Specification Approval Sample Clauses

Specification Approval. The Specifications attached hereto as Exhibit A for API and Bulk Product delivered to MMCO are the same as the specifications for API and Bulk Product procured by Allos as of the Effective Date for its own use. Changes made to such Specifications in accordance with this Section 6.1 or Section 6.2 shall retain such consistency with the then-current specifications for API and Bulk Product procured by Allos at such time for its own use, except to the extent any changes are required by Regulatory Authorities in the Licensed Territory. Allos agrees to make no changes to the API Specifications or the Bulk Product Specifications without following the procedures set forth in this Section 6.1 or Section 6.2. Allos will notify MMCO in writing at least [***] prior to filing any planned changes in the [***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. manufacturing process that are reportable to a Regulatory Authority or any planned changes in Specifications. MMCO will have the right to review and approve or reject such changes; provided, however, that MMCO will not have the right to reject any such changes which are mandated by applicable Laws or changes thereto. If Allos decides to implement a change to the manufacturing process for API or Bulk Product and such change is not required to be reported to a Regulatory Authority and does not change the applicable Specifications, then Allos shall notify MMCO in writing of such change promptly after Allos’ decision to implement such change. For clarity, MMCO will not have the right to approve or reject such change.
Sample 1
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Specification Approval. Specification initiation or revision that affects the scientific or technical content requires approval before proposed changes are implemented. This applies to manufacturing, testing, storage, and labeling of the Drug Substance, as well as any changes to the Materials Specifications for Raw Materials, Resins, and Drug Substance. Editorial or format changes to applicable specifications not affecting the scientific/technical content or intent of the specification will not require approval by Tercica. Those documents requiring Tercica approval are as follows: · Drug Substance specifications listed in the MPR · Materials Specifications Client Change Requests (CCRs) will be forwarded to Tercica via appropriate express mail or facsimile. When Tercica initiates a CCR for any applicable specifications, the appropriate CBSB department shall be provided the proposed specification and appropriate documentation that summarizes and justifies each change.
Sample 1Sample 2
Specification Approval. The Specifications attached hereto as Exhibit A for API and Bulk Product delivered to MMCO are the same as the specifications for API and Bulk Product procured by Allos as of the Effective Date for its own use. Changes made to such Specifications in accordance with this Section 6.1 or Section 6.2 shall retain such consistency with the then-current specifications for API and Bulk Product procured by Allos at such time for its own use, except to the extent any changes are required by Regulatory Authorities in the Licensed Territory. Allos agrees to make no changes to the API Specifications or the Bulk Product Specifications without following the procedures set forth in this Section 6.1 or Section 6.2. Allos will notify MMCO in writing at least [***] prior to filing any planned changes in the
Sample 1
Specification Approval. Specification initiation or revision requires approval before proposed changes are implemented. This applies to manufacturing, finishing, testing, storage, and labeling of BDS. Those documents and activities related to BDS manufacturing and testing requiring HALOZYME's prior written approval are as follows: - Raw Material Specifications - Raw Material source or grade changes - Manufacturing Processing material specifications - Manufacturing Processing material source or grade changes - Changes in beginning, intermediate or final processing steps, timing of processing steps, or beginning, intermediate or final sampling protocols - Changes in analytical methods or instrumentation - Changes in component, BDS or product retention sampling protocols, methods, state of storage or location of storage. - Changes in stability protocols, to include location and conditions of storage, storage environment monitoring