Package and Supply
Package and Supply Sample Clauses
Related to Package and Supply
Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);
Course Curriculum, Instruction, and Grading X. Xxxx College courses offered as dual credit, regardless of where they are taught, follow the same syllabus, course outline, textbook, grading method, and other academic policies as the courses outlined in the Hill College catalog. B. Approved courses being taught for dual credit must follow the approved master syllabus of the discipline and of Hill College. C. Textbooks should be identical to those approved for use by Hill College. Should an instructor propose an alternative textbook, the textbook must be approved in advance by the appropriate instructional department of Hill College and the Vice President of Instruction. Other instructional materials for dual credit/concurrent courses must be identical or at an equivalent level to materials used by Hill College. D. Courses which result in college‐level credit will follow the standard grading practices of Hill College, as identified by college policy and as identified in the appropriately approved course syllabus. The grades used in college records are A (excellent), B (above average), C (average), D (below average), F (failure), I (incomplete), W (withdrawn), WC (withdrawn COVID). The lowest passing grade is D. Grade point averages are computed by assigning values to each grade as follows: A = 4 points, B = 3 points, C = 2 points, D = 1 point, and F = 0 points. Grading criteria may be devised by Hill College and the ISD to allow faculty the opportunity to award high school credit only or high school and college credit depending upon student performance. E. Faculty, who are responsible for teaching dual credit/concurrent classes, are responsible for keeping appropriate records, certifying census date rosters, providing interim grade reports, certifying final grade reports at the end of the semester, certifying attendance, and providing other reports and information as may be required by Hill College and/or the School District.
Training and Support Licensor shall offer installation support to the Licensee and each of the Members, including assisting with the implementation of any Licensor software. Licensor will provide appropriate training to Licensee and Member staff relating to the use of the Licensed Materials and any Licensor software. Licensor will offer reasonable levels of continuing support to assist Licensee and Members in use of the Licensed Materials, including providing help files and other appropriate user documentation in connection with the use of and access to Licensed Materials. Licensor will, at a minimum, make its personnel available by email, telephone or via the Web, or in person during Licensor’s regular business hours, Monday through Friday, for training and user access support.
Services and Support 1.1 In exchange for your continued compliance with this Agreement, and any modification to this Agreement made by Intuit in accordance with Sections A.1.1, you shall have access to the Software/Subscription in accordance with the following provisions: (a) If you purchased a Subscription based license for the Software, which generally means that you will be paying for your use of the Software and Services on a monthly or annual basis, you shall receive as part of your active Subscription, so long as Intuit is receiving the applicable payment from you: (i) access to the features of the Software subscribed to by you; (ii) Updates and Enhancements; (iii) Version Protection, each defined in Section B.1.2 below; and (iv) additional products, services and/or discounts when and if they should be made available to you. If you have purchased a subscription that includes Support you will also be entitled to receive Support Services as defined below. Software licenses obtained through a subscription are eligible for Enhancements during the active subscription period only. The Subscription is cancellable by you in accordance with this Agreement, but you will not be entitled to any refunds if you cancel after the 60-Day Money Back Guarantee period, as defined in Section B.6. If you cancel your Subscription or if we do not receive the payment for your Subscription, or if the Subscription is in any way terminated in accordance with the terms of this Agreement, you will no longer have access to the Software and all related Services defined above upon the expiration of the current Subscription term, but you will retain access to your company data file stored on your device, which can be reinstated to a readable QuickBooks format upon reactivation of your Subscription or with the purchase of a license on the Software. (b) If you purchased your license to the Software under a one-time, upfront payment at retail or directly from Intuit and not under a Subscription, you shall receive: (i) a license to the specific version of the Software product you have selected that, subject to the license grant and restrictions in Section A.1.1, allows you access to the features of the Software; and (ii) Updates and Enhancements to the Software in accordance with the terms of the Termination provisions. Intuit's obligations under this Section B.1.1 are contingent upon you installing all updates and error corrections within thirty (30) days of being notified of their availability by Intuit (or its Representatives). QuickBooks 2015 Software purchased on a separate standalone basis are eligible for enhancements on a when-and-if available basis through May 31, 2018, which is the current support period for QuickBooks 2015.
