Patheon’s Responsibilities Sample Clauses

The "Patheon’s Responsibilities" clause defines the specific duties and obligations that Patheon, as a service provider or manufacturer, must fulfill under the agreement. This typically includes requirements such as adhering to quality standards, meeting production timelines, maintaining proper documentation, and complying with applicable laws and regulations. For example, Patheon may be responsible for manufacturing products according to agreed specifications and ensuring they are delivered on schedule. The core function of this clause is to clearly allocate operational responsibilities to Patheon, ensuring accountability and setting expectations for performance within the contractual relationship.
Patheon’s Responsibilities. Patheon will, at its expense, in consideration for the payments and reimbursements set forth in Section 2.2, provide the Transfer Services and use its commercially reasonable efforts to complete the Transfer Services in a timely fashion in accordance with the Timeline. Patheon will provide to Flexion all data and documentation necessary or reasonably useful to support Flexion’s submissions to the FDA, or any responses to questions raised by the FDA with respect to those Transfer Services, that are necessary or reasonably useful for Regulatory Approval of the Facility as the manufacturing, testing, and packaging site for the Product.
View SourceView Similar (4)
Patheon’s Responsibilities. In the event that a Recall results from the manufacture, packaging, storage, testing or handling of the Product by Patheon, and such Recall is due to Patheon’s failure to provide the Manufacturing Services in accordance with cGMPs or other Applicable Laws, or to have supplied Conforming Product, as determined by a Laboratory pursuant to Section 5.4 or otherwise agreed upon in writing by the Parties, Patheon shall be responsible for documented out-of-pocket expenses of such Recall and shall use its commercially reasonable efforts to replace Recalled Product with new Product, contingent upon the receipt from Depomed of all API required for the manufacture of such replacement Product, for which Patheon shall reimburse Depomed, subject to the limitation on liability for lost API set forth in Article 8, which will be captured and calculated in the API Yield under Section 5.6. In the event that Patheon is unable to replace the Recalled Product (except where this inability results from a failure to receive the required API), then upon request by Depomed, Patheon shall reimburse Depomed promptly for the Production Fees paid to Patheon with respect to the Recalled Product. In all other circumstances, costs and expenses associated with a Recall shall be Depomed’s responsibility. For purposes of this Agreement, the expenses of Recalls shall include, without limitation, the expenses of notification and destruction or return of the Recalled Product, and Depomed’s costs for the Product Recalled. Marketing and advertising expenses associated with the goodwill of the Product subject to the Recall shall not be included as an expense of Recall and shall, in all instances, be borne by Depomed.
View Source
Patheon’s Responsibilities. Patheon will, at its expense, in consideration for the payments and reimbursements set forth in Section 2.2, provide the Transfer Services in a professional and diligent manner, and use its commercially reasonable efforts to complete the Transfer Services in a timely fashion in accordance with the Timeline. Patheon will provide to Pacira all data and documentation necessary to support Pacira’s submissions to the FDA, or any responses to questions raised by the FDA with respect to those Transfer Services, that are necessary for Regulatory Approval of the Facility as the manufacturing, testing, and packaging site for the Product. Patheon will promptly notify Pacira in writing and by telephone if an authorized agent of a Regulatory Authority visits Manufacturing Suite A-2 or Manufacturing Suite B-2, or any other location in the Facility where the Product is being manufactured, packaged, stored or quality tested, will permit Pacira or its agents to be present at the Facility in order to support Patheon during such visit or inspection. Responsibility for the remediation of any issue detected during such visit or inspection shall be borne by the Party responsible for such issue (i.e., with respect to Pacira, issues pertaining to the Pacira Manufacturing Process, Pacira Manufacturing Equipment and Pacira Purchased Patheon Manufacturing Equipment, and with respect to Patheon, issues pertaining to the Facility and all other Equipment). Patheon will provide copies of regulatory correspondence related to such inspection in accordance with the review and comment procedures set forth in Section 3.16 of the Manufacturing and Supply Agreement.
View Source
Patheon’s Responsibilities. (a) Patheon will provide to Client all data and documentation necessary to support Client’s submissions to the FDA, or any responses to questions raised by the FDA with respect to those Transfer Services, that are necessary for Regulatory Approval of the Facility as the manufacturing, testing, and bulk-packaging site for the Product. (b) Patheon shall at its own cost ensure that any and all necessary licenses, registrations, and Regulatory Authority approvals have been obtained in connection with the Facility and Equipment used in connection with the Manufacture of the Product by Patheon. Any changes to the Transfer Services shall be subject to the change control procedure set out in Section 2.10(b) of the Manufacturing and Supply Agreement. (c) Patheon will promptly notify Client in writing and by telephone if an authorized agent of a Regulatory Authority visits the Manufacturing Suite, or any other location in the Facility where the Product is being manufactured, bulk-packaged, stored or quality tested, and the procedures set forth in Section 3.6 of the Manufacturing and Supply Agreement shall apply. (d) Patheon shall install and validate the Equipment in compliance with the capital requirements set forth in Exhibit B and the technical transfer process set forth in Exhibit C.
View Source

