Defensive Action definition

Defensive Action has the meaning provided in Section 10.5(a).
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Defensive Action has the meaning set forth in Section 10.2.1. (s) “Development” means all activities related to research, pre-clinical and other non- clinical testing, clinical development, statistical analysis and report writing in support thereof, and interactions with Regulatory Authorities regarding any of the foregoing, including for obtaining and maintaining Marketing Approval, and any post-approval activities (such as label expansion). When used as a verb, “Develop” means to engage in Development. (t) “Development Data” has the meaning set forth in Section 3.4. (u) “Development Plan” has the meaning set forth in Section 3.3. (v) “Disclosing Party” has the meaning set forth in Section 11.1. 4 (w) “Educational Materials” means training, educational and communication materials for the Product, including without limitation, any patient support or safety training materials. (x) “Effective Date” means the date of this Agreement as set forth above. (y) “FDA” means the United States Food and Drug Administration. (z) “First Commercial Sale” means, with respect to the Product and a country, the first sale for monetary value for use or consumption by the end user of such Product in such country after Marketing Approval for such Product has been obtained in such country. (aa) “Field” means all uses in humans. (bb) “Generic Market” has the meaning set forth in Section 6.3.3. (cc) “Generic Product” means, with respect to a country in the Territory, any drug product (including any authorized generic product) that: (i) contains the same active ingredient as the Product; and (ii) is marketed or sold by a Third Party without the right to reference any Marketing Authorization held by or on behalf of Viatris or any of its Affiliates in such country in the Territory. (dd) “Governmental Body” means (i) any domestic or foreign national, federal, provincial, state, municipal or other government or body, (ii) any international or multilateral body, (iii) any subdivision, ministry, department, secretariat, bureau, agency, commission, board, instrumentality or authority of any of the foregoing governments or bodies, (iv) any quasi-governmental or private body exercising any regulatory, expropriation or taxing authority under or for the account of any of the foregoing governments or bodies, or (v) any domestic, foreign, international, multilateral, or multinational judicial, quasi-judicial, arbitration or administrative court, grand jury, tribunal, commission, board or panel. (ee) “HCM” means ...
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Examples of Defensive Action in a sentence

  • The Party having the right to initiate any infringement suit or defend a Defensive Action under Section 9.3.2 (the “Controlling Party”) will have the sole and exclusive right to select counsel for and control any such suit or Defensive Action.

  • In the event Cerecor is the Defending Party, Cerecor shall bear one hundred percent (100%) of its reasonable, documented out of pocket expenses incurred in such Defensive Action, including, for such purposes, Avadel’s reasonable, documented out of pocket cost of rendering any assistance provided at Cerecor’s request pursuant to Section 6.4(c).

  • If any Product manufactured, used or sold by or on behalf of a Party, becomes the subject of a Third Party’s claim or assertion of infringement of a Patent granted by a jurisdiction in the Licensed Territory (any such claim or assertion, a “Defensive Action”), the Party first having notice of the Defensive Action shall promptly notify the other Party.

  • At the Defending Party’s request, the non-Defending Party shall provide the Defending Party with all relevant documentation (as may be requested by the Defending Party) evidencing that the Defending Party is validly empowered by the non-Defending Party to initiate and undertake such Defensive Action, as applicable.

  • The Parties acknowledge and agree that in the event that (***), LJI will have the right but not the obligation under the LJI Agreement to bring, defend, or maintain any appropriate suit or action involving such infringement or Defensive Action at its own cost and expense against alleged infringers and to defend such KKC Patent Rights from Defensive Actions.

  • If Cerecor has not exercised its first right to commence and/or undertake a Defensive Action within thirty (30) days of receipt of notice of the applicable Challenge, it shall promptly notify Avadel in writing and Avadel may, by written notice to Cerecor, commence and/or undertake such defense (either such Party who commences and/or undertakes such defense, the “Defending Party”).

  • The Party subject to such Defensive Action shall have the right to direct and control the defense thereof; provided, however, that the other Party may participate in the defense and/or settlement thereof at its own expense with counsel of its choice.

  • The non-Defending Party shall join the Defending Party in its Defensive Action if the Defending Party reasonably determines that this is necessary to demonstrate “standing to defend.” The Defending Party shall have the sole and exclusive right to select counsel for any defense initiated by it pursuant to this Section 6.4(b) (but not the non-Defending Party’s counsel).

  • Without limiting the rights of the Parties in Section 9.4(b) below, the Parties shall promptly agree on and enter into a joint defense agreement wherein such Parties agree to their shared, mutual interest in the outcome of such potential dispute (any, a “Joint Defense Agreement”), and thereafter, the Parties shall promptly meet to consider the Defensive Action and the appropriate course of action.

  • Cerecor shall have the first right but not the obligation to commence and undertake a Defensive Action or, subject to Section 6.5, negotiate or enter into any settlement or voluntary disposition thereof.