Generic Competitor definition

Generic Competitor means a pharmaceutical product with the same active ingredient, therapeutic dosage, dosing schedule, safety profile, and administration route as the Product, and which has been approved by the Regulatory Authority in the Territory with the Product as the reference product.

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Generic Competitor means, with respect to a particular Licensed Product in a country, a pharmaceutical product that (a) contains a highly similar (if such Licensed Product is regulated in such country as a biological product) or identical (if such Licensed Product is regulated in such country as a small molecule or other new chemical entity product) active ingredient(s) as such Licensed Product, (b) is approved for use in such country pursuant to an abbreviated or expedited regulatory approval process (or other process for countries where there is no such abbreviated or expedited process) governing approval of generic pharmaceutical products or bio-similar products based on (i) the then-current standards for regulatory approval in such country and/or on (ii) data generated by the Parties pursuant to this Agreement, and (c) is sold in the same country as such Licensed Product by any Third Party that is not a licensee or sublicensee of Servier (for such product or for such Licensed Product) or an Affiliate of Servier and that did not purchase such product in a chain of distribution that included any of Servier or its Affiliates or any such licensees or sublicensees.

Generic Competitor means, with respect to any Product in a country, a product containing the same active ingredient as the Product, and which Marketing Authorization and commercial sale of such product in such country is by an entity other than SERVIER or its Related Parties.

Examples of Generic Competitor in a sentence

• Additionally, during the Term, none of Partner or its Affiliates, Approved Sublicensees, or Distributors nor Atara or its Affiliates shall (a) take any action to seek, or engage in, the development, regulatory approval, manufacture or commercialization of a Generic Competitor or (b) enable any Third Party to do the same.

• If any Generic Competitor of the Licensed Product receives Marketing Authorization in the Territory and subsequently Knight’s market share [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.

• During the Term, none of Partner or its Affiliates, Approved Sublicensees, or Distributors shall (a) practice, or authorize any Third Party to practice, any Atara Intellectual Property for any purpose other than as expressly authorized in this Agreement, (b) take any action to seek, or engage in, the Development, Regulatory Approval, Manufacture or Commercialization of a Generic Competitor or (c) enable any Third Party to do the same.

• Minimum annual royalties shall be (i) $[*] for the first four Quarters following the Approval Date and (ii) $[*] for every four Quarter period thereafter, pro rated for any portion thereof, until the initial sale of a Generic Competitor to the Product.

• Minimum annual royalties shall be (i) $ 2,000,000 for the first four Quarters following the Approval Date and (ii) $ 4,000,000 for every four Quarter period thereafter, pro rated for any portion thereof, until the initial sale of a Generic Competitor to the Product.

More Definitions of Generic Competitor

Generic Competitor means, with respect to any Product in a country, a product containing the same active ingredient as the Product, and which Marketing Authorization and commercial sale of such product in such country is by an entity other than INTERCEPT, SERVIER, or their respective Affiliates or Sublicensees (not including distributors).

Generic Competitor means a pharmaceutical product for human use approved by FDA, that contains a buccal form of prochlorperazine maleate, and that is bioequivalent to the Product.

Generic Competitor means, with respect to any Product, [*];

Generic Competitor means, with respect to a Product, on a country-by-country basis within the Territory, one or more pharmaceutical product(s) (a) sold under a Marketing Authorization granted by an applicable Regulatory Authority to a Third Party (who is not an Affiliate of Partner or an Approved Sublicensee or a Distributor), (b) that contains the same or biologically similar active ingredient as the Product (whether or not in the same formulation or a similar formulation as the Product), and (c) is approved in reliance of a prior Marketing Authorization of the Product granted by the applicable Regulatory Authority, including for the avoidance of doubt, the Marketing Authorization transferred by ▇▇▇▇▇ to Partner under this Agreement.

Generic Competitor means, with respect to any Product in a country, a product containing the same active ingredient as the Product, and which Marketing Authorization and commercial sale of such product in such country is by an entity other than SERVIER or its Related Parties. Portions of this Exhibit, indicated by the m▇▇▇ “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

Generic Competitor means with respect to the Product, a non-proprietary product: (a) with […***…] as the Product; (b) that has obtained Regulatory Approval from the applicable Regulatory Authority solely by means of an abbreviated procedure for establishing equivalence to the Product; and (c) is legally marketed in such country by or under the authority of an entity other than Newsoara, its Affiliates or sublicensees.