GSK Development Plan definition

GSK Development Plan shall have the meaning assigned to it in Section 5.1(d).
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GSK Development Plan has the meaning set forth in Section 4.3.1.
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GSK Development Plan shall have the meaning assigned such term in Section 3.3.
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Examples of GSK Development Plan in a sentence

  • GSK shall continue to update the GSK Development Plan and Budget for such GSK Product, and shall submit such updated GSK Development Plan and Budget to the JSC for review and approval.

  • In the event that the actual Co-Development Costs are reasonably expected to exceed, as determined by the summation of actual costs to date and official GSK forecasts over the course of the remaining development plan, [ * ] of the estimated costs for the Co-Development Costs as set forth in the GSK Development Plan and Budget, Dynavax shall have [ * ].

  • The Clinical Development Committee shall review the initial GSK Development Plan at its first meeting, and shall [ * ] any modifications thereof necessary to reflect the Parties' ongoing efforts to optimize clinical development of the Current Product in the GSK Territory.

  • GSK shall perform its clinical and regulatory development of Licensed Products for the Licensed Indication in the GSK Territory in accordance with the GSK Development Plan, as updated pursuant to Section 3.3. GSK shall bear all of the costs and expenses incurred in connection with any of the activities reflected in the GSK Development Plan.

  • Within [********] following the exercise of an Option, for each GSK Development Program, GSK will prepare and provide to the JSC a summary of a [********] plan for the GSK Development Program that details the plan for conducting Development of at least [********] specifying significant clinical and non clinical studies and activities [********], with respect to Development of each GSK Development Compound (each a "GSK Development Plan").

  • GSK will provide the JSC with any significant updates and revisions to each GSK Development Plan and GSK Commercialization Plan for the JSC's review.

  • As soon as the information is available, but no later than [********] prior to the anticipated [********] for the [********] within a GSK Development Program, GSK will prepare and provide to the JSC a summary of a plan that is a continuation of the GSK Development Plan for such GSK Development Compound that details [********] for such GSK Development Compound, [********] (each a "GSK Commercialization Plan").

  • In accordance with Section 3.3, GSK shall devote Diligent Efforts to clinically and regulatorily develop and seek Regulatory Approval for the Current Product and the Current Pediatric Product (beginning at the time that GSK's diligence obligations with respect to the Current Pediatric Product become effective pursuant to such Section) for Licensed Indications [ * ] undertaking shall include carrying out the GSK Development Plan (as updated pursuant to Section 3.3).

  • GSK has, as confirmed in a letter from Gilead to GSK dated as of the Effective Date, provided to Gilead a written plan describing GSK's plans for any clinical trials GSK plans to conduct to support Regulatory Approval of the Current Product for the HBV Indication in the GSK Territory, including the [ * ] (such plan, the "GSK Development Plan").

Related to GSK Development Plan

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Plans has the meaning set forth in Section 3.2.

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Development Program means the implementation of the development plan.

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Development Phase means the period before a vehicle type is type approved.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Development Works means the external development works and internal development works on immovable property;

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, multi-apartment buildings, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Development Activities means those activities which are normally undertaken for the development, construction, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).