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.
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Competing Generic is defined in Section 8.3.2(d).
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Examples of Competing Generic in a sentence

  • 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.

  • 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.

  • The price for the Formulated TIMERx(R) product to be supplied by TIMERx Technologies to Schwxxx Xxxrma will vary depending on whether, and how many, Competing Generic Versions are in existence when the product units are ordered.

  • 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.

  • 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 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.
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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,
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Related to Competing Generic

  • Competing Product means [***].

  • Competing Products means any product or service in existence or under development that competes with any product or service of the Company Group about which the Participant obtained Confidential Information or for which the Participant provided advisory services or had sales, origination, marketing, production, distribution, research or development responsibilities in the last twenty-four (24) months of employment with the Company Group.

  • Competitive Product means a product or service, made or provided by a Competitor, which is the same as or is directly competitive with one with respect to which the Employee acquired confidential information relating to the Company, or its business, products or services by reason of the Employee's work with the Company.

  • Competing Services means to provide, manage, supervise, or consult about (whether as an employee, owner, partner, stockholder, investor, joint venturer, lender, director, manager, officer, employee, consultant, independent contractor, representative or agent, or otherwise) any services that are similar in purpose or function to services you provided to the Company in the two year period preceding the termination of your employment, that might involve the use or disclosure of Confidential Information, or that would involve business opportunities related to Relevant Products.

  • Competitive Products shall include any product or service that directly or indirectly competes with, is substantially similar to, or serves as a reasonable substitute for, any product or service in research, development or design, or manufactured, produced, sold or distributed by the Company;

  • Competing Product or Service means any product or service that is sold in competition with, or is being developed and that will compete with, a product or service developed, manufactured, or sold by Fiserv. For purposes of this Section 5, Competing Products or Services as to you are limited to products and/or services with respect to which you participated in the development, planning, testing, sale, marketing or evaluation on behalf of Fiserv during any part of your employment with Fiserv, or after the termination of your employment, during any part of the 24 months preceding the termination of your employment with Fiserv, or for which you supervised one or more Fiserv employees, units, divisions or departments in doing so.

  • Competing Proposal means a proposal, offer or invitation to the Company, any Party or any of a Party’s Affiliates (other than the Proposal), that involves the acquisition of Control of the Target, a sale of all or a substantial part of the assets of the Target, a restructuring or recapitalization of the Target, or some other transaction that would adversely affect, prevent or materially reduce the likelihood of the consummation of the Transaction with the Parties.

  • Restricted Territory means the United States of America.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Competing Activity means the providing of services or performance of activities for a Competitive Enterprise in a line of business that is similar to any line of business to which the Executive provided services to the Firm in a capacity that is similar to the capacity in which the Executive acted for the Firm while employed by the Firm, and (ii) “Competitive Enterprise” shall mean a business (or business unit) that (A) engages in any activity or (B) owns or controls a significant interest in any entity that engages in any activity, that in either case, competes anywhere with any activity in which the Firm is engaged up to and including the Executive’s Date of Termination. Further, notwithstanding anything in this Section 5, the Executive shall not be considered to be in violation of this Section 5 solely by reason of owning, directly or indirectly, any stock or other securities of a Competitive Enterprise (or comparable interest, including a voting or profit participation interest, in any such Competitive Enterprise) if the Executive’s interest does not exceed 5% of the outstanding capital stock of such Competitive Enterprise (or comparable interest, including a voting or profit participation interest, in such Competitive Enterprise).

  • Competing Permitted Bid means a Take-over Bid that:

  • Geographic Territory shall include any territory formally assigned to Employee as well as all territories in which Employee has provided any services, sold any products or otherwise had responsibility at any time during the eighteen (18) month period preceding Employee’s date of separation;

  • Competing Activities means the same or similar services as Xxxxxx Xxx Ltd is providing to the Restaurant under this Agreement or other activities having a similar purpose.

  • Competing Business means any person or entity that competes with the Company Group in the sale, marketing, production, distribution, research or development of Competing Products in the same markets.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Competing Organization means any person or organization engaged in, or with definitive plans to become engaged in, research or development, production, distribution, marketing or selling of a Competing Product.

  • Competitive Activities means any business activities in which the Company or any other member of the Company Group engage (or have committed plans to engage) during the Term of Employment, or, following termination of Employee’s employment hereunder, was engaged in business (or had committed plans to engage) at the time of such termination of employment.

  • Competing Transaction has the meaning set forth in Section 6.1(n).

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Generic Competition has the meaning set forth in Section 7.4.3.

  • Competitive Products or Services means, as of any time, those products or services of the type that any of the Bank Entities is providing, or is actively preparing to provide, to its customers.

  • Competing Entity means any entity or person that is engaged, directly or indirectly, in a Competitive Business.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Competitive Process means a formal sealed, electronic, or web-based bid procedure used for all nonclaims related purchases for goods and services over fifty thousand dollars. For purchases between five thousand dollars and fifty thousand dollars, competitive process means quotations obtained from at least three vendors by telephone or written quotations, or both, and supported by evidence of competition. Purchases up to five thousand dollars are exempt from competitive bids providing procurement is based on obtaining maximum quality at minimum cost.

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Least developed country end product means an article that—