Common use of Regulatory Approvals Clause in Contracts

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee If an Event of Default shall use Commercially Reasonable Efforts have occurred and be continuing, each Obligor shall take any action which the Secured Party may reasonably request in order to submit registration dossiers transfer and assign to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Secured Party, its Affiliates, and/or sublicensees or any to such one or more third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliatesparties as the Secured Party may designate, or its sublicensees; provided, however, that such rights are subject to the prior written consent a combination of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion each Governmental Approval of such owning Person. (d) Obligor. To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will enforce the provisions of clause this subsection, upon the occurrence and during the continuance of an Event of Default, the Secured Party is empowered to request the appointment of a receiver from any court of competent jurisdiction. Such receiver shall be instructed to seek from the Governmental Authority an involuntary transfer of control of each such Governmental Approval for the purpose of seeking a bona fide purchaser to whom control will ultimately be transferred. Each Obligor hereby agrees to authorize such an involuntary transfer of control upon the request of the receiver so appointed, and, if such Obligor shall refuse to authorize the transfer, its approval may be required by the court. Upon the occurrence and continuance of an Event of Default, such Obligor shall further use its reasonable best efforts to assist in obtaining Governmental Approvals, if required, for any action or transaction contemplated by this Security Agreement, including, without limitation, the preparation, execution and filing with the Governmental Authority of such Obligor’s portion of any necessary or appropriate application for the approval of the transfer or assignment of any portion of the assets (i) or (iiincluding any Governmental Approval) of such Obligor. Because each Obligor agrees that the Secured Party’s remedy at law for failure of such Obligor to comply with the provisions of this sentence require Licensee subsection would be inadequate and that such failure would not be adequately compensable in damages, such Obligor agrees that the covenants contained in this subsection may be specifically enforced, and such Obligor hereby waives and agrees not to delay assert any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges defenses against an action for specific performance of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsuch covenants. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers Subject to the relevant Regulatory Authorities terms and conditions herein, each party hereto agrees to use its reasonable best efforts to take, or cause to be taken, all action, and to do, or cause to be done as promptly as practicable, all things necessary, proper and advisable under applicable Laws to consummate and make effective as promptly as practicable the Transaction. Subject to appropriate confidentiality protections, each party hereto shall furnish to the other parties such necessary information and reasonable assistance as such other party may reasonably request in connection with respect to all necessary Regulatory Approvals in each Major Countrythe foregoing. (b) Licensee Each of the parties shall have cooperate with one another in good faith and use its reasonable best efforts to prepare all necessary documentation (including furnishing all information required under the right HSR Act or other Competition Laws) to effect promptly all necessary filings and to obtain Regulatory Approvalsall consents, which waivers and approvals necessary to consummate the transactions contemplated by this Agreement. Each party hereto shall be held by provide to the other parties copies of all correspondence between it (or its advisors) and any Governmental Antitrust Entity relating to the Transaction or any of the matters described in this Section 7.3. Each such party shall promptly inform the name other parties hereto of Licenseeany oral communication with, and Licensee provide copies of written communications with any Governmental Body regarding any such filings or any such transaction. No party hereto shall own all Submissions and Data independently participate in connection therewith. All pricingany formal meeting with any Governmental Body in respect of any such filings, formulary and marketing approvals shall also be obtained by and in investigation, or other inquiry without giving the name other parties hereto prior notice of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingmeeting and, to the extent legally possiblepermitted by such Governmental Body, being the sole contact opportunity to attend and/or participate. Without limiting the obligations of Buyer pursuant to this Section 7.3, Buyer shall (i) control the strategy for obtaining any consents, waivers and approvals from any Governmental Antitrust Entity in connection with such Regulatory Authoritiesthe Transaction and (ii) control the overall development of the positions to be taken and the regulatory actions to be requested in any filing or submission with a Governmental Body in connection with the Transaction and in connection with any investigation or other inquiry or litigation by or before, subject or any negotiations with, a Governmental Body relating to the rights Transaction and of Xxxxx all other regulatory matters incidental thereto; provided that Buyer shall consult and cooperate with the Seller Representative with respect to such strategy, positions and requested regulatory action (including in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto relating to proceedings under this Section 4.4the HSR Act or other Competition Laws) and consider the Seller Representative’s views in good faith. (c) Each Party Without limiting the generality of the undertakings pursuant to this Section 7.3, the parties hereto shall provide or cause to be provided as promptly as practicable to any Governmental Antitrust Entity information and documents requested or required to be submitted by any Governmental Antitrust Entity, including filing any notification and report form and related material required under the HSR Act or any other applicable Competition Law at a date to be mutually agreed by the parties (but not to exceed thirty (30) days from the execution of this Agreement without the written consent of the Seller Representative), and thereafter to respond promptly to any request for additional information or documentary material that may be made and use best efforts to obtain early termination of the waiting period under the HSR Act and to obtain required approval under any other applicable Competition Law, as set forth in Section 3.4(b) of the Company Disclosure Letter. Fees associated with filings required by the HSR Act and any other applicable Competition Law shall be borne by Buyer. (d) Further, each of the parties hereto shall take any and all actions necessary to resolve such objections, if any, as may be asserted by any Governmental Antitrust Entity with respect to the Transaction under any Competition Law. In connection therewith, if any Legal Proceeding is instituted (or threatened to be instituted) challenging the Transaction as in violation of any Competition Law, each of the parties hereto shall cooperate and use its best efforts to contest and resist any such Legal Proceeding, and to have full access to vacated, lifted, reversed or overturned any decree, judgment, injunction or other order whether temporary, preliminary or permanent, that is in effect and that prohibits, prevents or restricts consummation of the Transaction, including by pursuing all available avenues of administrative and judicial appeal and all available legislative action, unless, by mutual agreement, Buyer and the right Seller Representative decide that litigation is not in their respective best interests. Buyer and the Companies shall take any and all actions necessary as may be required to reference cause the expiration of the notice periods under the HSR Act or other Competition Laws with respect to the Transactions reasonably promptly, and in any NDAs and/or their foreign equivalent based on Immune Modulator owned case, prior to the Outside Date. In connection with and without limiting the foregoing, each of Buyer and the Companies agree to promptly take any and all steps necessary to avoid or eliminate each and every impediment under any Competition Laws that may be asserted by any Governmental Antitrust Entity, so as to enable the parties to close the Transaction reasonably promptly and, in any case, prior to the Outside Date. The parties hereto shall cooperate and work together in good faith in an effort to cause the expiration of the notice periods under the HSR Act or any other PartyCompetition Laws prior to December 31, 2017, or as promptly as practicable thereafter. Without limiting the generality of the foregoing, Buyer shall: (i) at Buyer’s sole cost, comply with all restrictions and conditions, if any, imposed or requested by any (A) Governmental Antitrust Entity with respect to Competition Laws in connection with granting any necessary clearance or terminating any applicable waiting period including (1) agreeing to sell, divest, hold separate, license, cause a third party to acquire, or otherwise dispose of, any Subsidiary, operations, divisions, businesses, product lines, customers or assets of Buyer, its Affiliates, and/or sublicensees Panadero Corp or any of its Subsidiaries contemporaneously with or after the Closing and regardless as to whether a third party filing Buyer has been identified or approved prior to the Closing (a “Divestiture”), (2) taking or committing to take such NDAs and/or their foreign equivalent on behalf of such Partyother actions that may limit Buyer, its Affiliates, Panadero Corp or any of its Subsidiaries’ freedom of action with respect to, or its sublicensees; providedability to retain, howeverone or more of its operations, that such rights are subject divisions, businesses, products lines, customers or assets, and (3) entering into any Order, consent decree or other agreement to the prior written consent effectuate any of the Person owning the NDA foregoing or foreign equivalent (B) third party in connection with a Divestiture; (ii) terminate any Contract or other business relationship as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate required to obtain such any necessary third party consents. Notwithstanding the foregoing, the rights granted clearance of any Governmental Antitrust Entity or to a Party to access and reference obtain termination of any NDAs and/or their foreign equivalent, as contemplated herein, shall applicable waiting period under any Competition Laws; and (iii) not extend to such Party’s sublicensees any waiting period or enter into any agreement or understanding with any Governmental Antitrust Entity without the prior written consent of the Person owning the NDA or foreign equivalent, such consent Companies (not to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law unreasonably withheld, conditioned or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authoritydelayed). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee The parties hereto shall have not, and shall cause their respective Affiliates not to, acquire or agree to acquire, by merging with or into or consolidating with, or by purchasing a substantial portion of the sole right assets of or equity in, or by any other manner, any business or any corporation, partnership, association or other business organization or division thereof, or otherwise acquire or agree to obtain all pricing and reimbursement approvals in all countries acquire any assets, if the entering into of a definitive agreement relating to, or the consummation of such acquisition, merger or consolidation could reasonably be expected to: (i) impose any delay in the Territory obtaining of, or increase the risk of not obtaining, any consents of any Governmental Antitrust Entity necessary to consummate the transactions contemplated hereby or the expiration or termination of any applicable waiting period; (ii) increase the risk of any Governmental Antitrust Entity entering an Order prohibiting the consummation of the transactions contemplated hereby; (iii) increase the risk of not being able to remove any such Order on appeal or otherwise; or (iv) delay or prevent the consummation of the transactions contemplated hereby. (f) The parties hereto shall take promptly, in which Licensed Products shall the event that any permanent or preliminary injunction or other Order is entered or becomes reasonably foreseeable to be soldentered in any Legal Proceeding that would make the consummation of the Transaction in accordance with the terms of this Agreement unlawful or that would prevent or delay consummation of the Transaction, any and all steps (including the appeal thereof, the posting of a bond or the taking of the steps contemplated by subsection (d)) necessary to vacate, modify or suspend such injunction or order so as to permit such consummation. (g) Notwithstanding the foregoing or any other provision of this Agreement (including Sections 7.3(d) and (f)), (1) none of the Sellers, the Seller Representative, Panadero Corp or any of its Subsidiaries shall, without Buyer’s prior written consent, take or commit to take any of the actions listed in clauses (i)–(iii) of Section 7.3(d) or any actions contemplated by Section 7.3(f) and (2) the Sellers, the Seller Representative, Panadero Corp and any of its Subsidiaries shall, at Buyer’s written request, take or commit to take any of the actions listed in clauses (i)–(iii) of Section 7.3(d) or any actions contemplated by Section 7.3(f), in each case so long as such actions are conditioned on the closing of the Transaction.

Regulatory Approvals. (a) Licensee Subject to and in accordance with the provisions of this Section 6.4, each of the Parties shall use Commercially Reasonable Efforts commercially reasonable efforts to submit registration dossiers obtain (and shall cooperate fully with the other Parties in obtaining) as promptly as practicable the Contributor Approvals, the SEP Approvals and all other authorizations, consents, clearances, orders, expirations, waivers or terminations of any applicable waiting periods and approvals of all Government Entities that may be or may become reasonably necessary, proper or advisable under this Agreement or any of the other Transaction Documents and applicable Laws to consummate and make effective the relevant Regulatory Authorities Transactions as promptly as practicable and in any event, in respect of the First Closing Transactions, no later than the Outside Date. SEP shall pay all filing fees in connection with respect to SEP Approvals. SE Corp shall pay all necessary Regulatory Approvals in each Major Countryfiling fees for all Contributor Approvals. (b) Licensee shall have the right to obtain Regulatory ApprovalsAs promptly as practicable, which shall be held by and in no event later than (i) fifteen Business Days after the name of Licenseedate hereof, or (ii) such later date as such filings and Licensee notifications may be required, SE Corp and SEP shall own all Submissions make, or cause to be made, (i) any filings with, or notices to, the Wyoming Public Service Commission and Data promptly file any supplemental information required or requested in connection therewith. All pricingtherewith and (ii) all filings and notifications with all Government Entities that may be or may become reasonably necessary, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx proper or advisable under this Section 4.4Agreement and applicable Laws to consummate and make effective the Transactions. (c) Each Party shall have full access to SE Corp and SEP may not, without the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by consent of the other Party(which consent shall not be unreasonably withheld, its Affiliatesdelayed or conditioned), and/or sublicensees (i) cause any such filing or submission applicable to it to be withdrawn or refiled for any third party filing reason, including to provide the applicable Government Entity with additional time to review any or all of the Transactions or (ii) consent to any voluntary extension of any statutory deadline or waiting period or to any voluntary delay of the consummation of the Transactions at the behest of any Government Entity. Each of SE Corp and SEP shall use commercially reasonable efforts to supply promptly any information and documentary material that may be requested pursuant to any applicable Laws in connection with such NDAs and/or their foreign equivalent on behalf filings or submissions. (d) Subject to applicable Laws relating to the sharing of information, SE Corp and SEP shall promptly notify each other of any communication such Party receives from any Government Entity (other than communications for purely logistical purposes) and permit such other Party to review in advance any proposed applications, notices, filings, submissions, undertakings, correspondence and communications of any nature (including responses to requests for information and inquiries from any Government Entity) by such Party, its Affiliatesas applicable, to any Government Entity and shall provide such other Party with copies of all applications, notices, filings, submissions, undertakings, correspondence and communications of any nature (including responses to requests for information and inquiries from any Government Entity) between such Party, as applicable, or any of its sublicenseesRepresentatives, on the one hand, and any Government Entity or members of the staff of any Government Entity, on the other hand, in each case to the extent relating to the matters that are the subject of this Agreement and the other Transaction Documents, except with respect to Taxes (which are covered by Section 6.8). Except with respect to Taxes (which are covered by Section 6.8), neither Party shall agree to participate in any meeting or discussion with any Government Entity relating to the matters that are the subject of this Agreement (including in respect of satisfying or obtaining the SEP Approvals and the Contributor Approvals) or any of the other Transaction Documents unless such Party consults with the other Party in advance and, to the extent permitted by such Government Entity, gives such other Party the opportunity to attend and participate at such meeting or discussion. SE Corp and SEP shall coordinate and cooperate fully with each other in exchanging such information and providing such assistance as each other may reasonably request in connection with the foregoing and shall keep each other informed of the status of discussions relating to obtaining or concluding the SEP Approvals and the Contributor Approvals; provided, however, that the foregoing shall not require SE Corp and SEP or any of their respective Affiliates (i) to disclose any information that in the reasonable judgment of such rights are subject to the prior written consent Party or any of the Person owning the NDA or foreign equivalent its respective Affiliates (as the case may be and be) would result in the disclosure of any information contained therein. In the event that a Party trade secrets of third parties or violate any of its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority obligations with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances andconfidentiality, (ii) to disclose any privileged information or confidential competitive information of such Party or any of its respective Affiliates or (iii) to disclose the valuation of, or any communications analyses or other work product regarding the valuation of, all or any part of (A) the Conveyed Interests, (B) the Total Unit Consideration, the Second Closing Exchanged GP Units and the Third Closing Exchanged GP Units, (C) the Companies or (D) the Companies’ assets. If either Party seeks to withhold information from the other Party for any reason permitted by this Section 6.4(d), such withholding Party shall nonetheless provide a redacted version of the information so withheld to the other Party and, subject to the requirement that such outside counsel not disclose the unredacted version to any other Person, a complete, unredacted version of the same to the outside legal counsel of the other Party. Neither Party shall be required to comply with any provision of this Section 6.4(d) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any that such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to compliance would be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productprohibited by applicable Law. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Upon the terms and subject to the conditions of this Agreement, each of the parties shall use Commercially Reasonable Efforts its reasonable best efforts to submit registration dossiers take, or cause to be taken, all actions and to do, or cause to be done, and cooperate with each other in order to do, all things necessary, proper or advisable under applicable Law (including under any Antitrust Law and under any applicable Gaming Law) to consummate the relevant Regulatory Authorities transactions contemplated by this Agreement at the earliest practicable date, including: (i) causing the preparation and filing of all forms, registrations and notices required to be filed to consummate the Mergers and the taking of such actions as are necessary to obtain any requisite expiration or termination of any applicable waiting period under the HSR Act; (ii) taking the steps necessary or desirable to obtain all consents, approvals (including Gaming Approvals) or actions of, make all filings with and give all notices to any Governmental Entity or any other Person required in order to permit consummation of the transactions contemplated by this Agreement; (iii) defending all lawsuits and other proceedings by or before any Governmental Entity challenging this Agreement or the consummation of the Mergers; and (iv) resolving any objection asserted with respect to all necessary Regulatory Approvals in each Major Countrythe transactions contemplated under this Agreement raised by any Governmental Entity and preventing the entry of any court order, and vacating, lifting, reversing or overturning any injunction, decree, ruling, order or other action of any Governmental Entity that would prevent, prohibit, restrict or delay the consummation of the transactions contemplated by this Agreement. (b) Licensee shall have In furtherance and not in limitation of the right provisions of Section 5.7(a), each of the parties, as applicable, agrees to obtain Regulatory Approvalsprepare and file as promptly as practicable, which shall be held by and in any event by no later than fifteen (15) Business Days from the name date of Licenseethis Agreement, an appropriate Notification and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, Report Form pursuant to the extent legally possible, being HSR Act. Each of the sole contact Company and Parent shall pay all of its own filing fees and other charges for the filings required under the HSR Act with such Regulatory Authorities, subject respect to the rights of Xxxxx under this Section 4.4it and its Subsidiaries. (c) Each Party shall have full access to In furtherance and not in limitation of the provisions of Section 5.7(a), Parent and the right Company agree to, and agree to reference cause their Affiliates and their respective directors, officers, partners, managers, members, principals and stockholders to, prepare and submit to the Gaming Authorities all applications and supporting documents necessary to obtain all required Gaming Approvals as promptly as practicable, and in any NDAs and/or their foreign equivalent based on Immune Modulator owned event no later than thirty (30) days from the date of this Agreement. (d) If any of the Parent Entities or the Company receives a request for information or documentary material from any Governmental Entity with respect to this Agreement or any of the transactions contemplated hereby, including but not limited to a Request for Additional Information or Documentary Material under the HSR Act or requests for supporting, supplemental, or additional documentation from any Gaming Authorities, then such party shall in good faith make, or cause to be made, as soon as reasonably practicable and after consultation with the other parties, a response which is, at a minimum, in substantial compliance with such request. (e) The parties shall keep each other apprised of the status of matters relating to the completion of the transactions contemplated by this Agreement and work cooperatively in connection with obtaining the approvals of or clearances from each applicable Governmental Entity, including: (i) cooperating with each other in connection with filings required to be made by any party under any Antitrust Law or applicable Gaming Law and liaising with each other in relation to each step of the procedure before the relevant Governmental Entities and as to the contents of all communications with such Governmental Entities. In particular, to the extent permitted by Law or Governmental Entity, no party will make any written communication with any Governmental Entity in relation to the transactions contemplated hereunder without first providing the other parties with a copy of such communication in draft form and giving such other parties a reasonable opportunity to discuss its content before it is filed with the relevant Governmental Entities, and such first party shall consider all reasonable comments timely made by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesparties in this respect; provided, however, that no party shall be required to provide the other parties with any written communications with any Governmental Entity (or related materials) if such rights are subject party reasonably determines that the disclosure of such written communications with any Governmental Entity (or related materials) would be materially prejudicial to such party’s business; (ii) furnishing to the prior written consent other parties all information within its possession that is required for any application or other filing to be made by the other parties pursuant to applicable Law in connection with the transactions contemplated by this Agreement; (iii) promptly notifying each other of any communications (and, unless precluded by Law, providing copies of any such communications that are in writing) from or with any Governmental Entity with respect to the transactions contemplated by this Agreement and ensuring to the extent permitted by Law or Governmental Entity that each of the Person owning parties is entitled to attend any substantive meetings with or other appearances before any Governmental Entity with respect to the NDA transactions contemplated by this Agreement, unless a party has a reasonable basis to object to the presence of the other parties at any such meetings or foreign equivalent appearances; (iv) consulting and cooperating with one another in connection with all analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto in connection with proceedings under or relating to the Antitrust Laws or applicable Gaming Laws; and (v) without prejudice to any rights of the parties hereunder, consulting and cooperating in all respects with the other in defending all lawsuits and other proceedings by or before any Governmental Entity challenging this Agreement or the consummation of the transactions contemplated by this Agreement. (f) In addition, Parent and the Company shall take, or cause to be taken, all other action and do, or cause to be done, all other things necessary, proper or advisable under all Antitrust Laws and/or applicable Gaming Laws to consummate the transactions contemplated by this Agreement as promptly as practicable, including using its reasonable best efforts to obtain as promptly as practicable the case may be expiration or termination of all waiting periods and obtain all Permits and all other approvals and any information contained therein. In other consents required to be obtained in order for the event that parties to consummate the transactions contemplated by this Agreement. (g) No actions taken pursuant to this Section 5.7 shall be considered for purposes of determining whether a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Material Adverse Effect has occurred. (h) Notwithstanding the foregoing, commercially, competitively and/or personal sensitive information and materials of a party will be provided to the rights granted other parties on an outside counsel-only basis, provided that the parties shall cooperate to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent enable appropriate communications to be at made available to the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority other party with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting commercially or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productcompetitively sensitive information redacted if necessary. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. The Parties will cooperate with each other and use best efforts to promptly prepare all necessary documentation, to effect all necessary filings and to obtain all necessary permits, consents, waivers, approvals and authorizations of, the Bank Regulators and any other Governmental Entities necessary to consummate the transactions contemplated by this Agreement and MainSource will make all necessary filings in respect of the required Regulatory Approvals as promptly as practicable after the date hereof (provided that Cheviot Financial has timely provided all information requested in writing by MainSource or its counsel, within thirty (30) days after the date hereof). In no event shall MainSource be required to agree to any prohibition, limitation, or other requirement that would, individually or in the aggregate, (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to prohibit or materially limit the relevant Regulatory Authorities with respect to ownership or operation by MainSource or any MainSource Subsidiary of all necessary Regulatory Approvals in each Major Country. or any material portion of the business or assets of Cheviot Financial or any Cheviot Financial Subsidiary, (b) Licensee compel MainSource or any MainSource Subsidiary to dispose of or hold separate all or any material portion of the business or assets of Cheviot Financial or any Cheviot Financial Subsidiary, (c) impose a material compliance burden, penalty or obligation on MainSource or any MainSource Subsidiary resulting from noncompliance by Cheviot Financial with its regulatory obligations; or (d) otherwise materially impair the value of Cheviot Financial and the Cheviot Financial Subsidiaries to MainSource and the MainSource Subsidiaries (any such requirement alone, or more than one such requirement together, a “Burdensome Condition”). The Parties will furnish each other and each other’s counsel with all information concerning themselves, their subsidiaries, directors, officers and stockholders and such other matters as may be necessary or advisable in connection with any application, petition or any other statement or application made to any Bank Regulator or Governmental Entity in connection with the Merger, and the other transactions contemplated by this Agreement. Cheviot Financial shall have the right to obtain Regulatory Approvals, which shall be held by review and in the name of Licenseecomment on, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact practicable to consult with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained thereinMainSource on, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials information which are relevant to the matters to be addressed at any such meeting or appears in any such telephone call (it being understood that filing made in no event will connection with the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to transactions contemplated by this Agreement with any Regulatory AuthorityBank Regulator or any Governmental Entity. Notwithstanding MainSource shall give Cheviot Financial and its counsel the foregoingopportunity to review and comment on, Licensee will have sole discretion as and to the extent practicable to consult with MainSource on, each filing prior to its being filed with a Bank Regulator and shall give Cheviot Financial and its counsel copies of, and an opportunity to review, if material, prior to their being filed with or sent to a Bank Regulator, any regulatory strategy filings, amendments and decision-making supplements to such filings and all responses to requests for any Licensed Productadditional information and replies to comments. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers Subject to the relevant Regulatory Authorities terms and conditions of this Agreement, each Constituent Corporation will use its best efforts to take, or cause to be taken, all actions reasonably necessary or advisable under applicable law to consummate the Merger, including (i) making or causing to be made the filings required by law with respect to all necessary Regulatory Approvals in each Major Countrythe Merger as promptly as is practicable, (ii) complying, as promptly as is reasonably practicable, with any requests received from a governmental body by such Constituent Corporation with respect to the Merger, and (iii) resolving any formal or informal objections of any governmental body with respect to any such filings or the Merger. (b) Licensee shall have The Constituent Corporations covenant and agree that if any required regulatory approval to consummate the right Merger is denied or not obtained, the Constituent Corporations will use their best efforts to obtain Regulatory Approvalswork together to restructure the Merger to achieve or acquire all required regulatory approvals, which shall it being agreed that in all such instances the benefits sought to be held delivered by and in the name Constituent Corporations from the Merger, financial or otherwise, will not change as a result of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4restructuring. (c) Each Party Until the earlier of the Effective Time or the termination of this Agreement, each Constituent Corporation shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by promptly notify the other Party, its Affiliates, and/or sublicensees or Constituent Corporation of any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject communication it receives from any governmental body relating to the prior written consent regulatory consents, registrations, approvals, permits and authorizations that are the subject of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, this Section 13 and shall cause its Affiliates not to, unreasonably withhold or delay consentpermit the other Constituent Corporation to review in advance any proposed communication by such Constituent Corporation to any governmental body in connection therewith to the extent permitted by applicable law. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties No Constituent Corporation shall agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference participate in any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) meeting with any material meetings between Licensee and any Regulatory Authority with governmental body in respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible matter unless it consults with the other Constituent Corporation in the circumstances advance and, (ii) to the extent reasonably possiblepermitted by such governmental body, gives the other Constituent Corporation the opportunity to provide Xxxxx, attend and participate at least five (5) business days before any such meeting, . The Constituent Corporation will coordinate and cooperate fully with each other in exchanging such information and providing such assistance any other Constituent Corporation may reasonably request in connection with the matters set forth in this Section 13. The Constituent Corporations will provide each other with copies of all documentscorrespondence, correspondence filings, or communications between them or any of their representatives, on the one hand, and any governmental body or members of its staff, on the other materials which are relevant hand, with respect to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as foregoing to the regulatory strategy and decision-making for any Licensed Productextent permitted by applicable law. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall Each of SBBX and PFS will cooperate with the other and use Commercially Reasonable Efforts best efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to promptly prepare all necessary documentation, to effect all necessary filings and to obtain all necessary permits, consents, waivers, approvals and authorizations of the SEC, the Bank Regulators and any other third parties and governmental bodies necessary to consummate the transactions contemplated by this Agreement, and PFS and Provident Bank will make all necessary filings in respect of the required Regulatory Approvals in each Major Country. (b) Licensee shall have as promptly as practicable after the right to obtain Regulatory Approvals, which shall be held by and in the name of Licenseedate hereof, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in no later than forty-five (45) days after the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesdate hereof; provided, however, that such rights are subject in no event shall PFS or Provident Bank be required to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoingany prohibition, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalentlimitation, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative other requirement that would (i) attend (but not participate in) prohibit or materially limit the ownership or operation by PFS or Provident Bank of all or any material meetings between Licensee and portion of the business or assets of SBBX or any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances andSBBX Subsidiary, (ii) compel PFS or Provident Bank to dispose of or hold separate all or any material portion of the extent reasonably possiblebusiness or assets of SBBX or any SBBX Subsidiary, (iii) impose a material compliance burden, penalty or obligation on PFS or Provident Bank resulting from noncompliance by SBBX or any SBBX Subsidiary with its regulatory obligations or (iv) otherwise materially impair the value of SBBX and the SBBX Subsidiaries to provide Xxxxx, at least five PFS and Provident Bank (5) business days before any such meetingrequirement alone, with copies of all documentsor more than one such requirement together, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority“Burdensome Condition”). Licensee SBBX and PFS will also provide Xxxxx furnish each other and each other’s counsel with access all information concerning themselves, their subsidiaries, directors, officers and shareholders and such other matters as may be necessary or advisable in connection with the Proxy Statement-Prospectus and any application, petition or any other statement or application made by or on behalf of SBBX, PFS to all exchanges of material correspondence related any Bank Regulator or governmental body in connection with the Merger, and the other transactions contemplated by this Agreement. SBBX shall have the right to activities conducted pursuant to review and approve in advance any filing made in connection with the transactions contemplated by this Agreement with any Regulatory Authoritygovernmental body. Notwithstanding PFS shall give SBBX and its counsel the foregoingopportunity to review and comment on each filing prior to its being filed with a Bank Regulator or the SEC and shall give SBBX and its counsel the opportunity to review and comment on all regulatory filings, Licensee will have sole discretion as amendments and supplements to such filings and all responses to requests for additional information and replies to comments prior to their being filed with, or sent to, a Bank Regulator or the regulatory strategy and decision-making for any Licensed ProductSEC. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. Each party hereto shall cooperate and prepare and file as soon as practicable, but in any event within fifteen (a15) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to days of the relevant Regulatory Authorities with respect to date of this Agreement, all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right documentation to effect all necessary applications, notices, petitions, filings and other documents, and obtain all permits, licenses, and other governmental authorizations, consents and approvals necessary or advisable to obtain the Required Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties The parties further agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable best efforts (i) to provide Xxxxx with as much advance notice of take any such meeting action, make any undertaking or telephone call as is reasonably possible receive any clearance or approval required by any Governmental Authority or applicable Law, including those specified in the circumstances and, Sections 9.3(a) and 9.3(b) and (ii) to satisfy any conditions imposed by any Governmental Authority in all final and nonappealable Governmental Orders. Each of the extent parties shall respond as promptly as practicable to any inquiries or requests received from any Governmental Authority for additional information or documentation. Each of the parties shall use reasonable best efforts to avoid or eliminate each and every impediment under any antitrust, competition, or trade or telecom regulation Law (including the Communications Act of 1934, the HSR Act, if applicable, and the Exon-Xxxxxx Amendment) that may be asserted by any Governmental Authority with respect to the transactions contemplated by this Agreement so as to enable the Closing Date to occur as soon as reasonably possible. The steps involved in the preceding sentence shall include proposing, negotiating, committing to and effecting, by consent decree, hold separate order or otherwise, the sale, divestiture or disposition of such assets or businesses of Parent or its Affiliates (including their respective Subsidiaries) or agreeing to such limitations on its or their conduct or actions as may be required in order to obtain the Required Regulatory Approvals and, if applicable, all required approvals under the HSR Act as soon as reasonably possible, to provide Xxxxxavoid the entry of, at least five (5) business days before or to effect the dissolution of, any such meetinginjunction, with copies of all documents, correspondence and temporary restraining order or other materials which are relevant to the matters to be addressed at any such meeting or order in any such telephone call (it being understood that in no event will the provisions of clause (i) suit or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoingproceeding, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall which would otherwise have the sole right to obtain all pricing effect of preventing or delaying the Closing Date, and reimbursement approvals defending through litigation on the merits, including appeals, any claim asserted in all countries in the Territory in which Licensed Products shall be soldany court by any party.

Regulatory Approvals. (a) Licensee Each of the parties hereto shall cooperate and use Commercially Reasonable Efforts their respective reasonable best efforts to submit registration dossiers take, or cause to be taken, all action, and to do, or cause to be done as promptly as practicable, all things necessary, proper and advisable under applicable Laws, to consummate and make effective as promptly as practicable the Transactions, including providing any notices to any Person required in connection with the consummation of the Transactions, and obtaining any licenses, consents, waivers, approvals, authorizations, qualifications and Governmental Orders necessary to consummate the Transactions; provided, that in no event shall any party be required to pay any material fee, penalty or other consideration to obtain any license, Permit, consent, approval, authorization, qualification or waiver required under any Contract for the consummation of the Transactions (other than fees or expenses payable to the relevant Regulatory Authorities SEC in connection with respect the Transactions, including the Registration Statement, filing fees payable pursuant to all the HSR Act or other Competition Laws, and any other ordinary course filing fees in connection with Governmental Filings required to consummate the Transactions). Subject to appropriate confidentiality protections and applicable Competition Laws, each party hereto shall furnish to the other parties such necessary Regulatory Approvals information and reasonable assistance as such other party may reasonably request in each Major Countryconnection with the foregoing. (b) Licensee Each of the parties hereto shall have the right cooperate with one another and use their reasonable best efforts to prepare all necessary documentation (including furnishing all information (i) required under any applicable Competition Laws or other applicable Laws or (ii) requested by a Governmental Entity pursuant to applicable Competition Laws) to effect promptly all necessary filings with any Governmental Entity and to obtain Regulatory Approvalsall necessary, which proper or advisable actions or nonactions, approvals consents, waivers, exemptions and approvals of any Governmental Entity necessary to consummate the Transactions. Each party hereto shall be held by provide to the other parties copies of all correspondence between it (or its advisors) and any Governmental Entity relating to the Transactions or any of the matters described in this Section 8.07. Each of the name parties hereto shall promptly inform the other of Licenseeany substantive oral communication with, and Licensee provide copies of any written communications with, any Governmental Entity regarding any such filings or any such transaction, unless prohibited by reasonable request of any Governmental Entity. No party hereto shall own all Submissions and Data independently participate in connection therewith. All pricingany meeting or substantive conference call with any Governmental Entity in respect of any such filings, formulary and marketing approvals shall also be obtained by and in investigation or other inquiry without giving the name other party prior notice of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingmeeting or substantive conference call and, to the extent legally possiblepermitted by such Governmental Entity, being the sole contact opportunity to attend or participate. In the event a party is prohibited from participating in or attending any meeting or substantive conference call, the participating party shall keep the other party promptly and reasonably apprised with such Regulatory Authoritiesrespect thereto, subject to the rights extent permitted by applicable Law. To the extent permissible under applicable Law, the parties hereto will consult and cooperate with one another in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of Xxxxx any party hereto relating to proceedings under Competition Laws or other applicable Laws. Any documents or other materials provided pursuant to this Section 8.07(b) may be redacted or withheld as necessary to address reasonable privilege or confidentiality concerns, and to remove references concerning the valuation of the Company or other competitively sensitive material or personally-identifiable information or other sensitive personal or financial information, and the parties may, as each deems advisable, reasonably designate any material provided under this Section 4.48.07 as “outside counsel only material.” Such “outside counsel only materials” and the information contained therein shall be given only to legal counsel of the recipient and will not be disclosed by such legal counsel to employees, officers, or directors of the recipient without the advance written consent of the party providing such materials. Notwithstanding the foregoing, neither party shall be obligated to share with the other party documents responsive to items 4(c) and 4(d) on the Notification and Report Form for Certain Mergers and Acquisitions under the HSR Act. (c) Without limiting the generality of the undertakings pursuant to this Section 8.07, each party hereto shall use reasonable best efforts to provide or cause to be provided (including, with respect to filings pursuant to the HSR Act, by its “Ultimate Parent Entities”, as that term is defined in the HSR Act) as promptly as reasonably practicable to any Governmental Entity information and documents relating to such party as requested by such Governmental Entity or necessary, proper or advisable to permit consummation of the Transactions, including filing any notification and report form and related material required under the HSR Act and any other filing or notice that may be required with any other Governmental Entity as promptly as reasonably practicable after the date hereof (and, in the case of filings under the HSR Act, no later than 10 Business Days after the date hereof), and thereafter to respond as promptly as reasonably practicable to any request for additional information or documentary material relating to such party that may be made (including under the HSR Act and any similar Competition Law regarding preacquisition notifications for the purpose of competition reviews). Each Party of the Company and Purchaser shall have full access supply as promptly as practicable any additional information and documentary material relating to such party that may be requested by any Governmental Entity and the right furnish to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Partysuch necessary information and reasonable assistance as the other may request in connection with the preparation of any required applications, notices, registrations and requests as may be required or advisable to be filed with any Governmental Entity (including, with respect to Purchaser and its Affiliates, and/or sublicensees providing financial information and certificates as well as personal information of senior management or control persons, and making individuals with appropriate seniority and expertise available to participate in discussions or hearings). Purchaser shall cause the filings made by it (or by its Ultimate Parent Entity, if applicable) under the HSR Act to be considered for grant of “early termination,” and make any third party filing such NDAs and/or their foreign equivalent on behalf further filings pursuant thereto that may be necessary, proper, or advisable in connection therewith. (d) Purchaser shall provide, or cause to be provided, all agreements, documents, instruments, affidavits, statements or information that may be required or requested by any Governmental Entity relating to (i) Purchaser and its Affiliates (including any of such Party, its Affiliatesits, or its sublicensees; providedAffiliates’, howeverdirectors, that such rights officers, employees, partners, members or shareholders), (ii) all Persons who are subject deemed or may be deemed to “control” Purchaser and its Subsidiaries within the meaning of applicable Mortgage Laws and (iii) Purchaser’s and its Affiliates’ structure, ownership, businesses, operations, regulatory and legal compliance, assets, liabilities, financing, financial condition or results of operations, or any of its or their directors, officers, employees, partners, members or shareholders. (e) If any objections are asserted with respect to the prior written consent Transactions under any applicable Law or if any Action is instituted by any Governmental Entity or any private party challenging any of the Person owning Transactions as violative of any applicable Law, each of the NDA parties hereto shall, at the sole cost and expense of Purchaser, cooperate with one another in good faith and use their reasonable best efforts to: (i) oppose or foreign equivalent defend against any action to prevent or enjoin consummation of this Agreement (and the Transactions), and (ii) take such action as reasonably necessary to overturn any regulatory action by any Governmental Entity to prevent or enjoin consummation of this Agreement (and the case Transactions), including by defending any Action brought by any Governmental Entity in order to avoid entry of, or to have vacated, overturned or terminated, including by appeal if necessary, in order to resolve any such objections or challenge as such Governmental Entity or private party may be and have to any information contained therein. In of the event that a Party or its Affiliates is Transactions under such applicable Law so as to permit the owner consummation of such NDA or foreign equivalent as the case may be or information contained thereinTransactions in their entity. (f) Notwithstanding the foregoing, such Party shall notPurchaser shall, and shall cause its controlled Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate take any and all actions necessary to obtain such any authorization, consent or approval of a Governmental Entity (including in connection with any Governmental Filings) necessary third party consents. Notwithstanding or advisable so as to enable the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent consummation of the Person owning Transactions to occur as expeditiously as possible (and in any event, no later than the NDA Outside Date) and to resolve, avoid or foreign equivalenteliminate any impediments or objections, such consent if any, that may be asserted with respect to be at the sole discretion Transactions under any Law, or to otherwise oppose, avoid the entry of, or to effect the dissolution of, any order, decree, judgment, preliminary or permanent injunction that would otherwise have the effect of such owning Person. (d) To preventing, prohibiting, restricting, or delaying the extent not prohibited by law or regulationconsummation of the Transactions, Xxxxx shall have right to have one (1) representative including: (i) attend proposing, negotiating, committing to and effecting, by consent decree, hold separate order or otherwise, the sale, divestiture, licensing or disposition of, or holding separate of, businesses, product lines, rights or assets of Purchaser or its controlled Affiliates (but not participate inincluding the Company and its Subsidiaries) or any material meetings between Licensee and interest therein (including entering into customary ancillary agreements relating to any Regulatory Authority with respect to Licensed Products such sale, divestiture, licensing or disposition of such businesses, product lines, rights or assets) and (ii) listen otherwise taking or committing to take actions that after the Closing Date would limit Purchaser’s or its controlled Affiliates’ (but not participate including the Company’s and its Subsidiaries’), freedom of action with respect to, or its ability to retain or control, one or more of the businesses, product lines, rights or assets of Purchaser and its controlled Affiliates (including the Company and its Subsidiaries) or interest therein, in each case as may be required in order to enable the consummation of the Transactions to occur as expeditiously as possible (and in any event no later than the Outside Date). (g) From the date of this Agreement until Closing, neither Purchaser nor any of its controlled Affiliates shall acquire or agree to acquire, by merging with or into or consolidating with, or by purchasing a substantial portion of the assets of or any equity in) , or by any other manner, any assets or Person, if the execution and delivery of a definitive agreement relating to, or the consummation of, such acquisition could in any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and (individually or in the relevant Regulatory Authority. Licensee will use reasonable efforts aggregate): (i) impose any delay in obtaining, or increase the risk of not obtaining, consents of a Governmental Entity necessary to provide Xxxxx with as much advance notice consummate the Transactions or the expiration or termination of any such meeting or telephone call as is reasonably possible in the circumstances andapplicable waiting period, (ii) increase the risk of a Governmental Entity seeking or entering a Governmental Order prohibiting the consummation of the Transactions, (iii) increase the risk of not being able to remove any such Governmental Order on appeal or otherwise, or (iv) otherwise prevent or delay the consummation of the Transactions. (h) Notwithstanding anything in this Agreement to the extent reasonably possiblecontrary, nothing in this Agreement shall require any Seller-Side Party to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) take, or cause to be taken, any action with respect to Blackstone or any of its Affiliates, including any affiliated investment funds or any portfolio company (as such term is commonly understood in the private equity industry) of Blackstone or any of its Affiliates, including selling, divesting or otherwise disposing of, or conveying, licensing, holding separate or otherwise restricting or limiting its freedom of action with respect to, any assets, business, products, rights, licenses or investments, or interests therein, other than with respect to the Company and its Subsidiaries, or (ii) provide, or cause to be provided, (A) nonpublic or other confidential financial or sensitive personally identifiable information of this sentence require Licensee Blackstone, its Affiliates or its or their respective directors, officers, employees, managers or partners, or its or their respective control persons’ or direct or indirect equityholders’ and their respective directors’, officers’, employees’, managers’ or partners’ (each of the foregoing Persons, a “Blackstone Related Person”) nonpublic or other confidential financial or sensitive personally identifiable information (other than such information with respect to delay the officers and directors of the Company which may be provided to a Governmental Entity on a confidential basis) or (B) any meeting other nonpublic, proprietary or telephone call other confidential information of a Blackstone Related Person that exceeds the scope of information that such Blackstone Related Person has historically supplied in connection with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsimilar governmental filing or notification. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Without limiting the generality of Section 6.3, as soon as reasonably practicable (and in any event within ten (10) Business Days) following the date hereof, each of Parent and the Company shall file with the FTC and the Antitrust Division of the DOJ a Notification and Report Form relating to this Agreement and the transactions contemplated hereby (including the Offer and the Merger) as required by the HSR Act, and Parent shall file comparable pre-merger notification filings, forms and submissions with any Governmental Authority that is required by the Antitrust Laws of the Specified Jurisdiction. Each of Parent and the Company shall use Commercially Reasonable Efforts reasonable best efforts to submit registration dossiers to promptly (i) cooperate and coordinate with the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and other in the name making of Licenseesuch filings, (ii) supply the other with any information or documents that may be required in order to effectuate such filings, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions (iii) comply with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned request for additional information made by the FTC, the DOJ or the competition or merger control authorities of any other Partyjurisdiction. Each party hereto shall promptly inform the other party or parties hereto, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be, of any communication from any Governmental Authority regarding any of the transactions contemplated by this Agreement (including the Offer and the Merger). If any party hereto or Affiliate thereof receives a request for additional information or documentary material from any such Governmental Authority with respect to the transactions contemplated by this Agreement (including the Offer and the Merger), then such party shall use reasonable best efforts to make, or cause to be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalentmade, as contemplated hereinsoon as reasonably practicable and after consultation with the other party, an appropriate response in compliance with such request. Neither Parent nor the Company shall not commit or agree (or permit their respective Subsidiaries or Affiliates to commit or agree) with any Governmental Authority to stay, toll or extend to such Party’s sublicensees any applicable waiting period under the HSR Act or other applicable Antitrust Laws, without the prior written consent of the Person owning the NDA or foreign equivalent, other (such consent not to be at unreasonably withheld or delayed). Parent shall have the sole discretion right to direct, lead, and make final decisions regarding all communications with any Governmental Authority and strategy relating to the HSR Act and any other Antitrust Laws of such owning Personany other jurisdiction in connection with the transactions contemplated hereby consistent with its obligations hereunder, subject to prior good faith consultation with the Company. (db) To Notwithstanding anything to the extent not prohibited by law contrary set forth in this Agreement, none of Parent, Merger Sub or regulationany of their Subsidiaries shall be required to, Xxxxx shall have right and the Company and its Subsidiaries may not, without the prior written consent of Parent, become subject to, consent to, or offer or agree to, or otherwise take any action with respect to, any requirement, condition, limitation, understanding, agreement or order to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice sell, license, assign, transfer, divest, hold separate or otherwise dispose of any such meeting assets, business or telephone call as is reasonably possible in portion of business of the circumstances andCompany, the Surviving Corporation, Parent, Merger Sub or any of their respective Subsidiaries, (ii) to conduct, restrict, operate, invest or otherwise change the extent reasonably possibleassets, to provide Xxxxxbusiness or portion of business of the Company, at least five the Surviving Corporation, Parent, Merger Sub or any of their respective Subsidiaries in any manner, or (5iii) impose any restriction, requirement or limitation on the operation of the business days before or portion of the business of the Company, the Surviving Corporation, Parent, Merger Sub or any of their respective Subsidiaries; provided that, if requested by Parent, the Company will become subject to, consent to, or offer or agree to, or otherwise take any action with respect to, any such meetingrequirement, with copies of all documentscondition, correspondence and other materials which are relevant to limitation, understanding, agreement or order so long as such requirement, condition, limitation, understanding, agreement or order is only binding on the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries Company in the Territory in which Licensed Products shall be soldevent the Closing occurs.

