Common use of Regulatory Cooperation Clause in Contracts

Regulatory Cooperation. Each of the Parties shall and shall cause its respective Affiliates to use commercially reasonable efforts to take, or cause to be taken, all actions, and to do, or cause to be done, and to assist and cooperate with the other Parties in doing, all things necessary, proper or advisable to defend in response to a Governmental Entity inquiry, investigation or challenge, in the most expeditious manner practicable, the Transaction and the other transactions contemplated by this Agreement and the other Transaction Documents, including seeking to close any pending investigations. Each of the Parties shall furnish to the other Parties such necessary information and reasonable assistance as such other Party may reasonably request in connection with the foregoing, and shall cooperate with the other Parties including, but not limited to, through (i) providing advance notice of meetings and calls with any Governmental Entity, (ii) providing notice of agency contacts and requests, (iii) providing the opportunity for Sellers (or, as appropriate, its outside counsel) to attend meetings and calls with any Governmental Entity and review in advance any material agency submissions by Purchaser, (iv) the discussion of timing agreements, and (v) the discussion of document production parameters, interview schedules, and investigational hearing schedules. Subject to Purchaser’s obligations in this Section 5.5(a), in all instances, Purchaser will make the final determination as to the appropriate course of action with any Governmental Entity regarding any antitrust investigation or challenge by such Governmental Entity to the Transaction, provided however that Purchaser will consult with Sellers and consider in good xxxxx Xxxxxxx’ views in material aspects of the defense strategy and tactics and Sellers will in good faith use commercially reasonable efforts to assist and support Purchaser in defense of the Transaction. Each of the Sellers and Purchaser may, as each deems advisable and necessary, reasonably designate any competitively sensitive material provided to the other under this Section 5.5 as “outside counsel only.” Such material and the information contained therein shall be given only to the outside legal counsel of the recipient and will not be disclosed by such outside counsel to employees, officers, or directors of the recipient unless express permission is obtained in advance from the source of the materials (the Sellers or Purchaser, as the case may be) or its legal counsel.

Regulatory Cooperation. Each (a) Subject to applicable laws, rules and regulations, each Party will have the right to attend all material meetings, conferences and discussions by the other Party with Regulatory Authorities in the United States pertaining to Development of the Parties Product, and with Regulatory Authorities outside the United States to the extent such meetings, conferences and discussions are directed to Development Activities within the Development Program that are conducted outside the United States, if any, (collectively, “Development Program Regulatory Interactions”), and with respect to such Development Program Regulatory Interactions: (i) Oncothyreon shall control the messaging and be the lead Party interacting with such Regulatory Authorities in connection with Development Program Regulatory Interactions directed to Development Activities under the Oncothyreon IND, and (ii) Array shall cause its respective Affiliates to control the messaging and be the lead Party interacting with such Regulatory Authorities in connection with other Development Program Regulatory Interactions. Each Party shall use commercially reasonable efforts (A) to take, or cause provide the other Party with reasonable advance notice of all Development Program Regulatory Interactions directed to be taken, all actionssuch Party’s Regulatory Filings, and to doprovide advance copies of material documents and information relating to such Development Program Regulatory Interactions, or cause and (b) to provide the JDC with advance drafts of any material documents and material correspondence to be donesubmitted to Regulatory Authorities pertaining to Development Activities in the Development Program or Marketing Authorization for the Product in the United States or the Major EU Countries, in each case to the extent practicable under the circumstances. The submitting Party shall consider in good faith any comments of the JDC regarding such material documents and material correspondence that are provided by the JDC prior to their submission. (b) Without limiting the provisions above regarding Development Program Regulatory Interactions, Array also agrees to use reasonable efforts (1) to provide advance copies of material documents and information relating to material meetings, conferences and discussions with Regulatory Authorities outside the United States pertaining to Development of the Product, and (2) to assist provide the JDC with advance drafts of any material documents and material correspondence to be submitted to Regulatory Authorities pertaining to Development of the Product or Marketing Authorization for the Product, in each case to the extent practicable under the circumstances. Array shall consider in good faith any comments of the JDC regarding such material documents and material correspondence that are provided by the JDC prior to their submission. Oncothyreon agrees to fully cooperate with the and provide assistance to Array in connection with Marketing Approvals or other Parties in doing, all things necessary, proper or advisable filings to defend in response to a Governmental Entity inquiry, investigation or challenge, any Regulatory Authority anywhere in the most expeditious manner practicable, Territory relating to the Transaction and the other transactions contemplated by this Agreement and the other Transaction DocumentsProduct, including seeking by executing any required documents, providing access to close any pending investigations. Each personnel and providing Array with copies of the Parties all reasonably required documentation, and shall furnish fully cooperate as Array may from time to the other Parties such necessary information and reasonable assistance as such other Party may reasonably time request in connection with the foregoing, and shall cooperate