Generic Drug Enforcement Act Sample Clauses

Generic Drug Enforcement Act. To the Knowledge of Agouron, none of the individuals set forth on Exhibit 3.2(z) have ever (i) been employed or contracted for services by Agouron, or (ii) contributed to the development of any of the Investigational Compounds.
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Generic Drug Enforcement Act. Supplier has not used and will not use in the manufacture of the BX7, Validation Batches or the API Compound in any capacity the services of any person, including any firm or individual, debarred or subject to debarment under the Generic Drug Enforcement Act of 1992, amending the Act at 21 U.S.C. 335a. Supplier agrees to notify Adolor immediately in the event any person providing services to Supplier relating to this Agreement is debarred or becomes subject to debarment.
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Generic Drug Enforcement Act. 37 3.3 Representations and Warranties of Warner-Lambert and Merger Sub . . . . . . . . . . . . . . . . . . . . . . . 37 (a) Organization . . . . . . . . . . . . . . . . . . . . 37 (b) Corporate Authorization . . . . . . . . . . . . . . 37 (c) Non-Contravention . . . . . . . . . . . . . . . . . 37 (d) No Business Activities . . . . . . . . . . . . . . . 38 ARTICLE IV
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Generic Drug Enforcement Act. Neither Purchaser, it Affiliates nor any of their respective officers, directors, employees, agents or consultants have been charged with or convicted under federal law for conduct relating to the development or approval of, or otherwise relating to the regulation of, any product under the Generic Drug Enforcement Act of 1992 or any other relevant statute, law or regulation.
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Generic Drug Enforcement Act. PII has not used and will not use in the manufacture of Drug Product in any capacity the services of any person, including any firm or individual, debarred or subject to debarment under the Generic Drug Enforcement Act of 1992, amending the Act at 21 U.S.C. 335a. PII agrees to notify Adolor immediately in the event any person providing services to PII relating to this Agreement is debarred or becomes subject to debarment.
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Generic Drug Enforcement Act. Neither Noven, its Affiliates nor any of their respective officers, directors, employees, agents or consultants have been charged with or convicted under federal law for conduct relating to the development or approval of, or otherwise relating to the regulation of, any product under the Generic Drug Enforcement Act of 1992 or any other relevant statute, law or regulation. Neither Noven, its Affiliates nor any of their respective officers, directors, employees, agents or consultants has been debarred under Section 306(a) or Section 306(b) of the FDC Act, nor convicted of any offense required to be listed under Section 306(k)(2) of the FDC Act.
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Generic Drug Enforcement Act. Neither P&GP, its Affiliates nor any of their respective officers, directors, employees, agents or consultants have been charged with or convicted under federal law for conduct relating to the development or approval of, or otherwise relating to the regulation of, any product under the Generic Drug Enforcement Act of 1992 or any other relevant statute, law or regulation. Neither P&GP, its Affiliates nor any of their respective officers, directors, employees, agents or consultants has been debarred under Section 306(a) or Section 306(b) of the FDC Act, nor convicted of any offense required to be listed under Section 306(k)(2) of the FDC Act.
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Related to Generic Drug Enforcement Act

  • Regulatory Enforcement Actions The Company, the Bank and its other Subsidiaries are in compliance in all material respects with all laws administered by and regulations of any Governmental Agency applicable to it or to them, the failure to comply with which would have a Material Adverse Effect. None of the Company, the Bank, the Company’s or the Bank’s Subsidiaries nor any of their officers or directors is now operating under any restrictions, agreements, memoranda, commitment letter, supervisory letter or similar regulatory correspondence, or other commitments (other than restrictions of general application) imposed by any Governmental Agency, nor are, to the Company’s knowledge, (a) any such restrictions threatened, (b) any agreements, memoranda or commitments being sought by any Governmental Agency, or (c) any legal or regulatory violations previously identified by, or penalties or other remedial action previously imposed by, any Governmental Agency remains unresolved.

