Common use of Regulatory Meetings and Communications Clause in Contracts

Regulatory Meetings and Communications. (a) For each country in the Territory, unless the Joint Project Team otherwise specifies, the Parties shall be jointly responsible for conducting meetings and discussions related to Licensed Products with the Regulatory Authorities in each country of the Territory. Each Party shall be given the opportunity to have one or more of its representatives participate in all substantive discussions and meetings with Regulatory Authorities which relate to Licensed Products, including, but not limited to, with respect to any Drug Approval Applications. (b) The Joint Project Team, through its members with regulatory and drug safety expertise, shall develop processes and procedures for the conduct and reporting to the Parties of telephone communications and written correspondence with Regulatory Authorities in the Territory related to Licensed Product. To the extent either Party receives material written or oral communication from the FDA or any other Regulatory Authority relating to Licensed Products, the Party receiving such communication shall notify the other Party and provide a copy of any written communication to the other Party as soon as reasonably practicable. (c) Within sixty (60) days after the Effective Date, the Parties' respective regulatory affairs or other applicable departments, including the members of the Joint Project Team with regulatory and drug safety expertise, shall meet and agree upon processes and procedures to recommend to the Joint Project Team for sharing information needed to support each Party's respective regulatory responsibilities, including without limitation, development of appropriate safety databases relating to Antegren, or, as applicable, other Licensed Products. The processes and procedures adopted by the Joint Project Team under this Section for sharing of information and adverse event reporting shall be consistent with Article 13. (d) The Parties shall cooperate in good faith with respect to the conduct of any inspections by any Regulatory Authority of a Party's site and facilities related to Licensed Products, and each Party shall at a minimum be given the opportunity to attend the summary, or wrap up, meeting related to Licensed Products with such Regulatory Authority at the conclusion of such site inspection. Each Party shall consider the attendance of the other Party at any such regulatory inspections, but shall not be obligated to accept the other Party's attendance at such inspections if such attendance would result in the disclosure to the other Party of confidential information or trade secrets unrelated to the Licensed Products.

Regulatory Meetings and Communications. (a) For each country FALK shall be responsible for conducting all meetings and discussionx xxd routine telephone communications with the EMEA or other Regulatory Authority, related to clinical studies, Drug Approval Applications and Regulatory Approvals for the Licensed Product in the Field in the Territory, unless the Joint Project Team otherwise specifies, the Parties ; provided that FALK shall be jointly responsible for conducting use [********************** ***************] to conduct sxxx meetings and discussions related to Licensed Products with facilitate the Regulatory Authorities Approval of the Licensed Product in each country of the Field in the Territory. Each Party ALTUS shall assist FALK in these efforts. FALK will keep ALTUS and the Steering Committxx xpprised of all matexxxx communications with such regulatory authorities, and ALTUS or its designee shall be entitled to attend all meetings with Regulatory Authorities. FALK shall [*****************] with respect to the conduct of any inxxxxtions by any Regulatory Authority of FALK's site and facilities related to the Licensed Product, and each Xxxxx shall be given the opportunity to have one attend such site inspection and the summary, or more of its representatives participate in all substantive discussions and meetings with Regulatory Authorities which relate to Licensed Productswrap up, including, but not limited to, with respect to any Drug Approval Applications. (b) The Joint Project Team, through its members with regulatory and drug safety expertise, shall develop processes and procedures for the conduct and reporting meeting related to the Parties Licensed Product with such regulatory authority at the conclusion of telephone communications and written correspondence with Regulatory Authorities in the Territory related to Licensed Productsuch site inspection. To the extent either Party receives material written or material oral communication from the FDA or any other Regulatory Authority regulatory authority relating to the Licensed ProductsProduct in the Field in the Territory, the Party receiving such communication shall notify the other Party and provide a copy of any written communication to the other Party as soon as reasonably practicable. (c) Within sixty (60) days after the Effective Date, the Parties' respective regulatory affairs or other applicable departments, including the members of the Joint Project Team with regulatory and drug safety expertise, shall meet and agree upon processes and procedures to recommend to the Joint Project Team for sharing information needed to support each Party's respective regulatory responsibilities, including without limitation, development of appropriate safety databases relating to Antegren, or, as applicable, other Licensed Products. The processes and procedures adopted by the Joint Project Team under this Section for sharing of information and adverse event reporting shall be consistent with Article 13. (d) The Parties shall cooperate in good faith with respect to the conduct of any inspections by any Regulatory Authority of a Party's site and facilities related to Licensed Products, and each Party shall at a minimum be given the opportunity to attend the summary, or wrap up, meeting related to Licensed Products with such Regulatory Authority at the conclusion of such site inspection. Each Party shall consider the attendance of the other Party at any such regulatory inspections, but shall not be obligated to accept the other Party's attendance at such inspections if such attendance would result in the disclosure to the other Party of confidential information or trade secrets unrelated to the Licensed Products.