Regulatory Approvals. (a) Licensee Each party shall use Commercially Reasonable Efforts all reasonable efforts to submit registration dossiers file or otherwise submit, as soon as practicable after the date of this Agreement, all notices, applications, reports and other documents required to the relevant Regulatory Authorities be filed by such party with or otherwise submitted by such party to any Governmental Body with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of LicenseeTransaction, and Licensee shall own all Submissions and Data in connection therewithto submit promptly any additional information requested by any such Governmental Body. All pricing, formulary and marketing approvals shall also be obtained by and in Without limiting the name generality of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted Company and Parent shall, promptly after the date of this Agreement, prepare and file (a) the notification and report forms required to a Party be filed under the HSR Act, (b) any notification or other document required to access be filed in connection with the Transaction under any applicable foreign Legal Requirement relating to antitrust or competition matters, and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend (c) all applications necessary to such Party’s sublicensees obtain all required Governmental Authorizations under Gaming Laws. Also without limiting the prior written consent generality of the Person owning foregoing, the NDA or foreign equivalent, such consent Company and Parent shall use all reasonable efforts to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) take all reasonable action necessary to ensure that no state takeover statute or similar statute or regulation is or becomes applicable to any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products Contemplated Transaction or this Agreement and (ii) listen if any state takeover statute or similar statute or regulation becomes applicable to the Transaction or this Agreement, take all reasonable action necessary to ensure that the Transaction may be consummated as promptly as practicable on the terms contemplated by this Agreement and otherwise to minimize the effect of such statute or regulation thereon. The Company and Parent shall respond as promptly as practicable to: (but not participate inA) any material telephone conversation between Licensee inquiries or requests received from the Federal Trade Commission or the Department of Justice for additional information or documentation; and (B) any Regulatory Authority inquiries or requests received from any state attorney general, foreign antitrust or competition authority or other Governmental Body in connection with antitrust or competition matters. At the request of Parent, the Company shall agree to divest, sell, dispose of, hold separate or otherwise take or commit to take any other action with respect to Licensed Products any of the businesses, product lines or assets of the Acquired Corporations, provided that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as action is reasonably possible in conditioned upon the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies consummation of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.Merger I.

Regulatory Approvals. (a) Licensee 5.2.1 As between the Parties, Mersana shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant be solely responsible for, and shall solely own, all applications for Regulatory Authorities Approval and Pricing Approval with respect to Licensed Products in the Mersana Territory and Licensee shall be solely responsible for, and shall solely own, all necessary applications for Regulatory Approvals Approval and Pricing Approval with respect to Licensed Products in each the Licensee Territory (to the extent consistent with Section 5.6 and the Pharmacovigilance Agreement, which shall govern with respect to required safety reports to Regulatory Authorities). Each Party will allow the other Party a reasonable opportunity to review and comment on all applications for Regulatory Approval (and not applications for Pricing Approvals) in the United States, Canada, China, Russia and the Major CountryMarket Countries with respect to a Licensed Product in advance of submission of any such application for Regulatory Approval by such Party or any of its Affiliates, licensees or Sublicensees, and such Party will, and will cause its Affiliates, licensees or Sublicensees to, reasonably consider all comments timely provided by such other Party in connection therewith. 5.2.2 To the extent permitted by the applicable Regulatory Authority, in connection with applications for Regulatory Approval (band not applications for Pricing Approval) Licensee in the United States, Canada, China, Russia and the Major Market Countries, each Party shall provide prior written notice reasonably in advance of, and the other Party shall have the right to obtain Regulatory Approvalshave a designee participate in, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact meetings with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned Authorities being conducted by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, Party or its Affiliates, licensees or its sublicensees; providedSublicensees, however, that and the other Party shall have the right to participate in internal meetings or discussions of such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is Affiliates, licensees or Sublicensees (or the owner of such NDA applicable portions thereof) occurring before or foreign equivalent as the case may be or information contained thereinafter, and related to, such Party shall notmeetings, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to be provided with advance access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without materials prepared for such meetings. 5.2.3 Each Party, in connection with applications for Regulatory Approval (and not applications for Pricing Approval) in the prior written consent United States, Canada, China, Russia and the Major Market Countries, shall also have the right to review and comment upon any material correspondence between the other Party or its Affiliates, licensees or Sublicensees and the Regulatory Authorities or their agents. 5.2.4 Each Party, in connection with applications for Regulatory Approval (and not applications for Pricing Approval) in the United States, Canada, China, Russia and the Major Market Countries, shall provide the other Party regularly prepared minutes of material meetings with any Regulatory Authority regarding Licensed Products in the Field conducted by or on behalf of such Party or its Affiliates, licensees or Sublicensees, and available material teleconference reports with any Regulatory Authority regarding Licensed Products in the Field conducted by or on behalf of such Party or its Affiliates, licensees or Sublicensees. 5.2.5 All materials provided under this Section 5.2 shall be deemed Confidential Information of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Personproviding Party. (d) 5.2.6 To the extent not prohibited by law or regulation, Xxxxx shall have right that any application for Regulatory Approval and Pricing Approval is a required safety report to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx , this Section 5.2 shall not apply to such filing and Section 5.6 shall control with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productrespect such filing. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Subject to Section 7.1, promptly after the Effective Date, but taking into account the anticipated Closing Date, Seller and Texas Genco shall each file or cause to be filed with the Federal Trade Commission and the Department of Justice all notifications required to be filed under the HSR Act and the rules and regulations promulgated thereunder with respect to the Transactions. Seller and Texas Genco shall consult with each other as to the appropriate time of filing such notifications and shall agree in good faith upon the timing of such filings, respond promptly to any requests for additional information made by either of such agencies, and use Commercially Reasonable Efforts to cause the waiting periods under the HSR Act to terminate or expire at the earliest possible date after the date of filing. (b) Subject to Section 7.1, promptly after the Effective Date, Purchasers and Seller shall jointly submit applications to the NRC requesting the NRC Approvals, and the Parties shall respond promptly to any requests for additional information made by the NRC, cooperate in connection with any presentation or proceeding associated with such NRC application and use their respective Commercially Reasonable Efforts to cause the NRC Approvals to be obtained at the earliest possible date after the date of filing. The Parties shall consult with each other as to the appropriate time of filing such applications and shall agree in good faith upon the timing of such applications. Each Party will bear its own costs of the preparation of any such filing, and Purchasers (ratably in accordance with their Proportionate Shares), on the one hand, and Seller, on the other hand, will share equally the cost of all filing fees with respect to any NRC filings required to consummate the Transactions. (c) Without limiting the generality of Texas Genco's undertakings pursuant to Section 7.5(a), each Purchaser shall: (i) take promptly any or all of the following actions to the extent necessary to eliminate any concerns on the part of any Governmental Authority regarding the legality under any Law of such Purchaser's acquisition of the Purchased Assets: entering into negotiations, providing information, making proposals, entering into and performing agreements or submitting to judicial or administrative orders, holding separate (through the establishment of a trust or otherwise) particular assets or categories of assets, or businesses, of such Purchaser or its Affiliates, or agreeing to dispose of one or more assets or properties (whether owned by such Purchaser or its Affiliates) whether before or after the Closing; provided, however, that nothing in this Agreement shall require such Purchaser or its Affiliates to dispose of or sell assets or properties, hold separate particular assets or categories of assets, or businesses, or agree to dispose of or hold separate one or more assets or properties, except that Texas Genco or its Affiliates shall, if required, agree to dispose of or sell assets or properties with an aggregate fair market value of U.S. $10 million or less and agree to such reasonable undertakings necessary to consummate such dispositions or sales as a condition to eliminating a Governmental Authority's concerns regarding the legality under any Law of such Purchaser's acquisition of the Purchased Assets; (ii) use Commercially Reasonable Efforts (including taking the steps contemplated by Section 7.5(c)(i)) to prevent the entry in a judicial or administrative proceeding brought under any Law by any Governmental Authority or any other party for a permanent or preliminary injunction or other order that would make consummation of the Transactions unlawful or that would prevent or delay such consummation; (iii) take promptly, in the event that such an injunction or order has been issued in such a proceeding, any and all Commercially Reasonable Efforts, including the appeal thereof or the posting of a bond or the steps contemplated by Section 7.5(c)(i) necessary to vacate, modify or suspend such injunction or order so as to permit such consummation on a schedule as close as possible to that contemplated by this Agreement; (iv) subject to Section 7.1, have the primary responsibility for securing the transfer, reissuance, procurement or modification, as applicable, of the Permits, Seller Licenses and STP Owners Licenses included in Purchaser's Required Regulatory Approvals effective as of the Closing Date. Seller shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities cooperate with respect to all necessary Regulatory Approvals each Purchaser's efforts in each Major Country.this regard and assist in any transfer of Transferable Permits; (bv) Licensee shall have take such actions, if required under the Acid Rain Requirements, to notify the USEPA, TCEQ and any other Governmental Authority of the change of ownership of the STP Interest and the appointment by each Purchaser of one or more replacement Designated Representative(s), effective at 12:00 a.m. on the day following the Closing Date; and (vi) take, along with Seller, all Commercially Reasonable Efforts, including executing any required forms or providing appropriate notices to Governmental Authorities, in a timely fashion, for each Purchaser to obtain all, or the rights to all, Emission Allowances that are to be transferred to it pursuant to Section 2.1(p), Section 2.1(q) and Section 2.1(r), including the right to obtain Regulatory Approvals, which shall receive such Emission Allowances that are to be held by and allocated or issued in the name of Licensee, future. Each Purchaser and Licensee shall own all Submissions Seller further acknowledge and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, agree that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case actions may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not required prior to, unreasonably withhold on or delay consent. In after the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonClosing Date. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee The Parent and the Holders agree that, at the request of the other party, from time to time, they shall use Commercially Reasonable Efforts cooperate with and assist each other to submit registration dossiers determine whether a Regulatory Approval is or would be required in connection with any proposed or potential exchange of the Preferred Shares pursuant to this Agreement or the Series B-1 Preferred Share Terms or Series B-2 Preferred Share Terms, as applicable, including cooperation from the Parent and the Holders in providing each other with such financial and other information as is required to assess whether the size of the transaction, size of the parties or other thresholds applicable to the relevant determination of whether a Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major CountryApproval are attained. (b) Licensee The Parent and the Holders agree that, at the request of the other party, from time to time, they shall have the right cooperate with and assist each other to obtain any Regulatory Approval that is determined by the Holders or the Parent, each acting reasonably and on the advice of counsel, to be required in connection with the exchange of the Preferred Shares pursuant to this Agreement or the Series B-1 Preferred Share Terms or Series B-2 Preferred Share Terms, as applicable, or in connection with the exercise of voting rights or Beneficiary Votes as contemplated in Section 6.2 of the Engaged Investor Rights Agreement and the Oaktree Investor Rights Agreement. Such mutual cooperation shall include: (i) using commercially reasonable efforts to take, or cause to be taken, all actions, and to do, or cause to be done, all things necessary or advisable under applicable Law to obtain any such Regulatory Approval as promptly as practicable following the request of the other party, including: (i) the preparation and filing of all forms, registrations and notifications required to be filed in connection with such Regulatory Approvals; (ii) satisfaction of any conditions required to obtain such Regulatory Approval; and (iii) obtaining (and cooperating with each other in obtaining) any consent, which shall authorization, expiration or termination of a waiting period, permit, order or approval of, waiver or any exemption by, any Governmental Entity required to be held obtained or made by and in the name of Licensee, and Licensee shall own all Submissions and Data parties in connection therewith. All pricing, formulary with such Regulatory Approval; and (ii) keeping each other fully informed as to the status of and marketing approvals shall also be obtained by the processes and proceedings relating to obtaining any such Regulatory Approval and promptly notifying each other of any material communication from any Governmental Entity in the name respect of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with any Regulatory Authorities concerning any Licensed Products includingApproval and, to the extent legally possiblenot precluded by such Governmental Entity, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by giving the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject parties the opportunity to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall notreview drafts of, and shall cause its Affiliates not toprovides final copies of, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documentssubmissions, correspondence or filings, and other materials which are relevant to the matters to be addressed at any such meeting or attend and participate in any such telephone call (it being understood that in no event will the provisions of clause (i) communications or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productmeetings. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to Following the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have occurrence and during the right to obtain Regulatory Approvalscontinuation of an Event of Default, which shall be held by and in the name of Licenseepromptly, and Licensee shall own at its expense, execute and deliver, or cause to be executed and delivered, all Submissions and Data in connection therewith. All pricingapplications, formulary and marketing approvals shall also be obtained by and in the name of Licenseecertificates, instruments, registration statements, and Licensee will all other documents and papers the Collateral Agent may reasonably request and as may be required by law to acquire any Governmental Approval or the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning consent, approval, registration, qualification or authorization of any Licensed Products including, to other Person deemed necessary or appropriate for the extent legally possible, being the sole contact with such Regulatory Authorities, subject to effective exercise of any of the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and Security Agreement. Without limiting the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf generality of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, if an Event of Default shall have occurred and be continuing, each Obligor shall take any action which the rights granted Collateral Agent may request in order to transfer and assign to the Collateral Agent, or to such one or more third parties as the Collateral Agent may designate, or to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent combination of the Person owning the NDA or foreign equivalentforegoing, such consent to be at the sole discretion each Government Approval of such owning Person. (d) Obligor. To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will enforce the provisions of clause this subsection, upon the occurrence and during the continuance of an Event of Default, the Collateral Agent is empowered to request the appointment of a receiver from any court of competent jurisdiction. Such receiver shall be instructed to seek from the Governmental Authority an involuntary transfer of control of each such Governmental Approval for the purpose of seeking a bona fide purchaser to whom control will ultimately be transferred. Each Obligor hereby agrees to authorize such an involuntary transfer of control upon the request of the receiver so appointed, and, if such Obligor shall refuse to authorize the transfer, its approval may be required by the court. Upon the occurrence and continuance of an Event of Default, such Obligor shall further use its best efforts to assist in obtaining Governmental Approvals, if required, for any action or transaction contemplated by this Security Agreement, including, without limitation, the preparation, execution and filing with the Governmental Authority of such Obligor’s portion of any necessary or appropriate application for the approval of the transfer or assignment of any portion of the assets (i) or (iiincluding any Governmental Approval) of such Obligor. Because each Obligor agrees that the Collateral Agent’s remedy at law for failure of such Obligor to comply with the provisions of this sentence require Licensee subsection would be inadequate and that such failure would not be adequately compensable in damages, such Obligor agrees that the covenants contained in this subsection may be specifically enforced, and such Obligor hereby waives and agrees not to delay assert any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges defenses against an action for specific performance of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsuch covenants. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. Acquiror and the Company and their respective Subsidiaries will cooperate and use all reasonable best efforts to as promptly as possible prepare, but in no event later than thirty (a30) Licensee shall use Commercially Reasonable Efforts days following the date hereof, file, effect and obtain all Requisite Regulatory Approvals, and the parties will comply with the terms of such Requisite Regulatory Approvals. Each of Acquiror and the Company will have the right to submit registration dossiers review in advance, and to the relevant Regulatory Authorities extent practicable each will consult with the other, in each case subject to applicable Legal Requirements relating to the exchange of information, with respect to all necessary substantive written information submitted to any Regulatory Approvals Authority in each Major Country. (b) Licensee shall have connection with the right to obtain Requisite Regulatory Approvals. In exercising the foregoing right, which shall be held by each of the parties will act reasonably and in as promptly as practicable. Each party agrees that it will consult with the name other party with respect to obtaining all permits, consents, approvals and authorizations of Licenseeall Regulatory Authorities necessary or advisable to consummate the Contemplated Transactions, and Licensee shall own each party will keep the other party apprised of the status of material matters relating to completion of the Contemplated Transactions. Acquiror and the Company will, upon request, furnish the other party with all Submissions information concerning itself, its Subsidiaries, directors, officers and Data stockholders and such other matters as may be reasonably necessary or advisable in connection therewith. All pricingwith any filing, formulary and marketing approvals shall also be obtained notice or application made by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Partyother party or any of its Subsidiaries with or to any Regulatory Authority in connection with the Contemplated Transactions. Notwithstanding the foregoing or anything else in this Agreement, nothing shall require Acquiror to, and the Company and its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party Subsidiaries shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of Acquiror, agree to, take any action or commit to take any action in connection with, or agree to any condition on, or request with respect to, any Requisite Regulatory Approval that would (a) materially and adversely affect the Person owning business, operations or financial condition of Acquiror (measured on a scale relative to Acquiror and its Subsidiaries, taken as a whole after giving effect to the NDA Contemplated Transactions), (b) require Acquiror or foreign equivalentany of its Subsidiaries to make any material covenants or commitments with a Regulatory Authority or other third party, such consent or complete any divestitures, whether prior to be at or subsequent to the sole discretion of such owning Person. Closing, (c) result in a Material Adverse Effect on Acquiror and its Subsidiaries, taken as a whole after giving effect to the Contemplated Transactions or (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) restrict in any material meetings between Licensee respect or impose a material burden on Acquiror or any of its Subsidiaries (including, after the Effective Time, the Company and any Regulatory Authority its Subsidiaries) in connection with the transactions contemplated hereby or with respect to Licensed Products the business or operation of Acquiror or any of its Subsidiaries (including, after the Effective Time, the Company and its Subsidiaries) (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions for purposes of clause (i) or (ii) of this sentence require Licensee d), materiality shall be measured on a scale relative to delay any meeting or telephone call with Acquiror and its Subsidiaries, taken as a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as whole after giving effect to the regulatory strategy and decision-making for any Licensed ProductContemplated Transactions) (a “Burdensome Condition””). (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee The Endo Companies and the Buyers shall use Commercially Reasonable Efforts cooperate, both prior to submit registration dossiers and promptly after Closing, as required, to prepare (including providing required information), identify and file with the FDA and any other applicable Governmental Authority the notices, applications, submissions and information required pursuant to any applicable Law or requirement to transfer the Regulatory Approvals from the Endo Companies to the relevant Regulatory Authorities Buyers or assist the Buyers with respect to all necessary obtaining Regulatory Approvals in their own name, as the case may be, and to reasonably assist the Buyers with obtaining Regulatory Approvals in their (or their designees’) own name, including any Distribution Licenses, that are not, pursuant to applicable Health Care Laws, able to be transferred from the Endo Companies to the Buyers. Sellers shall use commercially reasonable efforts to submit to the applicable Governmental Authority prior to Closing, all notices, applications, submissions, and information required to transfer the Regulatory Approvals to the Buyers and assist the Buyers with obtaining Regulatory Approvals in their (or their designees’) own name, as the case may be, and in each Major Countrycase to the extent permitted by Law or permitted or requested by the applicable Governmental Authority. The Parties also agree to use all commercially reasonable efforts to take any and all other actions required by the FDA and any other applicable Governmental Authority to effect the transfer of the Regulatory Approvals from the Sellers to the Buyers. Notwithstanding anything contained herein, it is acknowledged and agreed that any obligations hereunder of the Endo Companies in respect of the Consents, Permits or Regulatory Approvals procured or required for the Business of the Specified Subsidiaries shall be: (A) limited to providing to the Buyers, information, documents and such other cooperation as may be reasonably requested by the Buyers; and (B) only in respect of Consents, Permits or Regulatory Approvals, which pursuant to Law, require any action to, approval of, or notification, the relevant Governmental Authority in relation to acquisition of the Specified Subsidiaries by the Buyers. (b) Licensee shall Subject to the terms of the Transition Services Agreement (if such agreement is executed), with respect to each Product in each jurisdiction, from and after the Closing Date, until the date on which the relevant Buyer receives an assignment or transfer of the Regulatory Approval for such Product in such jurisdiction, or a replacement thereof naming the relevant Buyer as the Regulatory Approval holder for such Product in such jurisdiction, and until such time as the Buyers have the right to obtain all required Regulatory Approvals, which shall be held by and including Distribution Licenses, that will allow the Buyers to operate the Business in respect of such Products, the name of LicenseeEndo Companies shall, and Licensee shall own with respect to each such Product in each such jurisdiction, maintain in continuous effect all Submissions and Data in connection therewith. All pricingapplicable Regulatory Approvals, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to for the extent legally possiblebenefit of the Buyers, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4all Distribution Licenses. (c) Each Party Buyers shall have full access to indemnify, defend and hold the right to reference Sellers harmless from and against any NDAs and/or their foreign equivalent based and all Liabilities arising out of or in connection with any Regulatory Approval from and after the Closing through the date on Immune Modulator owned by which the other Party, its Affiliates, and/or sublicensees Buyers receive an assignment or any third party filing such NDAs and/or their foreign equivalent on behalf transfer of such Party, its AffiliatesProduct Approval (or the related Regulatory Approval) for such Product, or its sublicensees; provided, however, that such rights are subject to a replacement thereof naming the prior written consent of the Person owning the NDA or foreign equivalent Buyers as the case may be Product Approval (or the related Regulatory Approval) holder for such Product, except for any and any information contained therein. In all Liabilities that result from the event that a Party Sellers’ failure to comply with or its Affiliates is maintain the owner of such NDA or foreign equivalent Regulatory Approvals as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Personrequired under applicable Laws. (d) To Prior to the extent not prohibited by law or regulationClosing and after the Closing Date and until the end of the Wind-Down Period, Xxxxx the Endo Companies and Buyers shall have right each use commercially reasonable efforts to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and cooperate with each other to obtain any Regulatory Authority with respect Approvals as required under applicable Laws in order to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and carry on the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting Business or in any such telephone call (it being understood that in no event will connection with the provisions of clause (i) or (ii) execution, delivery and performance of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges Agreement and each of material correspondence related to activities conducted the Ancillary Agreements contemplated pursuant to this Agreement transaction. Each of the Sellers and Buyers shall be responsible for their own costs in providing such cooperation; provided, that neither Party hereto shall be required to make any payments to any third parties in connection with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion such cooperation except as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries may be provided in the Territory Chapter 11 Plan or the Plan Administrator Agreement (as defined in which Licensed Products shall be soldthe Chapter 11 Plan).

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of LicenseePromptly, and Licensee shall own at its expense, execute and deliver, or cause to be executed and delivered, all Submissions and Data in connection therewith. All pricingapplications, formulary and marketing approvals shall also be obtained by and in the name of Licenseecertificates, instruments, registration statements, and Licensee will all other documents and papers the Administrative Agent may reasonably request and as may be required by law to acquire any Governmental Approval or the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning consent, approval, registration, qualification or authorization of any Licensed Products including, to other Person deemed necessary or appropriate for the extent legally possible, being the sole contact with such Regulatory Authorities, subject to effective exercise of any of the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and Security Agreement. Without limiting the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf generality of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, if an Event of Default shall have occurred and be continuing, each Obligor shall take any action which the rights granted Administrative Agent may reasonably request in order to transfer and assign to the Administrative Agent, or to such one or more third parties as the Administrative Agent may designate, or to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent combination of the Person owning the NDA or foreign equivalentforegoing, such consent to be at the sole discretion each Government Approval of such owning Person. (d) Obligor. To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will enforce the provisions of clause this subsection, upon the occurrence and during the continuance of an Event of Default, the Administrative Agent is empowered to request the appointment of a receiver from any court of competent jurisdiction. Such receiver shall be instructed to seek from the Governmental Authority an involuntary transfer of control of each such Governmental Approval for the purpose of seeking a bona fide purchaser to whom control will ultimately be transferred. Each Obligor hereby agrees to authorize such an involuntary transfer of control upon the request of the receiver so appointed, and, if such Obligor shall refuse to authorize the transfer, its approval may be required by the court. Upon the occurrence and continuance of an Event of Default, such Obligor shall further use its reasonable best efforts to assist in obtaining Governmental Approvals, if required, for any action or transaction contemplated by this Security Agreement, including, without limitation, the preparation, execution and filing with the Governmental Authority of such Obligor’s portion of any necessary or appropriate application for the approval of the transfer or assignment of any portion of the assets (i) or (iiincluding any Governmental Approval) of such Obligor. Because each Obligor agrees that the Administrative Agent’s remedy at law for failure of such Obligor to comply with the provisions of this sentence require Licensee subsection would be inadequate and that such failure would not be adequately compensable in damages, such Obligor agrees that the covenants contained in this subsection may be specifically enforced, and such Obligor hereby waives and agrees not to delay assert any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges defenses against an action for specific performance of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsuch covenants. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to Bayer is solely responsible for obtaining and maintaining all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own from all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingnecessary for the performance of the Manufacturing Services at the Bayer Facility. Purchaser is solely responsible for obtaining and maintaining all Regulatory Approvals necessary to further process, to distribute or sell the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Products. Each Party shall have full access to upon request and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned as reasonably necessary provide all documents or information requested by the other Party to support the other Party’s efforts to obtain, maintain, or defend Regulatory Approvals to manufacture, further process, distribute or sell the Products and/or will modify its operations or facilities as required to permit the other Party to obtain, maintain, or defend necessary Regulatory Approvals to manufacture, further process, distribute and sell the Products; provided if the modifications to operations or facilities requested by a Party are modifications which would require the other Party to change the manner of operations existing as of the date of this Agreement or to add facilities not in place as of the date of this Agreement, such Party will reimburse the other Party’s reasonable direct costs in making such modifications and the Parties shall engage in good faith negotiations to adjust the price set forth in Section 3.1 to reflect the increase or decrease of ongoing costs of processing the Products hereunder resulting from any such modifications; provided further that if the Parties cannot reach an agreement to adjust the price pursuant to this Section 5.4 despite such good faith negotiations, (i) if the requested modifications will affect only the Product operations of such Party at either the Bayer Facility or the Purchaser’s Facility, as applicable, the matter shall be resolved in accordance with Section 12.9, or (ii) if the requested modifications will, in the sole discretion of the affected Party, its Affiliates, and/or sublicensees or adversely affect in any third party filing such NDAs and/or their foreign equivalent on behalf material manner other operations of such PartyParty at either the Bayer Facility or the Purchaser’s Facility, its Affiliatesas applicable, or its sublicensees; provided, however, that such rights are subject to separate from the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner Product operations of such NDA Party at either the Bayer Facility or foreign equivalent the Purchaser’s Facility, as the case may be or information contained thereinapplicable, such Party shall notnot be required to make any such modifications until the Parties reach such agreement; provided further such Party will have no obligation to reimburse the other Party for any maintenance, and shall cause its Affiliates not to, unreasonably withhold repair or delay consent. In replacement of existing facilities or for the event that substitution of their equivalent or for any increases in costs associated with the other Party’s conduct of operations in a third party is fashion similar to or equivalent to the owner manner in which those operations were being conducted in the absence of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, request as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) date of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductAgreement. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall The Parties will cooperate with each other and use Commercially Reasonable Efforts all reasonable efforts to submit registration dossiers promptly prepare all necessary documentation, to effect all necessary filings and to obtain all necessary permits, consents, waivers, approvals and authorizations of the relevant SEC, the Regulatory Authorities with respect and any other third parties and governmental bodies necessary to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have consummate the right to obtain Regulatory Approvals, which shall be held transactions contemplated by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesAgreement; provided, however, that such rights are subject to the prior written consent in no event shall any of the Person owning Investors Parties be required to agree to any prohibition, limitation, or other requirement that would prohibit or materially limit the NDA ownership or foreign equivalent operation by any of the Investors Parties of all or any material portion of the business or assets of Roma Financial or any Roma Subsidiary, compel any of the Investors Parties to dispose of or hold separate all or any material portion of the business or assets of Roma Financial or any Roma Subsidiary, continue in effect after the Effective Time the OCC Agreement or any provision thereof, or otherwise materially impair the value of Roma Financial to Investors Bancorp (together, a “Burdensome Condition”). The Parties will furnish each other and each other’s counsel with all information concerning themselves, their Subsidiaries, directors, officers and shareholders and such other matters as the case may be necessary or advisable in connection with the Proxy Statement-Prospectus and any information contained therein. In the event that a Party Member Proxy Statement and any application, petition or its Affiliates is the owner of such NDA any other statement or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree application made to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority or Governmental Entity in connection with respect the Mergers, and the other transactions contemplated by this Agreement. Roma Financial shall have the right to Licensed Products review the information relating to Roma Financial and (ii) listen to (but not participate in) any material telephone conversation between Licensee and Roma Subsidiary, which appear in any filing made in connection with the transactions contemplated by this Agreement with any Regulatory Authority or any Governmental Entity. Investors Bancorp shall give Roma Financial and its counsel the opportunity to review each filing prior to its being filed with respect a Regulatory Authority and shall give Roma Financial and its counsel the opportunity to Licensed Products that is pre-scheduled between Licensee review all regulatory filings, amendments and the relevant supplements to such filings and all responses to requests for additional information and replies to comments prior to their being filed with, or sent to, a Regulatory Authority. Licensee Investors Bancorp will use reasonable efforts (i) furnish to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with Roma Financial copies of all documents, correspondence statements and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (reports as it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement files with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as Authorities with respect to the regulatory strategy and decision-making for any Licensed ProductMergers. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee The parties hereto shall use Commercially Reasonable Efforts their reasonable best efforts, and cooperate with each other, to submit registration dossiers promptly prepare and file all necessary documentation, to effect all applications, notices, petitions, amendments, filings and refilings, and to obtain as promptly as practicable all permits, consents, approvals and authorizations of all third parties and Governmental Entities which are necessary or advisable to consummate the Merger. The Company and Parent shall have the right to review in advance, and to the relevant Regulatory Authorities extent practicable each will consult the other on, in each case subject to applicable laws relating to the exchange of information, all the information relating to the Company or Parent, as the case may be, and any of their respective Subsidiaries, which appears in any filing made with, or written materials submitted to, any third party, including any Governmental Entity, in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto shall act reasonably and as promptly as practicable. The parties hereto agree that they will consult with each other with respect to the obtaining of all permits, consents, approvals and authorizations of all third parties and Governmental Entities necessary Regulatory Approvals in or advisable to consummate the transactions contemplated by this Agreement and each Major Countryparty will keep the other apprised of the status of matters relating to completion of the transactions contemplated herein. (b) Licensee shall have Parent and the right to obtain Regulatory ApprovalsCompany shall, which shall upon request, furnish each other with all information concerning themselves, their Subsidiaries, directors, officers and shareholders and such other matters as may be held by and in the name of Licensee, and Licensee shall own all Submissions and Data reasonably necessary or advisable in connection therewith. All pricingwith the Proxy Statement-Prospectus, formulary the S-4 or any other statement, filing, notice or application made by or on behalf of Parent, the Company or any of their respective Subsidiaries to any Governmental Entity in connection with the Merger and marketing approvals shall also be obtained the other transactions contemplated by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4Agreement. (c) Each Party shall have full access to Parent and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned Company shall promptly furnish each other with copies of written communications received by Parent or the other PartyCompany, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and be, or any information contained therein. In of their respective Subsidiaries, Affiliates or Associates (as such terms are defined in Rule 12b-2 under the event that a Party Exchange Act as in effect on the date of this Agreement) from, or its Affiliates is delivered by any of the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not foregoing to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent Governmental Entity in respect of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Persontransactions contemplated hereby. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Each Obligor shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of Licenseepromptly, and Licensee shall own at its expense, execute and deliver, or cause to be executed and delivered, all Submissions and Data in connection therewith. All pricingapplications, formulary and marketing approvals shall also be obtained by and in the name of Licenseecertificates, instruments, registration statements, and Licensee will all other documents and papers the Administrative Agent may reasonably request and as may be required by law to acquire any Governmental Approvals or the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning consent, approval, registration, qualification or authorization of any Licensed Products including, to other Person deemed necessary for the extent legally possible, being the sole contact with such Regulatory Authorities, subject to effective exercise of any of the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and Agreement. Without limiting the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf generality of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, if an Event of Default shall have occurred and be continuing, each Obligor shall take any reasonable action which the rights granted Administrative Agent may reasonably request in order to transfer and assign to the Administrative Agent, or to such one or more third parties as the Administrative Agent may designate, or to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent combination of the Person owning the NDA or foreign equivalentforegoing, such consent to be at the sole discretion each Government Approval of such owning Person. (d) Obligor. To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will enforce the provisions of clause this subsection, upon the occurrence and during the continuance of an Event of Default, the Administrative Agent is empowered to request the appointment of a receiver from any court of competent jurisdiction. Such receiver shall be instructed to seek from the Governmental Authority an involuntary transfer of control of each such Governmental Approval for the purpose of seeking a bona fide purchaser to whom control will ultimately be transferred. Each Obligor hereby agrees to authorize such an involuntary transfer of control upon the request of the receiver so appointed, and, if such Obligor shall refuse to authorize the transfer, its approval may be required by the court. Upon the occurrence and continuance of an Event of Default, such Obligor shall further use its reasonable best efforts to assist in obtaining Governmental Approvals, if required, for any action or transaction contemplated by this Agreement, including, without limitation, the preparation, execution and filing with the Governmental Authority of such Obligor’s portion of any necessary application for the approval of the transfer or assignment of any portion of the assets (i) or (iiincluding any Governmental Approval) of such Obligor. Because each Obligor agrees that the Administrative Agent’s remedy at law for failure of such Obligor to comply with the provisions of this sentence require Licensee Section would be inadequate and that such failure would not be adequately compensable in damages, such Obligor agrees that the covenants contained in this Section may be specifically enforced, and such Obligor hereby waives and agrees not to delay assert any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges defenses against an action for specific performance of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsuch covenants. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Subject to and in accordance with the provisions of this Section 6.4, each of the Parties shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right commercially reasonable efforts to obtain Regulatory (and shall cooperate fully with the other Parties in obtaining) as promptly as practicable the Company Approvals, which shall the Buyer Approvals and all other authorizations, consents, clearances, orders, expirations, waivers or terminations of any applicable waiting periods and approvals of all Government Entities that may be held by or may become reasonably necessary, proper or advisable under this Agreement or any of the other Transaction Documents and applicable Laws to consummate and make effective the Transactions as promptly as practicable and in any event no later than the name of LicenseeOutside Date. Buyer shall pay all filing fees in connection with Buyer Approvals, and Licensee Seller shall own pay all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle filing fees for all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesCompany Approvals; provided, however, that Buyer, on the one hand, and Seller, on the other hand, will each pay at the time of filing one half of any fees required with respect to any filings made pursuant to the HSR Act. (b) As promptly as practicable (and, in the case of filings required to be made pursuant to the HSR Act, not later than five Business Days following the date of this Agreement), Seller and Buyer shall promptly make all filings and notifications with all Government Entities that may be or may become necessary or advisable under this Agreement and applicable Laws to consummate and make effective the Transactions. (c) Seller and Buyer may not, without the consent of the others Parties (which consent shall not be unreasonably withheld, delayed or conditioned), (i) cause any such rights are filing or submission applicable to it to be withdrawn or refiled for any reason, including to provide the applicable Government Entity with additional time to review any or all of the Transactions or (ii) consent to any voluntary extension of any statutory deadline or waiting period or to any voluntary delay of the consummation of the Transactions at the behest of any Government Entity. Seller and Buyer shall use commercially reasonable efforts to supply as promptly as practicable and advisable any information and documentary material that may be requested pursuant to any applicable Laws in connection with such filings or submissions. (d) Subject to applicable Laws relating to the sharing of information, Seller and Buyer shall promptly notify each other of any communication Seller or Buyer, as applicable, receives from any Government Entity (other than communications for purely logistical purposes) and, subject to the prior written consent proviso below in this clause (d), permit the other Party to review in advance any proposed applications, notices, submissions, filings related to any pre-Closing period, undertakings, correspondence and communications of any nature (including responses to requests for information and inquiries from any Government Entity) by such Party, as applicable, to any Government Entity and shall provide such other Party with copies of all applications, notices, submissions (including above referenced filings), undertakings, correspondence and communications of any nature (including responses to requests for information and inquiries from any Government Entity) between such Party, as applicable, or any of its Representatives, on the one hand, and any Government Entity or members of the Person owning staff of any Government Entity, on the NDA other hand, in each case to the extent relating to the matters that are the subject of this Agreement and the other Transaction Documents, except with respect to Taxes (which are covered by Section 6.10(b)). Except with respect to Taxes (which are covered by Section 6.10(b)) and subject to the proviso below in this clause (d), Seller and Buyer shall not agree to participate in any substantive meeting or foreign equivalent discussion with any Government Entity relating to the matters that are the subject of this Agreement (including in respect of satisfying or obtaining the Buyer Approvals and the Company Approvals) or any of the other Transaction Documents unless, to the extent practicable, such Party consults with such other Parties in advance and, to the extent permitted by such Government Entity, gives such other Parties the opportunity to attend and participate at such meeting or discussion. Seller and Buyer shall coordinate and cooperate fully with each other in exchanging such information and providing such assistance as each may reasonably request in connection with the foregoing and shall keep each other informed of the status of discussions relating to obtaining or concluding the Buyer Approvals and the Company Approvals; provided, however, that the foregoing shall not require Seller and Buyer or any of their respective Affiliates (i) to disclose any information that in the reasonable judgment of such Party or any of its Affiliates (as the case may be) would result in the disclosure of any trade secrets of third parties or violate any of its obligations with respect to confidentiality, (ii) to disclose any privileged information or confidential competitive information of such Party or any of its Affiliates or (iii) to disclose the valuation of, or any communications, analyses or other work product regarding the valuation of, the Securities, the Company or the Company’s assets or any other communications, analyses or other work product regarding the desirability or feasibility of the Transactions or similar transactions involving the Securities, the Company or the Company’s assets. None of the Parties shall be required to comply with any provision of this Section 6.4(d) to the extent that such compliance would be prohibited by applicable Law. (e) Seller and Buyer shall use their reasonable best efforts to (i) cause the early termination or the expiration of the applicable waiting periods under the HSR Act and any information contained therein. In other applicable Laws with respect to the event that a Party or its Affiliates Transactions as promptly as is the owner of such NDA or foreign equivalent reasonably practicable, (ii) resolve any objections as the case may be asserted by any Government Entity with respect to the Transactions and (iii) contest and resist any action or information contained thereinproceeding instituted (or threatened in writing to be instituted) by any Government Entity challenging the Transactions as violating any applicable Law; provided, such Party however, nothing in this Section 6.4 or elsewhere in this Agreement shall notrequire, and shall cause its Affiliates not toor be construed to require, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained thereinBuyer, the Parties Company, Seller or any of their respective Subsidiaries or Affiliates to make, proffer, propose, negotiate, offer to effect or consent, commit or agree to reasonably cooperate any sale, divestiture, lease, licensing, transfer, disposal, divestment or other encumbrance of, or to obtain such necessary third party consents. Notwithstanding the foregoinghold separate any assets, licenses, businesses or interest of Buyer, the rights granted Company, Seller or any of their respective Subsidiaries or Affiliates. None of the Company, Seller or any of their respective Subsidiaries or Affiliates shall take, or agree to a Party to access and reference take, any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees of the actions described in this clause (e) without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonBuyer. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. Each party shall use its reasonable best efforts to file, as soon as practicable after the date of this Agreement, all notices, reports and other documents required to be filed by such party with any Governmental Body with respect to the Offer, the Merger and the other transactions contemplated by this Agreement, the Tender and Voting Agreement and the Acquisition Co. Option Agreement, and to submit promptly any additional information requested by any such Governmental Body. Without limiting the generality of the foregoing, the Company and Parent shall, promptly after the date hereof, prepare and file any notifications required under any applicable antitrust Laws in connection with the Offer, the Merger or the other transactions contemplated by this Agreement, the Tender and Voting Agreement and the Acquisition Co. Option Agreement. The Company and Parent shall respond as promptly as practicable to any inquiries or requests received from any antitrust authority or other Governmental Body in connection with antitrust or related matters. Each of the Company and Parent shall (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to give the relevant Regulatory Authorities other party prompt notice of the commencement or threat of commencement of any Proceeding by or before any Governmental Body with respect to all necessary Regulatory Approvals in each Major Country. the Offer, the Merger or any of the other transactions contemplated by this Agreement, the Tender and Voting Agreement and the Acquisition Co. Option Agreement, (b) Licensee shall have keep the right other party informed as to obtain Regulatory Approvals, which shall be held by and in the name status of Licenseeany such Proceeding or threat, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall promptly inform the other party of any communication to or from any Governmental Body regarding the Offer, the Merger or any of the other transactions contemplated by this Agreement, the Tender and Voting Agreement and the Acquisition Co. Option Agreement. Except as may be prohibited by any Governmental Body or by any Law, (x) each party will consult and cooperate with the other, and will consider in good faith the views of the other, in connection with any analysis, appearance, presentation, memorandum, brief, Proceeding under or relating to any foreign, federal or state antitrust or fair trade Law, and (y) in connection with any such Proceeding, each party will permit authorized Representatives of the other to be present at each meeting or conference relating to any such Proceeding and to have full access to and be consulted in connection with any document, opinion or proposal made or submitted to any Governmental Body in connection with any such Proceeding. At the right request of Parent, the Company shall agree to reference divest, sell, dispose of, hold separate or otherwise take or commit to take any NDAs and/or their foreign equivalent based on Immune Modulator owned by action that limits its freedom of action with respect to its or the other PartySubsidiaries’ ability to operate or retain any of the businesses, its Affiliates, and/or sublicensees product lines or assets of the Company or any third party filing such NDAs and/or their foreign equivalent on behalf of such PartySubsidiary, its Affiliates, or its sublicensees; provided, however, that any such rights are subject to action is conditioned upon the prior written consent consummation of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonOffer. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers Subject to the relevant Regulatory Authorities terms and conditions of this Agreement, each Constituent Corporation will use its best efforts to take, or cause to be taken, all actions reasonably necessary or advisable under applicable law to consummate the Merger, including (i) making or causing to be made the filings required by law with respect to all necessary Regulatory Approvals in each Major Countrythe Merger as promptly as it practicable, (ii) complying, as promptly as is reasonably practicable, with any requests received from a governmental body by such Constituent Corporation with respect to the Merger, and (iii) resolving any formal or informal objections of any governmental body with respect to any such filings or the Merger. (b) Licensee shall have The Constituent Corporations covenant and agree that if any required regulatory approval to consummate the right Merger is denied or not obtained, the Constituent Corporations will use their best efforts to obtain Regulatory Approvalswork together to restructure the Merger to achieve or acquire all required regulatory approvals, which shall it being agreed that in all such instances the benefits sought to be held delivered by and in the name Constituent Corporations from the Merger, financial or otherwise, will not change as a result of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4restructuring. (c) Each Party Until the earlier of the Effective Time or the termination of this Agreement, each Constituent Corporation shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by promptly notify the other Party, its Affiliates, and/or sublicensees or Constituent Corporations of any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject communication it receives from any governmental body relating to the prior written consent regulatory consents, registrations, approvals, permits and authorizations that are the subject of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, this Section 11 and shall cause its Affiliates not to, unreasonably withhold or delay consentpermit the other Constituent Corporations to review in advance any proposed communication by such Constituent Corporations to any governmental body in connection therewith. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties No Constituent Corporation shall agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference participate in any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) meeting with any material meetings between Licensee and any Regulatory Authority with governmental body in respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible matter unless it consults with the other Constituent Corporations in the circumstances advance and, (ii) to the extent reasonably possiblepermitted by such governmental body, gives the other Constituent Corporations the opportunity to provide Xxxxx, attend and participate at least five (5) business days before any such meeting, . The Constituent Corporations will coordinate and cooperate fully with copies of all documents, correspondence each other in exchanging such information and providing such assistance any other materials which are relevant to Constituent Corporation may reasonably request in connection with the matters to be addressed at any such meeting or set forth in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.Section

