Generic Version definition
Generic Version means, with respect to a Licensed Product, a product (including a “biogeneric,” “follow-on biologic,” “follow-on biological medicine or product,” “follow-on protein product,” “similar biological medicine or product,” or “biosimilar product”) that: (a) within the U.S., is “biosimilar” or “interchangeable,” with respect to such Licensed Product as evaluated by the FDA or otherwise determined by Applicable Law; or (b) in the ROW, is determined by the applicable Regulatory Authority or by Applicable Law to be “similar,” “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” to such Licensed Product. For clarity, a Biosimilar of a Licensed Product shall constitute a Generic Version of such Licensed Product.
Generic Version means, with respect to a Licensed Product, a second or subsequent product (including a “biogeneric,” “follow-on biologic,” “follow-on biological product,” “follow-on protein product,” “similar biological medicinal product,” or “biosimilar product”) that is (a) in the United States, “therapeutically equivalent,” “comparable,” “biosimilar,” or “interchangeable,” as evaluated by the FDA, applying the definition of “therapeutically equivalent” set forth in the preface to the then-current edition of the FDA publication “Approved Drug Products With Therapeutic Equivalence Evaluations” or any other definitions set forth in the U.S. Code, FDA regulations, or other source of U.S. Law, FDA regulations, or guidelines and, outside the United States, such equivalent determination by the applicable Regulatory Authorities (including a determination that the second product is “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” with respect to the Licensed Product), in each case, as is necessary to permit pharmacists or other individuals authorized to dispense pharmaceuticals under Law to substitute one product for another product in the absence of specific instruction from a physician or other authorized prescriber under Law, and (b) is not an Authorized Generic Version of such Licensed Product; where “Authorized Generic Version” means any pharmaceutical product that (i) is sold under the Drug Approval Application for such [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Licensed Product, (ii) is sold under a different Trademark than such Licensed Product, and (iii) has a National Drug Code (“NDC”) number that differs from the NDC number for such Licensed Product (other than on a temporary basis as may be necessary to launch such Licensed Product in the applicable market).
Generic Version means, with respect to a Licensed Product, a product (including a “biogeneric,” “follow-on biologic,” “follow-on biological product,” “follow-on protein product,” “similar biological medicinal product,” or “biosimilar product”) that (a) (i) is “similar” or “interchangeable,” with respect to such Licensed Product as evaluated by the FDA, (ii) outside the United States, is determined by the applicable Regulatory Authorities to be
Examples of Generic Version in a sentence
If an Approved Generic Version (other than the Designated Product) is first put on the market in a nation during the first half of a calendar quarter, it will be deemed for purposes of this Section to have been on the market in such nation from the first day of such quarter, and if it is first put on the market in a nation during the second half of a calendar quarter, it will be deemed for purposes of this Section not to have been on the market in such nation until the first day of the following quarter.
If a Generic Licensee proposes to commercialize a Generic Version which contains a combination of APIs that are different (including different dosages, other than of EVG) from any Product under development or being marketed by Gilead, then such commercialization shall be subject to prior review and approval by Gilead with regard to safety considerations.
Gilead shall make commercially reasonable efforts to determine, by itself or through Generic Licensees, the regulatory status in each country of the Generic Version (i) with different combination of APIs and (ii) with alternate dosage, for which Gilead give the approval or consent pursuant to Section 3.3 or 3.13 of this Amendment, respectively and shall annually report to JT thereon.
Notwithstanding anything in this Agreement to the contrary, the License shall not include the right for Licensee to, and Licensee shall not, Manufacture, Commercialize or Develop any Generic Version of the Product.
Depomed, on behalf of itself and its Affiliates, hereby further covenants not to Commercialize, and not to permit or cause any licensee, sublicensee or other Third Party to Commercialize, a Generic Version in the Territory, either directly or indirectly through a Third Party, except for settlements mutually agreed to by Santarus and Depomed.
More Definitions of Generic Version
Generic Version means, with respect to a particular Product, a product sold (i) by a Third Party (who is not authorized by Eisai or any of its Affiliates and who neither Arena nor any of its Affiliates has authorized at Eisai’s request) or (ii) by Arena, any of its Affiliates or any Third Party authorized by Arena or any of its Affiliates that, in each case ((i) or (ii)), (a) contains as an active pharmaceutical agent the same Compound or Related Compound that such Product contains as an active pharmaceutical agent, and (b) (1) if sold in the United States, has been approved for sales introduction into commerce in the United States by reference to the Regulatory Approval for such Product in the United States pursuant to Section 505(b)(2) or 505(j) of the FFDCA (or the successor thereof) or (2) if sold in a country other than the United States, has been approved for sale in such country pursuant to an equivalent regulatory law or regulation, but excluding for clarity any Products sold by Eisai or any Eisai Related Party during the Term.
