PMTA Process Clause Samples

PMTA Process. On the Closing Date, the Seller shall, and shall cause its applicable Representatives to, submit to the FDA a completed version of Form 4057, in a form prepared by Buyer and agreed by the Parties, evidencing the transfer to Buyer of the relevant sections of the PMTA Filing applicable to the Product SKUs (the “Completed Form 4057 Filing”) and providing any additional information or documentation required by the FDA in relation to the change of control of the Product SKUs. In furtherance of the foregoing, Seller shall promptly provide Buyer with copies of all written correspondence and documentation received by, sent by or in the possession of Seller and its Affiliates or agents, regarding each PMTA submission for any Product SKU (including any communications with the FDA or any Person acting at their direction).
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Related to PMTA Process

  • Complaints Process The School shall establish and adhere to a process for resolving public complaints which shall include an opportunity for complainants to be heard. The final administrative appeal shall be heard by the School's Governing Board, except where the complaint pertains to a possible violation of any law or term under this Contract. The complaints process shall be readily accessible from the School’s website, as described in Section 11.4.1.

  • Change Order Process 12.2.1 Contractor shall provide Notice to Owner as soon as practicable, but no later than five (5) Business Days, after the time when Contractor knows of the impact of any Force Majeure Event, Owner Caused Delay or any other basis for a Change Order that will impact the Work. Failure to provide such Notice within ten (10) Business Days after the time when Contractor knows of the impact of any Force Majeure Event shall be deemed to be a waiver of the Contractor’s right to receive a Change Order with respect thereto. Such Notice shall, to the extent practicable, specify the estimated impact on the Target Price and/or the Project Schedule, as applicable, the impact upon the various portions of the Work occasioned by reason of such Force Majeure Event, Owner Caused Delay or any other basis for a Change Order, and shall substantiate the foregoing to the satisfaction of Owner. In the event that Contractor does not know or is unable to specify with reasonable certainty the impact upon the Work at the time such Notice is to be delivered, Contractor shall instead provide Owner with a notice of a potential or anticipated impact of any Force Majeure Event, Owner Caused Delay or any other basis for a Change Order that could impact the Work, and shall thereafter provide Owner (and, if requested by Owner, the Independent Engineer) with periodic supplemental Notices during the period that the Force Majeure Event, Owner Caused Delay or any other basis for a Change Order, as applicable, continues, detailing any developments, progress or other relevant information of which Contractor is aware. To the extent Owner (in consultation with the Independent Engineer with respect to a Material Change) agrees with the Contractor’s determination of a Force Majeure Event or Owner Caused Delay or any other basis for a Change Order, as applicable, and the effects thereof, Owner shall notify Contractor of Owner’s acceptance. In the event Owner (in consultation with the Independent Engineer with respect to a Material Change) does not accept the Contractor’s findings, Owner or Contractor shall be permitted to dispute such Change Order in accordance with Article 36, and Contractor shall be paid for any Work performed in respect of such disputed Change Order as provided in Section 12.2.5. 12.2.2 As soon as practicable, and in any event within fifteen (15) Days (or such other period as is mutually agreed by Owner and Contractor) after receipt from Owner of a request for a change or Notice of Owner’s acceptance under Section 12.2.1, Contractor shall submit to Owner a proposal for implementing the change indicating the estimated change to the Target Price and/or the Project Schedule, as applicable. If Owner (having consulted with the Independent Engineer in the case of a Material Change) agrees that the Contractor’s proposal should be implemented, Owner (having consulted with the Independent Engineer in the case of a Material Change) shall issue a Change Order incorporating such proposal. Upon receiving such Change Order, Contractor shall diligently perform the change in accordance with the terms thereof. 12.2.3 Contractor’s proposal required pursuant to Section 12.2.2 shall consist of: (a) a detailed material take-off with supporting calculations in accordance with the pricing structure herein, for pricing the change, (b) revisions, if any, to the Drawings and Specifications, (c) a schedule for the work associated with the proposed change, (d) the effect, if any, to the Target Price and/or the Project Schedule, as applicable, (e) the effect, if any, of the change on the Work, including the Performance Tests and/or Demonstration Tests (or protocol therefor), (f) changes, if any, to any right, liability or obligation of a Party or any other provision hereof and (g) changes, if applicable, to any Applicable Deadline.

  • Approval Process Tenant shall notify Landlord whether it approves of the submitted working drawings within three business days after Landlord’s submission thereof. If Tenant disapproves of such working drawings, then Tenant shall notify Landlord thereof specifying in reasonable detail the reasons for such disapproval, in which case Landlord shall, within five business days after such notice, revise such working drawings in accordance with Tenant’s objections and submit the revised working drawings to Tenant for its review and approval. Tenant shall notify Landlord in writing whether it approves of the resubmitted working drawings within one business day after its receipt thereof. This process shall be repeated until the working drawings have been finally approved by Landlord and Tenant. If Tenant fails to notify Landlord that it disapproves of the initial working drawings within three business days (or, in the case of resubmitted working drawings, within one business day) after the submission thereof, then Tenant shall be deemed to have approved the working drawings in question. Any delay caused by Tenant’s unreasonable withholding of its consent or delay in giving its written approval as to such working drawings shall constitute a Tenant Delay Day (defined below). If the working drawings are not fully approved (or deemed approved) by both Landlord and Tenant by the 15th business day after the delivery of the initial draft thereof to Tenant, then each day after such time period that such working drawings are not fully approved (or deemed approved) by both Landlord and Tenant shall constitute a Tenant Delay Day.

  • CENTRAL GRIEVANCE PROCESS The following process pertains exclusively to grievances on central matters that have been referred to the central process. In accordance with the School Boards Collective Bargaining Act central matters may also be grieved locally, in which case local grievance processes will apply.

  • Grievance Process (a) Either party, with the agreement of the other party, may submit a grievance to Grievance Mediation at any time within ten (10) working days after the Employer’s decision has been rendered at the step prior to arbitration. Where the matter is so referred, the mediation process shall take place before the matter is referred to Arbitrator. (b) Grievance Mediation shall be scheduled within twenty (20) working days of the grievance being submitted to mediation, or longer period as agreed by the parties. (c) No matter may be submitted to Grievance Mediation which has not been properly carried through the grievance procedure, provided that the parties may extend the time limits fixed in the grievance procedure. (d) The parties shall agree on a mediator. (e) Proceedings before the Mediator shall be informal. Accordingly, the rules of evidence will not apply, no record of the proceedings shall be made and legal counsel shall not be used by either party, unless otherwise mutually agreed. (f) If possible, an agreed statement of facts will be provided to the Mediator, and if possible, in advance of the Grievance Mediation Conference. (g) The Mediator will have the authority to meet separately with either party. (h) If no settlement is reached within five (5) working days following Grievance Mediation, the parties are free to submit the matter to Arbitration in accordance with the provisions of the collective agreement. In the event that a grievance which has been mediated subsequently proceeds to arbitration, no person serving as the Mediator may serve as an Arbitrator, unless otherwise mutually agreed. Nothing said or done by the mediator may be referred to Arbitration. (i) The Union and Employer will share the cost of the Mediator, if any.