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.
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.

Examples of Generic Competitor in a sentence

  • Example #1: Currently, Generic Competitor ‘1’ and Generic Competitor ‘2’ are marketed in Canada.

  • In the event that Generic Competitor ‘3’ chooses not to submit to a jurisdiction for listing at the compliant prince, Generic Competitor ‘1’ and Generic Competitor ‘2’ must still reduce their price to 25% of brand in order to be compliant with the Framework.

  • The Community Arts Grant Program focuses on developing new local cultural resources, and supporting programs and activities that reach diverse segments of the community.The Community Grants Program identifies two types of grants for funding: Seed Grants and Community Support Grants.Grant requests can range from $250 to$1,500 per grant year.

  • Kos and Barr Enter the Reverse Payment Agreement, Agreeing That Barr Will Not Launch A Generic Competitor to Niaspan For More Than Eight Years.

  • 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).

  • IQVIA, An Evaluation of Co-Pay Card Utilization in Brands After Generic Competitor Launch (IQVIA, January 2018), https://www.iqvia.com/ locations/united-states/library/fact-sheets/evaluation-of-co-pay-card-utilization.

  • If a Generic Competitor is first marketed and sold in the Field and Territory during the Royalty Term, then the royalty rate in Section 6.1.3(a) shall be lowered from [***] percent ([***]%) to [***] percent ([***]%) effective at the beginning of the subsequent Calendar Quarter.6.1.4. Pharmacovigilance Reimbursement.

  • By operation of the CLPs, if just one Generic Competitor launched a generic version of Bystolic prior to September 17, 2021 pursuant to any of the three above scenarios, all of the other Generic Competitors would have entered the market.

  • Generic Competitor 8 Id. at 179.9 Id.10 Id.11 Id. Amerigen“SETTLEMENT AGREEMENT between Forest Laboratories, Inc.

  • The site has been in use for approximately ten years and is worked by Mainstream in association with its other site in Loch Etive at Ardchattan.


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 SERVIER or its Related Parties.
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 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..
Generic Competitor means, with respect to any Product, [*];
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. page 5 of 58 110717/BCN/GG
Generic Competitor means, with respect to any Licensed Product in a country, [***]

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 business, individual, partnership, joint venture, association, firm, corporation or other entity, other than the Employer or its affiliates or subsidiaries, engaged, wholly or partly, in Company Activities.

  • 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 firm, partnership, joint venture, corporation and/or any other Person, and/or any licensee of such entity, that develops, manufactures, markets, distributes, provides, offers, or sells any services or products substantially similar to First Party’s services or 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;

  • 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 or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, 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 will not include (i) the mere ownership of securities in any such enterprise and the exercise of rights appurtenant thereto or (ii) participation in the management of any such enterprise other than in connection with the competitive operations of such enterprise.

  • 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 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.

  • 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 set out in section 4 of this 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