Regulatory Approvals. (a) Licensee The parties shall cooperate with each other and, subject to Section 6.1 and Section 6.4, use Commercially Reasonable Efforts their respective reasonable best efforts to submit registration dossiers take, or cause to the relevant Regulatory Authorities with respect to be taken, all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of Licenseeactions, and Licensee shall own all Submissions and Data in connection therewith. All pricingdo, formulary and marketing approvals shall also or cause to be obtained by and in the name of Licenseedone, and Licensee will be assist and cooperate with the principal interface and will otherwise handle other parties in doing, all interactions with Regulatory Authorities concerning any Licensed Products includingthings necessary, to the extent legally possible, being the sole contact with such Regulatory Authoritiesproper or advisable, subject to the rights of Xxxxx under limitations in this Section 4.4. (c) Each Party shall have full access 6.7, to consummate and make effective, as soon as reasonably possible, the Merger and the right other transactions contemplated by this Agreement, including using reasonable best efforts to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend make or cause to be made, in consultation and cooperation with the other and as promptly as practicable after the date of this Agreement, any filing with the United States Department of Justice (“DOJ”) and the United States Federal Trade Commission (“FTC”) required under the HSR Act relating to the Merger (but not participate in) any material meetings between Licensee in no event later than 15 Business Days after the date of this Agreement, unless otherwise agreed by counsel for the parties), a filing under the Investment Canada Act, and any Regulatory Authority foreign direct investment filings with respect the applicable government authorities in Italy and Germany relating to Licensed Products the Merger and other required filings subject to further analysis; (ii) listen prepare and file a draft CFIUS Notice, and, after receipt of confirmation reasonably acceptable to both Parent and the Company that CFIUS has no further comments or inquiries related to the draft CFIUS Notice, Parent and the Company shall, as promptly as practicable after such receipt, submit the CFIUS Notice; (but iii) prepare and file other necessary and advisable registrations, declarations, notices, petitions, applications and filings relating to the Merger, including the notice required under 22 C.F.R. section 122.4(b) of the International Traffic in Arms Regulations, with other Governmental Entities under antitrust, competition, foreign direct investment, trade regulation or similar Law as soon as reasonably practicable or where the ability to control timing of the registration, declaration, notice, petition, application or filing is not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is within the control of the submitting party, commence pre-scheduled between Licensee submission consultation procedures for, any registrations, declarations, notices, petitions, applications and filings with such Governmental Entities (and thereafter make any other required submissions and respond as promptly as reasonably practicable to any requests for additional information or documentary material); (iv) obtain all Consents or nonactions from any Governmental Entity or other Person which are required to be obtained under any other antitrust, competition, foreign direct investment, trade regulation or similar Law in connection with the consummation of the Merger and the relevant other transactions contemplated hereby, including the CFIUS Approval (collectively, the “Required Regulatory Authority. Licensee will use reasonable efforts Approvals”); (v) seek to avoid or prevent the initiation of any investigation, inquiry, claim, action, suit, arbitration, litigation or proceeding by or before any Governmental Entity challenging the Merger or the consummation of the other transactions contemplated by this Agreement; and (vi) furnish to the other all assistance, cooperation and information required for any such registration, declaration, notice or filing in order to achieve the effects set forth in the foregoing sub-clauses (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, and (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authorityv). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee TPB and SDI shall use Commercially Reasonable Efforts each promptly execute and file, or join in the execution and filing of, any application, notification, or other document that may be necessary in order to submit registration dossiers to obtain the relevant Regulatory Authorities authorization, approval, expiration, or termination of any waiting period or Consent of any Governmental Body that may be reasonably required or advisable in connection with respect to all necessary Regulatory Approvals in each Major Countrythe consummation of the Contemplated Transactions. (b) Licensee TPB and SDI shall have the right each use its commercially reasonable efforts to obtain Regulatory Approvalsall such authorizations, which shall be held by and in the name approvals, expirations or terminations of Licenseewaiting periods, and Licensee shall own all Submissions and Data in connection therewithConsents as promptly as possible after the execution of this Agreement, including the expiration or termination of the waiting period under the HSR Act, or under foreign competition Laws, with respect to the transactions contemplated by this Agreement. All pricing, formulary and marketing approvals shall also be obtained by and in Without limiting the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingforegoing, to the extent legally possiblenot completed prior to the date hereof, being TPB and SDI shall each use its commercially reasonable efforts to make, or cause to be made, all filings required of it or any of its respective Affiliates under the sole contact HSR Act and foreign competition Laws with respect to the transactions contemplated by this Agreement as promptly as reasonably practicable, and in any event shall file a Notification and Report Form pursuant to the HSR Act 15 Business Days after the execution of this Agreement, and any other filing or notification required pursuant to any foreign competition Law within 15 Business Days after the execution of this Agreement. TPB and SDI shall furnish promptly to the Federal Trade Commission (the “FTC”), the Antitrust Division of the United States Department of Justice and any other requesting governmental authority additional information reasonably requested pursuant to the HSR Act or any foreign competition Laws in connection with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4filings. (c) Each Party TPB and SDI shall have full access each use its commercially reasonable efforts to resolve objections, if any, as may be asserted by any Governmental Body with respect to the Contemplated Transactions under any applicable antitrust Laws, including responding promptly to and the right complying with any requests for information relating to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees this Agreement or any third party filing such NDAs and/or their foreign equivalent on behalf of such Partyinitial filings required under the HSR Act, its Affiliatesand any other additional filings (“Merger Notification Filings”) from any Governmental Body charged with enforcing, applying, administering, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and investigating any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Personantitrust Laws. (d) To Notwithstanding anything to the extent not prohibited by law or regulationcontrary herein, Xxxxx shall have right to have one (1) representative (i) attend (but TPB shall not participate in) have any material meetings between Licensee and obligation to litigate or contest any Regulatory Authority with respect to Licensed Products such Legal Proceeding or order resulting therefrom and (ii) listen TPB shall not be under an obligation to make proposals, execute or carry out agreements, or submit to orders providing for (but not participate inA) the sale, license, divestiture, or other disposition or holding separate of any assets of TPB or any of its respective Affiliates, (B) the imposition of any limitation or restriction on the ability of TPB or any of its respective Affiliates to freely conduct its business, or (C) any material telephone conversation between Licensee and limitation or regulation on the ability of TPB or any Regulatory Authority with respect of its Affiliates to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice exercise full rights of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies ownership of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductSDI. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall Each of Fox Chase and Univest will cooperate with the other and use Commercially Reasonable Efforts commercially reasonable efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to promptly prepare all necessary documentation, to effect all necessary filings and to obtain all necessary permits, consents, waivers, approvals and authorizations of the SEC, the Bank Regulators and any other third parties or Governmental Entities, necessary to consummate the transactions contemplated by this Agreement and Univest will make all necessary filings in respect of the required Regulatory Approvals as promptly as practicable after the date hereof (provided that Fox Chase has timely provided all information requested in writing by Univest or its counsel, within forty-five (45) days after the date hereof). Fox Chase and Univest will furnish each Major Country. (b) Licensee other and each other’s counsel with all information concerning themselves, their subsidiaries, directors, officers and shareholders and such other matters as may be necessary or advisable in connection with any application, petition or any other statement or application made by or on behalf of Fox Chase or Univest to any Bank Regulator or Governmental Entity in connection with the Merger or the Bank Merger, and the other transactions contemplated by this Agreement. Fox Chase shall have the right to obtain Regulatory Approvals, review and approve in advance all characterizations of the information relating to Fox Chase and any Fox Chase Subsidiary which shall be held by and appear in the name of Licensee, and Licensee shall own all Submissions and Data any filing made in connection therewith. All pricing, formulary and marketing approvals shall also be obtained with the transactions contemplated by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory AuthorityGovernmental Entity. Notwithstanding Univest shall give Fox Chase and its counsel the foregoingopportunity to review and comment on each filing prior to its being filed with a Bank Regulator and shall give Fox Chase and its counsel the opportunity to review and comment on all regulatory filings, Licensee will have sole discretion as amendments and supplements to such filings and all responses to requests for additional information and replies to comments prior to their being filed with, or sent to, a Bank Regulator. Univest shall notify Fox Chase promptly of the regulatory strategy and decision-making for receipt of any Licensed Productcomments of any Bank Regulator with respect to such filings. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. Each Party shall use reasonable best efforts to file or otherwise submit, as soon as practicable after the date of this Agreement but no later than required by applicable Law, all applications, notices, reports and other documents reasonably required to be filed by such Party with or otherwise submitted by such Party to any Governmental Authority with respect to the Merger and the other Contemplated Transactions, and to submit promptly any additional information requested by any such Governmental Authority. Each Party shall utilize reasonable best efforts to cooperate fully with the other Party in promptly seeking to obtain all such required consents, authorizations, orders and approvals. The Parties hereto shall not take any action that will have the effect of delaying, impairing or impeding the receipt of any required consents, authorizations, orders and approvals. The Parties shall each use their reasonable best efforts to resist any assertion that the Contemplated Transactions constitute a violation of antitrust or merger control Laws, rules or regulations. All filing fees which are due and owing upon respective filings under antitrust or merger control Laws shall be shared equally between the Company and Innovate. All analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings, arguments, and proposals made by or on behalf of either Party before any Governmental Authority or the staff or regulators of any Governmental Authority with respect to or in connection with this Agreement, the Merger and the other Contemplated Transactions shall be disclosed to counsel for the other Party hereunder in advance of any filing, submission or attendance, it being the intent that the Parties will consult and cooperate with one another, and consider in good faith the views of one another, in connection with any such analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings, arguments, and proposals. Each Party may, as it deems advisable and necessary, reasonably designate material provided to the other party as “Outside Counsel Only Material,” and also may reasonably redact the material as necessary to (a) Licensee remove personally sensitive information, (b) remove references concerning the valuation of the Company and its Subsidiaries or Innovate and its Subsidiaries conducted in connection with the approval and adoption of this Agreement and the negotiations and investigations leading thereto, (c) comply with contractual arrangements, (d) prevent the loss of a legal privilege or (e) comply with applicable Law. To the extent reasonably practicable, each Party shall use Commercially Reasonable Efforts give notice to submit registration dossiers to counsel for the relevant Regulatory Authorities other party with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have any meeting, discussion, appearance or contact with any Governmental Authority or the right to obtain Regulatory Approvals, which shall be held by and in the name staff or regulators of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions any Governmental Authority with Regulatory Authorities concerning any Licensed Products including, respect to the extent legally possibleMerger and the other Contemplated Transactions, being the sole contact with such Regulatory Authorities, subject notice being sufficient to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by provide the other Partyparty with the opportunity to attend and participate in such meeting, its Affiliatesdiscussion, and/or sublicensees appearance or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained thereincontact. In the event that a Party any Legal Proceeding is commenced challenging the Merger or its Affiliates is any of the owner of such NDA other Contemplated Transactions under antitrust, competition or foreign equivalent as the case may be or information contained therein, such Party shall notmerger control Laws, and shall cause its Affiliates not tosuch Legal Proceeding seeks, unreasonably withhold or delay consent. In would reasonably be expected to seek, to prevent the event that a third party is consummation of all or part of the owner of such NDA Merger or foreign equivalent or information contained thereinthe other Contemplated Transactions, the Parties agree shall cooperate with each other and use their respective reasonable best efforts to reasonably cooperate contest any such Legal Proceeding and to obtain such necessary third party consents. Notwithstanding have vacated, lifted, reversed, or overturned any decree, judgment, injunction or other Order, whether temporary, preliminary, or permanent, that is in effect and that prohibits, prevents or restricts consummation of the foregoing, Merger or the rights granted to a other Contemplated Transactions; provided that nothing in this sentence shall require any Party to access and reference divest any NDAs and/or their foreign equivalent, assets it owns as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) date hereof to the extent reasonably possiblesuch divestiture would have a material and adverse effect on the businesses of the combined company following consummation of the Merger, taken as a whole. The Company shall file (if not previously filed) the OCS Notice with the OCS as required to provide Xxxxx, at least five (5) business days before any such meeting, be made in connection with copies of all documents, correspondence the contemplated transaction and other materials which are relevant Innovate shall execute and deliver to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will Company an undertaking required under the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductInnovation Law. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Each party shall use Commercially Reasonable Efforts their respective commercially reasonable efforts to submit registration dossiers file or otherwise submit, as soon as practicable after the date of this Agreement, all notices, reports and other documents required to the relevant Regulatory Authorities be filed by such party with or otherwise submitted by such party to any Governmental Body with respect to all necessary Regulatory Approvals the Merger and the other Contemplated Transactions, and to submit promptly any additional information requested by any such Governmental Body. Without limiting the generality of the foregoing, the Company and Parent shall, promptly after the date of this Agreement, prepare and file any notification or other document required to be filed in each Major Countryconnection with the Merger under any applicable foreign Legal Requirement relating to antitrust or competition matters as promptly as practicable. The Company and Parent shall respond as promptly as practicable to any inquiries or requests received from any state attorney general, foreign antitrust or competition authority or other Governmental Body in connection with antitrust or competition matters. (b) Licensee Parent and the Company shall have use commercially reasonable efforts to cause to be taken all actions necessary to consummate the right Merger and make effective the other Contemplated Transactions. Without limiting the generality of the foregoing, each party to this Agreement: (i) shall make all filings and other submissions (if any) and give all notices (if any) required to be made and given by such party in connection with the Merger and the other Contemplated Transactions; (ii) shall use their commercially reasonable efforts to obtain Regulatory Approvalseach Consent (if any) required to be obtained (pursuant to any applicable Legal Requirement or Contract, which shall be held or otherwise) by and in the name of Licensee, and Licensee shall own all Submissions and Data such party in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in with the name Merger or any of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other PartyContemplated Transactions; and (iii) shall use commercially reasonable efforts to lift any injunction prohibiting, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Partyother legal bar to, its Affiliates, the Merger or its sublicensees; provided, however, that such rights are subject to the prior written consent any of the Person owning other Contemplated Transactions. Each party shall provide the NDA other with a copy of each proposed filing with or foreign equivalent as other submission to any Governmental Body relating to any of the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall notContemplated Transactions, and shall cause its Affiliates not to, unreasonably withhold give the other party a reasonable time prior to making such filing or delay consentother submission in which to review and comment on such proposed filing or other submission. In the event that a third Each party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) promptly deliver to the extent reasonably possibleother a copy of each such filing or other submission made, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence each notice given and other materials which are relevant to each Consent obtained during the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decisionPre-making for any Licensed ProductClosing Period. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Subject to the terms and conditions of this Agreement, each of SPAC, Holdings and the Company shall use Commercially Reasonable Efforts its commercially reasonable efforts, and shall cooperate fully with such other Parties, to submit registration dossiers take, or cause to be taken, all actions and to do, or cause to be done, all things reasonably necessary, proper or advisable under applicable Laws and regulations to consummate the Transactions (including the receipt of all applicable Consents of Governmental Authorities) and to comply as promptly as practicable with all requirements of Governmental Authorities applicable to the relevant Regulatory Authorities with respect Transactions, including using its commercially reasonable efforts to (i) prepare and promptly file all documentation to effect all necessary Regulatory Approvals in each Major Countryfilings, notices, petitions, statements, registrations, submissions of information, applications and other documents, (ii) obtain all Permits, Consents, approvals, authorizations, registrations, waivers, qualifications and orders of, and the expiration or termination of waiting periods by, Governmental Authorities to satisfy the consummation of the Transactions and to fulfill the conditions to the Closing and (iii) execute and deliver any additional instruments necessary to consummate the Transactions. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by In furtherance and not in the name limitation of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingSection 8.12(a), to the extent legally possiblerequired under the HSR Act or any other Laws that are designed to prohibit, being restrict or regulate actions having the sole contact with such Regulatory Authoritiespurpose or effect of monopolization or restraint of trade or that are designed to prohibit, subject restrict or regulate actions that may risk national security (collectively, “Antitrust Laws”), each of SPAC, Holdings and the Company agrees, and shall cause its Subsidiaries and Affiliates, to make any required filing or application under Antitrust Laws, as applicable, including preparing and making an appropriate filing pursuant to the rights HSR Act, at such Party’s sole cost and expense (including with respect to any filing fees), with respect to the Transactions as promptly as practicable, to supply as promptly as reasonably practicable any additional information and documentary material that may be reasonably requested pursuant to Antitrust Laws and to take all other actions reasonably necessary, proper or advisable to cause the granting of Xxxxx approval or consent by the Governmental Authority as soon as practicable. Each of SPAC, Holdings and the Company shall, in connection with its commercially reasonable efforts to obtain all requisite approvals and authorizations for the Transactions under this Section 4.4any Antitrust Law, use its commercially reasonable efforts to: (i) cooperate in all respects with each other of such Parties or their respective Affiliates in connection with any filing or submission and in connection with any investigation or other inquiry, including any proceeding initiated by a private Person, (ii) keep such other Parties reasonably informed of any material communication received by such Party or its Representatives from, or given by such Party or its Representatives to, any Governmental Authority and of any material communication received or given in connection with any proceeding by a private Person, in each case regarding any of the Transactions, (iii) permit a Representative of such other Parties and their respective outside counsel to review any material communication given by it to, and consult with each other in advance of any material meeting or conference with, any Governmental Authority or, in connection with any proceeding by a private Person, with any other Person, and to the extent permitted by such Governmental Authority or other Person, give a Representative or Representatives of such other Parties the opportunity to attend and participate in such meetings and conferences, (iv) in the event a Party’s Representative is prohibited from participating in or attending any meetings or conferences, each attending Party shall keep such Party promptly and reasonably apprised with respect thereto and (v) use commercially reasonable efforts to cooperate in the filing of any memoranda, white papers, filings, correspondence or other written communications explaining or defending the Transactions, articulating any regulatory, competitive or national security related argument, and responding to requests or objections made by any Governmental Authority. (c) Each Party shall have full access If any objections are asserted with respect to the Transactions under any applicable Law or if any Action is instituted (or threatened to be instituted) by any applicable Governmental Authority or any private Person challenging any of the Transactions as violative of any applicable Law or which would otherwise prevent, materially impede or materially delay the consummation of the Transactions, each of SPAC, Holdings and the right Company shall use its commercially reasonable efforts to reference resolve any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees such objections or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject Actions so as to the prior written consent timely permit consummation of the Person owning Transactions including in order to resolve such objections or Actions which, in any case if not resolved, could reasonably be expected to prevent, materially impede or materially delay the NDA or foreign equivalent as consummation of the case may be and any information contained thereinTransactions. In the event any Action is instituted (or threatened to be instituted) by a Governmental Authority or private Person challenging the Transactions, each of SPAC, Holdings and the Company shall, and shall cause their respective Representatives to, reasonably cooperate with each other and use their respective commercially reasonable efforts to contest and resist any such Action and to have vacated, lifted, reversed or overturned any Order, whether temporary, preliminary or permanent, that a is in effect and that prohibits, prevents or restricts consummation of the Transactions. (d) Prior to the Closing, each of SPAC, Holdings and the Company shall use its commercially reasonable efforts to obtain any Consents of Governmental Authorities or other third party as may be necessary for the consummation by such Party or its Affiliates is of the owner Transactions or required as a result of such NDA the execution or foreign equivalent as performance of, or consummation of the case may be or information contained thereinTransactions, by such Party or its Affiliates, and the other Parties shall notprovide reasonable cooperation in connection with such commercially reasonable efforts. With respect to Holdings, during the Interim Period, each of SPAC, Holdings and the Company shall use its commercially reasonable efforts to cause Holdings to qualify as “foreign private issuer” as such term is defined under Exchange Act Rule 3b-4 and to maintain such status through the Closing. (e) Notwithstanding the generality of the foregoing, each of SPAC, Holdings and the Company shall use its, and shall cause its Affiliates not toto use their, unreasonably withhold commercially reasonable efforts to consummate the transactions contemplated by the Subscription Agreements, including using its, and causing its Affiliates to use their, commercially reasonable efforts to enforce its or delay consenttheir rights under the Subscription Agreements to cause the PIPE Investors to pay to (or as directed by) Holdings the applicable purchase price under each PIPE Investor’s applicable Subscription Agreement in accordance with its terms. In None of SPAC, Holdings or the event that a third party is the owner of such NDA or foreign equivalent or information contained thereinCompany, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA such other Parties, permit or foreign equivalent, such consent to be at the sole discretion of such owning Person. any amendment, supplement or modification to or any waiver (din whole or in part) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting provision or telephone call as is reasonably possible in the circumstances andremedy under, (ii) to the extent reasonably possibleor any replacements of, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductSubscription Agreement. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall Each of Yardville and Acquirer will cooperate with the other and use Commercially Reasonable Efforts all reasonable best efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to promptly prepare all necessary Regulatory Approvals documentation, to effect all necessary filings and to obtain all necessary permits, consents, waivers, approvals and authorizations of the SEC, the Bank Regulators and any other third parties and governmental bodies necessary to consummate the transactions contemplated by this Agreement. Yardville and Acquirer will furnish each other and each other’s counsel with all information concerning themselves, their subsidiaries, directors, officers and stockholders and such other matters as may be necessary or advisable in each Major Country. (b) Licensee connection any application, petition or any other statement or application made by or on behalf of Yardville or Acquirer to any Bank Regulator or other Governmental Entity in connection with the Merger and the other transactions contemplated by this Agreement. Yardville and Acquirer shall have the right to obtain Regulatory Approvals, which shall be held by review and approve in the name of Licensee, and Licensee shall own advance all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent characterizations of the Person owning the NDA information relating to Yardville or foreign equivalent Acquirer, as the case may be be, and any information contained thereinof their respective Subsidiaries, which appear in any filing made in connection with the transactions contemplated by this Agreement with any Bank Regulator or other Governmental Entity. In exercising the event that a Party foregoing right, each of the parties shall act reasonably and as promptly as practicable. The parties shall consult with each other with respect to the obtaining of all permits, consents, approvals and authorizations of all third parties and Governmental Entities necessary or its Affiliates is advisable to consummate the owner transactions contemplated by this Agreement and each party will keep the other apprised of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In status of matters relating to completion of the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consentstransactions contemplated by this Agreement. Notwithstanding the foregoing, nothing contained herein shall be deemed to require Acquirer to take any action, or commit to take any action, or agree to any condition or restriction, in connection with obtaining the rights granted foregoing permits, consents, approvals and authorizations of third parties or Governmental Entities, that would reasonably be expected to have a Party material adverse effect (measured on a scale relative to access Yardville and reference its Subsidiaries, taken as a whole) on Acquirer, Yardville or the Surviving Corporation (a “Materially Burdensome Regulatory Condition”). In addition, Yardville agrees to cooperate and use its reasonable best efforts to assist Acquirer in preparing and filing such petitions and filings, and in obtaining such permits, consents, approvals and authorizations of third parties and Governmental Entities, that may be necessary or advisable to effect any NDAs mergers and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent consolidations of Subsidiaries of Yardville and Acquirer following consummation of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonMerger. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Each of the parties hereto shall cooperate and use Commercially Reasonable Efforts their respective reasonable best efforts to submit registration dossiers take, or cause to be taken, all action, and to do, or cause to be done as promptly as practicable, all things necessary, proper and advisable under applicable Laws, to consummate and make effective as promptly as practicable the Transactions, including providing any notices to any Person required in connection with the consummation of the Transactions, and obtaining any licenses, consents, waivers, approvals, authorizations, qualifications and Governmental Orders necessary to consummate the Transactions (including the FCA Approval and the CBI Approval); provided, that in no event shall any party be required to pay any material fee, penalty or other consideration to obtain any license, Permit, consent, approval, authorization, qualification or waiver required under any Contract for the consummation of the Transactions (other than fees or expenses payable to the relevant Regulatory Authorities SEC in connection with respect the Transactions, including the Proxy Statement / Prospectus, filing fees payable pursuant to all the HSR Act or other Antitrust Laws, and any other ordinary course filing fees in connection with Governmental Filings required to consummate the Transactions). Subject to appropriate confidentiality protections and applicable Antitrust Laws, each party hereto shall furnish to the other parties such necessary Regulatory Approvals information and reasonable assistance as such other party may reasonably request in each Major Countryconnection with the foregoing. (b) Licensee shall have the right FTAC agrees that each Sponsor Person required to obtain Regulatory ApprovalsFCA Approval and / or CBI Approval, which shall be held by make any such notification (the “Change of Control Notification”) to the FCA and / or CBI as promptly as practicably (and in any event within five (5) Business Days of the name date of Licenseethis Agreement). If at any time FTAC becomes aware of any event, circumstance or condition that would be reasonably likely to prevent FCA Approval or CBI Approval being satisfied, FTAC shall immediately inform the other parties, and Licensee shall own all Submissions and Data in connection therewith. All pricingreasonably cooperate with them to address any such event, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4circumstance or condition. (c) Each Party of the parties hereto shall have full access cooperate with one another and use their reasonable best efforts to prepare all necessary documentation (including furnishing all information (i) required under any applicable Antitrust Laws or other applicable Laws, (ii) requested by a Governmental Authority pursuant to applicable Antitrust Laws, or (iii) requested by the FCA or CBI as part of the FCA Approval and CBI Approval applications) to effect promptly all necessary filings with any Governmental Authority and to obtain all necessary, proper or advisable actions or nonactions, approvals consents, waivers, exemptions and approvals of any Governmental Authority necessary to consummate the Transactions, including the FCA Approval and the right CBI Approval. Each party hereto shall provide to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, parties copies of all correspondence between it (or its Affiliates, and/or sublicensees advisors) and any Governmental Authority relating to the Transactions or any third of the matters described in this Section 9.01. Each of the parties hereto shall promptly inform the other of any substantive oral communication with, and provide copies of any written communications with, any Governmental Authority regarding any such filings or any such transaction, unless prohibited by reasonable request of any Governmental Authority. No party filing hereto shall independently participate in any substantive meeting or substantive conference call with any Governmental Authority in respect of any such NDAs and/or their foreign equivalent filings, investigation or other inquiry without giving the other party prior notice of the substantive meeting or substantive conference call and, to the extent permitted by such Governmental Authority, the opportunity to attend or participate. In the event a party is prohibited from participating in or attending any meeting or substantive conference call, the participating party shall keep the other party promptly and reasonably apprised with respect thereto, to the extent permitted by applicable Law. To the extent permissible under applicable Law, the parties hereto will consult and cooperate with one another, and consider in good faith the views of one another so as to mutually agree on any strategies and decisions in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto relating to proceedings under Antitrust Laws or other applicable Laws. Any documents or other materials provided pursuant to this Section 9.01(c) may be redacted or withheld as necessary to address reasonable privilege or confidentiality concerns, and to remove references concerning the valuation of the Company or other competitively sensitive material or personally-identifiable information or other sensitive personal or financial information, and the parties may, as each deems advisable, reasonably designate any material provided under this Section 9.01 as “outside counsel only material.” Such “outside counsel only materials” and the information contained therein shall be given only to legal counsel of the recipient and will not be disclosed by such Partylegal counsel to employees, its Affiliatesofficers, or directors of the recipient without the advance written consent of the party providing such materials. Notwithstanding the foregoing, neither party shall be obligated to share with the other party documents responsive to items 4(c) and 4(d) on the Notification and Report Form for Certain Mergers and Acquisitions under the HSR Act. Without limiting the generality of the undertakings pursuant to this Section 9.01, each party hereto shall use reasonable best efforts to provide or cause to be provided (including, with respect to filings pursuant to the HSR Act, by its sublicensees“Ultimate Parent Entities”, as that term is defined in the HSR Act, and with respect to the FCA Approval and/or the CBI Approval, the Sponsor Persons, the Company, and the LLC to the extent that such approval is required by such Person) as promptly as reasonably practicable and advisable to any Governmental Authority information and documents relating to such party as requested by such Governmental Authority or necessary, proper or advisable to permit consummation of the Transactions, including filing any notification and report form and related material required under the HSR Act and any other filing or notice that may be required with any other Governmental Authority as promptly as reasonably practicable and advisable after the date hereof (and, in the case of filings under the HSR Act, no later than 10 Business Days after the date hereof), and thereafter to respond as promptly as reasonably practicable and advisable to any request for additional information or documentary material relating to such party that may be made (including under the HSR Act and any similar Antitrust Law regarding preacquisition notifications for the purpose of competition reviews). FTAC shall supply as promptly as practicable (and shall respond no later than five (5) days following any request) any additional information and documentary material relating to FTAC and the Sponsor Persons that may be requested by any Governmental Authority and furnish to the other such necessary information and reasonable assistance as the other may request in connection with the preparation of any required applications, notices, registrations and requests as may be required or advisable to be filed with any Governmental Authority (including, with respect to FTAC and the Sponsor Persons, providing financial information and certificates as well as personal information of senior management, directors or control persons, and requesting that individuals with appropriate seniority and expertise make themselves available to participate in discussions or hearings). FTAC shall cause the filings made by it (or by its ultimate parent entity, if applicable) under the HSR Act to be considered for grant of “early termination,” and make any further filings pursuant thereto that may be necessary, proper, or advisable in connection therewith. In furtherance and not in limitation of the foregoing, FTAC shall provide, or cause to be provided, all agreements, documents, instruments, affidavits, statements or information that may be required or requested by any Governmental Authority relating to (i) FTAC (including any of its directors, officers, employees, partners, members, shareholders or control persons) and (ii) FTAC’s structure, ownership, businesses, operations, regulatory and legal compliance, assets, liabilities, financing, financial condition or results of operations, or any of its or their directors, officers, employees, partners, members, shareholders or Affiliates (including to the extent required pursuant to paragraph 8 of the Sponsor Agreement). (d) If any objections are asserted with respect to the Transactions under any applicable Law or if any Action is instituted by any Governmental Authority or any private party challenging any of the Transactions as violative of any applicable Law, each of the parties hereto shall cooperate with one another in good faith and use their reasonable best efforts to: (i) oppose or defend against any action to prevent or enjoin consummation of this Agreement (and the Transactions), and (ii) take such action as reasonably necessary to overturn any regulatory action by any Governmental Authority to prevent or enjoin consummation of this Agreement (and the Transactions), including by defending any Action brought by any Governmental Authority in order to avoid entry of, or to have vacated, overturned or terminated, including by appeal if necessary, in order to resolve any such objections or challenge as such Governmental Authority or private party may have to any of the Transactions under such applicable Law so as to permit the consummation of the Transactions in their entity; provided, however, that any decision by the parties hereto to litigate in connection with such rights are subject to matters must be mutually agreed by the prior written consent of parties hereto. (e) Notwithstanding the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained thereinforegoing, such Party shall notFTAC shall, and shall cause its controlled Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate take any and all actions necessary to obtain such any authorization, consent or approval of a Governmental Authority (including in connection with any Governmental Filings) necessary third party consents. Notwithstanding or advisable so as to enable the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent consummation of the Person owning Transactions to occur as expeditiously as possible (and in any event, no later than the NDA Termination Date) and to resolve, avoid or foreign equivalenteliminate any impediments or objections, such consent if any, that may be asserted with respect to be at the sole discretion Transactions under any Law, or to otherwise oppose, avoid the entry of, or to effect the dissolution of, any order, decree, judgment, preliminary or permanent injunction that would otherwise have the effect of such owning Person. (d) To preventing, prohibiting, restricting, or delaying the extent not prohibited by law or regulationconsummation of the Transactions, Xxxxx shall have right to have one (1) representative including: (i) attend (but not participate in) any material meetings between Licensee proposing, negotiating, committing to and effecting, by consent decree, hold separate order or otherwise, the sale, divestiture, licensing or disposition of, or holding separate of, businesses, product lines, rights or assets of FTAC or its controlled Affiliates and any Regulatory Authority with respect interest therein (including entering into customary ancillary agreements relating to Licensed Products any such sale, divestiture, licensing or disposition of such businesses, product lines, rights or assets) and (ii) listen otherwise taking or committing to take actions that after the Closing Date would limit FTAC’s or its controlled Affiliates’ freedom of action with respect to, or its ability to retain or control, one or more of the businesses, product lines, rights or assets of FTAC and its controlled Affiliates or interest therein, in each case as may be required in order to enable the consummation of the Transactions to occur as expeditiously as possible (but and in any event no later than the Termination Date. (f) From the date of this Agreement until Closing, FTAC shall not participate acquire or agree to acquire, by merging with or into or consolidating with, or by purchasing a substantial portion of the assets of or any equity in) , or by any other manner, any assets or Person, or take any other action, if the execution and delivery of a definitive agreement relating to, or the consummation of, such acquisition, or the taking of any other action, could in any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and (individually or in the relevant Regulatory Authority. Licensee will use reasonable efforts aggregate): (i) impose any delay in obtaining, or increase the risk of not obtaining, consents of a Governmental Authority necessary to provide Xxxxx with as much advance notice consummate the Transactions or the expiration or termination of any such meeting or telephone call as is reasonably possible in the circumstances andapplicable waiting period, (ii) increase the risk of a Governmental Authority seeking or entering a Governmental Order prohibiting the consummation of the Transactions, (iii) increase the risk of not being able to remove any such Governmental Order on appeal or otherwise, or (iv) otherwise prevent or delay the consummation of the Transactions. (g) Notwithstanding anything in this Agreement to the extent reasonably possiblecontrary, nothing in this Agreement shall require PGHL or any of its respective Subsidiaries or any Affiliates (including Blackstone or CVC) to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) take, or cause to be taken, any action with respect to Blackstone, CVC or any of its or their Affiliates, including any affiliated investment funds or any portfolio company (as such term is commonly understood in the private equity industry) of Blackstone, CVC or any of its or their Affiliates, including selling, divesting or otherwise disposing of, or conveying, licensing, holding separate or otherwise restricting or limiting its freedom of action with respect to, any assets, business, products, rights, licenses or investments, or interests therein, other than with respect to the Company and its Subsidiaries, or (ii) provide, or cause to be provided, (A) nonpublic or other confidential financial or sensitive personally identifiable information of this sentence require Licensee Blackstone, CVC or any of its or their Affiliates or its or their respective directors, officers, employees, managers or partners, or its or their respective control persons’ or direct or indirect equityholders’ and their respective directors’, officers’, employees’, managers’ or partners’ (each of the foregoing Persons, a “Seller Related Person”) (other than such information with respect to delay the officers and directors of the Company which may be provided to a Governmental Authority on a confidential basis) or (B) any meeting other nonpublic, proprietary or telephone call other confidential information of a Seller Related Person that exceeds the scope of information that such Seller Related Person has historically supplied in connection with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsimilar governmental filing or notification. (eh) Licensee Notwithstanding anything else contained herein to the contrary, FTAC shall have pay, or cause to be paid, all filing fees payable by any Party pursuant to Antitrust Laws in connection with the sole right Transactions. (i) The parties agree not to obtain all pricing file an application under the FATA in respect of the condition to Closing in Section 10.01(b) unless the application is filed on a date that is more than one month after the date of this Agreement. The condition to Closing in Section 10.01(b) will be deemed to be satisfied if (i) there is a change of law or prevailing regulations relating to or issued under the FATA or (ii) the Company takes action permitted under Schedule 7.01 of the PGHL Schedules and, in either case, the Company determines, acting reasonably and reimbursement approvals after consulting with FTAC and giving due consideration to the input of FTAC and its advisors, that approval of the Treasurer under the FATA in all countries in order to complete the Territory in which Licensed Products shall be soldTransactions is no longer required and gives written notice to FTAC of such determination.