Related to Patheon’s Responsibilities

  • COUNTY’S RESPONSIBILITIES A. A County program liaison will monitor the submission of all correspondence required in this Agreement, including, but not limited to: 1. Quarterly Treatment Reports; 2. Financial reports such as annual budgets, cost allocation plans, and cost reports; 3. Incident reports; 4. Outcome data; 5. Monthly ▇▇▇▇▇ Reports 6. Other requested reports B. A County program liaison may visit Contractor during the contract term. The visits shall be for the purpose of reviewing any aspect of Contractor’s program operations. The visit may include, but is not limited to: 1. Review all pertinent participant records. 2. Conduct appropriate interviews/discussions with participants served by Contractor. 3. Review and monitor all correspondence and reports submitted by Contractor related to Contractor’s services provided under this Agreement. 4. Meet with appropriate program management and operations staff. 5. Conduct site visit(s) to Contractor’s program(s) at least once during the term of the Agreement to review all aspects of program operations. Site visit(s) may include a review of Contractor’s programmatic and fiscal documentation related to required reports on services specified in the Exhibits. a. Provide a written site review report documenting areas of compliance and any necessary corrective action(s) required. 6. A County program liaison may attend an organized activity of a selected component or selected components of Contractor’s program(s) at least once during the contract term. C. AODS will conduct periodic mandatory treatment provider meetings with representatives of all contracted service providers and appropriate staff. D. Provide ongoing technical assistance as needed. E. AODS shall act as intermediary on behalf of each contracted alcohol and drug service provider in the submission of the California Outcomes Measurement System (CalOMS) data submissions to the State of California. I. GENERAL ADMINISTRATIVE REQUIREMENTS A. Attend each of the following meetings: 1. Contractor shall attend periodic mandatory meetings; and 2. Drug and Alcohol Information System for You (DAISY) User Group meeting. 3. Other meetings as required by the County B. Contractor shall acknowledge the San Mateo County Alcohol and Other Drug Services (AODS) and/or the County of San Mateo as a funding source on newly developed promotional materials. C. Subcontracting requirements: 1. Pursuant to paragraph 12 of the body of this Agreement, Contractor may subcontract for provision of services described in this Agreement with written approval of the Director of the Human Services Agency or her designee. If Contractor subcontracts for any services under this Agreement, Contractor will guarantee that any and all subcontractors have and maintain the same level of insurance coverage required of the Contractor under this Agreement. Contractor and County will be listed as additional insured on all applicable insurance of subcontractor.

  • Specific Responsibilities Without limiting the responsibilities of the Manager, the Manager will: 1. Maintain office facilities (which may be in the offices of the Manager or a corporate affiliate but shall be in such location as the Trust reasonably determines). 2. Furnish statistical and research data, clerical services and stationery and office supplies. 3. Compile data for, prepare for execution by the Fund and file all the Fund’s federal and state tax returns and required tax filings other than those required by this Agreement to be made by the Fund’s custodian and transfer agent. 4. Prepare compliance filings pursuant to state securities laws with the advice of the Trust’s counsel. 5. Prepare the Trust’s Annual and Semi-Annual Reports to Shareholders and amendments to its Registration Statements (on Form N-1A or any replacement therefor). 6. Compile data for, prepare and file timely Notices to the SEC required pursuant to Rule 24f-2 under the 1940 Act. 7. Determine the daily pricing of the portfolio securities and computation of the net asset value and the net income of Fund in accordance with the Prospectus, resolutions of the Trust’s Board of Trustees, and the procedures set forth in EXHIBIT A: NET ASSET VALUE CALCULATIONS. 8. Keep and maintain the financial accounts and records of the Fund and provide the Trust with certain reports, as needed or requested by the Fund. 9. Provide officers for the Trust as requested by the Trust’s Board of Trustees. 10. Perform fund accounting services for the Fund as set forth in EXHIBIT B: FUND ACCOUNTING FUNCTIONS. 11. Generally assist in all aspects of the operations of the Fund.

