Acceptance of Batch Documentation Sample Clauses

Acceptance of Batch Documentation. In the case of Batches designated as cGMP Batches per the Scope of Work or Purchase Orders issued prior to Lead DMD Product Launch, Catalent will Manufacture them in accordance with the Product Requirements and Catalent will store and ship them in accordance with the applicable provisions of the Quality Agreement and the Storage Guidelines. As soon as Catalent has determined that a Batch complies with the Product Requirements, Catalent will send to Sarepta by a mutually agreed upon method the Batch Documentation. Sarepta will review the Batch Documentation to confirm that it meets the Product Requirements and to determine the appropriate use of that Batch. Within [**] of receipt of Batch Documentation, unless otherwise agreed to by the Parties, Sarepta shall either provide its acceptance of the Batch Documentation in accordance with the procedures set forth in the Quality Agreement (“Sarepta Approval”) or, in the event Sarepta has identified specific issues or deviations with the Batch Documentation, give written notice thereof to Catalent, and such specific issues or deviations shall be resolved by the Parties in accordance with the Quality Agreement. [**] Upon Sarepta Approval, the Batch Documentation will be deemed approved and the relevant Batch of Product may be made available for shipment as provided in Section 4.6(b), provided that the granting of Sarepta Approval with respect to a Batch shall not preclude a subsequent claim with respect to any Latent Defect in such Batch in accordance with Section 8.3.
Sample 1
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Acceptance of Batch Documentation. Catalent will Manufacture all Batches of Passage Bio Products in accordance with the Product Requirements and Catalent will store and ship them in accordance with the applicable provisions of this Agreement, the Quality Agreement and the Storage Guidelines. As soon as Catalent has determined that a Batch complies with the Product Requirements, Catalent will send the Batch Documentation to Passage Bio by a ​ mutually agreed upon method. For each Batch, Passage Bio will review the Batch Documentation to confirm that it meets the Product Requirements and to determine the appropriate use of that Batch. Within [*] Business Days of receipt of Batch Documentation, unless otherwise agreed to by the Parties, Passage Bio shall either provide its acceptance of the Batch Documentation in accordance with the procedures set forth in the Quality Agreement (“Passage Bio Approval”) or, in the event Passage Bio has identified specific issues or deviations with the Batch Documentation, give written notice thereof to Catalent, and such specific issues or deviations shall be resolved by the Parties in accordance with the Quality Agreement. If Passage Bio fails to respond within [*] Business Days with its acceptance of the Batch or provide written notice of issues or deviations with the Batch Documentation, Passage Bio Approval of the Batch will be deemed to have occurred. Upon Passage Bio Approval, the Batch Documentation will be deemed approved and the relevant Batch of Passage Bio Product will be made available for shipment as provided in Section 4.6(b), provided that the granting of Passage Bio Approval with respect to a Batch shall not preclude a subsequent claim with respect to any Latent Defect in such Batch in accordance with Section 8.3.
Sample 1

Related to Acceptance of Batch Documentation

  • Acceptance of Agreement Notwithstanding anything herein to the contrary, in order for this Award to become effective, the Participant must acknowledge acceptance of this Agreement no later than the sixtieth (60th) day following the Grant Date (the “Final Acceptance Date”). If the Participant’s acceptance of this Agreement does not occur by the Final Acceptance Date, then the entire Award will be forfeited and cancelled without any consideration therefor, except as otherwise determined in the Committee’s sole and absolute discretion.

  • Prompt Acceptance of Agreement The Restricted Share Unit grant evidenced by this Agreement shall, at the discretion of the Administrator, be forfeited if this Agreement is not manually executed and returned to the Company, or electronically executed by Awardee by indicating Awardee’s acceptance of this Agreement in accordance with the acceptance procedures set forth on the Company’s third-party equity plan administrator’s web site, within 90 days of the Grant Date.

  • Acceptance of Terms of Agreement THE RECEIPT AND ACCEPTANCE OF THE CERTIFICATE BY THE CERTIFICATEHOLDER, WITHOUT ANY SIGNATURE OR FURTHER MANIFESTATION OF ASSENT, SHALL CONSTITUTE THE UNCONDITIONAL ACCEPTANCE BY THE CERTIFICATEHOLDER OF ALL THE TERMS AND PROVISIONS OF THIS AGREEMENT, AND SHALL CONSTITUTE THE AGREEMENT OF THE OWNER TRUSTEE, ON BEHALF OF THE OWNER TRUST, THAT THE TERMS AND PROVISIONS OF THIS AGREEMENT SHALL BE BINDING, OPERATIVE AND EFFECTIVE AS BETWEEN THE OWNER TRUSTEE AND THE CERTIFICATEHOLDER.

