quality provisions set forth in any Quality Agreement between Manufacturer and Customer relating to a Facility, as the same may be amended or modified from time to time by mutual written agreement of the Parties. The form of Quality Agreement for each Facility is attached hereto as Attachment B. 1.99 "Recall" means a "recall", "correction" or "market withdrawal" and shall include any post-sale warning or mailing of information. 1.100 "Receiving Site" shall have the meaning set forth in Section 2.10(a). 1.101 "Record Retention Period" shall have the meaning set forth in Section 15.1. 1.102 "Records" means any books, documents, accounting procedures and practices and other data, regardless of type or form, of all matters relating to Manufacturer's performance of its obligations under this Agreement that enable Manufacturer to demonstrate compliance with such obligations, including, without limitation, Manufacturer's compliance with applicable Laws. -10- Source: UPJOHN INC, 10-12G, 1/21/2020 1.103 "Regulatory Approvals" means the permit, approval, consent, registration, license, authorization or certificate of a Governmental Authority necessary for the manufacturing, distribution, use, promotion and sale of a Product for one or more indications in a country or other regulatory jurisdiction, including approval of New Drug Applications and Biologics License Applications (each as defined by applicable Law) in the United States and Marketing Authorizations (as such term is defined by applicable Law) in the European Union. 1.104 "Release" means any release, spill, emission, leaking, dumping, pumping, injection, pouring, deposit, disposal, discharge, dispersal, leaching or migration into or through the indoor or outdoor environment (including ambient air, surface water, groundwater, land surface or subsurface strata, soil and sediments) or into, through or within any property, building, structure, fixture or equipment. 1.105 "Restricted Markets" means, as applicable and as may be updated from time to time, in each case, under Global Trade Control Laws, the