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By TaiMed Sample Clauses

By TaiMed. TaiMed shall be responsible, at its sole cost and expense (except as provided below in this Section 4.1), for all Regulatory Activities in the United States related to, and shall use Commercially Reasonable Efforts to obtain and maintain, Regulatory Approval of the Product in the United States until the effective date of transfer of Marketing Approval of such Product as per Section 4.2. TaiMed shall consult with and provide Theratechnologies with an opportunity to review and comment on any proposed Regulatory Filing with respect to the Product reasonably in advance of its submission and to participate in any communication with the FDA according to Section 4.3.
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By TaiMed. Following the Execution Date and until the effective date of transfer of Marketing Approval of a Product in the United States as per Section 4.2, TaiMed will maintain contacts and communication with the FDA with respect to such Product; provided that TaiMed shall consult with and provide Theratechnologies with an opportunity to participate in any telephone, video conference or face-to-face communication with the FDA to the extent substantive or material. TaiMed shall keep Theratechnologies fully informed of its substantive and/or material contacts and communications (including substantive and/or material written and material oral communications) with the FDA related to such Product, and shall, upon Theratechnologies’ reasonable request, promptly provide copies to Theratechnologies of all such reports and all submissions, filings and other correspondence to or from the FDA and other Governmental Bodies related to such Product in the United States (or, if applicable, minutes of any substantive or material oral communication).

Related to By TaiMed

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  • Notice of Material Breach and Intent to Exclude The parties agree that a material breach of this CIA by Indivior constitutes an independent basis for Indivior’s exclusion from participation in the Federal health care programs. The length of the exclusion shall be in OIG’s discretion, but not more than five years per material breach. Upon a determination by OIG that Indivior has materially breached this CIA and that exclusion is the appropriate remedy, OIG shall notify Indivior of: (a) Indivior’s material breach; and (b) OIG’s intent to exercise its contractual right to impose exclusion (this notification is hereinafter referred to as the “Notice of Material Breach and Intent to Exclude”).

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  • Litigation History There shall be no consistent history of court/arbitral award decisions against the Tenderer, in the last (Specify years). All parties to the contract shall furnish the information in the appropriate form about any litigation or arbitration resulting from contracts completed or ongoing under its execution over the year’s specified. A consistent history of awards against the Tenderer or any member of a JV may result in rejection of the tender.

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  • Polygraph Examination No employee shall be compelled to submit to a polygraph examination. No disciplinary action whatsoever shall be taken against an employee refusing to submit to a polygraph examination; nor shall any comment be anywhere recorded indicating that an employee offered to take, took or refused to take a polygraph examination unless otherwise agreed to in writing by the parties; nor shall any testimony or evidence of any kind regarding an employee's offer to take, refusal to take, or the results of a polygraph examination be admissible in any proceeding pursuant to this Agreement, unless otherwise agreed to in writing by the parties.

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