GSK Decision definition

GSK Decision means any [***] decision that is not a [***] (other than as provided in Section 2.1.5) with respect to (a) the Development and/or Commercialization of a Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. Product for [***]; (b) all [***] matters with respect to the Commercialization of any Co-Commercialized Product for any [***] Territory, including matters related to Sections 2.3.4(f), (h), (j) and (n)-(r); (c) all [***] of the Product; (d) all [***] matters in the [***] Territory relating to [***] other than [***] and other than the activities described in Section 3.1.3(b); provided, that the foregoing shall become GSK Decisions at such time as the Commercialization Regulatory Approval for the Product for the Indication of [***] is transferred to GSK in accordance with the Regulatory Filings Transfer Plan; and provided, further that all decisions related to the [***] portions of the Drug Approval Application for the Product for the Indication of [***] shall be GSK Decisions as of the Effective Date; (e) enforcement and defense of the [***]; (f) [***]; and (g) [***] of a [***] as described in Section 8.4.4 if [***] or if the Parties are unable to [***]; provided, that any GSK Decision cannot (i) commit SYNTA to perform any activity that conflicts with GSK Internal Policies (or decisions of the GSK Global Clinical Safety Board) or Applicable Laws; (ii) conflict with an approved Global Development Plan (as it relates to Development in the U.S. Territory) or Product Co-Commercialization Plan; or (iii) be detrimental to the global Branding applicable to a Product.

Examples of GSK Decision in a sentence

  • In the 2011 GSK Decision, the Panel decided that the categories of primary and secondary care within the meaning of Chapter 7, are exhaustive, and also that the phrase “and other customers” is a „catchall‟.

  • Of the distressed banks, in turn, 449 were allowed to fail as going concern entities and 824 survived as going concern entities through TARP government support.

  • Sanofi points out that the key issue in the 2011 GSK Decision concerned sales into the NHS stockpile and that the Panel was not asked to nor made any ruling in respect of dispensing doctors or direct to doctor sales.

Related to GSK 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:

  • Informed decision means a decision by a qualified patient, to request and obtain a prescription for medication that the qualified patient may self-administer to end his or her life in a humane and dignified manner, that is based on an appreciation of the relevant facts and after being fully informed by the attending physician of:

  • Adverse decision means a decision reducing,

  • 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.

  • return decision means an administrative or judicial decision or act, stating or declaring the stay of a third-country national to be illegal and imposing or stating an obligation to return;

  • the decisions means the decisions of the CMA on the questions which it is required to answer by virtue of section 35 of the Act;

  • Land use decision means an administrative decision of a land use authority or appeal authority regarding:

  • Adequacy Decision means a decision issued by the European Commission that a country or region or a category of recipients in such country or region is deemed to provide an “adequate” level of data protection.

  • Major Decision means:

  • JPC means Joint Planning Committee.

  • Final Approval Hearing means the hearing to be conducted by the Court to determine the fairness, adequacy, and reasonableness of the Settlement pursuant to Federal Rule of Civil Procedure 23 and whether to issue the Final Approval Order and Judgment.

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

  • 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.

  • Health care decision means any decision regarding the health care of the prospective donor.

  • 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.

  • Labor law decision means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

  • Final administrative decision means a decision by an agency

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • JDC has the meaning set forth in Section 3.2.

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

  • Appellate Decision-maker means a person who considers and decides appeals of determinations regarding responsibility and dismissals of formal complaints. The Appellate Decision-maker cannot be the same person as the Title IX Coordinator, Investigator, or Decision-maker. The Appellate Decision-maker may be a school district employee, or a third party designated by the school district.

  • Final Approval Order and Judgment means an order and judgment that the Court enters after the Final Approval Hearing, which finally approves the Settlement Agreement, certifies the Settlement Class, dismisses the Action with prejudice, and otherwise satisfies the settlement-related provisions of Federal Rule of Civil Procedure 23.

  • JSC has the meaning set forth in Section 3.1.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.