Regulatory Approvals. (a) Licensee Subject to and in accordance with the provisions of this Section 7.4, each of the Parties shall use Commercially Reasonable Efforts commercially reasonable efforts to submit registration dossiers obtain (and shall cooperate fully with the other Parties in obtaining) as promptly as practicable the Contributor Approvals, the SEP Approvals and all other authorizations, consents, clearances, orders, expirations, waivers or terminations of any applicable waiting periods and approvals of all Government Entities that may be or may become reasonably necessary, proper or advisable under this Agreement or any of the other Transaction Documents and applicable Laws to consummate and make effective the relevant Regulatory Authorities Transactions as promptly as practicable and in any event no later than the Outside Date. SEP shall pay all filing fees in connection with respect to SEP Approvals. Contributor shall pay all necessary Regulatory Approvals in each Major Countryfiling fees for all Contributor Approvals. (b) Licensee shall have the right to obtain Regulatory ApprovalsAs promptly as practicable, which shall be held by and in no event later than fifteen Business Days after the name of Licenseedate hereof, Contributor and Licensee shall own all Submissions SEP shall (i) promptly make any filings with, or notices to, the Wyoming Public Service Commission and Data promptly file any supplemental information required or requested in connection therewith. All pricingtherewith and (ii) make all filings and notifications with all Government Entities that may be or may become reasonably necessary, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx proper or advisable under this Section 4.4Agreement and applicable Laws to consummate and make effective the Transactions. (c) Each Party shall have full access to Contributor and SEP may not, without the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by consent of the other Party(which consent shall not be unreasonably withheld, its Affiliatesdelayed or conditioned), and/or sublicensees (i) cause any such filing or submission applicable to it to be withdrawn or refiled for any third party filing reason, including to provide the applicable Government Entity with additional time to review any or all of the Transactions or (ii) consent to any voluntary extension of any statutory deadline or waiting period or to any voluntary delay of the consummation of the Transactions at the behest of any Government Entity. Each of Contributor and SEP shall use commercially reasonable efforts to supply promptly any information and documentary material that may be requested pursuant to any applicable Laws in connection with such NDAs and/or their foreign equivalent on behalf filings or submissions. (d) Subject to applicable Laws relating to the sharing of information, Contributor and SEP shall promptly notify each other of any communication such other Party receives from any Government Entity (other than communications for purely logistical purposes) and permit such other Party to review in advance any proposed applications, notices, filings, submissions, undertakings, correspondence and communications of any nature (including responses to requests for information and inquiries from any Government Entity) by such Party, its Affiliatesas applicable, to any Government Entity and shall provide such other Party with copies of all applications, notices, filings, submissions, undertakings, correspondence and communications of any nature (including responses to requests for information and inquiries from any Government Entity) between such Party, as applicable, or any of its sublicenseesRepresentatives, on the one hand, and any Government Entity or members of the staff of any Government Entity, on the other hand, in each case to the extent relating to the matters that are the subject of this Agreement and the other Transaction Documents, except with respect to Taxes (which are covered by Section 7.8). Except with respect to Taxes (which are covered by Section 7.8), neither Party shall agree to participate in any meeting or discussion with any Government Entity relating to the matters that are the subject of this Agreement (including in respect of satisfying or obtaining the SEP Approvals and the Contributor Approvals) or any of the other Transaction Documents unless such Party consults with such other Party in advance and, to the extent permitted by such Government Entity, gives such other Party the opportunity to attend and participate at such meeting or discussion. Contributor and SEP shall coordinate and cooperate fully with each other in exchanging such information and providing such assistance as each may reasonably request in connection with the foregoing and shall keep each other informed of the status of discussions relating to obtaining or concluding the SEP Approvals and the Contributor Approvals; provided, however, that the foregoing shall not require Contributor and SEP or any of their respective Affiliates (i) to disclose any information that in the reasonable judgment of such rights are subject to the prior written consent Party or any of the Person owning the NDA or foreign equivalent its respective Affiliates (as the case may be and be) would result in the disclosure of any information contained therein. In the event that a Party trade secrets of third parties or violate any of its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority obligations with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances andconfidentiality, (ii) to disclose any privileged information or confidential competitive information of such Party or any of its respective Affiliates or (iii) to disclose the valuation of, or any communications analyses or other work product regarding the valuation of, the Contributed Interests, the Total Unit Consideration, the Companies or the Companies’ assets. If either Party seeks to withhold information from any of the other Party for any reason permitted by this Section 7.4(d), such Party, as applicable, shall nonetheless provide a redacted version of the information so withheld to the others and, subject to the requirement that such outside counsel not disclose the unredacted version to any other Person, a complete, unredacted version of the same to the outside legal counsel of the others. Neither Party shall be required to comply with any provision of this Section 7.4(d) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any that such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to compliance would be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productprohibited by applicable Law. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. 5.3.1 The Company shall, if required under the Antitrust Laws and requested by Axcan, (ai) Licensee no later than sixty (60) calendar days following the execution of this Agreement, make the initial filing required from the Company under the HSR Act in connection with the consummation of the Merger and the other transactions contemplated hereby; and (ii) as promptly as practicable following the execution of this Agreement, execute and file or, if appropriate, join in the execution and filing of, the applications, notifications, and other documents required for the lawful consummation of the Merger and the other transactions contemplated hereby under the Antitrust Laws of the jurisdictions identified in Section 5.3 of the Disclosure Schedule. Axcan shall use Commercially Reasonable Efforts to submit registration dossiers to (x) on the relevant Regulatory Authorities same day as the Company makes the initial filing, if any, required under clause (i) above, make Axcan’s initial filing under the HSR Act in connection with respect the consummation of the Merger and the other transactions contemplated hereby; and (y) as promptly as practicable following the execution of this Agreement, execute and file or, if appropriate, join in the execution and filing of, the applications, notifications, and other documents relating to all necessary Regulatory Approvals in each Major Country. filings that Axcan requests the Company to make under clause (bii) Licensee above. [*] shall have pay all filing fees associated with the right to obtain Regulatory Approvalsabove filings, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliatesapplications, or its sublicenseesnotifications, if any; provided, however, in the event a filing is required under the HSR Act solely because [*], such fees shall be [*]. If requested by Axcan, the Company shall use commercially reasonable efforts to promptly obtain, and to cooperate with Axcan to promptly obtain, all authorizations, approvals, clearances, consents, actions, or non-actions of any Governmental Entity in connection with the above filings, applications, or notifications; provided, that such rights are subject Axcan shall use commercially reasonable efforts to promptly obtain the same. The Company shall promptly inform Axcan of any material communication between the Company (including its representatives, counsel, or consultants) and any Governmental Entity regarding any of the transactions contemplated hereby. If the Company or any Affiliate of the Company receives any formal or informal request for supplemental information or documentary material from any Governmental Entity with respect to the prior written consent Merger or the other transactions contemplated hereby, then the Company shall make, or cause to be made, as soon as reasonably practicable, a response in compliance with such request. Axcan, as the purchaser, shall, if it so elects, lead all efforts to obtain any clearance, waiver, approval or authorization from any Governmental Entity that is necessary to enable the parties to consummate the Merger or the other transactions contemplated hereby and by the Merger Agreement, but shall consider in good faith the views of the Person owning Company. 5.3.2 Axcan shall promptly inform the NDA Company of any material communication between Axcan (including its representatives, counsel, or foreign equivalent consultants) * Confidential treatment requested. and any Governmental Entity regarding any of the transactions contemplated hereby. If Axcan or any Affiliate of Axcan receives any formal or informal request for supplemental information or documentary material from any Governmental Entity with respect to the transactions contemplated hereby, then Axcan shall make, or cause to be made, as soon as reasonably practicable, a response in compliance with such request. Axcan shall direct, in its sole discretion, the making of such response, but shall consider in good faith the views of the Company. 5.3.3 The Company and Axcan shall, to the extent permissible, promptly furnish the other with copies of notices or other communications between the Company (including its representatives, counsel and any Company Subsidiary) or Axcan (including its representatives, counsel and Subsidiaries), as the case may be be, and any Third Party and/or Governmental Entity with respect to such transactions. The Company and Axcan shall keep each other timely apprised of any inquiries or requests for additional information contained therein. In from any Governmental Entity pursuant to any Antitrust Law, to the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall notextent permissible, and shall cause its Affiliates not tocomply promptly with any such reasonable inquiry or request. The Company, unreasonably withhold or delay consent. In on the event that a third party is one hand, and Axcan, on the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated hereinother hand, shall not extend permit counsel for the other reasonable opportunity to such Party’s sublicensees without review in advance, to the prior written consent extent permissible, and consider in good faith the views of the Person owning other in connection with, any proposed written communication to any Governmental Entity relating to the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) transactions contemplated by this Agreement. To the extent not prohibited permitted by law the relevant Governmental Entity, each of Company, the Axcan, and their respective Subsidiaries and Affiliates shall permit each other (including each other’s representatives, counsel, or regulation, Xxxxx consultants) to attend meetings with a Governmental Entity relating to the transactions contemplated by this Agreement; provided however the Company shall have right to have one (1) representative (i) attend (but not participate in) in any material meetings between Licensee and any Regulatory Authority discussion or meeting with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) Governmental Entity to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies discussion or meeting involves an unrelated transaction or confidential information of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productthird party. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Subject to the terms and conditions of this Agreement, each of Purchaser, Holdings and the Company shall use Commercially Reasonable Efforts its commercially reasonable efforts, and shall cooperate fully with such other Parties, to submit registration dossiers take, or cause to be taken, all actions and to do, or cause to be done, all things reasonably necessary, proper or advisable under applicable Laws and regulations to consummate the Transactions (including the receipt of all applicable Consents of Governmental Authorities) and to comply as promptly as practicable with all requirements of Governmental Authorities applicable to the relevant Regulatory Authorities with respect Transactions, including using its commercially reasonable efforts to (i) prepare and promptly file all documentation to effect all necessary Regulatory Approvals in each Major Countryfilings, notices, petitions, statements, registrations, submissions of information, applications and other documents, (ii) obtain all Permits, Consents, approvals, authorizations, registrations, waivers, qualifications and orders of, and the expiration or termination of waiting periods by, Governmental Authorities to satisfy the consummation of the Transactions and to fulfil the conditions to the Merger and the Share Acquisition Closing and (iii) execute and deliver any additional instruments necessary to consummate the Transactions. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by In furtherance and not in the name limitation of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingSection 8.11(a), to the extent legally possiblerequired under the FCA or any other Laws that are designed to prohibit, being restrict or regulate actions having the sole contact with such Regulatory Authoritiespurpose or effect of monopolization or restraint of trade or that are designed to prohibit, subject restrict or regulate actions that may risk national security (collectively, “Antitrust Laws”), each of Purchaser, Holdings and the Company agrees to make any required filing or application under Antitrust Laws, as applicable, including preparing and making an appropriate filing pursuant to the rights FCA, at such Party’s sole cost and expense (including with respect to the FCA filing fee), with respect to the Transactions as promptly as practicable, to supply as promptly as reasonably practicable any additional information and documentary material that may be reasonably requested pursuant to Antitrust Laws and to take all other actions reasonably necessary, proper or advisable to cause the granting of Xxxxx approval or consent by the Governmental Authority as soon as practicable. Each of Purchaser, Holdings and the Company shall, in connection with its commercially reasonable efforts to obtain all requisite approvals and authorizations for the Transactions under this Section 4.4any Antitrust Law, use its commercially reasonable efforts to: (i) cooperate in all respects with each other of such Parties or their respective Affiliates in connection with any filing or submission and in connection with any investigation or other inquiry, including any proceeding initiated by a private Person, (ii) keep such other Parties reasonably informed of any material communication received by such Party or its Representatives from, or given by such Party or its Representatives to, any Governmental Authority and of any material communication received or given in connection with any proceeding by a private Person, in each case regarding any of the Transactions, (iii) permit a Representative of such other Parties and their respective outside counsel to review any material communication given by it to, and consult with each other in advance of any material meeting or conference with, any Governmental Authority or, in connection with any proceeding by a private Person, with any other Person, and to the extent permitted by such Governmental Authority or other Person, give a Representative or Representatives of such other Parties the opportunity to attend and participate in such meetings and conferences, (iv) in the event a Party’s Representative is prohibited from participating in or attending any meetings or conferences, each attending Party shall keep such Party promptly and reasonably apprised with respect thereto and (v) use commercially reasonable efforts to cooperate in the filing of any memoranda, white papers, filings, correspondence or other written communications explaining or defending the Transactions, articulating any regulatory, competitive or national security related argument, and responding to requests or objections made by any Governmental Authority. (c) Each Party shall have full access If any objections are asserted with respect to the Transactions under any applicable Law or if any Action is instituted (or threatened to be instituted) by any applicable Governmental Authority or any private Person challenging any of the Transactions as violative of any applicable Law or which would otherwise prevent, materially impede or materially delay the consummation of the Transactions, each of Purchaser, Holdings and the right Company shall use its commercially reasonable efforts to reference resolve any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees such objections or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject Actions so as to the prior written consent timely permit consummation of the Person owning Transactions including in order to resolve such objections or Actions which, in any case if not resolved, could reasonably be expected to prevent, materially impede or materially delay the NDA or foreign equivalent as consummation of the case may be and any information contained thereinTransactions. In the event any Action is instituted (or threatened to be instituted) by a Governmental Authority or private Person challenging the Transactions, each of Purchaser, Holdings and the Company shall, and shall cause their respective Representatives to, reasonably cooperate with each other and use their respective commercially reasonable efforts to contest and resist any such Action and to have vacated, lifted, reversed or overturned any Order, whether temporary, preliminary or permanent, that a is in effect and that prohibits, prevents or restricts consummation of the Transactions. (d) Prior to the Share Acquisition Closing and the Merger Closing, as applicable, each of Purchaser, Holdings and the Company shall use its commercially reasonable efforts to obtain any Consents of Governmental Authorities or other third party as may be necessary for the consummation by such Party or its Affiliates is of the owner Transactions or required as a result of such NDA the execution or foreign equivalent as performance of, or consummation of the case may be or information contained thereinTransactions, by such Party or its Affiliates, and the other Parties shall notprovide reasonable cooperation in connection with such commercially reasonable efforts. With respect to Holdings, during the Interim Period, each of Purchaser, Holdings and the Company shall use its commercially reasonable efforts to cause Holdings to qualify as “foreign private issuer” as such term is defined under Exchange Act Rule 3b-4 and to maintain such status through the Share Acquisition Closing. (e) Notwithstanding the generality of the foregoing, each of Purchaser, Holdings and the Company shall use its, and shall cause its Affiliates not toto use their, unreasonably withhold commercially reasonable efforts to consummate the transactions contemplated by the Subscription Agreements, including using its, and causing its Affiliates to use their, commercially reasonable efforts to enforce its or delay consenttheir rights under the Subscription Agreements to cause the PIPE Investors to pay to (or as directed by) Holdings the applicable purchase price under each PIPE Investor’s applicable Subscription Agreement in accordance with its terms. In None of Purchaser, Holdings or the event that a third party is the owner of such NDA or foreign equivalent or information contained thereinCompany, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA such other Parties, permit or foreign equivalent, such consent to be at the sole discretion of such owning Person. any amendment, supplement or modification to or any waiver (din whole or in part) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting provision or telephone call as is reasonably possible in the circumstances andremedy under, (ii) to the extent reasonably possibleor any replacements of, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductSubscription Agreement. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee The Company shall (i) no later than three (3) Business Days following the execution of this Agreement, make the initial filing required from the Company under the HSR Act in connection with the consummation of the Merger and the other transactions contemplated hereby; and (ii) as promptly as practicable following the execution of this Agreement, execute and file or, if appropriate, join in the execution and filing of, the applications, notifications, and other documents required for the lawful consummation of the Merger and the other transactions contemplated hereby under the Antitrust Laws of the jurisdictions identified in Section 5.3 of the Company Disclosure Letter. Acquiror shall pay or cause to be paid all filing fees associated with the above filings, applications, or notifications. The Company shall use Commercially Reasonable Efforts commercially reasonable efforts to submit registration dossiers obtain, and to cooperate with Acquiror to promptly obtain, all authorizations, approvals, clearances, consents, actions, or non-actions of any Governmental Entity in connection with the relevant Regulatory Authorities above filings, applications, or notifications and, for further clarity, each of the Company and Acquiror shall request early termination of any waiting periods associated with such filings, applications or notifications. The Company shall promptly inform Acquiror of any material communication between the Company (including its representatives, counsel, or consultants) and any Governmental Entity regarding any of the transactions contemplated hereby. If the Company or any Affiliate of the Company receives any formal or informal request for supplemental information or documentary material from any Governmental Entity with respect to all necessary Regulatory Approvals the Merger or the other transactions contemplated hereby, then the Company shall make, or cause to be made, as soon as reasonably practicable, a response in each Major Countrycompliance with such request. The Company shall direct, in its sole discretion, the making of such response, but shall consider in good faith the views and input of the Acquiror. (b) Licensee Acquiror shall have no later than three (3) Business Days following the right to obtain Regulatory Approvalsexecution of this Agreement, which shall be held by and in make the name of Licensee, and Licensee shall own all Submissions and Data initial filing required from Acquiror under the HSR Act in connection therewithwith the consummation of the Merger and the other transactions contemplated hereby. All pricingAcquiror shall pay or cause to be paid all filing fees associated with the filings required under the HSR Act. Acquiror shall promptly inform the Company of any material communication between Acquiror (including its representatives, formulary counsel, or consultants) and marketing approvals shall also be obtained by and in any Governmental Entity regarding any of the name transactions contemplated hereby. If Acquiror or any Affiliate of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions Acquiror receives any formal or informal request for supplemental information or documentary material from any Governmental Entity with Regulatory Authorities concerning any Licensed Products including, respect to the extent legally possibletransactions contemplated hereby, being the sole contact then Acquiror shall make, or cause to be made, as soon as reasonably practicable, a response in compliance with such Regulatory Authoritiesrequest. Acquiror shall direct, subject to in its sole discretion, the rights making of Xxxxx under this Section 4.4such response, but shall consider in good faith the views and input of the Company. (c) Each Party The Company and Acquiror shall have full access keep each other apprised of the status of matters relating to and the right completion of the transactions contemplated by this Agreement and, to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the extent permissible, promptly furnish the other Partywith copies of notices or other communications between the Company (including its representatives and counsel and any Company Subsidiary) or Acquiror (including its representatives, its Affiliatescounsel and Subsidiaries), and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be be, and any information contained thereinthird party and/or Governmental Entity with respect to such transactions. In The Company, on the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall notone hand, and shall cause its Affiliates not toAcquiror, unreasonably withhold or delay consent. In on the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated hereinother hand, shall not extend keep the other timely appraised of any inquiries or requests for additional information from any Governmental Entity pursuant to any Antitrust Law, to the extent permissible and shall use its commercially reasonable efforts to comply promptly with any such Party’s sublicensees without inquiry or request. The Company, on the prior written consent one hand, and Acquiror, on the other hand (including their respective Representatives), shall permit counsel for the other party reasonable opportunity to review in advance, to the extent permissible, and consider in good faith the views and input of the Person owning other party in connection with, any proposed written communication to any Governmental Entity relating to the NDA transactions contemplated by this Agreement. Each of the Company, on the one hand, and Acquiror, on the other hand, agrees not to participate in any substantive meeting or foreign equivalentdiscussion, either in person or by telephone, with any Governmental Entity in connection with the transactions contemplated by this Agreement unless it consults with the other party in advance and, to the extent not prohibited by such consent Governmental Entity, gives the other party the opportunity to be at the sole discretion of such owning Personattend and participate. (d) To Notwithstanding anything in this Agreement to the extent not prohibited contrary, if any administrative or judicial action or proceeding (each a “Proceeding”) is instituted or threatened to be instituted, or any decree, judgment, injunction or other order, whether temporary, preliminary or permanent (each an “Order”) is entered or threatened to be entered, in each case challenging the consummation of the Merger or any other transaction contemplated by law this Agreement as violative of any Antitrust Law, the parties shall use commercially reasonable efforts to contest, avoid, vacate, modify, or regulationsuspend each such Proceeding or Order, Xxxxx including through litigation. Nothing in this Section 5.3 shall have limit a party’s right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of terminate this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted Agreement pursuant to Section 7.1(b) if such party has, until such date, complied in all material respects with its obligations under this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductSection 5.3. (e) Licensee shall have Notwithstanding anything in this Agreement to the sole right to obtain all pricing contrary, the parties hereto understand and reimbursement approvals in all countries in the Territory in which Licensed Products agree that neither party hereto shall be soldrequired by this Section 5.3 to (i) enter into any settlement, undertaking, consent decree, stipulation or agreement with any Governmental Entity in connection with the transactions contemplated hereby, (ii) divest or otherwise hold separate (including by establishing a trust or otherwise) or (iii) take any other action (or otherwise agreeing to do any of the foregoing) with respect to any of its or the Surviving Corporation’s Subsidiaries or any of their respective Affiliates’ businesses, assets or properties.

Regulatory Approvals. (a) Licensee shall Each of First West Virginia and CB will cooperate with the other and use Commercially Reasonable Efforts reasonable efforts to submit registration dossiers to promptly prepare and as soon as practicable following the relevant Regulatory Authorities with respect to date hereof file all necessary Regulatory Approvals documentation to obtain all necessary permits, consents, waivers, approvals and authorizations of the Bank Regulators or any other third parties or Governmental Entities necessary to consummate the transactions contemplated by this Agreement. First West Virginia and CB will furnish each other and each other’s counsel with all information concerning themselves, their Subsidiaries, directors, officers and stockholders and such other matters as may be necessary or advisable in each Major Country. (b) Licensee connection with any application, petition or other statement made by or on behalf of First West Virginia or CB to any Bank Regulator or Governmental Entity in connection with the Merger, Bank Merger and the other transactions contemplated by this Agreement. First West Virginia shall have the right to obtain Regulatory Approvals, which shall be held by review and approve in advance all characterizations of the name of Licensee, information relating to First West Virginia and Licensee shall own all Submissions and Data any First West Virginia Subsidiary that appears in any filing made in connection therewithwith the transactions contemplated by this Agreement with any Governmental Entity. All pricingIn addition, formulary First West Virginia and marketing approvals CB shall also each furnish to the other for review a copy of each such filing made in connection with the transactions contemplated by this Agreement with any Governmental Entity prior to its filing. Each of First West Virginia and CB will cooperate with each other and use their reasonable best efforts to address any conditions in any regulatory approval to allow for the consummation of the transactions contemplated by this Agreement. Each of CB and First West Virginia agrees to keep the other party apprised of the status of material matters relating to completion of the transactions contemplated hereby, including advising the other party upon receiving any communication from a Bank Regulator or Governmental Entity, the consent or approval of which is required for the consummation of the Merger and the other transactions contemplated by this Agreement, that causes such party to believe that there is a reasonable likelihood that any required consent or approval from a Bank Regulator or Governmental Entity will not be obtained by and in or that the name receipt of Licenseesuch consent or approval may be materially delayed (a “Regulatory Communication”). Upon the receipt of a Regulatory Communication, and Licensee will be without limiting the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingscope of the foregoing, CB shall, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned permitted by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by applicable law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) promptly advise First West Virginia of the receipt of any material meetings between Licensee and any Regulatory Authority substantive communication from a Bank Regulator or Governmental Entity with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances andtransactions contemplated hereby, (ii) provide First West Virginia with a reasonable opportunity to participate in the preparation of any response thereto and the preparation of any other substantive submission or communication to any Bank Regulator or Governmental Entity with respect to the extent reasonably possible, transactions contemplated hereby and to provide Xxxxx, at least five (5) business days before review any such meetingresponse, with copies of all documents, correspondence and other materials which are relevant submission or communication prior to the matters filing or submission thereof, and (iii) provide First West Virginia (as permitted by such Bank Regulators) with a reasonable opportunity to be addressed at any such meeting or participate in any such meetings or substantive telephone call (it being understood conversations that in no event will CB or any CB Subsidiaries or their respective representatives may have from time to time with any Bank Regulator or Governmental Entity with respect to the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to transactions contemplated by this Agreement with any Regulatory AuthorityARTICLE IX CLOSING CONDITIONS 9.1 Conditions to Each Party’s Obligations Under this Agreement. Notwithstanding The respective obligations of each party to effect the foregoing, Licensee will have sole discretion as Closing shall be subject to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have fulfillment at or prior to the sole right to obtain all pricing and reimbursement approvals in all countries in Closing Date of the Territory in following conditions, none of which Licensed Products shall may be sold.waived:

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers Xxxxxxxx and LMP shall, as promptly as practicable following the Effective Date, file with the United States Federal Trade Commission (the “FTC”) and the United States Department of Justice (the “DOJ”), the notification and report form required from each of Xxxxxxxx and LMP for the transactions contemplated by this Agreement and any supplemental information requested in connection therewith pursuant to the relevant Regulatory Authorities HSR Act, which forms shall specifically request early termination of the waiting period prescribed by the HSR Act. Each of Xxxxxxxx and LMP shall furnish to each other’s counsel such necessary information and reasonable assistance as the other may request in connection with respect to its preparation of any filing or submission that is necessary under the HSR Act. The Parties agree that LMP, on the one hand, and Xxxxxxxx, on the other hand, shall each be responsible for 50% of any and all necessary Regulatory Approvals filing fees payable in each Major Countryconnection with the foregoing filings. (b) Licensee Xxxxxxxx and LMP shall have use their respective commercially reasonable efforts to promptly obtain any clearance required under the right HSR Act for the consummation of the transactions contemplated by this Agreement and shall keep each other apprised of the status of any communications with, and any inquiries or requests for additional information from any Governmental Authority and shall comply promptly with any such inquiry or request. LMP and Xxxxxxxx shall use their commercially reasonable efforts to obtain Regulatory Approvalsany necessary approval from any Government Authority under the HSR Act. Notwithstanding anything contained in this Agreement to the contrary, which neither LMP nor Xxxxxxxx nor any of their Subsidiaries or other Affiliates shall be held by and in obligated to do any of the name following: (i) dispose or transfer any asset other than pursuant to this Agreement; (ii) license or otherwise make available to any Person any technology or other intellectual property rights; (iii) hold separate any assets or operations (either before or after the applicable Closing Date); or (iv) change or modify any course of Licensee, and Licensee shall own all Submissions and Data in connection therewithconduct or otherwise make any commitment regarding future operations. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4.MIPA – AAG Honda 35 (c) Each Party shall have full access The Parties commit to instruct their respective counsel to cooperate with each other and use commercially reasonable efforts to facilitate and expedite the right identification and resolution of any issues arising under the HSR Act at the earliest practicable dates. Such commercially reasonable efforts and cooperation include counsel’s undertaking (i) to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by keep each other appropriately informed of communications from and to personnel of the reviewing Governmental Authority, and (ii) to confer with each other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf regarding appropriate contacts with and response to personnel of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonGovernmental Authority. (d) To Each of LMP and Xxxxxxxx shall use its reasonable best efforts to “substantially comply” as promptly as practicable with any request for additional information or documentary material issued by a Governmental Authority under 15 U.S.C. Sec 18(e) and in conjunction with the extent not prohibited by law or regulation, Xxxxx shall have right Contemplated Transactions (a “Second Request”). Each of LMP and Xxxxxxxx will certify to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority substantial compliance with respect thereto as promptly as practicable. Each of LMP and Xxxxxxxx agrees to Licensed Products take all reasonable steps to assert, defend, and support certification of substantial compliance with any Second Request. Each of LMP and Xxxxxxxx agrees to give such advance notices as may be required (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance including, if necessary, notice of any such meeting or telephone call as is an anticipated Closing Date), and to otherwise reasonably possible in the circumstances and, (ii) cooperate to give effect to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies rights of all documents, correspondence and the other materials which are relevant to the matters to be addressed at any such meeting or set forth in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductSection 6.20. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers Xxxxxxxx and LMP shall, as promptly as practicable following the Effective Date, file with the United States Federal Trade Commission (the “FTC”) and the United States Department of Justice (the “DOJ”), the notification and report form required from each of Xxxxxxxx and LMP for the transactions contemplated by this Agreement and any supplemental information requested in connection therewith pursuant to the relevant Regulatory Authorities HSR Act, which forms shall specifically request early termination of the waiting period prescribed by the HSR Act. Each of Xxxxxxxx and LMP shall furnish to each other’s counsel such necessary information and reasonable assistance as the other may request in connection with respect to its preparation of any filing or submission that is necessary under the HSR Act. The Parties agree that LMP, on the one hand, and Xxxxxxxx, on the other hand, shall each be responsible for 50% of any and all necessary Regulatory Approvals filing fees payable in each Major Countryconnection with the foregoing filings. (b) Licensee Xxxxxxxx and LMP shall have use their respective commercially reasonable efforts to promptly obtain any clearance required under the right HSR Act for the consummation of the transactions contemplated by this Agreement and shall keep each other apprised of the status of any communications with, and any inquiries or requests for additional information from any Governmental Authority and shall comply promptly with any such inquiry or request. LMP and Xxxxxxxx shall use their commercially reasonable efforts to obtain Regulatory Approvalsany necessary approval from any Government Authority under the HSR Act. Notwithstanding anything contained in this Agreement to the contrary, which neither LMP nor Xxxxxxxx nor any of their Subsidiaries or other Affiliates shall be held by and in obligated to do any of the name following: (i) dispose or transfer any asset other than pursuant to this Agreement; (ii) license or otherwise make available to any Person any technology or other intellectual property rights; (iii) hold separate any assets or operations (either before or after the applicable Closing Date); or (iv) change or modify any course of Licensee, and Licensee shall own all Submissions and Data in connection therewithconduct or otherwise make any commitment regarding future operations. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4.MIPA – AAG Toyota 35 (c) Each Party shall have full access The Parties commit to instruct their respective counsel to cooperate with each other and use commercially reasonable efforts to facilitate and expedite the right identification and resolution of any issues arising under the HSR Act at the earliest practicable dates. Such commercially reasonable efforts and cooperation include counsel’s undertaking (i) to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by keep each other appropriately informed of communications from and to personnel of the reviewing Governmental Authority, and (ii) to confer with each other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf regarding appropriate contacts with and response to personnel of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonGovernmental Authority. (d) To Each of LMP and Xxxxxxxx shall use its reasonable best efforts to “substantially comply” as promptly as practicable with any request for additional information or documentary material issued by a Governmental Authority under 15 U.S.C. Sec 18(e) and in conjunction with the extent not prohibited by law or regulation, Xxxxx shall have right Contemplated Transactions (a “Second Request”). Each of LMP and Xxxxxxxx will certify to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority substantial compliance with respect thereto as promptly as practicable. Each of LMP and Xxxxxxxx agrees to Licensed Products take all reasonable steps to assert, defend, and support certification of substantial compliance with any Second Request. Each of LMP and Xxxxxxxx agrees to give such advance notices as may be required (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance including, if necessary, notice of any such meeting or telephone call as is an anticipated Closing Date), and to otherwise reasonably possible in the circumstances and, (ii) cooperate to give effect to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies rights of all documents, correspondence and the other materials which are relevant to the matters to be addressed at any such meeting or set forth in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductSection 6.20. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Northland shall use Commercially Reasonable Efforts file with the appropriate governmental entities all the applications for the Regulatory Approvals that are necessary for Northland to submit registration dossiers obtain relating to the relevant Regulatory Authorities transactions hereunder and for all other consents, permits and authorizations that Northland is required to obtain in connection with respect the consummation of the transactions contemplated by this Agreement. In addition, Northland shall cooperate with Buyer and use commercially reasonable efforts to promptly prepare and file all necessary Regulatory Approvals in each Major Countrydocumentation; to effect all applications, notices, petitions and filings; and to obtain as promptly as practicable all permits, consents, approvals, waivers and authorizations of all third parties and governmental entities which are necessary or advisable for Northland to obtain to consummate the transactions contemplated by this Agreement. (b) Licensee Subject to applicable laws relating to the exchange of information, Northland and Buyer shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own consult with each other on all Submissions and Data information in connection therewith. All pricingwith obtaining all permits, formulary consents, approvals and marketing approvals shall also be obtained authorizations from all third parties and governmental entities which are necessary or advisable to consummate the transactions contemplated by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4Agreement. (c) Each Party Northland and Buyer shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the keep each other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent apprised of the Person owning the NDA or foreign equivalent as the case may be status of all applications and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Personfilings. (d) To Except for any confidential portions thereof, as determined at the extent not prohibited by law or regulationdiscretion of the Party responsible for making and filing any documentation with respect to any Regulatory Approval, Xxxxx such Party shall have right to have one (1) representative promptly (i) attend (but not participate in) any material meetings between Licensee provide a copy of the filing, and any Regulatory Authority supplement, amendment or item of additional information in connection with respect the filing, to Licensed Products the other Parties and (ii) listen deliver to (but not participate in) any the other Parties a copy of each material telephone conversation between Licensee notice, order, opinion and any Regulatory Authority with other item of correspondence received by it in respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting filing from any governmental entity whose consent or telephone call as approval is reasonably possible in required for consummation of the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of transactions contemplated by this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductAgreement. (e) Licensee Buyer and Northland shall have promptly advise each other of any communication received from a governmental entity which causes such Party to believe that there is reasonable likelihood that a requisite Regulatory Approval will not be obtained or that the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall receipt of such approval will be soldmaterially delayed.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to Antitrust Law and Foreign Investment Law Filings. Each of Parent and Merger Sub (and their respective Affiliates, if applicable), on the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of Licenseeone hand, and Licensee shall own all Submissions the Company (and Data in connection therewith. All pricingits Affiliates, formulary and marketing approvals shall also be obtained by and in if applicable), on the name of Licenseeother hand, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingwill, to the extent legally possiblerequired in the reasonable judgment of counsel to Parent and the Company, being use their respective reasonable best efforts to (i) file with the sole contact FTC and the Antitrust Division of the DOJ a Notification and Report Form relating to this Agreement and the Merger as required by the HSR Act no later than 20 Business Days following the date of this Agreement; and (ii) promptly file comparable pre-merger or post-merger notification filings, forms and submissions with any Governmental Authority that are required by other applicable Antitrust Laws or any Foreign Investment Laws or that are, in the reasonable judgment of Parent after considering the views of the Company in good faith, advisable in connection with the Merger. Each of Parent and the Company will (A) cooperate and coordinate (and cause its respective Affiliates to cooperate and coordinate, if applicable) with the other in the making of such Regulatory Authoritiesfilings; (B) use its respective reasonable best efforts to supply the other (or cause the other to be supplied) with any information that may be required in order to make such filings; (C) use its respective reasonable best efforts to supply (or cause the other to be supplied) any additional information that reasonably may be required or requested by the FTC, the DOJ or the Governmental Authorities of any other applicable jurisdiction in which any such filing is made; (D) use its respective reasonable best efforts to take all action necessary to (1) cause the expiration or termination of the applicable waiting periods pursuant to the HSR Act and any other Antitrust Laws or Foreign Investment Laws applicable to the Merger and (2) obtain any required consents pursuant to any Antitrust Laws or Foreign Investment Laws applicable to the Merger, in each case as soon as practicable; and (E) prior to independently participating in any material meeting, or engaging in any substantive conversation, with any Governmental Authority in respect of any such filings or any investigations or other inquiries relating thereto, provide notice to the other party of such meeting or conversation and, unless prohibited by such Governmental Authority, the opportunity to attend or participate. The Parties shall collaborate with each other in good faith with respect to developing, and executing on, the strategy for regulatory approval; provided that in the event the parties do not agree on the strategy for regulatory approval, Parent shall have final decision-making authority so long as Parent exercises such final decision-making authority in good faith and subject to Parent’s obligation hereunder (but subject to the rights limitations herein) to use its reasonable best efforts to take all action necessary to (1) cause the expiration or termination of Xxxxx under the applicable waiting periods pursuant to the HSR Act and any other Antitrust Laws or Foreign Investment Laws applicable to the Merger and (2) obtain any required consents pursuant to any Antitrust Laws or Foreign Investment Laws applicable to the Merger, in each case as soon as practicable. Each of Parent and Merger Sub (and their respective Affiliates, if applicable), on the one hand, and the Company (and its Affiliates), on the other hand, will permit the other Party and its Representatives to review in advance any written communication proposed to be made by such Party to any Governmental Authority and consider in good faith the views of the other Party and promptly inform the other of any substantive communication from any Governmental Authority regarding the Merger in connection with such filings. If any Party or Affiliate thereof receives a request for additional information or documentary material from any Governmental Authority with respect to the Merger pursuant to the HSR Act or any other Antitrust Laws or any Foreign Investment Laws applicable to the Merger, then such Party will use reasonable best efforts to make (or cause to be made), as soon as reasonably practicable and after consultation with the other Parties, an appropriate response in compliance with such request. Each of Parent and the Company may, as they deem necessary, designate any sensitive materials to be exchanged in connection with this Section 4.46.2 as “outside-counsel only. ” Any such materials, as well as the information contained therein, shall be provided only to a receiving party’s outside counsel (cand mutually-acknowledged outside consultants) Each Party shall have full access and not disclosed by such counsel (or consultants) to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Partyemployees, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliatesofficers, or its sublicensees; provided, however, that such rights are subject to directors of the prior receiving party without the advance written consent of the Person owning the NDA party supplying such material or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Personinformation. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall The Parties will cooperate with each other and use Commercially Reasonable Efforts best efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to promptly prepare all necessary documentation, to effect all necessary filings and to obtain all necessary permits, consents, waivers, approvals and authorizations of, the Bank Regulators and any other Governmental Entities necessary to consummate the transactions contemplated by this Agreement and ISBC and Investors Bank will make all necessary filings in respect of the required Regulatory Approvals in each Major Country. (b) Licensee shall have as promptly as practicable after the right to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesdate hereof; provided, however, that such rights are subject in no event shall ISBC or Investors Bank be required to agree to any prohibition, limitation, or other requirement of any Bank Regulator that would (a) prohibit or materially limit the prior written consent ownership or operation by ISBC or Investors Bank of all or any material portion of the Person owning the NDA business or foreign equivalent as the case may be and assets of BOP or any information contained therein. In the event that a Party BOP Subsidiary, (b) compel ISBC or its Affiliates is the owner Investors Bank to dispose of such NDA or foreign equivalent as the case may be hold separate all or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent material portion of the Person owning the NDA business or foreign equivalentassets of BOP or any BOP Subsidiary, such consent to be at the sole discretion of such owning Person. (c) impose a material compliance burden, penalty or obligation on ISBC or Investors Bank resulting from noncompliance by BOP with its regulatory obligations; or (d) To otherwise materially impair the extent not prohibited value of BOP and the BOP Subsidiaries (any such requirement alone, or more than one such requirement together, a “Burdensome Condition”). The Parties will furnish each other and each other’s counsel with all information concerning themselves, their subsidiaries, directors, officers and stockholders and such other matters as may be necessary or advisable in connection with any application, petition or any other statement or application made to any Bank Regulator or Governmental Entity in connection with the Merger, and the other transactions contemplated by law or regulation, Xxxxx this Agreement. BOP shall have the right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee review, and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possiblepracticable to consult with ISBC and Investors Bank on, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials the information which are relevant to the matters to be addressed at any such meeting or appears in any such telephone call (it being understood that filing made in no event will connection with the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to transactions contemplated by this Agreement with any Regulatory AuthorityBank Regulator or any Governmental Entity. Notwithstanding ISBC shall give BOP and its counsel the foregoingopportunity to review, Licensee will have sole discretion as and to the extent practicable to consult with ISBC and Investors Bank on, each filing prior to its being filed with a Bank Regulator and shall give BOP and its counsel the opportunity to review all regulatory strategy filings, amendments and decision-making supplements to such filings and all responses to requests for any Licensed Productadditional information and replies to comments prior to their being filed with, or sent to, a Bank Regulator. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee By no later than thirty (30) days after the Agreement Date, Acquiror shall use Commercially Reasonable Efforts make all appropriate filings with Regulatory Authorities for approval of the Contemplated Transactions, including the preparation of an application or any amendment thereto or any other required statements or documents filed or to submit registration dossiers be filed by any party with: (a) the Federal Reserve pursuant to the relevant BHCA and/or the FRA; (b) the OCC pursuant to the NBA; (c) the DFPR pursuant to the IBA; and (d) any other Person or Regulatory Authority pursuant to any applicable Legal Requirement, for authority to consummate the Contemplated Transactions. The Company will cooperate and will cause the Bank to cooperate, in good faith, to assist Acquiror and Acquiror Bank in preparing and filing any required notices, applications or other information with Regulatory Authorities for the purpose of obtaining all necessary approvals of the Contemplated Transactions. Prior to the making of any filing pursuant to this Section 8.1(a), the Company and its counsel shall be provided with the opportunity to comment upon all non-confidential portions thereof, and Acquiror agrees promptly to advise the Company and its counsel of, and share with them, any material communication received by Acquiror or its counsel from any Regulatory Authorities with respect to all the non-confidential portions of such filings. Acquiror and the Company agree that Acquiror’s counsel will have primary responsibility for the preparation of the necessary Regulatory Approvals in each Major Countryapplications for regulatory approval of the Contemplated Transactions. (b) Licensee By no later than thirty (30) days after the Agreement Date, the Company shall have make all appropriate filings with the right Regulatory Authorities for approval of the Xxxxx Payment. Prior to obtain Regulatory Approvalsthe making of any filing pursuant to this Section 8.1(b), which Acquiror and its counsel shall be held by and in provided with the name of Licenseeopportunity to comment upon all non-confidential portions thereof, and Licensee shall own all Submissions the Company agrees promptly to advise Acquiror and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licenseeits counsel of, and Licensee will be share with them, any material communication received by the principal interface and will otherwise handle all interactions with Company or its counsel from any Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is prethe non-scheduled between Licensee confidential portions of such filings. Acquiror and the relevant Regulatory Authority. Licensee Company agree that the Company’s counsel will use reasonable efforts (i) to provide be responsible for the preparation of the necessary applications for regulatory approval of the Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductPayment. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. During the period from the Agreement Date and continuing until the earlier of the termination of this Agreement in accordance with the terms hereof and the Closing: (a) Licensee Each of Purchaser and the Seller Parties shall within fifteen (15) Business Days execute and file, or join in the execution and filing of, any application, notification or other document that may be necessary in order to obtain the authorization, approval or consent of any Governmental Authority, whether federal, state, provincial, local or foreign, which may be required in connection with the consummation of the Sale Transaction and the other Transactions, including any filings required under the HSR Act and any filings required under the applicable requirements of antitrust or other competition laws of jurisdictions other than the United States. Each of Purchaser and the Seller Parties shall use Commercially Reasonable Efforts their respective reasonable best efforts to submit registration dossiers obtain, and to the relevant Regulatory Authorities cooperate with each other to obtain promptly, all such authorizations, approvals, consents and expirations and terminations of any applicable HSR waiting period. With respect to all necessary Regulatory Approvals any filing fees associated with such authorizations, approvals and consents, Purchaser shall pay any associated filing fees payable by Purchaser for filings directly connected with Purchaser’s acquisition of the Transferred Assets, but Seller shall pay any associated filing fees connected with Seller’s acquisition of the Purchaser Common Stock (and any associated filing fees connected with any subsequent transfer of the Purchaser Common Stock by Seller to its equityholders or any other third-parties). Notwithstanding anything else in each Major Countrythis Agreement, the Seller Parties will cooperate and coordinate with Purchaser in any filing to or other communications with any applicable Governmental Authority and will not apply for, accept, amend or terminate any Governmental Grants or make any application or request for authority in connection with any Governmental Grants, unless it first obtained the written consent of Purchaser. (b) Licensee Each of Purchaser and the Seller Parties shall promptly inform the other of any material communication between such party and any Governmental Authority regarding the Sale Transaction and the other Transactions. Purchaser shall have the right to obtain Regulatory Approvalsdirect all matters with any Governmental Authority relating to the Sale Transaction and other Transactions, which including that all filings, correspondence, communications, or responses to any Governmental Authority by any party with respect to any of the Transactions shall be held subject to prior review and approval by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingPurchaser; provided that, to the extent legally possiblepracticable, being Purchaser and Seller shall consult and cooperate with each other and consider in good faith the sole contact views of one another with respect to developing and executing the strategy to obtain regulatory approval. Subject to the foregoing clause: (i) if Purchaser receives any request for supplemental information or documentary material from the OIO with respect to the Sale Transaction and the other Transactions, then Section 5.4(c) will apply; (ii) if Purchaser receives any request for supplemental information or documentary material from any Governmental Authority other than the OIO with respect to the Sale Transaction and the other Transactions, then Purchaser shall make or cause to be made, as soon as reasonably practicable, a response in compliance with such Regulatory Authoritiesrequest and, subject except where such information relates solely to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, Purchaser or its Affiliates, and/or sublicensees its business or any third party filing such NDAs and/or their foreign equivalent on behalf its investors, permit counsel to the Seller Parties an opportunity to review the response in advance, and Purchaser shall consider in good faith the views of such Partycounsel in connection with, any proposed written communications by Purchaser and/or its Affiliates, Affiliates to any such Governmental Authority concerning the Sale Transaction or its sublicenseesother Transactions; provided, however, that Purchaser may redact from the copies of such rights are subject proposed communications provided to counsel to the prior Seller Parties any competitively sensitive, commercially sensitive or other proprietary information of Purchaser, and any personal or private information that relates to any individual(s); and (iii) if any Seller Party receives any request for supplemental information or documentary material from any Governmental Authority with respect to the Sale Transaction and the other Transactions, then the applicable Seller Party shall make or cause to be made, a response in compliance with such request and permit counsel to Purchaser an opportunity to review the response in advance, and the Seller Parties shall consider in good faith the views of such counsel in connection with, any proposed written communications by the Seller Parties to any Governmental Authority concerning the Sale Transaction or other Transactions; provided, however, that the Seller Parties may redact from the copies of such proposed communications provided to counsel to Purchaser any competitively sensitive, commercially sensitive or other proprietary information of Seller, and any personal or private information that relates to any individual(s). Other than any pre-application meeting with the OIO, which shall be attended only by representatives of Purchaser, both Purchaser and Seller shall be represented at all in-person meetings (including such meetings conducted virtually) and substantive conversations with any Governmental Authority to the extent permitted by such Governmental Authority. Each of Purchaser and the Seller Parties may, as they deem necessary, designate any sensitive materials to be exchanged in connection with this Section 5.4(b) as “outside-counsel only.” Any such materials, as well as the information contained therein, shall be provided only to a receiving party’s outside counsel (and mutually-acknowledged outside consultants) and not disclosed by such counsel (or consultants) to any employees, officers, or directors of the receiving party without the advance written consent of the Person owning the NDA party supplying such materials or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Personinformation. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers The Company and Buyer shall, as promptly as practicable and before the expiration of any relevant legal deadline, but in no event later than ten (10) Business Days following the execution and delivery of this Agreement, file with (i) the FTC and the United States Department of Justice (the “DOJ”), the notification and report form required for the Merger and any supplemental information requested in connection therewith pursuant to the relevant Regulatory Authorities HSR Act, which forms shall specifically request early termination of the waiting period prescribed by the HSR Act and (ii) any other Governmental Entity, any other filings, reports, information and documentation required for the transactions contemplated hereby pursuant to any Other Antitrust Laws. Each of the Company and Buyer shall furnish to each other’s counsel such necessary information (which the receiving party shall treat as confidential information to be kept confidential in the manner required under the Confidentiality Agreement) and reasonable assistance as the other may reasonably request in connection with respect its preparation of any filing or submission that is necessary under the HSR Act and any Other Antitrust Laws and shall consult with each other in good faith prior to making any such filing or submission. Buyer shall pay all necessary Regulatory Approvals filing fees payable in each Major Countryconnection with such filings. (b) Licensee Each of the Company and Buyer shall have use reasonable best efforts to promptly obtain any clearance required under the right HSR Act and any Other Antitrust Laws for the consummation of the transactions contemplated by this Agreement and shall keep each other apprised of the status of any communications with, and any inquiries or requests for additional information from any Governmental Entity and shall comply promptly with any such inquiry or request. Each of the Company and Buyer shall take commercially reasonable steps necessary to avoid or eliminate each and every impediment under any applicable Law that may be asserted against it by any Governmental Entity or any other Person so as to enable the Parties to expeditiously consummate the Mergers; provided, that neither Party shall be required to make any divestiture, or agree to hold separate, or to any other structural or conduct relief in order to obtain Regulatory Approvalsclearance from any Governmental Entity and none of the Company, which the Stockholders, Buyer or their respective Affiliates shall be held obligated to contest, administratively or in court, any Order or Action of any Governmental Entity or any other Person respecting the transactions contemplated by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4Agreement. (c) Each Party shall have full access The Parties commit to instruct their respective counsel to cooperate with each other and use commercially reasonable efforts to facilitate and expedite the identification and resolution of any issues arising under the HSR Act and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be Other Antitrust Laws at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative earliest practicable dates. Such commercially reasonable efforts and cooperation include counsel’s undertaking (i) attend (but not participate in) any material meetings between Licensee to keep each other appropriately informed of communications from and any Regulatory Authority with respect to Licensed Products personnel of the reviewing Governmental Entity, and (ii) listen to (but not participate in) any material telephone conversation between Licensee confer with each other regarding appropriate contacts with and any Regulatory Authority with respect response to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice personnel of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductGovernmental Entity. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. The Parent and the Company, as applicable to that Party, covenant and agree with respect to obtaining the Regulatory Approvals required for the completion of the transactions contemplated by this Agreement that, subject to the term and conditions of this Agreement, until the earlier of the Effective Time and the time that this Agreement is terminated in accordance with its terms: (a) Licensee In respect of the COFECE Approval, within thirty (30) business days of this Agreement or such other date as the Parties may reasonably agree, the Parent and the Company shall use Commercially Reasonable Efforts each submit a notification to submit registration dossiers COFECE to obtain the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major CountryCOFECE Approval. (b) Licensee The Parent and the Company shall have (and shall cause their respective Subsidiaries, as applicable), to file, as promptly as practicable but in any event within thirty (30) business days after the right date of this Agreement or such other date as the Parent and the Company may reasonably agree, any other filings or notifications under any other applicable federal, provincial, state or foreign Law required to obtain any other Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to The Parent and the right Company shall use (and shall cause their respective Subsidiaries to reference use) their respective commercially reasonable efforts to obtain the Regulatory Approvals as promptly as practicable after the date of this Agreement and, in any NDAs and/or their foreign equivalent based on Immune Modulator owned by event, in order to allow the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesEffective Time to occur before the Outside Date; provided, however, that such rights are subject nothing in this Agreement shall require either Party or their respective Subsidiaries to propose, negotiate, effect or agree to, by consent decree, hold separate order or otherwise, the prior written consent sale, transfer, divestiture, license or other disposition of any assets or businesses of the Person owning Parent or the NDA Company or foreign equivalent as the case may be and their respective Subsidiaries or otherwise take any information contained therein. In the event action that a Party prohibits or its Affiliates is the owner limits either Parties’ or their respective Subsidiaries’ freedom of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not action with respect to, unreasonably withhold or delay consent. In either Parties’ or their respective Subsidiaries’ ability to own, retain, control, operate or exercise full rights of ownership with respect to any of the event that a third party is businesses or assets of the owner of such NDA or foreign equivalent or information contained thereinParent, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference Company or any NDAs and/or of their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Personrespective Subsidiaries. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right All filing fees (including any Taxes thereon) in respect of any filing made to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and Governmental Entity in respect of any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and Approvals shall be paid by the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductParent. (e) Licensee With respect to obtaining the Regulatory Approvals, each of the Parent and the Company shall have (and shall cause their respective Subsidiaries) to cooperate and coordinate with one another and shall provide such assistance as the sole right to obtain all pricing and reimbursement approvals other Party may reasonably request in all countries in connection with obtaining the Territory in which Licensed Products shall be sold.Regulatory Approvals. In particular:

Regulatory Approvals. (a) Licensee Tilray and Privateer shall use Commercially Reasonable Efforts each promptly execute and file, or join in the execution and filing of, any application, notification, or other document that may be necessary in order to submit registration dossiers to obtain the relevant Regulatory Authorities authorization, approval, expiration or termination of any waiting period or Consent of any Governmental Body that may be reasonably required or advisable in connection with respect to all necessary Regulatory Approvals in each Major Countrythe consummation of the Contemplated Transactions. (b) Licensee Tilray and Privateer shall have the right each use its commercially reasonable efforts to obtain Regulatory Approvalsall such authorizations, which shall be held by and in the name approvals, expirations or terminations of Licenseewaiting periods, and Licensee shall own all Submissions and Data in connection therewithConsents as promptly as possible after the execution of this Agreement, including the expiration or termination of the waiting period under the HSR Act, or under foreign competition Laws, with respect to the transactions contemplated by this Agreement. All pricing, formulary and marketing approvals shall also be obtained by and in Without limiting the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingforegoing, to the extent legally possiblenot completed prior to the date hereof, being Tilray and Privateer shall each use its commercially reasonable efforts to make, or cause to be made, all filings required of it or any of its respective Affiliates under the sole contact HSR Act and foreign competition Laws with respect to the transactions contemplated by this Agreement as promptly as reasonably practicable, and in any event shall file a Notification and Report Form pursuant to the HSR Act 10 Business Days after the execution of this Agreement, and any other filing or notification required pursuant to any foreign competition Law within 10 Business Days after the execution of this Agreement. Tilray and Privateer shall furnish promptly to the Federal Trade Commission (the “FTC”), the Antitrust Division of the United States Department of Justice and any other requesting governmental authority additional information reasonably requested pursuant to the HSR Act or any foreign competition Laws in connection with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4filings. (c) Each Party Tilray and Privateer shall have full access each use its commercially reasonable efforts to resolve objections, if any, as may be asserted by any Governmental Body with respect to the Contemplated Transactions under any applicable antitrust Laws, including responding promptly to and the right complying with any requests for information relating to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees this Agreement or any third party filing such NDAs and/or their foreign equivalent on behalf of such Partyinitial filings required under the HSR Act, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party other additional filings (“Merger Notification Filings”) from any Governmental Body charged with enforcing, applying, administering or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference investigating any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Personantitrust Laws. (d) To Notwithstanding anything to the extent not prohibited by law or regulationcontrary herein, Xxxxx shall have right to have one (1) representative (i) attend (but Tilray shall not participate in) have any material meetings between Licensee and obligation to litigate or contest any Regulatory Authority with respect to Licensed Products such Legal Proceeding or order resulting therefrom and (ii) listen Tilray shall not be under an obligation to make proposals, execute or carry out agreements or submit to orders providing for (but not participate inA) the sale, license, divestiture, or other disposition or holding separate of any assets of Tilray or any of its respective Affiliates, (B) the imposition of any limitation or restriction on the ability of Tilray or any of its respective Affiliates to freely conduct its business, or (C) any material telephone conversation between Licensee and limitation or regulation on the ability of Tilray or any Regulatory Authority with respect of its Affiliates to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice exercise full rights of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies ownership of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductPrivateer. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall Each of SWNB and Hanmi will cooperate with the other and use Commercially Reasonable Efforts reasonable efforts to submit registration dossiers to promptly prepare and as soon as practicable following the relevant Regulatory Authorities with respect to date hereof file all necessary Regulatory Approvals documentation to obtain all necessary permits, consents, waivers, approvals and authorizations of the Bank Regulators or any other third parties or Governmental Entities necessary to consummate the transactions contemplated by this Agreement. SWNB and Hanmi will furnish each other and each other’s counsel with all information concerning themselves, their Subsidiaries, directors, officers and stockholders and such other matters as may be necessary or advisable in each Major Country. (b) Licensee connection with any application, petition or other statement made by or on behalf of SWNB or Hanmi to any Bank Regulator or Governmental Entity in connection with the Merger, Bank Merger and the other transactions contemplated by this Agreement. SWNB shall have the right to obtain Regulatory Approvals, which shall be held by review and approve in advance all characterizations of the name of Licensee, information relating to SWNB and Licensee shall own all Submissions and Data any SWNB Subsidiary that appears in any filing made in connection therewithwith the transactions contemplated by this Agreement with any Governmental Entity. All pricingIn addition, formulary SWNB and marketing approvals Hanmi shall also each furnish to the other for review a copy of each such filing made in connection with the transactions contemplated by this Agreement with any Governmental Entity prior to its filing. Each of SWNB and Hanmi will cooperate with each other and use their reasonable best efforts to address any conditions in any regulatory approval to allow for the consummation of the transactions contemplated by this Agreement. Each of Hanmi and SWNB agrees to keep the other party apprised of the status of material matters relating to completion of the transactions contemplated hereby, including advising the other party upon receiving any communication from a Bank Regulator or Governmental Entity, the consent or approval of which is required for the consummation of the Merger and the other transactions contemplated by this Agreement, that causes such party to believe that there is a reasonable likelihood that any required consent or approval from a Bank Regulator or Governmental Entity will not be obtained by and in or that the name receipt of Licenseesuch consent or approval may be materially delayed (a “Regulatory Communication”). Upon the receipt of a Regulatory Communication, and Licensee will be without limiting the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingscope of the foregoing, Hanmi shall, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned permitted by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by applicable law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) promptly advise SWNB of the receipt of any material meetings between Licensee and any Regulatory Authority substantive communication from a Bank Regulator or Governmental Entity with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances andtransactions contemplated hereby, (ii) provide SWNB with a reasonable opportunity to participate in the preparation of any response thereto and the preparation of any other substantive submission or communication to any Bank Regulator or Governmental Entity with respect to the extent reasonably possible, transactions contemplated hereby and to provide Xxxxx, at least five (5) business days before review any such meetingresponse, with copies of all documents, correspondence and other materials which are relevant submission or communication prior to the matters filing or submission thereof, and (iii) provide SWNB (as permitted by such Bank Regulators) with a reasonable opportunity to be addressed at any such meeting or participate in any such meetings or substantive telephone call (it being understood conversations that in no event will the provisions of clause (i) Hanmi or (ii) of this sentence require Licensee any Hanmi Subsidiaries or their respective representatives may have from time to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement time with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as Bank Regulator or Governmental Entity with respect to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.transactions contemplated by this Agreement

Regulatory Approvals. (a) Licensee To the extent required by the Antitrust Laws, the Company shall (i) no later than sixty (60) days following the Agreement Date, make the initial filing required from the Company under the HSR Act in connection with the consummation of the Merger and the other transactions contemplated hereby; and (ii) as promptly as practicable following the execution of this Agreement, execute and file or, if appropriate, join in the execution and filing of, the applications, notifications, and other documents required for the lawful consummation of the Merger and the other transactions contemplated hereby under the Antitrust Laws of the jurisdictions identified in Section 5.4 of the Disclosure Schedule. [*] The Company shall use Commercially Reasonable Efforts commercially reasonable efforts to submit registration dossiers promptly obtain, and to cooperate with Acquiror to promptly obtain, all authorizations, approvals, clearances, consents, waivers, actions, or non-actions required from any Governmental Entity under any Antitrust Law in connection with the relevant Regulatory Authorities Merger or the other transactions contemplated hereby. The Company shall promptly inform Acquiror of any material communication between the Company (including its representatives, counsel, or consultants) and any Governmental Entity regarding any of the transactions contemplated hereby. If the Company or any Affiliate of the Company receives any formal or informal request for supplemental information or documentary material from any Governmental Entity with respect to the Merger or the other transactions contemplated hereby, then the Company shall make, or cause to be made, as soon as reasonably practicable, a response in compliance with such request. Acquiror, as the purchaser, shall lead all efforts to obtain any clearance, waiver, approval or authorization from any Governmental Entity that is necessary Regulatory Approvals to enable the parties to consummate the Merger or the other transactions contemplated hereby, but shall consider in each Major Countrygood faith the views of the Company. (b) Licensee To the extent required by the Antitrust Laws, Acquiror shall have (i) no later than sixty (60) days following the right to obtain Regulatory ApprovalsAgreement Date, which shall be held by make the initial filing required from Acquiror under the HSR Act in connection with the consummation of the Merger and the other transactions contemplated hereby; and (ii) as promptly as practicable following the execution of this Agreement, execute and file or, if appropriate, join in the name of Licenseeexecution and filing of, the applications, notifications, and Licensee other documents required for the lawful consummation of the Merger and the other transactions contemplated hereby under the Antitrust Laws of the jurisdictions identified in Section 5.4 of the Disclosure Schedule. [*] Acquiror shall own use commercially reasonable efforts to promptly obtain all Submissions and Data authorizations, approvals, clearances, consents waivers, actions, or non-actions required from any Governmental Entity under any Antitrust Law in connection therewithwith the Merger or the other transactions contemplated hereby. All pricingAcquiror shall promptly inform the Company of any material communication between Acquiror (including its representatives, formulary counsel, or consultants) and marketing approvals shall also be obtained by and in any Governmental Entity regarding [*] Confidential treatment requested. 75 CONFIDENTIAL TREATMENT REQUESTED any of the name transactions contemplated hereby. If Acquiror or any Affiliate of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions Acquiror receives any formal or informal request for supplemental information or documentary material from any Governmental Entity with Regulatory Authorities concerning any Licensed Products including, respect to the extent legally possibletransactions contemplated hereby, being the sole contact then Acquiror shall make, or cause to be made, as soon as reasonably practicable, a response in compliance with such Regulatory Authoritiesrequest. Acquiror shall direct, subject to in its sole discretion, the rights making of Xxxxx under this Section 4.4such response, but shall consider in good faith the views of the Company. (c) Each Party The Company and Acquiror shall have full access keep each other apprised of the status of matters relating to and the right completion of the transactions contemplated by this Agreement and, to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the extent permissible, promptly furnish the other Partywith copies of notices or other communications between the Company (including its representatives, counsel and any Company Subsidiary) or Acquiror (including its Affiliatesrepresentatives, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Partycounsel and Subsidiaries), its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be be, and any Third Party and/or Governmental Entity with respect to such transactions. The Company and Acquiror shall keep each other timely apprised of any inquiries or requests for additional information contained thereinfrom any Governmental Entity pursuant to any Antitrust Law, to the extent permissible, and shall comply promptly with any such reasonable inquiry or request. In The Company, on the event that one hand, and Acquiror, on the other hand, shall permit counsel for the other reasonable opportunity to review in advance, to the extent permissible, and consider in good faith the views of the other in connection with, any proposed written communication to any Governmental Entity relating to the transactions contemplated by this Agreement. (d) Notwithstanding anything in this Agreement to the contrary, if any administrative or judicial action or proceeding (each a Party “Proceeding”) is instituted or its Affiliates threatened to be instituted, or any decree, judgment, injunction or other order, whether temporary, preliminary or permanent (each an “Order”) is entered or threatened to be entered, in each case challenging the owner consummation of the Merger or any other transaction contemplated by this Agreement as violative of any Antitrust Law, the Parties shall use commercially reasonable efforts to contest, avoid, vacate, modify, or suspend each such NDA Proceeding or foreign equivalent as the case may be or information contained thereinOrder, including through litigation. Nothing in this Section 5.4 shall limit a Party’s right to terminate this Agreement pursuant to Section 7.1(b) if such Party has, until such date, complied in all material respects with its obligations under this Section 5.4. (e) Notwithstanding anything in this Agreement to the contrary, nothing contained in this Agreement shall be deemed to require Acquiror or any Subsidiary or Affiliate thereof to agree to any Action of Divestiture. The Company shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA Acquiror, take or foreign equivalent, such consent agree to be at the sole discretion take any Action of such owning PersonDivestiture. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee So long as any Loan or any other Obligation shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee remain unpaid or any Lender shall have any Commitment under the right to obtain Regulatory ApprovalsCredit Agreement, which each Grantor shall be held by and in the name of Licenseepromptly, and Licensee shall own at its expense, execute and deliver, or cause to be executed and delivered, all Submissions applications, certificates, instruments, registration statements and Data all other documents the Collateral Agent may reasonably request and as may be required by law in connection therewith. All pricingwith the obtaining of any FCC Consents, formulary and marketing approvals shall also State Consents or the consent, approval, registration, qualification or authorization of any other Person necessary or deemed by the Collateral Agent to be obtained by and in appropriate for the name effective exercise of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the of its rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and Agreement. Without limiting the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf generality of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, if an Event of Default shall have occurred and be continuing, each Grantor shall take any action which the rights granted Collateral Agent may reasonably request in order to transfer and assign to the Collateral Agent, or to such one or more third parties as the Collateral Agent may designate, or to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent combination of the Person owning the NDA foregoing, each FCC License, State License or foreign equivalent, such consent to be at the sole discretion other Government Approval of such owning Person. (d) Grantor. To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will enforce the provisions of clause this Section 12, upon the occurrence and during the continuance of an Event of Default, the Collateral Agent is empowered to request the appointment of a receiver from any court of competent jurisdiction. Such receiver shall be instructed to seek from the FCC or other Governmental Authority an involuntary transfer of control of each such FCC License, State License or other Governmental Approval for the purpose of seeking a bona fide purchaser to whom control will ultimately be transferred. Each Grantor hereby agrees to authorize such an involuntary transfer of control upon the request of the receiver so appointed, and, if such Grantor shall refuse to authorize the transfer, its approval may be required by the court. Upon the occurrence and continuance of an Event of Default, such Grantor shall further use its reasonable best efforts to assist in obtaining FCC Consents, State Consents or other governmental approvals, if required, for any action or transaction contemplated by this Security Agreement, including, without limitation, the preparation, execution and filing with the FCC or other governmental authority of such Grantor's portion of any necessary or appropriate application for the approval of the transfer or assignment of any portion of the assets (i) including any FCC Licenses, State Licenses or (iiother Governmental Approval) of such Grantor. Because each Grantor agrees that the Collateral Agent's remedy at law for failure of such Grantor to comply with the provisions of this sentence require Licensee Section 12 would be inadequate and that such failure would not be adequately compensable in damages, such Grantor agrees that the covenants contained in this Section 12 may be specifically enforced, and such Grantor hereby waives and agrees not to delay assert any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges defenses against an action for specific performance of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsuch covenants. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of LicenseePromptly, and Licensee shall own at its expense, execute and deliver, or cause to be executed and delivered, all Submissions and Data in connection therewith. All pricingmaterial applications, formulary and marketing approvals shall also be obtained by and in the name of Licenseecertificates, instruments, registration statements, and Licensee will all other documents and papers the Administrative Agent may reasonably request and as may be required by law to acquire any Governmental Approval or the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning consent, approval, registration, qualification or authorization of any Licensed Products including, to other Person deemed necessary or appropriate for the extent legally possible, being the sole contact with such Regulatory Authorities, subject to effective exercise of any of the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and Security Agreement. Without limiting the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf generality of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, if an Event of Default shall have occurred and be continuing, each Obligor shall take any action which the rights granted Administrative Agent may reasonably request in order to transfer and assign to the Administrative Agent, or to such one or more third parties as the Administrative Agent may designate, or to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent combination of the Person owning the NDA or foreign equivalentforegoing, such consent to be at the sole discretion each Government Approval of such owning Person. (d) Obligor. To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will enforce the provisions of clause this subsection, upon the occurrence and during the continuance of an Event of Default, the Administrative Agent is empowered to request the appointment of a receiver from any court of competent jurisdiction. Such receiver shall be instructed to seek from the Governmental Authority an involuntary transfer of control of each such Governmental Approval for the purpose of seeking a bona fide purchaser to whom control will ultimately be transferred. Each Obligor hereby agrees to authorize such an involuntary transfer of control upon the request of the receiver so appointed, and, if such Obligor shall refuse to authorize the transfer, its approval may be required by the court. Upon the occurrence and continuance of an Event of Default, such Obligor shall further use its commercially reasonable efforts to assist in obtaining Governmental Approvals, if required, for any action or transaction contemplated by this Security Agreement, including, without limitation, the preparation, execution and filing with the Governmental Authority of such Obligor's portion of any necessary or appropriate application for the approval of the transfer or assignment of any portion of the assets (i) or (iiincluding any Governmental Approval) of such Obligor. Because each Obligor agrees that the Administrative Agent's remedy at law for failure of such Obligor to comply with the provisions of this sentence require Licensee subsection would be inadequate and that such failure would not be adequately compensable in damages, such Obligor agrees that the covenants contained in this subsection may be specifically enforced, and such Obligor hereby waives and agrees not to delay assert any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges defenses against an action for specific performance of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsuch covenants. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. 6.1 The parties acknowledge that the Proposed Acquisition, the Reconstruction and matters related thereto will be subject to review by the Regulatory Authorities. In this connection, the parties and/or Bidco will be making such filings as may be required under the EC Merger Regulation and the HSR Act, as well as taking appropriate action in other applicable jurisdictions. 6.2 A and B each agrees to use all reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary or advisable (ataking into account the tax effects of such efforts, actions and things as determined by the tax working group) Licensee to complete as promptly as reasonably practicable the Proposed Acquisition, the Reconstruction and the matters related thereto and to co-operate with each other in connection with the foregoing. In furtherance of the foregoing, A and B shall use Commercially Reasonable Efforts all reasonable efforts to submit registration dossiers to the relevant Regulatory Authorities resolve such objections, if any, as may be asserted with respect to all necessary Regulatory Approvals the Proposed Acquisition, the Reconstruction or matters related thereto under any applicable law or regulation to enable the Proposed Acquisition, the Reconstruction and the matters related thereto to be completed in each Major Countryan expeditious manner. 6.3 Each of the parties shall promptly inform the other of any material communication (bwritten or oral) Licensee shall have to or from any Regulatory Authority regarding the right to obtain Regulatory ApprovalsProposed Acquisition, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, Reconstruction or matters related thereto to the fullest extent legally possible, being permitted by law and applicable regulations and having due regard for the sole contact with such Regulatory Authorities, subject need to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or maintain their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees competitive independence. If either party or any third party filing Affiliate thereof receives a request for additional information or documentary material from any such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen the Proposed Acquisition, the Reconstruction or matters related thereto, then such party will endeavour in good faith to (but not participate in) any material telephone conversation between Licensee and any make, or cause to be made, as soon as reasonably practicable, an appropriate response in compliance with such request. 6.4 Without limiting the general nature of the parties' obligations set forth in clause 6.2, the parties will make such divestitures or other commitments as approved by the Committee, if any, as may be reasonably required by the Regulatory Authority with respect Authorities to Licensed Products that is pre-scheduled between Licensee enable the Proposed Acquisition, the Reconstruction and the matters related thereto to be completed in an expeditious manner. Any divested assets may be sold to either A or B, if allowed by the relevant antitrust Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx , in accordance with as much advance notice of any such meeting or telephone call as clause 7.7. 6.5 It is reasonably possible in the circumstances andparties' intent, (ii) to the extent reasonably possiblepracticable (taking into account the tax implications of all relevant matters), to provide Xxxxxcomplete the Proposed Acquisition, the Reconstruction and the matters related thereto at least five (5) business days before such time as all regulatory approvals have been received from the Regulatory Authorities of the European Union, the United States and such other jurisdictions as the Committee may determine appropriate. 6.6 The parties agree that they will use all reasonable efforts to exhaust all legal remedies in an effort to obtain any such meetingnecessary approvals not previously obtained, with copies of all documents, correspondence and other materials which are relevant including but not limited to appeals to the highest appellate court, tribunal or other body having jurisdiction over the matter in dispute, seeking rehearings where necessary and continuing with the approval processes until final determinations have been received, in each case to enable the Proposed Acquisition, the Reconstruction and the matters related thereto to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Producteffected. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall The Parties will cooperate with each other and use Commercially Reasonable Efforts best efforts to submit registration dossiers promptly prepare all necessary documentation, to effect all necessary filings and to obtain all necessary permits, consents, waivers, approvals and authorizations of, the relevant Regulatory Authorities with respect and any other governmental bodies necessary to consummate the transactions contemplated by this Agreement and Buyer will make and cause Xxxxxxxx Bank to make, all necessary filings in respect of the required Regulatory Approvals in each Major Country. (b) Licensee shall have as promptly as practicable after the right to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesdate hereof; provided, however, that such rights are subject in no event shall Buyer or Xxxxxxxx Bank be required to agree to any prohibition, limitation, or other requirement that would (a) prohibit or materially limit the prior written consent ownership or operation by Buyer or Xxxxxxxx Bank of all or any material portion of the Person owning business or assets of Seller or any Seller Subsidiary, (b) compel Buyer or Xxxxxxxx Bank to dispose of or hold separate all or any material portion of the NDA business or foreign equivalent assets of Seller or any Seller Subsidiary, or (c) otherwise materially impair the value of Seller and the Seller Subsidiaries to Buyer and Xxxxxxxx Bank (any such requirement alone, or more than one such requirement together, a “Burdensome Condition”). The Parties will furnish each other and each other’s counsel with all information concerning themselves, their respective Subsidiaries, directors, officers and Stockholders and such other matters as the case may be and necessary or advisable in connection with any information contained therein. In the event that a Party application, petition or its Affiliates is the owner of such NDA any other statement or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree application made to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority or Governmental Entity in connection with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee the Mergers, and the relevant Regulatory Authorityother transactions contemplated by this Agreement. Licensee will use reasonable efforts (i) Seller shall have the right to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances andreview, (ii) and to the extent reasonably possiblepracticable to consult with Buyer and Xxxxxxxx Bank on, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials the information which are relevant to the matters to be addressed at any such meeting or appears in any such telephone call (it being understood that filing made in no event will connection with the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to transactions contemplated by this Agreement with any Regulatory AuthorityAuthority or any Governmental Entity. Notwithstanding Buyer shall give Seller and its counsel the foregoingopportunity to review, Licensee will have sole discretion as and to the extent practicable to consult with Buyer and Xxxxxxxx Bank on, each filing prior to its being filed with a Regulatory Authority and shall give Seller and its counsel the opportunity to review all regulatory strategy filings, amendments and decision-making supplements to such filings and all responses to requests for any Licensed Productadditional information and replies to comments prior to their being filed with, or sent to, a Regulatory Authority. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee The Seller and the relevant Regulatory Authority. Licensee will Buyer shall cooperate and prepare and file as soon as practicable, but in any event no later than February 21, 2011, all necessary documentation to effect all necessary applications, notices, petitions, filings and other documents, and to use reasonable best efforts to obtain, all permits, licenses, and other governmental authorizations, consents and approvals necessary or advisable to obtain the Required Approvals. The Seller and the Buyer further agree to use reasonable best efforts (i) to provide Xxxxx with as much advance notice of take any such meeting action, make any undertaking or telephone call as is reasonably possible in the circumstances and, receive any clearance or approval required by any Governmental Authority or applicable Law and (ii) to satisfy any conditions imposed by any Governmental Authority in all Final Orders. The Seller and the extent Buyer shall respond as promptly as practicable to any inquiries or requests received from any Governmental Authority for additional information or documentation. The Seller and the Buyer shall use reasonable best efforts to avoid or eliminate each and every impediment under any antitrust, competition, or trade or energy regulation Law (including (A) the regulations set forth by the NHPUC and (B) the HSR Act) that may be asserted by any Governmental Authority with respect to the transactions contemplated by this Agreement so as to enable the Closing Date to occur as soon as reasonably possible. The steps involved in the preceding sentence shall include, subject to the limitations described below, proposing, negotiating, committing to and effecting, by consent decree, hold separate order or otherwise, the sale, divestiture or disposition of such assets or businesses of the Buyer or its Affiliates (including their respective Subsidiaries) or agreeing to such limitations on its or their conduct or actions as may be required in order to obtain the Required Approvals as soon as reasonably possible, to provide Xxxxxavoid the entry of, at least five (5) business days before or to effect the dissolution of, any such meetinginjunction, with copies of all documents, correspondence and temporary restraining order or other materials which are relevant to the matters to be addressed at any such meeting or order in any such telephone call (it being understood that suit or proceeding, which would otherwise have the effect of preventing or delaying the Closing Date, and defending through litigation on the merits, including appeals, any claim asserted in no event will the provisions of clause (i) or any court by any party. (ii) of this sentence require Licensee No party shall be required to delay take any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted actions pursuant to this Agreement with any Regulatory Authority. Notwithstanding Section 7.6(b)(i) if such actions, individually or in the foregoingaggregate, Licensee will have sole discretion as to would result in the regulatory strategy and decision-making for any Licensed Productconditions set forth in Sections 8.2(c) or 8.3(c) not being satisfied. (eiii) Licensee shall have Notwithstanding anything in this Agreement to the sole right to obtain all pricing and reimbursement approvals in all countries contrary, in the Territory event that any Person intervenes in which Licensed Products or opposes any proceedings in connection with the Required Approvals, no party shall be soldrequired to take any action to avoid or settle such intervention or opposition, other than on commercially reasonable terms.

Regulatory Approvals. (a) Licensee Subject to the terms and conditions of this Agreement, each of SPAC and the Company shall use Commercially Reasonable Efforts its commercially reasonable efforts, and shall cooperate fully with the other, to submit registration dossiers take, or cause to be taken, all actions and to do, or cause to be done, all things reasonably necessary, proper or advisable under applicable Laws to consummate the Transactions (including the receipt of all applicable Consents of Governmental Authorities) and to comply as promptly as practicable with all requirements of Governmental Authorities applicable to the relevant Regulatory Authorities with respect Transactions, including using its commercially reasonable efforts to (i) prepare and promptly file all documentation to effect all necessary Regulatory Approvals in each Major Countryfilings, notices, petitions, statements, registrations, submissions of information, applications and other documents, (ii) obtain all Consents, registrations, qualifications and orders of, and the expiration or termination of waiting periods by, Governmental Authorities necessary to consummate the Transactions and to fulfill the conditions to the Closing, and (iii) execute and deliver any additional instruments necessary to consummate the Transactions. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by In furtherance and not in the name limitation of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingSection 6.13(a), to the extent legally possiblerequired under the HSR Act or any other Laws that are designed to prohibit, being restrict or regulate actions having the sole contact with such Regulatory Authoritiespurpose or effect of monopolization or restraint of trade or that are designed to prohibit, subject restrict or regulate actions that may risk national security (collectively, “Antitrust Laws”), each of SPAC and the Company agrees, and shall cause its Subsidiaries and Affiliates, to make any required filing or application under Antitrust Laws, including preparing and making an appropriate filing pursuant to the rights HSR Act, with respect to the Transactions as promptly as practicable, to supply as promptly as reasonably practicable any additional information and documentary material that may be reasonably requested pursuant to Antitrust Laws and to take all other actions reasonably necessary, proper or advisable to cause the granting of Xxxxx approval or consent by the applicable Governmental Authority as soon as practicable; provided, that the applicable HSR Act filing fees and any filing fees in connection with any other Antitrust Law shall be paid 50% by SPAC and 50% by the Company. Each of SPAC and the Company shall, in connection with its commercially reasonable efforts to obtain all requisite approvals and authorizations for the Transactions under this Section 4.4any Antitrust Law, use its commercially reasonable efforts to (i) cooperate in all respects with each other in connection with any filing or submission and in connection with any investigation or other inquiry, including any proceeding initiated by a private Person, (ii) keep the other reasonably informed of any material communication received by such Party or its Representatives from, or given by such Party or its Representatives to, any Governmental Authority and of any material communication received or given in connection with any proceeding by a private Person, in each case regarding the Transactions, (iii) permit a Representative of such other Party and its outside counsel to review any material communication given by it to, and consult with each other in advance of any material meeting or conference with, any Governmental Authority or, in connection with any proceeding by a private Person, with any other Person, and to the extent permitted by such Governmental Authority or other Person, give a Representative or Representatives of such other Party the opportunity to attend and participate in such meetings and conferences, (iv) in the event a Party’s Representative is prohibited from participating in or attending any meetings or conferences, each attending Party shall keep such Party promptly and reasonably apprised with respect thereto, and (v) use commercially reasonable efforts to cooperate in the filing of any memoranda, white papers, filings, correspondence or other written communications explaining or defending the Transactions, articulating any regulatory, competitive or national security related argument, and responding to requests or objections made by any Governmental Authority. (c) Each Party shall have full access If any objections are asserted with respect to the Transactions under any applicable Law or if any Action is instituted (or threatened to be instituted) by any applicable Governmental Authority or any private Person challenging any of the Transactions as violative of any applicable Law or that would otherwise prevent, materially impede or materially delay the consummation of the Transactions, each of SPAC and the right Company shall use its commercially reasonable efforts to reference resolve any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees such objections or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject Actions so as to the prior written consent timely permit consummation of the Person owning Transactions including in order to resolve such objections or Actions that, if not resolved, could reasonably be expected to prevent, materially impede or materially delay the NDA or foreign equivalent as consummation of the case may be and any information contained thereinTransactions. In the event that any Action is instituted (or threatened to be instituted) by a Party Governmental Authority or its Affiliates is private Person challenging the owner Transactions, each of such NDA or foreign equivalent as SPAC and the case may be or information contained therein, such Party shall notCompany shall, and shall cause its Affiliates not their respective Representatives to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate with each other and use their respective commercially reasonable efforts to obtain contest and resist any such necessary third party consents. Notwithstanding the foregoingAction and to have vacated, the rights granted to a Party to access lifted, reversed or overturned any Order, whether temporary, preliminary or permanent, that is in effect and reference any NDAs and/or their foreign equivalentthat prohibits, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent prevents or restricts consummation of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonTransactions. (d) To Prior to the extent not prohibited by law or regulationClosing, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee each of SPAC and the relevant Regulatory Authority. Licensee will Company shall use its commercially reasonable efforts (i) to provide Xxxxx with obtain any Consents of Governmental Authorities or other third party as much advance notice may be necessary for the consummation by such Party or its Affiliates of any such meeting the Transactions or telephone call required as is reasonably possible in a result of the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting execution or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) performance of this sentence require Licensee to delay any meeting Agreement, or telephone call consummation of the Transactions, by such Party, and the other Parties shall provide reasonable cooperation in connection with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsuch commercially reasonable efforts. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee In respect of the Competition Act Approval and the Investment Canada Act Approval, (i) within ten Business Days after the date of this Agreement or such other date as the Parties may reasonably agree, Gold Fields shall use Commercially Reasonable Efforts file with the Commissioner a submission requesting an Advance Ruling Certificate or, in the alternative, a No Action Letter; (ii) if an Advance Ruling Certificate or No Action Letter shall not have been obtained within 16 days following filing of Gold Fields’ submission, Gold Fields or Yamana may at any time thereafter, acting reasonably, notify the other Party that it intends to submit registration dossiers file a notification pursuant to subsection 114(1) of the relevant Regulatory Authorities Competition Act, in which case Gold Fields and Yamana shall each file their respective notifications pursuant to subsection 114(1) of the Competition Act as promptly as practicable but in any event within ten Business Days following the date Gold Fields or Yamana, as applicable, notified the other Party of its intention to file a notification; and (iii) within ten Business Days after the date of this Agreement or such other date as the Parties may reasonably agree, Gold Fields shall file with the responsible Minister with respect to all necessary Regulatory Approvals in each Major Countrythe transactions contemplated by this Agreement an application for review under the Investment Canada Act, including Gold Fields’ proposed written undertakings to the Minister or his designees. (b) Licensee Gold Fields and Yamana shall, and shall have cause their respective Subsidiaries, as applicable, to, file, as promptly as practicable after the right date of this Agreement, any other filings or notifications under any other applicable federal, provincial, state or foreign Law required to obtain any other Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products Approvals including, to for the extent legally possible, being avoidance of doubt the sole contact with such Regulatory Authorities, subject to approval of the rights of Xxxxx under this Section 4.4SARB and the JSE. (c) Each All filing fees (including any Taxes thereon) in respect of any filing made to any Governmental Entity in respect of any Regulatory Approvals shall be shared by the Parties equally. (d) The Parties shall use their commercially reasonable efforts to: (i) obtain the Regulatory Approvals at the earliest possible date. For greater certainty, but without limiting the generality of the foregoing, the Parties shall request that the Regulatory Approvals be processed by the applicable Governmental Entity on an expedited basis and, to the extent that a public hearing is held, the Parties shall request the earliest possible hearing date for the consideration of the Regulatory Approvals; (ii) respond promptly to any request for additional information or documentary materials made by any Governmental Entity in connection with the Regulatory Approvals; and (iii) make such further filings as may be necessary, proper or advisable in connection therewith. (e) With respect to obtaining the Regulatory Approvals, each of Gold Fields and Yamana shall cooperate with one another and shall provide such assistance as the other Party may reasonably request in connection with obtaining the Regulatory Approvals. In particular: (i) no Party shall have full access extend or consent to and any extension of any applicable waiting or review period or enter into any agreement with a Governmental Entity to not consummate the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned transactions contemplated by the other Partythis Agreement, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to except upon the prior written consent of the Person owning other Party; (ii) the NDA Parties shall exchange drafts of all submissions, correspondence, filings, presentations, applications, plans, consent agreements and other documents to be made or foreign equivalent as submitted to or filed with any Governmental Entity in respect of the case transactions contemplated by this Agreement, will consider in good faith any suggestions made by the other Party and its counsel and will provide the other Party and its counsel with final copies of all such submissions, correspondence, filings, presentations, applications, plans, consent agreements and other documents, and all pre-existing business records or other documents, submitted to or filed with any Governmental Entity in respect of the transactions contemplated by this Agreement; provided, however, that, subject to Section 5.7(f), information indicated by either Party to be competitively sensitive shall be provided on an external counsel-only basis; (iii) each Party will keep the other Party and their respective counsel fully apprised of all written (including email) and oral communications and all meetings with any Governmental Entity and their staff in respect of the Regulatory Approvals, and will not participate in such communications or meetings without giving the other Party and their respective counsel the opportunity to participate therein; provided, however, that, subject to Section 5.7(f), where competitively sensitive information may be and discussed or communicated, the other Party’s external legal counsel shall be provided with any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be communications or information contained therein, on an external counsel-only basis and shall have the right to participate in any such meetings on an external counsel-only basis; and (iv) each Party shall notmake available its Representatives, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In on the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent reasonable request of the Person owning other Party and its counsel, to assist in obtaining the NDA or foreign equivalentRegulatory Approvals, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited including by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material making introductions to, and arranging meetings between Licensee with, key stakeholders and any Regulatory Authority with respect to Licensed Products leaders of Governmental Authorities and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible participating in the circumstances andthose meetings, (ii) providing strategic input, including on any materials prepared for obtaining the Regulatory Approvals, and (iii) responding promptly to the extent reasonably possiblerequests for support, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to information, comments or input where reasonably requested in connection with the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductApprovals. (ef) Licensee With respect to Sections 5.7(e)(ii) and (iii) above, where a Party (in this Section 5.7 only, the “Disclosing Party”) provides any submissions, communications, information, correspondence, filings, presentations, applications, plans, consent agreements or other documents to the other Party (the “Receiving Party”) on an external counsel-only basis, the Disclosing Party shall have also provide the sole right Receiving Party with a redacted version of any such submissions, communications, information, correspondence, filings, presentations, applications, plans, consent agreements or other documents. (g) None of the Parties shall enter into any transaction, investment, agreement, arrangement or joint venture or take any other action, the effect of which would reasonably be expected to make obtaining the Regulatory Approvals materially more difficult or challenging, or reasonably be expected to materially delay the obtaining of the Regulatory Approvals. (h) The Parties shall use (and shall cause their respective Subsidiaries to use) their respective commercially reasonable efforts to take or cause to be taken all actions necessary or advisable on their respective parts to consummate the transactions contemplated by this Agreement as promptly as practicable after the date of this Agreement. To the extent that the Minister or his designees propose any amendments or require enhancements to the proposed written undertakings contemplated in Section 5.7(a)(iii), Gold Fields shall use its commercially reasonable efforts to propose, negotiate and enter into undertakings necessary to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be soldInvestment Canada Act Approval.

Regulatory Approvals. (a) Licensee In connection with the Transactions, each of the Parties shall use Commercially Reasonable Efforts to submit registration dossiers (and, to the relevant Regulatory Authorities extent required, shall cause its Affiliates to) undertake reasonable best efforts to comply promptly but in no event later than ten (10) Business Days after the date hereof with respect any required notification and reporting requirements of the HSR Act. Each of the Parties shall, subject to all giving CorpAcq Holdco and CCVII prior reasonable notice and an opportunity to consult on any third party communications or applications in advance of circulation or submission (to the extent permissible under applicable Laws), cooperate and use their respective commercially reasonable efforts to consummate and make effective as promptly as practicable the Transactions, including providing any notices to any Person required in connection with the consummation of the Transactions, and obtaining any licenses, consents, waivers, approvals, authorizations, qualifications and Governmental Orders necessary Regulatory Approvals to consummate the Transactions (including the FCA Approval and approval of the UK Takeover Panel) and any necessary approvals required under applicable Antitrust Laws; provided, that in no event shall any Party be required to pay any material fee, penalty or other consideration to obtain any license, Permit, consent, approval, authorization, qualification or waiver required under any Contract for the consummation of the Transactions (other than fees or expenses payable to the SEC in connection with the Transactions, including the Proxy Statement/Prospectus, potential filing fees payable pursuant to Antitrust Laws, and any other ordinary course filing fees in connection with Governmental Filings required to consummate the Transactions). Subject to appropriate confidentiality protections and applicable Antitrust Laws, each Major CountryParty shall promptly furnish to the Company, CorpAcq Holdco and CCVII such necessary information and reasonable assistance as the Company, CorpAcq Holdco and CCVII may reasonably request in connection with the foregoing. (b) Licensee shall have The CorpAcq Parties and the right Sponsor Persons agree that BermudaCo and the Company and the Sponsor Persons, if required to obtain Regulatory ApprovalsFCA Approval, which shall be held by make any such notification (the “Change of Control Notification”) to the FCA as promptly as practicable (and in any event within 20 Business Days of the name date of Licenseethis Agreement). If at any time CorpAcq Parties or the Sponsor Persons become aware of any event, circumstance or condition that would be reasonably likely to prevent FCA Approval being satisfied, CorpAcq Parties shall promptly inform CCVII or, in the case of the Sponsor Persons, the Sponsor Persons shall promptly the CorpAcq Parties, and Licensee shall own all Submissions and Data in connection therewith. All pricingreasonably cooperate with them to address any such event, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4circumstance or condition. (c) Each of the Company, CorpAcq Holdco and CCVII shall cooperate with one another and use their reasonable best efforts to prepare or otherwise procure the provision of any necessary documentation (including furnishing all information (i) required under any applicable Antitrust Laws or other applicable Laws, (ii) requested by a Governmental Authority pursuant to applicable Antitrust Laws, or (iii) requested by the FCA as part of the FCA Approval applications) to effect promptly all necessary filings with any Governmental Authority and to obtain all necessary, proper or advisable actions or nonactions, approvals consents, waivers, exemptions and approvals of any Governmental Authority necessary to consummate the Transactions, including the FCA Approval. Except with respect to the FCA Approval, each Party shall have full access provide to the Company and CorpAcq Holdco (in the right case of CCVII) or CCVII (in the case of any Seller or CorpAcq Party) copies of all correspondence between it (or its advisors) and any Governmental Authority relating to reference the Transactions or any NDAs and/or their foreign equivalent based of the matters described in this Section 9.01. Except with respect to the FCA Approval, each Party shall promptly inform the Company and CorpAcq Holdco (in the case of CCVII) or CCVII (in the case of any Seller or CorpAcq Party) of any substantive oral communication with, and provide copies of any written communications with, any Governmental Authority regarding any such filings or any such transaction, unless prohibited by reasonable request of any Governmental Authority. Except with respect to the FCA Approval, no Party shall independently participate in any substantive meeting or substantive conference call with any Governmental Authority in respect of any such filings, investigation or other inquiry without giving the Company and CorpAcq Holdco (in the case of CCVII) or CCVII (in the case of any Seller or CorpAcq Party) prior notice of the substantive meeting or substantive conference call and, to the extent permitted by such Governmental Authority, the opportunity to attend or participate. In the event a Party is prohibited from participating in or attending any meeting or substantive conference call, the participating Party shall keep the Company and CorpAcq Holdco (in the case of CCVII) or CCVII (in the case of any Seller or CorpAcq Party) promptly and reasonably apprised with respect thereto, to the extent permitted by applicable Law. To the extent permissible under applicable Law, each CorpAcq Party, on Immune Modulator owned by one hand, and CCVII, on the other Partyhand will consult and cooperate with the other, its Affiliatesand consider in good faith the views of the other so as to mutually agree on any strategies and decisions in connection with any analyses, and/or sublicensees appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or any third party filing such NDAs and/or their foreign equivalent submitted by or on behalf of any such PartyParty relating to proceedings under Antitrust Laws or other applicable Laws. Any documents or other materials provided pursuant to this Section 9.01(c) may be redacted or withheld as necessary to address reasonable privilege or confidentiality concerns, its Affiliatesand to remove references concerning the valuation of CorpAcq Holdco or other competitively sensitive material or personally-identifiable information or other sensitive personal or financial information, and the parties may, as each deems advisable, reasonably designate any material provided under this Section 9.01 as “outside counsel only material.” Such “outside counsel only materials” and the information contained therein shall be given only to legal counsel of the recipient and will not be disclosed by such legal counsel to employees, officers, or its sublicenseesdirectors of the recipient without the advance written consent of the party providing such materials. Without limiting the generality of the undertakings pursuant to this Section 9.01, each Party shall use reasonable best efforts to provide or cause to be provided (including, with respect to the FCA Approval, the Company, any Sponsor Person and BermudaCo to the extent that such approval is required by such Person) as promptly as reasonably practicable and advisable to any Governmental Authority information and documents relating to such Party as requested by such Governmental Authority or necessary, proper or advisable to permit consummation of the Transactions, including filing any notification that may be required with any Governmental Authority as promptly as reasonably practicable and advisable after the date hereof, and thereafter to respond as promptly as reasonably practicable and advisable to any request for additional information or documentary material relating to such Party that may be made (including under Antitrust Law regarding any preacquisition notifications for the purpose of competition reviews). Each Party shall supply as promptly as practicable and advisable any additional information and documentary material that may be requested by any Governmental Authority and furnish to the other such necessary information and reasonable assistance as the other may request in connection with the preparation of any required applications, notices, registrations and requests as may be required or advisable to be filed with any Governmental Authority. In furtherance and not in limitation of the foregoing, each Party shall provide, or cause to be provided, all agreements, documents, instruments, affidavits, statements or information that may be required or requested by any Governmental Authority. With respect to the FCA Approval only, each Party in respect of which FCA Approval is required shall keep the Company, CorpAcq Holdco and CCVII informed of any substantive or written communication with the FCA in connection with the FCA Approval. (d) If any objections are asserted with respect to the Transactions under any applicable Law or if any Action is instituted by any Governmental Authority or any private party challenging any of the Transactions as violative of any applicable Law, each of the CorpAcq Parties, on the one hand, and CCVII, on the other hand, shall cooperate with one another in good faith and use their reasonable best efforts to take such action as reasonably necessary to overturn any regulatory Action by any Governmental Authority to prevent or enjoin consummation of this Agreement (and the Transactions); provided, however, that any decision by the CorpAcq Parties or CCVII to litigate in connection with such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may matters must be and any information contained therein. In the event that a Party or its Affiliates is the owner of mutually agreed by such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductParties. (e) Licensee Each of the CorpAcq Parties and CCVII shall have the sole right use commercially reasonable efforts to obtain all pricing any authorization, consent or approval of a Governmental Authority (including in connection with any Governmental Filings) necessary or advisable so as to enable the consummation of the Transactions to occur as expeditiously as possible (and reimbursement approvals in all countries any event, no later than the Termination Date). Notwithstanding anything to the contrary, portfolio companies managed by Affiliates of CCVII are under no obligation to undertake any actions in this Section 9.01(e), and CCVII is under no obligation to cause such portfolio companies to undertake any actions in this Section 9.01(e). (f) During the Interim Period, no Party shall acquire or agree to acquire, by merging with or into or consolidating with, or by purchasing a substantial portion of the assets of or any equity in, or by any other manner, any assets or Person, or take any other action, if the execution and delivery of a definitive agreement relating to, or the consummation of, such acquisition, or the taking of any other action, could in any material respect (individually or in the Territory aggregate): (i) impose any material delay in which Licensed Products shall be soldobtaining, or increase the risk of not obtaining, consents of a Governmental Authority necessary to consummate the Transactions or the expiration or termination of any applicable waiting period, (ii) materially increase the risk of a Governmental Authority seeking or entering a Governmental Order prohibiting the consummation of the Transactions, (iii) materially increase the risk of not being able to remove any such Governmental Order on appeal or otherwise, or (iv) otherwise prevent or delay the consummation of the Transactions.

