Lot Disposition Sample Clauses

Lot Disposition. 7.1 Record inspection results on appropriate approved Work Instructions. 7.2 Document any discrepant inspection findings in accordance with QA-052. 7.3 Disposition, sign and date the documents. 7.4 If inspection passes forward lot to QA Pending Release Cage and IPRs/WI and all attachments to Materials Department for ERP transaction.
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Lot Disposition. For each lot, DSM will provide the documentation required in Appendix III.
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Lot Disposition. CATALENT QA is responsible for the MANUFACTURER’S RELEASE of PRODUCT. INTERMUNE QA is responsible for the FINAL RELEASE of PRODUCT.
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Lot Disposition. For each lot, LONZA will provide the release documentation required in Appendix III.
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Lot Disposition. 5.5.1 Release of the PRODUCTS for further labeling and distribution by SCHERING is the absolute responsibility of IDEC Quality. Quality Agreement 9 June 1999 7 5.5.2 For each lot released, IDEC will provide SCHERING a copy of the Certificate of Analysis (COA) and a Certificate of Compliance (COC). 5.5.3 Certificate of Analysis (COA): This document will include the name of the PRODUCTS, the lot number and the date of manufacture. The COA will list the In-Process QC tests performed, action limits and actual test results. The COA will also list the product release QC tests performed, specifications and actual test results.
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Lot Disposition. 8 7.3 QUALITY ASSURANCE CERTIFICATE OF COMPLIANCE/ANALYSIS........8
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Lot Disposition. For each lot, ORPHAN will provide the documentation and a copy of executed Batch Record of the Product, as listed in Appendix 4.
Sample 1
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Lot Disposition. 6.3.1 CATALENT QA is responsible for the MANUFACTURER’S RELEASE of PRODUCT. INTERMUNE QA is responsible for the FINAL RELEASE of PRODUCT. 6.3.2 CATALENT QA reviews and approves BATCH RECORDS according to its approved internal procedures. 6.3.3 The executed batch record must be reviewed by both CATALENT and INTERMUNE for a period of time (“Initial Period”) that is mutually agreed upon. Initial Period is the period of time related to the manufacturing of the Process Validation lots and ([ * ]) PRODUCT batches after the Process Validation campaign. After CATALENT review and approval of the manufacturing batch record and analytical test results, CATALENT will send copies of the following documentation to INTERMUNE QA for its review: • Copies of executed BATCH RECORDS and analytical data • Copies of MINOR AND MAJOR DEVIATION reports and investigations associated with the batch. • Certificate of Analysis (COA) • Certificate of Compliance (COC) After the completion of the Initial Period, CATALENT will send • Certificate of Analysis; • Certificate of Compliance; • A list of all batch deviations; InterMune/Catalent - KY Quality Agreement Confidential • Copies of all deviation and OOS/OOT investigations and sheet (“Reconciliation Sheet”) which reports miscellaneous batch information. The specific batch information to be included on the Reconciliation Sheet will be developed and mutually agreed to by both parties. Examples of the type of information for the Reconciliation Sheet include, Kg of Product per batch, a list of investigations for deviations or OOS per batch, in-process yields, etc. 6.3.4 CATALENT QA shall release PRODUCT batches to INTERMUNE within [ * ] days from the last unit operation. 6.3.5 For the FINAL RELEASE, INTERMUNE QA shall review all deviations and investigations as part of its review and release process. 6.3.6 INTERMUNE will review the PRODUCT batch records and all associated documentation and provide comments to CATALENT within [ * ] ([ * ]) calendar days of receiving the documentation. CATALENT agrees to respond to the comments and any deficiencies or discrepancies within [ * ] ([ * ]) business days. 6.3.7 CATALENT will provide additional requested information (e.g., investigation reports, summary of SOPs) to INTERMUNE in order for INTERMUNE to complete the disposition of the PRODUCT. 6.3.8 INTERMUNE shall notify CATALENT of its disposition of the PRODUCT in writing. PRODUCT cannot be shipped until CATALENT receives the INTERMUNE FINAL RELEA...
Sample 1
Lot Disposition. For each lot, LONZA will provide the release documentation required in Appendix III. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Related to Lot Disposition

  • Data Disposition When the contracted work has been completed or when the Data is no longer needed, except as noted above in Section 5.b, Data shall be returned to DSHS or destroyed. Media on which Data may be stored and associated acceptable methods of destruction are as follows: Data stored on: Will be destroyed by:

  • Final Disposition Notwithstanding any other provision in this Agreement, no determination as to entitlement to indemnification under this Agreement shall be required to be made prior to the final disposition of the Proceeding.

