Analytical and Validation Methodology Sample Clauses

Analytical and Validation Methodology. Any analytical and validation methodology supplied by Barrier and required for use by DSM in the production of Product hereunder (i) must be certified by Barrier to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (ii) must be validated per current regulatory guidelines, and (iii) must be readily available to DSM personnel during any regulatory inspection in the DSM site. Periodic recertification of methods validations may be required in accordance with CGMP. Required analytical and validation methodology which is not supplied by Barrier, or not previously developed by DSM for Barrier, will be developed by DSM at Barrier’s expense according to DSM’s standard rates.
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Analytical and Validation Methodology. Any analytical and validation methodology supplied by AMAG and required for use by DSM in the production of Product hereunder (i) must be certified by AMAG to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (ii) must be validated per current regulatory guidelines, and (iii) must be readily available to DSM personnel during any regulatory inspection in the DSM site. Periodic re-certification of methods validations may be required in accordance with CGMP. Required analytical and validation methodology which is not supplied by AMAG (or not previously developed by DSM for AMAG) will be developed by DSM, at AMAG’s expense, according to DSM’s standard rates for development.
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Analytical and Validation Methodology. Any analytical and validation methodology supplied by OMEROS and required for use by DSM in the Manufacture of Product under this Agreement (a) shall be certified by OMEROS to the best of its knowledge to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (b) shall be validated per current regulatory guidelines, and (c) shall be readily available to DSM personnel during any regulatory inspection in the DSM site. Periodic re-certification of methods validations may be required in accordance † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION with Applicable Pharmaceutical Law. Required analytical and validation methodology that is not supplied by OMEROS (or not previously developed by DSM for OMEROS) shall be developed by DSM, at OMEROS’ expense, according to DSM’s standard rates for development.
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Analytical and Validation Methodology. Any analytical and validation methodology supplied by Discovery Labs and required for use by DSM in the production of Product hereunder (i) must be certified by Discovery Labs to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (ii) must be validated per current regulatory guidelines, and (iii) must be readily available to DSM personnel during any regulatory inspection in the DSM site. Periodic re-certification of methods validations may be required in accordance with CGMP. Required analytical and validation methodology which is not supplied by Discovery Labs (or not previously developed by DSM for Discovery Labs) will be developed by DSM, at Discovery Labs expense, according to DSM’s standard rates for development.
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Analytical and Validation Methodology. Any analytical and validation methodology supplied by Onyx and required for use by DSM in the production of Product hereunder (i) must be certified by Onyx to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (ii) must be validated per current regulatory guidelines, and (iii) must be readily available to DSM personnel during any regulatory inspection in the DSM Facility. Periodic re-certification of methods [*] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. validations may be required in accordance with CGMP. Required analytical and validation methodology which is not supplied by Onyx (or not previously developed by DSM for Onyx) will be developed by DSM, at Onyx’s expense, according to DSM’s standard rates for development.
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Related to Analytical and Validation Methodology

  • 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.

  • Maintenance and Support Services As long as you are not using the Help Desk as a substitute for our training services on the Tyler Software, and you timely pay your maintenance and support fees, we will, consistent with our then-current Support Call Process:

  • Measurement and Monitoring Tools Contractor shall implement measurement and monitoring tools and procedures reasonably designed to measure its performance of the Services and assess such performance against any applicable service levels. Contractor shall provide LAUSD with a monthly report of service level performance under any applicable Work Order. Upon LAUSD’s request, Contractor shall provide LAUSD with access to the measurement and monitoring tools described herein, and to any information that they generate.

  • Access to and Maintenance of Auction Records The Auction Agent shall afford to the Company, its agents, independent public accountants and counsel, access at reasonable times during normal business hours to review and make extracts or copies (at the Company's sole cost and expense) of all books, records, documents and other information concerning the conduct and results of Auctions, provided that any such agent, accountant or counsel shall furnish the Auction Agent with a letter from the Company requesting that the Auction Agent afford such person access. The Auction Agent shall maintain records relating to any Auction for a period of two years after such Auction (unless requested by the Company to maintain such records for such longer period not in excess of four years, then for such longer period), and such records, in reasonable detail, shall accurately and fairly reflect the actions taken by the Auction Agent hereunder. The Company agrees to keep confidential any information regarding the customers of any Broker-Dealer received from the Auction Agent in connection with this Agreement or any Auction, and shall not disclose such information or permit the disclosure of such information without the prior written consent of the applicable Broker- Dealer to anyone except such agent, accountant or counsel engaged to audit or review the results of Auctions as permitted by this Section 2.7, provided that the Company reserves the right to disclose any such information if it is advised by its counsel that its failure to do so would (i) be unlawful or (ii) expose it to liability, unless the Broker-Dealer shall have offered indemnification satisfactory to the Company. Any such agent, accountant or counsel, before having access to such information, shall agree to keep such information confidential and not to disclose such information or permit disclosure of such information without the prior written consent of the applicable Broker-Dealer, provided that such agent, accountant or counsel may reserve the right to disclose any such information if it is advised by its counsel that its failure to do so would (i) be unlawful or (ii) expose it to liability, unless the Broker-Dealer shall have offered indemnification satisfactory to such agent, accountant or counsel.

  • 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.

  • 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.

  • 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.

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