FINAL EXECUTION VERSION
1.116 Invention means any and all discoveries, developments, improvements, modifications, formulations, compositions of matter, processes and other inventions (whether patentable or not patentable) that are invented (as determined in accordance with U.S. patent laws) in the course of activities performed under this Agreement by or on behalf of either Party or both Parties, including all rights, title and interest in and to the intellectual property rights therein.
1.117 Isolex Platform Patents means the Patent Rights Controlled by Baxalta as of the Effective Date, or that come to be Controlled by Baxalta at any time during the Term, that claim the Isolex Platform Technology.
1.118 Isolex Platform Technology means the technology Controlled by Baxalta as of the Effective Date, or that come to be Controlled by Baxalta at any time during the Term, relating to the Isolex cell separator machine, disposables, reagents and methods of use thereof.
1.119 Joint Inventions has the meaning set forth in Section 9.1.2.
1.120 Joint Patents has the meaning set forth in Section 9.1.2.
1.121 JSC has the meaning set forth in Section 3.1.1.
1.122 Know-How means techniques, data, inventions, practices, methods, trade secrets, knowledge, sources of supply, patent positioning, know-how, skill, experience, test data (including manufacturing, pharmacological, toxicological, preclinical and clinical test data) and analytical and quality control data or descriptions, including all proprietary information submitted to relevant Regulatory Authorities to support an application for Marketing Approval or an application for Reimbursement Approval, and in each case in written, oral, electronic or other form.
1.123 Launch Milestone has the meaning set forth in Section 8.3.2.
1.124 Law means all laws, statutes, rules, regulations, ordinances, orders, judgments and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign, including all such laws, statutes, rules, regulations, ordinances, orders, judgments and other pronouncements pertaining to the pharmaceutical industry or the healthcare industry and all anti-bribery or anti-corruption laws, including the FDCA and the FCPA and their implementing regulations and all foreign equivalents thereof.
1.125 Licensed Product means a Licensed Product Candidate for which the Commercial Option Exercise Date has occurred, including in any preparation, formulation, dosage, packaging or method of administration.
1.126 Licensed Product Candidate means each Variant Directed to an Included Target that is the subject of a Development Plan.
1.127 Licensed Product Marks has the meaning set forth in Section 9.11.
1.128 Litigation Conditions has the meaning set forth in Section 13.3.1.