Common use of Regulatory Activities Clause in Contracts

Regulatory Activities. 4.1.1 IMPATIENTS shall have the sole and exclusive right to make contact with patients and physicians relating to the EAP of Product, and to file applications for Early Access Approvals therefor (including the setting of the overall regulatory strategy therefor), and to communicate with the Regulatory Authorities to secure Early Access Approvals for Product in the Territory. HEMISPHERX shall support IMPATIENTS as may be reasonably necessary in obtaining Early Access Approvals for the Product, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Early Access Approvals, in each case in accordance with the terms and conditions of this Agreement. 4.1.2 HEMISPHERX shall collaborate with IMPATIENTS to provide IMPATIENTS with (a) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to the development of Product in the Field received by HEMISPHERX or its Affiliates, collaborators or licensees from, or filed by HEMISPHERX or its Affiliates, collaborators or licensees with, the Regulatory Authorities, and (b) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by HEMISPHERX or its Affiliates, collaborators or licensees with the Regulatory Authorities relating to the development or commercialization of Product in the Field, including copies of all contact reports produced by HEMISPHERX or its Affiliates or licensees, in each case ((a) and (b)) within fifteen (15) Business Days of its receipt, forwarding or production of the foregoing, as applicable. If such written or electronic correspondence received from any such Regulatory Authority relates to the withdrawal, suspension, or revocation of a Regulatory Approval or Early Access Approval for Product in the Field, the prohibition or suspension of the supply of a Product in the Field, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety and quality of a Product in the Field, the notified Party shall notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable. 4.1.3 HEMISPHERX shall, in accordance with the Quality Agreement, make every reasonable effort to notify IMPATIENTS promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product in the Territory in the Field, and shall include in such notice the reasoning behind such determination, and any supporting facts. HEMISPHERX (or its licensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory. If a Regulatory Authority in the Territory mandates a recall, market suspension, or market withdrawal, then HEMISPHERX (or its licensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 4.1.3, HEMISPHERX or its licensee, whichever responsible for the recall, market suspension, or market withdrawal, shall be solely responsible for the execution thereof, and IMPATIENTS shall reasonably cooperate in all such recall efforts.

Regulatory Activities. 4.1.1 Subject to review and input from the JSC, which will reasonably be considered, IMPATIENTS shall have the sole and exclusive right to make contact with recruit patients and physicians relating to for the EAP of Product, and to file applications for Early Access Approvals therefor (therefor, including the setting of the overall regulatory strategy therefor), and to communicate with the Regulatory Authorities to secure Early Access Approvals for Product Products in the Territory. HEMISPHERX CELSION shall support IMPATIENTS IMPATIENTS, as may be reasonably necessary necessary, in obtaining Early Access Approvals for the Product, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Early Access Approvals, in each case in accordance with the terms and conditions of this Agreement. 4.1.2 HEMISPHERX CELSION shall collaborate with IMPATIENTS to provide IMPATIENTS with (a) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to the development of Product in the Field received by HEMISPHERX CELSION or its Affiliates, collaborators or licensees from, or filed by HEMISPHERX CELSION or its Affiliates, collaborators or licensees with, the Regulatory Authorities, and (b) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by HEMISPHERX CELSION or its Affiliates, collaborators or licensees with the Regulatory Authorities relating to the development or commercialization of Product in the Field, including copies of all contact reports produced by HEMISPHERX CELSION or its Affiliates or licensees, in each case ((a) and (b)) within fifteen (15) Business Days of its receipt, forwarding or production of the foregoing, as applicable. If such written or electronic correspondence received from any such Regulatory Authority relates to the withdrawal, suspension, or revocation of a Regulatory Approval or Early Access Approval for Product in the Field, the prohibition or suspension of the supply of a Product in the Field, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety and quality of a Product in the Field, the notified Party shall notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable, with CELSION’s obligation being limited to matters that involve or have an impact on the EAP. 4.1.3 HEMISPHERX CELSION shall, in accordance with the Quality Agreement, make every reasonable effort to notify IMPATIENTS promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product in the Territory in the Field, and shall include in such notice the reasoning behind such determination, and any supporting facts. HEMISPHERX CELSION (or its licensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory. If a Regulatory Authority in the Territory mandates a recall, market suspension, or market withdrawalwithdrawal is mandated by a Regulatory Authority in the Territory, then HEMISPHERX CELSION (or its licensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 4.1.3Section, HEMISPHERX CELSION (or its licensee, whichever ) responsible for the recall, market suspension, or market withdrawal, withdrawal shall be solely responsible for the execution thereof, and IMPATIENTS shall reasonably cooperate in all such recall efforts.

