Disposition Package definition

Disposition Package has the meaning set forth in Section 8.8.1.
Disposition Package means, with respect to any shipment of Drug Product, the documentation and records defined pursuant to the relevant Quality Agreement (as defined in Section 2.8), which may include copies of the Certificate of Analysis, Certificate of Compliance, quality control documentation and manufacturing batch records for such shipment; written
Disposition Package means the compilation of data, records and documentation for a GMP Batch, including but not limited to, executed batch manufacturing records, genealogy, certificate of analysis (“COA”) and associated Quality Control data, and any other data, records or documentation required under the Quality Agreement.

Examples of Disposition Package in a sentence

  • The responsibility for determining which employees fall within the scope of this statute resides with the Military Department Secretaries and Heads of other DoD Components, who may delegate this authority in writing.

  • ATTACHMENT B AMGEN Disposition Package The following documents are to comprise the AMGEN Disposition Package to support the release of the Product to AKERO: Stage of Manufacture Disposition Package Documents Drug Substance Manufacture CoA CoC Nonconformance’s lot summary report Attachment B version date: June 7, 2018 Agreed and accepted for: Agreed and accepted for: AKERO THERAPEUTICS, INC.

  • EXHIBIT B AMGEN Disposition Package The following documents are to comprise the AMGEN Disposition Package to support the release of each Product batch to COMPANY: General Nonconformance List and Summary for cell banking, Drug Substance and Drug Product (Report includes only 1ot-tied nonconformances deemed by AMGEN to have a potential Nonconformance the safety, identity, strength, potency, or quality of the Product, according to established AMGEN procedures.

  • In addition to the LCP, the Stewardship Council is developing a disposition package for the Lease Area (the " Disposition Package") in order to carry out the objectives of the LCP with respect to the Lease Area.

  • A certificate of analysis shall accompany each shipment of the Merck Compound to Syndax, as part of the Disposition Package described in Section 8.7.

  • Within a reasonable time of receiving the Disposition Package, USTK shall notify the Servicer of its approval or disapproval of the disposition.

  • If USTK fails to respond, the Disposition Package shall be considered disapproved.

  • Patheon shall have no liability for any deviations for which it has not received notice within such [*] day period that should reasonably have been discovered within such time period by review of the Disposition Package of such shipment.

  • Social Robots in the Healthcare and Therapy of the ElderlyThere are several social robots such as KASPAR, Pepper, Keapon, NAO, PARO, the effectiveness of which was investigated in mental health disorders, and these robots have been employed for the reduction of the emotion of loneliness, depression and anxiety among the elderly (Cifuentes et al., 2020).

  • Dyax shall be taken to have accepted such Batch on the earlier of actual notification by Dyax of its acceptance of Fujifilm's findings in the Disposition Package or in the absence of notice of rejection of such findings or the Batch within ten (10) Business Days from such delivery of the Disposition Package.


More Definitions of Disposition Package

Disposition Package has the meaning set forth in Section 8.7.1 (After Manufacturer’s Release).
Disposition Package has the meaning set forth in Section 8.8.1. 1.22. “Effective Date” has the meaning set forth in the preamble. 1.23. “EMA” has the meaning set forth in the definition of Applicable Law. 1.24. “Exclusions List” has the meaning set forth in the definition of Violation. 1.25. “FDA” has the meaning set forth in the definition of Applicable Law. 1.26. “Filing Party” has the meaning set forth in Section 10.1.1(c). 1.27. “Final Study Report” has the meaning set forth in Section 3.11. 1.28. “Force Majeure” has the meaning set forth Article 16.
Disposition Package means, with respect to any shipment of Drug Product, the documentation and records defined pursuant to the relevant Quality Agreement (as defined in Section 2.8), which may include copies of the Certificate of Analysis, Certificate of Compliance, quality control documentation and manufacturing batch records for such shipment; written confirmation that such batch records have been reviewed and approved by Patheon quality assurance unit; and any other documentation required by law that is in Patheon’s possession and required by Gilead for the release of the batch or batches of Drug Product in such shipment.
Disposition Package shall have the meaning specified in Section 5.03.
Disposition Package means a written proposal submitted to USTK by the Servicer which shall identify the Timberland Investment that the Servicer believes should be disposed of, the reasons for the disposition recommendation (including the risks and opportunities of the disposition), potential purchasers/bidders, assessment of the risks and opportunities of continuing to hold the Timberland Investment, expected disposition expenses, the Servicer's proposed strategy for marketing and effectuating the disposition, the recommended sales price (including appraisals or other data, calculations and assumptions supporting such recommendation) and any other matter reasonably requested by USTK.

