Example ContractsClausesBiosimilar Competition
Biosimilar Competition
Biosimilar Competition contract clause examples

Biosimilar Competition. If during any Calendar Quarter during the Royalty Period for a Product in a given country, ​and such Product sold in such Calendar Quarter in such country (as determined by data obtained from a mutually agreed upon Third Party source), then the percentage royalty payable on Net Sales of such Product in such country will be reduced by ​ for such Calendar Quarter.

Biosimilar Competition. (i) Subject to this [Section 9.10], including [Sections 9.10.2, 9.10.3, 9.10.4 and 9.10.6, PARTNER]R]R]R]R] shall have the right, but not the obligation, to prosecute, manage and settle any litigation with respect to Biosimilar Products in the Licensed Field and the Territory and any proceedings associated therewith, in connection with any Patents, including any invalidity, unpatentability or unenforceability challenges, oppositions and post-grant proceedings in connection therewith. If either Party receives a notice or a copy of an application submitted to the FDA or its foreign counterpart for a Biosimilar Product (a “Biosimilar Application”) for which a Licensed Product is a “reference product” as such term is used in [Section 351(i)(4)] of the PHSA, or an equivalent under its foreign counterpart, whether or not such notice or copy is provided under any Applicable Laws, or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for Regulatory Approval, such Party shall, within ​, notify the other Party and provide the other Party with copies of such notice or communication to the extent permitted by Applicable Law. PARTNER shall carry out any such rights and responsibilities of the “reference product sponsor,” as defined in [Section 351(l)(1)(A)] of the PHSA, for purposes of such Biosimilar Application, provided that PARTNER’s rights to bring an action for patent Infringement under [Section 351(l)(6)] of the PHSA based on any REGENX Patents, Collaboration Patents or Joint Patents are subject to REGENX’s applicable sole or first rights to bring an action for patent Infringement under [Sections 9.10.3 and 9.10.4]4], and to the rights of the applicable REGENX Licensors and the limitations imposed on REGENX, its Affiliates and its and their respective sublicensees that are set forth in the applicable Third Party License Agreements. The Parties shall cooperate seeking to obtain access to the Biosimilar Application and related confidential information, including in accordance with [Section 351(l)(1)(B)(iii)] of the PHSA, if applicable. If permitted pursuant to Applicable Law, upon one Party’s request, the other Party shall assist the requesting Party in identifying and listing any and all relevant Patents pursuant to [Section 351(l)(1)(3)(A)] or [Section 351(l)(7)] of the PHSA, in preparing, pursuant to [section 351(l)(3)(C)] of the PHSA, a detailed statement regarding the reference product sponsor’s opinion that any such Patent will be infringed and a response to the statement by the filer of the Biosimilar Application concerning validity and enforceability, in negotiating with the filer of the Biosimilar Application pursuant to [Section 351(l)(4)] of the PHSA, and in selecting Patents enforceable under this [Section 9.10] for and conducting litigation pursuant to [Section 351(l)(5)], [Section 351(l)(6)], and [Section 351(l)(9)] of the PHSA, to the extent applicable, and shall cooperate with the requesting Party in responding to relevant communications with respect to such lists and statements from the filer of the Biosimilar Application. The Parties shall cooperate and assist each other in seeking an injunction against any commercial marketing by the filer of a Biosimilar Application as permitted pursuant to [Section 351(l)(8)(B)] of the PHSA or in filing an action for infringement against the filer of such Biosimilar Application.

Biosimilar Competition. If, in a particular country, a Third Party obtains approval for and sells a Biosimilar Product with respect to a particular Product and achieves Biosimilar Competition in such country with respect to such Product, then the Net Sales for such Product in such country will be reduced by ​ for the remainder of the Royalty Term for such Product in such country, subject to Section 5.5.4 (Mechanics of Adjustment to Royalties).

