1.7 Anti-Corruption Laws means all Applicable Laws regarding public or private-sector corruption, bribery, kickbacks, speed or facilitation payments, ethical business conduct, money laundering, embezzlement, political contributions, gifts, gratuities, expenses, entertainment, hospitalities, agency relationships, commissions, lobbying, books and records, and financial controls, including the FCPA, the UK Bribery Act 2010, the U.S. Travel Act, and other anti-corruption laws.
1.8 Applicable Law means applicable laws, rules, and regulations, including any rules, regulations, guidelines, or other requirements of any Regulatory Authority, which may be in effect from time to time.
1.9 Approval means, with respect to a product, any approval (including Marketing Approvals and Pricing Approvals (for purposes of use in this definition, the terms Marketing Approvals and Pricing Approvals shall not be limited to Collaboration Products in the Field)), registration, license or authorization from any Regulatory Authority required for development, manufacture or commercialization of such product in a regulatory jurisdiction in the Territory.
1.10 Biologic Product means a Cost-Share Product that is not a Small Molecule Product.
1.11 Business Day means any day other than a Saturday, a Sunday or a day on which commercial banks in New York, New York, are authorized or required by law to remain closed.
1.12 Cell Line Development Activities means, cell line development activities to be performed by Regeneron or one of its Affiliates pursuant to a Research Plan.
1.13 Cell Line Development Costs means, with respect to a cell line, the sum of the following items, in each case to the extent directly attributable to Cell Line Development Activities with respect to such cell line in accordance with this Agreement: (a) Out-of-Pocket Costs (including fees and expenses) incurred in performing any Cell Line Development Activities, and (b) Cell Line Development FTE Costs.
1.14 Cell Line Development FTE Cost means the product of (a) the number of FTEs performing Cell Line Development Activities under a Research Plan and (b) the applicable FTE Rate for such FTEs.
1.15 Cell Line Development Payment Report means, with respect to a Quarter, the Quarterly report prepared by Regeneron in accordance with Section 2.4(c) that sets forth in reasonable detail the Cell Line Development Costs incurred by Regeneron for such Quarter.
1.16 Change of Control means, with respect to a Party (or its ultimate parent), (a) a merger, acquisition, consolidation or reorganization of such Party (or its ultimate parent) with a Third Party that results in the voting securities of such Party (or its ultimate parent) outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, or (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the beneficial owner (as such term is used in Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder (or, in each case, any successor thereto), except that a Person shall be deemed to have beneficial ownership of all shares that any such Person has the right to acquire, whether such right may be exercised immediately or only after the passage of time), directly or indirectly, of more than fifty percent (50%) of the combined voting power of the outstanding securities of such Party (or its ultimate parent), or (c) the sale or other transfer to a Third Party of all or substantially all of such Partys (or its ultimate parents) business to which the subject matter of this Agreement relates; provided that, with respect to the foregoing clauses (a)(c), any transaction between a Party and a Third Party that is a Non-Affiliate Investor shall not be considered a Change of Control for purposes of this Agreement.