Common use of Compliance with Government Regulations Clause in Contracts

Compliance with Government Regulations. a) Fujifilm shall perform each Program in a timely and diligently manner; in accordance with the terms and conditions of this Agreement, the applicable SoW and the Quality Agreement; in compliance with all applicable Legal Requirements, including cGMP (as applicable); in compliance with standard operating procedures and protocols already in place at Fujifilm or as agreed upon by the Parties from time to time; and in compliance with all reasonable written directions and requests of Alder. Fujifilm shall manufacture GMP Product in compliance with the Process Specification, cGMP and all other applicable Legal Requirements. Fujifilm shall use the applicable Facility to perform each Program, and shall not use a different facility without the prior written consent of Alder. Fujifilm warrants [***]. This clause is a material clause of this Agreement, and Fujifilm shall promptly notify Alder if it becomes of aware of [***]. b) Alder acknowledges that Fujifilm has consulted with Alder in designing each Program in a manner consistent with current U.S. and European regulatory guidelines. Notwithstanding the foregoing, while Fujifilm [***], Fujifilm [***]. Alder shall have responsibility for determining [***]. The foregoing shall not be construed in derogation of Fujifilm’s obligations set forth in Section 3(a) above. c) Should any applicable Legal Requirements change, Fujifilm will [***] satisfy the new requirements. In the event that compliance with such new Legal Requirements specifically pertaining to Alder’s Product increases or decreases the cost or time required to perform each Program, the Parties shall negotiate an equitable adjustment in the price or schedule, or both, to reflect the [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. increase or decrease, and the Parties shall enter into a Program Amendment Order, as herein after defined, in accordance with Section 6 of this Agreement. Changes to Fujifilm’s facility to entitle it to operate as [***]. d) in the event of a conflict between or among any of the standards set forth in this Section 3, Fujifilm shall comply with the most stringent standard which is permitted by law; in the event of a conflict in Applicable Law, the Parties shall agree on which Applicable Law shall be followed by Fujifilm in its performance of each Program to comply with regulatory requirements and advance the applicable Program. e) Alder shall notify Fujifilm promptly if any Product is the subject of a recall, withdrawal, field alert or similar action (collectively a “Recall”), and provide Fujifilm with a copy of all documents relating to such Recall. Fujifilm shall reasonably cooperate with Alder in connection with any Recall, [***]. Alder shall [***], and provided further than Alder [***]. For clarity, [***].

Compliance with Government Regulations. a) Fujifilm 6.1 Coherent shall perform each Program in a timely not sell any Products to, or for the use of, any ultimate purchaser with which Palomar could not deal under the laws or regulations of the United States, including, without limitation, the regulations of the United States Food and diligently manner; in accordance Drug Administration. Coherent shall comply with all other laws and regulations of the terms United States and conditions any other cognizant jurisdiction relating to the marketing and sale of the Products. 6.2 Palomar and Coherent shall comply with all other laws and regulations of the United States and any other cognizant jurisdiction relating to the manufacturing and labeling of the Distributed Products. 6.3 During the term of this Agreement, the applicable SoW and the Quality Agreement; in compliance with all applicable Legal Requirements, including cGMP (as applicable); in compliance with standard operating procedures and protocols already in place at Fujifilm or as agreed upon by the Parties from time to time; and in compliance with all reasonable written directions and requests of Alder. Fujifilm shall manufacture GMP Product in compliance with the Process Specification, cGMP and all other applicable Legal Requirements. Fujifilm Palomar shall use its commercially reasonable best efforts to maintain in full force and effect all governmental approvals necessary for the applicable Facility sale and manufacture of the Distributed Products in the Territory, except for Japan, including, without limitation, the United States and Europe (CE Xxxx). The parties shall meet within the next 90 days to perform each Programdetermine whether to apply for the necessary licenses to sell any of the Distributed Products in Japan. Within that 90 day period, Coherent may notify Palomar that it will undertake to obtain such licenses, in which case, all costs thereof shall be borne by Coherent, the licenses shall be in both Coherent's and Palomar's name. If Coherent has obtained such licenses, upon termination of this Agreement Palomar may either (i) reimburse Coherent for its out of pocket expenses incurred in procuring these licenses, in which case Coherent shall assign its interest in the licenses to Palomar or (ii) elect not to reimburse Coherent, in which case Palomar shall not use a different facility without sell Distributed Products in Japan pursuant to such licenses. Nothing contained herein shall restrict Palomar's ability to obtain its own licenses in Japan. 