Forecast Modification; Monitoring Sample Clauses

Forecast Modification; Monitoring. (a) Passage Bio will be afforded the flexibility to make modification requests to the Initial and Rolling Forecasts, as set forth below (each a “Forecast Modification”). Following the delivery of the Initial or Rolling Forecasts, if a Forecast Modification is made for [*] that requests the Manufacture of one or more Batch(es) of Passage Bio Product(s) other than that which was originally forecasted, Catalent shall use commercially reasonable efforts, but shall not be obligated, to Manufacture the Batch(es) of different Passage Bio Product(s). If a Forecast Modification is made for [*] that requests additional Batches over what was originally forecast (the “Additional Batches”), Catalent shall use commercially reasonable efforts, but shall not be obligated, to Manufacture the Additional Batches. (b) Subject to its requirement to meet the Minimum Annual Threshold requirement, if the Forecast Modification results in a reduction of the number of Batches forecasted for [*] and that reduction is attributable to [*] [*], agreed to by Catalent, that results in [*] in the quantity of Bulk Drug Substance being Manufactured in single Batch (e.g., [*]), Passage Bio shall [*]. (c) If the Forecast Modification reduces the number of Batches of Bulk Drug Substance of a Passage Bio Product that were to be Delivered by Catalent during the Binding Orders Period under Section 2.5.2 and Passage Bio is unable to substitute one or more Batches as provided for in subsection (a) above, Passage Bio shall be obligated to pay Catalent according to the table below for all such Batches ordered in that Binding Orders Period that were cancelled. Cancellation of any orders of Drug Product of a Passage Bio Product shall be subject to the same cancellation fees below; provided that no such cancellation fees shall apply for any such orders of Drug Product cancelled prior to the date that is [*] ([*]) days prior to the Manufacturing Start Date for the cancelled Batch of Drug Product. ​ ​ During the period in which Catalent is Manufacturing Bulk Drug Substance and/or Drug Product, the JSC will have periodic teleconferences or meetings to monitor and review the status of Manufacturing operations and to address any issues that may arise. ​
Sample 1
AutoNDA by SimpleDocs
Forecast Modification; Monitoring. In addition to the [***], BridgeBio will be afforded the flexibility to make modification requests to the Initial and Rolling Forecasts, as set forth below (each a “Forecast Modification”). If a Forecast Modification is made prior to or [***] that requests additional Batches of BridgeBio Product over what was originally forecast (the “Additional Batches”), Catalent shall use commercially reasonable efforts, but shall not be obligated, to Manufacture the Additional Batches. If the Forecast Modification results in a reduction of Batches to be Delivered by Catalent during the [***], BridgeBio shall be obligated to pay Catalent for all Batches ordered for [***]. During the period in which Catalent is Manufacturing BridgeBio Product, the JSC will have periodic teleconferences or meetings to monitor and review the status of Manufacturing operations and to address any issues that may arise.
Sample 1

Related to Forecast Modification; Monitoring

  • Integration; Modification This Construction Services Agreement represents the entire understanding of District and Contractor as to those matters contained herein, and supersedes and cancels any prior oral or written understanding, promises or representations with respect to those matters covered herein, and it shall not be amended, altered or changed except by a written agreement signed by the parties hereto.

  • CONTRACT MODIFICATION The following is adopted as the new CTC for the Contract effective December 29, 2022:

  • Cost Modifications The parties may agree to a reduction in the cost of the Contract at any time during which the Contract is in effect. Without intending to impose a limitation on the nature of the reduction, the reduction may be to hourly, staffing or unit costs, the total cost of the Contract or the reduction may take such other form as the State deems to be necessary or appropriate.