Regulatory Meetings and Communications. (a) For each country From the Effective Date until the date of the receipt of Regulatory Approval for a Product in the Territory, unless the Joint Project Team otherwise specifiesU.S., the Parties following provisions shall be jointly responsible for conducting meetings and discussions related to Licensed Products apply: (i) The applicable Regulatory Lead shall consult with the other party reasonably in advance of the date of any anticipated meeting with a Regulatory Authorities Authority and shall consider any timely recommendations made by such other party in preparation for such meeting. Up to three (3) representatives of such other party, in each country of case, with appropriate subject matter expertise, may attend scheduled meetings between the Territory. Each Party shall be given Regulatory Lead and the opportunity to have one or more of its representatives participate in all substantive discussions and meetings with applicable Regulatory Authorities which relate to Licensed Products, including, but not limited to, Authority with respect to any Drug Approval Applications. (b) The Joint Project TeamProduct, through its members with regulatory and drug safety expertise, shall develop processes and procedures for the conduct and reporting to the Parties extent permissible by such Regulatory Authority. The Regulatory Lead shall (x) inform the other party of telephone communications any unscheduled teleconferences and written correspondence meetings (other than teleconferences and meetings that are solely administrative in nature) with Regulatory Authorities in the Territory related with respect to Licensed Product. To the extent either Party receives material written or oral communication from the FDA or any other Regulatory Authority relating to Licensed Products, the Party receiving such communication shall Product reasonably promptly after they occur and (y) promptly notify the other Party party of, and provide a copy of (or, in the case of oral correspondence or communication, a reasonably detailed summary of), any written material correspondence or other communication from any Regulatory Authority relating to the other Party as soon as reasonably practicableany Product. (cii) Within sixty (60) days after Unless exigent action is required with respect to such Regulatory Filing or a material communication with a Regulatory Authority with respect to a given Product or unless otherwise determined by the Effective DateJSC, the Parties' respective regulatory affairs or Regulatory Lead shall provide the other applicable departmentsparty with copies of all material Regulatory Filings (which, including for clarity, shall not be required to include communications that are solely administrative in nature) prior to submission within a reasonable amount of time and reasonably consider comments of such other party (but in the members event of a disagreement between the parties with respect to such comments and proposed revisions, such matter shall be escalated to the JSC for review). The Regulatory Lead shall consult with the other party regarding, and keep the other party informed of, the status of the Joint Project Team with regulatory and drug safety expertisepreparation of all Regulatory Filings (which, for clarity, shall meet not be required to include communications that are solely administrative in nature) it submits, Regulatory Authority review of any such Regulatory Filings, and agree upon processes and procedures to recommend to the Joint Project Team for sharing information needed to support each Party's respective regulatory responsibilities, including without limitation, development of appropriate safety databases relating to Antegren, or, as applicable, other Licensed Products. The processes and procedures adopted by the Joint Project Team under this Section for sharing of information and adverse event reporting shall be consistent with Article 13. (d) The Parties shall cooperate in good faith all Regulatory Approvals that it obtains with respect to the conduct of any inspections by any applicable Product. The Regulatory Authority of a Party's site and facilities related to Licensed Products, and each Party Lead shall at a minimum be given the opportunity to attend the summary, or wrap up, meeting related to Licensed Products with such Regulatory Authority at the conclusion of such site inspection. Each Party shall consider the attendance of the other Party at any such regulatory inspections, but shall not be obligated to accept the other Party's attendance at such inspections if such attendance would result in the disclosure provide to the other Party party copies of confidential information or trade secrets unrelated to all final Regulatory Filings it submits promptly after the Licensed Productssubmission.

