GMP Grade definition

GMP Grade means production of a Product in accordance with the Regulatory Standards and the process and procedures described in the Manufacturing Information.
GMP Grade means Product that has been produced in accordance with applicable Good Manufacturing Practices with respect to active pharmaceutical ingredients.
GMP Grade means rhPTH that has been produced in accordance with the Regulatory Standards and the Specifications.

Examples of GMP Grade in a sentence

  • In such event, Cephalon will use commercially reasonable efforts, including the making of capital investments, to scale-up and expand its manufacturing facility in Beltsville, Maryland to provide GMP Grade IGF-1 for such purpose.

  • Chiron will use commercially reasonable efforts, including the making of capital investments, to scale-up and expand the Vacaville Facility to up to [CONFIDENTIAL TREATMENT REQUESTED] capacity to produce GMP Grade IGF-1 in quantities sufficient for the Collaboration's commercial purposes as specified in the Marketing Plans.

  • This Agreement, and any and all rights, duties and obligations hereunder, shall not be assigned, transferred, delegated or sublicensed by any Investor without the prior written consent of the Company, except to a Permitted Transferee.

  • Neose shall transfer limited rights in the Neose Technology to BioGeneriX ****, as required, solely for GMP Grade manufacturing of the Development Product by BioGeneriX, ****.

  • Subject to reasonable supply terms mutually agreed upon by the parties, Neose shall use Reasonable Commercial Efforts to supply all chemicals and enzymes covered by the Neose Technology, solely for GMP Grade manufacturing of any Product by or for BioGeneriX, in contemplation of sale under a BLA (commencing with the first validation batch), in accordance with this Agreement, and BioGeneriX shall reimburse Neose’s Allowable Costs for such reagents.

  • NPS will have final responsibility for confirming Quality Assurance and for the release of each Batch of GMP Grade PTH and TEDUGLUTIDE manufactured by SYNCO for commercial use.

  • Phase I will end when SYNCO has manufactured the ten (10) Batches of GMP Grade rhPTH and NPS' Quality Assurance has released for clinical use or early commercial sale these ten (10) Batches pursuant to Article 6.

  • Provide and maintain appropriate personnel, facilities, equipment, the Facility, and support documents to carry out the manufacture of Batches of GMP Grade Product as required by this Agreement.

  • The manufacturing, release and delivery of GMP Grade Product for the pre-launch Campaign shall be done according to SYNCO's manufacturing schedule.

  • Neither Ma▇▇▇▇▇▇, the Exchange Agent nor the Surviving Corporation shall (absent manifest error) be liable to any former holder of York Common Stock for any cash held in the Exchange Fund which is delivered to a public official pursuant to any applicable abandoned property, escheat or similar law.


More Definitions of GMP Grade

GMP Grade means Copolymer that has been produced in accordance with Good Manufacturing Practice regulations as defined by the FDA. 2 "Manufacturing Facility" means the manufacturing facility of CytRx, or any manufacturing facility of a third party licensed and engaged by CytRx to supply the Copolymer in accordance with Section 2.1.
GMP Grade means Copolymer that has been produced in accordance with Good Manufacturing Practice regulations as defined by the FDA. -------------------- The "[X]" marks in Exhibit 10.4 represents deleted material which is subject to a request for Confidential Treatment and has been filed separately with the Secretary of the Securities and Exchange Commission.