  • Contract Modifications It is understood that changes are inherent in operations of the type covered by this contract. The number of changes, the scope of those changes, and the impact they have on the progress of the original operations cannot be defined at this time. The PURCHASER is notified that changes are anticipated and that there will be no compensation made to the PURCHASER directly related to the number of changes made. Each change will be evaluated for extension of contract time and increase or decrease in compensation based on its own merit. STATE reserves the right to make, at any time during the contract, such modifications as are necessary or desirable; provided such modifications shall not change the character of the operations to be done nor increase the cost, unless such operations or cost increase is approved in writing by PURCHASER. Any modifications so made shall not invalidate this contract nor release PURCHASER of obligations under the performance bond. PURCHASER agrees to do the modified operations as if it had been a part of the original contract. If any change under this section causes an increase or decrease in the PURCHASER's cost of, or the time required for the performance of any part of the operations, the PURCHASER must submit a written statement setting forth the nature and specific extent of the claim. Such claim shall include all time and cost impacts against the contract and be submitted as soon as possible, but no later than 30 days after receipt of any written notice of modification of the contract. If the PURCHASER discovers site conditions which differ materially from what was represented in the contract or from conditions that would normally be expected to exist and be inherent to the activities defined in the contract, the PURCHASER shall notify the STATE's Authorized Representative immediately and before the area has been disturbed. The STATE's Authorized Representative will investigate the area and make a determination as to whether or not the conditions differ materially from either the conditions stated in the contract or those which could reasonably be expected in execution of this particular contract. If it is determined that a differing site condition exists, any compensation or credit will be determined based on an analysis by STATE's Authorized Representative. If the PURCHASER does not concur with the decision of the STATE's Authorized Representative and/or believes that it is entitled to additional compensation, the PURCHASER may proceed to file a claim. All claims shall be submitted in writing and shall include a detailed, factual statement of the basis of the claim, pertinent dates, contract provisions which support or allow the claim, reference to or copies of any documents which support the claim, the exact dollar value of the claim, and specific time extension requested for the claim. If the claim involves operations to be completed by subcontractors, the PURCHASER will analyze and evaluate the merits of the subcontractor's claim. PURCHASER shall forward the subcontractor's claim and PURCHASER's evaluation of such claim to STATE's Authorized Representative. The STATE's Authorized Representative will not consider direct claims from subcontractors, suppliers, manufacturers, or others not a party to this contract. The decision of the STATE shall be final and binding unless the PURCHASER requests mediation.

  • Implementation Report Within 150 days after the Effective Date, Ensign Group shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, address, phone number, and position description of the Compliance Officer required by Section III.A, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.A; 3. the names and positions of the members of the Board of Directors who are responsible for satisfying the Board of Directors compliance obligations described in Section III.A.3; 4. a copy of Ensign Group’s Code of Conduct required by Section III.B.1; 5. the number of individuals required to complete the Code of Conduct certification required by Section III.B.1, the percentage of individuals who have completed such certification, and an explanation of any exceptions (the documentation supporting this information shall be available to OIG upon request); 6. a summary of all Policies and Procedures required by Section III.B (copies of the Policies and Procedures shall be made available to OIG upon request); 7. the following information regarding each type of training required by Section III.C: a. a description of such training, including a summary of the topics covered, the length of sessions, and a schedule of training sessions; b. the number of individuals required to be trained, percentage of individuals actually trained, and an explanation of any exceptions. A copy of all training materials and the documentation supporting this information shall be made available to OIG upon request. 8. a description of the Disclosure Program required by Section III.E; 9. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; (d) a summary and description of any and all current and prior engagements and agreements between Ensign Group and the IRO; and (e) a certification from the IRO regarding its professional independence and objectivity with respect to Ensign Group; 10. a description of the process by which Ensign Group fulfills the requirements of Section III.F regarding Ineligible Persons; 11. a list of all of Ensign Group’s locations (including locations and mailing addresses); the corresponding name under which each location is doing business; the corresponding phone numbers and fax numbers; each location’s Medicare and state Medicaid program provider number and/or supplier number(s); and the name and address of each Medicare and state Medicaid program contractor to which Ensign Group currently submits claims; 12. a description of Ensign Group’s corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and

  • Agreement Modifications No waiver, alteration or modification of any of the provisions of this Construction Services Agreement shall be binding upon either District or Contractor unless the same shall be in writing and signed by both District and Contractor.

  • Agreement Modification 15.1 Any agreement to change the terms of this Agreement in any way shall be valid only if the change is made in writing and approved by mutual agreement of authorized representatives of the parties hereto.

  • Compliance; Modification The Asset Representations Reviewer will cooperate with and provide information to the Issuer regarding the Asset Representations Reviewer’s compliance with this Section 4.10. The Asset Representations Reviewer and the Issuer agree to modify this Section 4.10 as necessary from time to time for either party to comply with applicable law.

  • Amendment; Modification No supplement, modification, or amendment of this Agreement shall be binding unless executed in writing and signed by both Parties.

  • Forecasting Manager and Sprint PCS will work cooperatively to generate mutually acceptable forecasts of important business metrics including traffic volumes, handset sales, subscribers and Collected Revenues for the Sprint PCS Products and Services. The forecasts are for planning purposes only and do not constitute Manager's obligation to meet the quantities forecast.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!