6.4 During the prior written consent of Alder. Fujifilm warrants [***]. This clause is a material clause term of this Agreement, and Fujifilm shall promptly notify Alder if it becomes of aware of [***]. b) Alder acknowledges that Fujifilm has consulted with Alder in designing each Program Coherent determines to sell Distributed Products in a manner consistent with current U.S. country within the Territory where regulatory approval is required but not obtained, Coherent shall use its commercially reasonable best efforts to obtain, at its sole cost and European regulatory guidelines. Notwithstanding expense, any such governmental approvals necessary for the foregoing, while Fujifilm [***], Fujifilm [***]. Alder shall have responsibility for determining [***]. The foregoing shall not be construed sale of Distributed Products in derogation of Fujifilm’s obligations set forth in Section 3(a) abovesuch country. c) Should any applicable Legal Requirements change, Fujifilm will [***] satisfy the new requirements. In the event that compliance with such new Legal Requirements specifically pertaining to Alder’s Product increases or decreases the cost or time required to perform each Program, the Parties shall negotiate an equitable adjustment in the price or schedule, or both, to reflect the [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. increase or decrease, and the Parties shall enter into a Program Amendment Order, as herein after defined, in accordance with Section 6 of this Agreement. Changes to Fujifilm’s facility to entitle it to operate as [***]. d) in the event of a conflict between or among any of the standards set forth in this Section 3, Fujifilm shall comply with the most stringent standard which is permitted by law; in the event of a conflict in Applicable Law, the Parties shall agree on which Applicable Law shall be followed by Fujifilm in its performance of each Program to comply with regulatory requirements and advance the applicable Program. e) Alder shall notify Fujifilm promptly if any Product is the subject of a recall, withdrawal, field alert or similar action (collectively a “Recall”), and provide Fujifilm with a copy of all documents relating to such Recall. Fujifilm shall reasonably cooperate with Alder in connection with any Recall, [***]. Alder shall [***], and provided further than Alder [***]. For clarity, [***].

Compliance with Government Regulations. a) Fujifilm shall perform each Program in a timely and diligently manner; in accordance with the terms and conditions of this Agreement, the applicable SoW and the Quality Agreement; in compliance with all applicable Legal Requirements, including cGMP (as applicable); in compliance with standard operating procedures and protocols already in place at Fujifilm or as agreed upon by the Parties from time to time; and in compliance with all reasonable written directions and requests of Alder. Fujifilm shall manufacture GMP Product in compliance with the Process Specification, cGMP and all other applicable Legal Requirements. Fujifilm shall use the applicable Facility to perform each Program, and shall not use a different facility without the prior written consent of Alder. Fujifilm warrants [***]that it has not been debarred, disqualified or banned from performing the types of services contemplated under this Agreement, and covenants that it will not knowingly employ, contract with or utilize any person or entity that has been so debarred, disqualified or banned to perform any services under this Agreement or is not properly qualified by applicable training, experience and supervision to carry out the tasks assigned in connection with this Agreement. This clause is a material clause of this Agreement, and Fujifilm shall promptly notify Alder if it becomes of aware of [***]any such debarment, disqualification or banishment, or of any such poorly qualified person or entity. b) Alder acknowledges that Fujifilm has consulted with Alder in designing each Program in a manner consistent with current U.S. and European regulatory guidelines. Notwithstanding the foregoing, while Fujifilm [***]believes such design to be consistent with current U.S. and European regulatory guidelines, Fujifilm [***]does not warrant that a Program and/or Program results will satisfy the requirements of any regulatory agencies at the time of submission of Program results to such agencies. Alder shall have responsibility for determining [***]regulatory strategy and for all regulatory decisions relating to a Program or a Product, except for those matters that Fujifilm, in its sole discretion, deems contrary to regulatory requirements imposed on Fujifilm by a regulatory authority or commitments made by Fujifilm to regulatory authorities. The foregoing shall not be construed in derogation of Fujifilm’s obligations set forth in Section 3(a) above. c) Should any applicable Legal Requirements change, Fujifilm will [***] satisfy the new requirements. In the event that compliance with such new Legal Requirements specifically pertaining to Alder’s Product increases or decreases the cost or time required to perform each Program, the Parties shall negotiate an equitable adjustment in the price or schedule, or both, to reflect the [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. required to perform each Program, the Parties shall negotiate an equitable adjustment in the price or schedule, or both, to reflect the increase or decrease, and the Parties shall enter into a Program Amendment Order, as herein after defined, in accordance with Section 6 of this Agreement. Changes to Fujifilm’s facility to entitle it to operate as [***]. d) in the event of a conflict between or among any of the standards set forth in this Section 3, Fujifilm shall comply with the most stringent standard which is permitted by law; in the event of a conflict in Applicable Law, the Parties shall agree on which Applicable Law shall be followed by Fujifilm in its performance of each Program to comply with regulatory requirements and advance the applicable Program. e) Alder shall notify Fujifilm promptly if any Product is the subject of a recall, withdrawal, field alert or similar action (collectively a “Recall”), and provide Fujifilm with a copy of all documents relating to such Recall. Fujifilm shall reasonably cooperate with Alder in connection with any Recall, [***]. Alder shall [***], and provided further than Alder [***]. For clarity, [***].