and recording methods, assay and assessment methods, frequencies of assay's and assessments or service providers of assay and assessments. - Any changes to the material specifications for component and finished BDS. *** Confidential material redacted and submitted separately to the Commission Editorial or format changes to applicable specifications, not affecting the scientific or technical content or intent of the specification, will not require approval by HALOZYME. Those documents requiring HALOZYME's written approval are as follows; - BDS Specifications and Testing - Raw Material Specifications and Testing - BDS Specification Summary - Standard Test Method Specification Change Requests (SCRs) will be forwarded to HALOZYME via e-mail, express mail, or facsimile. The following documents and activities related to BDS manufacturing and testing will be approved by AVID and notification of implementation will be forwarded to HALOZYME. - Changes in frequency of re-validation of manufacturing programs - Changes in chemical or biological monitoring activities of facilities or equipment - Changes in preventative maintenance schedules for manufacturing equipment - Changes in equipment or facilities cleaning and manufacturing preparatory activities When HALOZYME initiates a change request on all applicable specifications, the appropriate AVID department shall be provided the proposed specification and appropriate documentation, which summarizes and justifies each change. AVID will promptly implement changes in specifications, providing these changes, in AVID's goo...
Sample 1
Specification Approval. Specification initiation or revision that affects the scientific or technical content requires approval before proposed changes are implemented. This applies to manufacturing, finishing, testing, storage, labeling of the product as well as any changes to the material specification for component and finished product. Editorial or format changes to applicable specifications, not affecting the scientific/technical content or intent of the specification, will not require approval by [TP NAME]. Those documents requiring [TP NAME] approval are as follows: **Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. The omitted portions have been filed separately with the Commission. [GRAPHIC OMITTED] XXXXXX LABORATORIES PHARMACEUTICAL PRODUCTS DIVISION DOCUMENT GP.0074 -------------------------------------------------------------------------------- ISSUE DATE SUPERCEDES 05/08/2000 07/15/1999 -------------------------------------------------------------------------------- ATTACHMENT A-3 (Cont.)
Sample 1
Specification Approval. Supplier will use only the Product Supply Specifications for the manufacture and supply of Products. Any changes in the Product Supply Specifications shall be agreed upon by Nymox and Recordati in writing, be compliant with Regulatory Authorities requirements, and be validated in accordance with GMP prior to implementation. Supplier will provide to Recordati a copy of (a) the current manufacturing formula, (b) in-process, stability and release test Specifications and methods, (c) list of Raw Materials (and all sources thereof), Specifications, and process instructions, (d) bulk packaging components (and all sources thereof), and (e) any changes to the foregoing agreed upon by Nymox and Recordati in accordance with Section 3.14 below, and (f) anything else that may be or become necessary to satisfy regulatory requirements during the Term.
Sample 1
Specification Approval. Supplier will use only the Product Supply Specifications for the manufacture and supply of Products. Any changes in the Product Supply Specifications shall be agreed upon by Nymox and Recordati in writing, be compliant with Regulatory Authorities requirements, and be validated in accordance with GMP prior to implementation. Supplier will provide to Recordati a copy of (a) the current manufacturing formula, (b) in-process, stability and release test Specifications and methods, (c) list of Raw Materials (and all sources thereof), Specifications, and process instructions, (d) bulk packaging components (and all sources thereof), and (e) any changes to the foregoing agreed upon by Nymox and Recordati in accordance with Section 3.14 below, and (f) anything else that may be or become necessary to satisfy regulatory requirements during the Term.
Sample 1
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Related to Specification Approval