Regulatory Approvals. 6.1.1. No later than three (3) Business Days after the date hereof, Seller and Purchaser shall jointly cause to be filed by Seller's FCC counsel one or more applications with the FCC requesting its consent to the assignment of the FCC Licenses from BCR License Sub to Purchaser, which applications are attached hereto at Exhibit A (the "FCC Application"). Each party shall pay its own expenses in connection with the preparation and prosecution of the FCC Application and shall share equally any filing fees associated with the FCC Application. 6.1.2. Upon the terms and subject to the conditions set forth in this Agreement, Seller and Purchaser shall each use their respective commercially reasonable efforts to promptly (a) Licensee shall use Commercially Reasonable Efforts take, or to submit registration dossiers cause to be taken, all actions, and to do, or to cause to be done, and to assist and cooperate with the relevant Regulatory Authorities with respect other parties in doing all things proper or advisable under applicable Law or otherwise to all necessary Regulatory Approvals in each Major Country. consummate and make effective the transactions contemplated by this Agreement; (b) Licensee shall have the right obtain from any Governmental Authority or other Person any actions, non-actions, clearances, waivers, consents, approvals, permits or Orders required to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by Seller, Purchaser or any of their respective Affiliates in connection with the authorization, execution, delivery and in performance of this Agreement, the name consummation of Licensee, the other transactions contemplated hereby and Licensee will be thereby and the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, assignment of the FCC Licenses from BCR License Sub to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. Purchaser; (c) Each Party shall furnish all information required for any application or other filing to be made pursuant to any applicable Law or any applicable regulations of any Governmental Authority in connection with the transactions contemplated by this Agreement, including filings in connection with the FCC Application, and to supply promptly any additional information and documentary material that may be requested in connection with such filings or applications; (d) avoid the entry of, or have full access to vacated or terminated, any Order that would restrain, prevent or delay the Closing or the FCC Order, including defending against and opposing any lawsuits or other proceedings (including any FCC reconsideration or review), whether judicial or administrative, reviewing or challenging this Agreement, the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by consummation of the other Partytransactions contemplated hereby and thereby or the assignment of the FCC Licenses from BCR License Sub to Purchaser; and (e) execute and deliver any additional instruments necessary to assign the FCC Licenses from BCR License Sub to Purchaser or to consummate any other transactions contemplated by this Agreement. No party to this Agreement shall consent to any voluntary delay of the assignment of the FCC Licenses from BCR License Sub to Purchaser or the consummation of the other transactions contemplated hereby at the behest of any Governmental Authority or other Person without the consent of the other party, its Affiliateswhich consent shall not be unreasonably withheld, and/or sublicensees conditioned or any third party filing such NDAs and/or their foreign equivalent on behalf delayed. 6.1.3. Notwithstanding anything in this Agreement to the contrary, if the Closing occurs before the FCC Order becomes a Final Order, the terms of such Party, its Affiliates, or its sublicenseesSection 6.1.2 shall survive the Closing until the FCC Order becomes a Final Order; provided, however, that such rights are subject terms shall only survive as applied to actions relating to the prior written consent obtaining of the Person owning the NDA or foreign equivalent as the case may be FCC Order and any information contained thereinsuch FCC Order becoming a Final Order. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent No assignment of the Person owning FCC Licenses shall occur prior to obtaining the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonFCC Order. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Each of the Parties shall cooperate and use Commercially Reasonable Efforts their respective reasonable best efforts to submit registration dossiers take, or cause to be taken, all action, and to do, or cause to be done as promptly as practicable, all things necessary, proper and advisable under applicable Laws, to consummate and make effective as promptly as practicable the Transactions, including providing any notices to any Person required in connection with the consummation of the Transactions, and obtaining any licenses, consents, waivers, approvals, authorizations, qualifications and Governmental Orders necessary to consummate the Transactions; provided, that in no event shall any party be required to pay any material fee, penalty or other consideration to obtain any license, Permit, consent, approval, authorization, qualification or waiver required under any Contract for the consummation of the Transactions (other than fees or expenses payable to the relevant Regulatory Authorities SEC in connection with respect the Transactions, including the Proxy Statement / Prospectus, filing fees payable pursuant to all the HSR Act or other Antitrust Laws, and any other ordinary course filing fees in connection with Governmental Filings required to consummate the Transactions). Subject to appropriate confidentiality protections and applicable Antitrust Laws, each party hereto shall furnish to the other parties such necessary Regulatory Approvals information and reasonable assistance as such other party may reasonably request in each Major Countryconnection with the foregoing. (b) Licensee Each of the Parties shall have the right cooperate with one another and use their reasonable best efforts to prepare all necessary documentation (including furnishing all information) (i) required under any applicable Antitrust Laws or other applicable Laws, (ii) requested by a Governmental Authority pursuant to applicable Antitrust Laws, to effect promptly all necessary filings with any Governmental Authority and to obtain Regulatory Approvalsall necessary, which proper or advisable actions or nonactions, approvals consents, waivers, exemptions and approvals of any Governmental Authority necessary to consummate the Transactions. Each party hereto shall be held by provide to the other parties copies of all substantive correspondence between it (or its advisors) and any Governmental Authority relating to the Transactions or any of the matters described in this Section 12.01. Each of the name parties hereto shall promptly inform the other of Licenseeany substantive oral communication with, and Licensee provide copies of any written communications with, any Governmental Authority regarding any such filings or any such transaction, unless prohibited by reasonable request of any Governmental Authority. No party hereto shall own all Submissions and Data independently participate in connection therewith. All pricingany substantive meeting or substantive conference call with any Governmental Authority in respect of any such filings, formulary and marketing approvals shall also be obtained by and in investigation or other inquiry without giving the name other party prior notice of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingsubstantive meeting or substantive conference call and, to the extent legally possiblepermitted by such Governmental Authority, being the sole contact opportunity to attend or participate. In the event a party is prohibited from participating in or attending any meeting or substantive conference call, the participating party shall keep the other party promptly and reasonably apprised with such Regulatory Authoritiesrespect thereto, subject to the rights extent permitted by applicable Law. To the extent permissible under applicable Law, the parties hereto will consult and cooperate with one another, and consider in good faith the views of Xxxxx one another so as to mutually agree on any strategies and decisions in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto relating to proceedings under Antitrust Laws or other applicable Laws. Any documents or other materials provided pursuant to this Section 12.01(b) may be redacted or withheld as necessary to address reasonable privilege or confidentiality concerns, and to remove references concerning the valuation of Trebia or other competitively sensitive material or personally-identifiable information or other sensitive personal or financial information, and the parties may, as each deems advisable, reasonably designate any material provided under this Section 4.412.01 as “outside counsel only material.” Such “outside counsel only materials” and the information contained therein shall be given only to legal counsel of the recipient and will not be disclosed by such legal counsel to employees, officers, or directors of the recipient without the advance written consent of the party providing such materials. Notwithstanding the foregoing, neither party shall be obligated to share with the other party documents responsive to items 4(c) and 4(d) on the Notification and Report Form for Certain Mergers and Acquisitions under the HSR Act. (c) Each Party Without limiting the generality of the undertakings pursuant to this Section 12.01, each party hereto shall have full access use reasonable best efforts to provide or cause to be provided (including, with respect to filings pursuant to the HSR Act, by its “Ultimate Parent Entities”, as that term is defined in the HSR Act) as promptly as reasonably practicable and advisable to any Governmental Authority information and documents relating to such party as requested by such Governmental Authority or necessary, proper or advisable to permit consummation of the Transactions, including filing any notification and report form and related material required under the HSR Act and any other filing or notice that may be required with any other Governmental Authority as promptly as reasonably practicable and advisable after the date hereof (and, in the case of filings under the HSR Act, no later than 10 Business Days after the date hereof), and thereafter to respond as promptly as reasonably practicable and advisable to any request for additional information or documentary material relating to such party that may be made (including under the HSR Act and any similar Antitrust Law regarding preacquisition notifications for the purpose of competition reviews). Trebia shall supply as promptly as practicable any additional information and documentary material relating to Trebia and the right Sponsor Persons that may be requested by any Governmental Authority and furnish to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Partyparties such necessary information and reasonable assistance as the other parties may request in connection with the preparation of any required applications, notices, registrations and requests as may be required or advisable to be filed with any Governmental Authority (including, with respect to Trebia and the Sponsor Persons, providing financial information and certificates as well as personal information of senior management, directors or control persons, and requesting that individuals with appropriate seniority and expertise make themselves available to participate in discussions or hearings). Trebia shall cause the filings made by it (or by its Affiliatesultimate parent entity, and/or sublicensees if applicable) under the HSR Act to be considered for grant of “early termination,” (to the extent available) and make any further filings pursuant thereto that may be necessary, proper, or advisable in connection therewith. In furtherance and not in limitation of the foregoing, Trebia shall provide, or cause to be provided, all agreements, documents, instruments, affidavits, statements or information that may be required or requested by any Governmental Authority relating to (i) Trebia (including any of its directors, officers, employees, partners, members, shareholders or control persons) and (ii) Trebia’s structure, ownership, businesses, operations, regulatory and legal compliance, assets, liabilities, financing, financial condition or results of operations, or any third of its or their directors, officers, employees, partners, members, shareholders or Affiliates (including to the extent required pursuant to the Sponsor Agreement, if so required). (d) If any objections are asserted with respect to the Transactions under any applicable Law or if any Action is instituted by any Governmental Authority or any private party filing challenging any of the Transactions as violative of any applicable Law, each of the parties hereto shall cooperate with one another in good faith and use their reasonable best efforts to: (i) oppose or defend against any action to prevent or enjoin consummation of this Agreement (and the Transactions), and (ii) take such NDAs and/or their foreign equivalent on behalf action as reasonably necessary to overturn any regulatory action by any Governmental Authority to prevent or enjoin consummation of such Partythis Agreement (and the Transactions), its Affiliatesincluding by defending any Action brought by any Governmental Authority in order to avoid entry of, or its sublicenseesto have vacated, overturned or terminated, including by appeal if necessary, in order to resolve any such objections or challenge as such Governmental Authority or private party may have to any of the Transactions under such applicable Law so as to permit the consummation of the Transactions in their entity; provided, however, that any decision by the parties hereto to litigate in connection with such rights are subject to matters must be mutually agreed by Txxxxx, X0 Holdco and Protected. (e) Notwithstanding the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained thereinforegoing, such Party shall notTrebia shall, and shall cause its controlled Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate take any and all actions necessary to obtain such any authorization, consent or approval of a Governmental Authority (including in connection with any Governmental Filings) necessary third party consents. Notwithstanding or advisable so as to enable the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent consummation of the Person owning Transactions to occur as expeditiously as possible (and in any event, no later than the NDA Termination Date) and to resolve, avoid or foreign equivalenteliminate any impediments or objections, such consent if any, that may be asserted with respect to be at the sole discretion Transactions under any Law, or to otherwise oppose, avoid the entry of, or to effect the dissolution of, any order, decree, judgment, preliminary or permanent injunction that would otherwise have the effect of such owning Person. (d) To preventing, prohibiting, restricting, or delaying the extent not prohibited by law or regulationconsummation of the Transactions, Xxxxx shall have right to have one (1) representative including: (i) attend (but not participate in) any material meetings between Licensee proposing, negotiating, committing to and effecting, by consent decree, hold separate order or otherwise, the sale, divestiture, licensing or disposition of, or holding separate of, businesses, product lines, rights or assets of Trebia or its controlled Affiliates and any Regulatory Authority with respect interest therein (including entering into customary ancillary agreements relating to Licensed Products any such sale, divestiture, licensing or disposition of such businesses, product lines, rights or assets) and (ii) listen otherwise taking or committing to take actions that after the Closing Date would limit Trebia’s or its controlled Affiliates’ freedom of action with respect to, or its ability to retain or control, one or more of the businesses, product lines, rights or assets of Trebia and its controlled Affiliates or interest therein, in each case as may be required in order to enable the consummation of the Transactions to occur as expeditiously as possible (but and in any event no later than the Termination Date. (f) From the date of this Agreement until Closing, Trebia shall not participate acquire or agree to acquire, by merging with or into or consolidating with, or by purchasing a substantial portion of the assets of or any equity in) , or by any other manner, any assets or Person, or take any other action, if the execution and delivery of a definitive agreement relating to, or the consummation of, such acquisition, or the taking of any other action, could in any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and (individually or in the relevant Regulatory Authority. Licensee will use reasonable efforts aggregate): (i) impose any delay in obtaining, or increase the risk of not obtaining, consents of a Governmental Authority necessary to provide Xxxxx with as much advance notice consummate the Transactions or the expiration or termination of any such meeting or telephone call as is reasonably possible in the circumstances andapplicable waiting period, (ii) increase the risk of a Governmental Authority seeking or entering a Governmental Order prohibiting the consummation of the Transactions, (iii) increase the risk of not being able to remove any such Governmental Order on appeal or otherwise, (iv) be reasonably expected to result in the failure to satisfy a condition to the extent reasonably possibleDebt Financing or the Cannae Backstop Amount, to provide Xxxxxas applicable, at least five or (5v) business days before any such meeting, with copies otherwise prevent or delay the consummation of all documents, correspondence and other materials which are relevant the Transactions. (g) Notwithstanding anything in this Agreement to the matters contrary, nothing in this Agreement shall require S1 Holdco, Protected or any of their respective Subsidiaries or Affiliates to (i) take, or cause to be addressed at taken, any such meeting action, including selling, divesting or in otherwise disposing of, or conveying, licensing, holding separate or otherwise restricting or limiting its freedom of action with respect to, any such telephone call assets, business, products, rights, licenses or investments, or interests therein, other than with respect to S1 Holdco, Protected or any of their respective Subsidiaries (it being understood that in no event will provided any action taken is conditioned upon the provisions of clause (iClosing) or (ii) provide, or cause to be provided, (A) nonpublic or other confidential financial or sensitive personally identifiable information of this sentence require Licensee Court Square or any of its or their Affiliates or its or their respective directors, officers, employees, managers or partners, or its or their respective control persons’ or direct or indirect equityholders’ and their respective directors’, officers’, employees’, managers’ or partners’ (each of the foregoing Persons, a “Seller Related Person”) (other than such information with respect to delay the officers and directors of S1 Holdco and the System1 Subsidiaries which may be provided to a Governmental Authority on a confidential basis) or (B) any meeting other nonpublic, proprietary or telephone call other confidential information of a Seller Related Person that exceeds the scope of information that such Seller Related Person has historically supplied in connection with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsimilar governmental filing or notification. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Sellers and Purchaser shall cooperate and use commercially reasonable efforts to obtain all consents, approvals and agreements of, and to give and make all notices and filings with, any Governmental Authority necessary to authorize, approve or permit the consummation of the transactions contemplated by this Agreement, the Related Agreements and any other agreements contemplated hereby or thereby, including, without limitation, as set forth on SCHEDULE 3.19 and SCHEDULE 4.5; PROVIDED, HOWEVER, that nothing in this Agreement shall require, or be construed to require, Purchaser or Sellers to proffer to, or agree to, sell, divest, lease, license, transfer, dispose of or otherwise encumber or hold separate, before or after the Effective Time of any Closing, material assets, licenses, operations, rights, product lines, businesses or their interest therein or any of their respective Affiliates or to agree to any material changes or restriction on, or other material impairment of the ability of Purchaser or Sellers, as the case may be, to own or operate, any such assets, licenses, product lines, businesses or interests therein. Without limiting the generality of the foregoing, Purchaser and Sellers and their respective Affiliates shall, as promptly as reasonably practicable, file with all foreign Government Authorities applications and/or notices required to be made by them to obtain the non-US approvals set forth in SCHEDULE 3.19 or SCHEDULE 4.5, as the case may be. Purchaser and UBOC will keep each other informed of the status of matters relating to obtaining the regulatory approvals set forth on SCHEDULE 3.19 and SCHEDULE 4.5. It is expressly understood by the Parties that each Party shall use Commercially Reasonable Efforts commercially reasonable efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee ensure that representatives of both Purchaser and UBOC shall have the right to obtain Regulatory Approvalsattend and participate in any hearing, which shall be held by and in the name of Licenseeproceeding, and Licensee shall own all Submissions and Data in connection therewith. All pricingmeeting, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions conference or similar event before or with Regulatory Authorities concerning any Licensed Products including, a Governmental Authority or other organization relating to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees Agreement or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained thereina Related Agreement. In the event that a Party or its Affiliates is the owner furtherance of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access Purchaser and reference any NDAs and/or their foreign equivalent, as contemplated herein, UBOC shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use provide each other reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances andhearing, (ii) to the extent reasonably possibleproceeding, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters conference or similar event. The notice required to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of given under this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products Section 5.10.1 shall be soldgiven to representatives of UBOC or Purchaser entitled to receive notices hereunder.

Regulatory Approvals. (a) Licensee 2.1. This Agreement, and any amendment or modification hereof, will be submitted to the appropriate State Commission for approval in accordance with Section 252 of the Act. ALLTEL and Carrier shall use Commercially Reasonable Efforts their best efforts to submit registration dossiers obtain approval of this Agreement by any regulatory body having jurisdiction over this Agreement. Carrier shall not order services under this Agreement before the Effective Date except as may otherwise be agreed in writing between the Parties. In the event any governmental authority or agency rejects any provision hereof, the Parties shall negotiate promptly and in good faith only such revisions as may reasonably be necessary to achieve approval. 2.2. The Parties acknowledge that the respective rights and obligations of each Party as set forth in this Agreement are based on the text of the Act and the rules and regulations promulgated thereunder by the FCC and the Commission as of the Effective Date (“Applicable Rules”). In the event of any amendment to the relevant Regulatory Authorities with respect Act, any effective legislative action or any effective regulatory or judicial order, rule, regulation, arbitration award or other legal action purporting to all necessary Regulatory Approvals in each Major Country. apply the provisions of the Act which revises, modifies or reverses the Applicable Rules (b) Licensee shall have the right individually and collectively, “Amended Rules”), either Party may, by providing written notice to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliatesrequire that the affected provisions of this Agreement be renegotiated in good faith and this Agreement shall be amended accordingly to reflect the pricing, and/or sublicensees terms and conditions of each such Amended Rules relating to any of the provisions in this Agreement. If the Parties do not come to agreement on the rates, terms, and conditions of the proposed modification within forty-five (45) days of the date upon which notice was received by one of the Parties, then either Party may seek relief of the dispute from the Commission, FCC, or other court of competent jurisdiction. 2.3. Section 2.2 shall control notwithstanding any third party filing other provision of this Agreement to the contrary. Any rates, terms or conditions thus developed or modified shall be substituted in place of those previously in effect and shall be deemed to have been effective under this Agreement as of the effective date established by the Amended Rules, whether such NDAs and/or their foreign equivalent on behalf action was commenced before or after the Effective Date of this Agreement. Should the Parties be unable to reach agreement with respect to the applicability of such Party, its Affiliates, order or its sublicensees; provided, however, that such rights are subject the resulting appropriate modifications to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained thereinthis Agreement, the Parties agree shall present any such issues to reasonably cooperate the Commission or the FCC to obtain such necessary third party consents. Notwithstanding establish appropriate interconnection arrangements under the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent Act in light of the Person owning the NDA or foreign equivalentAmended Rules, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood the intent of the parties that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be soldbrought into conformity with the then current obligations under the Act as determined by the Amended Rules.

Regulatory Approvals. If an Event of Default shall have occurred and be continuing, upon the request of the Administrative Agent, each Grantor will, at its expense, promptly execute and deliver, or cause the execution and delivery of, all applications, certificates, instruments, registration statements and all other documents and papers the Administrative Agent may reasonably request or as may be required by law in connection with the obtaining of any consent, approval, registration, qualification or authorization of the FCC and any applicable PUC (acollectively, the "REGULATORY AUTHORITIES") Licensee or of any other Person necessary or reasonably appropriate for the effective exercise of any rights under this Security Agreement. Without limiting the generality of the foregoing, if an Event of Default shall use Commercially Reasonable Efforts have occurred and be continuing, the Grantors shall take any action which the Administrative Agent may reasonably request in order to submit registration dossiers transfer and assign to the relevant Administrative Agent, or to such one or more third parties as the Administrative Agent may designate, or to a combination of the foregoing, each Communications License. To enforce the provisions of this Section, upon the occurrence and during the continuance of an Event of Default, the Administrative Agent is empowered to request the appointment of a receiver from any court of competent jurisdiction. Such receiver shall be instructed to seek from the Regulatory Authorities with respect an involuntary transfer of control of each such Communications License for the purpose of seeking a bona fide purchaser to all necessary Regulatory Approvals whom control will ultimately be transferred. The Grantors hereby agree to authorize such an involuntary transfer of control upon the request of the receiver so appointed and, if the Grantors shall refuse to authorize the transfer, their approval may be required by the court. Upon the occurrence and during the continuance of an Event of Default, the Grantors shall further use their best efforts to assist in each Major Country. (b) Licensee shall have obtaining approval of the right to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject if required, for any action or transactions contemplated by this Security Agreement including, without limitation, the preparation, execution and filing with the Regulatory Authorities of the assignor's or transferor's portion of any application or applications for consent to the rights assignment of Xxxxx any Communications License or transfer of control necessary or reasonably appropriate under this Section 4.4. (c) Each Party shall have full access the rules and regulations of the Regulatory Authorities for the approval of the transfer or assignment of any portion of the Collateral, together with any Communications License. The Grantors acknowledge that the assignment or transfer of each Communications License is integral to the Administrative Agent's and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned Lenders' realization of the value of the Collateral, that there is no adequate remedy at law for failure by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject Grantors to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority comply with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) this Section and that such failure would cause irreparable injury not adequately compensable in damages, and therefore agree that each and every covenant contained in this Section may be specifically enforced, and the Grantors hereby waive and agree not to assert any defenses against an action for specific performance of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsuch covenants. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers Upon the terms and subject to the relevant Regulatory Authorities conditions hereof, and except as otherwise expressly provided in this Agreement, Parent, Merger Sub and the Company shall, and Parent shall cause its Affiliates to, use their respective reasonable best efforts to, as promptly as practicable (i) take, or cause to be taken, all appropriate action and do, or cause to be done, all things necessary, proper or advisable under applicable Law or otherwise to consummate the transactions contemplated hereby, (ii) obtain from or provide to any Governmental Body or any other Person all Consents, licenses, Permits, waivers, approvals, authorizations, notices or orders required or advisable to be obtained or made by Parent or the Company or any of their respective Affiliates and Subsidiaries in connection with the authorization, execution and delivery of this Agreement and the consummation of the transactions contemplated hereby and (iii) make all necessary or advisable filings, and thereafter make any other required or requested submissions in connection therewith, with respect to all necessary Regulatory Approvals in each Major Countrythis Agreement and the transactions contemplated hereby required or advisable under applicable Law. (b) Licensee To the extent not prohibited by applicable Law, each party shall have use its reasonable best efforts to furnish to the right other parties all information required for any application, notification, or other filing to obtain Regulatory Approvalsbe made pursuant to any applicable Laws in connection with the transactions contemplated by this Agreement. Parent, which Merger Sub, and the Company shall give each other reasonable prior notice of any substantive communication with, and any proposed understanding, undertaking or agreement with, any Governmental Body regarding any such applications, notifications, or filings or any such transaction. The parties hereto agree that both Parent and the Company shall be held by represented at all in-person meetings and in all substantive conversations with any Governmental Body regarding the name of Licenseematters set forth in this Section 6.2(b), except if, and Licensee shall own all Submissions to the extent that, any Governmental Body objects to any party’s being represented at any such meeting or in any such conversation. The parties hereto will consult and Data cooperate with one another in connection therewithwith strategy, including any filings, analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto in connection with proceedings under or relating to any applicable law. All pricingNotwithstanding the foregoing, formulary nothing in this Agreement shall require any party to provide to the other party any information or materials that are (i) personally identifiable information, (ii) confidential competitive information or (iii) legally privileged. (c) Without limiting the foregoing, Parent and marketing approvals the Company, as necessary, shall, and Parent shall also cause its Affiliates to, (i) make or cause to be obtained made all filings and submissions required of each of them or any of their respective Subsidiaries or Affiliates under the HSR Act or other applicable Law (which filings and submissions shall seek early termination if made pursuant to the HSR Act and the equivalent, if available, with respect to any such other applicable Law) with respect to the transactions contemplated hereby as promptly as practicable and, in any event, within 15 Business Days after the date of this Agreement in the case of all filings required under the HSR Act, (ii) use reasonable best efforts to comply at the earliest practicable date with any request under the HSR Act, the Xxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the Federal Trade Commission Act, as amended, and any other United States federal or state or foreign Laws, Orders or administrative or judicial doctrines that are designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade (collectively, the “Antitrust Laws”) for additional information, documents, or other materials received by each of them or any of their respective Subsidiaries from the FTC, the Antitrust Division of the United States Department of Justice or any other Governmental Body in respect of such filings or such transactions, and (iii) cooperate with each other in connection with any such filing and in connection with resolving any investigation or other inquiry of any of the name of LicenseeFTC, the Antitrust Division or other Governmental Body under any Antitrust Laws with respect to any such filing or any such transaction. (d) Without limiting the foregoing (but subject to Section 6.2(f)), Parent shall, and Licensee will shall cause its Affiliates to, (i) file or cause to be filed with the principal interface applicable Governmental Bodies the Form A Filings and will otherwise handle all interactions other Consents, declarations, filings and notifications listed on Schedule 5.3(b) (collectively, the “Transaction Regulatory Filings”) as promptly as practicable and, in any event, within 15 Business Days after the date of this Agreement, (ii) use reasonable best efforts to comply at the earliest practicable date with any request by the Governmental Body for additional information, documents, or other materials (including supplements or amendments to the Transaction Regulatory Authorities concerning any Licensed Products Filings), (iii) cooperate with the DQ Companies in connection with the Transaction Regulatory Filings, each amendment or supplement thereto (including, to the extent legally possiblepermitted by applicable Law, being the sole contact with providing copies of all such Regulatory Authorities, subject documents to the rights Company at least three Business Days prior to filing and considering all reasonable additions, deletions or changes suggested in connection therewith), in connection with resolving any investigation or other inquiry of Xxxxx under this Section 4.4any Governmental Body and in connection with any administrative hearing or meeting with any Governmental Body. If any Governmental Body requires that a hearing be held in connection with any such filing or approval, Parent shall arrange for such hearing to be held promptly after it receives notice that such hearing is required. Parent shall provide the Company with prompt notice of Parent’s or any of its Affiliate’s receipt of any approval, consent, authorization, notice or other communication of any Governmental Body with respect to the Transaction Regulatory Filings. (ce) Each Party Without limiting the foregoing, (i) the Company, Parent and their respective Affiliates shall have full access not extend any waiting period or comparable period under the HSR Act or other Antitrust Laws or enter into any agreement with any Governmental Body not to and consummate the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Partytransactions contemplated hereby, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to except with the prior written consent of the Person owning the NDA other parties, and (ii) Parent agrees to, and to cause its Affiliates to, use their reasonable best efforts to promptly take all actions and do or foreign equivalent cause to be done all things that are necessary or advisable or as the case may be and requested or required by any information contained thereinGovernmental Body to consummate the transactions contemplated by this Agreement. In addition to, and without limiting the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained thereinforegoing, such Party Parent shall not, and shall cause its Affiliates not to, unreasonably withhold directly or delay consent. In the event that a third party is the owner of such NDA indirectly (whether by merger, consolidation or foreign equivalent otherwise), acquire, purchase, lease or information contained therein, the Parties license (or agree to acquire, purchase, lease or license) any Overlapping Business if doing so would reasonably cooperate be expected to: (x) impose any material delay in the obtaining of, or increase the risk of not obtaining, consents, approvals, authorizations or waivers of Governmental Bodies necessary to obtain such necessary third party consents. Notwithstanding consummate the transactions contemplated by this Agreement, including the expiration or termination of any applicable waiting period under the HSR Act; or (y) materially increase the risk of any Governmental Body entering an Order prohibiting the consummation of the transactions contemplated by this Agreement. (f) Without limiting the foregoing, Parent and the rights granted Company shall reasonably cooperate with the other to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend as promptly as practicable (but not participate inno later than 15 Business Days) any material meetings between Licensee after the date of this Agreement, prepare and any Regulatory Authority with respect submit to Licensed Products and CFIUS a pre-filing draft of a CFIUS Notice; (ii) listen as promptly as practicable after the parties’ resolution of all questions and comments received from CFIUS staff on the draft CFIUS Notice (or receipt of confirmation that the CFIUS staff have no such questions or comments), submit the final CFIUS Notice to CFIUS pursuant to 31 C.F.R. Part 800 Subpart E; (but not participate iniii) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable best efforts to provide any information requested by CFIUS or any other agency or branch of the U.S. government in connection with the CFIUS review, or investigation of the Transactions, within the time periods specified in the applicable regulations or otherwise specified by CFIUS staff; (iv) use reasonable best efforts to ensure that any information furnished pursuant to the foregoing clauses (i) - (iii) is true, correct and complete in all material respects; and (v) use their respective reasonable best efforts to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood obtain CFIUS Approval; provided that in no event will shall Parent be required to agree to any CFIUS Burdensome Condition as a condition of obtaining CFIUS Approval. For the provisions avoidance of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to doubt, Parent shall pay all exchanges of material correspondence related to activities conducted pursuant to this Agreement filing fees associated with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductCFIUS notice. (eg) Licensee shall have the sole right Subject to obtain all pricing Section 6.2(e) and reimbursement approvals in all countries Section 6.2(f), in the Territory in which Licensed Products event any Action or investigation by any Governmental Body or other Person is commenced or threatened that challenges or questions the validity or legality of the transactions contemplated hereby or if any Order (whether temporary, preliminary or permanent) is entered, enforced or attempted to be entered or enforced by any Governmental Body that would make consummation of the transactions contemplated hereby illegal or otherwise delay or prohibit the consummation of the transactions contemplated hereby, the Company, Parent and their respective Affiliates shall take any and all actions reasonably necessary to contest and defend against any such Action or investigation to avoid entry of, or to have vacated, lifted, reversed, repealed, rescinded or terminated, any Order (whether temporary, preliminary or permanent) that prohibits, prevents or restricts consummation of the transactions contemplated hereby, provided, that no Party shall be soldrequired by the foregoing covenant to commence litigation against a Governmental Body. (h) Parent shall pay all filing fees related to the filings under the HSR Act and the Transaction Regulatory Filings.