Compliance with Government Regulations. a) Fujifilm shall perform each Program in a timely and diligently manner; in accordance with operate the terms and conditions of this Agreement, the applicable SoW and the Quality Agreement; GMP Facility in compliance with Applicable Law and any requirements provided for in the Quality Agreement for all applicable Legal Requirementsaspects of Manufacturing (including but not limited to testing, including cGMP holding, packaging, labeling and delivery of the Product and/or intermediates produced for Sponsor). For clarity, this shall include the obligation for Fujifilm to operate the GMP Facility as compliant with (i) the U.S. Federal Food, Drug and Cosmetics Act, as applicableamended (21 U.S.C. et seq.); in compliance with standard operating procedures , (ii) U.S. regulations found at 21 CFR Parts 11, 210, 211, 600, & 610, (iii) ICH Q7 GMP Guidance for Active Pharmaceutical Ingredients, (iv) EC Directive 2003/94/EC, (v) the EC Guide to Good Manufacturing Practice for Medicinal Products and protocols already in place at Fujifilm Division 2 of the Food and Drug Regulations (Canada), (vi) the latest Health Canada, FDA and EMA guidance documents all pertaining to manufacturing and quality control practice and (vii) the good manufacturing practices required by any other Regulatory Authority to the extent such required practices do not contradict or negate the requirements or guidance documents issued by FDA or EMA, all as agreed upon by the Parties updated, amended and revised from time to time; and in compliance with all reasonable written directions and requests of Aldertime (collectively, “cGMP”). Fujifilm shall manufacture GMP Product not permit debarred persons to participate in compliance with the Process Specification, cGMP and all other applicable Legal RequirementsProgram or persons for whom debarment is pending or threatened. Fujifilm shall use the applicable Facility undertake commercially reasonable steps to perform each Program, and shall not use a different facility without the prior written consent of Alder. Fujifilm warrants [***]. This clause is a material clause of this Agreement, and Fujifilm shall promptly notify Alder if it becomes of aware of [***]prevent such participation. b) Alder acknowledges Sponsor shall have the sole right and responsibility for determining regulatory strategy, decision and actions relating to the Program and the Product. Subject to each Party’s contractual obligations under this Agreement, Fujifilm shall have the sole right and responsibility for determining regulatory strategy, decision and actions to the extent relating to (i) the Facilities; (ii) Fujifilm’s quality systems; or (iii) any requirement imposed directly on Fujifilm by a Regulatory Authority, provided that a Regulatory Authority requirement shall not be considered to be “a requirement imposed directly on Fujifilm has consulted by a Regulatory Authority” if it is applicable to or imposed on Sponsor regarding the services provided by Fujifilm with Alder respect to the Product, but is not applicable to other Fujifilm’s client in designing each Program in a manner consistent respect to Fujifilm’s services provided to them. Fujifilm hereby [**], as of the Effective Date, [**] Sponsor with current U.S. and European regulatory guidelinescommercial supply of Product or otherwise complying with its obligations hereunder. Notwithstanding the foregoing, while Fujifilm [***], ] Sponsor will consult with Fujifilm [***]. Alder shall have responsibility for determining [***]. The foregoing shall not in respect to and prior to any action that may be construed in derogation of reasonably expected to impact Fujifilm’s obligations set forth in Section 3(a) abovewith respect to the Product. c) Should any applicable Legal Requirements change, Fujifilm will [***] satisfy the new requirements. In the event that compliance with such new Legal Requirements specifically pertaining to Alder’s Product increases or decreases the cost or time required to perform each Program, the Parties shall negotiate an equitable adjustment in the price or schedule, or both, to reflect the [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. increase or decrease, and the Parties shall enter into a Program Amendment Order, as herein after defined, in accordance with Section 6 of this Agreement. Changes to Fujifilm’s facility to entitle it to operate as [***]. d) in the event of a conflict between or among any of the standards set forth in this Section 3, Fujifilm shall comply with the most stringent standard which is permitted by law; in the event of a conflict in Applicable Law, the Parties shall agree on which Applicable Law shall be followed by Fujifilm in its performance of each Program to comply with regulatory requirements and advance the applicable Program. e) Alder shall notify Fujifilm promptly if any Product is the subject of a recall, withdrawal, field alert or similar action (collectively a “Recall”), and provide Fujifilm with a copy of all documents relating to such Recall. Fujifilm shall reasonably cooperate with Alder in connection with any Recall, [***]. Alder shall [***], and provided further than Alder [***]. For clarity, [***].

