Common use of Development and Regulatory Activities Clause in Contracts

Development and Regulatory Activities. (a) Orion and its Affiliates, and, to Orion’s Knowledge, their licensees and partners have conducted, or have caused their respective contractors or consultants to conduct, their development and manufacturing of Dexmedetomidine Products, including GLP and non-GLP preclinical studies and clinical studies for Dexmedetomidine Products, in accordance with (i) applicable laws or regulations, (ii) the standards of the relevant Regulatory Authorities, and (iii) scientific standards applicable to the conduct of such studies and activities; in each case of the country in which and at the time such studies are or were conducted. Neither Orion nor its officers, employees or subcontractors, has made an untrue statement of a material fact to any Regulatory Authority with respect to any Dexmedetomidine Product, or has knowingly failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to a Dexmedetomidine Product. During the term of this Agreement, Orion shall not, and shall cause its officers, employees and subcontractors not to, knowingly make any untrue statement of material fact to any Regulatory Authority with respect to the Dexmedetomidine Product, or knowingly fail to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the Dexmedetomidine Product. (b) In the course of its Development or manufacturing of any Dexmedetomidine Products, Orion has not conducted any activities in violation of applicable laws and regulations of the country in which and at the time such studies were conducted, including then currently applicable Good Laboratory Practices (“GLP”), current Good Clinical Practices (“GCP”), and current Good Manufacturing Practices (“cGMP”) or similar or corresponding regulations or guidelines. Specifically with respect to A▇▇▇▇▇/Hospira’s NDA for Precedex in the United States, to which Orion has a right of reference, to Orion’s Knowledge, preclinical toxicological work was conducted in accordance with then-current GLPs, all pivotal NDA clinical studies were conducted in accordance with then-current GCPs, and all manufacturing information met GMP standards. To the Knowledge of Orion as of the Effective Date, there are no problems that would reasonably require that any previous or current Development, manufacturing or Commercialization activities by Orion or its Affiliates be materially delayed, suspended or abandoned before their completion. (c) To Orion’s Knowledge, neither Orion nor any of its Affiliates has employed, and Orion and its Affiliates will not knowingly employ, any personnel, and has not knowingly used and will not knowingly use, in connection with the Development of Dexmedetomidine Product, a contractor or consultant, debarred by the FDA (or subject to a similar sanction of a Regulatory Authority outside the United States), or who is subject of an FDA debarment investigation or proceeding (or similar proceeding of a Regulatory Authority outside the United States). (d) As of the Effective Date, neither Orion, nor any of its Affiliates, nor, to Orion’s Knowledge, any of their respective licensees, partners or subcontractors, has received any notice in writing or otherwise has knowledge of any facts which have led Orion to believe that any of the Regulatory Filings relating to Dexmedetomidine Product are not currently in good standing with, the FDA or any other Regulatory Authority. As of the Effective Date, there are, to Orion’s Knowledge, no inquiries, actions or other proceedings pending before or, to Orion’s Knowledge, threatened by, any Regulatory Authority or other government agency with respect to (i) Orion Dexmedetomidine API; (ii) a Dexmedetomidine Product; or (iii) any facility where Orion Dexmedetomidine API is manufactured except to the extent such proceeding with respect to a facility does not materially interfere with Orion’s ability to supply to Licensee Dexmedetomidine API that meets cGMP standards.

Development and Regulatory Activities. (a1) Orion and its Affiliates, and, to Orion’s Knowledge, their licensees and partners have conducted, or have caused their respective contractors or consultants to conduct, their development and manufacturing of Dexmedetomidine Fadolmidine Products, including GLP and non-GLP preclinical studies and clinical studies for Dexmedetomidine Fadolmidine Products, in accordance with (i) applicable laws or regulations, (ii) the standards of the relevant Regulatory Authorities, and (iii) scientific standards applicable to the conduct of such studies and activities; in each case of the country in which and at the time such studies are or were conducted. Neither Orion nor its officers, employees or subcontractors, has made an untrue statement of a material fact to any Regulatory Authority with respect to any Dexmedetomidine Fadolmidine Product, or has knowingly failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to a Dexmedetomidine Fadolmidine Product. During the term of this Agreement, Orion shall not, and shall cause its officers, employees and subcontractors not to, knowingly make any untrue statement of material fact to any Regulatory Authority with respect to the Dexmedetomidine Fadolmidine Product, or knowingly fail to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the Dexmedetomidine Fadolmidine Product. (b2) In the course of its Development or manufacturing of any Dexmedetomidine Fadolmidine Products, Orion has not conducted any activities in violation of applicable laws and regulations of the country in which and at the time such studies were conducted, including then currently applicable Good Laboratory Practices (“GLP”), current Good Clinical Practices (“GCP”), and current Good Manufacturing Practices (“cGMP”) or similar or corresponding regulations or guidelines. Specifically with respect to A▇▇▇▇▇/Hospira’s NDA for Precedex in the United States, to which Orion has a right of reference, to Orion’s Knowledge, preclinical