Regulatory Approvals. (a) Licensee Each Party shall cooperate and use reasonable best efforts to prepare and file as soon as practicable all applications, notices, petitions, filings and other documents necessary to obtain, and shall use Commercially Reasonable Efforts reasonable best efforts to submit registration dossiers obtain, the Seller Required Statutory Approvals, Company Required Statutory Approvals and the Purchaser Required Statutory Approvals. The Parties further agree to use reasonable best efforts (i) to take any act, make any undertaking or receive any clearance or approval required by any Governmental Entity or applicable Law and (ii) to satisfy any conditions imposed by any Governmental Entity in all Final Orders, in each case in order to consummate the relevant Regulatory Authorities transaction contemplated hereby as soon as reasonably possible. Each of the Parties shall (i) respond as promptly as practicable to any inquiries or requests received from any Governmental Entity for additional information or documentation and (ii) not enter into any agreement with any Governmental Entity that would reasonably be expected to adversely affect the Parties’ ability to consummate the transactions contemplated by this Agreement, except with the prior consent of the other Parties (which shall not be unreasonably withheld or delayed). Each of the Parties shall use reasonable best efforts to avoid or eliminate each and every impediment under any antitrust, competition, or trade or energy regulation law that may be asserted by any Governmental Entity with respect to all necessary Regulatory the transactions contemplated hereby so as to enable the Closing Date to occur as soon as reasonably possible. The actions required by the immediately preceding sentence shall include proposing, negotiating, committing to and effecting, by consent decree, hold separate order or otherwise, the sale, divestiture or disposition of such assets or businesses of Purchaser or its Affiliates (including their respective Subsidiaries) or agreeing to such limitations on its or their conduct or actions as may be required in order to obtain the Seller Required Statutory Approvals, the Company Required Statutory Approvals and the Purchaser Required Statutory Approvals as soon as reasonably possible, to avoid the entry of, or to effect the dissolution of, any injunction, temporary restraining order or other order in each Major Country. (b) Licensee shall any suit or proceeding, which would otherwise have the right to obtain Regulatory Approvals, which shall be held by and in effect of preventing or delaying the name of LicenseeClosing Date, and Licensee shall own all Submissions and Data defending through litigation on the merits, including appeals, any claim asserted in connection therewith. All pricing, formulary and marketing approvals shall also be obtained any court by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesPerson; provided, however, that the undertaking of any such rights are subject action does not result in a Company Material Adverse Effect or a Purchaser Material Adverse Effect. Each Party shall use reasonable best efforts to prepare and make all necessary filings as expeditiously as reasonably practicable and thereafter to make promptly any other required submissions with respect to this Agreement and the transactions contemplated hereby required under the Hart-Scott-Rodino Antitrust Improvements Act of 1000, xx xxxxxxx (the “HSR Act”). Prior to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained thereinClosing, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative Purchaser will: (i) attend determine the need for a filing under the Connecticut Transfer Act (but not participate inC.G.S. § 22a-134 et seq.) any material meetings between Licensee and any Regulatory Authority (the “CTA”) in connection with respect to Licensed Products the transactions contemplated by this Agreement, and (ii) listen if Purchaser determines that the CTA is applicable to the transaction, Purchaser or a “party associated with the transfer of the establishment” as defined in Conn. Gen. Stat. 22a-134(9) will prepare and make any filings required under the CTA, (but not participate iniii) Purchaser or a party associated with the transfer of the establishment will execute the forms as the certifying party, and will thereafter be solely responsible for compliance (including for any material telephone conversation between Licensee and any Regulatory Authority penalties resulting from non-compliance) with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible CTA; provided, however, that, in the circumstances and, case of clauses (ii) to the extent reasonably possibleand (iii) above, to provide Xxxxx, at least five (5) business days before any such meeting, “party associated with copies the transfer of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products establishment” shall be soldan Affiliate of Purchaser.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers Subject to the relevant Regulatory Authorities terms and conditions herein provided, each of the parties agrees to use their reasonable best efforts to take, or cause to be taken, all actions, and to do, or cause to be done as promptly as practicable, all things necessary, proper and advisable under applicable Laws to consummate and make effective as promptly as practicable the Merger and the other transactions contemplated by this Agreement and the Epicor Offer, the Epicor Merger and the other transactions contemplated by the Epicor Merger Agreement. Subject to appropriate confidentiality protections, each party hereto shall furnish to the other parties such necessary information and reasonable assistance as such other party may reasonably request in connection with respect to all necessary Regulatory Approvals in each Major Countrythe foregoing. (b) Licensee Subject to applicable Laws and the instructions of any Governmental Body, the Company and Parent each shall have keep the right other reasonably apprised of the status of matters relating to completion of the transactions contemplated hereby and the Epicor Merger Agreement, including using their reasonable best efforts to prepare all necessary documentation (including furnishing all information required under the Competition Laws) to effect promptly all necessary filings with any Governmental Body and to obtain Regulatory Approvalsall consents, which shall be held waivers and approvals of any Governmental Body necessary to consummate the Merger and the other transactions contemplated by and this Agreement and, solely in the name case of LicenseeParent, the Epicor Offer, the Epicor Merger and the other transactions contemplated by the Epicor Merger Agreement. Subject to applicable Laws, the instructions of any Governmental Body and any confidentiality obligation, each party hereto shall provide to the other parties copies of all correspondence between it (or its advisors) and any Governmental Antitrust Entity or other Governmental Body relating to the transactions contemplated by this Agreement, and Licensee to the extent permissible under any confidentiality obligations and the Competition Laws, the Epicor Merger Agreement or any of the matters described in this Section 7.4. Subject to applicable Laws, the instructions of any Governmental Body and any confidentiality obligation, each such party shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in promptly inform the name other parties hereto of Licenseeany oral communication with, and Licensee will be provide copies of written communications with, any Governmental Body regarding any such filings or any such transaction. No party hereto shall independently participate in any formal meeting with any Governmental Body or in respect to any filings, investigation, or other inquiry regarding the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingtransactions contemplated by this Agreement, without giving the other parties hereto prior notice of the meeting and, to the extent legally possiblepermitted by such Governmental Body, being the sole contact opportunity to attend and/or participate. To the extent permissible under applicable Law, the parties hereto will consult and cooperate with such Regulatory Authoritiesone another in connection with any analyses, subject appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto relating to proceedings under the Competition Laws. The parties may, as they deem advisable, designate any competitively sensitive materials provided to the rights of Xxxxx other under this Section 4.47.4(b) or any other section of this Agreement as “outside counsel only.” Such materials and the information contained therein shall be given only to outside counsel of the recipient and will not be disclosed by such outside counsel to employees, officers, or directors of the recipient without the advance written consent of the party providing such materials. (c) Each Party Without limiting the generality of the undertakings pursuant to this Section 7.4, the parties hereto shall have full access provide or cause to be provided (including by their “ultimate parent entities” as that term is defined in the HSR Act) as promptly as practicable to any Governmental Antitrust Entity information and documents requested by such Governmental Antitrust Entity or necessary, proper or advisable to permit consummation of the transactions contemplated by this Agreement and the right Epicor Merger Agreement, including filing any notification and report form and related material required under the HSR Act (and any similar Law enforced by any Governmental Antitrust Entity regarding preacquisition notifications for the purpose of competition reviews) as promptly as practicable, but in no event later than ten (10) Business Days after the date hereof, and thereafter to reference respond promptly to any NDAs and/or request for additional information or documentary material that may be made under the HSR Act (and any similar Law enforced by any Governmental Antitrust Entity regarding preacquisition notifications for the purpose of competition reviews). The parties shall use their foreign equivalent based on Immune Modulator owned reasonable best efforts to cause the filings under the HSR Act to be considered for grant of “early termination,” and make any further filings pursuant thereto that may be necessary, proper, or advisable in connection therewith. Parent shall be responsible for all filing fees under the HSR Act and under any such other laws or regulations applicable to Parent as well as all fees and expenses of the Company in responding to any requests for additional information. (d) If any objections are asserted with respect to the transactions contemplated hereby or the Epicor Merger Agreement under any Competition Law or if any Legal Proceeding is instituted by any Governmental Antitrust Entity or any private party challenging any of the transactions contemplated hereby or by the Epicor Merger Agreement as violative of any Competition Law, each of Parent and the Company shall at their respective cost and expense, use its reasonable best efforts to: (i) oppose or defend against any action that seeks to prevent or enjoin consummation of (x) the Merger or any other Partytransaction contemplated by this Agreement or (y) the Epicor Offer, its Affiliatesthe Epicor Merger or any other transaction contemplated by the Epicor Merger Agreement, and/or sublicensees (ii) subject to Section 7.4(e), take such action as reasonably necessary to overturn any regulatory action by any Governmental Antitrust Entity to prevent or enjoin consummation of (x) the Merger or any third party filing such NDAs and/or their foreign equivalent on behalf of such Partyother transaction contemplated by this Agreement or (y) the Epicor Offer, its Affiliatesthe Epicor Merger or any other transaction contemplated by the Epicor Merger Agreement, including by defending any Legal Proceeding brought by any Governmental Antitrust Entity in order to avoid entry of, or its sublicensees; providedto have vacated, howeveroverturned or terminated, that including by appeal if necessary, in order to resolve any such rights are subject objections or challenge as such Governmental Antitrust Entity or private party may have to the prior written consent such transactions under such Competition Law so as to permit consummation of the Person owning transactions contemplated by this Agreement and the NDA or foreign equivalent as Epicor Merger Agreement. (e) Notwithstanding the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained thereinforegoing, such Party shall notParent shall, and shall cause its Affiliates not Subsidiaries to, unreasonably withhold take all actions necessary to avoid or delay consent. In eliminate each and every impediment under any Competition Law so as to enable the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent consummation of the Person owning transactions contemplated hereby, and by the NDA or foreign equivalentEpicor Merger Agreement, such consent including the Merger, Epicor Offer and the Epicor Merger, to be at occur as soon as reasonably possible (and in any event no later than the sole discretion of such owning Person. (d) To Business Day prior to the extent not prohibited by law or regulationOutside Date), Xxxxx shall have right to have one (1) representative including: (i) attend proposing, negotiating, committing to and effecting, by consent decree, hold separate order or otherwise, the sale, divestiture or disposition of businesses, product lines or assets of Parent or its Subsidiaries (but not participate in) any material meetings between Licensee including the Surviving Corporation and any Regulatory Authority with respect to Licensed Products its Subsidiaries and (ii) listen to (but not participate in) any material telephone conversation between Licensee Epicor and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances andits Subsidiaries), (ii) terminating existing relationships, contractual rights or obligations of Parent or its Subsidiaries (including the Surviving Corporation and its Subsidiaries and Epicor and its Subsidiaries, (iii) terminating any venture or other arrangement, and (iv) otherwise taking or committing to take actions that after the extent reasonably possibleClosing Date would limit Parent’s or its Subsidiaries’ (including the Surviving Corporation’s and its Subsidiaries’ and Epicor’s and its subsidiaries’), freedom of action with respect to, or its ability to provide Xxxxxretain, at least five one or more of the businesses, product lines or assets of Parent and its Subsidiaries (5) business days before including the Surviving Corporation and its Subsidiaries and Epicor and its Subsidiaries), in each case as may be required in order to avoid the entry of, or to effect the dissolution of, any such meeting, with copies of all documents, correspondence and other materials preliminary or permanent injunction which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall would otherwise have the sole right to obtain all pricing effect of preventing the consummation of the transactions contemplated hereby and reimbursement approvals in all countries in by the Territory in which Licensed Products shall be soldEpicor Merger Agreement, including the Merger, Epicor Offer and the Epicor Merger.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers Subject to the relevant Regulatory Authorities terms and conditions of this Agreement, each Party will use its reasonable best efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary, proper or advisable under applicable Law to consummate the Merger as soon as practicable after the date hereof, including (i) preparing and filing or otherwise providing, in consultation with the other Party and as promptly as practicable and advisable after the date hereof, all documentation to effect all necessary applications, notices, petitions, filings and other documents and to obtain as promptly as reasonably practicable all waiting period expirations or terminations, consents, clearances, waivers, licenses, orders, registrations, approvals, permits and authorizations necessary or advisable to be obtained from any Governmental Entity in order to consummate the Merger, and (ii) taking all steps as may be necessary, subject to the limitations in this Section 10.04, to obtain all such waiting period expirations or terminations, consents, clearances, waivers, licenses, registrations, permits, authorizations, orders and approvals. In furtherance and not in limitation of the foregoing, each Party agrees to (x) make an appropriate filing of a Notification and Report Form pursuant to the HSR Act with respect to the Merger as promptly as practicable, and in any event within five (5) Business Days after the execution of this Agreement, and to supply as promptly as reasonably practicable and advisable any additional information and documentary materials that may be requested pursuant to the HSR Act and to take all other actions necessary Regulatory Approvals in each Major Countryto cause the expiration or termination of the applicable waiting periods under the HSR Act as soon as reasonably practicable and (y) make all other necessary or advisable filings as promptly as reasonably practicable after the date hereof, and to supply as promptly as reasonably practicable and advisable any additional information and documentary materials that may be requested under any applicable Antitrust Laws. (b) Licensee Notwithstanding anything to the contrary in this Agreement, Parent shall, and shall have cause its Affiliates to, cooperate in good faith with all Governmental Entities and undertake promptly (x) any and all actions (including cooperating and negotiating in good faith with all Governmental Entities) necessary, proper or advisable to satisfy the right conditions set forth in Sections 7.01(c), 7.01(d), 7.01(g), 7.02(c), 7.02(d) and 7.02(f) to complete lawfully the transactions contemplated by this Agreement as soon as practicable (but in any event prior to the Outside Date) and (y) any and all actions necessary, proper or advisable to avoid, prevent, eliminate or remove the actual or threatened commencement of any proceeding under any Antitrust Law in any forum by or on behalf of any Governmental Entity or the issuance of any Order that would (or to obtain Regulatory Approvalsthe agreement or consent of any Governmental Entity to the transactions contemplated hereby the absence of which would) delay, enjoin, prevent, restrain or otherwise prohibit the consummation of the transactions contemplated by this Agreement, including (i) proffering and consenting and agreeing to an Order or other agreement providing for the sale, licensing or other disposition, or the holding separate of, or other limitations or restrictions on, particular assets, categories of assets or lines of business of the Company or any of its Subsidiaries or the Parent or any of its Affiliates, (ii) promptly effecting such disposition, licensing or holding separate of assets or lines of business, in each case, at such time as may be necessary to permit the lawful consummation of the transactions contemplated hereby on or prior to the Outside Date, (iii) offering to terminate any existing relationships and contractual rights and obligations and, if the offer is accepted, promptly terminating such relationships and rights, and (iv) otherwise offering to take or offering to commit to take any action which shall it is capable of taking and, if the offer is accepted, promptly taking or committing to take such action, that limits their freedom of action with respect to any of the assets or business of the Parent or any of its Affiliates or the Company or any of its Subsidiaries, or their ability to retain any of their assets or lines of business, if any such action would not reasonably be held by expected to require the Parent and its Affiliates (including, following the Merger, the Company and its Subsidiaries) to incur or suffer costs, expenses or liabilities, or suffer diminution in the name combined value of LicenseeParent, the Company and Licensee shall own all Submissions and Data their respective Subsidiaries following the Merger, in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and an aggregate amount in excess of the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4amount set forth on Schedule 10.04(b). (c) Each Party shall have full access to of the Parent and the right Company shall, in connection with and without limiting the efforts referenced above in this Section 10.04 to reference obtain all waiting period expirations or terminations, consents, clearances, waivers, licenses, orders, registrations, approvals, permits and authorizations for the Merger under the HSR Act or any NDAs and/or their foreign equivalent based other applicable Antitrust Law, (i) cooperate in all respects and consult with each other in connection with any filing or submission and in connection with any investigation or other inquiry, including any proceeding initiated by a private party, including by allowing the other Party to have a reasonable opportunity to review in advance and comment on Immune Modulator owned by drafts of filings and submissions and reasonably considering in good faith comments of the other Party, its Affiliates(ii) promptly inform the other Party of any communication received by such Party from, and/or sublicensees or given by such Party to, the Antitrust Division of the Department of Justice (the “DOJ”), the Federal Trade Commission (the “FTC”) or any third party filing other Governmental Entity, by promptly providing copies to the other Party of any such NDAs and/or their foreign equivalent on behalf written communications, and of such Partyany communication received or given in connection with any proceeding by a private party, its Affiliatesin each case regarding any of the Transactions and (iii) permit the other Party to review in advance any communication that it gives to, and consult with each other in advance of any meeting, substantive telephone call or its sublicenseesconference with, the DOJ, the FTC or any other Governmental Entity or, in connection with any proceeding by a private party, with any other Person, and to the extent permitted by the DOJ, the FTC or other applicable Governmental Entity or other Person, give the other Party the opportunity to attend and participate in any in-person meetings, substantive telephone calls or conferences with the DOJ, the FTC or other Governmental Entity or other Person; provided, however, that such rights are subject materials required to be provided pursuant to the prior written consent foregoing clauses (i)-(iii) may be redacted (A) to remove references concerning the valuation of the Person owning Parent, the NDA Company or foreign equivalent any of their respective Subsidiaries, (B) as necessary to comply with contractual arrangements and (C) as necessary to address reasonable privilege or confidentiality concerns; provided, further, that each of the case may be Parent and the Company may, as each deems advisable and necessary, reasonably designate any competitively sensitive material provided to the other under this Section 10.04(c) as “Antitrust Counsel Only Material” which such material and the information contained therein. In therein shall be given only to the event that a Party outside antitrust 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 Parent on the one hand or the Company on the other) or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party legal counsel. (d) The Parent shall not, and shall cause its Affiliates not to, unreasonably withhold acquire (including by merger, consolidation or delay consent. In the event that acquisition of stock or assets or any other means) or publicly announce an intention to so acquire, or enter into any definitive agreements, providing for any acquisitions of, any equity interests in or a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent material portion of the assets of any Person owning the NDA (or foreign equivalent, such consent any business or division thereof) to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative any such acquisition (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority involves products and/or services which compete with respect to Licensed Products the primary products and/or services offered by the Group Companies, and (ii) listen to would reasonably be expected (but not participate inand actually does) any cause material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and additional substantive review of the relevant Regulatory Authority. Licensee will use reasonable efforts Merger under the HSR Act which prevents the conditions set forth in Section 7.01(c), Section 7.01(d) (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant related to the matters HSR Act), Section 7.01(g) (to be addressed at any such meeting or in any such telephone call the extent related to the HSR Act), Section 7.02(c), Section 7.02(d) (it being understood that in no event will to the provisions of clause (iextent related to the HSR Act) or Section 7.02(f) (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence the extent related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as HSR Act) from being satisfied prior to the regulatory strategy and decision-making for any Licensed ProductExtended Outside Date. (e) Licensee In connection with and without limiting the foregoing, in the event that the Parent requests the Company to do so, (x) the Company shall have give any notices to third parties required under any Contracts, and (y) the sole right Company shall use, and cause each of the Group Companies to use, its commercially reasonable efforts to obtain all pricing any third party consents to any Contracts, in each case of clauses of (x) and reimbursement approvals (y), that are necessary, proper or advisable to consummate the Merger and set forth on Schedule 10.04(e). Notwithstanding anything to the contrary herein, none of the Company or any of its Subsidiaries shall be required to (i) pay any consent or other fee, payment or consideration or otherwise incur any other cost, expense, obligation or Liability in all countries connection with obtaining any third party consents or (ii) make any concession or provide any security (including a guaranty) or otherwise agree to any obligations or accommodations (financial or otherwise) in connection with obtaining any third party consents (except, in the Territory in which Licensed Products case of this clause (ii), if requested by and at the expense of the Parent and subject to, and not to become effective until, the occurrence of the Closing). (f) The Parent shall be soldsolely responsible for and pay all fees payable in connection with any filing or submission under any Antitrust Law in connection with the transactions contemplated by this Agreement.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to The Debtor will, and will -------------------- cause its appropriate Affiliates to, and the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals Purchaser will, and will cause its appropriate Affiliates to, use, in each Major Country. (b) Licensee shall have the right case, reasonable efforts to obtain Regulatory Approvalsany authorizations, which shall be held by consents, orders and in approvals of any Governmental Authority necessary for the name performance of Licenseeits respective obligations under this Agreement and any of the other transaction documents, and Licensee shall own all Submissions the consummation of the transactions contemplated by this Agreement and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be transaction documents and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably will cooperate fully with each other in all reasonable respects in promptly seeking to obtain such necessary third party authorizations, consents, orders and approvals. Notwithstanding Neither the Debtor nor the Purchaser will take any action that will have the effect of delaying, impairing or impeding the receipt of any required regulatory approvals. Without limiting the generality of the foregoing, the rights granted Debtor, the Purchaser and their respective ultimate parent entities will promptly file or cause to a Party to access be filed with the FTC and reference any NDAs and/or their foreign equivalentthe DOJ, as contemplated herein, shall not extend to such Party’s sublicensees without Notification and Report Forms and documentary materials which substantially comply with the prior written consent provisions of the Person owning H-S-R Act and the NDA rules thereunder. The Debtor will pay (or foreign equivalentwill reimburse the Purchaser for) all fees associated with the filing of any such Notification and Report Forms or related materials and information (other than the fees and expenses of the Purchaser's legal, such consent financial or other professionals engaged to be at the sole discretion provide services in respect of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee filing). The Purchaser and the relevant Regulatory AuthorityDebtor will promptly file any additional information requested as soon as practicable after receipt of a request for additional information. Licensee The Purchaser and the Debtor will use reasonable efforts (i) to provide Xxxxx obtain early termination of the applicable waiting period under the H-S-R Act. The parties to this Agreement will coordinate and cooperate with one another in exchanging such information and providing such reasonable assistance as much advance notice of any may be requested in connection with such meeting or telephone call as is reasonably possible in filing. The Debtor will supply the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, Purchaser with copies of all documentscorrespondence, correspondence filings or communications (or memoranda setting forth the substance thereof) between the Debtor or its representatives, on the one hand, and the FTC, the DOJ or any other materials which are relevant to Governmental Authority or members of their respective staffs, on the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call other hand, with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant respect to this Agreement with any Regulatory Authority. Notwithstanding or the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Producttransactions contemplated by this Agreement. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Buyer and Seller shall use Commercially Reasonable Efforts each promptly apply for, and take all reasonably necessary actions to submit registration dossiers obtain or make, as applicable, all Orders and Authorizations of, and all filings with, any Governmental Entity or other Person required to be obtained or made by it for the consummation of the transactions contemplated by this Agreement. Each party shall cooperate with and promptly furnish information to the other party necessary in connection with any requirements imposed upon such other party in connection with the consummation of the transactions contemplated by this Agreement. Without limiting the generality of the foregoing, Buyer and Seller shall, as promptly as practicable and before the expiration of any relevant Regulatory Authorities legal deadline, but in no event later than 10 Business Days following the execution of this Agreement, file with respect (i) the United States Federal Trade Commission (the “FTC”) and the United States Department of Justice (“DOJ”), the notification and report form required for the transactions contemplated hereby and any supplemental information requested in connection therewith pursuant to the HSR Act, which forms shall specifically request early termination of the waiting period prescribed by the HSR Act and (ii) any other Governmental Entity, any other filings, reports, information and documentation required for the transactions contemplated hereby pursuant to any Other Antitrust Laws. Each of Seller and Buyer shall furnish to each other’s counsel such necessary information and reasonable assistance as the other may request in connection with its preparation of any filing or submission that is necessary under the HSR Act and any Other Antitrust Laws. Buyer and Seller shall each be responsible for one half of all necessary Regulatory Approvals filing and other similar fees payable in each Major Countryconnection with such filings and for any local counsel fees. (b) Licensee Each of Buyer and Seller shall use its commercially reasonable efforts to promptly obtain any clearance required under the HSR Act and any Other Antitrust Laws for the consummation of the transactions contemplated by this Agreement. Each of Buyer and Seller shall keep the other apprised of the status of any communications with, and any inquiries or requests for additional information from, the FTC and the DOJ and other Governmental Entities and shall comply promptly with any such inquiry or request. Notwithstanding the foregoing, (i) Buyer shall not be required to (A) consent to the divestiture, license or other disposition or holding separate (through the establishment of a trust or otherwise) of any of its or its Affiliates’ assets or any Purchased Assets or (B) consent to any other structural or conduct remedy or enter into any settlement or agree to any order regarding antitrust matters respecting the transactions contemplated by this Agreement and (ii) Buyer and its Affiliates shall have no obligation to contest, administratively or in court, any Order or other action of any Governmental Entity or any other Person respecting the right to obtain Regulatory Approvals, which transactions contemplated by this Agreement; provided that each of Buyer and Seller shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, both promptly respond to the extent legally possible, being DOJ or the sole contact with such Regulatory Authorities, subject FTC to the rights of Xxxxx under this Section 4.4any request for additional information. (c) Each Party Buyer and Seller shall have full access instruct their respective counsel to cooperate with each other and use commercially reasonable efforts to facilitate and expedite the right identification and resolution of any issues arising under the HSR Act and Other Antitrust Laws at the earliest practicable dates. Such commercially reasonable efforts and cooperation include, but are not limited to, counsel’s undertaking (i) to reference keep each other appropriately informed of communications from and to personnel of any NDAs and/or their foreign equivalent based on Immune Modulator owned by the Governmental Entity, and (ii) to confer with each other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf regarding appropriate contacts with and response to personnel of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonGovernmental Entity. (d) To Seller shall assist Buyer in identifying the extent not prohibited Authorizations required by law Buyer to operate and conduct the Business from and after the Closing Date and will either transfer current Business Authorizations of the Seller Group to Buyer or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible assist Buyer in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productobtaining new Authorizations. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. 6.1.1. No later than one (1) Business Day after the date hereof, Seller and Purchaser shall jointly cause to be filed by Seller's FCC counsel an application with the FCC requesting the FCC's consent to the assignment of the FCC Licenses from BCR License Sub to Nassau License Sub, which application is attached hereto at Exhibit A (the "FCC Application"). Each party shall pay its own expenses in connection with the preparation and prosecution of the FCC Application and shall share equally any filing fees associated with the FCC Application. 6.1.2. Upon the terms and subject to the conditions set forth in this Agreement, Seller and Purchaser shall each use their respective reasonable best efforts to promptly (a) Licensee take, or to cause to be taken, all actions, and to do, or to cause to be done, and to assist and cooperate with the other parties in doing all things necessary, proper or advisable under applicable Law or otherwise to consummate and make effective the transactions contemplated by this Agreement; (b) obtain from any Governmental Authority or other Person any actions, non-actions, clearances, waivers, consents, approvals, permits or Orders required to be obtained by Seller, Purchaser or any of their respective Affiliates in connection with the authorization, execution, delivery and performance of this Agreement, the consummation of the other transactions contemplated hereby and thereby and the assignment of the FCC Licenses from BCR License Sub to Nassau License Sub; (c) furnish all information required for any application or other filing to be made pursuant to any applicable Law or any applicable regulations of any Governmental Authority in connection with the transactions contemplated by this Agreement, including filings in connection with the FCC Application, and to supply promptly any additional information and documentary material that may be requested in connection with such filings or applications; (d) avoid the entry of, or have vacated or terminated, any Order that would restrain, prevent or delay the Closing or the FCC Order, including defending against and opposing any lawsuits or other proceedings (including any FCC reconsideration or review), whether judicial or administrative, reviewing or challenging this Agreement, the consummation of the other transactions contemplated hereby and thereby or the assignment of the FCC Licenses from BCR License Sub to Nassau License Sub; and (e) execute and deliver any additional instruments necessary to assign the FCC Licenses from BCR License Sub to Nassau License Sub or to consummate any other transactions contemplated by this Agreement. No party to this Agreement shall use Commercially Reasonable Efforts consent to submit registration dossiers any voluntary delay of the assignment of the FCC Licenses from BCR License Sub to Nassau License Sub or the relevant Regulatory Authorities consummation of the other transactions contemplated hereby at the behest of any Governmental Authority or other Person without the consent of the other party, which consent shall not be unreasonably withheld, conditioned or delayed. Without limiting this Section 6.1.2, Purchaser agrees to take any and all steps and to make any and all undertakings necessary to (i) avoid or eliminate each and every impediment under any antitrust, merger control, competition, or trade regulation Law, including the Communications Act, that may be asserted by any Governmental Authority with respect to consummation of the transactions contemplated by this Agreement and (ii) resolve any objection that may be asserted by the FCC or any other Person in order to obtain promptly the FCC Order or satisfy or comply with any conditions imposed by the FCC Order, in all necessary Regulatory Approvals events so as to enable the Closing to occur as soon as reasonably possible, including proposing, negotiating, committing to, and effecting by consent decree, hold separate order, or otherwise, the sale, divestiture, licensing or disposition of such assets of Purchaser or any of its Affiliates (including any FCC license held by such persons) or otherwise taking or committing to take actions that limit Purchaser's or its Affiliates' freedom of action with respect to, or their ability to retain, any of their assets, in each Major Countrycase, as may be required in order to obtain the FCC Order or avoid the entry of, or to effect the dissolution of, any injunction, temporary restraining order, or other Order in any suit or proceeding, which would otherwise have the effect of preventing or delaying the Closing. Purchaser covenants that prior to the Closing, no changes shall be made in the direct or indirect ownership structure of Nassau License Sub, except for such changes that would not delay (A) the processing by the FCC of the FCC Application, and/or (B) the prompt issuance of the FCC Order. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and 6.1.3. Notwithstanding anything in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, this Agreement to the extent legally possiblecontrary, being if the sole contact with such Regulatory AuthoritiesClosing occurs before the FCC Order becomes a Final Order, subject to the rights terms of Xxxxx under this Section 4.4. (c) Each Party 6.1.2 shall have full access to and survive the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by Closing until the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesFCC Order becomes a Final Order; provided, however, that such rights are subject terms shall only survive as applied to actions relating to the prior written consent obtaining of the Person owning the NDA or foreign equivalent as the case may be FCC Order and any information contained thereinsuch FCC Order becoming a Final Order. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent No assignment of the Person owning FCC Licenses shall occur prior to obtaining the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonFCC Order. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Each of Purchaser, the Company and the Selling Stockholder (if necessary) shall use Commercially Reasonable Efforts (a) make or cause to submit registration dossiers to be made all filings (including the relevant Regulatory Authorities Foreign Filings) required of each of them or any of their respective Subsidiaries or Affiliates under the HSR Act or other Antitrust Laws with respect to the transactions contemplated hereby as promptly as practicable and, in any event, within ten (10) Business Days after the date of this Agreement in the case of all necessary Regulatory Approvals filings required under the HSR Act and, if practicable, within fifteen (15) Business Days in the case of all other filings (including the Foreign Filings) required by other Antitrust Laws, (b) comply at the earliest practicable date with any request under the HSR Act or other Antitrust Laws for additional information, documents, or other materials received by each Major Countryof them or any of their respective subsidiaries or Affiliates from the FTC, the Antitrust Division or any other Governmental Body in respect of such filings or such transactions, and (c) cooperate with each other in connection with any such filing (including, to the extent permitted by applicable law, providing copies of all such documents to the non-filing parties prior to filing and considering all reasonable additions, deletions or changes suggested in connection therewith) and in connection with resolving any investigation or other inquiry of any of the FTC, the Antitrust Division or other Governmental Body under any Antitrust Laws with respect to any such filing or any such transaction. Each such party shall furnish to each other all information required for any application or other filing to be made pursuant to any applicable Law in connection with the transactions contemplated by this Agreement. Each such party shall promptly inform the other parties hereto of any oral communication with, and provide copies of written communications with, any Governmental Body regarding any such filings or any such transaction. No party hereto shall independently participate in any formal meeting with any Governmental Body in respect of any such filings, investigation, or other inquiry without giving the other parties hereto prior notice of the meeting and, to the extent permitted by such Governmental Body, the opportunity to attend and/or participate. Subject to applicable Law, the parties hereto will consult and cooperate with one another in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto relating to proceedings under the HSR Act or other Antitrust Laws. Any party may, as it deems advisable and necessary, reasonably designate any competitively sensitive material provided to the other parties under this Section 8.4 as “outside counsel only.” Such materials 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 written permission is obtained in advance from the source of the materials. (b) Licensee Each of Purchaser and the Company shall have use its reasonable best efforts to resolve such objections, if any, as may be asserted by any Governmental Body with respect to the right to obtain Regulatory Approvalstransactions contemplated by this Agreement under the HSR Act, which shall be held by and in the name of LicenseeXxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the Federal Trade Commission Act, as amended, and Licensee shall own all Submissions and Data in any other United States federal or state or foreign statutes, rules, regulations, orders, decrees, administrative or judicial doctrines or other laws that are designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade (collectively, the “Antitrust Laws”). In connection therewith. All pricing, formulary if any Legal Proceeding is instituted (or threatened to be instituted) challenging any transaction contemplated by this Agreement as in violation of any Antitrust Law, each of Purchaser and marketing approvals the Company shall also be obtained by cooperate and in the name of Licenseeuse its reasonable best efforts to contest and resist any such Legal Proceeding, and Licensee will be to have vacated, lifted, reversed, or overturned any decree, judgment, injunction or other order whether temporary, preliminary or permanent, that is in effect and that prohibits, prevents or restricts consummation of the principal interface transactions contemplated by this Agreement, including by pursuing all available avenues of administrative and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingjudicial appeal, to the extent legally possibleunless by mutual agreement, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to Purchaser and the right Company decide that litigation is not in their respective best interests. Each of Purchaser and the Company shall use commercially reasonable efforts to reference take such action as may be required to cause the expiration of the notice periods under the HSR Act or other Antitrust Laws with respect to such transactions as promptly as possible after the execution of this Agreement. In connection with and without limiting the foregoing, each of Purchaser and the Company agree to use reasonable best efforts to take promptly steps necessary to avoid or eliminate any NDAs and/or their foreign equivalent based on Immune Modulator owned impediment under any Antitrust Laws that may be asserted by any federal, state and local and non-United States antitrust or competition authority, so as to enable the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesparties to close the transactions contemplated by this Agreement as expeditiously as possible; provided, however, that such rights are subject in no event shall Purchaser be required to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect effect or commit to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and effect, by consent decree, hold separate orders, trust or otherwise, the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice sale or disposition of any such meeting of the assets or telephone call as is reasonably possible in the circumstances andbusinesses of Purchaser or its Affiliates, (ii) otherwise take any action that limits the freedom of action of Purchaser or any of its Affiliates with respect to, or its respective ability to the extent reasonably possibleretain, to provide Xxxxxany of its businesses, at least five (5) business days before any such meetingproduct lines, with copies or assets or those of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) its Affiliates or (iiiii) propose or accept the imposition of this sentence require Licensee to delay any meeting conditions on Purchaser or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productits Affiliates. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee If legally required, Purchaser and Sellers shall use Commercially Reasonable Efforts (a) make or cause to submit registration dossiers to be made all filings required of each of them or any of their respective subsidiaries or Affiliates under the relevant Regulatory Authorities HSR Act or other Antitrust Laws (as defined below) with respect to the transactions contemplated hereby as promptly as practicable after the date of this Agreement, (b) comply at the earliest practicable date with any request under the HSR Act or other Antitrust Laws for additional information, documents, or other materials received by each of them or any of their respective subsidiaries from the FTC, the Antitrust Division or any other Governmental Body in respect of such filings or such transactions, and (c) cooperate with each other in connection with any such filing and in connection with resolving any investigation or other inquiry of any of the FTC, the Antitrust Division or other Governmental Body under any Antitrust Laws with respect to any such filing or any such transaction. Each such party shall use its commercially reasonable efforts to furnish to each other all necessary Regulatory Approvals information required for any application or other filing to be made pursuant to any applicable Law in each Major Countryconnection with the transactions contemplated by this Agreement. Each such party shall promptly inform the other parties hereto of any oral communication with, and provide copies of written communications with, any Governmental Body regarding any such filings or any such transaction. No party hereto shall independently participate in any formal meeting with any Governmental Body in respect of any such filings, investigation, or other inquiry without giving the other parties hereto prior notice of the meeting and, to the extent permitted by such Governmental Body, the opportunity to attend and/or participate. (b) Licensee If a filing under the HSR Act is legally required, Purchaser and Sellers shall have use commercially reasonable efforts to take such action as may be required to cause the right to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent expiration of the Person owning notice periods under the NDA HSR Act or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority other Antitrust Laws with respect to Licensed Products such transactions as promptly as possible after the execution of this Agreement. Purchaser and (ii) listen Sellers shall use commercially reasonable efforts to (but not participate in) resolve such objections, if any, as may be asserted by any material telephone conversation between Licensee and any Regulatory Authority Governmental Body with respect to Licensed Products the transactions contemplated by this Agreement under the HSR Act, the Xxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the Federal Trade Commission Act, as amended, and any other United States federal or state or foreign statutes, rules, regulations, orders, decrees, administrative or judicial doctrines or other laws that are designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade (collectively, the “Antitrust Laws”). In connection therewith, if any Legal Proceeding is instituted (or threatened to be instituted) challenging any transaction contemplated by this Agreement as in violation of any Antitrust Law, Purchaser and Sellers shall cooperate and use commercially reasonable efforts to contest and resist any such Legal Proceeding, and to have vacated, lifted, reversed, or overturned any decree, judgment, injunction or other order whether temporary, preliminary or permanent, that is pre-scheduled between Licensee in effect and that prohibits, prevents, or restricts consummation of the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice transactions contemplated by this Agreement, including by pursuing all available avenues of any such meeting or telephone call as administrative and judicial appeal and all available legislative action, unless, by mutual agreement, Purchaser and Tamtron decide that litigation is reasonably possible not in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Producttheir respective best interests. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee So long as any Loan or any other Obligation shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in remain unpaid, each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory AuthoritiesGrantor, subject to the rights of Xxxxx the Senior Lenders as set forth in SECTION 31 hereof, shall promptly, and at its expense, execute and deliver, or cause to be executed and delivered, all applications, certificates, instruments, registration statements and all other documents the Collateral Agent may reasonably request and as may be required by law in connection with the obtaining of any consents from the FCC or any state authorities or the consent, approval, registration, qualification or authorization of any other Person necessary or deemed by the Collateral Agent to be appropriate for the effective exercise of any of its rights under this Section 4.4. (c) Each Party Security Agreement. Without limiting the generality of the foregoing, if an Event of Default shall have full access to occurred and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Partybe continuing, its Affiliateseach Grantor, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written rights of the Senior Lenders as set forth in SECTION 31 hereof, shall take any action which the Collateral Agent may reasonably request in order to transfer and assign to the Collateral Agent, or to such one or more third parties as the Collateral Agent may designate, or to a combination of the foregoing, each FCC License, State License or other Government Approval of such Grantor. To enforce the provisions of this Section 12, upon the occurrence and during the continuance of an Event of Default, the Collateral Agent, subject to the rights of the Senior Lenders as set forth in SECTION 31 hereof, is empowered to request the appointment of a receiver from any court of competent jurisdiction. Such receiver shall be instructed to seek from the FCC or other Governmental Authority an involuntary transfer of control of each such FCC License, State License or other Governmental Approval for the purpose of seeking a bona fide purchaser to whom control will ultimately be transferred. Each Grantor hereby agrees to authorize such an involuntary transfer of control upon the request of the receiver so appointed, and, if such Grantor shall refuse to authorize the transfer, its approval may be required by the court. Upon the occurrence and continuance of an Event of Default, such Grantor shall further use its reasonable best efforts to assist in obtaining the consent of the Person owning FCC or any state authority or other governmental approvals, if required, for any action or transaction contemplated by this Security Agreement, including, without limitation, the NDA preparation, execution and filing with the FCC or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner other governmental authority of such NDA Grantor's portion of any necessary or foreign equivalent as appropriate application for the case may be approval of the transfer or information contained thereinassignment of any portion of the assets (including any FCC Licenses, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold State Licenses or delay consent. In the event that a third party is the owner other Governmental Approval) of such NDA or foreign equivalent or information contained therein, Grantor. Because each Grantor agrees that the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be Collateral Agent's remedy at the sole discretion law for failure of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right Grantor to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority comply with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) this Section 12 would be inadequate and that such failure would not be adequately compensable in damages, such Grantor agrees that the covenants contained in this Section 12 may be specifically enforced, and such Grantor hereby waives and agrees not to assert any defenses against an action for specific performance of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsuch covenants. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers Xxxxxxxx and LMP shall, as promptly as practicable following the Effective Date, file with the United States Federal Trade Commission (the “FTC”) and the United States Department of Justice (the “DOJ”), the notification and report form required from each of Xxxxxxxx and LMP for the transactions contemplated by this Agreement and any supplemental information requested in connection therewith pursuant to the relevant Regulatory Authorities HSR Act, which forms shall specifically request early termination of the waiting period prescribed by the HSR Act. Each of Xxxxxxxx and LMP shall furnish to each other’s counsel such necessary information and reasonable assistance as the other may request in connection with respect to its preparation of any filing or submission that is necessary under the HSR Act. The Parties agree that LMP, on the one hand, and Xxxxxxxx, on the other hand, shall each be responsible for 50% of any and all necessary Regulatory Approvals filing fees payable in each Major Countryconnection with the foregoing filings. (b) Licensee Xxxxxxxx and LMP shall have use their respective commercially reasonable efforts to promptly obtain any clearance required under the right HSR Act for the consummation of the transactions contemplated by this Agreement and shall keep each other apprised of the status of any communications with, and any inquiries or requests for additional information from any Governmental Authority and shall comply promptly with any such inquiry or request. LMP and Xxxxxxxx shall use their commercially reasonable efforts to obtain Regulatory Approvalsany necessary approval from any Government Authority under the HSR Act. Notwithstanding anything contained in this Agreement to the contrary, which neither LMP nor Xxxxxxxx nor any of their Subsidiaries or other Affiliates shall be held by and in obligated to do any of the name following: (i) dispose or transfer any asset other than pursuant to this Agreement; (ii) license or otherwise make available to any Person any technology or other intellectual property rights; (iii) hold separate any assets or operations (either before or after the applicable Closing Date); or (iv) change or modify any course of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will conduct or otherwise handle all interactions with Regulatory Authorities concerning make any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4commitment regarding future operations. (c) Each Party shall have full access The Parties commit to instruct their respective counsel to cooperate with each other and use commercially reasonable efforts to facilitate and expedite the right identification and resolution of any issues arising under the HSR Act at the earliest practicable dates. Such commercially reasonable efforts and cooperation include counsel’s undertaking (i) to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by keep each other appropriately informed of communications from and to personnel of the reviewing Governmental Authority, and (ii) to confer with each other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf regarding appropriate contacts with and response to personnel of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonGovernmental Authority. (d) To Each of LMP and Xxxxxxxx shall use its reasonable best efforts to “substantially comply” as promptly as practicable with any request for additional information or documentary material issued by a Governmental Authority under 15 U.S.C. Sec 18(e) and in conjunction with the extent not prohibited by law or regulation, Xxxxx shall have right Contemplated Transactions (a “Second Request”). Each of LMP and Xxxxxxxx will certify to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority substantial compliance with respect thereto as promptly as practicable. Each of LMP and Xxxxxxxx agrees to Licensed Products take all reasonable steps to assert, defend, and support certification of substantial compliance with any Second Request. Each of LMP and Xxxxxxxx agrees to give such advance notices as may be required (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance including, if necessary, notice of any such meeting or telephone call as is an anticipated Closing Date), and to otherwise reasonably possible in the circumstances and, (ii) cooperate to give effect to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies rights of all documents, correspondence and the other materials which are relevant to the matters to be addressed at any such meeting or set forth in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductSection 6.20. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers The Company, Parent, R1 and Merger Sub will, as promptly as practicable and no later than ten (10) Business Days following the date of this Agreement, file with the United States Federal Trade Commission and the United States Department of Justice, the notification form required pursuant to the relevant Regulatory Authorities HSR Act for the Transactions, which form will specifically request early termination of the waiting period prescribed by the HSR Act. The Company, Parent, R1 and Merger Sub will use reasonable best efforts to make all other necessary filings with respect such Governmental Entities as promptly as practicable following the date of this Agreement. Each of the Company, Parent, R1 and Merger Sub will furnish to each other’s counsel such necessary information and reasonable assistance as the other may request in connection with its preparation of any filing or submission that is necessary under the HSR Act and will provide any supplemental information requested by any Governmental Entity as promptly as practicable. The Company, Parent, R1 and Merger Sub will use all necessary Regulatory Approvals reasonable best efforts to comply as promptly as practicable with any requests made for any additional information in each Major Countryconnection with such filings. All fees and expenses in connection with any filing pursuant to the HSR Act, Competition Laws or any application or filing before a Governmental Entity shall be borne by Parent and R1. (b) Licensee shall Subject to the immediately following sentence, the Company, Parent, R1 and Merger Sub will use their reasonable best efforts to promptly obtain any clearance required under the HSR Act for the consummation of the Transactions and will keep each other apprised of the status of any communications with, and any inquiries or requests for additional information from, any Governmental Entity and will comply as promptly as practicable with any such inquiry or request. Parent, R1 and Merger Sub will use their respective reasonable best efforts to avoid or eliminate each and every impediment under the HSR Act that may be asserted by any Governmental Entity so as to enable the parties to close the Transactions by no later than the Outside Date, including but not limited to (i) proposing, negotiating, committing to or effecting, by consent decree, hold separate order or otherwise, the sale, divestiture or disposition of its assets, properties or businesses or of the assets, properties or businesses to be acquired, and the entrance into such other arrangements, as necessary or advisable in order to avoid the entry of, and the commencement of 57 litigation seeking the entry of, or to effect the dissolution of, any injunction or other order in any suit or proceeding which would otherwise have the right effect of materially delaying or preventing the consummation of the Transactions; (ii) opposing or defending through completion of litigation on the merits any claim, Action, suit, investigation or other proceeding brought by any Governmental Entity or other Person challenging the Transactions under any Law, including any such action as reasonably necessary to appeal and overturn any Order preventing or enjoining the Transactions; and (iii) agreeing to such limitations on conduct or actions of members of Parent, R1 and their Affiliates after the Closing as may be required in order to obtain Regulatory Approvals, which shall be held by and satisfaction of the closing conditions set forth in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, Section 7.01 prior to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicenseesOutside Date; provided, however, that such rights are subject notwithstanding the foregoing or anything in this Agreement to the contrary, in no event shall Parent, R1 or any of their respective Affiliates be required to, nor shall the Company or any of its Affiliates, without prior written consent of Parent, take any actions under this paragraph if such actions would result in a material adverse effect, as measured on the Person owning Company. (c) The parties hereto commit to instruct their respective counsel to cooperate with each other and use reasonable best efforts to facilitate and expedite the NDA or foreign equivalent as identification and resolution of any issues arising under the case may be HSR Act at the earliest practicable dates. Such reasonable best efforts and cooperation include counsel’s undertaking (i) to keep each other appropriately informed of material communications from and to personnel of the reviewing Governmental Entities in connection with the Transactions and (ii) to confer with each other regarding appropriate contacts with and to the extent practicable, consult with the others prior to any information contained therein. In the event that a Party or its Affiliates is the owner response to personnel of such NDA Governmental Entities in respect of any filings, applications, investigation or foreign equivalent as other inquiry concerning the case may be Transactions and the content of any such contacts or information contained thereinpresentations. The Company, Parent, R1 and Merger Sub will, to the extent practicable, consult with the other parties prior to any meeting or discussion with any Governmental Entity with respect of any such Party shall notfilings, applications, investigation or other inquiry, and shall cause its Affiliates not towill give the other party prior notice of the meeting or discussion and, unreasonably withhold or delay consent. In to the event that a third party is extent permitted by the owner of such NDA or foreign equivalent or information contained thereinrelevant Governmental Entity, the Parties agree opportunity to reasonably cooperate attend and participate in such meeting or discussion (which, at the request of either Parent or the Company, will be limited to obtain such necessary third party consentsoutside antitrust counsel only). Notwithstanding Each of Parent and the foregoingCompany will have the right to review (subject to appropriate redactions for confidentiality and attorney-client privilege concerns) and approve the content of any presentations, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior white papers or other written consent of the Person owning the NDA or foreign equivalent, such consent materials to be at the sole discretion submitted to any Governmental Entity in advance of any such owning Personsubmission. (d) To Prior to the extent Closing, Parent and Merger Sub will not, and will not prohibited permit any of their respective Subsidiaries to, acquire or agree to acquire (by law merging or regulationconsolidating with, Xxxxx shall have right or by purchasing a substantial portion of the assets of or equity in, or by any other manner), any Person or portion thereof, or otherwise acquire or agree to have one (1) representative acquire any assets, if the entering into a definitive agreement relating to, or the consummation of, such acquisition, merger or consolidation would reasonably be expected to (i) attend (but not participate in) impose any material meetings between Licensee and delay in the obtaining of, or materially increase the risk of not obtaining, any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice permits, orders or other approvals of any such meeting Governmental Entity necessary to consummate the Transactions or telephone call as is reasonably possible in the circumstances andexpiration or termination of any applicable waiting period, (ii) to increase the extent reasonably possible, to provide Xxxxx, at least five (5) business days before risk of any such meeting, with copies Governmental Entity entering an order prohibiting the consummation of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) Transactions or (iiiii) delay the consummation of this sentence require Licensee the Transactions to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding date later than the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductOutside Date. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Each of Purchaser and Seller shall use Commercially Reasonable Efforts commercially reasonable efforts to submit registration dossiers (i) make or cause to be made all filings required of each of them or any of their respective Subsidiaries or Affiliates under the relevant Regulatory Authorities HSR Act or other Antitrust Laws with respect to the transactions contemplated hereby as promptly as practicable and, in any event, within ten days after the date of this Agreement, (ii) comply at the earliest practicable date with any request under the HSR Act or other Antitrust Laws for additional information, documents, or other materials received by each of them or any of their respective Subsidiaries from the FTC, the Antitrust Division or any other Governmental Body in respect of such filings or such transactions and (iii) cooperate with each other in connection with any such filing (including, to the extent permitted by applicable Law, providing copies of all necessary Regulatory Approvals such documents to the non-filing parties prior to filing and considering all reasonable additions, deletions or changes suggested in connection therewith) and in connection with resolving any investigation or other inquiry of any of the FTC, the Antitrust Division or other Governmental Body under any Antitrust Laws with respect to any such filing or any such transaction. Each of Purchaser on the one hand and Seller on the other hand shall be responsible for and shall pay one-half of all filing fees for required filings under the HSR Act. Each such party shall use commercially reasonable efforts to furnish to each Major Countryother all information required for any application or other filing to be made pursuant to any applicable Law in connection with the transactions contemplated by this Agreement. Each such party shall promptly inform the other parties hereto of any oral communication with, and provide copies of written communications with, any Governmental Body regarding any such filings or any such transaction. Subject to applicable Law, no party hereto shall independently participate in any formal meeting with any Governmental Body in respect of any such filings, investigation, or other inquiry without giving the other parties hereto prior notice of the meeting and, to the extent permitted by such Governmental Body, the opportunity to attend and/or participate. Subject to applicable Law, the parties hereto will consult and cooperate with one another in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto relating to proceedings under the HSR Act or other Antitrust Laws. (b) Licensee Each of Purchaser and Seller shall use commercially reasonable efforts to resolve such objections, if any, as may be asserted by any Governmental Body with respect to the transactions contemplated by this Agreement under the HSR Act, the Xxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the Federal Trade Commission Act, as amended, and any other United States federal or state or foreign statutes, rules, regulations, orders, decrees, administrative or judicial doctrines or other laws that are designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade (collectively, the “Antitrust Laws”). In connection therewith, if any Legal Proceeding is instituted (or threatened to be instituted) challenging any transaction contemplated by this Agreement as in violation of any Antitrust Law, Seller shall use commercially reasonable efforts, and Purchaser shall cooperate with Seller and its Affiliates, to contest and resist any such Legal Proceeding, and to have vacated, lifted, reversed, or overturned any decree, judgment, injunction or other order whether temporary, preliminary or permanent, that is in effect and that prohibits, prevents, or restricts consummation of the right transactions contemplated by this Agreement, including by pursuing all available avenues of administrative and judicial appeal and all available legislative action, unless, by mutual agreement, Purchaser and Seller decide that litigation is not in their respective best interests. Each of Purchaser and Seller shall use commercially reasonable efforts to obtain Regulatory Approvalstake such action as may be required to cause the expiration of the notice periods under the HSR Act or other Antitrust Laws with respect to such transactions as promptly as possible after the execution of this Agreement. Notwithstanding anything to the contrary provided herein, which neither Purchaser nor any of its Affiliates shall be held required (i) to hold separate (including by and trust or otherwise) or divest any of its businesses, product lines or assets, or any of the Purchased Assets, (ii) to agree to any limitation on the operation or conduct of NetBank Finance, or any of Purchaser’s business or operations, or (iii) to waive any of the conditions to this Agreement set forth in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.49.1. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding Without limiting the foregoing, Seller and Purchaser shall cooperate with the rights granted other and use their commercially reasonable efforts to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative promptly: (i) attend (but not participate in) any material meetings between Licensee file applications and any Regulatory Authority notices, as applicable, with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee the OTS under the Bank Merger Act, the Home Owners’ Loan Act, as amended, and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any regulations promulgated thereunder, and obtain approval of, or non-objection to, such meeting or telephone call as is reasonably possible in the circumstances andapplications and notices, (ii) file any required applications or notices with any foreign or state banking, insurance or other Regulatory Authorities and obtaining approval of such applications and notices, (iii) make any notices to or filings with the extent reasonably possibleSmall Business Administration, to provide Xxxxx(iv) make any notices or filings under the HSR Act, at least five and (5v) business days before make any such meetingfilings with and obtain any consents and approvals in connection with compliance with the applicable provisions of the rules and regulations of any applicable industry self-regulatory organization, with copies of all documentsor that are required under consumer finance, correspondence mortgage banking and other materials which are relevant to similar Laws (collectively, the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a “Regulatory AuthorityConsents”). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Each of Acquiror and the Company shall use Commercially Reasonable its Best Efforts to submit registration dossiers (i) make or cause to be made all filings required of each of them or any of their respective Subsidiaries or Affiliates under the relevant Regulatory Authorities HSR Act or other Antitrust Laws with respect to the transactions contemplated hereby as promptly as practicable and, in any event, within ten (10) days after the date of this Agreement, (ii) comply at the earliest practicable date with any request under the HSR Act or other Antitrust Laws for additional information, documents, or other materials received by either of them or any of their respective Subsidiaries or Affiliates from the FTC, the Antitrust Division of the Department of Justice (the “Antitrust Division”) or any other Governmental Authority in respect of such filings or such transactions, and (iii) cooperate with each other in connection with any such filing (including, to the extent permitted by applicable Law, providing copies of all necessary Regulatory Approvals such documents to the non-filing parties prior to filing and considering all reasonable additions, deletions or changes suggested in connection therewith) and in connection with resolving any investigation or other inquiry of any of the FTC, the Antitrust Division or other Governmental Authority under any Antitrust Laws with respect to any such filing or any such transaction. Acquiror shall be responsible for all filing fees and legal and other expenses, including those of the Company associated with the required filings under the HSR Act; provided, however, in the event of a second request by the FTC, the Antitrust Division or any other Governmental Authority in respect of such filings, all expenses incurred in connection with responding to such requests shall be borne by the party incurring such expenses. Each such party shall use its Best Efforts to furnish to each Major Countryother in a timely manner all information required for any application or other filing to be made pursuant to any applicable law in connection with the transactions contemplated by this Agreement. Each such party shall promptly inform the other parties hereto of any oral communication with, and provide copies of written communications with, any Governmental Authority regarding any such filings or any such transaction and permit the other party to review in advance any proposed communication by such party to any Governmental Authority. No party hereto shall independently participate in any formal meeting with any Governmental Authority in respect of any such filings, investigation, or other inquiry without giving the other parties hereto prior notice of the meeting and, to the extent permitted by such Governmental Authority, the opportunity to attend and/or participate. Subject to applicable Law, the parties hereto shall consult and cooperate with one another in connection with the matters described in this Section 6.05, including in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto relating to proceedings under the HSR Act or other Antitrust Laws. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name Each of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to Acquiror and the right Company shall use its Best Efforts to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Partyresolve such objections, its Affiliatesif any, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and asserted by any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Governmental Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee the transactions contemplated by this Agreement under the HSR Act, the Sxxxxxx Act, as amended, the Cxxxxxx Act, as amended, the Federal Trade Commission Act, as amended, and any Regulatory Authority other Laws that are designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade (collectively, the “Antitrust Laws”). In connection therewith, if any Legal Proceeding is instituted (or threatened to be instituted) challenging any transaction contemplated by this Agreement as in violation of any Antitrust Law, the Company and Acquiror shall use their Best Efforts to contest and resist any such Legal Proceeding, and to have vacated, lifted, reversed or overturned any decree, judgment, injunction or other order whether temporary, preliminary or permanent, that is in effect and that prohibits, prevents or restricts consummation of the transactions contemplated by this Agreement, unless, by mutual agreement, Acquiror and the Company decide that litigation is not in their respective best interests. Each of Acquiror and the Company shall use its Best Efforts to take such action as may be required to cause the expiration of the notice periods under the HSR Act or other Antitrust Laws with respect to Licensed Products that is pre-scheduled between Licensee and such transactions as promptly as possible after the relevant Regulatory Authorityexecution of this Agreement. Licensee will use reasonable efforts Notwithstanding anything to the contrary provided herein, neither Acquiror or the Company nor any of their respective Affiliates shall be required, in connection with the matters covered by this Section 6.05, (i) to provide Xxxxx with as much advance notice pay any amounts (other than the payment of any such meeting or telephone call as is reasonably possible in the circumstances andfiling fees and expenses and fees of counsel, accountants and other advisors and experts), (ii) to the extent reasonably possiblecommence litigation (as opposed to defend litigation), to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (iiiii) to waive any of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant the conditions to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productset forth in ARTICLE VII. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. Subject to Section 2(b), promptly, and at its expense, execute and deliver, or cause to be executed and delivered, all applications, certificates, instruments, registration statements, and all other documents and papers the Collateral Agent may reasonably request (ait being understood that the Collateral Agent shall not be required to make any such request unless directed by the Required Secured Parties) Licensee shall use Commercially Reasonable Efforts or as may be required by law to submit registration dossiers acquire any Governmental Approval or the consent, approval, registration, qualification or authorization of any other Person deemed necessary or appropriate for the effective exercise of any of the rights under this Security Agreement. Without limiting the generality of the foregoing and subject to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee Intercreditor Agreement, if an Event of Default shall have occurred and be continuing, each Obligor shall take any action which may be necessary or as the right Collateral Agent may reasonably request (it being understood that the Collateral Agent shall not be required to obtain Regulatory Approvalsmake any such request unless directed by the Required Secured Parties) in order to transfer and assign to the Collateral Agent, which shall be held by and in or to such one or more third parties as the name Collateral Agent may designate, or to a combination of Licenseethe foregoing, and Licensee shall own all Submissions and Data in connection therewitheach Government Approval of such Obligor. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingIn addition, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned required by the other PartyCollateral Agent, each Obligor agrees to execute any document or instrument, and to take any action, necessary under applicable law (including the Federal Assignment of Claims Act) in order for the Collateral Agent to exercise its Affiliates, and/or sublicensees rights and remedies (or to be able to exercise its rights and remedies at some future date) with respect to any third party filing such NDAs and/or their foreign equivalent on behalf Accounts of such Party, its Affiliates, or its sublicenseesObligor where the account debtor is a Governmental Authority; provided, however, that unless an Event of Default has occurred and is continuing, the Collateral Agent shall hold in escrow all documents and instruments executed by the Obligors to comply with the terms of the Federal Assignment of Claims Act and comparable state law and shall not file such rights are documents and instruments with any Governmental Authority. To enforce the provisions of this subsection, upon the occurrence and during the continuance of an Event of Default, subject to the prior written consent Intercreditor Agreement, the Collateral Agent is empowered to request the appointment of a receiver from any court of competent jurisdiction. Such receiver shall be instructed to seek from the Governmental Authority an involuntary transfer of control of each such Governmental Approval for the purpose of seeking a bona fide purchaser to whom control will ultimately be transferred. Each Obligor hereby agrees to authorize such an involuntary transfer of control upon the request of the Person owning receiver so appointed, and, if such Obligor shall refuse to authorize the NDA or foreign equivalent as the case transfer, its approval may be required if so ordered by such court. Subject to the Intercreditor Agreement, upon the occurrence and continuance of an Event of Default, such Obligor shall further use its reasonable best efforts to assist in obtaining Governmental Approvals, if required, for any information contained therein. In action or transaction contemplated by this Security Agreement, including, without limitation, the event that a Party or its Affiliates is preparation, execution and filing with the owner Governmental Authority of such NDA Obligor’s portion of any necessary or foreign equivalent as appropriate application for the case may be approval of the transfer or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In assignment of any portion of the event that a third party is the owner assets (including any Governmental Approval) of such NDA or foreign equivalent or information contained therein, Obligor. Because each Obligor agrees that the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such PartyCollateral Agent’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be remedy at the sole discretion law for failure of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right Obligor to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority comply with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to subsection would be inadequate and that such failure would not be adequately compensable in damages, such Obligor agrees that the covenants contained in this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsubsection may be specifically enforced. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Each of the parties hereto shall cooperate and use Commercially Reasonable Efforts their respective reasonable best efforts to submit registration dossiers take, or cause to be taken, all action, and to do, or cause to be done as promptly as practicable, all things necessary, proper and advisable under applicable Laws, to consummate and make effective as promptly as practicable the Transactions, including providing any notices to any Person required in connection with the consummation of the Transactions, and obtaining any licenses, consents, waivers, approvals, authorizations, qualifications and Governmental Orders necessary to consummate the Transactions (including the FCA Approval and the CBI Approval); provided, that in no event shall any party be required to pay any material fee, penalty or other consideration to obtain any license, Permit, consent, approval, authorization, qualification or waiver required under any Contract for the consummation of the Transactions (other than fees or expenses payable to the relevant Regulatory Authorities SEC in connection with respect the Transactions, including the Proxy Statement / Prospectus, filing fees payable pursuant to all the HSR Act or other Antitrust Laws, and any other ordinary course filing fees in connection with Governmental Filings required to consummate the Transactions). Subject to appropriate confidentiality protections and applicable Antitrust Laws, each party hereto shall furnish to the other parties such necessary Regulatory Approvals information and reasonable assistance as such other party may reasonably request in each Major Countryconnection with the foregoing. (b) Licensee shall have the right FTAC agrees that each Sponsor Person required to obtain Regulatory Approvals, which shall be held by FCA Approval and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees / or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated hereinCBI Approval, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of make any such meeting or telephone call as is reasonably possible in notification (the circumstances and, (ii“Change of Control Notification”) to the extent reasonably possible, to provide Xxxxx, at least five FCA and / or CBI as promptly as practicably (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Product. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.within five

