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“Development” or “Develop” means engaging in preclinical and clinical drug development activities, including, but 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, report writing, preclinical studies, Clinical Trials, regulatory filing submission and approval and regulatory affairs.

“Development” or “Develop” means engaging in preclinical and clinical drug development activities, including, but 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, report writing, preclinical studies, Clinical Trials, regulatory filing submission and approval and regulatory affairs.

“Development” or “Develop” means engaging in- all preclinical development activities and all clinical drug development activities, including, but not limited to, discovery,and regulatory activities regarding Compound or Product. Development shall include, without limitation, all preclinical testing, test method development,development and stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, analytical methodqualification and validation, manufacturing process validation, cleaning validation, post-approval changes, quality assurance/quality control, Clinical Studies, manufacturing clinical supplies, regulatory affairs, statistical analysis,analysis and report writing, preclinical studies, Clinical Trials, regulatory filing submission and approval and regulatory affairs.writing. When used as a verb, “Develop” shall mean to engage in Development.

“Development” or “Develop” means engaging in preclinicalall activities undertaken with respect to any product related to research, pre-clinical and other non-clinical drug development activities, including, but not limited to, discovery,testing, test method development,development and stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, analytical methodqualification and validation, manufacturing process validation, cleaning validation, post-approval changes, quality assurance/quality control, clinical studies, including manufacturing in support thereof, statistical analysis,analysis and report writing, preclinical studies, Clinical Trials,the preparation and submission of Drug Approval Applications or BLAs, regulatory filing submissionaffairs with respect to the foregoing and approval and regulatory affairs.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” means to engage in Development.

“Development” or “Develop” means engaging in preclinicalall activities related to research, pre-clinical and other non-clinical drug development activities, including, but not limited to, discovery,testing, test method development,development and stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, analytical methodqualification and validation, manufacturing process validation, cleaning validation, post-approval changes, quality assurance/quality control, Clinical Studies, including Manufacturing in support thereof, statistical analysis,analysis and report writing, preclinical studies, Clinical Trials,the preparation and submission of Drug Approval Applications, regulatory filing submissionaffairs with respect to the foregoing and approval and regulatory affairs.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” means to 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” means engaging inshall mean all preclinical research and development activities and all clinical drug development activities, including, but not limited to,among other things: drug 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,analysis and report writing, preclinical studies, Clinical Trials, regulatory filing submissionconducting clinical trials for the purpose of obtaining and approvalmaintaining Marketing Authorization (including without limitation, post-marketing studies), and regulatory affairs.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” means activities conducted for the purpose of evaluating and progressing compounds, products, or “Develop” means engaging in preclinicalprocesses 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 drug development activities, including, but not limited to, discovery, test method development, stability testing, toxicology,pharmacology studies, toxicology studies, formulation, process development, manufacturing scale-up, development-stage manufacturing, analytical method validation,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 validation, cleaning validation, post-approval changes,development and scale-up (including API and drug product production), quality assurance/assurance and quality control, statistical analysis, report writing, preclinicaltechnical support, pharmacokinetic studies, Clinical Trials,clinical studies, biomarker and companion diagnostic discovery and development, regulatory filing submissionaffairs activities, and approval and regulatory affairs.all other activities relating to seeking, obtaining or maintaining any Regulatory Approvals from the FDA or any other applicable Regulatory Authority.

“Develop” or “Development” means to engage in research and development activities intended to research, discover or “Develop” means engaging in preclinicaldevelop 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 clinical drug development activities, including, but not limited to, discovery, # clinical trials (except for Phase IV Studies), # assay/test method development, validation and stability testing, toxicology, formulation,# formulation development, # manufacture of pre-clinical, clinical and commercial supplies, and manufacturing process development, manufacturing scale-up, development-stage manufacturing, analytical methodup and validation, manufacturing process validation, cleaning validation, post-approval changes,# quality assurance/quality control, statistical analysis, report writing, preclinical studies, Clinical Trials,and regulatory filingaffairs (including without limitation the preparation, submission and approvalmaintenance of all INDs and regulatory affairs.NDAs for the Products), and # to have any of the activities described in (i)-(vii) performed.

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