Development or Develop - all preclinical development activities and all clinical drug development 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. When used as a verb, Develop shall mean to engage in Development.
Development or Develop -means all preclinical development activities undertaken with respect to any product related to research, pre-clinical and all other non-clinical drug development 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,clinical studies, including manufacturing clinical supplies, regulatory affairs,in support thereof, statistical analysis and report writing.writing, the preparation 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 or maintaining a Regulatory Approval. When used as a verb, Develop shall meanmeans to engage in Development.
Development or Develop - allmeans engaging in preclinical development activities and all clinical drug development and regulatory activities regarding Compound or Product. Development shall include, without limitation, all preclinical testing,activities, including, but not limited to, discovery, test method development anddevelopment, stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification anddevelopment-stage manufacturing, analytical method validation, manufacturing process validation, cleaning validation, post-approval changes, quality assurance/quality control, statistical analysis, report writing, preclinical studies, Clinical Studies, manufacturing clinical supplies,Trials, regulatory affairs, statistical analysisfiling submission and report writing. When used as a verb, Develop shall mean to engage in Development.approval and regulatory affairs.
Development or Develop - allmeans engaging in preclinical development activities and all clinical drug development and regulatory activities regarding Compound or Product. Development shall include, without limitation, all preclinical testing,activities, including, but not limited to, discovery, test method development anddevelopment, stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification anddevelopment-stage manufacturing, analytical method validation, manufacturing process validation, cleaning validation, post-approval changes, quality assurance/quality control, statistical analysis, report writing, preclinical studies, Clinical Studies, manufacturing clinical supplies,Trials, regulatory affairs, statistical analysisfiling submission and report writing. When used as a verb, Develop shall mean to engage in Development.approval and regulatory affairs.
DevelopmentDevelop or Develop - all preclinical development activities and allDevelopment means the conduct of clinical drug development activities pertaining to a Development Candidate or Product, including toxicology, pharmacology, test method development, stability testing, process development, technology transfer, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical studies (including investigator-sponsored clinical trials, Supplemental Trials, Required Phase 4 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 regarding Compound or Product.(including regulatory activities directed to obtaining pricing and reimbursement approvals). For clarity, Development shall include, without limitation, all preclinical testing, test method developmentwill exclude any Research, Commercialization 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. When used as a verb, Develop shall mean to engage in Development.Manufacturing activities.
Development or Develop -means all preclinical development activities related to research, pre-clinical and all other non-clinical drug development 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,including Manufacturing in support thereof, statistical analysis and report writing.writing, the preparation 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 or maintaining a Regulatory Approval. When used as a verb, Develop shall meanmeans to engage in Development.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.
Development or Develop -shall mean all preclinical research and development activities and all clinical drug development and regulatory activities regarding Compound or Product. Development shall include, without limitation, all preclinical testing, test method development and stability testing,activities, including, among other things: drug discovery, 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. When used aswriting, 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 verb, DevelopMarketing Authorization, maintain a label or obtain any label change, but shall mean to engage in Development.exclude Commercialization Studies.
Development or Develop - all preclinical development activities“Development” means pre-clinical and all clinical drug development and regulatory activities regarding Compoundwhich occur prior to or Product. Development shall include, without limitation, all preclinical testing,as a condition of Regulatory Approval including, among other things: test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualificationdevelopment-stage manufacturing, analytical method validation, manufacturing process validation, cleaning validation, scale-up and validation, quality assurance/quality control, Clinical Studies, manufacturingpost approval changes and requirements, pre- clinical supplies,and clinical studies, regulatory affairs, statistical analysisfiling submissions and report writing.pre-approvals, and regulatory affairs related to the foregoing. When used as a verb, Develop shall mean“Develop” means to engage in Development.
DevelopmentDevelop or Develop - all preclinicalDevelopment means activities conducted for the purpose of evaluating and progressing compounds, products, or processes for submission of information to a Regulatory Authority for the purpose of obtaining or maintaining Regulatory Approval of a product, and establishing 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 activitiesand scale-up (including 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 activities, and all clinical drug development and regulatoryother activities regarding Compoundrelating to seeking, obtaining 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. When used as a verb, Develop shall mean to engage in Development.maintaining any Regulatory Approvals from the FDA or any other applicable Regulatory Authority.
DevelopmentDevelop or Develop - all preclinicalDevelopment means to engage in research and development activities intended to research, discover or develop Compounds and/or to support INDs, NDAs or other Regulatory Approvals for Products, including, without limitation, # development of the applicable active drug substance(s), # toxicology, pre-clinical and all clinical drug development and regulatory activities regarding Compound or Product. Development shall include, without limitation, all preclinical testing, activities, # clinical trials (except for Phase IV Studies), # assay/test method developmentdevelopment, validation and stability testing, toxicology, formulation,# formulation development, # manufacture of pre-clinical, clinical and commercial supplies, and manufacturing process development, manufacturing scale-up, qualificationup and validation, # quality assurance/quality control, Clinical Studies, manufacturing clinical supplies,statistical analysis, and regulatory affairs, statistical analysisaffairs (including without limitation the preparation, submission and report writing. When used as a verb, Develop shall meanmaintenance of all INDs and NDAs for the Products), and # to engagehave any of the activities described in Development.[(i)-(vii)])] performed.
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