  • Regulatory Enforcement Matters Except as disclosed in the Registration Statement, the Prospectus and the Disclosure Package, neither the Company nor any of its subsidiaries is subject or is party to, or has received any written notice that any of them may or will become subject or party to any investigation with respect to, any cease-and-desist order, written agreement, consent agreement, memorandum of understanding or other regulatory enforcement action, proceeding or order with or by, or is a party to any commitment letter or similar undertaking to, or is subject to any directive by, or has been a recipient of any supervisory letter from, or has adopted any board resolutions at the request of, any Regulatory Agency (as defined below) that in any material respect (considered on a consolidated basis) currently relates to or restricts the conduct of their business or that in any manner relates to their capital adequacy, their credit policies, or their management (each, a “Regulatory Agreement”), nor has the Company or any of its subsidiaries been advised in writing by any Regulatory Agency that it is considering issuing or requesting any such Regulatory Agreement, where any such Regulatory Agreement could reasonably be expected to have a Material Adverse Effect. Except as disclosed in the Registration Statement, the Prospectus and the Disclosure Package, there is no unresolved violation, criticism or exception by any Regulatory Agency with respect to any report or statement relating to any examination of the Company or any of its subsidiaries which, in the reasonable judgment of the Company, is expected to result in a Material Adverse Effect or is expected to prevent or materially delay the transactions contemplated by this Agreement. As used herein, the term “Regulatory Agency” means any federal or state agency charged with the supervision or regulation of depository institutions, or holding companies of depository institutions, or engaged in the insurance of depository institution deposits, or engaged in the regulation and enforcement of consumer financial services, or any court, administrative agency or commission or other federal or state governmental agency, authority or instrumentality having supervisory or regulatory authority with respect to the Company or any of its subsidiaries.

  • Patent Enforcement (a) If either Party learns of an infringement, unauthorized use, misappropriation or ownership claim or threatened infringement or other such claim (any of the foregoing, an “infringement”) by a Third Party with respect to any Licensed Technology within the Territory, such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such infringement.

  • No Enforcement Actions Notwithstanding Section D of Article V, the Custodian shall not be under any duty or obligation to take action, by legal means or otherwise, to effect collection of any amount, if the Securities upon which such amount is payable are in default, or if payment is refused after due demand or presentation, unless and until (i) it shall be directed to take such action by Written Instructions and (ii) it shall be assured to its satisfaction (including prepayment thereof) of reimbursement of its costs and expenses in connection with any such action.

  • Enforcement Actions Either the Company or Executive may bring an action in court to compel arbitration under this Agreement and to enforce an arbitration award. Except as otherwise provided in this Agreement, neither party shall initiate or prosecute any lawsuit in any way related to any arbitrable claim, including without limitation any claim as to the making, existence, validity, or enforceability of the agreement to arbitrate. All arbitration hearings under this Agreement shall be conducted in Las Vegas, Nevada.

  • INFRINGEMENT AND PATENT ENFORCEMENT 11.1 PHS and Licensee agree to notify each other promptly of each infringement or possible infringement of the Licensed Patent Rights, as well as, any facts which may affect the validity, scope, or enforceability of the Licensed Patent Rights of which either party becomes aware.

  • Enforcement of Licensed Patents Each party shall promptly notify the other in writing of any alleged or threatened infringement of any Patent included in the Licensed Patents of which such party becomes aware.

  • Anti-Terrorism Neither Buyer or Seller, nor any of their affiliates, are in violation of any Anti-Terrorism Law (as hereinafter defined) or engages in or conspires to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law. “Anti-Terrorism Laws” shall mean any laws relating to terrorism or money laundering, including: Executive Order No. 13224; the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001, Public Law 107-56, as the same has been, or may hereafter be, renewed, extended, amended or replaced; the applicable laws comprising or implementing the Bank Secrecy Act; and the applicable laws administered by the United States Treasury Department’s Office of Foreign Asset Control (as any of the foregoing may from time to time be amended, renewed, extended, or replaced).

