Manufacturing Audit Sample Clauses

Manufacturing Audit. Xxxx, either itself or through or with its representatives, shall have the right, twice each calendar year, or more often if a reasonable basis exists therefore (such as, by way of example and not limitation, a change in, or material noncompliance with, applicable laws, regulations and governmental guidelines), upon reasonable notice and during normal business hours, to subject the manufacturing facilities where Corium manufactures, or has manufactured, Products to a cGMP audit or inspection at Xxxx’x expense. This inspection shall be conducted to ensure compliance with all requirements of applicable laws and regulations, including cGMPs, and all guidelines promulgated by the FDA as well as evolving standards required by the FDA. Such inspection and auditing shall be permitted upon reasonable notice and during normal business hours, taking into account Corium’s manufacturing cycle of Products.
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Manufacturing Audit. Agile, either itself or through or with its representatives, shall have the right, once each calendar year, or more often if there is a legitimate basis for unusual concern (such as a change in, or material noncompliance with, applicable laws, regulations and governmental guidelines), upon reasonable notice and during normal business hours, to subject the manufacturing facilities where Corium manufactures, or has manufactured, Product to a cGMP audit or inspection at Agile’s expense. This inspection shall be conducted to ensure compliance with all requirements of applicable laws and regulations, including cGMPs, and all applicable guidelines promulgated by the FDA and other relevant regulatory agencies, as well as applicable evolving standards required by the FDA and other relevant regulatory agencies. Such inspection and auditing shall be permitted upon reasonable notice and during normal business hours, taking into account Corium’s manufacturing cycle of Product.
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Manufacturing Audit. Kamada shall, as reasonably deemed necessary by Chiesi, but no more frequently than once in any [*****] period and upon not less than [*****] prior written notice from Chiesi and in a manner calculated not to unreasonably interfere with Kamada’ or its Third Party manufacturers’ conduct of business, allow Chiesi employees or Representatives reasonable access to its and/or its Third Party manufacturers’ manufacturing, packaging, testing, stability, and quality control facilities, as the case may be, that relate to the Product, including the actual process of manufacture and packaging of the Product, at Chiesi's expense. The audit shall be conducted by Chiesi's personnel and any of its designated Representatives each of whom shall, in connection with their participation in such audit, agree to execute a confidentiality agreement in favor of Kamada. Such audits will be conducted during Kamada’s normal business hours and at times mutually agreeable to the Parties.
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Manufacturing Audit. The term “Manufacturing Audit” shall mean an audit of the Facility by agents of STRYKER for purposes of reviewing SUPPLIER’s procedures and processes used in manufacturing the Product and SUPPLIER’s compliance with this Agreement. Any STRYKER employees or agents conducting a Manufacturing Audit, Event MA and observational visits, shall be qualified to conduct such audits or visits, shall comply with all SUPPLIER’s facility rules regarding safety and security notified by SUPPLIER to STRYKER and its employees and agents and shall execute a written agreement to maintain in confidence all information obtained during the course of any such audit except for disclosure to STRYKER, such agreement to be negotiated between the Parties. Each Manufacturing Audit shall be conducted during SUPPLIER’s normal business hours and upon at least fifteen (15) business days’ prior written notice to SUPPLIER in the case of an Annual MA, or within two business days prior written notice to SUPPLIER in the case of an Event MA. In all cases STRYKER shall ensure that its employees or agents will conduct each Manufacturing Audit as is reasonably practicable not to interfere with the normal and ordinary operation of the Facility. During a Manufacturing Audit, upon STRYKER’s request, SUPPLIER shall make available for STRYKER’s review and inspection all equipment and facilities used in or in relation to the manufacture, packaging, testing, labeling or storing of the Product, records and supporting documents (e.g., manufacturing, analytical, and testing documentation) with respect to each production lot of the Product and other materials used in the manufacture of the Product. At any such audit, STRYKER shall have the right to obtain copies of records concerning the Product; provided however, that STRYKER pays SUPPLIER for its reasonable costs associated with making such copies. STRYKER or its Affiliates’ employees or agents will be escorted at all times by SUPPLIER personnel. All audits will be conducted in accordance to all regulations STRYKER must comply to, including but not limited to: QXX, XXX00000, Medical Device Directive (“MDD”), MHLW Ordinance No. 169 and the CMDR.
