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.
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GMP Grade means Product that has been produced in accordance with applicable Good Manufacturing Practices with respect to active pharmaceutical ingredients.
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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.
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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.

  • Trade name: Neutral Protease NB GMP Grade from Clostridium histolyticum (Contd.

  • 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.

  • During Phase II, SYNCO warrants that the Batches of rhPTH will be GMP Grade and SYNCO assumes all other obligations in respect thereto, including guaranteeing an average Yield per Batch of the manufacturing process (as established according to Article 4.4), as calculated over thirty (30) Batches manufactured during Phase II which are released by NPS in accordance with Article 6.6.

  • Facile & Scalable Synthesis of Plant-Based Cholesterol (BotaniChol®) in GMP Grade [cited 2021 Aug 15].

  • The H135 GMP Hypoxystation was designed for customers running GMP certified facilities, to allow manipulation of samples under strict hypoxic conditions whilst maintaining GMP compliance.Developing a GMP compliant workstation involved the creation of innovative laminar airflow technology and it is this feature that ensures maintenance of EU GMP Grade A particulate counts in the processing chamber.

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

  • 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.

  • PCE is the only Site COC that has been detected in soil above the laboratory detection limit at this property.

  • Each of BioGeneriX and Neose will use Reasonable Commercial Efforts, including capital investments, to produce, or have produced, GMP Grade Products (in the case of BioGeneriX) and chemicals and enzymes covered by the Neose Technology (in the case of Neose), in each case, in quantities sufficient for the purposes of the Collaboration.


More Definitions of GMP Grade

GMP Grade means rhPTH that has been produced in accordance with the Regulatory Standards and the Specifications.
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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.
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Related to GMP Grade

  • Finished grade means the approved elevation of ground surface of lands upon which fill has been placed in accordance with this By-law;

  • Pay grade means the monthly salary applicable to class titles of service personnel;

  • Established Grade means that grade established by the City for the particular area in which a sidewalk is to be constructed.

  • Passing grade means work of such character that credit would be entered on the records were the semester to close at that time.

  • Highest adjacent grade means the highest natural elevation of the ground surface prior to construction next to the proposed walls of a structure.

  • Highest Adjacent Grade (HAG means the highest natural elevation of the ground surface, prior to construction, immediately next to the proposed walls of the structure.

  • Existing grade means the grade before grading.

  • Highest Rating Category means, with respect to a Permitted Investment, that the Permitted Investment is rated by S&P or Moody’s in the highest rating category given by that rating agency for that general category of security. By way of example, the Highest Rating Category for tax exempt municipal debt established by S&P is “A 1+” for debt with a term of one year or less and “AAA” for a term greater than one year, with corresponding ratings by Moody’s of “MIG 1” (for fixed rate) or “VMIG 1” (for variable rate) for three months or less and “Aaa” for greater than three months. If at any time (i) both S&P and Moody’s rate a Permitted Investment and (ii) one of those ratings is below the Highest Rating Category, then such Permitted Investment will, nevertheless, be deemed to be rated in the Highest Rating Category if the lower rating is no more than one rating category below the highest rating category of that rating agency. For example, a Permitted Investment rated “AAA” by S&P and “Aa3” by Moody’s is rated in the Highest Rating Category. If, however, the lower rating is more than one full rating category below the Highest Rating Category of that Rating Agency, then the Permitted Investment will be deemed to be rated below the Highest Rating Category. For example, a Permitted Investment rated “AAA” by S&P and “A1” by Moody’s is not rated in the Highest Rating Category.

  • Lowest Adjacent Grade (LAG means the elevation of the ground, sidewalk or patio slab immediately next to the building, or deck support, after completion of the building.

  • Investment Grade means a rating of Baa3 or better by Moody’s (or its equivalent under any successor rating categories of Moody’s); a rating of BBB- or better by S&P (or its equivalent under any successor rating categories of S&P); and the equivalent investment grade credit rating from any additional Rating Agency or Rating Agencies selected by the Company.

  • Rating Category means one of the generic rating categories of any Rating Agency without regard to any refinement or gradation of such rating by a numerical modifier or otherwise.

  • Threshold Rating means the short-term unsecured debt rating of P-1 by Moody's and A-1 by Standard & Poor's.

  • 2 Wire Analog Voice Grade Loop or “Analog 2W” provides an effective 2-wire channel with 2-wire interfaces at each end that is suitable for the transport of analog Voice Grade (nominal 300 to 3000 Hz) signals and loop-start signaling. This Loop type is more fully described in Verizon Technical Reference (TR)-72565, as revised from time-to-time. If “Customer-Specified Signaling” is requested, the Loop will operate with one of the following signaling types that may be specified when the Loop is ordered: loop-start, ground-start, loop- reverse-battery, and no signaling. Customer specified signaling is more fully described in Verizon TR-72570, as revised from time-to- time. Verizon will not build new facilities.

  • Nameplate Capacity Rating means the maximum capacity of the Facility as stated by the manufacturer, expressed in kW, which shall not exceed 10,000 kW.

  • Investment Grade Credit Rating means (a) with respect to Fitch, a credit rating of BBB- or higher, (b) with respect to Xxxxx’x, a credit rating of Baa3 or higher and (c) with respect to S&P, a credit rating of BBB- or higher.

  • Xxxxx’x Rating means, at any time, the rating issued by Xxxxx’x and then in effect with respect to the Borrower’s senior unsecured long-term debt securities without third-party credit enhancement.

  • Gross vehicle weight rating means the weight specified by the manufacturer as the loaded weight of a single vehicle.

  • Rating Point means the V&H coordinates associated with a particular telephone number for rating purposes.

  • Mxxxx’x Rating means, with respect to a Reference Obligation, as of any date of determination:

  • Working level month (WLM) means an exposure to 1 working level for 170 hours (2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month).

  • Minimum Level (ML means the concentration at which the entire analytical system must give a recognizable signal and an acceptable calibration point. The ML is the concentration in a sample that is equivalent to the concentration of the lowest calibration standard analyzed by a specific analytical procedure, assuming that all the method-specified sample weights, volumes and processing steps have been followed.

  • Moody’s Industry Classification means the industry classifications set forth in Schedule 4 hereto, as such industry classifications shall be updated at the option of the Servicer if Moody’s publishes revised industry classifications. The determination of which Moody’s Industry Classification to which an Obligor belongs shall be made in good faith by the Servicer.

  • Sound level meter means an instrument which includes a microphone, amplifier, RMS detector, integrator or time averager, output meter, and weighting networks used to measure sound pressure levels.

  • Grade means the average level of finished ground adjoining a building or structure at all exterior walls;

  • S&P Rating means, at any time, the rating issued by S&P and then in effect with respect to the Borrower’s senior unsecured long-term debt securities without third-party credit enhancement.

  • eligible Categories means Categories (1) through (4) set forth in the table in paragraph 1 of Schedule 1 to this Agreement;