Compliance with Government Regulations. a) Fujifilm shall operate a compliant current cGMP facility located at RTP, NC and Billingham, UK (each a “Fujifilm Facility”) pursuant to (a) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq.), (b) U.S. regulations in Title 21 of the U.S. Code of Federal Regulations Parts 210, 211, 600 and 610, and (c) the EC Guide to Good Manufacturing Practice for Medicinal Products, v.4, including relevant sections of DIR 2003/94/EC International Conference on Harmonization (ICH) , in each case including successor laws, regulations or guides. All Product requested by Sponsor under this Agreement shall be manufactured solely by Fujifilm at the Fujifilm Facility in RTP, NC. [* * *] In addition, Fujifilm shall perform each Program in a timely compliance in all respects with statutory and diligently manner; in accordance with regulatory guidelines applicable to the terms and conditions of this Agreement, the applicable SoW and the Quality Agreement; in compliance with all applicable Legal Requirements, including cGMP (as applicable); in compliance with standard operating procedures and protocols already in place at Fujifilm or as agreed upon by the Parties from time to time; and in compliance with all reasonable written directions and requests of AlderProduct’s clinical phase. Fujifilm shall manufacture GMP Product not permit debarred persons to participate in compliance with the Process Specification, cGMP and all other applicable Legal Requirementsany Program. Fujifilm shall use the applicable Facility undertake reasonable steps to perform each Program, and shall not use a different facility without the prior written consent of Alder. Fujifilm warrants [***]. This clause is a material clause of this Agreement, and Fujifilm shall promptly notify Alder if it becomes of aware of [***]prevent such participation. b) Alder Sponsor and Fujifilm each acknowledges that Fujifilm it has consulted with Alder the other Party in designing each the Program in a manner consistent with current U.S. US and European EU regulatory guidelines. Notwithstanding the foregoing, while Fujifilm [***], Fujifilm [***]neither Party warrants that the Program and/or the Program results will satisfy the requirements of any regulatory agencies at the time of submission of Program results to such agencies. Alder Sponsor shall have the right and responsibility for determining [***]. The foregoing regulatory strategy, decision and actions to the extent relating to the Product and Fujifilm shall not be construed in derogation of have the right and responsibility for determining regulatory strategy, decision and actions to the extent relating to (i) the Fujifilm Facility; (ii) Fujifilm’s quality systems; (iii) any requirement imposed on Fujifilm by a Regulatory Authority or (iv) any other commitments made by Fujifilm prior to, on or after the Effective Date of this Agreement. Fujifilm shall monitor and maintain reasonable records respecting its compliance with cGMPs, including the process of establishing and implementing the operating procedures, equipment files, and the training of personnel as are reasonably necessary to assure such compliance. Fujifilm hereby represents that, to Fujifilm’s knowledge, no requirement imposed on Fujifilm by a Regulatory Authority as of the Effective Date or any other commitments made by Fujifilm prior to the Effective Date of this Agreement shall delay or prevent Fujifilm from performing the Program or otherwise complying with its obligations set forth hereunder, and Fujifilm shall immediately notify Sponsor during the term of this Agreement if that representation is no longer accurate on an ongoing basis, in Section 3(a) abovereasonable detail with a plan to immediately correct such delay or non-compliance. c) Should any applicable Legal Requirements such U.S. government or European Medicines Agency (“EMA”) regulatory requirements change, Fujifilm will [***] use reasonable efforts to satisfy the new requirements. In the event that compliance with such new Legal Requirements specifically pertaining to Alder’s Product increases U.S. or decreases the cost or time required to perform each Program, the Parties shall negotiate an equitable adjustment EMA regulatory requirements necessitates a change in the price or scheduleScope, or both, Fujifilm will submit to reflect the [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. increase or decrease, and the Parties shall enter into Sponsor a Program Amendment Change Order, as herein after defined, in accordance with Section 6 7 of this Agreement. Changes to Fujifilm’s facility to entitle it to operate as [***]. d) Sponsor shall provide Fujifilm with information in Sponsor’s possession concerning any health hazards or potential health hazards associated with exposure to or the handling, storage, use or disposal of raw materials and/or Product, including, without limitation, a Material Safety Data Sheet for Product, if one exists. In the event of a