Example ContractsClausesCommunications With Regulatory Authorities
Communications With Regulatory Authorities
Communications With Regulatory Authorities contract clause examples

After [[Organization A:Organization]] proceeds with the In-Licensing, [[Organization A:Organization]] shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities, for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities). shall support [[Organization A:Organization]], as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the applicable Development Plan. Notwithstanding the foregoing, shall retain the right to prepare, obtain, and maintain all regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities) solely for to perform the Development activities undertaken pursuant to Sections 3.1.2, 3.1.4 and 3.1.7.

Licensee shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA and other regulatory authorities in the Field in the Territory with respect to Licensed Product.

Commencing upon the assignment of an IND by to [[Organization A:Organization]] pursuant to [Section 3.7.1(ii)], [[Organization A:Organization]] shall have the sole right and responsibility to maintain in its name such IND, and to conduct communications with the applicable Regulatory Authorities with respect to such IND. Without limiting the foregoing, [[Organization A:Organization]] shall have the sole right and responsibility to prepare, obtain and maintain in its name all other INDs necessary to perform its obligations under the Development Plan, and to conduct communications with the applicable Regulatory Authorities with respect to such INDs. Notwithstanding the foregoing, shall have the right and responsibility to maintain in its name an IND and to conduct communications with the applicable Regulatory Authorities with respect to such IND solely for to perform the Development activities undertaken pursuant to Sections. 3.1.2, 3.1.4 and 3.1.7.

Responsibility. Subject and pursuant to the terms of this Agreement, Allergan shall have the sole right and responsibility, at its sole expense, to Develop the Licensed Products and, without limiting the generality of the foregoing, to # file all Drug Approval Applications or BLAs and make all other filings with the Regulatory Authorities, and to otherwise seek all Regulatory Approvals for Licensed Products, in the Territory, as well as to conduct all correspondence and communications with Regulatory Authorities regarding such matters and # report all adverse events to Regulatory Authorities if and to the extent required by Applicable Law.

Communications. WuXi ATU shall keep Graphite reasonably informed about the status of the Services. WuXi ATU agrees to participate in activities including meetings and/or conference calls that may be held on a regular basis between the Project Managers and other WuXi ATU and Graphite personnel to evaluate, review or discuss the progress made on the performance of the Services.

Communications. Except to the extent required by Applicable Law as required under Section 11.2, WuXi ATU shall not communicate with any regulatory or government authorities, including but not limited to the FDA, on Graphite’s behalf without Graphite’s prior written authorization.

Communications. All Participant or Beneficiary notices, designations, elections, consents or waivers must be made in a form the Administrator (or, as applicable, the Trustee or Insurer) specifies or otherwise approves. Any person entitled to notice under the Plan may waive the notice or shorten the notice period unless such actions are contrary to applicable law.

Adverse Experiences. Prior to [[Organization A:Organization]] proceeding with the In-Licensing, shall have responsibility (either itself or with the support of Third Party subcontractors) for communications with all Regulatory Authorities regarding the safety of the Lead Compound, including submitting or causing to be submitted to all Regulatory Authorities reports of adverse experiences and other required safety information and reports in accordance with all requirements of Applicable Laws. shall provide a copy of any and all such reports and other required safety information to [[Organization A:Organization]] within […​…] after regulatory submission.

Authorization of Governmental Authorities. No action by (including any authorization, consent or approval), in respect of, or filing with, any governmental authority or regulatory body, except such filing as may be necessary and/or required for disclosure by the Securities and Exchange Commission or pursuant to state securities or “blue sky” laws, is required for, or in connection with, the valid and lawful authorization, execution, delivery and performance by it of this Settlement Agreement.

The Company agrees that the Administrative Agent may, but shall not be obligated to, make any Communications available to the Lenders and the L/C Issuer by posting the Communications on IntraLinks™, DebtDomain, SyndTrak, ClearPar or any other electronic system chosen by the Administrative Agent to be its electronic transmission system (the “Platform”).

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