Biosimilar Product means [***].
Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.
Biosimilar Product means, on a country-by-country basis, a biologic product determined by the FDA or other Regulatory Authority outside of the United States to be biosimilar or interchangeable with a Product under Applicable Law. A Product licensed, marketed, sold, manufactured or produced by Pyxis, its Affiliates, or Sublicensees will not constitute a Biosimilar Product.
Examples of Biosimilar Product in a sentence
Because Hospira’s manufacturing process for the Hospira Epoetin Biosimilar Product is still secret [i.e., even after disclosure of the aBLA] without the disclosure required by 42 U.S.C. § 262(l)(2), Amgen cannot conduct a full and complete evaluation of its patent portfolio as to Hospira’s specific processes of manufacture.
More Definitions of Biosimilar Product
Biosimilar Product means in a particular country with respect to a Product that contains a Compound that is a protein or peptide, any pharmaceutical product that: (a) has received all necessary approvals by the applicable Regulatory Authorities in such country to market and sell such product as a pharmaceutical product; (b) is marketed or sold by a Third Party that has not obtained the rights to market or sell such product as a licensee, sublicensee or distributor of BMS or any of its Affiliates, licensees or sublicensees with respect to such product; and (c) is approved as a (i) “biosimilar” (in the United States) of such Product, (ii) as a “similar biological medicinal product” (in the EU) with respect to which such Product is the “reference medicinal product” or (iii) if not the US or EU, as the foreign equivalent of a “biosimilar” or “similar biological medicinal product” of such Product; in each case for use in such country pursuant to an expedited regulatory approval process governing approval of generic biologics based on the then-current standards for regulatory approval in such country (e.g., the Biologics Price Competition and Innovation Act of 2009 or an equivalent under foreign law) and where such regulatory approval was based in significant part upon clinical data generated by BMS (or its Affiliate or sublicensee) with respect to such Product.
Biosimilar Product means, with respect to a particular Product in a country, a pharmaceutical product that (a) contains an analytically comparable or identical active ingredient(s) as such Product, (b) is approved for use in such country pursuant to a regulatory approval process governing approval of generic, interchangeable or biosimilar biologics based on the then-applicable standards for regulatory approval in such country, whether or not such regulatory approval was based in whole or in part upon clinical data generated by the Parties pursuant to this Agreement or was obtained using some other type of abbreviated or expedited approval process and (c) is sold in the same country as such Product by any Third Party that is not a Sublicensee of BMS or its Affiliates and did not purchase such product in a chain of distribution that included any of BMS or any of its Affiliates or its Sublicensees.
Biosimilar Product means a pharmaceutical product which, with respect to a Licensed Product (a) has been licensed as a biosimilar or interchangeable product by the FDA pursuant to Section 351(k) of the Public Health Service Act (42 U.S.C. § 262(k)), as may be amended, or any subsequent or superseding law, statute or regulation, (b) has been authorized as a similar biological medicinal product in the EU pursuant to Directive 2001/EC/83, as may be amended, or any subsequent or superseding law, statute or regulation, or (c) has otherwise
Biosimilar Product means (i) a biologic product that comprises the same *** that is a Licensed Product and any related formulations thereof; (ii) a biologic product that comprises *** that is a Licensed Product and any related formulations thereof, so as to permit the biosimilar applicant to rely for approval on certain existing scientific knowledge about the safety and efficacy of the *** that is a Licensed Product, and the various related formulations thereof, whereby the biologic product may be approved anywhere in the world via an abbreviated regulatory pathway or marketed as a biosimilar, biogeneric, interchangeable, subsequent entry biologic, follow-on biologic, or any such term used to describe a biologic product that purports to be comparable to any *** that is a Licensed Product; or (iii) a biologic product that but for a license granted by AbbVie covering such biologic product (without limiting any provisions of the Exclusive License Agreement), the researching, developing, making, having made, using, selling, offering for sale, importing and otherwise exploiting such biologic product would infringe one or more claims of patents claiming or covering any Licensed Product. The Parties acknowledge and agree that the term “Biosimilar Product” shall not include (A) a Licensed Product licensed or produced by Receptos, including by way of Receptos exercising the license granted by AbbVie hereunder, or (B) those biologic products described in (i) or (ii) above with respect to which Receptos elects to grant a license to a Third Party, so as to prevent such biologic product from infringing one or more claims of patents on any Licensed Product.
Biosimilar Product means with respect to a Licensed Product, a therapeutic product that (i) contains as an active ingredient any [***], (ii) is Bioequivalent to such Licensed Product, and (iii) is [***].
Biosimilar Product means with respect to a particular Licensed Product in a given country, a product comprising an ADC sold by a Third Party not authorized by Licensee or its Affiliates or Sublicensees that is approved by the applicable Regulatory Authority for such country through an application or submission filed with a Regulatory Authority for marketing approval of a biologic product claimed to be biosimilar or interchangeable to such Licensed Product, including an application filed under 42 U.S.C. § 262(k) (or any successor thereto) or any similar laws or regulations in a country outside the United States in reliance on data generated for a Regulatory Approval of such Licensed Product.
Biosimilar Product has the meaning set forth in Section 7.4(a).