the Final Date. The parties agree to negotiate in good faith a new commercial manufacturing agreement by [], and if the parties are unable to finalize such new agreement prior [], the parties shall mutually agree upon an extension of the Remaining Period, which will include payment of applicable Suite Fees and new Batch commitments to ensure continuity of supply of Product until such new agreement is executed.”
“Regulatory Standards” means # applicable standards of the International Standards Organization (“ISO”) and applicable ISO-certified processes; # other quality standards and quality assurance plans referenced in the Specifications; # laws and requirements of Regulatory Authorities referenced in the Specifications; and # any other applicable laws and requirements of Regulatory Authorities relating to the manufacture and supply of Supply Deliverables (or components thereof) by Supplier for commercial sale.
The Parties shall negotiate in good faith the terms of, and shall seek to enter into, separate clinical and commercial manufacturing agreements, and/or amendments to existing manufacturing agreements, under which WuXi would manufacture and supply Licensed Products for Arcus in the Territory (the Manufacturing Agreements). The Parties intend to enter into such Manufacturing Agreements # no later than prior to the Initiation of Phase I Clinical Studies for the first Licensed Product (for the clinical manufacturing agreement) and # no later than prior to the anticipated date of Regulatory Approval of the first Licensed Product (for the commercial manufacturing agreement).
progress report, (d) progress with respect to procuring upstream Gas supply; and (e) any other information that [[Organization A:Organization]] has reasonably requested to enable [[Organization A:Organization]] to evaluate the status and progress of [[Organization B:Organization]]’s efforts toward establishing the Commercial Start Date.
On and after the Effective Date of this Second Amendment, this Second Amendment shall form a part of the Supply Agreement and each reference in the Supply Agreement to this Agreement, hereunder, hereof, or words of like import referring to the Supply Agreement shall mean and be a reference to the Supply Agreement, as amended by the First and Second Amendments.
Technical Supply Failure (SGI) means that, on a Product-by-Product basis, and on a month-by-month basis for each month of a consecutive month period, the failure by SGI or its Third Party manufacturer(s) to # deliver, in a manner consistent with the applicable operating procedures, at least of the number of unit doses of SGI Antibody required by a binding rolling forecast set by a process to be agreed by the Parties in the SGI Antibody Commercial Supply Agreement, or # maintain sufficient inventory so together with clause (a) at least of such forecast would be supplied.
“Fuel Supply Agreement” means any of # that certain Petroleum Product Sale Agreement dated as of May 1, 2013 by and between CST Marketing and Supply Company and Valero Marketing and Supply 885707.04-LACSR02A - MSW
The terms under which SGI will supply clinical supplies of SGI Antibodies to Unum for use as part of the Development Candidates in the Territory under the Late Clinical Development Plan will be set forth in a supply agreement to be entered into between the Parties no later than days prior to the date of initiation of a Clinical Trial of the first Development Candidate in the Territory (the SGI Antibodies Clinical Supply Agreement). Such SGI Antibodies Clinical Supply Agreement will contain terms and conditions that are consistent with this Agreement.
Supply Agreement - see the recitals.
The Parties hereby agree to terminate the License and Supply Agreement in its entirety as of the Termination Agreement Effective Date. As of the Termination Agreement Effective Date, all rights and obligations of the Parties under the License and Supply Agreement, and all sublicenses under the ARS Intellectual Property Rights granted by Recordati (if any), shall be, and hereby are, automatically terminated. For clarity, on execution of this Agreement, unless otherwise specified in this Agreement, all provisions of the License and Supply Agreement, including any which are expressly stated in the License and Supply Agreement as surviving its termination, or which might otherwise have done so by implication, are terminated.
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