FDA Action Sample Clauses

FDA Action. Such termination shall be immediately effective in the event of action by the FDA or any federal, state or local regulatory agency, board, or group removing or recalling Product or materially interrupting with the continuous manufacturing, packaging, or shipping of the Product;
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FDA Action. In the event that, based upon a decision with respect to, or resolution of, the FDA Action, Licensor has the legal right to perform Procedures in the Field at its Broomfield, Colorado site and/or other locations within the United States (collectively, “U.S. Facilities”) and Licensee does not have such right, then, subject to the terms and conditions of this Agreement, subject to Licensor being in compliance with its obligations under this Agreement, effective upon the date on which Licensor has such right, Licensor shall be granted the U.S. Sublicense under Section 2.1(c) (but only with respect to the particular U.S. Facilities at which it has such right) and shall be obligated to pay the royalty amount to Licensee provided for in Section 4.4. Once granted, the U.S. Sublicense shall continue in full force and effect notwithstanding that Licensee subsequently obtains the legal right to perform Procedures in the Field within the United States. All Procedures performed by Licensor at its U.S. Facilities pursuant to the U.S. Sublicense shall be in accordance with protocols that are approved in writing by Licensee (such approval not to be unreasonably withheld). Licensor shall advise Licensee promptly in writing as to any material developments with regard to the FDA Action and shall furnish to Licensee promptly copies of all documents submitted by Licensor and/or its counsel to, and received by Licensor and/or its counsel from, the FDA and/or its counsel in connection with the FDA Action. In connection with any settlement of the FDA Action, (a) Licensor shall seek to include Licensee as a third party beneficiary of the provisions thereof and (b) Licensor shall discuss proposed settlement terms with Licensee to the extent they relate to the Field.
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FDA Action. Each Party shall have the right to terminate this Agreement immediately if the Product is withdrawn from the market due to material health or safety concerns relating to the Product.
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FDA Action. (a) The FDA or DEA shall have taken any action which results in a partial or total suspension of either Company's production or shipment of products or seizure of either Company's products; (b) the Companies shall have failed to make a written response, within 10 days, to the FDA, with a copy to the Administrative Agent, to any written communication received from the FDA that raises any deficiencies in either Company's operations; (c) the FDA or DEA shall have imposed fines against the Companies in an aggregate amount greater than $250,000; or (d) the FDA or DEA shall have taken any other material adverse action based on an alleged failure to comply with governmental laws or regulations.
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FDA Action. There shall have been no adverse action taken by the Food and Drug Administration that would, or would be reasonably expected to, prohibit or significantly limit the manufacture, sale, promotion or distribution of any products of STC or the operation of STC; and
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FDA Action. There shall have been no adverse action taken by the Food and Drug Administration that would, or would reasonably be expected to, prohibit or significantly limit the manufacture, sale, promotion or distribution of any products of Epitope or the operations of Epitope;
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FDA Action. In the unlikely event of a product recall, either taken voluntarily or as required by the United States Food and Drug Administration (FDA), or other relevant US regulatory authority, CBL shall notify MFI within 72 hours of the commencement of such recall effort.
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FDA Action. In the event that the U.S. Food and Drug Administration (or any successor or designee thereof, the “FDA”) acts to restrict any Product in the Product Line from sale or distribution in the United States (an “FDA Action”), and if such FDA Action directly results in the failure of the Product Line to generate Net Sales sufficient to equal the Minimum Annual Royalty Fee in any year during the Term, the Company shall, irrespective of its actual Net Sales of the Product Line: (a) continue to pay in cash to Xxxxxxx on a quarterly basis the Minimum Annual Royalty Fee for a period of four years and thereafter pay in cash to Xxxxxxx on a quarterly basis two times the amount of the Minimum Annual Royalty Fee; and (b) issue to Xxxxxxx that number of fully-paid, non-assessable restricted shares of common stock of the Company equal to One Hundred Thousand Dollars ($100,000.00), with such shares to be valued as of the date of issuance by the Company to Xxxxxxx (collectively, sub-clauses (a) and (b) are referred to hereinafter as the “FDA Fees”). The FDA Fees shall be paid: (x) no later than fifteen (15) days following the anniversary of such FDA Action then in effect; (y) only during the Term; and (z) only once during the twelve (12) month period in which such FDA Action is in effect; provided that, if the FDA later rescinds an applicable FDA Action (whether by notice to the Company directly or by other action), the Company shall no longer be obligated to pay the FDA Fees as of the effective time of such rescission. It is the parties’ intention that the FDA Fees shall be prorated for any partial or incomplete period as contemplated herein.
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Related to FDA Action

  • Regulatory Action (a) If Executive is removed and/or permanently prohibited from participating in the conduct of the Bank’s affairs by an order issued under Section 8(e)(4) or 8(g)(1) of the Federal Deposit Insurance Act (“FDIA”) (12 U.S.C. 1818(e)(4) and (g)(1)), all obligations of the Bank under this Agreement shall terminate, as of the effective date of such order.

