DP Release definition

DP Release means, with respect to Active Drug Product, the date on which Bioverativ receives the ADP Certificate of Analysis and the ADP Certificate of Conformance, and with respect to Diluent, the date on which Bioverativ receives the Diluent Certificate of Analysis and the Diluent Certificate of Conformance.
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Examples of DP Release in a sentence

  • DP Release AttributesDrug product release specification is intended to provide a safe and effective product to patients; in several instances, over decades, we have determined the practical limits of manufacturing parenteral products and I do not see why this wisdom cannot be applied to establishing DP release attributes.DP attributes determine the safety and efficacy because of their relationship with the process.

  • Drug Substance (DS) & Drug Product (DP) Release and Stability Specifications3.2.S.4.5 and 3.2.P.5.6 Justification of Specifications(b) (4) 10 Page(s) have been Withheld in Full as B4 (CCI/TS) immediately following this pageBLA 761039Page 17 (b) (4) PRESCRIBING INFORMATION We reserve comment on the proposed labeling until the application is otherwise adequate.

Related to DP Release

  • Pre-Release shall have the meaning set forth in Section 2.09.

  • New Release means new releases, updates or versions of the Software made generally available by SAP through unrestricted shipment pursuant to SAP Support after the Effective Date of the Agreement.

  • Release of Claims means the Release of Claims in substantially the same form attached hereto as Exhibit A (as the same may be revised from time to time by the Company upon the advice of counsel).

  • Work release means a program of partial confinement

  • Current Release means the latest version of the Software offered for general commercial distribution at a given point in time, including all New Releases.

  • Waiver and Release means the Waiver and Release attached hereto as Exhibit A.

  • Earned release means earned release from confinement as

  • Release Agreement means an agreement, substantially in a form approved by the Company, pursuant to which Executive releases all current or future claims, known or unknown, arising on or before the date of the release against the Company, its subsidiaries and its officers.

  • General Release has the meaning stated in Section 6.03.

  • Proof of Claim and Release means the Proof of Claim and Release form for submitting a Claim, which, subject to approval of the Court, shall be substantially in the form attached hereto as Exhibit A-2, that a Class Member must complete and submit should that Class Member seek to share in a distribution of the Net Settlement Fund.

  • SHIPPING RELEASE means the document issued by the inspector or the inspection agency nominated by the Purchaser authorising the Contractor to ship the Stores on satisfactory completion of inspection.

  • Conditional release means a revocable modification of a

  • Threatened Release means a substantial likelihood of a Release which requires action to prevent or mitigate damage to the soil, surface waters, groundwaters, land, stream sediments, surface or subsurface strata, ambient air or any other environmental medium comprising or surrounding any Property which may result from such Release.

  • Release means any release, spill, emission, leaking, pumping, pouring, injection, escaping, deposit, disposal, discharge, dispersal, dumping, leaching or migration of any Hazardous Material into the indoor or outdoor environment (including the abandonment or disposal of any barrels, containers or other closed receptacles containing any Hazardous Material), including the movement of any Hazardous Material through the air, soil, surface water or groundwater.

  • Major Release means a major update or upgrade to the Software, which includes significant enhancements and/or a major redesign of the Software, identified by Bosch by a change to the first digit in the release number (e.g. change from version 2.0 to 3.0).

  • Minor Release means a minor update or upgrade to the Software (including service releases or bug fixes), identified by Bosch by a change in the second or following digit in the release number (e.g. change from version 2.1 to 2.2 or 2.2.1 to 2.2.2.).

  • Deed of Release has the meaning set out in the Restructuring Implementation Deed;

  • Software Release means any subsequent version of Software provided by EMC after initial Delivery of Software, but does not mean a new Product.

  • Release Deadline means the deadline prescribed by Employer for the execution of the general release described in this paragraph (d)(2) of Section 7, which deadline shall in no event be later than 60 days following the date Executive’s employment terminates;

  • Mutual Release means the Mutual Release, substantially in the form attached as Exhibit F hereto.

  • Accidental release means an unanticipated emission of a regulated substance or other extremely hazardous substance into the ambient air from a stationary source.

  • Maintenance Release means any update, upgrade, release or other adaptation or modification of the Software, including any updated Documentation, that Contractor may generally provide to its licensees from time to time during the Term, which may contain, among other things, error corrections, enhancements, improvements or other changes to the user interface, functionality, compatibility, capabilities, performance, efficiency or quality of the Software.

  • Closing Press Release has the meaning set forth in Section 5.4(b).

  • Collateral Release Period means each period commencing with the occurrence of a Collateral Release Event and continuing until the occurrence of the next Collateral Reinstatement Event, if any, immediately following such Collateral Release Event.

  • Third-Party Release means the release given by each of the Releasing Parties to the Released Parties as set forth in Article VIII.E of the Plan.

  • Signing Press Release has the meaning set forth in Section 5.4(b).