Officially Discontinue definition

Officially Discontinue means any of: (a) delisting the NDA Product with the FDA; (b) delisting or removing all Licensed Patents, or the NDA Product, from the FDA’s Orange Book; (c) seeking or otherwise undertaking any action with the FDA to withdraw the NDA Product from the market; and/or (d) deleting, removing, designating as “obsolete” or canceling any National Drug Code(s) or any other relevant code(s) for the NDA Product from the applicable National Drug Data File maintained by First Databank (or any successor or equivalent organization), or from any other pricing database.
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Officially Discontinue means any of: (i) delisting the Brand Product with the FDA; (ii) delisting the ‘529 patent and/or ‘510 patent from the Orange Book; (iii) seeking action with the FDA to withdraw Brand Product from the market, unless required, requested or recommended by the FDA or another governmental authority to do so; or (iv) deleting, removing or canceling any National Drug Code(s) for the Brand Product from the applicable National Drug File.
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Officially Discontinue means any of: (a) delisting the products described in Neos NDA with the FDA; (b) delisting the Licensed Patents from the Orange Book unless Neos reasonably determines in good faith that such delisting is required under applicable law; (c) seeking action with the FDA to withdraw COTEMPLA XR-ODT™ from the market, unless required, requested or recommended by the FDA or another governmental authority to do so; or (d) deleting, removing, or canceling any National Drug Code(s) for COTEMPLA XR-ODT™from the applicable National Drug File.
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Examples of Officially Discontinue in a sentence

  • Section 10.01 From and after the Effective Date, Plaintiffs shall not (i) file any citizen petition or other submissions with the FDA or any other governmental agency that interferes with Actavis’s efforts to: (a) obtain FDA approval of the Actavis ANDAs; or (b) Market the Actavis Products as of the date and under the terms provided in this Settlement Agreement; or (ii) Officially Discontinue the NDA Products prior to expiration of the Licensed Patents.

  • Subject to Actavis’s compliance, neither shall Neos nor any of its Affiliates Officially Discontinue the products described in the Neos NDA prior to the expiration of the Licensed Patents, unless required, requested, or recommended to do so by the FDA or other governmental authority or applicable law.

  • From and after the Effective Date, Plaintiffs shall not (a) file any citizen petition or other regulatory submissions with the FDA or any other governmental agency, or otherwise interfere with Taro’s efforts to: (i) obtain FDA approval of the Taro ANDA; or (ii) Market the Taro Generic Product as of the date and under the terms provided in this Settlement Agreement; or (b) Officially Discontinue the NDA Product prior to expiration of the Licensed Patents for reasons other than safety or efficacy.

  • The Cadence Parties shall not, and shall not cause, authorize or encourage any Third Party to, Officially Discontinue the Cadence Product prior to expiration of the Licensed Patents.

  • From and after the Effective Date, Plaintiffs shall not (i) file any citizen petition or other regulatory submissions with the FDA or any other governmental agency, or otherwise interfere with Xxxxxxx’x efforts to: (a) obtain FDA approval of the Paddock ANDA; or (b) Market the Paddock Generic Product as of the date and under the terms provided in this Settlement Agreement; or (ii) Officially Discontinue the NDA Product prior to expiration of the Licensed Patents for reasons other than safety or efficacy.

  • Subject to Teva’s compliance, neither shall Neos nor any of its Affiliates Officially Discontinue the products described in the Neos NDA prior to the expiration of the Licensed Patents, unless required, requested, or recommended to do so by the FDA or other governmental authority or applicable law.


More Definitions of Officially Discontinue

Officially Discontinue means any of: (i) delisting Abstral® with the FDA; (ii) delisting the Licensed Patents from the Orange Book unless Orexo reasonably determines in good faith that such delisting is required under applicable law; (iii) seeking action with the FDA to withdraw Abstral® from the market, unless required, requested or recommended by the FDA or another governmental authority to do so; or (iv) deleting, removing or canceling any National Drug Code(s) for Abstral® from the applicable National Drug File.
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Officially Discontinue means any of: (a) delisting the NDA Product with the FDA; (b) delisting or removing any Licensed Patents, or the NDA Product, from the FDA’s Orange Book; (c) seeking or otherwise undertaking any action with the FDA to withdraw the NDA Product from the market other than actions to withdraw in response to toxicity, efficacy, or other safety concerns associated with the NDA Product; and/or (d) deleting, removing, designating as “obsolete” or canceling any National Drug Code(s) or any other relevant code(s) for the NDA Product from the applicable National Drug Data File maintained by First Databank (or any successor or equivalent organization), or from any other pricing database.
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Officially Discontinue means any of: (a) delisting the Cadence Product with the FDA; (b) seeking or otherwise undertaking any action with the FDA to withdraw the Cadence Product from the market; and/or (c) deleting, removing, designating as “obsolete” or canceling any National Drug Code(s) or any other relevant code(s) for the Cadence Product from the applicable National Drug Data File maintained by First Databank (or any successor or equivalent organization), or from any other pricing database. “Orange Book” means the FDA publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations (or any successor publication thereto). “Pediatric Exclusivity” means the period of exclusivity provided by 21 U.S.C. § 355a(b)(1)(B) (as amended or replaced) and/or 21 U.S.C. § 355a(c)(1)(B) (as amended or replaced). “Pending Litigation” means Cadence Pharmaceuticals, Inc. and *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
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Officially Discontinue means any of: (a) delisting the products described in Neos NDA with the FDA; (b) delisting the Licensed Patents from the Orange Book unless Neos reasonably determines in good faith that such delisting is required under applicable law; (c) seeking action with the FDA to withdraw ADZENYS XR-ODT® from the market, unless required, requested or recommended by the FDA or another governmental authority to do so; or (d) deleting, removing, or canceling any National Drug Code(s) for ADZENYS XR-ODT® from the applicable National Drug File. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Related to Officially Discontinue

