Transfer of Manufacturing Responsibility Sample Clauses

Transfer of Manufacturing Responsibility. (a) Upon written notice from Zai made any time after [*] after the Effective Date, Zai may request a technology transfer for any or all stages of the Manufacturing process of Licensed Product for which Entasis has completed Manufacturing process development (each such stage, a “Manufacturing Stage”). After receipt of any such request from Zai, Entasis shall promptly provide all assistance reasonably necessary to enable transfer of such Manufacturing Stage(s) to Zai or its designee, including (i) providing all available information relevant to such transfer, including available CMC documentation in Entasis’s control, pursuant to a written technology transfer plan as initially proposed by Entasis and mutually agreed upon by the Parties, and (ii) upon Zai’s request and at Zai’s expense, providing regulatory support to coordinate FDA inspection of Zai’s drug substance and drug product manufacturing facilities for Licensed Product by or on behalf of Zai. Zai shall reimburse Entasis’s good faith estimate of internal expenses and costs at the FTE Rate for FTEs engaged to assist Zai in connection with a Manufacturing Stage transfer initiated by Zai pursuant to this Section 7.2(a). In addition, Zai shall reimburse Entasis for all out-of-pocket expenses and costs incurred by Entasis to assist Zai in connection with such Manufacturing Stage transfer. Entasis shall invoice Zai on a [*] basis for the foregoing costs incurred by Entasis, and Zai shall pay the amount invoiced within [*] after the date of any such invoice. (b) Upon written notice from Entasis made at any time after [*], Entasis may transfer, at Entasis’s expense, to Zai or its designee any or all Manufacturing Stages for Licensed Products, provided that Zai shall have the right to decline the transfer of any such Manufacturing Stage if Zai intends to internally develop such Manufacturing Stage. Following such notice, Entasis shall promptly provide all assistance reasonably necessary to enable transfer of such Manufacturing Stage(s) to Zai or its designee, including (i) providing all available information relevant to such transfer, including available CMC documentation in Entasis’s control, pursuant to a written technology transfer plan as initially proposed by Entasis and mutually agreed upon by the Parties, and (ii) upon Zai’s request and at Zai’s expense, providing regulatory support to coordinate FDA inspection of Zai’s drug substance and drug product manufacturing facilities for Licensed Product by or...
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Transfer of Manufacturing Responsibility. In order to assist Celgene to perform the Celgene Manufacturing Responsibilities or, if selected by Agios pursuant to Section 4.1(b), the Agios Commercial-Scale Manufacturing Responsibilities, Agios shall (a) transfer, or have transferred, to Celgene or its designee, pursuant to a technology transfer plan to be mutually agreed by the Parties, all Manufacturing Technology Controlled by Agios and used in Manufacturing Licensed Products at the time of such transfer to the extent relevant to the Celgene Manufacturing Responsibilities or, if selected by Agios pursuant to Section 4.1(b), the Agios Commercial-Scale Manufacturing Responsibilities, and (b) provide reasonable assistance in connection with the transfer of such Manufacturing responsibility to Celgene or its designee. Costs incurred by either Party in such transfer shall be Development Costs.
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Transfer of Manufacturing Responsibility. In order to assist Celgene to perform the Celgene Manufacturing Responsibilities, Vividion shall (a) transfer, or have transferred, to Celgene or its designee all Manufacturing Technology Controlled by Vividion and used in Manufacturing Licensed Products at the time of such transfer to the extent relevant to the Celgene Manufacturing Responsibilities and use Commercially Reasonable Efforts to complete such transfer within [***] days after the Effective Date, and (b) provide reasonable assistance in connection with the transfer of such Manufacturing responsibility to Celgene or its designee. The Out-of-Pocket Costs incurred by Vividion in connection with such transfer shall be reimbursed by Celgene within [***] days after receipt by Celgene of an invoice for such costs.