conflict between that any such information is updated or among any of corrected, Sponsor shall promptly notify Fujifilm thereof and provide Fujifilm with the standards set forth in updated or corrected information. e) Subject to this Section 3, Fujifilm shall comply with the most stringent standard which is permitted by law; in the event of a conflict in Applicable Lawgovernment regulations, the Parties Party primarily responsible for compliance shall agree on determine in good faith which Applicable Law regulations shall be followed by Fujifilm in its performance of each the Program to comply with regulatory requirements and advance the applicable Program. e) Alder shall notify Fujifilm promptly if any Product is the subject of a recall, withdrawal, field alert or similar action (collectively a “Recall”), and provide Fujifilm with a copy of all documents relating to such Recall. Fujifilm shall reasonably cooperate with Alder in connection with any Recall, [***]. Alder shall [***], and provided further than Alder [***]. For clarity, [***].

Compliance with Government Regulations. (a) Fujifilm shall Laureate will perform each the Program in a timely accordance with the Scope. Subject to Sections 6(c) and diligently manner; 16(a) below, Laureate will also comply with applicable government regulatory requirements, including all such requirements concerning cGMP appropriate to the Program. (b) Laureate shall be responsible for obtaining, at its expense, any Facility, licenses, permits and regulatory and government approvals necessary for the development, manufacture and supply of the Bulk Intermediate in accordance with the terms and conditions of this Agreement, . Laureate shall provide Customer with a letter of reference to Laureate's Drug Master File ("DMF") that describes the applicable SoW and the Quality Agreement; Facility for inclusion or use in compliance with all applicable Legal Requirements, including cGMP (as applicable); in compliance with standard operating procedures and protocols already in place at Fujifilm or as agreed upon by the Parties from time to time; and in compliance with all reasonable written directions and requests of Alder. Fujifilm shall manufacture GMP Product in compliance with the Process Specification, cGMP and all other applicable Legal Requirements. Fujifilm shall use the applicable Facility to perform each Program, and shall not use a different facility without the prior written consent of Alder. Fujifilm warrants [***]. This clause is a material clause of this Agreement, and Fujifilm shall promptly notify Alder if it becomes of aware of [***]Customer's regulatory submissions. b) Alder acknowledges that Fujifilm has consulted with Alder in designing each Program in a manner consistent with current U.S. and European regulatory guidelines. Notwithstanding the foregoing, while Fujifilm [***], Fujifilm [***]. Alder shall have responsibility for determining [***]. The foregoing shall not be construed in derogation of Fujifilm’s obligations set forth in Section 3(a) above. (c) Should any applicable Legal Requirements changegovernment regulatory requirements be changed, Fujifilm Laureate will use commercially reasonable efforts to comply with the applicable changed requirements. If compliance with such applicable changed regulatory requirements necessitates, in the reasonable discretion of Laureate, a material change in the Scope or the Program, or an increase in the cost of the Services provided by Laureate, Laureate will submit to Customer a revised technical and cost proposal for Customer's acceptance and, on and after the date of such submission upon written notice to Customer, may suspend any and all Services impacted by the applicable changed regulatory requirements until such time as Customer and Laureate reach agreement on a revised proposal. If the parties are unable to agree upon a revised Scope or Program or cost structure, as the case may be, within [******* (**)] satisfy days of Customer's receipt of Laureate's written notice, Laureate, at its sole and exclusive option, may cease performance of its obligations under the new requirements. existing Program by providing not less than [******* (**)] days' written notice and this Agreement shall terminate effective upon expiration of such notice period. (d) In the event that compliance with such new Legal Requirements specifically pertaining Laureate reasonably determines that a conflict exists between US government regulations applicable to Alder’s Product increases or decreases the cost or time required to perform each Program, performance of the Parties shall negotiate an equitable adjustment in Services and/or the price or schedule, or both, to reflect the [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. increase or decrease, Program and the Parties applicable regulations of any foreign governmental agency or regulatory authority, Laureate shall enter into a Program Amendment Order, as herein after definedprovide written