GSK-5 Development Plan definition

GSK-5 Development Plan means the Development plan attached to this Amendment No. 4 as Attachment 1, which may be amended from time to time pursuant to Section 5 of this Amendment No. 4.
Sample 1

Examples of GSK-5 Development Plan in a sentence

  • Isis shall have the ability to make any changes to the GSK-5 Development Plan that do not require the Parties to make a Material Amendment to the GSK-5 Development Plan to affect such a change without the prior consent of GSK, provided, that such changes [***].

  • Thereafter, Isis and GSK (as applicable) will continue to conduct the GSK-5 Development Plan in accordance with such amended GSK-5 Development Plan.

  • Until GSK exercises its Option for the GSK-5 Program in accordance with the Agreement (as amended by this Amendment No. 4), GSK will be responsible for and will use Commercially Reasonable Efforts to perform the activities allocated to GSK under the GSK-5 Development Plan, and shall be responsible for payment of all costs and expenses related to GSK's conduct of such activities.

  • Isis will consider in good faith any changes to the GSK-5 Development Plan that are requested by GSK that do not require the Parties to make a Material Amendment to the GSK-5 Development Plan to affect such a change.

  • As of the Amendment No. 4 Effective Date, the Parties have agreed to the GSK-5 Development Plan (which is attached hereto as Attachment 1).

  • The initial agreed-upon GSK-5 Development Plan is attached to this Amendment No. 4 as Attachment 1.

  • If the Parties mutually agree to make such a Material Amendment (excluding Material Amendments to the Natural History Study) (including any associated Additional Costs and the payment schedule thereof), such proposed Material Amendment shall be deemed an Approved Change, and the GSK-5 Development Plan will be amended to expressly incorporate such Approved Change.

  • In addition, after such Option exercise by GSK, GSK will be solely responsible for all costs and expenses associated with Development, Manufacture and Commercialization of Licensed Compounds and related Licensed Products from the GSK-5 Program, excluding those costs and expenses for those activities for which Isis is responsible under the GSK-5 Development Plan, or for which Isis is otherwise responsible to provide at no cost to GSK under Section 4.2 of the Agreement.

  • The Parties will conduct the Natural History Study as part of the GSK-5 Development Plan.

  • Subject to Section 5 of this Amendment No. 4 and until GSK exercises its Option for the GSK-5 Program in accordance with the Agreement (as amended by this Amendment No. 4), Isis will be solely responsible for the costs and expense for the Costs of Goods for the GSK-5 Development Plan.

Related to GSK-5 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.

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

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

  • Development Program means the implementation of the development plan.

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

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

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

  • 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.

  • 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 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.

  • 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.

  • 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;

  • Research Plan shall have the meaning set forth in Section 2.1.

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

  • 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.

  • 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.

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • 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.

  • 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.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.