1.35. Development, Developing or Develop means under this Agreement, with respect to Drug Candidates, Licensed Drug Candidates and Licensed Products, the research and development activities related to the generation, characterization, optimization, construction, use and production of Drug Candidates, Licensed Drug Candidates and Licensed Products, any other non-clinical, pre-clinical or clinical research and development activities related to the testing and qualification of Drug Candidates, Licensed Drug Candidates and Licensed Products, as applicable, including toxicology studies, pharmacology studies, statistical analysis and report writing, pre-clinical testing, Clinical Studies, regulatory affairs and registration activities, and all other activities necessary to prepare and file applications for Regulatory Approval and to seek, obtain and maintain Regulatory Approval. For the sake of clarity, Development includes activities conducted as or post-Regulatory Approval study.
1.36. Drug Candidate means any Compound that inhibits or modulates Polq, and any derivatives, analogs, metabolites, salts, esters, free acid forms, free base forms, pro- drug forms, racemates, solvates or optically active forms of such Compound that is generated, developed, discovered, identified or modified in the course of performance of the Research Plan.
1.37. Drug Candidate Selection Period has the meaning set forth in Section 3.4.
1.38. Effective Date has the meaning set forth in the Preamble.
1.39. EMA means the European Medicines Agency, or any successor entity thereto performing similar functions.
1.40. FD&C Act means the United States Federal Food, Drug and Cosmetic Act, as amended.
1.41. FDA means the United States Food and Drug Administration and any successor Governmental Authority having substantially the same function.
1.42. Field means any and all uses.
1.43. First Commercial Sale means, with respect to a country, the first sale for end use or consumption of a Licensed Product in such country, [***], after all Regulatory Approvals legally required for such sale have been granted by the Regulatory Authority of such country.
1.44. FTE has the meaning set forth in Section 6.1.4.
1.45. GAAP means generally accepted accounting principles as practiced in the United States or International Financial Reporting Standards (IFRS), in each case, consistently applied.
1.46. GCP or Good Clinical Practices means, with respect to any applicable jurisdiction, the then-current standards, practices and procedures for clinical trials for pharmaceuticals promulgated or endorsed by the applicable Regulatory Authority in such jurisdiction (including, with respect to the United States, the FDA) as set forth in the applicable Laws of such jurisdiction, including, with respect to the United States, the guidelines titled Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance and related regulatory requirements imposed by the FDA, and with respect to jurisdictions outside the United States, comparable regulatory standards, practices and procedures promulgated by the EMA or other Regulatory Authority, as applicable, including any applicable quality guidelines promulgated under the International Conference on Harmonization (ICH), in each case as they may be updated from time to time.