GSK’s Obligations Sample Clauses

GSK’s Obligations. In furtherance of the foregoing, and subject ----------------- to GSK's termination rights pursuant to Article 16 (including those safety related ** = 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. termination rights pursuant to Section 16.4), GSK may not, either individually or as a member of the Joint Steering Committee: **

GSK’s Obligations. 2.1 With effect from the Commencement Date and in consideration of the Price, GSK shall Manufacture (or have Manufactured) and supply to the Purchaser, as applicable, Commercial API and the Commercial Products, as ordered from time to time by the Purchaser in accordance with Clause 10 (Product Forecasts and Orders), in each case subject to the terms of this Agreement. 2.2 GSK shall Manufacture (or have Manufactured), as applicable, the Commercial API and Commercial Products at the Manufacturing Site, in each case in accordance with: (A) Current Good Manufacturing Practice; (B) the Specifications; (C) the Manufacturing Licence; (D) the Quality Agreement; and (E) all laws and regulations relevant to the Manufacture of the relevant Product at the Manufacturing Site. 2.3 Notwithstanding Clause 31.1, GSK shall not be required to use in the Manufacture of Commercial Product any API that has not been Manufactured by or for GSK under this Agreement. For the avoidance of doubt, Commercial API Manufactured by or for GSK under this Agreement and subsequently stored by or on behalf of Purchaser (including by a Third Party) shall be considered ‘Manufactured by or for GSK under this Agreement’. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. 2.4 Subject to Clause 3 (Development Services), with effect from the Effective Date GSK shall perform the Development Services, if any are requested and agreed by the Parties, in accordance with the Scope of Work and all laws and regulations relevant to the performance of the Development Services. 2.5 Subject to Clause 2.2 and without prejudice to the generality of Clause 38 (Sub-Contractors), the Parties hereby acknowledge that GSK may: (A) use the Person(s) who from time to time own and operate the relevant Manufacturing Site to Manufacture the Commercial API and Commercial Products for and on behalf of GSK, provided that: (i) such Manufacture shall take place at the Manufacturing Site; and (ii) GSK shall remain primarily liable to the Purchaser as principal obligor for the performance of its obligations under this Agreement in respect of such Manufacture; and (B) nominate any member of the GSK Group to act as its Nominated Supplier under this Agreement to supply Products to, and receive payment from, the Purc...

GSK’s Obligations. In furtherance of the foregoing, and ----------------- subject to GSK's termination rights pursuant to Article 16 (including those safety related termination rights pursuant to Section 16.4), **.

GSK’s Obligations. To the extent required or permitted by law, GSK will use Diligent Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Agreement Term, all applicable Patent Rights for any Licensed Product being Developed by GSK hereunder that GSK intends to, or has begun to Commercialize, and that have become the subject of an NDA submitted to any applicable Regulatory Authority, such listings to include all so-called “Orange Book” listings required under the Xxxxx-Xxxxxx Act and all so called “Patent Register” listings as required in Canada. Prior to such listings, the Parties will meet, through the Joint Patent Subcommittee, to evaluate and identify all applicable Patent Rights, and GSK shall have the right to review, where reasonable, original records relating to any invention for which Patent Rights are being considered by the Joint Patent Subcommittee for any such listing. Notwithstanding the preceding sentence, GSK will retain final decision making authority as to the listing of all applicable Patent Rights for such Licensed Product, regardless of which Party owns such Patent Right, and any such final decision made in good-faith on the matter shall not be subject to any further review under Section 13.1 or otherwise under this Agreement.

GSK’s Obligations. In furtherance of the foregoing, and ----------------- subject to GSK's termination rights pursuant to Article 16 (including those safety related termination rights pursuant to Section 16.4), GSK may not, either individually or as a member of the Joint Steering Committee: (a) POI Product. ** the POI Product in the United States or the ROW. ----------- (b) OBD Acute Product. Subject to Section 4.4.4, ** the OBD Acute ----------------- Product in the United States or the ROW. (c) OBD Chronic Product. ** Developing the OBD Chronic Product in the ------------------- United States or the ROW. (d) Constipation Product and IBS Product. ** designed to assess whether ------------------------------------ to ** each of the Constipation Product and the IBS Product to further ** and thereafter to a ** in accordance with the applicable U.S. Development Plan.

