RETAINS Clause Samples
The 'RETAINS' clause establishes which rights, property, or interests a party will continue to hold after entering into an agreement. In practice, this clause might specify that a seller retains certain intellectual property rights or that an employee retains ownership of personal inventions created outside of work. Its core function is to clearly delineate what is excluded from the transfer or assignment, thereby preventing misunderstandings and disputes over ownership or control after the agreement is executed.
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RETAINS. Biozyme shall retain a sufficient quantity of each production run of Product to enable the performance of the tests required by this Article 5 at least twice. Such samples shall be retained during such period as is required by the Specifications, GMP requirements and all applicable regulatory requirements.
RETAINS. 13.1 Procedures should be in place for the handling, quantity and storage of retain samples for raw materials, intermediates and drug substance.
RETAINS. 2.4.1. Ash S▇▇▇▇▇▇ agrees to store all retained samples for API as specified in the Specifications and Test Record form for that specific material. The quantity of retain samples will be as specified on Ash S▇▇▇▇▇▇’ Specification and Test Record form provided that the quantity is sufficient to perform three full tests of the item shall be retained. API retain samples will be maintained and retained by Ash S▇▇▇▇▇▇ for a period ending five years following the end of the calendar year in which the Product lot including such API reaches the end of it’s shelf life.
RETAINS. 17. 1Lifecore is responsible for retaining samples from each lot of product in accordance with 21 CFR 211.170, EU GMP Annex 13, and EU GMP Annex 19. Lifecore shall store the retained samples under appropriate storage conditions and in a secure area. SamplesMaterials/ProductsRetention Period […***…] […***…] […***…] […***…] […***…] […***…] […***…]
RETAINS. From each batch/lot of product produced a minimum of three cases per lot will be pulled evenly from the beginning, middle, and end of every batch/lot of product. Ensure the product is labeled to identify when and from where the samples were taken.
RETAINS. 17.1 Lifecore is responsible for retaining samples from each lot of product in accordance with 21 CFR 211.170, EU GMP Annex 13, and EU GMP Annex 19. Lifecore shall store the retained samples under appropriate storage conditions and in a secure area.
17.2 Lifecore is responsible for annual inspections of reference/retention samples.
17.3 Semnur will notify Lifecore of formal discontinuation or completion of clinical trials involving Lifecore-manufactured Product.