Bulk Drug Specifications definition

Bulk Drug Specifications means the qualitative, quantitative, functional and analytical specifications (including in-process specifications) developed by or on behalf of Trubion that describe testing methods and acceptance criteria for Bulk Drug and in-process Bulk Drug, as such specifications may be amended from time to time by the Parties in accordance with Section 6.2, including without limitation such amendments as may be required to obtain or maintain approval from the FDA, EMEA, and other regulatory authorities. A copy of the Bulk Drug Specifications, current as of the Effective Date, is attached as Exhibit E. Bulk Drug Specifications are a type of Specifications.

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Bulk Drug Specifications means specifications developed by Immunex for ------------------------ Bulk Drug as set forth in the Product sBLA, including, without limitation, testing methods and acceptance criteria for each Batch generated, a summary of which is attached to the Quality Agreement, as such specifications may be amended from time to time in accordance with Section 6.2 hereof, ----------- including, without limitation, such amendments as * Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. The omitted portions of this exhibit have been filed separately with the SEC. may be required to obtain approval from the FDA and other applicable regulatory authorities in the United States.

Bulk Drug Specifications means specifications developed by Genentech for Bulk Drug, including, without limitation, testing methods and acceptance criteria for each Batch generated, a summary of which is attached to the Quality Agreement, as such specifications may be amended from time to time in accordance with Article 8 hereof, including, without limitation, such amendments as may be required to obtain and/or maintain Regulatory Approval in the Territory.

Examples of Bulk Drug Specifications in a sentence

Lonza shall provide sufficient and suitable storage facilities that meet the Bulk Drug Specifications for Bulk Drug and raw materials and components.
Section 6.2 of this Agreement sets forth the notification and approval procedure for changes to the Bulk Drug Specifications or the Manufacturing Process.
Such stability testing shall include testing to validate the lead times for shipment, the shelf life of Bulk Drug, and the Bulk Drug Specifications applicable to shipment, storage and handling of Bulk Drug.
Cubist warrants to Abbott that Bulk Drug supplied to Abbott hereunder shall meet the Bulk Drug Specifications.
Lonza shall cooperate with Trubion in good faith to implement all agreed upon changes to the Bulk Drug Specifications or Manufacturing Process in accordance with the agreed upon schedule.
Such stability testing shall include testing to validate the lead times for shipment, the shelf life of Bulk Drug and the Bulk Drug Specifications applicable to shipment, storage and handling of Bulk Drug.
Abbott shall have the option to direct NaPro to use its reasonable be▇▇ ▇▇▇orts to restore the corrupted or contaminated Bulk Drug to meet Bulk Drug Specifications (subject to all applicable regulatory requirements), or replace the corrupted, contaminated or damaged Bulk Drug to meet Bulk Drug Specifications at Abbott's expense within ninety (90) days of Abbott's notice to NaPro ▇▇▇▇ ▇▇▇ Bulk Drug has become corrupted, con▇▇▇▇▇▇▇▇d or damaged.
Subject to Section 4.4, Genentech shall provide ------------------ ----------- sufficient and suitable storage facilities that meet the Bulk Drug Specifications for Bulk Drug and raw materials.
Cubist further warrants to Abbott that Bulk Drug supplied to Abbott hereunder shall meet the Bulk Drug Specifications set forth on Exhibit 1.
Subject to the foregoing, for each [*] manufactured on such fourth bioreactor in conformance with cGMP, the Bulk Drug Specifications, the Target Yield, and the warranties in Section 7.1, Genentech shall pay Lonza an amount equal to [*].

More Definitions of Bulk Drug Specifications

Bulk Drug Specifications means the written specifications for Bulk Drug Substance set forth in Exhibit A as amended from time to time pursuant to Subparagraph 6.1.

Bulk Drug Specifications means specifications developed by Immunex for

Bulk Drug Specifications means the detailed description and parameters of Bulk Drug set forth on Exhibit 1.2.

Bulk Drug Specifications means the detailed description and parameters of Bulk Drug set forth on Exhibit 1.2. * Confidential treatment requested: Material has been omitted and filed with the Commission.

Bulk Drug Specifications means the specifications for the manufacture of the Bulk Drug set forth in Exhibit C-1, as such specifications may be amended from time to time either: (a) by mutual written agreement of the Parties; (b) in response to directives issued by a relevant governmental authority in connection with an Application for Regulatory Approval or marketing of the Finished Product in a particular jurisdiction; or (c) if applicable, based upon the decision of the Development Committee to pursue the Abbott Formulated Product or the NaPro Oral Formulated Product in add▇▇▇▇▇ to or in lieu of the NaPro Formulated Product. "Business Day" shall mean any day of the week other than a Saturday, Sunday or any other day on which commercial banks in the City of Chicago are authorized to close.