Decision-Making Authority BMS shall have the sole decision-making authority for the operations and Commercialization strategies and decisions, including funding and resourcing, related to the Commercialization of Products; provided that such decisions are not inconsistent with the express terms and conditions of this Agreement, including BMS’ diligence obligations set forth in Section 5.1.
Decision Making The Joint Development Committee and Joint Commercialization Committee shall each act by unanimous agreement of its members, with each Party having one vote. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as follows:
(a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing:
(i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *];
(ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and
(iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and
(b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.
Initial Decision Maker The Architect will serve as the Initial Decision Maker pursuant to Article 15 of AIA Document A201–2017, unless the parties appoint below another individual, not a party to this Agreement, to serve as the Initial Decision Maker.
Developer Authority Consistent with Good Utility Practice and this Agreement, the Developer may take whatever actions or inactions with regard to the Large Generating Facility or the Developer Attachment Facilities during an Emergency State in order to (i) preserve public health and safety, (ii) preserve the reliability of the Large Generating Facility or the Developer Attachment Facilities, (iii) limit or prevent damage, and (iv) expedite restoration of service. Developer shall use Reasonable Efforts to minimize the effect of such actions or inactions on the New York State Transmission System and the Connecting Transmission Owner’s Attachment Facilities. NYISO and Connecting Transmission Owner shall use Reasonable Efforts to assist Developer in such actions.
E1 Authority Data E1.1 The Contractor shall not delete or remove any proprietary notices contained within or relating to the Authority Data.
Signing Authority Will the above-named Partner be able to sign contracts on behalf of the Partnership? ☐ Yes ☐ No Partner 2: with a mailing address of . a.) Ownership: %
Final Decision Concessionaire covenants that the decision of the Commissioner of Department, relative to the performance of the terms and conditions of this Agreement, shall be final and conclusive.
Contracting authority The contracting authority of this public contract is Enabel, the Belgian development agency, public-law company with social purposes, with its registered office at Xxx Xxxxx 000, 0000 Xxxxxxxx xx Xxxxxxx (enterprise number 0264.814.354, RPM/RPR Brussels). Enabel has the exclusive competence for the execution, in Belgium and abroad, of public service tasks of direct bilateral cooperation with partner countries. Moreover, it may also perform other development cooperation tasks at the request of public interest organisations, and it can develop its own activities to contribute towards realisation of its objectives. For this procurement contract, Xxxxxx is represented by person(s) who shall sign the award letter and are mandated to represent the organisation towards third parties.
Governing Law, Regulatory Authority, and Rules The validity, interpretation and enforcement of this Agreement and each of its provisions shall be governed by the laws of the state of New York, without regard to its conflicts of law principles. This Agreement is subject to all Applicable Laws and Regulations. Each Party expressly reserves the right to seek changes in, appeal, or otherwise contest any laws, orders, or regulations of a Governmental Authority.
Regulatory Submissions With respect to the Governmental Approvals of the Agreement Products in the Territory:
(a) Unless otherwise required by Applicable Law, any Governmental Approvals and any Regulatory Submissions relating to Agreement Products in the Territory shall be filed, owned and held in the name of EVOLUS or its Affiliates.
(b) EVOLUS shall be solely responsible, at its expense, and shall use commercially reasonable efforts to timely prepare, file, prosecute, and maintain all Regulatory Submissions relating to Agreement Products in the Territory, including any reports or amendments necessary to maintain Governmental Approvals, and for seeking any revisions of the conditions of each Governmental Approval.
(c) EVOLUS shall have sole authority and responsibility and shall use commercially reasonable efforts to develop, modify, seek and/or obtain any necessary Governmental Approvals of any Labeling, packaging, advertising or other promotional or informational materials used in connection with Agreement Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval.
(d) EVOLUS will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Agreement Products in the Territory prior to and after any Governmental Approval.
(e) Subject to the terms and conditions of this Agreement, EVOLUS may file any submissions that are intended to change or modify Labeling or prescribing information approved by Health Canada for the Agreement Products in the field for the Territory; provided that, except as required by Applicable Laws, EVOLUS will provide to the DISTRIBUTOR a draft of such submission at least ten (10) business days prior to a planned submission to the applicable Regulatory Authority and EVOLUS will give reasonable consideration to any comments the DISTRIBUTOR may have. For greater certainty it is acknowledged and agreed that the labeling with respect to Products for distribution in Canada will be different than labeling for Products for distribution in the United States, as a result of among other things, the requirement in Canada to have the label in both English and French languages.