  • Officially Designated means designated by the Shareholder of Record:

  • Socially and Economically Disadvantaged Individuals means those individuals who are citizens of the United Stated (or lawfully admitted permanent residents) and who are women, Black Americans, Hispanic Americans, Native Americans, Asian-Pacific Americans, or Asian-Indian Americans and any other minorities of individuals found to be disadvantaged by the Small Business Administration pursuant to Section 8 (a) of the Small Business Act, RIPTA shall make a rebuttal presumption the individuals in the following groups are socially and economically disadvantaged. RIPTA may also determine, on a case-by-case basis, that individuals who are not a member of one of the following groups are socially and economically disadvantaged:

  • Socially and economically disadvantaged individual means any individual who is a citizen (or lawfully admitted permanent resident) of the United States and who is —

  • Economically disadvantaged individual means an individual who is either: (1) eligible for services under the Workforce Investment Act of 1988 (WIA) (29 U.S.C.A 2801 et seq.), as determined by the San Francisco Private Industry Council; or (2) designated “economically disadvantaged” for the First Source Hiring Administration, as an individual who is at risk of relying upon, or returning to, public assistance.

  • Historically Disadvantaged Individual (HDI) - means a South African citizen:

  • Historically disadvantaged individuals (HDIs means all South African citizens –

  • Socially and economically disadvantaged person means an individual who is a citizen or lawful permanent resident of the United States and who is Black, Hispanic, Native American, Asian, Female; or a member of another group or an individual found to be disadvantaged by the Small Business Administration pursuant to Section 3 of the Small Business Act.

  • Haryana DISCOMs means the UTTAR HARYANA BIJLI VITRAN NIGAM LIMITED

  • Economically disadvantaged means to be eligible to receive free or reduced price

  • Historically Disadvantaged Individual (HDI) means a South African citizen -

  • Attack directed against any civilian population means a course of conduct involving the multiple commission of acts referred to in paragraph 1 against any civilian population, pursuant to or in furtherance of a State or organizational policy to commit such attack;

  • Intimidating, threatening, abusive, or harming conduct means, but is not limited to, conduct that does the following:

  • Institutionalized individual means an individual who is an inpatient in a nursing facility, who is an inpatient in a medical institution and with respect to whom payment is made based on a level of care provided in a nursing facility or who is eligible for home- and community-based waiver services.

  • Financially Evaluated Entity means the company which has been evaluated for the satisfaction of the financial requirement set forth in Clause 2.1.3 hereof;

  • Deadly weapon means any weapon, whether loaded or unloaded, from which a shot may be discharged, or a switchblade knife, gravity knife, billy, blackjack, bludgeon, or metal knuckles.

  • Specially Designated Nationals and Blocked Persons list maintained by the Office of Foreign Assets Control of the United States Department of the Treasury found at: xxxxx://xxx.xxxxxxxx.xxx/ofac/downloads/sdnlist.pdf;

  • Financially Literate means the ability to read and understand a set of financial statements that present a breadth and level of complexity of accounting issues that are generally comparable to the breadth and complexity of the issues that can reasonably be expected to be raised by the Corporation’s financial statements.

  • Disadvantaged Business Enterprise (DBE) means a firm certified as such by the Department in accordance with 49 CFR Part 26.

  • Current Employees has the meaning set forth in Section 6.4(a).

  • relevant Minister means the Secretary of State or the Minister for the Cabinet Office;

  • City Managerial Employee means the City Manager, the Assistant City Manager, the City Clerk, and any City department head or director. In the event CONTRACTOR violates the provisions of this paragraph, CONTRACTOR shall be required to pay damages to OWNER in an amount equal to any and all compensation which is received by the former Elected Officer or City Managerial Employee of OWNER from or on behalf of the contracting person or entity, or an amount equal to the former Elected Officer's or City Managerial Employee's last two (2) years of gross compensation from OWNER, whichever is greater.

  • Disclosure Order has the meaning set forth in Section 10.7.

  • Institutionalized means a person who is located voluntarily or involuntarily in a hospital, medical treatment facility, nursing home, acute care facility, or mental hospital.

  • Current Employee has the meaning set forth in Section 7.8(a).

  • Backsiphonage means the flow of water or other liquids, mixtures or substances into the potable water system from any source other than its intended source, caused by the reduction of pressure in the potable water system.

  • Recruit means any full-time or part-time law enforcement