toxicological work was conducted in accordance with then-current GLPs, all pivotal NDA clinical studies were conducted in accordance with then-current GCPs, and all manufacturing information met GMP standards. To the Knowledge of Orion as of the Effective Date, there are no problems that would reasonably require that any previous or current Development, manufacturing or Commercialization activities by Orion or its Affiliates be materially delayed, suspended or abandoned before their completion. (c3) To Orion’s Knowledge, neither Orion nor any of its Affiliates has employed, and Orion and its Affiliates will not knowingly employ, any personnel, and has not knowingly used and will not knowingly use, in connection with the Development of Dexmedetomidine Fadolmidine Product, a contractor or consultant, debarred by the FDA (or subject to a similar sanction of a Regulatory Authority outside the United States), or who is subject of an FDA debarment investigation or proceeding (or similar proceeding of a Regulatory Authority outside the United States). (d4) As of the Effective Date, neither Orion, nor any of its Affiliates, nor, to Orion’s Knowledge, any of their respective licensees, partners or subcontractors, has received any notice in writing or otherwise has knowledge of any facts which have led Orion to believe that any of the Regulatory Filings relating to Dexmedetomidine Fadolmidine Product are not currently in good standing with, the FDA or any other Regulatory Authority. As of the Effective Date, there are, to Orion’s Knowledge, no inquiries, actions or other proceedings pending before or, to Orion’s Knowledge, threatened by, any Regulatory Authority or other government agency with respect to (i) Orion Dexmedetomidine Fadolmidine API; (ii) a Dexmedetomidine Fadolmidine Product; or (iii) any facility where Orion Dexmedetomidine Fadolmidine API is manufactured except to the extent such proceeding with respect to a facility does not materially interfere with Orion’s ability to supply to Licensee Dexmedetomidine Fadolmidine API that meets cGMP standards.

Development and Regulatory Activities. (a) Orion and its Affiliates, and, to Orion’s Knowledge, their licensees and partners have conducted, or have caused their respective contractors or consultants to conduct, their development and manufacturing of Dexmedetomidine Products, including GLP and non-GLP preclinical studies and clinical studies for Dexmedetomidine Products, in accordance with (i) applicable laws or regulations, (ii) the standards of the relevant Regulatory Authorities, and (iii) scientific standards applicable to the conduct of such studies and activities; in each case of the country in which and at the time such studies are or were conducted. Neither Orion nor its officers, employees or subcontractors, has made an untrue statement of a material fact to any Regulatory Authority with respect to any Dexmedetomidine Product, or has knowingly failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to a Dexmedetomidine Product. During the term of this Agreement, Orion shall not, and shall cause its officers, employees and subcontractors not to, knowingly make any untrue statement of material fact to any Regulatory Authority with respect to the Dexmedetomidine Product, or knowingly fail to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the Dexmedetomidine Product. (b) In the course of its Development or manufacturing of any Dexmedetomidine Products, Orion has not conducted any activities in violation of applicable laws and regulations of the country in which and at the time such studies were conducted, including then currently applicable Good Laboratory Practices (“GLP”), current Good Clinical Practices (“GCP”), and current Good Manufacturing Practices (“cGMP”) or similar or corresponding regulations or guidelines. Specifically with respect to A▇▇▇▇▇▇/Hospira’s NDA for Precedex in the United States, to which Orion has a right of reference, to Orion’s Knowledge, preclinical toxicological work was conducted in accordance with then-current GLPs, all pivotal NDA clinical studies were conducted in accordance with then-current GCPs, and all manufacturing information met GMP standards. To the Knowledge of Orion as of the Effective Date, there are no problems that would reasonably require that any previous or current Development, manufacturing or Commercialization activities by Orion or its Affiliates be materially delayed, suspended or abandoned before their completion. (c) To Orion’s Knowledge, neither Orion nor any of its Affiliates has employed, and Orion and its Affiliates will not knowingly employ, any personnel, and has not knowingly used and will not knowingly use, in connection with the Development of Dexmedetomidine Product, a contractor or consultant, debarred by the FDA (or subject to a similar sanction of a Regulatory Authority outside the United States), or who is subject of an FDA debarment investigation or proceeding (or similar proceeding of a Regulatory Authority outside the United States). (d) As of the Effective Date, neither Orion, nor any of its Affiliates, nor, to Orion’s Knowledge, any of their respective licensees, partners or subcontractors, has received any notice in writing or otherwise has knowledge of any facts which have led Orion to believe that any of the Regulatory Filings relating to Dexmedetomidine Product are not currently in good standing with, the FDA or any other Regulatory Authority. As of the Effective Date, there are, to Orion’s Knowledge, no inquiries, actions or other proceedings pending before or, to Orion’s Knowledge, threatened by, any Regulatory Authority or other government agency with respect to (i) Orion Dexmedetomidine API; (ii) a Dexmedetomidine Product; or (iii) any facility where Orion Dexmedetomidine API is manufactured except to the extent such proceeding with respect to a facility does not materially interfere with Orion’s ability to supply to Licensee Dexmedetomidine API that meets cGMP standards.