Product Supply 5.1 In the event that Eisai notifies Radius of its desire to purchase bulk substance of Compound from Radius, Radius shall supply Eisai with all amount of such bulk substance of Compound, which meets specifications for the Product determined by Radius in the course of its Development activities pursuant to this Agreement, required by Eisai for commercial sales of Product in Japan With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai the bulk substance of Compound for * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of the bulk substance of Compound required for clinical trials in Japan. Radius shall charge [*] for applicable bulk substance of Compound. Radius shall ship such bulk substance of Compound, FOB point of manufacturing. 5.2 In the event that Eisai notifies Radius of its desire to purchase Semi-Product from Radius which meets specifications determined by Radius in the course of its Development activities pursuant to this Agreement, Radius shall supply Eisai with all amount of Semi-Product required by Eisai for commercial sales of Product in Japan. With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai Semi-Product for the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of Semi-Product required for clinical trials in Japan. Radius shall charge [*] for Semi-Product. Radius shall ship such Semi-Product, FOB point of manufacturing. 5.3 The Parties agree that they shall, in good faith, discuss, negotiate and execute necessary agreements containing mutually acceptable terms, including but not limited to, a supply agreement for either bulk substance of Compound or Semi-Product as well as a quality control agreement of either bulk substance of Compound or Semi-Product, in the event that Eisai notifies Radius as set forth in Article 5.1 or 5.2. 5.4 As manufacturer of the Product, Radius shall be responsible for: (a) the control of the quality of the Product promoted and sold under the Radius trademarks; as provided in Article 2.3; and (b) ensuring that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable good manufacturing practices (GMP) and shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product; and Radius warrants that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable GMP and * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product and will be free from defects in material and workmanship. Radius shall resolve any product liability issues in the Territory relating to the Product and shall resolve any product liability issues in Japan relating to the Product or the bulk substance of Compound or Semi-Product, as the case may be, supplied to Eisai pursuant to this Article 5 in the event and to the extent related to a breach of the warranty set forth in Article 5.4(b) at its own expense and subject to Article 5.5. 5.5 Radius’ obligations with respect to product liability in the Territory and Japan shall include the following responsibilities, each to be taken at Radius’ expense: (a) Radius shall report, at its expense, to appropriate authorities, in accordance with local requirements, all adverse events related to use of the Product in the Territory or Japan. Eisai shall provide to Radius, upon Radius’ request, reasonable assistance in connection with the reporting of all of adverse events, responding to safety queries and assessing safety issues, in each case, to the extent related to the Product in Japan. Adverse events shall be recorded in a single, centralized database, which shall be held and owned by Radius. Radius will provide, upon request by Eisai, any safety information in Radius’ control and reasonably required by Eisai in connection with the development and commercialization of the Product in Japan and all reasonable assistance in responding to safety queries related to the Product and in assessing safety issues related to the Product in Japan. Details of safety reporting activities relating to the Product will be addressed in a pharmacovigilance contract, which the Parties shall enter into after the Effective Date. (b) In the event that (i) Radius determines that an event, incident, or circumstance may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market; (ii) any regulatory authority in the Territory threatens to remove a Product from the market; or (iii) any regulatory authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent regarding the use of Product, Radius shall promptly advise Eisai in writing, and shall provide Eisai with copies of all relevant correspondence, notices and the like. Notwithstanding anything the contrary herein, Radius shall have final authority to make all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product in the Territory. After establishing SC pursuant to Article 3.5, all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product shall be decided by the SC as set forth in Article 3.6; provided that in the event that the Parties take different positions with respect to recall, market withdrawal or other corrective action with respect to the Product, then Radius shall have the right to cease supplying bulk substance of Compound or Semi-Product to Eisai for Japan if, after good faith discussions with Eisai, Radius reasonably believes that that continued supply to Eisai exposes Radius to liability as a result of its decision with respect to the Territory. If Radius elects to cease supply, it will terminate supply in an orderly manner, as soon as practical and in accordance with a schedule agreed to by Eisai and Radius. In the event of a recall, market withdrawal or other corrective action with respect to the Product in Japan, and at Radius’ request, Eisai shall provide reasonable assistance to Radius, at Radius’ cost and expense, in conducting any such recall, market withdrawal or other corrective action with respect to the Product in Japan. 5.6 THE WARRANTY IN SECTION 5.4(b) IS IN LIEU OF ANY OTHER WARRANTY WITH RESPECT TO THE PRODUCT, BULK SUBSTANCE OF COMPOUND OR SEMI-PRODUCT SUPPLIED BY RADIUS HEREUNDER, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL (INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE).