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Transfer of Manufacturing Responsibility. The Manufacturing Agreement shall set forth, among other things, the procedures for the transfer of Marketed Product manufacturing responsibility to Advancis or its designee.
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Transfer of Manufacturing Responsibility. In order to assist Celgene to perform the Celgene Manufacturing Responsibilities, Agios shall (a) transfer, or have transferred, to Celgene or its designee all Manufacturing Technology Controlled by Agios and used in Manufacturing Licensed Products at the time of such transfer to the extent relevant to the Celgene Manufacturing Responsibilities and use Commercially Reasonable Efforts to complete such transfer within [**] after the Effective Date, and (b) provide reasonable assistance in connection with the transfer of such Manufacturing responsibility to Celgene or its designee. The Out-of-Pocket Costs incurred by Agios in connection with such transfer shall be reimbursed by Celgene within [**] after receipt by Celgene of an invoice for such costs.
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Transfer of Manufacturing Responsibility. (a) after the Effective Date the Parties shall commence, and diligently pursue, the transfer of responsibility for manufacturing Collaboration Compounds and bulk Covered Products from OXiGENE to BMS. Each Party shall designate a liaison to implement such transfer process and coordinate it with the performance of such Party's other obligations under this Agreement. The Parties shall use commercially reasonable efforts to complete such transfer as expeditiously as possible. In connection with such transfer OXiGENE shall assign to BMS any Third Party contracts into which OXiGENE has entered regarding such manufacturing that BMS requests to be assigned and that may be so assigned. OXiGENE shall use reasonable commercial efforts to obtain any necessary Third Party consents in connection with any such assignments. (b) Until the completion of such transfer, OXiGENE shall use reasonable commercial efforts to supply BMS, through OXiGENE's use of Third Party manufacturers, with BMS's requirements for Collaboration Compounds and bulk Covered Products for use under this Agreement, pursuant to a supply arrangement(s) that OXiGENE has disclosed to BMS. OXiGENE shall manufacture same, or shall cause OXiGENE's Third Party manufacturers to manufacture same, in accordance with current Good Manufacturing Practices under 21 C.F.R. 210 and 211 and all applicable laws, rules and regulations. The cost to BMS of Collaboration Compounds and bulk Covered Products supplied pursuant to this Section 11.1(b) shall be ******% of the invoiced price OXiGENE pays therefor. BMS shall pay such invoices within 45 days after receipt thereof. OXiGENE shall provide proof of such prices paid by OXiGENE from time to time, upon BMS's request. OXiGENE shall invoice BMS quarterly for, and BMS shall pay for, the Collaboration Compounds and bulk Covered Products supplied pursuant to this Section 11.1(b). (c) Upon the completion of such transfer, BMS shall have sole responsibility for manufacturing all Collaboration Compounds and/or bulk Covered Products for the Parties under this Agreement.
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Transfer of Manufacturing Responsibility. At any time on or [***], Catalyst shall have the right, itself or through any Third Party manufacturer, to Manufacture the Compound and the Product in or outside the Territory for purposes of Development, filing for and obtaining Regulatory Approval and Commercializing the Compound and the Products in the Field in the Territory. Catalyst shall give written notice to Santhera of its election to so Manufacture the Compound and the Product and, upon such written notice, (a) the Manufacturing License shall automatically go into effect, (b) the Parties, through the JSC, shall discuss and agree upon a schedule and plan for transition of the Manufacture of the Compound and the Product for the Territory to Catalyst or its Third Party manufacturer(s), including a technology transfer plan, and (c) if requested by Catalyst, the Parties will use good faith efforts to implement assignments to Catalyst of Santhera’s agreements with its Third Party manufacturers (“CMO”) to the extent applicable to Manufacture and supply of the Compound and the Product for the Territory, provided that Santhera’s agreements with its relevant CMO may remain in place, at Xxxxxxxx’s discretion, to the extent applicable to Manufacture and supply of the Compound and the Product for territories other than the Territory. Without limiting the foregoing, for any such CMO agreement that is not assignable (without the consent of the CMO or otherwise), Santhera will make a good faith effort to obtain consent from the applicable CMO or to otherwise enable the assignment of such agreement to Catalyst to the extent applicable to Manufacture and supply of the Compound and the Product for the Territory. In addition, Santhera and Catalyst shall provide reasonable assistance and cooperation in connection with the transition of the Manufacture of the Compound and Product to Catalyst or its Third Party manufacturers (including, if applicable, CMOs), including implementing the agreed-upon technology transfer plan, in accordance with such schedule agreed upon by the Parties, which assistance shall include: (i) providing an introduction to Santhera’s CMO(s) or other Third Party manufacturers for Compound and Product and facilitating negotiations with such entities; (ii) granting any authorizations reasonably requested by Catalyst or its CMOs or other Third Party manufacturers in connection with the Manufacture of the Compound and Product for the Territory; and (iii) transferring to Catalyst and its CMOs or other ...