GSK’s Obligations. GSK will be responsible for listing with the applicable Regulatory Authorities in the Territory during the Term of the Agreement, all applicable Patents included within the Licensed Technology in the U.S. FDA’s Orange Book (or equivalent). Prior to such listings, the Parties will meet, through the Joint Patent Subcommittee, to evaluate and identify all applicable Patent rights, and subject to any restrictions Amicus may have under third party agreements covering the Amicus Patents included in the Licensed Technology (including the Background License Agreements), GSK will have the right to review, where reasonable, original records relating to any invention for which Patent rights are being considered for any such listing. Notwithstanding the foregoing, GSK will determine, in its sole discretion, which Patents in the Territory included within the Licensed Technology shall be listed in the Orange Book (or equivalent) for a Product, regardless of which Party owns such Patent. In addition, subject to any restrictions Amicus may have under third party agreements covering the Amicus Patents included in the Licensed Technology (including the Background License Agreements), GSK shall determine, in its sole discretion, to which Patents included within the Licensed Technology (excluding Patents relating solely to the Amicus Proprietary Chaperone Technology) GSK would apply the U.S. Xxxxx-Xxxxxx extension and Supplementary Protection Certificate Extensions and other Patent Term Extensions for countries in the Territory. The Parties will cooperate with each other in gaining Patent term extension where applicable to Products. Upon GSK’s reasonable request, Amicus shall timely provide any documentation or other assistance required in order to obtain such Patent term extensions, subject to any restrictions Amicus may have under third party agreements covering the applicable Amicus Patent (including the Background License Agreements).

GSK’s Obligations. GSK will promptly, accurately and completely list, with the applicable Regulatory Authorities during the Agreement Term, all applicable GSK Orange Book Patents. Prior to such listings, the Parties will meet, through the Joint Patent Committee, to evaluate and identify all applicable Patent Rights, and GSK will have the right to review, where reasonable, original records relating to any invention for which Patent Rights are being considered by the Joint Patent Committee for any such listing. Notwithstanding the preceding sentence, GSK will retain final decision-making authority as to the listing of all applicable GSK Orange Book Patents for such Licensed Product (excluding Isis Core Technology Patents), regardless of which Party owns such GSK Orange Book Patent.

GSK’s Obligations. GSK will be responsible for all rebates, administrative fees and chargeback claims for PR Product dispensed or purchased in the Territory on and after the Effective Date during the Term (it being understood and agreed that the information contained in any report from the applicable rebate or chargeback program will be deemed to be the date for purposes of determining the date of such claim). GSK will also be responsible for all rebates, administrative fees and chargebacks pursuant to any government rebate or chargeback programs to which GSK is a party as permitted under this Agreement with respect to government claims for PR Product dispensed or purchased in the Territory on and after the Effective Date (it being understood and agreed that the information contained in any report from the applicable rebate or chargeback program will be deemed to be the date for purposes of determining the date of such claim). GSK will reimburse Santarus for all rebates, administrative fees and chargebacks that Santarus is obligated to pay under agreements or programs with the Managed Care Market with respect to claims for PR Product dispensed in the Territory on and after the Effective Date. On a monthly basis, GSK shall promptly provide to Santarus all information reasonably requested by Santarus in order for Santarus to determine the amount of rebates and chargebacks attributable to PR Products dispensed in the Territory. All payments due to Santarus by GSK as set forth in the immediately *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. preceding sentence will be made by GSK to Santarus within thirty (30) days after GSK’s receipt of an invoice from Santarus setting forth requested payments in reasonable detail, the form and timing of which detail have been agreed upon by the Parties in a separate letter agreement of even date hereof, the terms and conditions of which letter agreement are incorporated herein. Any rebates, administrative fees or chargebacks to be reimbursed to Santarus by GSK with respect to agreements or programs with the Managed Care Market entered into by Santarus after the Effective Date shall be in accordance with Santarus’ normal business practice so as not to provide for higher rebates, administrative fees or chargebacks in the Territory than in the United States (excluding the Territory).

GSK’s Obligations. The parties have agreed that GSK:

GSK’s Obligations. Except as may be otherwise expressly authorized herein, GSK shall; (i) not disclose or provide any Software or Documentation to any other party; (ii) not disclose the results of any benchmarking activity to a third party other than consultants or others working for GSK under appropriate confidentiality agreements; (iii) not alter, reverse engineer, disassemble, decompile or copy any Software; (iv) limit access to the Software to its employees, Contractors and Investigators who require access in connection with GSK's use of the Software as authorized hereunder and who have agreed in writing or are otherwise legally bound to observe obligations of confidentiality with respect to confidential information belonging to party's with whom GSK deals; (v) take the same precautions, including secure storage of all media containing copies of the Software, to prevent unauthorized or improper use or disclosure of the Deliverables that GSK takes to protect its own confidential Phase Forward SLSA 8.7 information of a similar nature; and (v) not remove from, and reproduce on any authorized copies of, the Deliverables all titles, trademarks, trade names, and copyright, patent and other proprietary or restrictive legends or notices.