1.16“Created” means, with respect to any Data and Technology, made, created, authored, invented (whether conceived of or first reduced to practice or both) or developed, as applicable.
1.17“CSPC Competitor” means a Third Party that: (a) [*]; or (b) [*].
1.18“Data and Technology” means all creations, inventions, discoveries, know-how, works of authorship, data, and other information, including study data, development data, information (including scientific, technical or regulatory information), methods, techniques, materials, technology, results, analyses, laboratory, safety, pharmacology, toxicology, chemistry, manufacturing and controls (CMC) data, manufacturing and formulation methodologies and techniques, formulas, recipes, test methodologies, quality systems information, efficacy studies and data, absorption, distribution, metabolism and excretion studies and data, and regulatory information, filings and supporting data.
1.19“Development” means any and all clinical drug development activities conducted before or after obtaining Marketing Approval that are reasonably related to or leading to the development, preparation, and submission of data and information to a Regulatory Authority for the purpose of obtaining, supporting or expanding Marketing Approval or to the appropriate body for obtaining, supporting or expanding Pricing Approval, including all activities related to pharmacokinetic profiling, design and conduct of Clinical Studies, regulatory affairs, statistical analysis, report writing, and regulatory filing creation and submission (including the services of outside advisors and consultants in connection therewith). “Development” shall not include Manufacturing or Commercialization. When used as a verb, “Develop” means to engage in Development.
1.20“Directed To” means, with regard to any [*] or product, that such [*] or product: (a) binds specifically and directly to the Target; and (b) [*], as determined based on reasonable experimental data or generally accepted scientific literature, in either case available at the time of completion of preclinical development of such [*] or product.
1.21“Divestiture” means, with respect to a Competing Product of Elevation or the successor of Elevation in a Change of Control, the divestiture of such Competing Product through: (a) an outright sale or assignment of all rights in such Competing Product to a Third Party with no further material role, influence or authority of the applicable party, directly or indirectly, with respect to such Competing Product; or (b) the complete cessation of all Development, Manufacture, and Commercialization activities with respect to such Competing Product. When used as a verb, “Divest” and “Divested” means to cause or have caused a Divestiture.
1.22“EMA” means the European Medicines Agency or any successor entity thereto.
1.23“EU” means collectively, Italy, United Kingdom, Spain, France, and Germany.