“Development” or “Develop” shall mean all preclinical research and development activities and all clinical drug development activities, including, among other things: drug discovery, toxicology, formulation, statistical analysis and report writing, conducting clinical trials for the purpose of obtaining and maintaining Marketing Authorization (including without limitation, post-marketing studies), and regulatory affairs related to all of the foregoing. Development shall include all clinical studies (including Phase III-B) that are primarily intended to support or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.

“Develop” or “Development” or “Develop” shall mean all preclinical research and development activities and allmeans the conduct of clinical drug development activities, including, among other things: drug discovery,activities pertaining to a Development Candidate or Product, including toxicology, formulation,pharmacology, test method development, stability testing, process development, technology transfer, formulation development, delivery system development, quality assurance and quality control development, statistical analysis and report writing, conducting clinical trials for the purpose of obtaining and maintaining Marketing Authorization (including without limitation, post-marketing studies), and regulatory affairs related to all of the foregoing. Development shall include allanalysis, clinical studies (including investigator-sponsored clinical trials, Supplemental Trials, Required Phase III-B) that are primarily intended4 Clinical Trials and any post-approval studies required by the relevant Regulatory Authority), regulatory affairs, pharmacovigilance, Regulatory Approval and Pricing Approval, and clinical study regulatory activities (including regulatory activities directed to support or maintain a Marketing Authorization, maintain a label or obtainobtaining pricing and reimbursement approvals). For clarity, Development will exclude any label change, but shall excludeResearch, Commercialization Studies.and Manufacturing activities.

“Development” or “Develop” shall mean- all preclinical research and development activities and all clinical drug development activities, including, among other things: drug discovery,and regulatory activities regarding Compound or Product. Development shall include, without limitation, all preclinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, manufacturing clinical supplies, regulatory affairs, statistical analysis and report writing, conducting clinical trials for the purpose of obtaining and maintaining Marketing Authorization (including without limitation, post-marketing studies), and regulatory affairs relatedwriting. When used as a verb, “Develop” shall mean to all of the foregoing. Development shall include all clinical studies (including Phase III-B) that are primarily intended to support or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.engage in Development.

“Development” or “Develop” shall mean allmeans engaging in preclinical research and development activities and all clinical drug development activities, including, among other things: drugbut not limited to, discovery, test method development, stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, analytical method validation, manufacturing process validation, cleaning validation, post-approval changes, quality assurance/quality control, statistical analysis andanalysis, report writing, conducting clinical trials for the purpose of obtainingpreclinical studies, Clinical Trials, regulatory filing submission and maintaining Marketing Authorization (including without limitation, post-marketing studies),approval and regulatory affairs related to all of the foregoing. Development shall include all clinical studies (including Phase III-B) that are primarily intended to support or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.affairs.

“Development”“Development” or “Develop” shall mean allmeans engaging in preclinical research and development activities and all clinical drug development activities, including, among other things: drugbut not limited to, discovery, test method development, stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, analytical method validation, manufacturing process validation, cleaning validation, post-approval changes, quality assurance/quality control, statistical analysis andanalysis, report writing, conducting clinical trials for the purpose of obtainingpreclinical studies, Clinical Trials, regulatory filing submission and maintaining Marketing Authorization (including without limitation, post-marketing studies),approval and regulatory affairs related to all of the foregoing. Development shall include all clinical studies (including Phase III-B) that are primarily intended to support or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.affairs.

“Development” or “Develop” shall meanmeans all preclinical researchactivities undertaken with respect to any product related to research, pre-clinical and other non-clinical testing, test method development activities and all clinical drug development activities, including, among other things: drug discovery,stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, clinical studies, including manufacturing in support thereof, statistical analysis and report writing, conducting clinical trials for the purposepreparation and submission of Drug Approval Applications or BLAs, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining andor maintaining Marketing Authorization (including without limitation, post-marketing studies), and regulatory affairs relateda Regulatory Approval. When used as a verb, “Develop” means to all of the foregoing. Development shall include all clinical studies (including Phase III-B) that are primarily intended to support or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.engage in Development.

“Development” or “Develop” shall meanmeans all preclinical researchactivities related to research, pre-clinical and other non-clinical testing, test method development activities and all clinical drug development activities, including, among other things: drug discovery,stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, including Manufacturing in support thereof, statistical analysis and report writing, conducting clinical trials for the purposepreparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining andor maintaining Marketing Authorization (including without limitation, post-marketing studies), and regulatory affairs relateda Regulatory Approval. When used as a verb, “Develop” means to all of the foregoing. Development shall include all clinical studies (including Phase III-B) that are primarily intended to support or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...​...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

“Develop” or “Development” means activities conducted for the purpose of evaluating and progressing compounds, products, or “Develop” shall mean all preclinical research and development activities and all clinical drug development activities, including, among other things: drug discovery, toxicology, formulation, statistical analysis and report writing, conducting clinical trialsprocesses for submission of information to a Regulatory Authority for the purpose of obtaining or maintaining Regulatory Approval of a product, and maintaining Marketing Authorizationestablishing manufacturing capabilities for products. For a particular Product Candidate or Licensed Product, Development includes non-clinical activities, pharmacology studies, toxicology studies, formulation, chemical analysis, bioanalytical analysis, material performance studies (such as measurements of stability, physical form, dissolution, or visual or spectroscopic analysis, and the like), manufacturing process development and scale-up (including without limitation, post-marketing studies)API and drug product production), quality assurance and quality control, technical support, pharmacokinetic studies, clinical studies, biomarker and companion diagnostic discovery and development, regulatory affairs relatedactivities, and all other activities relating to all ofseeking, obtaining or maintaining any Regulatory Approvals from the foregoing. Development shall include all clinical studies (including Phase III-B) that are primarily intended to supportFDA or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.other applicable Regulatory Authority.