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.
Reporting and Payment Procedures 1. Payment Procedures
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.
Introduction and Statement of Policy The National Institutes of Health (NIH) has established NIH-designated data repositories (e.g., database of Genotypes and Phenotypes (dbGaP), Sequence Read Archive (SRA), NIH Established Trusted Partnerships) for securely storing and sharing controlled-access human data submitted to NIH under the NIH Genomic Data Sharing (GDS)
Automated decisions For purposes hereof “automated decision” shall mean a decision by the data exporter or the data importer which produces legal effects concerning a data subject or significantly affects a data subject and which is based solely on automated processing of personal data intended to evaluate certain personal aspects relating to him, such as his performance at work, creditworthiness, reliability, conduct, etc. The data importer shall not make any automated decisions concerning data subjects, except when: a) i. such decisions are made by the data importer in entering into or performing a contract with the data subject, and