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities Other than with respect to the Competition Act Approval, which shall be governed by Section 4.6, as soon as reasonably practicable following the date of this Agreement, the Parties shall prepare and file all necessary documents, registrations, statements, petitions, filings and applications for all necessary Regulatory Approvals in each Major Countryand use commercially reasonable efforts to obtain and maintain all such Regulatory Approvals. (b) Licensee shall have Other than with respect to the right to obtain Regulatory ApprovalsCompetition Act Approval, which shall be held governed by Section 4.6, the Party responsible at Law for obtaining a Regulatory Approval shall be the Party to make the filing to obtain such approval (or any remedy or change thereto) but will do so only once each Party hereto has reviewed any filing and has had the opportunity to provide comment on it and any statement in any application that creates an obligation on a Party must have the consent of that Party before it is included in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4application. (c) Each Party Subject to any applicable Law, the Parties shall have full access cooperate with and keep one another fully informed as to the status of and the right processes and proceedings related to reference obtaining the Regulatory Approvals, and shall promptly notify each other of any NDAs and/or their foreign equivalent based on Immune Modulator owned communication from any Governmental Authority in respect of the Arrangement, this Agreement or the transactions contemplated hereby and respond as promptly as reasonably possible to any inquiries or requests received from a Governmental Authority in respect of any Regulatory Approval; and shall not make any submissions or filings, participate in any substantive meetings, conversations or correspondence with any Governmental Authority in respect of obtaining the Regulatory Approvals unless it consults with the other Party in advance and, to the extent not precluded by such Governmental Authority, gives the other Party the opportunity to review drafts of any submissions, filings or correspondence (including responses to requests for information and inquiries from any Governmental Authority) and will provide the other Party a reasonable opportunity to comment thereon and consider those comments in good faith, and shall provide each other with all information necessary to support the applications for the Regulatory Approvals, as reasonably required by the Party making the filing; and shall provide the other Party and its outside counsel with final copies of all such material submissions, filings, correspondence, presentations, applications, plans and other material documents submitted to or filed with any Governmental Authority in respect of the Regulatory Approvals. (d) Notwithstanding any other requirement in this Section 4.5, where a Party (a “Disclosing Party”) is required under this Section 4.5 to provide information to another Party (a “Receiving Party”) that the Disclosing Party reasonably deems to be confidential or competitively or commercially sensitive information, its Affiliates, and/or sublicensees the Disclosing Party may provide a redacted version removing the confidential or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, competitively or its sublicensees; provided, however, that such rights are subject commercially sensitive information to the prior written consent of Receiving Party; provided that: (i) the Person owning Disclosing Party also provides a complete, non-redacted version to the NDA Receiving Party’s outside legal counsel on an external counsel-only basis and the Receiving Party may not request such competitively or foreign equivalent as commercially sensitive information from its outside legal counsel; and (ii) nothing in this Agreement requires either Party to share with the case may be and any information contained therein. In the event that a other Party or its Affiliates is outside legal counsel any information that relates to the owner valuation of such NDA or foreign equivalent as the case may be transactions contemplated under this Agreement or information contained thereinrelating to possible transactions with other Persons. (e) Nothing in this Agreement shall require the Purchaser to propose, such Party shall notnegotiate, and shall cause its Affiliates not to, unreasonably withhold effect or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding (and neither the foregoingCompany nor its Subsidiaries may, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning Purchaser, propose, negotiate, effect or agree to), by consent decree, by consent agreement, hold separate Order or otherwise, the NDA sale, transfer, divestiture, license or foreign equivalentother disposition of any assets or businesses of the Purchaser or the Company or any of their respective Subsidiaries or otherwise take any action that prohibits or limits the freedom of action of the Purchaser with respect to, such consent or the ability of the Purchaser to be at the sole discretion own, retain, control, operate or exercise full rights of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority ownership with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and of the businesses or assets of the Purchaser, the Company or any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Producttheir respective Subsidiaries. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Acquiror and the Company shall use Commercially Reasonable Efforts their respective reasonable best efforts to submit registration dossiers promptly file or cause to be filed, within five (5) Business Days from the relevant Regulatory Authorities date hereof, all required filings under the HSR Act and all required filings under other applicable Antitrust Laws that Acquiror and the Company reasonably determine in good faith to be necessary or appropriate to consummate the Transactions (collectively, the “Antitrust Filings”), shall consult and cooperate with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and other in the name preparation of Licenseesuch filings, and Licensee shall own all Submissions promptly inform each other of any material communication received by such party from any Antitrust Authority regarding the Transactions. The Company and Data Acquiror shall review and discuss in advance, and consider in good faith the views of each other in connection therewithwith any proposed written or material oral communication with any Antitrust Authority. All pricing, formulary Acquiror and marketing approvals the Company shall also be obtained by and not participate in any meeting with any Governmental Entity unless it first consults with the name of Licenseeother in advance, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned permitted by the Governmental Entity, gives the other Party, its Affiliates, and/or sublicensees the opportunity to be present thereat. Neither Acquiror nor the Company shall agree to any voluntary extension of any statutory deadline or waiting period or to any third party filing such NDAs and/or their foreign equivalent on behalf voluntary delay of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior consummation of the Transactions at the behest of any Antitrust Authority without the written consent of the Person owning other (such consent not to be unreasonably withheld, conditioned or delayed). Each of Acquiror and the NDA or foreign equivalent as the case may Company shall be and responsible for its own filing fees required to be paid in connection with any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consentsAntitrust Filing. Notwithstanding anything in this Agreement to the foregoingcontrary, nothing in this Section 9.02 shall require the rights granted Company or Acquiror to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) propose, negotiate, commit to or effect, by consent decree, hold separate order, or otherwise, the sale, transfer, license, divestiture or other disposition of, or any material meetings between Licensee and prohibition or limitation on the ownership, operation, effective control or exercise of full rights of ownership of, any Regulatory Authority with respect to Licensed Products of the businesses, product lines or assets of Acquiror or of the Company or the Company Subsidiaries, and (ii) listen to defend any judicial or administrative action or similar proceeding instituted (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters threatened to be addressed at instituted) by any such meeting Person under any Antitrust Law or in seek to have any such telephone call (it being understood that in no event will the provisions of clause (i) stay, restraining order, injunction or (ii) of this sentence require Licensee to delay similar order entered by any meeting Governmental Entity vacated, lifted, reversed, or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productoverturned. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals S&T will, and will cause its appropriate Affiliates to, and each of Parent and Merger Sub will use, in each Major Country. (b) Licensee shall have the right case, its best efforts to obtain Regulatory Approvalsany authorizations, which shall be held by consents, orders and in approvals of any Governmental Authority necessary for the name performance of Licenseeits respective obligations pursuant to this Agreement and the Transaction Documents, and Licensee shall own all Submissions the consummation of the transactions contemplated hereby and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licenseethereby, and Licensee will be the principal interface and will otherwise handle cooperate fully with each other in all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate reasonable respects in promptly seeking to obtain such necessary third party authorizations, consents, orders and approvals. Notwithstanding Neither S&T, Parent, nor Merger Sub will take any action that will have the effect of delaying, impairing or impeding the receipt of any required regulatory approvals. Without limiting the generality of the foregoing, if applicable, S&T and Parent will promptly file or cause to be filed with the rights granted to a Party to access Federal Trade Commission ("FTC") and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent Antitrust Division of the Person owning United States Department of Justice ("DOJ"), Notification and Report Forms and documentary materials which substantially comply with the NDA provisions of the HSR Act and the rules thereunder. S&T shall pay (or foreign equivalentshall reimburse Parent for) all fees associated with the filing of any such Notification and Report Forms or related materials and information (other than the fees and expenses of Parent's legal, such consent financial or other professionals engaged to be at the sole discretion provide services in respect of such owning Person. (d) To filing); PROVIDED, HOWEVER, that Parent shall pay all fees associated with any Notification, Report Forms and documentary materials necessary to substantially comply with the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee provisions of the HSR Act and the relevant Regulatory Authorityrules thereunder. Licensee Parent and S&T will promptly file any additional information requested as soon as practicable after receipt of a request for additional information. Parent and S&T will use reasonable efforts (i) to provide Xxxxx obtain early termination of the applicable waiting period under the HSR Act. The parties hereto will coordinate and cooperate with one another in exchanging such information and providing such reasonable assistance as much advance notice of any may be requested in connection with such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, filing. S&T will supply Parent with copies of all documentscorrespondence, correspondence filings or communications (or memoranda setting forth the substance thereof) between S&T or its representatives, on the one hand, and the FTC, the DOJ or any other materials which are relevant to Governmental Authority or members of their respective staffs, on the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call other hand, with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant respect to this Agreement with any Regulatory Authority. Notwithstanding or the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Producttransactions contemplated hereby. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee As soon as practicable and in no event later than thirty (30) calendar days after the date of this Agreement, and assuming the full and timely cooperation and assistance of Seller, Purchaser shall prepare and file any applications, notices and filing required in order to obtain the Regulatory Approvals. Purchaser, with the reasonable cooperation of Seller, at Purchaser’s expense, shall use Commercially Reasonable Efforts reasonable best efforts to submit registration dossiers obtain each such approval as promptly as reasonably practicable in order to permit the Closing to occur not later than August 28, 2009, except Purchaser need not take any action that would give rise to Purchaser’s right to terminate this Agreement pursuant to Section 10.1(h). Seller will use reasonable best efforts to cooperate in connection therewith (including the furnishing of any information and any reasonable undertaking or commitments which may be required to obtain the Regulatory Approvals). Each party will provide the other with copies of any applications and all correspondence relating to Regulatory Approvals prior to filing, other than material filed in connection therewith under a claim of confidentiality. If any Regulatory Authority shall require the modification of any of the terms and provisions of this Agreement as a condition to granting any Regulatory Approval, the parties hereto will negotiate in good faith to seek a mutually agreeable adjustment to the relevant Regulatory Authorities with respect terms of the transaction contemplated hereby, such agreement not to all necessary Regulatory Approvals in each Major Countrybe unreasonably withheld, conditioned or delayed. (b) Licensee The parties shall have promptly advise each other upon receiving any communication from any governmental entity whose consent or approval is required for consummation of the right transactions contemplated by this Agreement which causes such party to obtain believe that there is a reasonable likelihood that any Regulatory Approvals, which shall be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also Approval or other consent or approval required hereunder will not be obtained by and in or that the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice receipt of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to approval will be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productmaterially delayed. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Each of the parties hereto shall cooperate and use Commercially Reasonable Efforts their respective reasonable best efforts to submit registration dossiers take, or cause to be taken, all action, and to do, or cause to be done as promptly as practicable, all things necessary, proper and advisable under applicable Laws, to consummate and make effective as promptly as practicable the Transactions, including providing any notices to any Person required in connection with the consummation of the Transactions, and obtaining any licenses, consents, waivers, approvals, authorizations, qualifications and Governmental Orders necessary to consummate the Transactions; provided, that in no event shall any party be required to pay any material fee, penalty or other consideration to obtain any license, Permit, consent, approval, authorization, qualification or waiver required under any Contract for the consummation of the Transactions (other than fees or expenses payable to the relevant Regulatory Authorities SEC in connection with respect the Transactions, including the Proxy Statement / Prospectus, filing fees payable pursuant to all Antitrust Laws, and any other ordinary course filing fees in connection with Governmental Filings required to consummate the Transactions). Subject to appropriate confidentiality protections and applicable Antitrust Laws, each party hereto shall furnish to the other parties such necessary Regulatory Approvals information and reasonable assistance as such other party may reasonably request in each Major Countryconnection with the foregoing. (b) Licensee Each of the parties hereto shall have the right cooperate with one another and use their reasonable best efforts to prepare all necessary documentation (including furnishing all information (i) required under any applicable Antitrust Laws or other applicable Laws or (ii) requested by a Governmental Authority pursuant to applicable Antitrust Laws) to effect promptly all necessary filings with any Governmental Authority and to obtain Regulatory Approvalsall necessary, which proper or advisable actions or nonactions, approvals consents, waivers, exemptions and approvals of any Governmental Authority necessary to consummate the Transactions. Each party hereto shall be held by provide to the other parties copies of all correspondence between it (or its advisors) and any Governmental Authority relating to the Transactions or any of the matters described in this Section 9.01. Each of the name parties hereto shall promptly inform the other of Licenseeany substantive oral communication with, and Licensee provide copies of any written communications with, any Governmental Authority regarding any such filings or any such transaction, unless prohibited by reasonable request of any Governmental Authority. No party hereto shall own all Submissions and Data independently participate in connection therewith. All pricingany substantive meeting or substantive conference call with any Governmental Authority in respect of any such filings, formulary and marketing approvals shall also be obtained by and in investigation or other inquiry without giving the name other party prior notice of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products includingsubstantive meeting or substantive conference call and, to the extent legally possiblepermitted by such Governmental Authority, being the sole contact opportunity to attend or participate. In the event a party is prohibited from participating in or attending any meeting or substantive conference call, the participating party shall keep the other party promptly and reasonably apprised with such Regulatory Authoritiesrespect thereto, subject to the rights extent permitted by applicable Law. To the extent permissible under applicable Law, the parties hereto will consult and cooperate with one another and consider in good faith the views of Xxxxx one another so as to mutually agree on any strategies and decisions, in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto relating to proceedings under Antitrust Laws or other applicable Laws. Any documents or other materials provided pursuant to this Section 9.01(b) may be redacted or withheld as necessary to address reasonable privilege or confidentiality concerns, and to remove references concerning the valuation of Pubco or other competitively sensitive material or personally-identifiable information or other sensitive personal or financial information, and the parties may, as each deems advisable, reasonably designate any material provided under this Section 4.49.01 as “outside counsel only material.” Such “outside counsel only materials” and the information contained therein shall be given only to legal counsel of the recipient and will not be disclosed by such legal counsel to employees, officers, or directors of the recipient without the advance written consent of the party providing such materials. Notwithstanding the foregoing, neither party shall be obligated to share with the other party documents responsive to items 4(c) and 4(d) on the Notification and Report Form for Certain Mergers and Acquisitions under the HSR Act. Without limiting the generality of the undertakings pursuant to this Section 9.01, each party hereto shall use reasonable best efforts to provide or cause to be provided as promptly as reasonably practicable and advisable to any Governmental Authority information and documents relating to such party as requested by such Governmental Authority or necessary, proper or advisable to permit consummation of the Transactions, as promptly as reasonably practicable and advisable after the date hereof (and, in the case of filings under any applicable Antitrust Law, no later than ten (10) Business Days after the date hereof), and thereafter to respond as promptly as reasonably practicable and advisable to any request for additional information or documentary material relating to such party that may be made (including under any applicable Antitrust Law regarding preacquisition notifications for the purpose of competition reviews). SPAC shall respond as promptly as practicable to any request for additional information and documentary material relating to SPAC by any Governmental Authority and furnish to the other such necessary information and reasonable assistance as the other may request in connection with the preparation of any required applications, notices, registrations and requests as may be required or advisable to be filed with any Governmental Authority (including, with respect to SPAC and its Affiliates, providing financial information and certificates as well as personal information of senior management or control persons, and requesting that individuals with appropriate seniority and expertise make themselves available to participate in discussions or hearings). In furtherance and not in limitation of the foregoing, if the Parties cannot agree on a jointly developed strategy, notwithstanding their respective good faith attempts to do so, SPAC shall have the final say with respect to the strategy and the final authority to direct and implement the strategy; provided, that SPAC shall not, without the Company’s prior written consent, and nothing in this Agreement shall require any Company Party to, offer, accept or agree to (A) dispose, hold separate or license any part of its businesses, operations, assets or product lines, (B) not compete in any geographic area or line of business, (C) restrict the manner in which, or whether, any Persons may carry on business in any part of the world, or (D) any limitations on the ability of any Person to acquire, hold or exercise full rights of ownership with respect to any securities. (c) Each Party If any objections are asserted with respect to the Transactions under any applicable Law or if any Action is instituted by any Governmental Authority or any private party challenging any of the Transactions as violative of any applicable Law, each of the Parties shall have full access cooperate with one another in good faith and use their reasonable best efforts to oppose or defend against any action to prevent or enjoin consummation of this Agreement (and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning PersonTransactions). (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) Notwithstanding anything else contained herein to the extent reasonably possiblecontrary, to provide XxxxxSPAC shall pay, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters or cause to be addressed at paid, all filing fees payable by any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted Party pursuant to this Agreement Antitrust Laws in connection with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductTransactions. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers to the relevant Regulatory Authorities with respect to all necessary Regulatory Approvals in each Major Country. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of LicenseePromptly, and Licensee shall own at its expense, execute and deliver, or cause to be executed and delivered, all Submissions applications, certificates, instruments, registration statements, and Data all other documents and papers the Canadian Agent may reasonably request and as may be required by law in connection therewith. All pricingwith the obtaining of any Governmental Approval or the consent, formulary and marketing approvals shall also be obtained by and in approval, registration, qualification or authorization of any other Person deemed necessary or appropriate for the name effective exercise of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to of the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and Security Agreement. Without limiting the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf generality of such Party, its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, if an Event of Default shall have occurred and be continuing, each Obligor shall take any action which the rights granted Canadian Agent may reasonably request in order to transfer and assign to the Canadian Agent, or to such one or more third parties as the Canadian Agent may designate, or to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent combination of the Person owning foregoing, each Governmental Approval of the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) Obligors. To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will enforce the provisions of clause this subsection, upon the occurrence and during the continuance of an Event of Default, the Canadian Agent is empowered to request the appointment of a receiver from any court of competent jurisdiction. Such receiver shall be instructed to seek from the Governmental Authority an involuntary transfer of control of each such Governmental Approval for the purpose of seeking a bona fide purchaser to whom control will ultimately be transferred. Each Obligor hereby agrees to authorize such an involuntary transfer of control upon the request of the receiver so appointed, and, if such Obligor shall refuse to authorize the transfer, its approval may be required by the court. Upon the occurrence and during the continuance of an Event of Default, such Obligor shall further use its reasonable best efforts to assist in obtaining Governmental Approvals, if required, for any action or transaction contemplated by this Security Agreement, including, without limitation, the preparation, execution and filing with the Governmental Authority of such Obligor’s portion of any necessary or appropriate application for the approval of the transfer or assignment of any portion of the assets (i) or (iiincluding any Governmental Approval) of such Obligor. Because each Obligor agrees that the Canadian Agent’s remedy at law for failure of such Obligor to comply with the provisions of this sentence require Licensee subsection would be inadequate and that such failure would not be adequately compensable in damages, such Obligor agrees that the covenants contained in this subsection may be specifically enforced, and such Obligor hereby waives and agrees not to delay assert any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges defenses against an action for specific performance of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productsuch covenants. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. Acquiror and the Company and their respective Subsidiaries will cooperate and use all reasonable best efforts to as promptly as possible prepare, but in no event later than thirty (a30) Licensee shall use Commercially Reasonable Efforts days following the date hereof, file, and to submit registration dossiers thereafter effect and obtain all Requisite Regulatory Approvals, and the parties will comply with the terms of such Requisite Regulatory Approvals. Each of Acquiror and the Company will have the right to review in advance, and to the relevant Regulatory Authorities extent practicable each will consult with the other, in each case subject to applicable Legal Requirements relating to the exchange of information, with respect to all necessary substantive written information submitted to any Regulatory Approvals Authority in each Major Country. (b) Licensee shall have connection with the right to obtain Requisite Regulatory Approvals. In exercising the foregoing right, which shall be held by each of the parties will act reasonably and in as promptly as practicable. Each party agrees that it will consult with the name other party with respect to obtaining all permits, consents, approvals and authorizations of Licenseeall Regulatory Authorities necessary or advisable to consummate the Contemplated Transactions, and Licensee shall own each party will keep the other party apprised of the status of material matters relating to completion of the Contemplated Transactions. Acquiror and the Company will, upon request, furnish the other party with all Submissions information concerning itself, its Subsidiaries, directors, officers and Data stockholders and such other matters as may be reasonably necessary or advisable in connection therewith. All pricingwith any filing, formulary and marketing approvals shall also be obtained notice or application made by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by the other Party, its Affiliates, and/or sublicensees or any third party filing such NDAs and/or their foreign equivalent on behalf of such Partyother party or any of its Subsidiaries with or to any Regulatory Authority in connection with the Contemplated Transactions. Notwithstanding the foregoing or anything else in this Agreement, nothing shall require Acquiror to, and the Company and its Affiliates, or its sublicensees; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party Subsidiaries shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of Acquiror, agree to, take any action or commit to take any action in connection with, or agree to any condition on, or request with respect to, any Requisite Regulatory Approval that would (a) materially and adversely affect the Person owning business, operations or financial condition of Acquiror (measured on a scale relative to Acquiror and its Subsidiaries, taken as a whole after giving effect to the NDA Contemplated Transactions), (b) require Acquiror or foreign equivalentany of its Subsidiaries to make any material covenants or commitments with a Regulatory Authority or other third party, such consent or complete any divestitures, whether prior to be at or subsequent to the sole discretion of such owning Person. Closing, (c) result in a Material Adverse Effect on Acquiror and its Subsidiaries, taken as a whole after giving effect to the Contemplated Transactions or (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) restrict in any material meetings between Licensee respect or impose a material burden on Acquiror or any of its Subsidiaries (including, after the Effective Time, the Company and any Regulatory Authority its Subsidiaries) in connection with the transactions contemplated hereby or with respect to Licensed Products the business or operation of Acquiror or any of its Subsidiaries (including, after the Effective Time, the Company and its Subsidiaries) (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions for purposes of clause (i) or (ii) of this sentence require Licensee d), materiality shall be measured on a scale relative to delay any meeting or telephone call with Acquiror and its Subsidiaries, taken as a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as whole after giving effect to the regulatory strategy and decision-making for any Licensed ProductContemplated Transactions) (a “Burdensome Condition”). (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee shall use Commercially Reasonable Efforts to submit registration dossiers Prior to the relevant Regulatory Closing, each Party shall, and shall cause its Affiliates to, use commercially reasonable efforts to (i) promptly obtain all authorizations, clearances, consents, orders and approvals of all Governmental Authorities that may be or become necessary or advisable for its execution and delivery of, and the performance of its obligations pursuant to, this Agreement and the Transaction Agreements; (ii) cooperate with the other parties in promptly seeking to obtain all such authorizations, clearances, consents, orders and approvals; and (iii) provide such other information and documents to any Governmental Authority as such Governmental Authority may reasonably request in connection herewith. Avalon shall pay all applicable filing or notice fees required in connection with any notice or filing made with any Governmental Authority pursuant to this Section 9.01; provided, that the Company shall pay all filing fees under the HSR Act and any other applicable Antitrust Laws with respect to all necessary Regulatory Approvals in each Major Countrythe transactions contemplated by this Agreement and the Transaction Agreements. (b) Licensee shall have the right to obtain Regulatory Approvals, which shall be held by and in the name of LicenseeEach Party agrees to, and Licensee shall own all Submissions cause its respective Affiliates to, make promptly, and Data no later than ten (10) Business Days after the Execution Date unless mutually agreed otherwise by the parties, its respective filing, if necessary, pursuant to the HSR Act with respect to the Transactions and the Transaction Agreements. Each party further agrees that it will supply as promptly as practicable to the appropriate Governmental Authorities any additional information and documentary material that may be requested in connection therewithwith its respective filing pursuant to the HSR Act. All pricing, formulary and marketing approvals shall also be obtained by and in the name of LicenseeEach party agrees to, and Licensee will be the principal interface shall cause its respective Affiliates to, make as promptly as practicable its respective filings and will otherwise handle all interactions with Regulatory Authorities concerning notifications, if any, under any Licensed Products includingother applicable antitrust, competition, merger control or foreign investment Law and to supply as promptly as practicable to the extent legally possible, being the sole contact with such Regulatory Authorities, subject appropriate Governmental Authorities any additional information and documentary material that may be requested pursuant to the rights of Xxxxx under this Section 4.4applicable antitrust, competition, merger control or foreign investment Law. (c) Each Party shall have full access to and the right to reference any NDAs and/or their foreign equivalent based on Immune Modulator owned by promptly notify the other Party, its Affiliates, and/or sublicensees Parties of any substantive communication it or any third of its Representatives receives from the SEC, the United States Department of Justice or the Federal Trade Commission primarily relating to the Transactions and permit the other Parties to review in advance and provide comments (which shall be considered in good faith) on any proposed substantive communication by such party filing to any such NDAs and/or Governmental Authority. None of the Parties shall agree to participate in any substantive meeting or teleconference with the SEC, the United States Department of Justice or the Federal Trade Commission in respect of any filings or investigation (including any settlement of an investigation) primarily relating to the Transactions unless it consults with the other parties in advance and, to the extent permitted by such Governmental Authority, gives the other parties the opportunity to attend and participate at such meeting or teleconference. Each Party shall, and shall cause its Representatives to, coordinate and cooperate fully with each other in exchanging such information and providing such assistance as the other Parties may reasonably request in connection with the foregoing and in seeking the expiration or termination of any applicable waiting periods, including under the HSR Act. Each Party shall, and shall cause its Representatives to, provide each other with copies of all material correspondence, filings or communications between them or any of their foreign equivalent respective Representatives, on behalf the one hand, and any Governmental Authority or members of such Partyits staff, its Affiliateson the other hand, or its sublicenseeswith respect to the Transactions; provided, however, that such rights are subject to the prior written consent of the Person owning the NDA or foreign equivalent as the case may be and any information contained therein. In the event that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained therein, such Party shall not, and shall cause its Affiliates not to, unreasonably withhold or delay consent. In the event that a third party is the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent of the Person owning the NDA or foreign equivalent, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) nothing herein shall require any material meetings between Licensee and Party to provide a copy of its respective filing pursuant to the HSR Act to any Regulatory Authority with respect to Licensed Products other Party and (ii) listen materials may be redacted (A) as necessary to comply with contractual requirements or applicable Law; and (but not participate inB) any material telephone conversation between Licensee and any Regulatory Authority with respect as necessary to Licensed Products that is preaddress reasonable attorney-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice of any such meeting client or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting privilege or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed Productconfidentiality concerns. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.

Regulatory Approvals. (a) Licensee Subject to the terms and conditions of this Agreement (including Section 5.10(e)) and separate and apart from the obligations set forth in Section 5.11, Seller and Buyer shall use Commercially Reasonable Efforts their commercially reasonable efforts to submit registration dossiers take or cause to be taken all actions, and to do or cause to be done all things necessary, proper or advisable under applicable Laws, to obtain as promptly as practicable all the relevant Regulatory Authorities Seller Government Approvals, the Buyer Government Approvals and all other authorizations, consents, clearances, orders, expirations, waivers or terminations of any applicable waiting periods and approvals of any Government Entity that may be or may become reasonably necessary, proper or advisable under this Agreement and applicable Laws to consummate and make effective the Transactions. In furtherance and not in limitation of the foregoing, as promptly as practicable, and, in any event, (i) no later than ten Business Days after the date hereof, Seller and Buyer shall make any notification required with respect to the Transactions pursuant to the HSR Act, which notification shall specifically request early termination of the waiting period prescribed by the HSR Act and (ii) promptly file any supplemental information required or requested in connection therewith. Seller and Buyer shall, and shall cause their respective Affiliates to, request expedited treatment of such filings, promptly make any appropriate or necessary subsequent or supplemental filings, and cooperate with one another in the preparation of such filings in such manner as is reasonably necessary and appropriate. Further, as promptly as practicable, and in no event later than ten Business Days after the date hereof, Seller and Buyer shall promptly make all necessary Regulatory other initial filings and notifications with respect to the Seller Government Approvals, the Buyer Government Approvals and all other initial authorizations, consents, clearances, orders, expirations, waivers or terminations of any applicable waiting periods and approvals of any Government Entity that may be or may become reasonably necessary, proper or advisable under this Agreement and applicable Laws (including with respect to applicable Antitrust Laws as reasonably determined by Buyer in each Major Countryconsultation with Seller) to consummate and make effective the Transactions. (b) Licensee Separate and apart from the obligations set forth in Section 5.11, neither Seller nor Buyer may, without the consent of the other (which consent shall have not be unreasonably withheld, conditioned or delayed), (i) cause any such filing or submission applicable to it to be withdrawn or refiled for any reason, including to provide the right applicable Government Entities with additional time to obtain Regulatory Approvalsreview any or all of the Transactions, which or (ii) consent to any voluntary extension of any statutory deadline or waiting period or to any voluntary delay of the consummation of the Transactions at the behest of any Government Entity. Subject to compliance with all applicable Laws, Seller and Buyer shall supply promptly to each other any information and documentary material that may be held by and in the name of Licensee, and Licensee shall own all Submissions and Data in connection therewith. All pricing, formulary and marketing approvals shall also be obtained by and in the name of Licensee, and Licensee will be the principal interface and will otherwise handle all interactions with Regulatory Authorities concerning requested pursuant to any Licensed Products including, to the extent legally possible, being the sole contact with such Regulatory Authorities, subject to the rights of Xxxxx under this Section 4.4Antitrust Laws or any other applicable Laws. (c) Each Subject to Section 5.10(d) and separate and apart from the obligations set forth in Section 5.11, each of Seller and Buyer shall, in connection with the efforts referenced in Section 5.10(a) to obtain all the Seller Government Approvals, the Buyer Government Approvals and all other authorizations, consents, clearances, orders, expirations, waivers or terminations of any applicable waiting periods and approvals of any Government Entity that may be or may become reasonably necessary, proper or advisable under this Agreement and applicable Laws to consummate and make effective the Transactions, use its commercially reasonable efforts to: (i) cooperate with each other in connection with any filing or submission and in connection with any investigation or other inquiry, including any proceeding initiated by a private party related to this Agreement or the Transactions; (ii) keep the other Party reasonably informed of any communication received by such Party from, or given by such Party to, any Government Entity with competent jurisdiction over Antitrust Laws and of any communication received or given in connection with any proceeding by a private party, in each case regarding any of the Transactions; and (iii) subject to any applicable privileges (including attorney-client privilege), and to the extent permitted by a Government Entity with competent jurisdiction over Antitrust Laws or such other applicable Government Entity, permit the other Party to review any communication given by it to, and consult with each other in advance of any communication, meeting or conference with, any Government Entity with competent jurisdiction over Antitrust Laws or any other Government Entity or, in connection with any proceeding by a private party, with any other Person, and give the other Party the opportunity to attend and participate in such meetings and conferences. (d) Subject to Section 5.10(e) and separate and apart from the obligations set forth in Section 5.11, in the event that any Action is instituted (or threatened to be instituted) by a Government Entity or private party challenging the Transactions, each of Seller and Buyer shall, and shall cause its Affiliates to, cooperate in all respects with each other and use its respective commercially reasonable efforts to contest and resist any such Action and to have full access vacated, lifted, reversed or overturned any decree, judgment, injunction or other order, whether temporary, preliminary or permanent, that is in effect and that prohibits, prevents or restricts consummation of the Transactions. (e) Notwithstanding anything to the contrary contained in this Agreement (except for the obligations set forth in Section 5.11), the Parties agree and acknowledge that neither this Section 5.10 nor any other provision in this Agreement shall require, or be construed to require, Seller or Buyer or any of their respective Affiliates (including the Company and the right Company’s Subsidiaries), in order to reference obtain all the Seller Government Approvals and the Buyer Government Approvals, and all other authorizations, consents, clearances, orders, expirations, waivers or terminations of any NDAs and/or their foreign equivalent based on Immune Modulator owned by applicable waiting periods and approvals of any Government Entity that may be or may become reasonably necessary, proper or advisable under this Agreement and applicable Laws to consummate and make effective the Transactions, to: (i) (A) sell, lease, license, transfer, dispose of, divest or otherwise encumber, or hold separate pending any such action or (B) propose, negotiate or offer to effect, or consent or commit to, any such sale, leasing, licensing, transfer, disposal, divestiture or other Partyencumbrance, its Affiliatesor holding separate, and/or sublicensees before or after the Closing, of any assets, licenses, operations, rights, product lines, businesses or interest therein of Buyer or the Company (or any third party filing such NDAs and/or of their foreign equivalent respective Subsidiaries or other Affiliates); or (ii) take or agree to take any other action or agree or consent to any limitations or restrictions on behalf freedom of such Party, its Affiliatesaction with respect to, or its sublicenseesability to, retain or make changes in any such assets, licenses, operations, rights, product lines, businesses or interest therein of Buyer or the Company (or any of their respective Subsidiaries or other Affiliates); provided that Buyer agrees, to the extent necessary to obtain all the Seller Government Approvals and the Buyer Government Approvals and all other authorizations, consents, clearances, orders, expirations, waivers or terminations of any applicable waiting periods and approvals of any Government Entity that may be or may become reasonably necessary, proper or advisable under this Agreement and applicable Laws to consummate and make effective the Transactions, to (I) divest those assets or businesses or products or product lines of the Company and the Company’s Subsidiaries and (II) take such other actions with respect to the Company, the Company’s Subsidiaries or the Business to the extent such divestitures or other actions contemplated by the foregoing clauses (I) and (II) of this Section 5.10(e) that do not result in the sale, lease, licensing, assignment, transfer, divestiture or disposition of any assets of the Company or its Subsidiaries (including any Company Material Contract) that, individually or in the aggregate, directly contributed to more than $20 million of the consolidated revenues to the Company and its Subsidiaries for the twelve-month period ending on September 30, 2014 (the imposition of any requirement by the applicable Government Entity to take any such action in order to obtain any Seller Government Approval or any Buyer Government Approval other than those expressly set forth in the foregoing clauses (I) and (II) of this Section 5.10(e) being referred to as a “Burdensome Condition”); provided, however, that such rights are subject Buyer can compel Seller to the prior written consent take any of the Person owning actions referred to above (or agree to take such actions) if such actions are only effective after the NDA Closing; and provided further that neither Seller nor Buyer shall be required to agree to any term or foreign equivalent as take any action in connection with obtaining all the case may be Seller Government Approvals and the Buyer Government Approvals and all other authorizations, consents, clearances, orders, expirations, waivers or terminations of any information contained therein. In the event applicable waiting periods and approvals of any Government Entity that a Party or its Affiliates is the owner of such NDA or foreign equivalent as the case may be or information contained thereinmay become reasonably necessary, such Party proper or advisable under this Agreement and applicable Laws to consummate and make effective the Transactions that are not conditioned upon the consummation of the Transactions. (f) From the date of this Agreement through the Closing, except as contemplated by this Agreement (or, in each case, incidental thereto), the Parties shall not, and shall cause its their Affiliates not to, unreasonably withhold make any acquisition or enter into any joint venture or knowingly take any affirmative actions (other than those taken in the Ordinary Course of business) that would reasonably be expected to materially hinder or delay consent. In the event that a third party is obtaining of clearance or any necessary approval of any Government Entity under any Antitrust Laws or the owner of such NDA or foreign equivalent or information contained therein, the Parties agree to reasonably cooperate to obtain such necessary third party consents. Notwithstanding the foregoing, the rights granted to a Party to access and reference any NDAs and/or their foreign equivalent, as contemplated herein, shall not extend to such Party’s sublicensees without the prior written consent expiration of the Person owning the NDA or foreign equivalentrequired waiting period under any Antitrust Laws, such consent to be at the sole discretion of such owning Person. (d) To the extent not prohibited by law or regulation, Xxxxx shall have right to have one (1) representative (i) attend (but not participate in) any material meetings between Licensee and any Regulatory Authority in each case with respect to Licensed Products and (ii) listen to (but not participate in) any material telephone conversation between Licensee and any Regulatory Authority with respect to Licensed Products that is pre-scheduled between Licensee and the relevant Regulatory Authority. Licensee will use reasonable efforts (i) to provide Xxxxx with as much advance notice consummation of any such meeting or telephone call as is reasonably possible in the circumstances and, (ii) to the extent reasonably possible, to provide Xxxxx, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials which are relevant to the matters to be addressed at any such meeting or in any such telephone call (it being understood that in no event will the provisions of clause (i) or (ii) of this sentence require Licensee to delay any meeting or telephone call with a Regulatory Authority). Licensee will also provide Xxxxx with access to all exchanges of material correspondence related to activities conducted pursuant to this Agreement with any Regulatory Authority. Notwithstanding the foregoing, Licensee will have sole discretion as to the regulatory strategy and decision-making for any Licensed ProductTransactions. (e) Licensee shall have the sole right to obtain all pricing and reimbursement approvals in all countries in the Territory in which Licensed Products shall be sold.