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Transfer of Manufacturing Responsibility. Subject to the last sentence in Section 5.4 (Transfer of Manufacturing Know-How), Partner will have the right to assume responsibility for Manufacturing the Licensed Products for use in the Field in the Territory pursuant to the Manufacturing Responsibility Transfer Plan, which right it may exercise at any time during the Term by providing written notice to uniQure (the date of such notice, the “Manufacturing Responsibility Transfer Notice Date”). In such notice, Partner will (a) elect to Manufacture all or part of Partner’s requirements for the Licensed Products (i) through the CMO(s) then engaged by uniQure, in which case uniQure will transfer or assign to Partner all applicable agreements between uniQure and such CMO (if and to the extent that such agreement is transferrable or assignable and relates solely to the Licensed Products) or Partner may enter into its own direct agreement with such CMO, (ii) itself, in which case uniQure will transfer the uniQure Manufacturing Know-How to Partner in accordance with Section 5.4 (Transfer of Manufacturing Know-How), or (iii) through a CMO designated by Partner (subject to approval of such CMO by uniQure if required by and in accordance with Section 2.2.2 (Right to Subcontract)), in which case uniQure will transfer the uniQure Manufacturing Know-How to such CMO in accordance with Section 5.4 (Transfer of Manufacturing Know-How), and (b) give uniQure the notice required by Section 14.2 of the Supply Agreement relating to either the termination of the Supply Agreement or the request to have uniQure serve as a second source of Manufacture of the Licensed Products in accordance therewith.
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Transfer of Manufacturing Responsibility 
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Related to Transfer of Manufacturing Responsibility

  • Transfer of Materials To facilitate the conduct of activities under the Research Plan or an Additional Research Plan, as applicable, either Party (the “Transferor Party”) may, at its election, provide Materials to the other Party (the “Transferee Party”) solely as mutually agreed by the Parties or as set forth in the Research Plan or any Additional Research Plan. All such Materials (a) will remain the sole property of the Transferor Party, (b) will be used only in the exercise if the Transferee Party’s rights or fulfillment of the Transferee Party’s obligations under this Agreement, (c) except as provided in the Research Plan or Additional Research Plan or as otherwise agreed by the Parties, (i) will remain solely under the control of the Transferee Party, (ii) will not be used or delivered by the Transferee Party to or for the benefit of any Third Party, and (iii) will not be used in research or testing involving human subjects, and (d) will be subject to all additional restrictions and obligations that the Transferor Party has identified in a written notice to the Transferee Party as being necessary for the Transferor Party to comply with its obligations to Third Parties with respect to the applicable Material, which notice is provided at or prior to the delivery of such Materials to the Transferee Party. Without limitation to ARTICLE 7, all Materials supplied under this Section 2.1.9 are supplied “as is”, with no warranties of fitness for a particular purpose, and must be used with prudence and appropriate caution in any experimental work, as not all of their characteristics may be known. Following the completion of the activities for which the applicable Materials were supplied under this Section 2.1.9 or upon the Transferor Party’s earlier request, the Transferee Party will either destroy or return to the Transferor Party, at the Transferor Party’s sole discretion, all Materials provided by the Transferor Party that are unused; provided that Vertex will have the right to retain and continue to use any Materials provided by Company that Vertex has the right to Exploit under the license granted to Vertex pursuant to Section 4.1.1.

