Impax Regulatory Responsibilities Clause Samples

Impax Regulatory Responsibilities. (i) Subject to Section 5.1.1, except as otherwise agreed by the Parties, Impax shall have the sole right and responsibility [***] for (a) preparing, submitting and maintaining all Regulatory Documentation and Regulatory Approvals in accordance with Applicable Law and (b) and conducting all written and oral communication and discussions with, and preparing and responding to all correspondence with, Regulatory Authorities in the Field in the Territory in accordance with Applicable Law, in each case ((a) and (b)) with respect to (1) any Additional Products, (2) any Impax Studies (including the INDs filed by Impax or its Affiliates therefor), and (3) the Manufacture of Licensed Products other than Supplied Products (collectively, the “Impax Primary Regulatory Responsibilities”). (ii) Except as otherwise agreed by the Parties, Impax shall have primary operational responsibility for preparing (a) all Regulatory Documentation and Regulatory Approvals and (b) all correspondence with, Regulatory Authorities in the Field in the Territory, in each case ((a) and (b)) with respect to (1) the Existing Products in any dosage strength other than (A) the dosage strengths approved by the FDA in the Territory as of the Effective Date and (B) [***], (2) the Existing Products in any New Indication, and (3) any changes to the Product Labels and Inserts proposed by Impax for Existing Products in the Approved Indications (collectively, the “Impax Supporting Regulatory Responsibilities”). All Regulatory Documentation and correspondence prepared by Impax pursuant to this Section 5.2.2(ii) shall be submitted to the FDA by and in the name of, and [***]. Any such [***], and AstraZeneca shall [***] such Regulatory Documentation within [***]. (iii) Impax shall perform the Impax Primary Regulatory Responsibilities and the Impax Supporting Regulatory Responsibilities at its sole cost; provided, however, that Impax shall not be obligated to reimburse AstraZeneca for any costs AstraZeneca incurs in providing materials for, attending, and assisting with any Impax Primary Regulatory Responsibilities or Impax Supporting Regulatory Responsibilities. (iv) Prior to submission to any Regulatory Authority, Impax shall submit to AstraZeneca [***] the form and content of, and strategy for, each item of Material Impax Regulatory Documentation proposed by Impax. AstraZeneca’s [***] pursuant to this Section 5.2.2(iv) shall [***]. AstraZeneca shall use Commercially Reasonable Efforts to [***] within (i) ...

Related to Impax Regulatory Responsibilities

  • Regulatory Responsibilities 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.

  • Company Responsibilities The Company will undertake responsibilities as set forth below: 1. Provide reliable and accurate detailed information, materials, documentation and 2. Make decisions and take future actions, as the Company determines in its sole discretion, on any recommendations made by APS in connection with this Agreement. APS’ delivery of the services and the fees charged are dependent on (i) the Company’s timely and effective completion of its responsibilities; and (ii) timely decisions and approvals made by the Company’s management. The Company shall be responsible for any delays, additional costs or other deficiencies caused by not completing its responsibilities.

  • University Responsibilities 4.1 The University will provide a room accommodation to The Resident for a period of one academic year or the portion of the academic year remaining when occupancy begins (limited to the subsequent fall and spring semesters) exclusive of the Winter Recess period unless The Resident is assigned to a facility that remains open during this time or is approved to live on-campus during Winter Recess. Services provided by the University begin on the official check-in dates for the specific area and include access to the assigned building and room. 4.2 In accordance with University policy, the University will provide staff that will help facilitate a living experience that complements the academic mission of the University. 4.3 Exclusive of unanticipated weather events and building system failures that may disrupt service and subject to the availability of applicable resources, the University will provide adequate light, heat, electricity, hot water and telecommunication services (limited to video and internet connection) to residents. Student rooms shall be furnished.

  • City Responsibilities 2.8.1 CITY shall make available to CONSULTANT all technical data that is in CITY'S possession, reasonably required by CONSULTANT relating to the SERVICES. 2.8.2 CITY shall provide access to and make all provisions for CONSULTANT to enter upon public and private lands, to the fullest extent permitted by law, as reasonably required for CONSULTANT to perform the SERVICES. 2.8.3 CITY shall examine all reports, correspondence, and other documents presented by CONSULTANT upon request of CITY, and render, in writing, decisions pertaining thereto within a reasonable time so as not to delay the work of CONSULTANT. 2.8.4 It is expressly understood and agreed that all work done by CONSULTANT shall be subject to inspection and acceptance by CITY and approval of SERVICES shall not forfeit the right of CITY to require correction, and nothing contained herein shall relieve CONSULTANT of the responsibility of the SERVICES required under the terms of this Contract until all SERVICES have been completed and accepted by CITY.

  • Joint Responsibilities The relationship between SAE ITC, the Activities and its Members shall be, and at all times, advisory only, and no party shall have the authority to enter into any contract or commitment in the name of, or on behalf of, any other party. Nothing in this Agreement shall be construed to confer upon either party the status of employee, agent, partner, joint venturer or legal representative of the other, it being intended by all parties to remain independent legal entities solely responsible for its own actions.