Manufacture and Supply As between the Parties, Otsuka shall be responsible for, shall bear all costs associated with, and shall have all decision-making authority over, all Manufacturing Activities (subject to discussion of CMC matters with Acucela through the JDC or applicable Operating Team as discussed below); provided, that Otsuka shall supply Licensed Product to Acucela or its permitted subcontractors for use in clinical trials conducted in accordance with each Development Plan and, if applicable, Commercialization Plan (i.e., Phase 3b Clinical Trials or Post-Approval Studies, if any), free of charge and in such quantities as are agreed by the JDC or the JCC (as applicable) or are otherwise required to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall supply promotional samples of Licensed Product to Acucela for use in its performance of Co-Promotion, in such quantities and on such terms as are determined by the JCC. The cost of promotional samples of Licensed Product, which shall be included in Commercialization Costs, shall be established by the JCC based on Otsuka’s per-unit cost to manufacture such promotional samples (but, for the avoidance of doubt, Otsuka shall have no obligation to disclose any information relating to its manufacturing costs), but in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by the Parties. Acucela’s and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise of its Opt-in Right pursuant to Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its Licensed Product supply obligations as set forth in the Development Plan or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities related to the Licensed Product (including Other Indication Product(s), as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC matters.
COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.
Quality Assurance The parties endorse the underlying principles of the Company’s Quality Management System, which seeks to ensure that its services are provided in a manner which best conforms to the requirements of the contract with its customer. This requires the Company to establish and maintain, implement, train and continuously improve its procedures and processes, and the employees to follow the procedures, document their compliance and participate in the improvement process. In particular, this will require employees to regularly and reliably fill out documentation and checklists to signify that work has been carried out in accordance with the customer’s specific requirements. Where necessary, training will be provided in these activities.
EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment.
4.2 Actively participates in the Peak Performance program.
4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards.
4.4 Completes mandatory training (including safety and quality training) as relevant to role.
4.5 Performs duties in accordance with the EMHS Vision and Values, WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act and Government, WA Health, EMHS and Departmental / Program specific policies and procedures.
SMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment.
4.2 Participates in an annual performance development review.
4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards.
4.4 Completes mandatory training (including safety and quality training) as relevant to role.
4.5 Performs duties in accordance with Government, WA Health, South Metropolitan Health Service and Departmental / Program specific policies and procedures.
4.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.
NMHS Governance, Safety and Quality Requirements 2.1 Participates in the maintenance of a safe work environment.
2.2 Participates in an annual performance development review.
2.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards.
2.4 Completes mandatory training (including safety and quality training) as relevant to role.
2.5 Performs duties in accordance with Government, WA Health, North Metropolitan Health Service and Departmental / Program specific policies and procedures.
2.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.
Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.
Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.
NATURE AND SCOPE 4.1 This Agreement is an agreement under the terms and conditions of which the Supplier/Service Provider will arrange for the supply/provision to Transnet of the Goods/Services which meet the requirements and specifications of Transnet, the delivery of which is controlled by means of Purchase Orders to be issued by Transnet and executed by the Supplier/Service Provider in accordance with this Agreement.
4.2 Such Purchase Orders and deliveries to Transnet shall be agreed between the Parties from time to time, subject to the terms of the Schedule of Requirements/Work Order.
4.3 Each properly executed Purchase Order forms an inseparable part of this Agreement as if it were fully incorporated into the body of this Agreement.
4.4 During the period of this Agreement, both Parties can make written suggestions for amendments to the Schedule of Requirements/Work Orders in accordance with procedures set out in clause 35 [Amendment and Change Control]. A Party will advise the other Party within 14 [fourteen] Business Days, or such other period as mutually agreed, whether the amendment is acceptable.
4.5 Insofar as any term, provision or condition in the Schedule of Requirements/Work Order conflicts with a like term, provision or condition in this Agreement and/or a Purchase Order, the term or provision or condition in this Master Agreement shall prevail, unless such term or provision or condition in this Master Agreement has been specifically revoked or amended by mutual written agreement between the Parties.
4.6 Time will be of the essence and the Supplier/Service Provider will perform its obligations under this Agreement in accordance with the timeframe(s) [if any] set out in the relevant schedule, save that the Supplier/Service Provider will not be liable under this clause if it is unable to meet such obligation within the time required as a direct result of any act or omission by Transnet and it has used its best endeavours to advise Transnet of such act or omission. In the event of such delay, any time deadlines detailed in the relevant schedule shall be extended by a period equal to the period of that delay.
Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards.
2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.