  • Manufacturing Technology Transfer Except as the Committee ------------ --------------------------------- may otherwise agree in writing, in order to effectuate an orderly transition of the uninterrupted availability of Product to LILLY for purposes contemplated under this Agreement, MEGABIOS, at least ninety (90) days prior to completion of the Project or completion of Phase I Clinical Trials, whichever is earlier, shall transfer to LILLY all information and instructions concerning the manufacturing process and related matters in MEGABIOS' possession which may be necessary for LILLY to manufacture Product (including information regarding obtaining necessary Lipids related thereto) for clinical trials and commercialization as contemplated hereunder including, but not limited to, analytical and manufacturing methods. MEGABIOS shall also provide assistance (in the form of consultation) to LILLY with respect to manufacturing matters for a period of [ * ] months after completion of the initial transfer of information and instructions as provided below. Such transfer and assistance by MEGABIOS will be referred to herein as the "Manufacturing Transfer." All such information, methods and instructions transferred to LILLY under this Section 4.3 shall be referred to herein as the "Manufacturing Information," and shall be maintained in confidence by LILLY pursuant to Section 7.1, except that LILLY's obligation to maintain in confidence such Manufacturing Information shall survive for ten (10) years following expiration or termination of this Agreement. LILLY agrees that it will use all such transferred Manufacturing Information only for the manufacture of the Products and shall not disclose or transfer such Manufacturing Information to any third party manufacturer except as provided in Section 2.10. MEGABIOS shall provide, and bear its costs for, up to [ * ] FTEs for a period of up to [ * ] months [ * ] in aggregate) to accomplish the Manufacturing Transfer. Such FTEs, at LILLY's request, shall include visits to LILLY's facilities by MEGABIOS personnel including up to [ * ] from MEGABIOS' head of manufacturing. MEGABIOS shall furnish any additional reasonable assistance beyond the assistance described above regarding manufacturing matters that LILLY may request and that MEGABIOS is able to provide, for up to [ * ] after the initial transfer of Manufacturing Information, providing that LILLY [ * ] incurred with respect to such additional assistance.

  • Licensee’s Responsibilities Licensee will be responsible for any and all damage to or relocation of existing facilities. Further, Licensee shall reimburse the City for all costs of replacing or repairing any property of the City, or of others, that is damaged by or on behalf of Licensee as a result of activities under this Agreement.

  • Licensee Responsibilities a. Licensee understands and agrees that all decisions regarding the tax treatment of items reflected on Tax Returns prepared by Licensee using the Software are made solely by Licensee and that use of the Software does not relieve Licensee of responsibility for the preparation, accuracy, content, and review of such Tax Returns. b. Licensee acknowledges that Licensee does not rely upon Drake for advice regarding the appropriate tax treatment of items reflected on Tax Returns prepared and/or processed using the Software. Licensee will review any computations made by the Software and satisfy Licensee that those computations and reporting are correct. c. Licensee is responsible for the keying of all information accurately into the Software, including but not limited to direct deposit information as it pertains to taxpayers’ data for receiving refunds. d. Licensee agrees to abide by and comply with all regulations and laws which pertain to the commercial preparation and electronic filing of Tax Returns, including but not limited to IRS Regulations, publications and other applicable laws. It is a violation of this Agreement AND applicable law for Licensee to falsely indicate to Drake that Licensee has obtained taxpayer’s Code 26 CFR §301.7216 compliant “Consent to e. Licensee agrees not to use the Software or any of Drake’s services for any illegal, fraudulent or otherwise improper purpose. These may include, but are not limited to misrepresenting taxpayer information, falsely representing identities, activities that may circumvent security measures, technical or regulatory requirements or other IRS or State non-compliant activities. If it is determined, in Drake’s sole discretion, Licensee is non- compliant with this Section 4(e), or Licensee has attempted to misrepresent, mislead or otherwise provide false representation(s) as to its compliance with this or any other provision of this Agreement, Licensee shall forfeit