Product Process Timelines Clause Samples

Product Process Timelines. The parties do not contemplate beginning regulatory processing for all the Products immediately. The parties do contemplate that the Diagnostic Products are likely to be the first Products for which the parties will seek regulatory approval and thereafter distribute in the Territory. The parties will prepare a master plan which will specify the parties' then current intent regarding the approximate time for commencement of due diligence program activities and filing of an ARA for each Product. The parties will use their respective best efforts to complete the master plan within 90 days after signing this Agreement unless such time period is extended by mutual agreement of the parties. The master plan will be updated by the parties from time to time to adjust for changes in circumstances. Upon completion of the master plan, the parties will prepare Product specific timelines for each Product. Each Product specific timeline will include the anticipated milestones that must be accomplished to seek and obtain regulatory approval for the Product and the estimated time of completion of each milestone. The Product specific timelines will also be updated from time to time to adjust for changes in circumstances. The parties each will work diligently to perform their respective obligations in accordance with the timelines. The parties will periodically meet in person or telephonically in order to discuss and review the master plan and the Product specific timelines.
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Related to Product Process Timelines

  • Timeline Contractor must perform the Services and deliver the Deliverables according to the following timeline:

  • Timelines a) Timelines may be extended by mutual consent of the parties. b) Working days shall be defined as Monday through Friday excluding statutory holidays. c) Disputes that arise during non-instructional days (Summer Months, Christmas Break, and March Break) will have timelines automatically extended. d) Local grievance timelines will be held in abeyance while the dispute is in the CDRP, in the event that the matter is referred back locally.

  • Product Recalls (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such action. The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Milestone Schedule Please state the status and progress of each Milestone and identify any completed Milestone(s) for the previous calendar quarter.