  • Enforcement of Patents As between the Parties, (i) Prosecuting Party pursuant to 6.2.2 shall have the first right, but not the obligation, to prosecute any Infringement with respect to the Exclusive Licensed Patents including as a defense or counterclaim in connection with any Third Party Infringement Claim, at Prosecuting Party’s sole cost and expense, using counsel of Prosecuting Party’s choice and (ii) MedImmune shall have the sole right, but not the obligation, to prosecute Infringement with respect to the Non-Exclusive Licensed Technology, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at MedImmune’s sole cost and expense, using counsel of its choice. For purposes of this Section 6.3, the Party prosecuting any Infringement pursuant to the foregoing sentence with respect to a Patent shall be the “Enforcing Party.” In the event MedImmune prosecutes any such Infringement in the Field in the Territory, Licensee shall have the right to join as a party to such claim, suit or proceeding and participate with its own counsel at its sole cost and expense; provided that MedImmune shall retain control of the prosecution of such claim, suit or proceeding, including the response to any defense or defense of any counterclaim raised in connection therewith. In the event Licensee prosecutes any such Infringement in the Field in the Territory, MedImmune shall have the right to join as a party to such claim, suit or proceeding and participate with its own counsel at its sole cost and expense; provided that Licensee shall retain control of the prosecution of such claim, suit or proceeding, including the response to any defense or defense of any counterclaim raised in connection therewith. If the Enforcing Party or its designee does not take commercially reasonable steps to prosecute an Infringement in the Field (x) within [***] days following the first notice provided above with respect to such Infringement or (y) provided such date occurs after the first such notice of such Infringement is provided, [***] Business Days before the time limit, if any, set out in appropriate laws and regulations for filing of such actions, whichever comes first, then (1) the Enforcing Party shall so notify the non-Enforcing Party and (2) subject to any rights of any Third Parties under any In-License Agreements (or other applicable Third Party agreements existing as of the Effective Date) and upon the Enforcing Party’s written consent (such consent not to be unreasonably withheld, conditioned or delayed), the non-Enforcing may prosecute such alleged or threatened infringement in the Field at its sole cost and expense, whereupon the non-Enforcing Party shall be deemed the Enforcing Party with respect to such Infringement.

  • Enforcement of Patent Rights Kite, at its sole expense, shall have the right to determine the appropriate course of action to enforce Licensed Patent Rights or otherwise xxxxx the infringement thereof, to take (or refrain from taking) appropriate action to enforce Licensed Patent Rights, to defend any declaratory judgments seeking to invalidate or hold the Licensed Patent Rights unenforceable, to control any litigation or other enforcement action and to enter into, or permit, the settlement of any such litigation, declaratory judgments or other enforcement action with respect to Licensed Patent Rights, and shall consider, in good faith, the interests of Cabaret in so doing. Kite shall bring any such enforcement action in Kite’s own name; provided, however, if necessary for standing purposes only, (a) Kite shall have, subject to Cabaret prior consent which shall not be unreasonably withheld, delayed for more than […***…] after written request by Kite, or conditioned, the right to bring such action in the name of ***Confidential Treatment Requested Cabaret (all costs to be borne by Kite) if Cabaret is the party with legal standing, and (b) Cabaret shall make all reasonable efforts to enable Kite to bring such enforcement action in the name of any Licensor that is the party with legal standing. If Kite does not, within […***…] of receipt of notice from Cabaret, xxxxx the infringement or file suit to enforce the Licensed Patent Rights against at least one infringing party, Cabaret shall have the right to take whatever action it deems appropriate to enforce the Licensed Patent Rights; provided, however, that, within […***…] after receipt of notice of Cabaret’s intent to file such suit, Kite shall have the right to jointly prosecute such suit and to fund up to […***…] the costs of such suit. The party controlling any such enforcement action shall not settle the action or otherwise consent to an adverse judgment in such action that diminishes the rights or interests of the non-controlling party without the prior written consent of the other party. All monies recovered upon the final judgment or settlement of any such suit to enforce the Licensed Patent Rights shall be used (a) first, to reimburse the costs and expenses (including reasonable attorneys’ fees and costs) of Kite and Cabaret; and (b) second, (i) if Cabaret is the controlling party in such action, any remaining recovery shall be divided equally between Kite and Cabaret, or (ii) if the controlling party is Kite, any remaining recovery shall be divided between Kite and Cabaret in shares that reflect the damages incurred by each party to reflect the applicable royalty to Cabaret hereunder for lost sales, and the lost profits (net of such royalties) to Kite for lost sales , provided that in any case the amount paid to Cabaret shall not be less than the applicable royalty rate if such recovery was received as Net Sales.

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