notice of same to Customer and Customer will designate, in accordance with Section 6 of this Agreement. Changes to Fujifilm’s facility to entitle it to operate as [***]. d) in the event of a conflict between or among any of the standards set forth in this Section 3writing, Fujifilm shall comply with the most stringent standard which is permitted by law; in the event of a conflict in Applicable Law, the Parties shall agree on which Applicable Law regulations shall be followed by Fujifilm Laureate in its performance of each the Services and/or the Program to comply with regulatory requirements and advance (the applicable Program"Customer Regulatory Designation"). e) Alder shall notify Fujifilm promptly if any Product is the subject of a recall, withdrawal, field alert or similar action (collectively a “Recall”), and provide Fujifilm with a copy of all documents relating to such Recall. Fujifilm shall reasonably cooperate with Alder in connection with any Recall, [***]. Alder shall [***], and provided further than Alder [***]. For clarity, [***].

Compliance with Government Regulations. a) Fujifilm shall perform each Program in a timely and diligently manner; in accordance with operate the terms and conditions of this Agreement, the applicable SoW and the Quality Agreement; GMP Facility in compliance with Applicable Law and any requirements provided for in the Quality Agreement for all applicable Legal Requirementsaspects of Manufacturing (including but not limited to testing, including cGMP holding, packaging, labeling and delivery of the Product and/or intermediates produced for Sponsor). For clarity, this shall include the obligation for Fujifilm to operate the GMP Facility as compliant with (i) the U.S. Federal Food, Drug and Cosmetics Act, as applicableamended (21 U.S.C. et seq.); in compliance with standard operating procedures , (ii) U.S. regulations found at 21 CFR Parts 11, 210, 211, 600, & 610, (iii) ICH Q7 GMP Guidance for Active Pharmaceutical Ingredients, (iv) EC Directive 2003/94/EC, (v) the EC Guide to Good Manufacturing Practice for Medicinal Products and protocols already in place at Fujifilm Division 2 of the Food and Drug Regulations (Canada), (vi) the latest Health Canada, FDA and EMA guidance documents all pertaining to manufacturing and quality control practice and (vii) the good manufacturing practices required by any other Regulatory Authority to the extent such required practices do not contradict or negate the requirements or guidance documents issued by FDA or EMA, all as agreed upon by the Parties updated, amended and revised from time to time; and in compliance with all reasonable written directions and requests of Aldertime (collectively, “cGMP”). Fujifilm shall manufacture GMP Product not permit debarred persons to participate in compliance with the Process Specification, cGMP and all other applicable Legal RequirementsProgram or persons for whom debarment is pending or threatened. Fujifilm shall use the applicable Facility undertake commercially reasonable steps to perform each Program, and shall not use a different facility without the prior written consent of Alder. Fujifilm warrants [***]. This clause is a material clause of this Agreement, and Fujifilm shall promptly notify Alder if it becomes of aware of [***]prevent such participation. b) Alder acknowledges Sponsor shall have the sole right and responsibility for determining regulatory strategy, decision and actions relating to the Program and the Product. Subject to each Party’s contractual obligations under this Agreement, Fujifilm shall have the sole right and responsibility for determining regulatory strategy, decision and actions to the extent relating to (i) the Facilities; (ii) Fujifilm’s quality systems; or (iii) any requirement imposed directly on Fujifilm by a Regulatory Authority, provided that a Regulatory Authority requirement shall not be considered to be “a requirement imposed directly on Fujifilm has consulted by a Regulatory Authority” if it is applicable to or imposed on Sponsor regarding the services provided by Fujifilm with Alder respect to the Product, but is not applicable to other Fujifilm’s client in designing each Program in a manner consistent respect to Fujifilm’s services provided to them. Fujifilm hereby [**], as of the Effective Date, [**] Sponsor with current U.S. and European regulatory guidelinescommercial supply of Product or otherwise complying with its obligations hereunder. Notwithstanding the foregoing, while Fujifilm [***], ] Sponsor will consult with Fujifilm in respect to and prior to any action that may be reasonably expected to impact Fujifilm’s obligations with respect to the Product. [***]] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. Alder shall have responsibility for determining [***]. The foregoing shall not be construed in derogation An unredacted version of Fujifilm’s obligations set forth in Section 3(a) abovethis exhibit has been filed separately with the Commission. c) Should