commercialized with respect to such Licensed Product in such country, then royalties shall once again be payable at the full rates set forth in Section 6.6.1. If any amount that Allergan is entitled to deduct from the royalty payments due to Editas under Section 6.6.1 with respect to a Licensed Product is not fully offset against such royalty amounts as a result of the proviso in the preceding sentence, such amount may be carried forward and applied to future periods until fully exhausted.
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Biosimilar Product Competition. Subject to Section 10.5.5 (Cumulative Reductions Floor) and the last sentence of the introductory paragraph of Section 10.5 (General), if, during the COVID-19 Royalty Term, on a country-by-country Licensed COVID-19 Product-by-Licensed COVID-19 Product, and Calendar Quarter-by-Calendar Quarter basis, for a given country, Licensed COVID-19 Product and Calendar Quarter, (i) the MAA for a Biosimilar Product as to such Licensed COVID-19 Product has been approved and such Biosimilar Product is being sold in such country in such Calendar Quarter and (ii) the Net Sales of such Licensed COVID-19 Product in such country decline by the percentage described in a given row in the table below in a Calendar Quarter relative to the average Calendar Quarter Net Sales of such Licensed COVID-19 Product in such country achieved in the [***] consecutive Calendar Quarters immediately prior to the Calendar Quarter in which the initial sale of such Biosimilar Product after receipt of approval for the Marketing Authorization for such Biosimilar Product in such country occurred, then the Net Sales in such country used for purposes of calculating worldwide Net Sales of such Licensed COVID-19 Product will be reduced by the corresponding amount set forth in the table below on and after such Calendar Quarter: Table 10.5.4(b) Biosimilar Reduction Percentage Decline in Net Sales in a Country Net Sales Reduction in such Country [***] [***] [***] [***] [***] [***] [***] [***]
Biosimilar Product Competition 

Related to Biosimilar Product Competition

  • 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.

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

  • 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.

  • Generic Competition If a Licensed Product is sold in a country where a product that is an AB Rated Product with respect to such Licensed Product is sold or marketed by a Third Party pursuant to a regulatory approval for the commercial sale and marketing thereof for human therapeutic or prophylactic use in such country, then the royalty rate applicable under Section 5.2(f)(i) to Net Sales of such Licensed Product in such country shall be reduced to [*] percent ([*]%) of the rate originally stated therein (i.e., reduced to [*]% or [*]%, depending on worldwide Net Sales), effective with respect to all Net Sales of such Licensed Product in such country occurring on or after the first day of the first calendar month following the month during which such AB Rated Product is first sold in such country.

  • 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.

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

  • Competitive Products Competitive Products" means products that serve the same function as, or that could be used to replace, products the Company provided to, offered to, or was in the process of developing for a present, former, or future possible customer/partner at any time during the twelve (12) months immediately preceding the last day of Participant's employment (or at any time during Participant's employment if Participant was employed for less than 12 months), with which Participant had direct responsibility for the sale or development of such products or managing those persons responsible for the sale or development of such products.

  • Combination Product The term “

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • 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.

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