Regulatory Activities. 4.1.1 IMPATIENTS (a) With respect to regulatory activities in all countries that are not Co-Marketing EA Territories: (i) Novartis shall use Commercially Reasonable Efforts to apply for, obtain and maintain any Approvals and any other licenses, permits, approvals or registrations as may be required by the FDA or any other relevant Public Authority for Commercializing Products in the United States and in such other countries in the world as Commercially Reasonable Efforts would require; (ii) Both Parties will have full access to all submissions to, including clinical studies and other supporting information, and communications with, the FDA and foreign counterparts thereof relating to the Product(s), and each Party, or its Affiliate(s) (or in the case of Novartis and at its discretion, sublicensees), shall have the sole and exclusive irrevocable right to make contact refer to and cross-reference in accordance with patients applicable Legal Requirements all such documents for purposes of obtaining an Approval for a Product in a Co-Marketing EA Country (to the extent Tanox is applying for an Approval for such Product in accordance with Sections 6.2(c) and physicians 6.6(b)) or an Abandoned Product; (iii) Except as otherwise agreed by the Project Steering Committee or as required by Legal Requirements, Novartis shall comply with all regulatory requirements, and shall maintain all government agency contacts, relating to the EAP Products; such activities shall include maintaining and updating any Approvals, the development and submission of ProductApproval Applications for new indications (if any, and to file applications for Early Access Approvals therefor (including after approval by the setting of the overall regulatory strategy thereforProject Steering Committee), the reporting of any adverse incidents or drug reactions to the FDA or other Public Authority, and to communicate the filing with the Regulatory Authorities to secure Early Access Approvals for Product in the Territory. HEMISPHERX shall support IMPATIENTS FDA or other Public Authority of any promotional and other materials as may be reasonably necessary to comply with Legal Requirements; (iv) Tanox shall cooperate with Novartis to obtain and maintain the effectiveness of any Approvals and any licenses, permits, approvals or registrations obtained in obtaining Early Access connection with the performance of this Agreement, including by providing materials, information and necessary personnel in connection with regulatory approval functions; and (v) Subject to Sections 6.2(c) and 6.6(b)with respect to Co-Marketing (if any) in East Asia, Novartis will hold all Approvals for the ProductProducts, subject to: (A) providing Tanox, promptly on Novartis’ receipt thereof, with copies of all material Products licensing/regulatory affairs correspondence and materials with respect to Approval activities in the USA or the Co-Promotion EA Territories; (B) promptly notifying Tanox of any meetings or material communications between Novartis and the FDA or other regulatory agency in the Co-Promotion EA Territories; (C) the right of Tanox to attend and participate in such meetings and to review, comment upon and approve all such written material communications including, without limitation, draft documents, meeting materials, letters and submissions to the FDA. (b) With respect to regulatory activities in support thereofall Co-Marketing EA Territories, including providing necessary documents or other materials required by Applicable Law to obtain Early Access Approvals, in each case the Parties will operate in accordance with the terms and conditions of this Agreementarrangement agreed upon under Section 6.2(c). 4.1.2 HEMISPHERX (c) Novartis and Tanox shall collaborate with IMPATIENTS timely advise each other of (i) all adverse drug reactions and other similar matters relevant to provide IMPATIENTS with maintaining approvals and registrations of the Product(s) of which either of them may be aware and (aii) access to any governmental regulatory problems, notices, actions or copies of all material written or electronic correspondence (other than regulatory filings) communications relating to the development of Product in the Field received by HEMISPHERX or its Affiliates, collaborators or licensees from, or filed by HEMISPHERX or its Affiliates, collaborators or licensees with, the Regulatory Authorities, and (b) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by HEMISPHERX or its Affiliates, collaborators or licensees with the Regulatory Authorities relating to the development