Quality Assurance Audit Sample Clauses

Quality Assurance Audit. Nuvelo will have the right to conduct reasonable quality assurance audits with respect to all facilities, operations and laboratories (and any records related thereto) operated by Bayer or its Third Party subcontractors, where Development activities are conducted, as is reasonably necessary solely for the purpose of verifying Bayer’s conformance with applicable GMP, GLP, GCP and other regulatory requirements in each country in the Bayer Territory. All audits initiated by Nuvelo will be conducted at Nuvelo’s sole expense, upon reasonable prior notice to Bayer, and during regular business hours. Bayer will have the right to conduct reasonable quality assurance audits with respect to all facilities, operations and laboratories (and any records related thereto) operated by Nuvelo or its Third Party contractors where Development or manufacturing activities for Licensed Product are conducted, including the right to audit activities that formed the basis of CMC documentation, only to the extent reasonably necessary for Bayer to carry out its Development and Commercialization obligations hereunder and as is reasonably necessary solely for the purpose of verifying Nuvelo’s conformance with applicable GMP, GLP, GCP and other regulatory requirements in the Nuvelo Territory. All audits initiated by Bayer will be conducted at Bayer’s sole expense, upon reasonable prior notice to Nuvelo, and during regular business hours.

Quality Assurance Audit. 1.1 AVL agrees that a Quality Assurance (“QA”) auditor to be selected by Adherex will be granted reasonable access to AVL’s facilities to conduct a QA audit at Adherex’s sole expense to evaluate the suitability of the Published Data for submission to the U.S. Food and Drug Administration or other equivalent regulatory agencies worldwide (the “QA Audit”). 1.2 Adherex shall agree in good faith with Prof. dr A.J.M. Balm of AVL when the QA Audit will be performed. The QA Audit is not expected to last longer then three (3) working days. 1.3 Adherex shall not use any confidential or proprietary AVL data, know-how, or information, or any part of it, obtained as a result of the QA Audit (the “QA Results”) for any purpose other than the evaluation of whether Adherex wishes to obtain the exclusive license to use the Licensed Data hereunder, and Adherex agrees that it and its representatives, employees and agents will maintain in strict confidence all QA Results and not use such QA Results for any other purpose than the QA Audit unless and until Adherex has provided the Notice and has received a confirmation thereof from AVL as set forth in Article 1.5 below. For greater certainty, this provision will not in any way limit Adherex’s ability to refer to or use any data that have been previously published and which are in the public domain. 1.4 Adherex will ensure that the auditor selected for the QA Audit agrees to abide by the terms of confidentiality and non-use outlined in Article 1.3 above and that the QA Results will not be copied or taken from the AVL facilities unless otherwise approved in writing by AVL. 1.5 No later than [*] weeks after the completion of the QA Audit, Adherex will give AVL written notice stating whether Adherex wishes to obtain an exclusive license in accordance with the terms and conditions of this Agreement (the “Notice”). AVL shall confirm the receipt of such Notice without undue delay. The Notice shall be provided to: NKI-AVL Technology Transfer Office , Room DC208 Attn. Mr. J. van der Hel, legal Adviser Plesmanlaan 121 1066 CX Amsterdam [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.

Quality Assurance Audit. Heska agrees that upon a minimum fifteen (15) days notice from i-STAT, representatives of i-STAT, during normal business hours, shall be permitted to visit all locations where Heska maintains inventory of Products to conduct a quality assurance audit of such facilities and/or an on-site surveillance of the inventory storage tracking. i-STAT shall have the right during reasonable business hours, to inspect the books and records of Heska relating to Product complaint documentation. In the event that an audit reveals items that i-STAT determines should be corrected by Heska, i-STAT shall provide, in writing, within thirty (30) days of such audit, a list of such items and any proposed corrective action to be taken by Heska. Heska shall respond within fifteen (15) days of receiving i-STAT's notification of the corrective action to be taken and an estimated completion date. If the parties disagree as to whether corrective action is necessary, the matter shall be resolved in accordance with the alternative dispute resolution procedures set forth in Section 11.9.

Quality Assurance Audit. Seller shall adhere to standard commercial practices in providing Goods. However, if there are any unique requirements, such as FFA or U.S. Government specifications required, the parties must mutually agree on such and specify on the face of an Order. With respect to quality, engineering, and manufacturing purposes only, Seller shall provide Buyer, Buyer’s customer, and U.S. Government or other regulatory agencies the right, upon reasonable written notice, to access and perform any inspection, test, audit, or investigation at Seller’s premises to verify compliance with the requirements of an Order. Notwithstanding the foregoing, Seller will not be required to provide any of the foregoing parties with any business or financial related data, records, or other information.

