Biovest Sample Clauses

Biovest. Biovest shall be solely responsible for employing personnel and obtaining the Equipment and Materials necessary to perform the Services in accordance with the terms of this Agreement and the applicable Project Addendum. Biovest will provide for and pay the compensation and other benefits of employees including, but not limited to salary, health, accident, workers’ compensation benefits and will pay all taxes and contributions which an employer is required to pay relating to the employment of employees. Biovest will maintain the Facility and all Equipment (including any AYTU Equipment if any), required for the Manufacture of Product in a state of repair and operating efficiency consistent with the requirements of cGMP and Applicable Law.
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Biovest. Biovest shall be responsible for obtaining and maintaining, at AYTU’s expense, during the Term of this Agreement (including any Project Addendum executed hereunder) all Government Approvals. In particular, but not by way of limitation of the foregoing, AYTU shall be responsible for payment of any FDA Drug Establishment Registration Fees associated with Biovest’s Development and/or Manufacture of Product in accordance with this Agreement and any Project Addendum executed hereunder. if at any time during the Term of this Agreement Biovest is involved in the manufacture of a product (or products) for a customer other than AYTU which would require Biovest to obtain an FDA Drug Establishment Registration, AYTU shall be responsible for only its pro rata portion of such annual FDA Registration Fee. At AYTU’s request, Biovest will provide AYTU with copies of all such Government Approvals and submissions to Authorities, and AYTU will have the right to use any information contained in such Government Approvals or submissions in connection with Government Approval and/or commercial development of Product. Biovest shall be responsible for monitoring and properly notifying AYTU of any Government Approvals required in connection with the Services. Biovest shall notify AYTU immediately (and in no case more than 3 business days) if any warning, citation, indictment, claim, lawsuit or proceeding issued or instituted by any Regulatory Authority against Biovest or any of its Affiliates or of any revocation of any license or permit issued to Biovest or any of its Affiliates, to the extent that such occurrences related directly to Biovest’s performance under this Agreement and/or any Project Addendum executed hereunder. Biovest shall promptly provide AYTU with copies of the relevant portions of any documents or a written summary of any oral observation received by Biovest in connection with the matters set forth in this Section 6.1.1. AYTU shall, upon written request of Biovest and at Biovest’s expense, participate in or provide any assistance in connection with the Government Approvals.

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