Disputes Regarding Conformity Sample Clauses

Disputes Regarding Conformity. After receipt of a rejection notice and samples from POZEN pursuant to the preceding subsection 8.4.1, Nycomed will be permitted, for a period of *********, to analyze the Materials rejected by POZEN for nonconformity to the Product Warranty, and to present its findings with respect to such Materials to POZEN. If the Parties cannot agree on whether such Materials conform to the Product Warranty within ********* of Nycomed’s receipt of POZEN’s written notice of rejection and samples, then, as soon as reasonably practicable, each Party will deliver samples of the Materials in question to an independent laboratory selected by Nycomed as soon as reasonably practicable and reasonably acceptable to POZEN, and the independent laboratory will analyze such samples according to the methods included in the Specifications and determine whether or not such Materials conform to *** Portion for which confidential treatment requested.
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Disputes Regarding Conformity. If Patheon and Depomed fail to agree on whether any rejected Product is Nonconforming, upon request by either Party, samples of such Product and any relevant documentation shall be submitted to an independent testing laboratory that is compliant with FDA regulations and guidelines, or, if the dispute relates to another item of compliance with the Specifications, an independent expert of recognized repute within the United States pharmaceutical industry, as applicable (the “Laboratory”), agreed upon by the Parties, in writing (such agreement not to be unreasonably withheld or delayed by either Party). The determination of the Laboratory shall be final and binding upon the Parties. The fees and expenses of the Laboratory shall be paid by the Party against which the determination is made. Patheon shall not destroy any rejected Product as to which there exists a dispute, until such dispute has been resolved. Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission.
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Disputes Regarding Conformity. In case of any disagreement between Buyer and Manufacturer as to whether Product conforms to the applicable Specifications, the quality assurance representatives of Buyer and Manufacturer will attempt in good faith to resolve any such disagreement and Buyer and Manufacturer will follow their respective SOPs to determine the conformity of the Product to the Specifications. If the foregoing discussions do not resolve the disagreement in a reasonable time (which will not exceed [**]), a representative sample of such Product will be submitted to an independent testing laboratory mutually agreed upon by Buyer and Manufacturer for tests and final determination of whether such Product conforms with such Specifications. The laboratory must be of recognized standing in the industry, and consent to the appointment of such laboratory will not be unreasonably withheld or delayed by either Manufacturer or Buyer. Such laboratory will use the applicable Test Methods contained in the Master Batch Record. The determination of conformance by such laboratory with respect to all or part of such Product will be final and binding on all parties absent manifest error. The fees and expenses of the laboratory incurred in making such determination will be paid by Manufacturer, if the determination is made against Manufacturer, or by Buyer, if the determination is made against Buyer. The Parties agree that any dispute with respect to whether Product has been Manufactured in accordance with cGMP shall be subject to Section 14.12 (Governing Law and Dispute Resolution).
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Disputes Regarding Conformity. After receipt of a rejection notice and samples from POZEN pursuant to the preceding subsection 8.4.1, Nycomed will be permitted, for a period of *********, to analyze the Materials rejected by POZEN for nonconformity to the Product Warranty, and to present its findings with respect to such Materials to POZEN. If the Parties cannot agree on whether such Materials conform to the Product Warranty within ********* of Nycomed’s receipt of POZEN’s written notice of rejection and samples, then, as soon as reasonably practicable, each Party will deliver samples of the Materials in question to an independent laboratory selected by Nycomed as soon as reasonably practicable and reasonably acceptable to POZEN, and the independent laboratory will analyze such samples according to the methods included in the Specifications and determine whether or not such Materials conform to the Product Warranty. Nycomed will use commercially reasonable efforts to cause the independent laboratory to complete such analysis as soon as reasonably practicable. The definitive result of such analysis by the independent laboratory will be binding on the Parties. The cost of such analysis will be borne by the Party whose assessment was incorrect.
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Disputes Regarding Conformity. After receipt of a rejection notice and samples from Buyer pursuant to the preceding Section 3.5, Nycomed will be permitted, for a period of *****, to analyze the LX Bulk *** Portion for which confidential treatment requested.
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Disputes Regarding Conformity. In the event of any disagreement between Company and Provider concerning whether a Batch was Manufactured in accordance with the Manufacturing Requirements and/or the event that Company does not agree with the analysis performed by Provider pursuant to Section 6.6 (Root Cause Analysis), the quality assurance representatives of [***] will attempt in good faith to resolve any such disagreement. If the foregoing discussions do not resolve the disagreement in a reasonable time (which will not exceed [***]), the matter shall be referred to [***] by providing written notice to the appropriate contact person specified in the Quality Agreement. If the discussions between [***] do not resolve the disagreement in a reasonable time (which will not exceed [***]) then [***].
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Related to Disputes Regarding Conformity

  • Review and Procedure Limitations The Asset Representations Reviewer will have no obligation (i) to determine whether a Delinquency Trigger has occurred, (ii) to determine whether the required percentage of Noteholders has voted to direct a Review, (iii) to determine which Receivables are subject to a Review, (iv) to obtain or confirm the validity of the Review Materials, (v) to obtain missing or insufficient Review Materials (except to the extent set forth in Section 3.04), or (vi) to take any action or cause any other party to take any action under any of the Basic Documents to enforce any remedies for breaches of any Eligible Representations. The Asset Representations Reviewer will only be required to perform the Tests provided in Exhibit A and will have no obligation to perform additional testing procedures on any ARR Receivables or to consider any additional information provided by any party. The Asset Representations Reviewer will have no obligation to provide reporting or information in addition to that described in Section 3.07. However, the Asset Representations Reviewer may review and report on additional information that it determines in good faith to be material to its performance under this ARR Agreement and may re-perform a Review with respect to an ARR Receivable as contemplated by Section 3.09. The Issuing Entity expressly agrees that the Asset Representations Reviewer is not advising the Issuing Entity or any Noteholder or any investor or future investor concerning the suitability of the Notes or any investment strategy. The Issuing Entity expressly acknowledges and agrees that the Asset Representations Reviewer is not an expert in accounting, tax, regulatory, or legal matters, and that the Asset Representations Reviewer is not providing legal advice as to any matter.