Related to Disposition Package

  • Disposition Notice is defined in Section 5.2(a).

  • Disposition Proceeds means, with respect to each Group I/II Non-Program Vehicle, the net proceeds from the sale or disposition of such Group I/II Eligible Vehicle to any Person (other than any portion of such proceeds payable by the Group I/II Lessee thereof pursuant to any Group I/II Lease).

  • Disposition Date shall have the meaning ascribed thereto in Subsection 5.1(d);

  • REO Disposition Proceeds All amounts received with respect to an REO Disposition pursuant to Section 4.16.

  • Final Asset Status Report As defined in Section 3.24(a)(vi).

  • Asset Status Report shall have the meaning assigned to such term in the Servicing Agreement or such other analogous term used in the Servicing Agreement.

  • Disposition Fee shall have the meaning set forth in Section 8.03.

  • REO Disposition The final sale by the Servicer of any REO Property.

  • Post-Closing Statement has the meaning set forth in Section 3.3(c).

  • REO Disposition Period As defined in Section 3.14. REO Proceeds: Proceeds, net of any related expenses of the Servicer, received in respect of any REO Property (including, without limitation, proceeds from the rental of the related Mortgaged Property) which are received prior to the final liquidation of such Mortgaged Property.

  • Disposition Event means any merger, consolidation or other business combination of the Corporation, whether effectuated through one transaction or series of related transactions (including a tender offer followed by a merger in which holders of Class A Common Stock receive the same consideration per share paid in the tender offer), unless, following such transaction, all or substantially all of the holders of the voting power of all outstanding classes of Common Stock and series of Preferred Stock that are generally entitled to vote in the election of Directors prior to such transaction or series of transactions, continue to hold a majority of the voting power of the surviving entity (or its parent) resulting from such transaction or series of transactions in substantially the same proportions as immediately prior to such transaction or series of transactions.

  • Dispositional hearing means a hearing to determine the order of disposition which should be made with respect to a child adjudged to be a ward of the court;

  • Specified Disposition means any disposition of all or substantially all of the assets or Capital Stock of any Subsidiary of the Borrower or any division, business unit, product line or line of business.

  • Final disposition means the burial, interment, cremation, removal from the state, or other disposition of a dead body or fetus.

  • Disposition or “Dispose” means the sale, transfer, license, lease or other disposition (including any sale and leaseback transaction) of any property by any Person, including any sale, assignment, transfer or other disposal, with or without recourse, of any notes or accounts receivable or any rights and claims associated therewith.

  • Net Disposition Proceeds means, with respect to any sale, transfer or other disposition of any assets of the Borrower, any Parent Guarantor or any of their respective Subsidiaries (other than sales permitted pursuant to clause (a), (b) or (c) of Section 7.2.9), the excess of

  • Final Closing Statement has the meaning set forth in Section 2.5(d).

  • Major Asset Disposition means the sale or other disposition in one transaction or a series of related transactions of 50% or more of the assets of the Company and its subsidiaries on a consolidated basis; and any specified percentage or portion of the assets of the Company shall be based on fair market value, as determined by a majority of the members of the Incumbent Board;

  • business acquisition report means a completed Form 51-102F4 Business Acquisition Report;

  • Pre-Closing Statement has the meaning set forth in Section 2.4(a).

  • Third Party Sale means any sale for resale in interstate commerce to a Power Purchaser that is not designated as part of Network Load under the Network Integration Transmission Service but not including a sale of energy through the PJM Interchange Energy Market established under the PJM Operating Agreement.

  • Material Disposition means any Disposition of property or series of related Dispositions of property that yields gross proceeds to the Borrower or any of its Subsidiaries in excess of $1,000,000.

  • Disposition Value means, at any time, with respect to any property

  • Specified Asset Sale has the meaning specified in Section 2.05(b)(vi).

  • Recovery Event any settlement of or payment in respect of any property or casualty insurance claim or any condemnation proceeding relating to any asset of any Group Member.

  • Asset Schedule means with respect to any Transaction as of any date, an asset schedule in the form of a computer tape or other electronic medium (including an Excel spreadsheet) generated by Seller and delivered to Buyer and the Custodian, which provides information (including, without limitation, the information set forth on Exhibit E attached hereto) relating to the Purchased Mortgage Loans in a format reasonably acceptable to Buyer.