  • Litigation; Regulatory Action (a) Except as set forth on Schedule 3.10 of the Company Disclosure Schedule, no litigation, claim, suit, investigation or other proceeding before any court, governmental agency or arbitrator is pending against the Company or any of its Subsidiaries, and, to the Knowledge of the Company, (i) no such litigation, claim, suit, investigation or other proceeding has been threatened and (ii) there are no facts which would reasonably be expected to give rise to such litigation, claim, suit, investigation or other proceeding.

  • Infringement Action In the event a Party brings an Infringement action in accordance with this Section 7.3 (the “Controlling Party”), such Controlling Party shall keep the other Party reasonably informed of the progress of any such action, and the other Party shall cooperate fully with the Controlling Party, including by providing information and materials, at the Controlling Party’s request and expense and if required to bring such action, the furnishing of a power of attorney or being named as a party. The other Party shall cooperate fully, including, if required to bring such action, the furnishing of a power of attorney or being named as a party. Neither Party shall have the right to settle any Infringement action under this Section 7.3 relating to Joint Patent Rights without the prior written consent of the other Party, which shall not be unreasonably withheld, conditioned or delayed.

  • Alternative Action In the event it shall become impossible for the Bank or the Plan Administrator to perform any act required by this Agreement due to regulatory or other constraints, the Bank or Plan Administrator may perform such alternative act as most nearly carries out the intent and purpose of this Agreement and is in the best interests of the Bank, provided that such alternative act does not violate Code Section 409A.

  • Regulatory Actions The following provisions shall be applicable to the parties to the extent that they are required to be included in employment agreements between a savings bank and its employees pursuant to Section 563.39(b) of the Office of Thrift Supervision (“OTS”) Rules and Regulations, 12 C.F.R. §563.39(b), or any successor thereto, and shall be controlling in the event of a conflict with any other provision of this Agreement, including without limitation Section 5 hereof.

  • Adverse Action The Indenture Trustee need not take an action that it determines might have a material adverse effect on the rights of the Noteholders not consenting to the action.

  • Declaratory Judgment Actions In the event that a declaratory judgment action is brought against M.I.T. or COMPANY by a third party alleging invalidity, unenforceability, or non-infringement of the PATENT RIGHTS, M.I.T., at its option, shall have the right within twenty (20) days after commencement of such action to take over the sole defense of the action at its own expense. If M.I.T. does not exercise this right, COMPANY may take over the sole defense of the action at COMPANY's sole expense, subject to Sections 7.4 and 7.5.

  • Infringement Actions 7.1 LICENSEE shall inform UNIVERSITY promptly in writing of any alleged infringement of the PATENT RIGHTS by a third party and of any available evidence thereof.

  • Required Actions (a) Each of the parties shall use their respective reasonable best efforts to take, or cause to be taken, all actions, and do, or cause to be done, and assist and cooperate with the other parties in doing, all things reasonably appropriate to consummate and make effective, as soon as reasonably possible, the Merger and the other transactions contemplated by this Agreement.

  • Subsequent Actions If, at any time after the Effective Time, the Surviving Corporation shall consider or be advised that any deeds, bills of sale, assignments, assurances or any other actions or things are necessary or desirable to vest, perfect or confirm of record or otherwise in the Surviving Corporation its right, title or interest in, to or under any of the rights, properties or assets of either of the Company or Merger Sub acquired or to be acquired by the Surviving Corporation as a result of, or in connection with, the Merger or otherwise to carry out this Agreement, the officers and directors of the Surviving Corporation shall be authorized to execute and deliver, in the name and on behalf of either the Company or Merger Sub, all such deeds, bills of sale, assignments and assurances and to take and do, in the name and on behalf of each of such corporations or otherwise, all such other actions and things as may be necessary or desirable to vest, perfect or confirm any and all right, title and interest in, to and under such rights, properties or assets in the Surviving Corporation or otherwise to carry out this Agreement.

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