  • Vendor Responsibilities Note: NO EXCEPTIONS OR REVISIONS WILL BE CONSIDERED IN C-M, O-S, V-W. Indemnification

  • CITY’S RESPONSIBILITIES 2.1. The CITY shall designate in writing a project coordinator to act as the CITY's representative with respect to the services to be rendered under this Agreement (the "Project Coordinator"). The Project Coordinator shall have authority to transmit instructions, receive information, interpret and define the CITY's policies and decisions with respect to the CONTRACTOR's services for the Project. However, the Project Coordinator is not authorized to issue any verbal or written orders or instructions to the CONTRACTOR that would have the effect, or be interpreted to have the effect, of modifying or changing in any way whatever: (a) The scope of services to be provided and performed by the CONTRACTOR; (b) The time the CONTRACTOR is obligated to commence and complete all such services; or (c) The amount of compensation the CITY is obligated or committed to pay the CONTRACTOR. 2.2. The Project Coordinator shall: (a) Review and make appropriate recommendations on all requests submitted by the CONTRACTOR for payment for services and work provided and performed in accordance with this Agreement; (b) Arrange for access to and make all provisions for the CONTRACTOR to enter the Project site to perform the services to be provided by the CONTRACTOR under this Agreement; and (c) Provide notice to the CONTRACTOR of any deficiencies or defects discovered by the CITY with respect to the services to be rendered by the CONTRACTOR hereunder. 2.3. The CONTRACTOR acknowledges that access to the Project Site, to be arranged by the CITY for the CONTRACTOR, may be provided during times that are not the normal business hours of the CONTRACTOR. 3.1. Services to be rendered by the CONTRACTOR shall be commenced subsequent to the execution of this Agreement upon written Notice to Proceed from the CITY for all or any designated portion of the Project and shall be for a period of two (2) years and three (3) month, with the option for two (2) additional one (1) year renewal. Time is of the essence with respect to the performance of this Agreement. 3.2. Should the CONTRACTOR be obstructed or delayed in the prosecution or completion of its services as a result of unforeseeable causes beyond the control of the CONTRACTOR, and not due to its own fault or neglect, including but not restricted to acts of God or of public enemy, acts of government or of the CITY, fires, floods, epidemics, quarantine regulations, strikes or lock-outs, then the CONTRACTOR shall notify the CITY in writing within 5 working days after commencement of such delay, stating the cause or causes thereof, or be deemed to have waived any right which the CONTRACTOR may have had to request a time extension. 3.3. No interruption, interference, inefficiency, suspension or delay in the commencement or progress of the CONTRACTOR's services from any cause whatsoever, including those for which the CITY may be responsible in whole or in part, shall relieve the CONTRACTOR of its duty to perform or give rise to any right to damages or additional compensation from the CITY. The CONTRACTOR's sole remedy against the CITY will be the right to seek an extension of time to its schedule. This paragraph shall expressly apply to claims for early completion, as well as claims based on late completion. [If Applicable-Provided, however, if through no fault or neglect of the CONTRACTOR, the services to be provided hereunder have not been completed within 18 months of the date hereof, the CONTRACTOR's compensation may be equitably adjusted, with respect to those services that have not yet been performed, to reflect the incremental increase in costs experienced by the CONTRACTOR after expiration of said 18 month period.] 3.4. Should the CONTRACTOR fail to commence, provide, perform or complete any of the services to be provided hereunder in a timely and reasonable manner, in addition to any other rights or remedies available to the CITY hereunder, the CITY at its sole discretion and option may withhold any and all payments due and owing to the CONTRACTOR until such time as the CONTRACTOR resumes performance of its obligations hereunder in such a manner so as to reasonably establish to the CITY's satisfaction that the CONTRACTOR's performance is or will shortly be back on schedule.

  • Client’s Responsibilities The Client’s responsibilities include the following: a. Enrolling. The Client must complete the Informed Consent for Collection and Storage (attached as Schedule 1) The Client must complete or facilitate the Gestational Carrier’s and if applicable, Egg Donor’s completion of the Health History Questionnaire and the Informed Consent to Testing of the Maternal Sample provided by ViaCord. For ▇▇▇▇ ▇▇▇▇▇▇▇ collected in New York State, where possible, the Child’s biological father should also complete a Health History Questionnaire. Generally, for Newborn Stem Cells to be used in treatment, the healthcare provider will need information about the Gestational Carrier and if applicable, Egg Donor. The Health History Questionnaire(s) provides much of the required information.Complete and accurate information is critical to Release and use of Newborn Stem Cells. If You do not provide a completed Health History Questionnaire(s) from the Gestational Carrier and if applicable, Egg Donor, VPL may be unable to Release the Newborn Stem Cells. In addition, if any information provided in the ViaCord Services Agreement or any of the Health History Questionnaire(s) is incomplete or incorrect, it is the Client’s responsibility to notify ViaCord and correct that information immediately.