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“Manufacture” shall mean all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including but not limited to test method development and stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing Licensed Compound or Licensed Product quality assurance/quality control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing.

“Manufacture” shall meanand “Manufacturing” means all activities related to the manufacturingsynthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of a pharmaceutical product,the Licensed Compound, any Licensed Product, or any ingredientintermediate thereof, including but not limited to test method developmentprocess development, process qualification and validation, scale-up, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing Licensed Compound or Licensed Product quality assurance/assurance, and quality control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing.control.

“Manufacture” shall meanor “Manufacturing” means any and all activities related to the manufacturingmanufacture, formulation and packaging of a pharmaceutical product, Compounds and/or any ingredient thereof, including but not limited to test method development and stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing Licensed Compound or Licensed Product quality assurance/Products, including, without limitation, related quality control development,and quality control testing (including in-process releaseassurance activities. For clarity, the Manufacture of pre-clinical, clinical and stability testing), packaging, release of product or any component or ingredient thereof, quality assurancecommercial supplies and Manufacturing activities related to manufacturingprocess development and releasescale up work will also be considered part of product, and regulatory activities related to all of the foregoing.Manufacturing.

“Manufacture” shall meanand “Manufacturing” means all activities related to the manufacturingproduction, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of a pharmaceutical product, or any ingredient thereof, including but not limited to test method development and stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing Licensed Compound or Licensed Product quality assurance/quality control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredientintermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing.quality control.

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