Quality Assurance Audit. Lilly, at its own expense, shall have the right to conduct quality assurance audits with respect to all facilities, operations, and laboratories where work under this Agreement is conducted by Antares, or on its behalf by subcontractors, (including, without limitation, work conducted by Antares related to the Device Development Plan) and to verify Antares’ conformance with applicable cGMP, cGLP, cGCP, cQSRs and other regulatory requirements including, without limitation, verifying appropriate inventory control and material accountability systems with respect to the Device. Such audits shall only be conducted upon reasonable notice during business hours. Antares shall make necessary changes as required by such audit based on an action plan agreed to by the Parties. ***-Denotes portions omitted pursuant to a request for confidentiality under Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with the omitted information intact has been filed separately with the Securities and Exchange Commission.

Quality Assurance Audit. Evidence showing that the Pharmacy staff have appropriate skills, knowledge and that they are up to date must be provided to Solutions4Health. Entries on PharmOutcomes must be accurate and reflect the nature of the consultation held. Number of safeguarding referrals will be retained in the Pharmacy for monitoring purposes. If there are any quality issues regarding the service delivered, Herefordshire ISHS will work with the pharmacy to improve outcomes and performance. The Pharmacy will be able to refer to the specialist service for further management of sexual health needs, which will include pathways for young and vulnerable people. All pharmacies must record all EHC consultations and prescriptions, using PharmOutcomes, including: Date of Consultation Client’s Date of Birth Client’s Postcode Completed EHC Consultation Form Exclusion form where appropriate and onward referral Solutions 4 Health will agree a timetable for regular monitoring meetings with each pharmacy, in order to review the performance of the contract. In keeping with the audit requirements set out in the PGD, an audit will be carried out within the first year, with subsequent re-audits to be agreed. The audit should include at least 20 sets of patient notes or 50% (whichever is smaller). A summary of the audit should be sent to the appropriate person as per Solutions4Health/PGD policy.

Quality Assurance Audit. This study will be patient to audit by Tonix or its designee. Audits may be performed to check compliance with GCP guidelines and can include: • Site audits • Trial Master File audits • Database audits • Document audits (e.g., Clinical Study Protocol and/or Clinical Study Report) Tonix or its designee may conduct additional audits on a selection of study sites, requiring access to patient notes, study documentation, and facilities or laboratories used for the study. The study site, facilities, all data (including source data), and documentation will be made available for audit by quality assurance auditors and for IRB or regulatory authorities according to GCP guidelines. The investigator agrees to cooperate with the auditor during the visit and will be available to supply the auditor with CRFs or other files necessary to conduct that audit. Any findings will be strictly confidential. If a regulatory authority informs the investigator that it intends to conduct an inspection, the investigator shall notify Tonix immediately.

Quality Assurance Audit. Lumara, at its own expense, shall have the right to conduct quality assurance audits with respect to all facilities, operations, and laboratories where work under this Agreement is conducted by Antares, or on its behalf by subcontractors, (including, without limitation, work conducted by Antares related to the Device Development Plan) and to verify Antares' conformance with applicable cGMP, cGLP, cGCP, cQSRs and other regulatory requirements including, without limitation, verifying appropriate inventory control and material accountability systems with respect to the Device, Prefilled Syringes and Products. Such audits shall only be conducted upon reasonable notice during business hours. [***]. TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED

Quality Assurance Audit. (a) ZGEN will have the right to conduct reasonable quality assurance audits with respect to all facilities, clinical sites, operations and laboratories (and any records related thereto) operated by Bayer or its Third Party subcontractors where Development or manufacturing activities for Licensed Product are conducted, including the right to audit activities that formed the basis of CMC documentation; provided, however, that such audits shall be conducted not more than once in any [ * ] ([ * ]) month period, other than “for cause” audits conducted in follow-up to findings of material deficiencies or critical observations made during previous audits, and such audits shall be limited to those portions of such facilities, clinical sites, operations, laboratories and records as are actually used for or related to Development or manufacturing activities for Licensed Product. All audits initiated by ZGEN will be conducted at ZGEN’s sole expense, upon reasonable prior notice to Bayer during regular business hours, and shall be subject to the confidentiality obligations of Article 14. (b) Bayer will have the right to conduct reasonable quality assurance audits with respect to all facilities, clinical sites, operations and laboratories (and any records related thereto) operated by ZGEN or its Third Party contractors where Development or manufacturing activities for Licensed Product are conducted, including the right to audit activities that formed the basis of CMC documentation; provided, however, that such audits shall be conducted not more than once in any [ * ] ([ * ]) month period, other than “for cause” audits conducted in follow-up to findings of material deficiencies or critical observations made during previous audits, and such audits shall be limited to those portions of such facilities, clinical sites, operations, laboratories and records as are actually used for or related to Development or manufacturing activities for Licensed Product. All audits initiated by Bayer will be conducted at Bayer’s sole expense, upon reasonable prior notice to ZGEN during regular business hours, and shall be subject to the confidentiality obligations of Article 14. (c) The Alliance Managers or JDC Team Leaders, as appropriate, shall facilitate and coordinate visits under this Section 6.4 and each Party shall use commercially reasonable efforts to accommodate such a visit by the other Party, including providing the individuals visiting with access to all relevant portions of t...