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

  • Sandoz, Press Release: Sandoz Announces U.S. Launch of Glatopa, the First Generic Competitor to Copaxone 20 mg (June 19, 2015) (online at www.us.sandoz.com/news/media-releases/sandoz-announces-us- launch-glatopatm-first-generic-competitor-copaxoner-20mg).

  • 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.

  • 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.

  • See, e.g., IQVIA, Fact Sheet: An Evaluation of Co-Pay Card Utilization in Brands After Generic Competitor Launch (2018), https://www.iqvia.com/locations/united- states/library/fact-sheets/evaluation-of-co-pay-card-utilization; AIDS Inst., Copay Accumulator Adjustment Programs: Putting Insurance Company Profits Over Patients 3–4, 8 (June 2020), https://aidsinstitute.net/documents/TAI- CoPay_Accumulator_Adjustment_Program_Report-w-Appendix.pdf.

  • 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).
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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.
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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 Xxxxx to Partner under this Agreement.
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Generic Competitor means, with respect to any Product, [*];
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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.
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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 mxxx “[***],” 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.
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Related to Generic Competitor

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

  • Direct Competitor means any individual, partnership, corporation, limited liability company, association, or other group, however organized, who competes with the Company in the full service restaurant business.

  • Competitor means any individual, corporation, partnership or other entity that engages in (or that owns a significant interest in any corporation, partnership or other entity that engages in) any business conducted by the Company or any of its Affiliates.

  • 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.

  • Company Competitor means any competitor of the Borrower and/or any of its subsidiaries.

  • Competing Product means [***].

  • 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.

  • Competitive Business means any person or entity that engages in any business activity that competes with the Company’s business in any way, in any geographic area in which the Company engages in business, including, without limitation, any state in the United States in which the Company sells or offers to sell its products from time to time.

  • 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;

  • Generic String means a string consisting of a word or term that denominates or describes a general class of goods, services, groups, organizations or things, as opposed to distinguishing a specific brand of goods, services, groups, organizations or things from those of others.

  • Competitive Business Activity means:

  • Generic Equivalent or "generically equivalent" means a drug that has an identical amount of the same active chemical ingredients in the same dosage form, that meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and that, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Generic name means a short title which is descriptive of the premium and benefit patterns of a policy or a rider.

  • 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 Activity means any business or activity of Executive or any third party that is the same as the Business or competitive with the Business.

  • Competitive Set As defined in the STR Reports. Lessor and Lessee shall work in good faith to determine any additions and deletions to the Hotel’s Competitive Set, on or before November 15th of each year, with such changes to be applicable for the following Fiscal Year. In the event Lessor and Lessee cannot agree to the Hotel’s Competitive Set by November 15th of any year, such unagreed items shall be determined by Xxxxx Travel Research (or, if it refuses or is unable to do so, by arbitration pursuant to Section 25.2). The costs of resetting the Hotel’s Competitive Set shall be borne equally by the parties.

  • Competitive Process means either an Open Competition or an Invitational Competition;

  • Competitive Infringement has the meaning set forth in Section 7.5.1.

  • 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.

  • licensed activity means any activity or activities listed in section 21 of the 2010 Act which is, or are authorised under the licence;

  • Competitive integrated employment means work (including self-employment) that is performed on a full-time or part-time basis:

  • Prospective Customer means any individual, corporation, trust or other business entity which has either (a) entered into a nondisclosure agreement with the Company or any Company subsidiary or affiliate or (b) has within the preceding 12 months received a currently pending and not rejected written proposal in reasonable detail from the Company or any of the Company’s subsidiary or affiliate.

  • 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 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).

  • Competitive service means any service offered by an electric