Biosimilar Products. If one or more Biosimilar Products with respect to a Licensed Product is sold commercially by one Biosimilar (or Interchangeable) Applicant in a particular country in the Territory during a particular calendar quarter (Biosimilar Product Presence), and during such calendar quarter the Net Sales of such Licensed Product has decreased by percent () or more when compared to peak Net Sales of such Licensed Product in such country in , and such decrease is attributable to such Biosimilar Product Presence, then the royalty rate (used with Net Sales to determine royalty payments) for such Licensed Product in such country during such calendar quarter and for the remainder of the Royalty Term will be reduced by percent () for purposes of determining Arcuss obligation to make royalty payments under this Agreement. Notwithstanding any other provision of this Agreement, Arcus will at all times pay a minimum royalty of percent () of Net Sales under [Section 5.4].
Biosimilar Product Presence shall have the meaning assigned thereto in [Section 5.5.1].
For purposes hereof, Generic Competition means, on a country-by-country and Product-by-Product basis, the unit volume of each component of a Biosimilar Product(s) sold in such country in the Licensed Territory by one (1) or more Third Party(ies) in a calendar quarter achieves a market share equal to or higher than of the unit volume of each component of the relevant Product sold in such country by SGI, its Affiliates and (sub)licensees. By way of example, but not limitation, for Generic Competition for a Product to satisfy the definition hereunder, # the applicable Biosimilar Product must meet the definition of Biosimilar Product for each of component of the relevant Product (i.e., there must be a Biosimilar Product for both # the applicable SGI Antibody that specifically targets a Collaboration Antigen in the relevant Product, and # the ACTR T-cells), and # the unit volume of each component of such Biosimilar Product sold in the country the Licensed Territory by one (1) or more Third Party(ies) in a calendar quarter must achieve a market share equal to or higher than of the unit volume of each component of the relevant Product sold in such country by SGI, its Affiliates and (sub)licensees. Unless otherwise agreed by the Parties, the unit volumes of each component of each Biosimilar Product sold during a calendar quarter will be as reported by IMS America Ltd. of Plymouth Meeting, Pennsylvania (IMS) or any successor to IMS or any other independent sales auditing firm reasonably agreed upon by the Parties.
Biosimilar Product means, on a country-by-country basis, a biologic product # whose licensing, approval, or marketing authorization relies in whole or in part on a prior approval, licensing or marketing authorization granted any Product, # whose licensing, approval, or marketing authorization relies in whole or in part on any data generated in support of a prior approval, licensing, or marketing authorization granted any Product, or # is determined by the FDA to be interchangeable with a Product, as set forth at 42 USC 262(k)(4). Any product or component thereof (including any Product or component thereof) licensed, marketed, sold, manufactured, or produced by a Party, its Affiliates or (sub)licensees will not constitute a Biosimilar Product.
In the event that such Licensed Product is regulated as a biologic in a particular jurisdiction, the term Generic Product shall be defined using comparable terms applicable to a follow-on biologic or biosimilar product approved through a similarly abbreviated Regulatory Approval process.
Regeneron will designate, to the extent permitted by applicable Law, the outside counsel and in-house counsel who will receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. § 262(l)(1)(B)(ii).
Biosimilars or Interchangeables. If either Party receives a copy of an application submitted to the FDA under subsection # of [Section 351] of the PHSA (a Biosimilar Application) naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in [Section 351(l)(9)(C)] of the PHSA), either Party shall, within [ ], notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the Biosimilar Application under [Section 351(l)(1)(B)(iii)] of the PHSA. Regardless of the Party that is the reference product sponsor for purposes of such Biosimilar Application, # shall have the sole right to designate pursuant to [Section 351(l)(1)(B)(ii)] of the PHSA the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application and manufacturing information, # shall have the sole right and discretion to list or not list any Patents, including Patents and Joint Patents, insofar as they claim or cover the applicable Licensed Product or biosimilar product as required pursuant to [Section 351] of the PHSA or related regulations or guidance, to respond to any communications with respect to such lists from the filer of the CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [......]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
“Technical Package” shall mean the documentation with respect to the Product, which is under development by DRL, and which shall be proprietary to DRL, and such Technical Package shall include data to support the biosimilar registration submission of the Product with Regulatory Authorities in the United States of America.
announces an Agreement with Dr. Reddy’s Laboratories, Ltd. to License its proposed biosimilar Abatacept for the Development, and Commercialization of COYA 302, Coya’s Proprietary Biologic Combination Product, for the Treatment of Neurodegenerative Diseases.
Neither the Company, any Subsidiary, nor, to the Company’s knowledge, any of its or their licensees, partners, collaborators or joint venturers has developed, manufactured, commercialized, produced, formulated, propagated, modified, customized, processed, distributed or sold any Company Product that did not comply with any express or implied warranty regarding such Company Product or that contained any unintended Hazardous Substance or that was otherwise adulterated, contaminated, mislabeled, defective, off-specification or improperly packaged or transported.
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