any such applicable Legal Requirements changerequirements of Regulatory Authorities change or should the mutually agreed upon expansion of the definition of Regulatory Authorities impact Fujifilm’s regulatory obligations hereunder, Fujifilm will [***] promptly notify the other Party of such change and the effect on the Program, and Fujifilm will use reasonable efforts to satisfy the new requirements. In the event that compliance with such new Legal Requirements specifically pertaining applicable regulatory requirements necessitates performing additional studies or other work not reasonably expected and anticipated as part of routine commercial manufacturing, Fujifilm will submit to Alder’s Product increases or decreases the cost or time required to perform each Program, the Parties shall negotiate an equitable adjustment in the price or schedule, or both, to reflect the [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. increase or decrease, and the Parties shall enter into Sponsor a Program Amendment Order, as herein after defined, Change Order in accordance with Section 6 10 of this Agreement. Changes to Fujifilm’s facility to entitle it to operate as [***]. d) in the event of a conflict between or among any of the standards set forth in Subject to this Section 34, Fujifilm shall comply with the most stringent standard which is permitted by law; in the event of a conflict in Applicable Lawgovernment regulations applicable to the performance of the Program, the Parties shall agree on which Applicable Law shall be followed by Sponsor and Fujifilm will [**] in its performance of each Program the Program; provided, however, that Fujifilm shall not be required to comply with regulatory requirements and advance the applicable Program[**]. e) Alder shall If Fujifilm receives any contact or communication from any Regulatory Authority governing commercial licensing of the Product, Fujifilm will (i) notify Fujifilm promptly if any Product is the subject of a recall, withdrawal, field alert or similar action (collectively a “Recall”), Sponsor and provide Fujifilm Sponsor with a copy copies of all documents relating any such communication (to such Recall. Fujifilm shall reasonably cooperate with Alder in connection with any Recall, the extent the communication relates to the Program) within [***]. Alder shall ] of Fujifilm’s determination that such communication relates to the Program (but not to exceed [***]] of Fujifilm’s receipt of such communication) and (ii) comply with all reasonable requests by Sponsor with respect to any actions to be taken or responses to be made to any such Regulatory Authority. Fujifilm will promptly inform Sponsor in the event that any such Regulatory Authority takes any action against Fujifilm for any reason that could be reasonably expected to have an effect on Fujifilm’s performance of the Program. Unless required by Applicable Law, Fujifilm will have no contact or communication with any such Regulatory Authority regarding the Product without the prior written consent of Sponsor, which consent will not be unreasonably withheld. If Fujifilm is required by Applicable Law to contact or communicate with any Regulatory Authority regarding the Product, Fujifilm shall provide Sponsor with reasonable prior notice to allow Sponsor the opportunity to participate in any such contact or communication, to the maximum extent permitted by law. In the event of an inspection of Fujifilm by a Regulatory Authority that pertains to Product, Fujifilm shall allow Sponsor and provided further than Alder its representatives to attend and participate in such inspection. The Quality Agreement shall govern with respect to obligations related to the Parties’ notifications and submissions to a Regulatory Authority governing the commercial license of the Product. f) Fujifilm shall secure and maintain in good order, at its sole cost and expense, such current governmental registrations, permits and licenses as are required by any Regulatory Authority or otherwise required by any Applicable Law in order for Fujifilm to perform its obligations under this Agreement. g) If Fujifilm receives notice of action or threat of action with respect to its debarment or debarment of any individual involved in the performance of Fujifilm’s obligations hereunder during the Term of this Agreement: (i) Fujifilm shall so notify Sponsor immediately and (ii) Sponsor shall have the right to terminate this Agreement immediately upon written notice. h) If Sponsor receives notice of action or threat of action with respect to its debarment or debarment of any individual involved in the performance of Sponsor’s obligations hereunder during the Term of this Agreement (i) Sponsor shall so notify Fujifilm immediately and (ii) in the event of Sponsor’s actual debarment, Fujifilm shall have the [***]] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. For clarity, [***]An unredacted version of this exhibit has been filed separately with the Commission.