  • Acceptance of Appointment; Standard of Performance Adviser accepts the appointment as discretionary portfolio manager and agrees to use its best professional judgment to make timely investment decisions for the Fund in accordance with the provisions of this Agreement.

  • Acceptance of AAU You will have accepted an AAU for an Offering if: (a) we receive your acceptance, prior to the time specified in the Invitation Wire for such Offering, by wire, telex, telecopy or electronic data transmission, or other written communication (any such communication being deemed “In Writing”) or orally (if promptly confirmed In Writing), in the manner specified in the Invitation Wire, of our invitation to participate in the Offering, or (b) notwithstanding that we did not send you an Invitation Wire or you have not otherwise responded In Writing to any such Wire, you: (i) agree (orally or by a Wire) to be named as an Underwriter in the relevant Underwriting Agreement executed by us as Manager, or (ii) receive and retain an economic benefit for participating in the Offering as an Underwriter. Your acceptance of the invitation to participate will cause such AAU to constitute a valid and binding contract between us. Your acceptance of the AAU as provided above or an Invitation Wire will also constitute acceptance by you of the terms of subsequent Wires to you relating to the Offering unless we receive In Writing, within the time and in the manner specified in such subsequent Wire, a notice from you to the effect that you do not accept the terms of such subsequent Wire, in which case you will be deemed to have elected not to participate in the Offering.

  • Acceptance of Terms of Trust Agreement, Guarantee and Indenture. THE RECEIPT AND ACCEPTANCE OF A TRUST SECURITY OR ANY INTEREST THEREIN BY OR ON BEHALF OF A SECURITYHOLDER OR ANY BENEFICIAL OWNER, WITHOUT ANY SIGNATURE OR FURTHER MANIFESTATION OF ASSENT, SHALL CONSTITUTE THE UNCONDITIONAL ACCEPTANCE BY THE SECURITYHOLDER AND ALL OTHERS HAVING A BENEFICIAL INTEREST IN SUCH TRUST SECURITY OF ALL THE TERMS AND PROVISIONS OF THIS TRUST AGREEMENT AND AGREEMENT TO THE SUBORDINATION PROVISIONS AND OTHER TERMS OF THE GUARANTEE AND THE INDENTURE, AND SHALL CONSTITUTE THE AGREEMENT OF THE TRUST, SUCH SECURITYHOLDER AND SUCH OTHERS THAT THE TERMS AND PROVISIONS OF THIS TRUST AGREEMENT SHALL BE BINDING, OPERATIVE AND EFFECTIVE AS BETWEEN THE TRUST AND SUCH SECURITYHOLDER AND SUCH OTHERS.

  • 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.

  • Acceptance of Terms and Conditions By electronically accepting this Award Agreement within 30 days after the date of the electronic mail notification by the Company to Grantee of the grant of this Award (“Email Notification Date”), Grantee agrees to be bound by the foregoing terms and conditions, the Plan, and any and all rules and regulations established by Motorola Mobility in connection with the assumption and substitution of the Award. If Grantee does not electronically accept this Award within 30 days of the Email Notification Date, Grantee will not be entitled to the Units.

  • Acceptance of Orders POSITION LIMITS.

  • Acceptance of Engagement The successor Servicer will accept its engagement by assuming the Servicer’s obligations under this Agreement or entering into an amendment to this Agreement or a new servicing agreement on substantially the same terms as this Agreement, in a form acceptable to the Owner Trustee and the Indenture Trustee. The successor Servicer will deliver a copy of the assumption, amendment or new servicing agreement to the other parties and the Indenture Trustee. The successor Servicer will accept its engagement as Administrator according to Section 3.5 of the Administration Agreement. Promptly following a successor Servicer’s acceptance of its engagement, the Indenture Trustee will notify the Issuer, the Owner Trustee and the Secured Parties of the engagement. On receipt of a notice of engagement, the Issuer will promptly notify the Rating Agencies and the Asset Representations Reviewer and the Owner Trustee will promptly notify the holder of the Residual Interest.

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