  • Labor Disputes; Compliance (a) Seller has complied in all material respects with all Legal Requirements relating to employment practices, terms and conditions of employment, equal employment opportunity, nondiscrimination, immigration, wages, hours, benefits, collective bargaining and other employment practices, the payment of social security and similar Taxes and occupational safety and health. Seller is not liable for the payment of any Taxes, fines, penalties, or other amounts, however designated, for failure to comply with any of the foregoing Legal Requirements.

  • Conformity with Plan This Agreement is intended to conform in all respects with, and is subject to all applicable provisions of, the Plan. Inconsistencies between this Agreement and the Plan shall be resolved in accordance with the terms of the Plan. In the event of any ambiguity in this Agreement or any matters as to which this Agreement is silent, the Plan shall govern. A copy of the Plan is available upon request to the Administrator.

  • Compliance with Laws; Environmental Matters (i) Except with respect to Environmental Laws, the Employee Retirement Income Security Act of 1974, as amended ("ERISA"), taxes and regulatory compliance, which are the subjects of Sections 3.01(j)(ii), 3.01(l), 3.01(n) and 3.01(u), respectively, each of the Company and its Subsidiaries is in compliance with all Laws and Orders (collectively, "Legal Provisions") applicable to it, its properties or other assets or its business or operations, except for failures to be in compliance that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect. Each of the Company and its Subsidiaries has in effect all approvals, authorizations, certificates, filings, franchises, licenses, notices and permits of or with all Governmental Entities (collectively, "Permits"), including all Permits under the Federal Food, Drug and Cosmetic Act of 1938, as amended (including the rules and regulations promulgated thereunder, the "FDCA"), necessary for it to own, lease or operate its properties and other assets and to carry on its business and operations as currently conducted, except where the failure to have such Permits individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. Since January 1, 2000, there has occurred no default under, or violation of, any such Permit, except for any such default or violation that individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. The consummation of the Merger, in and of itself, would not cause the revocation or cancelation of any such Permit that individually or in the aggregate would reasonably be expected to have a Material Adverse Effect.

  • Conformity with TIA Each amendment of this Indenture executed under this Article IX will conform to the requirements of the TIA as then in effect so long as this Indenture is qualified under the TIA.

  • Notification; Procedural Matters Promptly after receipt by an Indemnified Party under Section 3.1 of notice of any claim or the commencement of any action, such Indemnified Party shall, if a claim in respect thereof is to be made against the Indemnifying Party (or if a claim for contribution is to be made against another party) under Section 3.1, notify the Indemnifying Party (or other contributing party) in writing of the claim or the commencement of such action; provided, however, that the failure to notify the Indemnifying Party (or other contributing party) shall not relieve it from any liability which it may have under Section 3.1 except to the extent it has been materially prejudiced by such failure; and provided, further, however, that the failure to notify the Indemnifying Party shall not relieve it from any liability which it may have to any Indemnified Party (or to the party requesting contribution) otherwise than under Section 3.1. In case any such action is brought against any Indemnified Party and it notifies the Indemnifying Party of the commencement thereof, the Indemnifying Party shall be entitled to participate therein and, to the extent that, by written notice delivered to the Indemnified Party promptly after receiving the aforesaid notice from such Indemnified Party, the Indemnifying Party elects to assume the defense thereof, it may participate with counsel reasonably satisfactory to such Indemnified Party; provided, however, that if the defendants in any such action include both the Indemnified Party and the Indemnifying Party and the Indemnified Party or parties shall reasonably have concluded that there may be legal defenses available to it or them and/or other Indemnified Parties that are different from or additional to those available to the Indemnifying Party, or if the use of counsel chosen by the Indemnifying Party to represent the Indemnified Parties would present such counsel with a conflict of interest, the Indemnified Party or parties shall have the right to select separate counsel to assert such legal defenses and to otherwise participate in the defense of such action on behalf of such Indemnified Party or parties. Upon receipt of notice from the Indemnifying Party to such Indemnified Party of its election so to assume the defense of such action and approval by the Indemnified Party of such counsel, the Indemnifying Party shall not be liable to such Indemnified Party under this paragraph for any legal or other expenses subsequently incurred by such Indemnified Party in connection with the defense thereof, unless (i) the Indemnified Party shall have employed separate counsel (plus any local counsel) in connection with the assertion of legal defenses in accordance with the proviso to the immediately preceding sentence, (ii) the Indemnifying Party shall not have employed counsel reasonably satisfactory to the Indemnified Party to represent the Indemnified Party within a reasonable time after notice of commencement of the action or (iii) the Indemnifying Party shall have authorized the employment of counsel for the Indemnified Party at the expense of the Indemnifying Party. No party shall be liable for contribution with respect to any action or claim settled without its consent, which consent shall not be unreasonably withheld. In no event shall the Indemnifying Party be liable for the fees and expenses of more than one counsel (in addition to any local counsel) separate from its own counsel for all Indemnified Parties in connection with any one action or separate but similar or related actions in the same jurisdiction arising out of the same general allegations or circumstances.

  • COMPLIANCE WITH POLICIES AND PROCEDURES During the period that Executive is employed with the Company hereunder, Executive shall adhere to the policies and standards of professionalism set forth in the policies and procedures of the Company and IAC as they may exist from time to time.

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