all rights to use the Software or services of Drake provided in this Agreement, including but not limited to any rights to refunds of any monies paid to Drake. f. Licensee is solely responsible for the backup and retention of all data, unless such responsibility is specifically accepted by Drake. g. Licensee agrees to provide Drake a copy of Licensee’s completed E-File Application Summary, or other documentation required by Drake regarding ownership of an EFIN used with the Software by Licensee, prior to using the electronic filing services of Drake. Licensee understands that in order to use the electronic filing services of Drake or the IRS a valid EFIN must be obtained and maintained as current from the IRS. h. Licensee shall be responsible for acquiring and maintaining an information technology infrastructure with sufficient capabilities to operate the Software and comply with all provisions of this Agreement. i. Licensee shall not decompile, reverse assemble, or reverse engineer any Software or other information disclosed to Licensee hereunder. j. Licensee shall be responsible for complying with all export controls relating to the Software. k. Licensee shall be responsible to safeguard and prevent unauthorized access to Taxpayer Data. Licensee shall be responsible to secure usernames and passwords that allow access to Taxpayer Data. l. Licensee acknowledges that by using a computer system and the Software to prepare and transmit Tax Returns electronically, Licensee consents to the disclosure of all information relating to its use of the computer system and the Software to generate Tax Returns and to the electronic transmission of Tax Returns to the state and/or federal agency as applicable under existing law. m. Licensee acknowledges and consents to Drake’s collection through use of the Software of non-Tax Return related data and information, including IP address, device and system identifications, and other information required by Drake for its internal business purposes, fraud prevention, data privacy, and maintaining the security and integrity of the tax system and/or the Software.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • Limited Responsibility Each Party shall be responsible only for service(s) and facility(ies) which are provided by that Party, its affiliates, authorized agents, subcontractors, or others retained by such parties, and neither Party shall bear any responsibility for the services and facilities provided by the other Party, the other Party’s affiliates, agents, subcontractors, or other persons retained by such parties. No Party shall be liable for any act or omission of another Telecommunications Carrier (other than an affiliate) providing a portion of a service, unless such Telecommunications Carrier is an authorized agent, subcontractor, or other retained by the party providing the service.

  • 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);

  • Academic Freedom and Responsibility 5.1 The Florida Gulf Coast University affirms the principles of academic freedom and responsibility, which are rooted in a conception of the University as a community of scholars united in the pursuit of truth and wisdom in an atmosphere of tolerance and freedom. 5.2 Academic Freedom is the freedom of an employee to discuss all relevant matters in the classroom, to explore all avenues of scholarship, research, and creative expression, to speak freely on all matters of university governance, and to speak, write, or act as an individual, all without institutional discipline or restraint. 5.3 On the part of an employee, Academic Responsibility implies the honest performance of academic duties and obligations, the commitment to support the responsible exercise of freedom by others, and the candor to make it clear that the individual, while he or she may be freely identified as an employee of the University, he/she is not speaking as a representative of the University in matters of public interest. 5.4 On the part of the University, Academic Responsibility implies a commitment to xxxxxx within the FGCU community a climate favorable to responsible exercise of freedom, by adherence to principles of shared governance, which require that in the development of academic policies and processes, the professional judgments of employees are of primary importance.

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • PROPRIETARY/RESTRICTIVE SPECIFICATIONS If a prospective bidder considers the specification contained herein to be proprietary or restrictive in nature, thus potentially resulting in reduced competition, they are urged to contact the Procurement Division prior to bid opening. Specifications which are unrelated to performance will be considered for deletion via addendum to this Invitation for Bids.