Royalty Reduction Due to Biosimilar Competition. Subject to [Section 7.6.6], on a Licensed Product-by-Licensed Product and country-by-country basis, if during any ​ during the Royalty Term for such Licensed Product in such country there are ​ or more Biosimilar Products being sold in such country with respect to such Licensed Product, then the royalty rates used to calculate royalties due on Net Sales of such Licensed Product in such country for such ​ shall be reduced from the royalty rates set forth in [Section 7.6.1] as follows:

Biosimilar Applications. [Section 10.4(h)] of the Collaboration Agreement is hereby incorporated by reference into this Agreement.

Biosimilar Applications. Notwithstanding anything to the contrary herein, if either Party receives a copy of a Biosimilar Application referencing a Co-Funding Product or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing approval (such as in an instance described in 42 U.S.C. §262(l)(9)(C)), such Party shall within ​ notify the other Party. The owner of the relevant Patent Rights shall then seek permission to view the application and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, either Party shall within ​ notify and provide the other Party copies of such communication to the extent permitted by Applicable Laws. Promptly after receiving notice of a Biosimilar Application referencing a Co-Funding Product or any equivalent or similar communication or notice in the United States or any other jurisdiction referencing a Co-Funding Product, the Parties shall enter into an appropriate joint defense agreement. Regeneron shall have the right to be the Lead Litigation Party with respect to a Regeneron Co-Funding Product and Intellia shall have the right to be the Lead Litigation Party with respect to an Intellia Co-Funding Product. A Party that is not the Lead Litigation Party in a litigation shall consent to being joined in a litigation or being named as the plaintiff in a litigation if such being joined or named as a plaintiff is necessary to confer standing to bring the litigation or is otherwise necessary for the pendency of the litigation, and in such instance the joined Party shall provide reasonable cooperation and assistance to the Lead Litigation Party, and all Out-of-Pocket Costs incurred by the joined Party in connection therewith shall be shared by the Parties in accordance with their respective Co-Funding Percentages and treated as Other Shared Expenses.

Biosimilar Notices. Allogene will comply with the applicable provisions of 42 U.S.C. § 262(l) (or any amendment or successor statute thereto), any similar statutory or regulatory requirement enacted in the future regarding biologic products in the United States, or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction, in each case, with respect to any Biosimilar Notice received by Allogene from any Third Party regarding any Allogene Licensed Product that is being Commercialized in the applicable jurisdiction, and the exchange of information between any Third Party and Allogene pursuant to such requirements; provided that, prior to any submission of information by Allogene to a Third Party, [[Cellectis:Organization]] will have the right to review the patent information included in such proposed submission, solely with respect to Patent Rights Controlled by [[Cellectis:Organization]], and to make suggestions as to any changes to such patent information that [[Cellectis:Organization]] reasonably believes to be necessary; provided further that Allogene will determine the final content of any such submission. In the case of an Allogene Licensed Product approved in the United States under the PHS Act (or, in the case of a country in the Territory other than the United States, any similar law), to the extent permitted by Applicable Law, Allogene, as the sponsor of the application for the Allogene Licensed Product, will be the “reference product sponsor” under the PHS Act. Allogene will give written notice to [[Cellectis:Organization]] of receipt of a Biosimilar Notice received by Allogene with respect to an Confidential

Biosimilar Products. On a country-by-country and Product-by-Product basis, following the first commercial sale of one (1) or more Biosimilar Products with respect to a Product in any country in the Territory during the Royalty Term, the Royalty rates provided in [Section 8.4.2] for such Product will: be # permanently reduced in such country by ​ percent in such country during the Royalty Term once such Biosimilar Product(s) has or have a combined market share of ​ or more in such country; or # by ​ percent in such country during the Royalty Term once such Biosimilar Product(s) has or have a combined market share of ​ or more in such country, in which case, ​. The determination of market share for the purpose of this [Section 8.4.4], shall be measured in local currency, over the Calendar Quarter, as reported by IQVIA or other customary market intelligence service used by Lilly and reasonably acceptable to [[Merus:Organization]].

Biosimilar Competition” means, on a Product-by-Product, country-by-country, and Calendar Year-by-Calendar Year basis, a Biosimilar Product with respect to such Product is being marketed and sold by a Third Party in such Calendar Year in such country.

in the event that in any country or other jurisdiction in the Territory during the Royalty Term for a Licensed Product there is Biosimilar Competition resulting in ​;

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