Example ContractsClausesMeetings With Regulatory Authorities
Meetings With Regulatory Authorities
Meetings With Regulatory Authorities contract clause examples

Meetings with Regulatory Authorities. Each Party shall provide the other Party written notice within ​ after receiving written notice (including electronic notice) of any upcoming material meeting with any Regulatory Authority in the Territory related to Products. Licensee shall lead all interactions with Regulatory Authorities in the Territory with respect to Products. To the extent permitted by Applicable Law and by the Regulatory Authorities, Verrica Confidential

Meetings with Regulatory Authorities. Poseida shall provide Roche with prior written notice of any substantive meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority relating to any Therapeutic Product for such Therapeutic Program, within ​ after Poseida first receives notice of the scheduling of such meeting (or within such shorter period as may be necessary) in order to give Roche a reasonable opportunity to have a reasonable number, but at least ​ representatives attend such meeting. Roche shall have the right, but not the obligation, to attend and participate in all such meetings (including substantive preparatory pre-meetings with Poseida therefor), to the extent permitted by applicable law and such Regulatory Authority.

Meetings with Regulatory Authorities. Each Party shall provide the other Party with at least [ * ] days advance notification of key in-person meeting or teleconference (such as [ * ] in the U.S. and foreign similar or equivalent meetings) with the Regulatory Authorities [ * ] that relates to the Development of the Compounds and Collaboration Products under the Development Plan. Such other Party shall have the right, but not the obligation, to have its representatives attend (but, unless otherwise requested by the Party responsible for such meeting, not participate in) such meetings.

Meetings with Regulatory Authorities. At Kite’s request, Sangamo shall provide input to Kite in preparation for any in-person meeting or teleconference with a Regulatory Authority (or related advisory committees), and shall provide assistance to Kite in responding to any request of a Regulatory Authority that relates to any Licensed Product, ​.

Meetings with Regulatory Authorities. On a current and ongoing basis, each Party (through the JPT) shall provide the other Party with a list and schedule of any in-person meeting or material teleconference with Regulatory Authorities (or related advisory committees) in the Licensee Territory planned for ​ that relates to the Development of the Compound and Products under the Development Plan in the Licensee Territory (each, a “Regulatory Meeting”). In addition, each Party shall notify the other Party as soon as reasonably possible if such Party becomes aware of any additional Regulatory Meetings that become scheduled for such Calendar Quarter and will keep the other Party informed of any significant interface or communication with any Regulatory Authority which might affect efforts to obtain Regulatory Approval for the Product in the Licensee Territory. Each Party shall be solely responsible for any communications with any Regulatory Authorities occurring or required in connection with performing its regulatory responsibilities set forth in this Article 5 with respect to the Product in the Licensee Territory. With respect to Regulatory Meetings for which Licensee is the responsible Party, Ovid shall have the right to comment in preparation for all such Regulatory Meetings and the right, but not the obligation, to have its representatives attend any such Regulatory Meetings.

Meetings with Regulatory Authorities. Apollomics shall lead all interactions with Regulatory Authorities in the Apollomics Territory with respect to Licensed Products. Apollomics shall keep [[GlycoMimetics:Organization]] reasonably informed of any material regulatory developments related to Licensed Products in the Field in the Apollomics Territory. At each regularly scheduled JDC meeting, Apollomics shall provide [[GlycoMimetics:Organization]] with a list and schedule of any in-person meeting or teleconference with the applicable Regulatory Authorities (or related advisory committees) in the Apollomics Territory planned for the next Calendar Quarter that relates to any Licensed Product in the Field. In addition, Apollomics shall notify [[GlycoMimetics:Organization]] as soon as reasonably possible (but in no event later than five (5) Business Days if possible) after Apollomics becomes aware of any additional such meetings or teleconferences that become scheduled for such Calendar Quarter. To the extent permitted by Applicable Law and by the Regulatory Authorities (as reasonably determined by Apollomics), [[GlycoMimetics:Organization]] shall have the right to participate (whether directly or through a representative) in all such meetings and teleconferences, at [[GlycoMimetics:Organization]]’ cost. If such participation would result in the disclosure to [[GlycoMimetics:Organization]] of Apollomics’ Confidential Information unrelated to the subject matter of this Agreement, the Parties shall enter into a confidentiality agreement covering such unrelated subject matter.

