Kyowa Decision definition

Kyowa Decision means any decision made in Kyowa’s sole but reasonable discretion with respect to clinical development or Commercialization of Licensed Product in the Territory, including without limitation, determination of, in the Territory, (a) the Indication(s) in the Cancer Field, and Additional Field if applicable, to be pursued for Licensed Product, (b) Clinical Development Activities, (c) Regulatory Activities, (d) Marketing Activities, (e) trademarks to be used for Licensed Product, subject to Section 6.5 hereof, and (f) whether to develop one or more Licensed Back-Up Compounds in place of or in addition to ARQ 197 in accordance with Section 3.7 hereof or to include an Indication in the Additional Field in accordance with Section 3.8 hereof, except to the extent any decision, in ArQule’s sole but reasonable opinion, would have, or is having, a material adverse scientific, clinical, medical, regulatory or commercial impact on obtaining regulatory approval for the manufacture, use or sale of Licensed Product outside the Territory, or commercialization of Licensed Product outside of the Territory, in which event such decision will be an ArQule Decision.
Sample 1

Examples of Kyowa Decision in a sentence

  • If the Disputed Matter involves a Kyowa Decision, then Kyowa’s representatives on the JSC shall have the right to make the final decision on such Disputed Matter.

Related to Kyowa Decision

  • Final Decision means a final action of the commission determining the legal rights, duties, or privileges of any person. “Final decision” does not include preliminary, procedural, or intermediate actions by the commission, actions regulating the internal administration of the commission, or actions of the commission to enter into or refrain from entering into contracts or agreements with vendors to provide goods or services to the commission.

  • CPUC Decisions means CPUC Decisions 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000 and any other existing or subsequent decisions, resolutions or rulings related to resource adequacy, as may be amended from time to time by the CPUC.

  • key decision * means an executive decision which is likely to:

  • Adverse decision means a decision reducing,

  • Adequacy Decision refers to a legally-binding decision issued by the European Commission allowing the transfer of Personal Data from the European Economic Area to a third country which has been considered adequate in terms of data protection safeguards.

  • Proposed decision means the presiding officer’s recommended findings of fact, conclusions of law, decision, and order in a contested case in which the administrator did not preside.

  • Development order means any order granting, denying, or granting with conditions an application for a development permit.

  • Major Decision means:

  • Alternative dispute resolution means mediation, arbitration, conciliation, or other nonjudicial procedure that involves a neutral party in the decisionmaking process. The form of alternative dispute resolution chosen pursuant to this article may be binding or nonbinding, with the voluntary consent of the parties.

  • Record of Decision means a Record of Decision of an application for municipal planning approval as contemplated in section 55;

  • JPC means Joint Planning Committee.

  • Final Approval Hearing means the hearing before the Court where the Parties will request the Final Judgment to be entered by the Court approving the Settlement Agreement, the Fee Award, and the incentive award to the Class Representative.

  • Review Board has the meaning provided in Section 2.1(f)(i) of this Commercial Shared-Loss Agreement.

  • Decision-maker means a person who makes a determination regarding responsibility after the investigation has concluded. The Decision-maker cannot be the same person as the Title IX Coordinator, the Investigator, or the Appellate Decision-maker.

  • Investment Decisions Investment, trading, lending or other financial decisions, strategies or recommendations with respect to Investments, whether on behalf of the Master Servicer or any Affiliate thereof, the Special Servicer or any Affiliate thereof, the Operating Advisor or any Affiliate thereof, the Certificate Administrator or any Affiliate thereof, or the Trustee or any Affiliate thereof, as applicable, or any Person on whose behalf the Master Servicer or any Affiliate thereof, the Special Servicer or any Affiliate thereof, the Operating Advisor or any Affiliate thereof, the Certificate Administrator or any Affiliate thereof, or the Trustee or any Affiliate thereof, as applicable, has discretion in connection with Investments.

  • Decision means a determination, action, vote, or disposition upon a motion, proposal, recommendation, resolution, order, ordinance, bill, or measure on which a vote by members of a public body is required and by which a public body effectuates or formulates public policy.

  • independent review committee means the independent review committee of the investment fund established under National Instrument 81-107 Independent Review Committee for Investment Funds;