Disposition and Batch Record Review Sample Clauses

Disposition and Batch Record Review. Xxxxxxxxxx shall carry out Release or reject of each Batch of Drug Substance. On completion of Release of each Batch, and no later than [*****] Business Days following the performance of the final filtration and filling step of Drug Substance, Xxxxxxxxxx shall provide the Batch Record for such Batch to Dyax for review. Within [*****] Business Days following delivery of the complete Batch Record to Dyax, Dyax shall confirm in writing Dyax accepts Xxxxxxxxxx'x findings detailed in the Batch Record, or shall submit a complaint in accordance with the Quality Agreement in the form annexed thereto. Dyax shall be taken to have accepted such Batch on the earlier of actual notification by Dyax of its acceptance of Xxxxxxxxxx'x findings in the Batch Record or in the absence of notice of rejection of such findings or the Batch within [*****] Business Days from such delivery of the Batch Record. Should an error or omission have occurred, Xxxxxxxxxx shall have [*****] Business Days to correct same, after which the [*****] Business Day period for Dyax to review shall restart. For Drug Product release testing, the CoA will be provided no later than [*****] Business Days following recipient of the Drug Product vials.
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Disposition and Batch Record Review. Xxxx shall complete a Xxxx Disposition for each Batch of Drug Product. Xxxx shall ship Batch samples promptly after performance of the final manufacturing process step. On completion of Xxxx Release of each Batch, and no later than [*****] Business Days following the performance of the final manufacturing process step, Xxxx shall provide the Batch Record Package for such Batch to Dyax for review. Following receipt of the complete Batch Record Package and all Batch test results Dyax will complete a Dyax Disposition the Batch. Xxxx may be requested in accordance with the Quality Agreement to assist Dyax in any investigations to support Dyax Disposition. Not later than [*****] calendar days following delivery of the Batch samples and not later than [*****] calendar days after delivery of the complete Batch Record Package to Dyax, Dyax shall communicate to Xxxx any discovered problem that could result in rejection of the Batch or communicate the Dyax Disposition decision.
Sample 1Sample 2
Disposition and Batch Record Review. Xxxxxxxxxx shall carry out Release or reject of each Batch of Drug Substance and Drug Product. On completion of Release of each Batch, and no later than [*****] Business Days following the performance of the final filtration and filling step, Xxxxxxxxxx shall provide the Batch Record for such Batch to Dyax for review. Within [*****] Business Days following delivery of the complete Batch Record to Dyax, Dyax shall confirm in writing Dyax accepts Xxxxxxxxxx'x findings detailed in the Batch Record, or shall submit a complaint in accordance with the Quality Agreement in the form annexed thereto. Dyax shall be taken to have accepted such Batch on the earlier of actual notification by Xxxx of its acceptance of Xxxxxxxxxx'x findings in the Batch Record or in the absence of notice of rejection of such findings or the Batch within [*****] Business Days from such delivery of the Batch Record. Should 12 / 12 Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. an error or omission have occurred, Xxxxxxxxxx shall have [*****] Business Days to correct same, after which the [*****] Business Day period for Dyax to review shall restart. 4.5 Non-Conforming Batch of Drug Substance and/or Drug Product. The provisions below shall apply in the event that: (i) during Disposition of a Batch, it is ascertained that such Batch is a Non-Conforming Batch; or (ii) Dyax submits a complaint under the Quality Agreement in respect of a Batch within the period(s) set out in Section 4.4 above and Xxxxxxxxxx accepts that such Batch is a Non-Conforming Batch; or (iii) an independent expert appointed under the Quality Agreement determines that a Batch is a Non-
Sample 1

Related to Disposition and Batch Record Review

  • Review of Materials During the term of this Agreement, Client shall ensure that all prospectuses, statements of additional information, registration statements, proxy statements, reports to shareholders, advertising and sales literature or other materials prepared for distribution to Fund shareholders or the public, which refer to the Subadviser in any way, prepared by employees or agents of Client or its affiliates are consistent with information previously provided by Subadviser. Subadviser shall promptly notify the Client of any changes to information pertaining to the Subadviser and stated in the materials described in this Section 6(g).

  • Periodic Review of Costs of Environmental Compliance In the ordinary course of its business, the Company conducts a periodic review of the effect of Environmental Laws on the business, operations and properties of the Company and its subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties). On the basis of such review and the amount of its established reserves, the Company has reasonably concluded that such associated costs and liabilities would not, individually or in the aggregate, result in a Material Adverse Change.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Certificate of Analysis Seller shall provide a certificate of analysis and other documents as defined in the Quality Agreement for any Product to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and Product Specifications and as shall be agreed upon by the parties. For any batch that initially failed to meet any Product Specification, the certificate of analysis shall document the exception. Products that do not meet dissolution specifications at USP Stage I and II testing shall not be accepted by Buyer (and such requirement shall be included in the Product Specifications/Quality Manual).

  • Inspection and Testing Each Constructing Entity shall cause inspection and testing of the Interconnection Facilities that it constructs in accordance with the provisions of this section. The Construction Parties acknowledge and agree that inspection and testing of facilities may be undertaken as facilities are completed and need not await completion of all of the facilities that a Constructing Entity is building.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Inspection and Verification The Secured Parties and such persons as the Secured Parties may reasonably designate shall have the right to inspect the Collateral, all records related thereto (and to make extracts and copies from such records) and the premises upon which any of the Collateral is located, to discuss the Grantor’s affairs with the officers of the Grantor and its independent accountants and to verify under reasonable procedures the validity, amount, quality, quantity, value, condition and status of, or any other matter relating to, the Collateral, including, in the case of collateral in the possession of any third Person, by contacting any account debtor or third Person possessing such Collateral for the purpose of making such a verification. Out-of-pocket expenses in connection with any inspections by representatives of the Secured Parties shall be (a) the obligations of the Grantor with respect to any inspection after the Secured Parties’ demand payment of the Notes or (b) the obligation of the Secured Parties in any other case.

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

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