Regulatory Reports; Meetings with Regulatory Authorities. [[Savara:Organization]] shall keep [[Grifols:Organization]] informed of material regulatory developments relating to Licensed Products in the Territory.

Meetings with Regulatory Authorities. On a current and ongoing basis, each Party (through the JPT) shall provide the other Party with a list and schedule of any in-person meeting or material teleconference with Regulatory Authorities (or related advisory committees) in the Licensee Territory planned for ​ that relates to the Development of the Compound and Products under the Development Plan in the Licensee Territory (each, a “Regulatory Meeting”). In addition, each Party shall notify the other Party as soon as reasonably possible if such Party becomes aware of any additional Regulatory Meetings that become scheduled for such Calendar Quarter and will keep the other Party informed of any significant interface or communication with any Regulatory Authority which might affect efforts to obtain Regulatory Approval for the Product in the Licensee Territory. Each Party shall be solely responsible for any communications with any Regulatory Authorities occurring or required in connection with performing its regulatory responsibilities set forth in this Article 5 with respect to the Product in the Licensee Territory. With respect to Regulatory Meetings for which Licensee is the responsible Party, Ovid shall have the right to comment in preparation for all such Regulatory Meetings and the right, but not the obligation, to have its representatives attend any such Regulatory Meetings.

Meetings with Regulatory Authorities. At Sana’s request and Beam’s agreement (not to be unreasonably withheld), Beam shall provide reasonable assistance to Sana in preparation for any in-person meeting or teleconference with a Regulatory Authority (or related advisory committees) or other request of a Regulatory Authority, in each case to the extent such assistance is reasonably required in order for Sana to seek or obtain Marketing Approval for Licensed Products, and provided that Beam will not be required to provide any Beam Confidential Information or Know-How beyond what is agreed pursuant to a Technology Transfer Plan. In the event that Beam agrees to provide any such assistance, Sana shall reimburse Beam, in accordance with Section 8.2, for those documented and agreed upon costs and expenses incurred by Beam in connection with conducting such activities.

Meetings with Regulatory Authorities. [[3D Medicines:Organization]] shall lead all interactions with Regulatory Authorities in the [[3D Medicines:Organization]] Territory with respect to Licensed Products for use in the Field. [[3D Medicines:Organization]] shall keep [[Aravive:Organization]] reasonably informed of any material regulatory developments related to Licensed Products in the Field in the [[3D Medicines:Organization]] Territory. At each regularly scheduled JSC meeting, [[3D Medicines:Organization]] shall provide [[Aravive:Organization]] with a list and schedule of any in-person meeting or teleconference with the applicable Regulatory Authorities (or related advisory committees) in the [[3D Medicines:Organization]] Territory planned for the next Calendar Quarter that relates to any Licensed Product in the Field. In addition, [[3D Medicines:Organization]] shall notify [[Aravive:Organization]] as soon as reasonably possible (but in no event later than ​ if possible) after [[3D Medicines:Organization]] becomes aware of any additional such meetings or teleconferences that become scheduled for such Calendar Quarter. [[Aravive:Organization]] shall provide all assistance and documentation reasonably requested by [[3D Medicines:Organization]] to prepare for any such meeting or teleconference, including making available competent personnel to attend any such meeting or teleconference at [[3D Medicines:Organization]]’ reasonable request (subject to reimbursement by [[3D Medicines:Organization]] of [[Aravive:Organization]]’s costs and expenses with respect thereto). To the extent permitted by applicable Laws and by the Regulatory Authorities (as reasonably determined by [[3D Medicines:Organization]]), [[Aravive:Organization]] shall have the right to participate (whether directly or through a representative) in all such meetings and teleconferences, at [[Aravive:Organization]]’s cost.

Next results

Draft better contracts
faster with AllDrafts

AllDrafts is a cloud-based editor designed specifically for contracts. With automatic formatting, a massive clause library, smart redaction, and insanely easy templates, it’s a welcome change from Word.

And AllDrafts generates clean Word and PDF files from any draft.