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Manufacturing Audit. Seller shall permit not more frequently than [***], one or more qualified technical specialists from Buyer (or its sublicensee), upon reasonable prior notice and during normal business hours, to conduct audits (including quality, safety and environmental) of the portion of any its facilities or other facilities (to the extent Seller has audit or observation rights over other facilities) used to Manufacture, store, handle or distribute Supplied Product; provided, however, that Seller may refuse access to portions of such facilities where products other than the Supplied Product are Manufactured, stored, handled or distributed and; provided, further, that Seller shall allow and support such additional audits as reasonably requested by Buyer to address specific quality problems relating to the Supplied Product or in response to any applicable Governmental Authority requirements. Subject to compliance with the terms and conditions of the Seller Supply Agreements, one or more qualified technical specialists of Buyer shall be permitted to accompany Seller on Seller’s audits or observation visits of its Sources of Supply to the extent any such audit or observation relates to the Supplied Product; provided that, if Seller has the right to conduct such an audit but decides not to conduct such audit, Seller shall notify Buyer of its decision not to exercise such right and Buyer may then request Seller to exercise such right accompanied by one or more qualified technical specialists of Buyer, and Seller shall reasonably cooperate with such request including with respect to scheduling, scope and duration of the audit. Observations and conclusions of any such audits will be issued to Seller and Seller shall provide a written response within [***] of receipt of such observations and conclusions. The Parties shall discuss such response and agree on corrective action to be implemented. Seller shall ensure that agreed corrective action shall be implemented by the audited party, at the audited party’s expense.
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Manufacturing Audit. ONXEO will permit DARA’s representatives to examine or audit the manufacturing services and documentation for the Product performed hereunder at the manufacturing premises at which the work is conducted: (i) once every two (2) calendar years, upon reasonable advance written notice and not less than thirty (30) working days, during regular business hours, solely to determine that the manufacturing services are being performed in accordance with the Specifications, the FDA Rules and the Quality Agreement and this Supply Agreement (“Audit”), and (ii) without limitation of frequency, during regular business hours, in the event a serious issue arises with the performance of the manufacturing services or a negative finding results from any inspection pursuant to Section 6.7 below (“Audit for Cause”). DARA shall bear all costs and expenses for its own representatives during each Audit on manufacturing site, except for Audits for Cause, the costs of which shall be borne by ONXEO.
Sample 1
Manufacturing Audit. ACY shall have the right to inspect at reasonable intervals and during normal business hours, and on reasonable prior notice, the operations (including without limitation, all such aforesaid records, processes, and other facets of the manufacturing operations) and facilities of APOLLON wherein PRODUCT is manufactured, packaged, inspected, tested, labelled, stored or shipped, and to analyze any tangible material relevant thereto.
Sample 1
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Manufacturing Audit. For purposes of this Agreement, the term “Manufacturing Audit” shall mean an audit of Patheon’s Plant for the Product by employees and/or agents of New River for purposes of reviewing Patheon’s procedures and processes used in manufacturing the New River Products. Any such agents shall be qualified to conduct manufacturing audits, shall comply with all Patheon’s facility rules regarding safety and security notified by Patheon to New River and its employees and agents and shall execute a written agreement to maintain in confidence all information obtained during the count of any such audit except for disclosure to New River subject to the terms hereof. Each Manufacturing Audit shall be conducted during Patheon’s normal business hours and [***] to Patheon in the case of an Annual MA, or with at least 3 working days notice to Patheon in the case of an Event MA. The dates of the audit will be mutually agreed upon by the Parties. In all cases New River shall ensure that its employees or agents will conduct each Manufacturing Audit so as not, insofar as is reasonably practicable to interfere with the normal and ordinary operation of Patheon’s Plant. During a Manufacturing Audit, upon New River’s request, Patheon shall make available for New River’s review and inspection all equipment and facilities used in or in relation to the Manufacture of a Product, records and support documents (i.e. manufacturing and analytical) with respect to each Batch of the Product and other Raw Materials and packaging components used in the Manufacture or packaging of the Product hereunder. At any such audit, New River shall have the right to obtain copies of such batch records with respect to New River product(s), provided however, that New River pays Patheon for its reasonable costs associated with making such copies. All costs of an Event MA shall be borne by New River unless the requirement for audit arises as a result of the negligence of Patheon or the breach of the terms of this Agreement or the Manufacturing Agreement by Patheon, in which case Patheon shall absorb all costs associated with the audit.
Sample 1

Related to Manufacturing Audit

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Laboratory Testing All laboratories selected by UPS Freight for analyzing Controlled Substances Testing will be HHS certified.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • 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.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.

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