GSK Responsibilities Clause Samples
The "GSK Responsibilities" clause defines the specific duties and obligations that GlaxoSmithKline (GSK) must fulfill under the agreement. This may include providing certain products, services, information, or support, as well as adhering to timelines and quality standards relevant to the contract. By clearly outlining what is expected from GSK, this clause ensures accountability and helps prevent misunderstandings or disputes regarding each party's roles and contributions.
GSK Responsibilities. After the exercise of the Liquidia Respiratory Option or the Inhaled Option, GSK shall be solely responsible, at its expense, for preparing, filing and maintaining Regulatory Materials for the Research Products and Products. GSK shall own all Regulatory Materials for the Research Products and Products.
GSK Responsibilities. (a) GSK shall have the sole right and responsibility to record and collect payment for sales of GI Products throughout the United States.
(b) GSK will be responsible for storage, order receipt, order fulfillment, shipping and invoicing of Collaboration Products. In the case of Adolor Products in the United States, invoices shall be for the account of Adolor using an acceptable Adolor invoicing form and Adolor letterhead. The Joint Marketing Committee shall establish mechanisms for real-time data ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. exchange, invoicing schedules, credit control and other necessary standard operating procedures relating to the invoicing for the account of Adolor.
(c) In addition to the Detailing Requirements, GSK, at its sole expense, commencing ** (**) months after the NDA Acceptance, and on an annual basis for the period of the Adolor Product Promotion Term, shall provide, at a minimum, the marketing and sales support for the POI Product as set forth on Schedule 5.5.2. --------------
(d) GSK shall have the sole right and responsibility to distribute, sell, record sales and collect payments for Collaboration Products in the ROW during the ROW Term.
(e) GSK shall have sole responsibility for establishing and modifying the terms and conditions with respect to the sale of Collaboration Products in the ROW, including, without limitation, the price or prices at which the Collaboration Products in the ROW will be sold, any discount applicable to payments or receivables, and similar matters.
(f) Within ** (**) days after ** for the POI Product, GSK will be responsible, at the direction of the Joint Marketing Committee, for developing and implementing the healthcare insurance company and third party payor reimbursement strategy for the Collaboration Products; provided, however, that within ** (**) days after the ** anniversary of the First Commercial Sale of the POI Product and subject to the approval of the Joint Marketing Committee, Adolor may assume responsibility for such activities for any or all of the Adolor Products; provided further that such assumption of responsibilities by Adolor will not have a material adverse effect on the sales in the United States of the POI Product.
GSK Responsibilities. Notwithstanding that EPIZYME is primarily responsible for the conduct of the activities set forth in the Research Plans, GSK shall be responsible for, and shall use Commercially Reasonable Efforts to perform, the activities assigned to GSK under the Research Plan, including, if applicable, the provision of assays, crystallography, and, subject to clause (a)(iii) above, libraries Controlled by GSK for screening. In addition, GSK has the right but not the obligation to provide the foregoing resources or conduct the foregoing activities at GSK’s discretion and cost, whether or not the same are set forth in the Research Plan.
GSK Responsibilities. As between Tempus and GSK only, GSK shall be wholly and fully responsible for the acts and omissions of any Third Party who receives access to Tempus Software or Licensed Data (or any other Tempus Confidential Information, Tempus Background IP, or Tempus Arising IP) under this DAC as if such act or omission was performed by GSK Personnel.
GSK Responsibilities. Except as expressly provided otherwise -------------------- in this Agreement, GSK shall undertake and resource all development of Licensed Product(s) in the Field in the Territory so long as it retains full rights thereto under this Agreement, and shall bear all costs it incurs in conducting such development, including, without limitation, expenses incurred in conducting clinical trials. GSK shall be responsible, at its sole expense on a country-by- country basis, for the commercialization and distribution of such Licensed Product(s) in the Field in the Territory so long as GSK retains rights, on a country-by-country basis, thereto under this Agreement. Subject to its obligations in Section 4.1.2, GSK shall have the sole discretion, using its reasonable business judgment, to decide whether to commercialize a Licensed Product in a country in the Territory.
GSK Responsibilities. (i) GSK will commit such employees and resources as necessary to fulfill its obligations under this Agreement.
(ii) GSK shall have the right and obligation to select (and the obligation to make the applicable milestone payments to Sirna) the Target Compounds, and * Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Lead Compounds promptly after the JSC [***]* has decided that a Lead has met the Lead Criteria and a Target Compound has met the Lead Compound Criteria, respectively. GSK shall have the right [***]*.
(iii) GSK will provide Sirna with relevant GSK Know-How, equipment (e.g., [***]*, as further set forth in the Research Plan) and other information (including without limitation all reasonably necessary technology transfer and assistance towards the establishment at Sirna [***]* as described in the Research Plan) Controlled by GSK as reasonably necessary for Sirna to conduct its activities under the Agreement, subject to any limitations or reservations or obligations upon GSK due to other agreements. GSK will provide input and updates with respect to the Programs under the Research Collaboration on at least a quarterly basis each year.
(iv) GSK shall have sole responsibility and decision-making authority for all such matters pertaining to the Development of a Lead Compound (or other Target Compounds as may be applicable pursuant to Section 3.4 hereof) into a Licensed Product, in accordance with its Scientifically and Commercially Reasonable and Diligent Efforts and the applicable terms and conditions set forth herein.
(v) GSK will provide an updated Development Plan and annual summary reports with updates with respect to the Development of any Lead Compound (or other Target Compounds) or Licensed Product as necessary (at a minimum once per year) to the JSC for informational purposes during the Research Term and to Sirna thereafter during the Term.
GSK Responsibilities. GSK shall have the sole right and responsibility to [***]. With respect to sales of Collaboration Product in the United States, GSK shall [***], in accordance with Section 5.4.1 above. Furthermore, GSK shall be solely responsible for the distribution of Collaboration Product in the Territory during the term of the Agreement in accordance with Article 9. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
GSK Responsibilities. GSK shall fulfill and discharge all obligations under applicable Law, as well as procedures ensuring timely compliance with all Laws as are reasonable in accordance with accepted business practices and legal requirements to maintain the authorization and/or ability to Commercialize to Commercialize Collaboration Product in the Territory, including, without limitation, the following:
8.3.1 The maintenance of all Regulatory Approvals either by GSK or its Affiliate(s) necessary for the use and Commercialization of Collaboration Product for all approved indications in the European Union, Japan and All Other Countries, including, without limitation, maintaining such records and filing such reports as may be required under the provisions of the U.S. Federal Food, Drug and Cosmetic Act, as well as all other Laws, including, without limitation, all advertising and promotional literature and labeling in the European Union, Japan and All Other Countries relating to Collaboration Product.
8.3.2 Timely filing with appropriate Regulatory Authorities of all Adverse Event reports related to Collaboration Product in the European Union, Japan and All Other Countries. The procedures for sharing and reporting of Adverse Events encountered by each Party for Collaboration Product in the Territory shall be as set forth in the Safety Data Exchange Agreement to be entered into by the Parties in accordance with Section 8.4.2 below.
8.3.3 Creation of a master safety database which shall cross-reference any Adverse Events relating to Collaboration Product in the European Union, Japan and All Other Countries, in accordance with procedures set forth in the Safety Data Exchange Agreement to be entered into by the Parties in accordance with Section 8.4 below.
GSK Responsibilities