  • Authorization, Approval, etc No authorization, approval, or other action by, and no notice to or filing with, any governmental authority, regulatory body or any other Person is required either

  • APPROVAL OF PLANS AND SPECIFICATIONS The Plans and Specifications will conform to the requirements and conditions set out by applicable law or any effective restrictive covenant, and to all governmental authorities which exercise jurisdiction over the Leased Premises or the construction thereon.

  • Specification Changes Upon any change in the Product Specifications, stability protocols, QC laboratory methods raw material specification or Packaging Specifications (whether initiated by Horizon or made in response to a request by sanofi-aventis that is agreed to by Horizon), including the addition of new packaging configurations, new SKUs, new formulations, or a change in either raw materials or Packaging Component supply, Horizon shall promptly advise sanofi-aventis in writing of such changes, and sanofi-aventis shall promptly advise Horizon as to any scheduling and/or price adjustments which may result from such changes. Prior to implementation of such changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Product Price for any Product which embodies such changes, (b) any amounts to be reimbursed by Horizon to sanofi-aventis as described in the next sentence of this paragraph, and (c) any other amendments to this Agreement which may be necessitated by such changes (i.e., an adjustment to the lead time for purchase orders). Horizon shall reimburse sanofi-aventis for the mutually agreed upon reasonable expenses incurred by sanofi-aventis as a result of such changes, including, but not limited to, reimbursing sanofi-aventis for its mutually agreed validation and development costs, capital expenditure costs, costs for any Packaging Components or other materials rendered unusable as a result of such changes, and cost of required stability to support a change. If during the Term Horizon amends the Product Specifications or Packaging ***Confidential Treatment Requested MANUFACTURING AND SUPPLY AGREEMENT PAGE 7 Specifications (whether voluntarily or as required by law) so as to render obsolete quantities of the Active Ingredient, Excipients and/or Packaging Components for the Product on hand at sanofi-aventis, Horizon shall (i) accept the return of all such obsolete Active Ingredient and (ii) purchase from sanofi-aventis, at sanofi-aventis’ Acquisition Cost, all such obsolete Excipients and Packaging Components obtained by sanofi-aventis pursuant to its normal procurement policies to manufacture quantities of the Product pursuant to Horizon forecasts under Section 6.1. Sanofi-aventis’ normal procurement policies for purposes of the preceding sentence of this Article 5 shall be considered to be quantities of Excipients and Packaging Components corresponding to the immediately following […***…] months of Horizon’s most recent forecasted Product demand. If a change in Specifications is initiated by sanofi-aventis and approved by Horizon, any cost associated with said change shall be borne by sanofi-aventis. In the event that a change in Specifications is initiated by Horizon or driven by a regulatory or business change, the costs associated with qualification of the change shall be paid by Horizon. The amount of the change shall be reasonable and customary and subject to written approval by Horizon, such approval not to be unreasonably withheld. Sanofi-aventis, with written agreement and approval from Horizon, will be responsible for the appropriate (cGMP) destruction of any materials covered under this Article 5, and sanofi-aventis shall be reimbursed by Horizon at the reasonable and customary approved rate.

  • Specification 2.1 The Service Provider shall fully comply with the terms of this Agreement and, is subject to the Specification in Schedule 1.

  • Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Authorization; Approvals The issuance of the Policy and the execution, delivery and performance of this Agreement and the Insurance Agreement have been duly authorized by all necessary corporate proceedings. No further approvals or filings of any kind, including, without limitation, any further approvals of or further filings with any governmental agency or other governmental authority, or any approval of the Insurer’s board of directors or stockholders, are necessary for the Policy, this Agreement and the Insurance Agreement to constitute the legal, valid and binding obligations of the Insurer.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Required Approval Any indemnification under this Article shall be made by the Trust if authorized in the specific case on a determination that indemnification of the Agent is proper in the circumstances by (i) a final decision on the merits by a court or other body before whom the proceeding was brought that the Agent was not liable by reason of Disqualifying Conduct (including, but not limited to, dismissal of either a court action or an administrative proceeding against the Agent for insufficiency of evidence of any Disqualifying Conduct) or, (ii) in the absence of such a decision, a reasonable determination, based upon a review of the facts, that the Agent was not liable by reason of Disqualifying Conduct, by (1) the vote of a majority of a quorum of the Trustees who are not (x) “interested persons” of the Trust as defined in Section 2(a)(19) of the 1940 Act, (y) parties to the proceeding, or (z) parties who have any economic or other interest in connection with such specific case (the “disinterested, non-party Trustees”); or (2) by independent legal counsel in a written opinion.

  • Review and Approval Documents specified above must be submitted for review and approval by CITY Purchasing and Contracts prior to the commencement of work by CONTRACTOR. Neither approval by CITY nor failure to disapprove the insurance furnished by CONTRACTOR shall relieve CONTRACTOR of CONTRACTOR’S full responsibility to provide the insurance required by this Contract. Compliance with the insurance requirements of this Contract shall not limit the liability of CONTRACTOR or its sub-contractors, employees or agents to CITY or others, and shall be in addition to and not in lieu of any other remedy available to CITY under this Contract or otherwise. CITY reserves the right to request and review a copy of any required insurance policy or endorsement to assure compliance with these requirements.

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