Communications and Filings with Regulatory Authorities. 7.2.1 Except as set forth in […***…] and subject to […***…], ZLAB shall, at ZLAB’s cost and expense, prepare, submit and, with respect to communications, conduct any Registration Filing or other submission or communication to a Regulatory Authority with respect to the Product in the Field in the Territory in accordance with this Section 7.2.1.
Communications and Filings with Regulatory Authorities. 12.3.1 With respect to the Licensed Product, the MAH shall be responsible for all communications with the Regulatory Authorities in the US Territory and EU Territory (as applicable) with respect to the Licensed Product.
Communications and Filings with Regulatory Authorities. The provisions of this Section 3.2.6 shall not apply with respect to Eisai’s activities under Section 3.2.2(a), which shall be governed by Section 3.2.2(b), Section 3.2.2(c) or Section 3.2.2(d), as applicable. Each Party shall, subject to Applicable Law and except to the extent a need for exigent action prevents it from doing so, provide the other Party with copies of each Drug Approval Application or other submission or communication to a Regulatory Authority relating to the Licensed Compound or a Licensed Product in its own Territory a reasonable amount of time prior to the anticipated date for the submission or communication to allow the other Party to review and comment on such Drug Approval Application, submission or communication, and the first Party shall consider all reasonable comments and proposed revisions from the other Party in good faith in connection with effecting such submission or communication. The first Party shall consult with the other Party regarding, and keep the other Party reasonably informed of, the status of the preparation of all Drug Approval Applications it submits relating to a Licensed Product, Regulatory Authority review of any such Drug Approval Application, and all approvals of Drug Approval Applications or other Regulatory Approvals and other submissions (including INDs) that it obtains with respect to a Licensed Product in its Territory. Upon the other Party’s reasonable request, and subject to Applicable Law, the first Party shall provide to the other Party full, complete and correct copies of all final Drug Approval Applications it submits in its Territory. The first Party shall consult with the other Party reasonably in advance of the date of any anticipated meeting with a Regulatory Authority relating to the Licensed Compound or a Licensed Product and shall consider any timely and reasonable recommendations made by the other Party in preparation for such meeting. Upon the other Party’s reasonable request, the first Party shall, to the extent permitted by the relevant Regulatory Authority, permit the other Party to attend particular meetings between the first Party and any Regulatory Authority in the first Party’s Territory relating to the Licensed Compound or a Licensed Product if such meeting is anticipated to address a matter that does, or may be reasonably expected to, impact the Exploitation of the Licensed Compound or a Licensed Product in the other Party’s Territory and shall, where necessary, request that th...
Communications and Filings with Regulatory Authorities. To the extent permitted under applicable law, for obtaining Regulatory Approvals of the Licensed Product in the Territory, each Party shall provide the other Party with copies of material submissions to or communications with a Regulatory Authority (in the original language) relating to the Licensed Product in a reasonable amount of time prior to the anticipated date for the submission or communication to allow the other Party a reasonable opportunity to review and comment on submission or communication, and in such event each Party shall consider all comments and proposed revisions from the other Party in good faith in connection with effecting such submission or communication. In the event that an exigent action prevents a Party from allowing the other Party the time set forth above, such first Party shall make all efforts to provide the other Party with as much time as possible to review and comment as the timeline permits. Each Party shall consult with the other Party regarding, and keep the other Party informed of, the status of the preparation of all material submissions and communications it has with the applicable Regulatory Authority relating to each Licensed Product in the Territory.
Communications and Filings with Regulatory Authorities. To the extent permitted under applicable Law, each Party shall provide the other Party with copies of material submissions to or communications with a Regulatory Authority (in the original language) relating to any Licensed Product a reasonable amount of time prior to the anticipated date for the submission or communication to allow the other Party a reasonable opportunity to review and comment on submission or communication, and in such event each Party shall consider all comments and proposed revisions from the other Party in good faith in connection with effecting such submission or communication, provided that if such Regulatory Authority is the NMPA, then such copies may be redacted of any regulatory data or other information if obtaining permission to export or otherwise remove such data or information from Mainland China would, in Licensee’s reasonable opinion, be unreasonably costly. In the event that an exigent action prevents a Party from allowing the other Party the time set forth above, the such first Party shall make all efforts to provide the other Party with as much time as possible to review and comment as the timeline permits. Each Party shall consult with the other Party regarding, and keep the other Party informed of, the status of the preparation of all material submissions and communications it has with the applicable Regulatory Authorities relating to each Licensed Product in their respective territories.
Communications and Filings with Regulatory Authorities deCODE shall be responsible for all communications and filings with the Regulatory Authorities with respect to each of its Unilateral Products.
Communications and Filings with Regulatory Authorities. Genmab/Medarex shall be responsible for all communications and filings with the Regulatory Authorities with respect to each of its Unilateral Products.
Communications and Filings with Regulatory Authorities. With respect to each Licensed Product, Insmed shall promptly provide AstraZeneca with: (i) copies of all pre-clinical and clinical data compiled in support of regulatory filings; (ii) copies of all regulatory correspondence to or from the Regulatory Authorities; (iii) final draft copies of material, non-recurring submissions and filings reasonably in advance of submission or filing (e.g., INDs, CTAs, Drug Approval Applications, major supplements or amendments to the foregoing, material labeling supplements, Regulatory Authority meeting requests and core data sheets and filings related to new Indications and proposed labeling) to the Regulatory Authorities; (iv) notices of any revocations of Regulatory Approvals with respect to any such Licensed Product and any Licensed Product recalls or withdrawals in the Territory; and (v) reasonable responses to inquiries by AstraZeneca regarding the Regulatory Approval and Commercialization processes for any Licensed Product, including reasonable access to Insmed’s personnel in connection with such inquiries. Insmed shall promptly provide AstraZeneca with copies of all other documents and correspondence pertaining to each Licensed Product after they have been submitted to, or received from, the Regulatory Authorities. Insmed shall use Commercially Reasonable Efforts to implement procedures reasonably designed to avoid any failure to provide any material required to be provided to AstraZeneca under this Section 4.2.2 and to cure any such failure promptly after its discovery.
Communications and Filings with Regulatory Authorities. Northwest shall be responsible for all communications and filings with the Regulatory Authorities with respect to each of its Unilateral Products.
Communications and Filings with Regulatory Authorities. Medarex shall be responsible for all communications and filings with the Regulatory Authorities with respect to each of its Unilateral Products.