  • Asset Disposition If the Borrower or any of its Subsidiaries (other than a Financing Subsidiary) Disposes of any property which results in the receipt by such Person of Net Cash Proceeds in excess of $2,000,000 in the aggregate since the applicable Commitment Termination Date, the Borrower shall prepay an aggregate principal amount of such Loans owed to such Lender or Lenders equal to 100% of such Net Cash Proceeds no later than the fifth Business Day following the receipt of such Net Cash Proceeds (such prepayments to be applied as set forth in Section 2.09(b)).

  • Asset Dispositions, etc The Borrower will not, and will not permit any of its Subsidiaries to, sell, transfer, contribute or otherwise convey, or grant options, warrants or other rights with respect to, all or substantially all of the assets of (a) the Borrower or (b) the Subsidiaries of the Borrower, taken as a whole, except sales of assets between or among the Borrower and Subsidiaries of the Borrower.

  • Dispositions and Involuntary Dispositions Subject to Section 2.06(b)(ii)(D) and the terms set forth in any applicable Incremental Amendment, Extension Amendment, Refinancing Amendment or Replacement Amendment, the Borrower will prepay the Term Loans (if any) on the fifth Business Day following receipt of Net Cash Proceeds in an amount equal to 100% of the Net Cash Proceeds received from any Disposition pursuant Section 8.05(b) or any Involuntary Disposition by the Borrower or any Restricted Subsidiary; provided that if (x) the Borrower delivers, no later than the last day of such five Business Day period following receipt, a certificate of a Responsible Officer to the Administrative Agent setting forth the Borrower’s intent to reinvest such proceeds in assets useful in the business of the Borrower or any Restricted Subsidiary and (y) no Default or Event of Default shall have occurred and be continuing at the time of such certificate or at the proposed time of the application of such proceeds, and such proceeds shall not be required to be applied to prepay the Term Loans except to the extent such proceeds are not so reinvested within (A) twelve (12) months following receipt of such Net Cash Proceeds or (B) if the Borrower or any Restricted Subsidiary enters into a legally binding commitment to reinvest such Net Cash Proceeds within twelve (12) months following receipt thereof, the later of (I) twelve (12) months following receipt thereof and (II) one hundred eighty (180) days after the end of such 12-month period.

  • REO Disposition Within 30 days following an REO Disposition, the Servicer shall provide to the Master Servicer a statement of accounting for the related REO, including without limitation, (i) the loan number of the related Mortgage Loan, (ii) the date such Mortgaged Property was acquired in foreclosure or by deed in lieu of foreclosure, (iii) the date of REO Disposition, (iv) the gross sales price and related selling and other expenses, (v) accrued interest calculated from the date of acquisition to the disposition date and (vi) such other information as the related trustee may reasonably request.

  • Asset Dispositions Make any Asset Disposition, except: (a) the sale of obsolete, worn-out or surplus assets no longer used or usable in the business of the Borrower or any of its Restricted Subsidiaries; (i) non-exclusive licenses and sublicenses of intellectual property rights in the ordinary course of business not interfering, individually or in the aggregate, in any material respect with the conduct of the business of the Borrower and its Subsidiaries, (ii) exclusive licenses and sublicenses of intellectual property rights and other Asset Dispositions with respect to intellectual property granted or made in the ordinary course of business consistent with past practice or (iii) exclusive licenses and sublicenses, assignments of intellectual property rights and other Asset Dispositions with respect to intellectual property granted or made in the exercise of the Borrower’s reasonable business judgment, where such exclusive license, assignment or other Asset Disposition is not reasonably expected to have a Material Adverse Effect; (c) leases, subleases, licenses or sublicenses of real or personal property granted by the Borrower or any of its Restricted Subsidiaries to others in the ordinary course of business not interfering in any material respect with the business of the Borrower or any of its Restricted Subsidiaries; (d) Asset Dispositions in connection with Insurance and Condemnation Events; provided that the requirements of Section 4.4(b) are complied with in connection therewith; (e) Assets Dispositions in connection with transactions expressly permitted by Section 9.4; (f) Asset Dispositions not otherwise permitted pursuant to this Section; provided that (i) at the time of such Asset Disposition, no Event of Default shall exist or would result from such Asset Disposition and (ii) such Asset Disposition is made for Fair Market Value and the consideration received shall not be less than 75% in cash or Cash Equivalents; and (g) Asset Dispositions of accounts receivable transferred as part of a Permitted A/R Financing.

