1.73 Regulatory Authority means the international, federal, state or local governmental or regulatory bodies, agencies, departments, bureaus, courts or other entities responsible for (i) the regulation (including pricing) of any aspect of pharmaceutical or medicinal products intended for human use or (ii) health, safety or environmental matters generally.
1.74 Representatives of an entity means such entitys duly-authorized officers, directors, employees, agents, accountants, attorneys or other professional advisors.
1.75 Services means all work performed by Biogen for Vir pursuant to an SOW. Development Services shall mean Services consisting of Development activities, Technology Transfer Services shall mean Services consisting of Technology Transfer activities, Manufacturing Services shall mean Services consisting of pre-commercial/clinical Manufacturing activities as the context requires, and Unplanned Services shall have the meaning as set forth in Section 3.1.6.
1.76 SOW means a separate statement of work agreed to and executed by the Parties that defines the scope of work to be performed by Biogen and the responsibilities of the Parties with respect to such work, which statements of work shall be appended hereto at Attachment A as successive addenda upon execution thereof by duly authorized representatives of each of the Parties.
1.77 Specifications means the written specifications for Drug Substance or Drug Product, as applicable, agreed to by the Parties in an SOW, in each case as may be modified or amended by the mutual written agreement of the Parties from time to time.
1.78 Successful Batch(es) has the meaning set forth in Section 1.8.
1.79 Technology Transfer means the transfer, scale-up, testing, qualification, and licensure of a Facility necessary to Manufacture a Product, including: (a) transfer of the Manufacturing Process to the Facility, including the Process description, technical information, Manufacturing documentation, analytical methods, reference standards, materials, including, if stated in an applicable SOW, a portion of the master cell bank and/or working cell bank; (b) implementation of the Manufacturing Process at such Facility, including technical assistance and cooperation by appropriate employees of Biogen [***]; (c) all Manufacturing Process fit activities to the extent mutually agreed in the applicable SOW, including required process development and validation work and process engineering required to modify/equip and qualify such Facility for commercial Manufacturing; and (d) regulatory support for all required Regulatory Approvals of the Facility for commercial Manufacturing, each as relevant for the Facility in question and as further described in the applicable SOW(s).
1.80 Term has the meaning set forth in Section 12.1.
1.81 Third Party means any person, entity, or organization, including any government or sovereign, other than Biogen, Vir and their respective Affiliates.
1.82 Unplanned Services has the meaning set forth in Section 3.1.6.
1.83 Vir has the meaning set forth in the introductory paragraph, or any successor or permitted assign.
1.84 Vir Indemnitees has the meaning set forth in Section 9.1.
1.85 Vir Invention has the meaning set forth in Section 7.1.
1.86 Vir IP has the meaning set forth in Section 7.1.