Modification of Bulk Drug Substance Specifications Sample Clauses

Modification of Bulk Drug Substance Specifications. If the Bulk Drug Substance Specifications are modified by InterMune hereunder or the Bulk Drug Substance Specifications must be modified by requirement of the FDA or other regulatory agency, or a process change would be required under the CMC, or other applicable governmental application, and such modification or process change [*] Bulk Drug Substance, Abbott shall [*] for either the current or future stage of development or Bulk Drug Substance that [*] Abbott and InterMune shall [*] of such change. In the event the parties are unable to agree on such [*] Abbott may (i) [*] or (ii) [*] If such modification results in the requirement to reprocess and/or retest previously manufactured and otherwise acceptable Bulk Drug Substance, any additional costs incurred by Abbott in such reprocessing and/or retesting shall be paid by InterMune upon submission by Abbott of documentation and justification of such costs.
Sample 1Sample 2
AutoNDA by SimpleDocs
Modification of Bulk Drug Substance Specifications. Neither Party shall implement any modification, material or otherwise, to the Bulk Drug Substance Specifications without the other Party’s prior written approval, provided however that Xxxxxx’x consent shall not be unreasonably withheld. Prior written approval of Seattle Genetics for the purposes of this Section 8.2 shall be the written approval of Seattle Genetics’ Senior Vice President of Development or Chief Executive Officer. Abbott shall submit to Seattle Genetics a revised price for either the current or future Stage of development during the Project or the Bulk Drug Substance that reflects such cost increase or decrease resulting from any of the following events: (i) the Bulk Drug Substance Specifications are modified by mutual written agreement, (ii) the Bulk Drug Substance Specifications must be modified by requirement of any Regulatory Authority, or (iii) a process change is required as part of the CMC or other applicable governmental application, and such modification or process change materially increases or decreases Xxxxxx’x cost to manufacture Bulk Drug Substance. Abbott and Seattle Genetics shall mutually agree on the cost allocation of such change. In the event the Parties are unable to agree on such cost allocation, Abbott may refuse to implement the change in which event, Seattle Genetics may terminate this Agreement upon prior written notice and in accordance with Section 12.2 or Abbott may terminate this Agreement upon prior written notice and in accordance with Section 12.3. If such modification results in the requirement to reprocess and/or retest previously manufactured and otherwise acceptable Bulk Drug Substance, any additional costs incurred by Abbott in such reprocessing and/or retesting shall be paid within the [***] of the mutual written agreement of the Parties for Abbott to reprocess and/or retest the Bulk Drug Substance; or (ii) [***] after receipt of the final report of the results of the retest or reprocessing. The Parties hereby acknowledge that it is their joint objective to develop and implement a manufacturing process that is as efficient and cost effective as possible, and to continue to improve its efficiency, as may be permitted by Regulatory Authorities. During the Term, the Parties shall discuss and negotiate in good faith regarding the impact of [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with ...
Sample 1
Modification of Bulk Drug Substance Specifications. Abbott shall not implement any modification, material or otherwise, to the Bulk Drug Substance Specifications without ZymoGenetics’ prior written approval. Abbott shall submit to ZymoGenetics a revised price for either the current or future Stage of development during the Project or the Bulk Drug Substance that reflects such cost increase resulting from any of the following events: (i) the Bulk Drug Substance Specifications are modified by ZymoGenetics, (ii) the Bulk Drug Substance Specifications must be modified by requirement of any Regulatory Authority, or (iii) a process change is required as part of the CMC or other applicable governmental application, and such modification or process change increases Xxxxxx’x cost to manufacture Bulk Drug Substance. Abbott and ZymoGenetics shall mutually agree on the cost allocation of such change. In the event the Parties are unable to agree on such cost allocation, Abbott may (i) refuse to implement the change (in which event, ZymoGenetics may terminate this Agreement) or (ii) terminate this Agreement. If such modification results in the requirement to reprocess and/or retest previously manufactured and otherwise acceptable Bulk Drug Substance, any additional costs incurred by Abbott in such reprocessing and/or retesting shall be paid within the longer of: (i) sixty (60) days of the mutual written agreement of the Parties for Abbott to reprocess and/or retest the Bulk Drug Substance; or (ii) thirty (30) days after receipt of the final report of the results of the retest or reprocessing.
Sample 1
Modification of Bulk Drug Substance Specifications. Abbott shall not implement any modification, material or otherwise, to the Bulk Drug Substance Specifications without Seattle Genetics’ prior written approval. Abbott shall submit to Seattle Genetics a revised price for either the current or future Stage of development during the Project or the Bulk Drug Substance that reflects such cost increase or decrease resulting from any of the following events: (i) the Bulk Drug Substance Specifications are modified by Seattle Genetics, (ii) the Bulk Drug Substance Specifications must be modified by requirement of any Regulatory Authority, or (iii) a process change is required as part of the CMC or other applicable governmental application, and such modification or process change materially increases or decreases Xxxxxx’x cost to manufacture Bulk Drug Substance. Abbott and Seattle Genetics shall mutually agree on the cost allocation of such change. In the event the Parties are unable to agree on such cost allocation, Abbott may refuse to implement the change in which event, Seattle Genetics may terminate this Agreement in accordance with Section 12.2. If such modification results in the requirement to reprocess and/or retest previously manufactured and otherwise acceptable Bulk Drug Substance, any additional costs incurred by Abbott in such reprocessing and/or retesting shall be paid within the [*] of the mutual written agreement of the Parties for Abbott to reprocess and/or retest the Bulk Drug Substance; or [*] after receipt of the final report of the results of the retest or reprocessing. The Parties hereby acknowledge that it is their joint objective to develop and implement a manufacturing process that is as efficient and cost effective as possible, and to [*] Confidential treatment has been requested with respect to the omitted portions. continue to improve its efficiency, as maybe permitted by Regulatory Authorities. During the Term, the Parties shall discuss and negotiate in good faith regarding the impact of implementation of a scale-up process and/or improved process, which may result in a cost reduction.
Sample 1

Related to Modification of Bulk Drug Substance Specifications

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Technical Specifications Each Bloom System is an integrated system comprised of a fuel cell stack assembly and associated balance of plant components that converts a fuel into electricity using electrochemical means that (i) has a Nameplate Capacity of at least 0.5 kilowatts of electricity using an electrochemical process and (ii) has an electricity-only generation efficiency greater than thirty percent (30%).

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Specification Changes (a) During the Term, GSK will accept a labeling change from Prometheus as contemplated by this Section 4.2 but otherwise the Parties acknowledge and agree that GSK does not intend to make any material changes (such as packaging design, manufacturing process or similar or related changes) to the existing Product during the Term.

  • Specifications Shipper will ensure that all of its Products tendered at the Origin Point for transportation on the Pipeline System meet the applicable specifications for the Product as set forth in the Tariff (as defined below) (the “Specifications”).

  • Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.

  • Statement of Work Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, SECTION J, ATTACHMENT 1, April 30, 2004, attached hereto and made a part of this contract.

  • Hardware and Software Requirements In order to access and retain Disclosures electronically, you must satisfy the following computer hardware and software requirements: access to the Internet; an email account and related software capable of receiving email through the Internet; a web browser which is SSL-compliant and supports secure sessions, and hardware capable of running this software.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company, that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such Permits as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Time is Money Join Law Insider Premium to draft better contracts faster.