Service and Support 1. Brainlab shall be responsible for providing service and support for the Brainlab Technology in all Fields of Use. Brainlab shall be responsible for providing Xxxxx 0 and Level 2 service and support to customers for Products sold by Brainlab in the Therapeutic Delivery Field of Use and for Integrated Products sold by Brainlab in the MR Guided Stereotactic Placement Field of Use. Level 1 support shall include onsite training, help desk services, reseller interfacing, problem isolation and diagnosis, and Level 2 support shall include loading bug fixes, patches, and minor repair services. To the extent relating to SurgiVision Technology, SurgiVision shall provide Level 3 support, which shall include backup support services to assist Brainlab in meeting Level 1 and Level 2 support obligations by addressing certain technical support issues that are beyond the scope of Brainlab’s expertise. Brainlab will pay SurgiVision for Xxxxx 0 support services at standard rates as described in Appendix C, provided that such services were not required for Co-Development and Distribution Agreement between SurgiVision, Inc. and Brainlab Aktiengesellschaft CONFIDENTIAL warranty repair as contemplated in section X.3 below. Appendix C may be changed from time to time, as appropriate upon the mutual agreement of Brainlab and SurgiVision. SurgiVision will provide spare parts and other items for service to Brainlab at a price equal to [***]. Brainlab reserves the right to offer service packages to the end customer at its discretion. 2. SurgiVision shall be responsible for providing service and support to customers in the United States for ClearPoint Products sold in the MR Guided Stereotactic Placement Field of Use; provided, however, that SurgiVision shall be responsible for attending only the initial clinical cases using the ClearPoint Products (to the extent attendance is requested by the customer). For the avoidance of any doubt, the foregoing obligation does not apply to Integrated Products. To the extent Brainlab has a service package with the end user customer that covers ClearPoint Products (not including Integrated Products), SurgiVision shall be entitled to reasonable compensation from Brainlab under such arrangement in an amount to be agreed. 3. SurgiVision shall provide training on the ClearPoint Products, including joint attendance of SurgiVision and Brainlab personnel in initial clinical cases in the applicable region, to Brainlab personnel to enable Brainlab personnel to provide service and support to customers outside of the United States.
Maintenance and Support Services If this Agreement is for IT goods or services, this section applies: Unless otherwise specified in this Agreement: The Contractor shall promptly provide the Court with all Upgrades, including without limitation: (i) all Upgrades generally made available by Contractor to its other customers; (ii) Upgrades as necessary so that the Work complies with the Specifications and Applicable Law (including changes in Applicable Law); (iii) Upgrades as necessary so that the Work operates under new versions or releases of the Court’s operating system or database platform; and (iv) all on-site services necessary for installation of Upgrades. Without limiting any other obligation of Contractor under this Agreement, Contractor represents and warrants that it will maintain services, equipment, software or any other part of the Work so that they operate in accordance with their Specifications and Documentation; and The Contractor shall respond to the Court within four (4) hours after the Court reports a Technical Support Incident (such hours all occurring during Standard M&S Hours) to Contractor. DELIVERY, ACCEPTANCE, AND PAYMENT Delivery. Contractor shall deliver to the Court the Deliverables in accordance with this Agreement, including the Statement of Work. Unless otherwise specified by this Agreement, Contractor will deliver all goods purchased by the Court “Free on Board Destination Freight Prepaid” to the Court at the address and location specified by the Court. Title to all goods purchased by the Court vests in the Court upon payment of the applicable purchase price. Contractor will bear the risk of loss for any Work being delivered until received by the Court at the proper location. All shipments by Contractor or its Subcontractors must include packing sheets identifying: this Agreement number, the Court’s purchase order number, item number, quantity and unit of measure, part number and description of the goods shipped, and appropriate evidence of inspection, if required. Goods for different Agreements shall be listed on separate packing sheets.
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.
Other Products and Services As our customer, you have access to a suite of financial products and services availed by ourselves, our affiliates and strategic partners designed to help you address and achieve your financial needs and goals. You agree that you can obtain information about such Products and Services via our website xxx.xxxxxxxx.xxx.xx and you further agree that we can from time to time communicate information in relation to such Products or Services to you specifically or generally to all cardmembers via such communication mode as we consider appropriate.
Maintenance and Support NCR Voyix is solely responsible for providing any maintenance and support services with respect to the Software as specified in the Agreement, or as required under applicable law. The parties acknowledge that Apple has no obligation whatsoever to furnish any maintenance and support services with respect to the Software.