Regulatory Meetings and Communications. (aA) For each country in the TerritorySubject to applicable Law, unless the Joint Project Team otherwise specifies, the Parties Xxxxxxx shall be jointly exclusively responsible for conducting meetings and discussions related to Licensed Products Product with the Regulatory Authorities in each country of Authorities. Genmab shall have the Territory. Each Party shall be given the opportunity right to have one or [***] attend such meetings and discussions (unless Xxxxxxx agrees that more of its representatives participate in all substantive discussions and meetings with Regulatory Authorities which relate to Licensed Products, including, but not limited to, with respect to any Drug Approval Applications. (bGenmab people may attend) The Joint Project Team, through its members with regulatory and drug safety expertise, shall develop processes and procedures for the conduct and reporting to the Parties extent that they relate or are pertinent to Genmab’s obligations or deliverables under the Development Plan, unless prohibited by such Regulatory Authorities. Xxxxxxx shall give Genmab reasonable advance notice of telephone communications and written correspondence such activities to permit Genmab to participate. If any Regulatory Authority communicates with Regulatory Authorities in the Territory related Genmab relating to Licensed Product. To the extent either Party receives material written or oral communication from the FDA or any other Regulatory Authority relating to Licensed Products, the Party receiving such communication Genmab shall notify the other Party Xxxxxxx and provide a copy to Xxxxxxx of any written communication, or notes of any oral communication, within [***] of such communication’s occurrence. Genmab shall not respond to any such communication unless Xxxxxxx has given its prior written approval to the other Party as soon as reasonably practicableform and content of such response. (cB) Within sixty (60) days after the Effective Date, the Parties' respective regulatory affairs or other applicable departments, including the members of the Joint Project Team with regulatory and drug safety expertise, shall meet and agree upon processes and procedures to recommend to the Joint Project Team for sharing information needed to support each Party's respective regulatory responsibilities, including without limitation, development of appropriate safety databases relating to Antegren, or, as applicable, other Licensed Products. The processes and procedures adopted by the Joint Project Team under this Section for sharing of information and adverse event reporting shall be consistent with Article 13. (d) The Parties Genmab shall cooperate in good faith with Xxxxxxx with respect to the conduct of any inspections by any Regulatory Authority of a Party's site Genmab’s sites and facilities related to Licensed ProductsProduct, and each Party Xxxxxxx shall at a minimum be given the opportunity to attend the summary, or wrap up, meeting related to Licensed Products [***] with such Regulatory Authority at the conclusion of such site inspectioninspection (provided such meeting relates or is pertinent to Genmab’s obligations or deliverables under the Development Plan). Each Party Genmab shall consider the attendance of the other Party Xxxxxxx at any such regulatory inspectionsinspection, but shall not be obligated to accept the other Party's Xxxxxxx’x attendance at such inspections if such attendance would unavoidably result in the disclosure to the other Party Xxxxxxx of confidential information or trade secrets unrelated to [***] Xxxxxxx shall reimburse Genmab for all of Genmab’s reasonable Out of Pocket Expenses incurred in connection with any Regulatory Authority inspections referred to in this Clause 4.11(B) within [***] calendar days of the Licensed Productsdate of Genmab’s invoice in relation to the same. All such payments shall be made in US dollars.

Regulatory Meetings and Communications. (a) For each country in the Territory, unless the Joint Project Team otherwise specifies, the Parties shall be jointly responsible for conducting meetings and discussions related to Licensed Products with the Regulatory Authorities in each country of the TerritoryAuthorities. Each Party shall be given the opportunity to have one or more of its representatives participate in all substantive discussions and meetings with Regulatory Authorities which relate to Licensed Products, including, but not limited to, with respect to any Drug Approval Applications. (b) Each Party shall provide the other Party with a copy of any material documents or reports to be filed with the FDA or any other Regulatory Authority under this Agreement. The Joint Project Team, through its members with regulatory and drug safety expertise, Team shall develop processes and procedures for the conduct and reporting approve all such material documents or reports prior to the Parties of telephone communications and written correspondence with Regulatory Authorities in the Territory related to Licensed Productfiling. [ * ]. To the extent either Party receives material written or oral communication from the FDA or any other Regulatory Authority relating to Licensed Products, the Party receiving such communication shall notify the other Party and provide a copy of any written communication to the other Party as soon as reasonably practicable. (c) Within sixty (60) days [ * ] after the Effective Date, the Parties' respective regulatory affairs or other applicable departments, including the members of the Joint Project Team with regulatory and drug safety expertise, shall meet and agree upon on processes and procedures to recommend to the Joint Project Team for sharing information needed to support each Party's respective regulatory responsibilities, including including, without limitation, development of appropriate safety databases relating to Antegren, or, as applicable, other Licensed Products. The processes and procedures adopted by the Joint Project Team under this Section 4.5(c) for sharing of information and adverse event reporting shall be consistent with Article 13. (d) The Parties shall cooperate in good faith with respect to the conduct of any inspections by any Regulatory Authority of a Party's site and facilities related to Licensed Products, and each Party shall at a minimum be given the opportunity to [ * ] designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission. attend the summary, or wrap wrap-up, meeting related to Licensed Products with such Regulatory Authority at the conclusion of such site inspection. Each Party shall consider the attendance of the other Party at any such regulatory inspections, but shall not be obligated to accept the other Party's attendance at such inspections if such attendance would result in the disclosure to the other Party of confidential information or trade secrets unrelated to the Licensed Products[ * ].