Example ContractsClausesRegulatory Assistance
Regulatory Assistance
Regulatory Assistance contract clause examples

Regulatory Assistance. Upon [[Cytokinetics:Organization]]’ request, Ji Xing shall provide [[Cytokinetics:Organization]] with reasonable assistance and cooperation regarding any inquiries and correspondence with Regulatory Authorities relating to the Product.

Assistance. Consultant agrees to execute all papers, including patent applications, invention assignments and copyright assignments, and otherwise agrees to assist Trevi, at Trevi’s expense, to perfect in Trevi the right, title and other interest in the Work Product. If Trevi is unable for any reason, after reasonable effort, to secure Consultant’s signature on any document needed in connection with the actions specified above, Consultant hereby irrevocably designates and appoints Trevi as Consultant’s agent and attorney-in-fact, which appointment is coupled with an interest, to act for and on Consultant’s behalf, to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of this Section with the same legal force and effect as if executed by Consultant.

Regulatory Assistance. Provider will permit regulators with jurisdiction over BFA or any BFA Recipient to examine Provider’s activities relating to its performance under this Agreement and the Services. Subject to Section 17.6, Provider will cooperate and provide all information reasonably requested by the regulator in connection with any such examination and provide reasonable assistance and access to all equipment, records, and systems requested by the regulator relating to the Services.

Regulatory Assistance. Upon [[Cytokinetics:Organization]]’ request, Ji Xing shall provide [[Cytokinetics:Organization]] with reasonable assistance and cooperation regarding any inquiries and correspondence with Regulatory Authorities relating to the Product.

Assistance. Consultant agrees to assist Company, or its designee, at the Company’s expense, in every proper way to secure Company’s rights in the Inventions and Materials and any copyrights, patents, mask work rights or other intellectual property rights relating thereto in any and all countries, including the disclosure to Company of all pertinent information and data with respect thereto, the execution of all applications, specifications, oaths, assignments and all other instruments which Company shall deem necessary in order to apply for and obtain such rights and in order to assign and convey to Company, its successors, assigns and nominees the sole and exclusive right, title and interest in and to such Inventions and Materials, and any copyrights, patents, mask work rights or other intellectual property rights relating thereto. Consultant further agrees that Consultant’s obligation to execute or cause to be executed, when it is in Consultant’s power to do so, any such instrument or papers shall continue after the termination of this Agreement. Consultant agrees that if Company is unable because of Consultant’s unavailability, dissolution, incapacity, or for any other reason, to secure Consultant’s signature to apply for or to pursue any application for any United States or foreign patents or mask work or copyright registrations covering the Inventions and Materials assigned to Company and its duly authorized officers and agents as Consultant’s agent and attorney in fact, to act for and in Consultant’s behalf and stead to execute and file any such applications and to do all other lawfully permitted acts to

Atara shall provide Fujifilm with a copy of the relevant Facility related sections of Module 3 of Atara’s Chemistry, Manufacturing and Controls section of any submission to a Regulatory Authority supporting Atara’s regulatory filing activities for the applicable Product or Process which relates to or contains information about the Process; the Facility (including Fujifilm equipment); and/or the Fujifilm Services (“CMC Section”) in accordance with the Quality Agreement. ​ Atara shall reasonably consider Fujifilm’s comments to a CMC Section in relation to any information regarding, or impacting, Fujifilm including any information regarding the Process, equipment, controls and analytics or any information provided to Atara by Fujifilm related to or in accordance with the Quality Agreement. In the event the CMC Section materially impacts the Fujifilm Services in a SoW, the parties shall discuss in good faith and mutually agree to a Change to such SoW and any Delay arising as a result of such impact shall be deemed to be an Atara Delay.

Regulatory Assistance. As soon as practicable after the date on which the IND submitted to the FDA by Fate for a particular Licensed Product pursuant to [Section 4.4.3] becomes effective in the U.S. under 21 C.F.R. 312.40, Fate shall reasonably cooperate with Janssen to provide regulatory assistance with respect to such Licensed Product, as reasonably requested by Janssen, to facilitate Regulatory Filings and communications with Regulatory Authorities in the Territory for such Licensed Product; provided, however, that the foregoing shall not be construed as requiring Fate to transfer or disclose to Janssen any Fate Confidential Methods except as expressly set forth under and subject to the terms and conditions of Section Error! Reference source not found.. Fate’s reasonable cooperation as set forth above may be conducted by providing Janssen with reasonable access by teleconference or, during a period of ​ months after the submission of such IND, in-person at Fate’s facilities to those Fate personnel knowledgeable with respect to such regulatory matters, if any.

Assistance. Consultant agrees to execute upon Company's request a signed transfer of Company Innovations to Company for each of the Company Innovations, including, but not limited to, computer programs, notes, sketches, drawings and reports. Consultant agrees to assist Company in any reasonable manner to obtain, perfect and enforce, for Company's benefit, Company's rights, title and interest in any and all countries, in and to all patents, copyrights, moral right s, mask works, trade secrets, and other property rights in each of the Company Innovations. Consultant agrees to execute, when requested, for each of the Company Innovations (including derivative works, improvements, renewal s, extensions, continuations, divisionals, continuations in part, or continuing patent application s thereof), # patent , copyright, mask work or similar applications related to such Company Innovation, # documentation (including without limitation assignment s) to permit Company to obtain, perfect and enforce Company's right, title and interest in and to such Company Innovation, and # any other lawful documents deemed necessary by Company to carry out the purpose of this Agreement. If called upon to render assistance under this paragraph, Consultant will be entitled to a fair and reasonable fee in addition to reimbursement of authorized expenses incurred at the prior written request of Company. In the event that Company is unable for any reason to secure Consultant's signature to any document Consultant is required to execute under this Paragraph 4.1(c) ("Assistance"), Consultant hereby irrevocably designates and appoint s Company and Company's duly authorized officers and agents as Consultant's agents and attorneys-in-fact to act for and in Consultant's behalf and instead of Consultant, to execute such document with the same legal force and effect as if executed by Consultant.

Assistance. Praj will assist, and require its relevant employees and contractors to assist, [[Gevo:Organization]] in perfecting and enforcing [[Gevo:Organization]]’s rights in Praj Improvements. [[Gevo:Organization]] will reimburse Praj for reasonable costs incurred in assisting [[Gevo:Organization]] with Sections 7.1 and 7.2. To that end, Praj will, and will require its employees and contractors to, execute, verify, and deliver such documents and perform such other acts (including appearances as a witness) as [[Gevo:Organization]] may reasonably request in connection with applying for, obtaining, perfecting, evidencing, sustaining and enforcing the intellectual property rights in Praj Improvements. In the event Praj is unable for any reason, after reasonable effort, to secure Praj’s signature on any document needed in connection with the actions specified in Sections 7.1 and 7.2, Praj hereby irrevocably designates and appoints [[Gevo:Organization]] and its duly authorized officers and agents as Praj’s agent and attorney-in-fact, which appointment is coupled with an interest, to act for and on Praj’s behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of Sections 7.1 and 7.2 with the same legal force and effect as if executed by Praj.

Regulatory Assistance. APCETH shall provide commercially reasonable support for all regulatory activities related to the manufacture of the Product, including any updates to the CMC (Chemistry, Manufacturing, and Controls) part of the Marketing Authorization dossier and/or other documentation or information relevant for obtaining, updating and maintaining the Marketing Authorizations. APCETH is obliged to support and allow any pre‑approval inspection of the Facility required by any competent governmental authority, or any “mock audit” as part of pre-approval preparations and protocol. APCETH may charge BBB for its regulatory assistance under this [Section 8.2] at ​.

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