rules, regulations, ordinances and other pronouncements having the effect of law in any country, state, province, county, city or other political subdivision, and includes any rule or regulation of any Governmental Authority that may be in effect from time to time in the Territory. 1.57 "License Agreement" means that certain Collaboration and License Agreement between Janssen Pharmaceutica N.V. and Astex Therapeutics Limited executed in June 2008, as amended, pursuant to which Janssen was granted a license under one or more patents covering the Product. 1.58 "Losses" has the meaning set forth in Section 12.1.1. 1.59 "Marketing Approval" means, with respect to any product, approval by the FDA of an NDA for such product. 1.60 "Milestone Event" has the meaning set forth in Section 5.3. 1.61 "Milestone Payment" has the meaning set forth in Section 5.3. 1.62 "Minimum Number of Details Requirement" has the meaning set forth in Exhibit B. 1.63 "Minimum PDE Requirement" has the meaning set forth in Exhibit B. 1.64 "Minimum Reach Requirement" has the meaning set forth in Exhibit B. 1.65 "Minimum Top Target Requirement" has the meaning set forth in Exhibit B. 1.66 "NDA" means, with respect to any product, a New Drug Application for such product and all supplements to such New Drug Application filed pursuant to the requirements of the FDA. 1.67 "Net Sales" means [***]. 1.68 "Other Company Employees" has the meaning set forth in Section 2.2.2(a). 1.69 "Party" means each of Janssen and Company, which together are referred to as the "Parties". 1.70 "Passing Score" has the meaning set forth in Section 2.2.2(c). 1.71 "Payee Party" means, with regards to a payment pursuant to this Agreement, the Party that receives such payment from the other Party under this Agreement. 1.72 "Paying Party" means, with regards to a payment pursuant to this Agreement,