preparing for meetings or communications with Regulatory Authorities in connection with the other Parties including, but not limited to, through (i) providing advance notice of meetings and calls with any Governmental Entity, (ii) providing notice of agency contacts and requests, (iii) providing Product or Oncothyreon’s activities in the opportunity for Sellers (or, as appropriate, its outside counsel) to attend meetings and calls with any Governmental Entity and review in advance any material agency submissions by Purchaser, (iv) the discussion of timing agreements, and (v) the discussion of document production parameters, interview schedules, and investigational hearing schedules. Subject to Purchaser’s obligations in this Section 5.5(a), in all instances, Purchaser will make the final determination as to the appropriate course of action with any Governmental Entity regarding any antitrust investigation or challenge by such Governmental Entity to the Transaction, provided however that Purchaser will consult with Sellers and consider in good xxxxx Xxxxxxx’ views in material aspects Development of the defense strategy and tactics and Sellers will in good faith use commercially reasonable efforts to assist and support Purchaser in defense Product. (c) To facilitate the coordination of the Transaction. Each Parties with respect to timely preparation and submission of Regulatory Filings, the Sellers and Purchaser mayParties shall, as each deems advisable and necessarywithin a reasonable amount of time, reasonably designate any competitively sensitive material provided not to the other under this Section 5.5 as “outside counsel only.” Such material and the information contained therein shall be given only to the outside legal counsel of the recipient and will not be disclosed by such outside counsel to employees, officers, or directors of the recipient unless express permission is obtained in advance exceed six (6) months from the source Effective Date, agree upon and implement a procedure for the mutual exchange of regulatory information associated with the materials Product (the Sellers or Purchaser, as the case may be) or its legal counsel“Regulatory and Clinical Quality Agreement”).

Regulatory Cooperation. (a) Each Party shall use Commercially Reasonable Efforts to provide the other Party with all reasonable assistance and take all actions reasonably requested by such other Party, without changing the allocation of the Parties shall and shall cause its respective Affiliates responsibilities set forth in this Article 5, that are necessary or desirable to use commercially reasonable efforts enable: (a) Oncoheroes to takeseek, or cause to be taken, all actionsobtain, and maintain Regulatory Approvals for Product in the Licensed Field in the Territory; and (b) Allarity to doseek, or cause to be doneobtain, and to assist and cooperate with the other Parties in doing, all things necessary, proper or advisable to defend in response to a Governmental Entity inquiry, investigation or challenge, maintain Regulatory Approvals for Product in the most expeditious manner practicable, Retained Field in the Transaction and the other transactions contemplated by this Agreement and the other Transaction Documents, including seeking to close any pending investigationsTerritory. Each of the Parties shall furnish to the other Parties such necessary information and reasonable assistance as such other Party may reasonably request in connection with the foregoing, and shall cooperate with any inspection by any Regulatory Authority relating to Product, including any inspection prior to approval of an application for Regulatory Approval for Product. (b) The Parties shall share on a timely basis through the other JDC (or an applicable subcommittee) significant correspondence to or from a Regulatory Authority (including submissions of Regulatory Filings) that are relevant to Product. The Parties includingshall share and review such correspondence to or from a Regulatory Authority to assure that the Parties provide consistent responses to the Regulatory Authorities with respect to inquiries relevant to Product. Additionally, but not limited toto the extent that Allarity prepares a Drug Master File for the Product, through then Allarity shall provide Oncoheroes with a draft of such Drug Master File at least sixty (i60) providing advance notice days prior to completion thereof (as well as a final copy of meetings and calls with any Governmental Entity, (ii) providing notice of agency contacts and requests, (iii) providing the opportunity for Sellers (orsuch Drug Master File upon completion), as appropriate, its outside counselwell as any modifications or amendments thereto. Oncoheroes shall have the right to review and comment on any draft of the Drug Master File (as well as any modifications or amendments thereto) to attend meetings and calls shall provide Allarity with such comments within thirty (30) days of receipt thereof. Allarity shall consider any Governmental Entity and review in advance any material agency submissions by Purchaser, (iv) the discussion of timing agreements, and (v) the discussion of document production parameters, interview schedules, and investigational hearing schedules. Subject to Purchaser’s obligations in this Section 5.5(a), in all instances, Purchaser will make the final determination as to the appropriate course of action with any Governmental Entity regarding any antitrust investigation or challenge by such Governmental Entity to the Transaction, provided however that Purchaser will consult with Sellers and consider comments in good xxxxx Xxxxxxx’ views in material aspects of the defense strategy and tactics and Sellers will in good faith use commercially reasonable efforts to assist and support Purchaser in defense of the Transaction. Each of the Sellers and Purchaser may, as each deems advisable and necessary, reasonably designate any competitively sensitive material provided to the other under this Section 5.5 as “outside counsel onlyfaith.” Such material and the information contained therein shall be given only to the outside legal counsel of the recipient and will not be disclosed by such outside counsel to employees, officers, or directors of the recipient unless express permission is obtained in advance from the source of the materials (the Sellers or Purchaser, as the case may be) or its legal counsel.