  • No Dispositions Except for the transfer of assets in the ordinary course of business consistent with prior practice, no party shall sell, lease, encumber or otherwise dispose of, or agree to sell, lease, encumber or otherwise dispose of, any of its assets, which are material, individually or in the aggregate, to such party.

  • Permitted Dispositions (a) Owner may elect to sell or transfer the Hotel (in whole, but not in part), or to permit the transfer of a Controlling Interest, to another Person provided that: (i) such Person is not a Prohibited Party (defined below), and (ii) such Person shall agree, in the case of any sale or transfer of the Hotel, to be bound by the terms of this Agreement and the other Hyatt Agreements (including the Technical Services Agreement (if still in effect) and to assume all of Owner’s obligations hereunder and thereunder (accrued and unaccrued) by way of an assumption agreement reasonably acceptable to Hyatt, to be executed concurrently with the sale or transfer of the Hotel. (b) At least 30 calendar days in advance of the closing of any sale or transfer permitted under (a) above, Owner shall provide written notice to Hyatt, and shall promptly furnish all information reasonably requested by Hyatt to confirm that any prospective buyer or transferee is not a Prohibited Party. (c) In the case of any assignment of this Agreement and the other Hyatt Agreements, upon satisfaction of the conditions set forth in sub-sections (a)(i), (a)(ii) and (b) above, Owner shall be relieved of any liability or obligation hereunder arising after the date of such assignment. (d) If such sale pursuant to subsection (a) above is a transfer of a Controlling Interest, the transferee shall execute and deliver to Hyatt as a condition to such transfer an acknowledgement of all terms and conditions of this Agreement and that this Agreement shall continue to be binding upon Owner on and following the date of such transfer. (e) Owner may elect to effect a transfer of an Ownership Interest that does not constitute a Controlling Interest (as a transfer of a Controlling Interest is governed by the above provisions in this Section 12.2) to another Person, subject to this Agreement and provided that: (i) such transferee is not a Person or Persons (A) who do not have sufficient financial capacity (along with the other Persons having Ownership Interests) to perform the obligations of Owner under this Agreement, (B) who are controlled by or associated with organized crime, (C) who have been convicted of a serious crime such that the Person’s affiliation with the Hotel would materially and adversely impact the reputation of the Hotel, Hyatt and/or is Affiliates, (D) who is a Restricted Person, or (E) who would be considered by regulators in the gaming industry to be unsuitable business associates of Hyatt or its Affiliates or whose affiliation with the Hotel would in any way jeopardize the Hotel’s licenses; (ii) at least 30 calendar days in advance of any such transfer permitted under this subsection (e), Owner shall provide written notice to Hyatt, and shall promptly furnish all information reasonably requested by Hyatt to confirm that any prospective transferee is not a party prohibited by this subsection (e); and (iii) if such transferee is a Brand Owner or an investor in a Brand Owner, Owner shall institute and maintain appropriate confidentiality measures and controls reasonably designed to prevent such transferee and/or those individuals actively involved in the operations, management, marketing and strategic planning of the Person engaged, directly or indirectly, in the issuance of licenses, issuance of franchises or owning or controlling of a Brand Owner from obtaining any confidential or proprietary information of Hyatt and any other information deemed to be confidential pursuant to the Agreement. (f) In the case of any Ground Lease relating to the Hotel, whether to or from an Affiliate of the then Owner or any owner (direct or indirect) of Owner or otherwise, (i) the lessee shall become the “Owner” hereunder and shall assume all of the liabilities and obligations of Owner herein set forth; (ii) the lessor shall execute a Lessor Non-Disturbance Agreement as described in Section 13.3, and (iii) if the lessee is an Affiliate of Owner, the lessor shall not be relieved of any liabilities or obligations of Owner hereunder. (g) The use and presentation of Hyatt Trademarks (including as the same may appear in photographs of the Hotel) in any offering memorandum, prospectus or other similar distribution, as well as information relating to the terms and conditions of the Hyatt Agreements, shall be subject to Hyatt’s prior written approval. (h) Except as set forth above, Owner shall not transfer the Hotel or its Controlling Interest or assign its rights and obligations under this Agreement.

  • Notice of Disposition To the extent that this Option is designated as an Incentive Option, if Shares of Common Stock acquired upon exercise of the Option are disposed of within two years following the date of grant or one year following the transfer of such Shares to the Participant upon exercise, the Participant shall, promptly following such disposition, notify the Corporation in writing of the date and terms of such disposition and provide such other information regarding the disposition as the Administrator may reasonably require.

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