Competing Generic definition

Competing Generic means, with respect to a given Product and a given country in the Territory, a product sold by a Third Party in such country, other than as a Sublicensee of Lilly or its Affiliates under this Agreement, that (a) receives Marketing Authorization as a generic, follow-on, hybrid, or interchangeable product of such Product from the applicable Regulatory Authority in such country by referencing the Drug Approval Application (or data therein) for the Product or (b) which is approved under an abbreviated pathway under the FDCA or similar legislation in the relevant country. For purposes of this Agreement, Competing Generic in the United States means a product sold by a Third Party in such country, other than as a Sublicensee of Lilly or its Affiliates under this Agreement, that (i) receives approval under an abbreviated new drug application (“ANDA”) referencing Product], or (ii) receives approval through an FDCA section 505(b)(2) application referencing Product and is determined by the FDA to be therapeutically equivalent to Product as documented in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (the “Orange Book”), or (iii) receives approval through a process that does not exist as of the Effective Date but that satisfies the first sentence of this Section 1.37.

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Competing Generic means, with respect to a given Licensed Product (or Compound contained in a given Licensed Product) and a given country in the Territory, any pharmaceutical product sold by a Third Party within the Royalty Term in such country that receives Marketing Approval as a generic, follow-on or interchangeable product of such Licensed Product from the applicable Governmental Authority in such country by referencing or relying upon data from the Regulatory Materials for the Licensed Product or otherwise relying upon the approval of the Licensed Product.

Competing Generic means, with respect to a given Licensed Product and a given country in the Territory, a product sold by a Third Party in such country, other than as a Sublicensee of Lilly or its Affiliates under this Agreement, that (x) receives Marketing Authorization as a generic, follow-on, hybrid, biosimilar, or interchangeable product of such Licensed Product from the applicable Regulatory Authority in such country by referencing the Drug Approval Application (or data therein) for the Licensed Product or (y) which is approved under an abbreviated pathway under the BPCI Act or similar legislation in the relevant country.

Examples of Competing Generic in a sentence

The obligation to pay royalties continues until the later of (i) at least one unexpired Valid Claim covers any Licensed Product that is generating any Net Profits and (ii) no Valid Claim covers any of the Licensed Product that is generating any Net Profits, but no Competing Generic Product has been sold in the PRC or Hong Kong.
This Agreement expires at the latest of (i) when the last Valid Claim in a Licensed Patent or in an Improvement, Licensee Improvement or Joint Improvement patent expires or is finally and irrevocably held to be invalid or unenforceable by an authority of competent jurisdiction and (ii) the first documented, lawful third party sale of a Competing Generic Product in the PRC or Hong Kong, unless terminated earlier as provided herein or unless extended by mutual written agreement.
If a Competing Generic Version first comes into existence during the first half of a calendar quarter, it will be deemed to have been in existence from the first day of such quarter, and if it first comes into existence during the second half of a calendar quarter, it will be deemed not to have been in existence until the first day of the following quarter.
COUNTY is and shall at all times remain as to the CITY a wholly independent contractor.
For purposes of clarity, in any Calendar Quarter during which there are sales of a Competing Generic, the applicable royalty reduction shall be effective beginning in the Calendar Quarter in which the sales of such Competing Generic reaches the above threshold in such country.
Each Party shall notify the other as promptly as practicable if, during the Royalty Term, it becomes aware of an Approval being issued to sell a Competing Generic in the Territory.
ROYALTY RATES The royalty rates will vary depending on whether, and how many, Competing Generic Versions are in existence during the calendar quarter in which the royalties accrue, and the Net Sales then reached for that year.

More Definitions of Competing Generic

Competing Generic is defined in Section 8.3.2(d).

Competing Generic means, any topically delivered product in a given country or Region in the Territory, that contains a different active pharmaceutical ingredient as a Licensed Product and (a) is approved in reliance, in whole or in part, on a prior Regulatory Approval of a product other than the Licensed Product (“Other Reference Product”), (b) is otherwise approved under any then-existing laws and regulations in the applicable country or Region pertaining to approval of generic products, as a “generic” version of the Other Reference Product, which approval relies, in whole or in part, on a prior Regulatory Approval of such Other Reference Product or (c) is otherwise recognized by the applicable Regulatory Authority as an interchangeable product to the Other Reference Product and in each case (a) through (c), has received Regulatory Approval for the treatment of any Indication. 1.45 “Competing Product” means any (a) topically delivered product being Developed or that received Regulatory Approval for the treatment of any Indication; provided, that, [***], and (b) topically delivered selective phosphodiesterase-4 inhibitor being Developed or that received Regulatory Approval for any indication, [***]. 1.46 “Competitive Activities” has the meaning set forth in Section 2.8.2 (Business Combinations). 1.47 “Competitive Infringement” means any infringement of the Licensed Patent Rights that arises as a result of the making, using, offering to sell, selling, or importing of a product in the Field in the Territory that would be competitive with the Commercialization of a Licensed Product in the Field in the Territory. 1.48 “Compliance Breach” means a finding by a Regulatory Authority that Licensee or any of its Representatives, Affiliates, Sublicensees, or Subcontractors has committed a violation of Applicable Law in connection with its activities under this Agreement. 1.49 “Compliance Finding” means any findings in an audit conducted by or on behalf of Licensor in accordance with Section 12.8.2 (Compliance Audits), or information otherwise learned by Licensor, which findings or information reasonably indicate that there has been or will reasonably likely be a violation or a pattern of violations by Licensee or its Representatives,