Regulatory Cooperation. (a) Each Party shall use Commercially Reasonable Efforts to provide the other Party with all reasonable assistance and take all actions reasonably requested by such other Party, without changing the allocation of the Parties shall and shall cause its respective Affiliates responsibilities set forth in this Article 5, that are necessary or desirable to use commercially reasonable efforts enable: (a) Verrica to takeseek, or cause to be taken, all actionsobtain, and maintain Regulatory Approvals for Product in the Licensed Field in the Territory; and (b) Lytix to doseek, or cause to be doneobtain, and to assist and cooperate with the other Parties in doing, all things necessary, proper or advisable to defend in response to a Governmental Entity inquiry, investigation or challenge, maintain Regulatory Approvals for Product in the most expeditious manner practicable, Retained Field in the Transaction and the other transactions contemplated by this Agreement and the other Transaction Documents, including seeking to close any pending investigationsTerritory. Each of the Parties shall furnish to the other Parties such necessary information and reasonable assistance as such other Party may reasonably request in connection with the foregoing, and shall cooperate with any inspection by any Regulatory Authority relating to Product, including any inspection prior to approval of an application for Regulatory Approval for Product. (b) The Parties shall share on a timely basis through the other JSC (or an applicable subcommittee) significant correspondence to or from a Regulatory Authority (including submissions of Regulatory Filings) that are relevant to Product. The Parties includingshall share and review such correspondence to or from a Regulatory Authority to assure that the Parties provide consistent responses to the Regulatory Authorities with respect to inquiries relevant to Product. Additionally, but not limited toto the extent that Lytix prepares a Drug Master File for the Product, through then Lytix shall provide Verrica with a draft of such Drug Master File at least [***] days prior to completion thereof (i) providing advance notice as well as a final copy of meetings and calls with any Governmental Entity, (ii) providing notice of agency contacts and requests, (iii) providing the opportunity for Sellers (orsuch Drug Master File upon completion), as appropriate, its outside counselwell as any modifications or amendments thereto. Verrica shall have the right to review and comment on any draft of the Drug Master File (as well as any modifications or amendments thereto) to attend meetings and calls shall provide Lytix with such comments within [***] days of receipt thereof. Lytix shall consider any Governmental Entity and review in advance any material agency submissions by Purchaser, (iv) the discussion of timing agreements, and (v) the discussion of document production parameters, interview schedules, and investigational hearing schedules. Subject to Purchaser’s obligations in this Section 5.5(a), in all instances, Purchaser will make the final determination as to the appropriate course of action with any Governmental Entity regarding any antitrust investigation or challenge by such Governmental Entity to the Transaction, provided however that Purchaser will consult with Sellers and consider comments in good xxxxx Xxxxxxx’ views in material aspects of the defense strategy and tactics and Sellers will in good faith use commercially reasonable efforts to assist and support Purchaser in defense of the Transaction. Each of the Sellers and Purchaser may, as each deems advisable and necessary, reasonably designate any competitively sensitive material provided to the other under this Section 5.5 as “outside counsel onlyfaith.” Such material and the information contained therein shall be given only to the outside legal counsel of the recipient and will not be disclosed by such outside counsel to employees, officers, or directors of the recipient unless express permission is obtained in advance from the source of the materials (the Sellers or Purchaser, as the case may be) or its legal counsel.