or commercialization of Product in the Field, including copies of all contact reports produced by HEMISPHERX or its Affiliates or licensees, in each case ((a) and (bProduct(s)) within fifteen (15) Business Days of its receipt, forwarding or production of the foregoing, as applicable. If such written or electronic correspondence received from any such Regulatory Authority relates to the withdrawal, suspension, or revocation of a Regulatory Approval or Early Access Approval for Product in the Field, the prohibition or suspension of the supply of a Product in the Field, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety and quality of a Product in the Field, the notified Party shall notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable. 4.1.3 HEMISPHERX shall, in accordance with the Quality Agreement, make every reasonable effort to notify IMPATIENTS promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product in the Territory in the Field, and shall include in such notice the reasoning behind such determination, and any supporting facts. HEMISPHERX (or its licensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory. If a Regulatory Authority in the Territory mandates a recall, market suspension, or market withdrawal, then HEMISPHERX (or its licensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 4.1.3, HEMISPHERX or its licensee, whichever responsible for the recall, market suspension, or market withdrawal, shall be solely responsible for the execution thereof, and IMPATIENTS shall reasonably cooperate in all such recall efforts.

Regulatory Activities. 4.1.1 IMPATIENTS shall have the sole and exclusive right to make contact with recruit patients and physicians relating to for the EAP of Product, and to file applications for Early Access Approvals therefor (including the setting of the overall regulatory strategy therefor), and to communicate with the Regulatory Authorities to secure Early Access Approvals for Product Products in the Territory. HEMISPHERX COMPANY shall support IMPATIENTS IMPATIENTS, as may be reasonably necessary necessary, in obtaining Early Access Approvals for the Product, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Early Access Approvals, in each case in accordance with the terms and conditions of this Agreement. 4.1.2 HEMISPHERX COMPANY shall collaborate with IMPATIENTS to provide IMPATIENTS with (a) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to the development of Product in the Field received by HEMISPHERX COMPANY or its Affiliates, collaborators or licensees from, or filed by HEMISPHERX COMPANY or its Affiliates, collaborators or licensees licenses with, the Regulatory Authorities, and (b) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by HEMISPHERX COMPAXY or its Affiliates, collaborators or licensees with the Regulatory Authorities relating to the development or commercialization commercialisation of Product in the Field, including copies of all contact reports produced by HEMISPHERX COMPANY or its Affiliates Affiliates, collaborators or licensees, in each case ((a) and (b)) within fifteen (15) Business Days of its receipt, forwarding or production of the foregoing, as applicable. If such written or electronic correspondence received from any such Regulatory Authority relates to the withdrawal, suspension, or revocation of a Regulatory Approval or Early Access Approval for Product in the Field, the prohibition or suspension of the supply of a Product in the Field, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety and quality of a Product in the Field, the notified Party shall notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable. 4.1.3 HEMISPHERX shall, in accordance with the Quality Agreement, COMPANY shall make every reasonable effort to notify IMPATIENTS promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product in the Territory in the Field, and shall include in such notice the reasoning behind such determination, and any supporting facts. HEMISPHERX COMPANY (or its licensee) :) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory. If a Regulatory Authority in the Territory mandates lf a recall, market suspension, or market withdrawalwithdrawal is mandated by a Regulatory Authority in the Territory, then HEMISPHERX COMPANY (or its licensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 4.1.3Section, HEMISPHERX COMPANY (or its licensee, whichever ) responsible for the recall, market suspension, or market withdrawal, withdrawal shall be solely responsible for the execution thereof, and IMPATIENTS shall reasonably cooperate in all such recall efforts.