Generic Version means, with respect to [***] a Product, any other prescription pharmaceutical product sold by a Third Party that is not a Sublicensee, or distributor of Mereo, its Affiliate, or their Sublicensees, that (i) contains the same API(s) as such Product, (ii) has the same [***] as such Product and (ii) is “therapeutically equivalent” as evaluated by the FDA, applying the definition of “therapeutically equivalent” set forth in the preface to the FDA’s Orange Book (or, with respect to any country in the Territory outside the United States, is similarly substitutable under equivalent Applicable Law in such country), with respect to such [***], as such Product.
Generic Version means, with respect to a Product, on a country-by-country basis, a pharmaceutical product that: (a) is sold in a given country by a Third Party, other than Curis, any of its Affiliates or any Sublicensee, or any other Third Party in a chain of distribution originating from Curis, any of its Affiliates or any Sublicensee; (b) contains the same Program Compound (and, if such Product is a fixed-dose combination that also contains any other active pharmaceutical ingredient that is not a Program Compound, the same other active ingredient(s)) as such Product in the same dosage form, strength (for each active ingredient and route of administration) as such Product; and (c) has been approved for marketing by the relevant Regulatory Authority in such country in reliance on the Marketing Approval for such Product in such country, including any such pharmaceutical product that has been approved for marketing (i) in the US, pursuant to Section 505(b)(2) or Section 505(j) of the Act (21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j), respectively), (ii) in the EU or an EU member state, as a “generic medicinal product” pursuant to Article 10 of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (iii) in any other country or jurisdiction, pursuant to any equivalent of the foregoing laws, regulations or directives, wherein the approval of such pharmaceutical product is based on reference to the Marketing Approval for such Product in such country and a demonstration of bio-equivalence to such Product and, in each case, which may be substituted for the Product without any action by the physician or health care practitioner.
Generic Version means, with respect to a Product, on a country-by-country basis, a pharmaceutical product that: (a) is sold in a given country by a Third Party, other than a Related Party, a licensee or sublicensee of a Related Party, or any other Person in a chain of distribution originating from Licensee, a Related Party or any of their respective licensees or sublicensees; (b) contains the same Compound (and, if applicable, the same Other Active(s)) as such Product in the same dosage form as such Product; and (c) has been approved for marketing by the relevant Regulatory Authority in such country in reliance on the Marketing Approval for such Product in such country, including any such pharmaceutical product that has been approved for marketing (i) in the United States, pursuant to Section 505(b)(2) or Section 505(j) of the Act (21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j), respectively), (ii) in the European Union or a European Union member state, as a “generic medicinal product” pursuant to Article 10 of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (iii) in any other country or jurisdiction, pursuant to any equivalent of the foregoing laws, regulations or directives, wherein the approval of such pharmaceutical product is based on reference to the Marketing Approval for such Product in such country and a demonstration of bio-equivalence to such Product and which may be substituted for the Product without any action by the physician or health care practitioner.
Generic Version means, with respect to a Product being sold in a country, a pharmaceutical product that: (a) contains as the active ingredient the Licensed Compound in such Product (or any salt, hydrate, solvate or ester of such Licensed Compound), and (b) is authorized for sale and use in the country on the basis of a marketing authorization that relies, in whole or in part, on safety and efficacy data in the NDA submitted to obtain Regulatory Approval for such Product in the country, without a right of reference or other authorization from Astellas or any of its Related Parties, such marketing authorization being: (i) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the Act, as amended (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), (ii) in the EU pursuant to a provision of Articles 10(1), 10(2), 10(3), 10(4) or 10a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, each as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), and (iii) in any other country or jurisdiction pursuant to Applicable Law that is equivalent to such provisions, but excluding for clarity any “authorized generic” that is authorized or permitted by Astellas or a Related Party.
Generic Version means, with respect to a Licensed Product sold by Licensee (or any of its Affiliates or Sublicensees) in the Field in a particular country in the Territory, any product that (a) is approved for sale in such country in reliance on the prior approval of such Licensed Product as determined by the applicable Regulatory Authority; and (b) is sold by a Third Party (i) that is a Compulsory Sublicensee authorized to market and sell such product or (ii) that is not a Sublicensee of Licensee (or any of its Affiliates) authorized to market and sell such product and that has not otherwise been authorized, directly or indirectly, by Licensee (or any of its Affiliates or Sublicensees) to market and sell such product.
Generic Version means, as to a Product, another product that is not owned, controlled or authorized by Seller or its Affiliates, or Seller’s sublicensees and licensees (acting pursuant to a license or sublicense under the Product Patent Rights) and that has received Regulatory Approval through a regulatory process by which the sponsor of the application for such Regulatory Approval for such other product or the Regulatory Authority approving such application relies, in whole or in part, on data included in the DAA for such Product.