Development and Regulatory Activities. (a) Orion MacroMed represents, warrants and covenants to Diatos that: 9.3.1 MacroMed will and has conducted or will and has caused its Affiliates, and, to Orion’s Knowledge, their licensees and partners have conducted, or have caused their respective contractors or consultants to conduct, their development and manufacturing of Dexmedetomidine Products, including GLP and non-GLP conduct its preclinical studies and clinical studies for Dexmedetomidine Products, in accordance with (i) applicable laws or regulations, (ii) the known or published standards of the relevant Regulatory AuthoritiesAuthority, and (iii) scientific standards applicable to the conduct of such studies and activities; in each case of the country in which and at the time such studies are or were conducted, and to the extent not inconsistent therewith, such laws, regulations and standards of the United States and any ICH guidelines. Neither Orion MacroMed, any officer, employee of MacroMed, nor its officersto MacroMed’s knowledge, employees or subcontractorsany subcontractor of MacroMed, has made an untrue statement of a material fact to any Regulatory Authority with respect to any Dexmedetomidine Productthe Products, or has knowingly failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to a Dexmedetomidine Product. During the term of this Agreement, Orion MacroMed shall not, and shall cause its officers, employees and subcontractors not to, knowingly make any untrue statement of material fact to any Regulatory Authority with respect to the Dexmedetomidine ProductProducts, or knowingly fail to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the Dexmedetomidine Product. (b) 9.3.2 In the course of its Development or manufacturing development of any Dexmedetomidine Productsthe Product, Orion MacroMed will not conduct and has not conducted any development activities in violation of applicable laws and regulations of the country in which and at the time such studies were conductedregulations, including then currently applicable current Good Laboratory Practices (“GLP”), current Good Clinical Practices (“GCP”), and current Good Manufacturing Practices (“cGMPGMP”) or similar or corresponding regulations or guidelines. Specifically with respect to A▇▇▇▇▇/Hospira’s NDA for Precedex in the United States, to which Orion has a right of reference, to Orion’s Knowledge, preclinical toxicological work was conducted in accordance with then-current GLPs, all pivotal NDA clinical studies were conducted in accordance with then-current GCPs, and all manufacturing information met GMP standards). To the Knowledge knowledge of Orion MacroMed as of the Effective Execution Date, there are no problems that would reasonably require that any previous or current Development, manufacturing or Commercialization development activities by Orion or its Affiliates be materially delayed, suspended or abandoned before their completion. (c) 9.3.3 To Orion’s Knowledgeits knowledge, neither Orion nor any of its Affiliates MacroMed has employed, not employed and Orion and its Affiliates will not knowingly employ, employ any personnel, and has not knowingly used and will not knowingly use, in connection with the Development of Dexmedetomidine Product, use a contractor or consultant, debarred by the FDA (or subject to a similar sanction of a Regulatory Authority outside the United States), or who is subject of an FDA debarment investigation or proceeding (or similar proceeding of a Regulatory Authority outside the United States). (d) 9.3.4 As of the Effective Execution Date, neither Orion, MacroMed nor any of its Affiliates, nor, to OrionMacroMed’s Knowledgeknowledge, any of their respective licensees, partners or its subcontractors, has received any notice in writing or otherwise has knowledge of any facts which have led Orion MacroMed to believe that any of the Regulatory Filings regulatory filings relating to Dexmedetomidine Product are not currently in good standing with, the FDA or any other Regulatory Authority. As of the Effective Execution Date, there are, to Orion’s Knowledge, are no inquiries, actions or other proceedings pending before or, to OrionMacroMed’s Knowledgeknowledge, threatened by, any Regulatory Authority or other government agency with respect to (i) Orion Dexmedetomidine API; (ii) a Dexmedetomidine Product; Product or (iii) any facility where Orion Dexmedetomidine API is manufactured except Products are manufactured, and neither MacroMed nor, to the extent knowledge of MacroMed its subcontractors, has received written notice threatening any such proceeding inquiry, action or other proceeding. 9.3.5 MacroMed has all regulatory approvals that are required to manufacture Product for the conduct of clinical trials being conducted as of the Execution Date, and to its knowledge, such manufacture is in compliance with respect the terms and conditions of such regulatory approvals. All current regulatory approvals are valid and in full force and effect. As of the Execution Date, to a facility does not materially interfere with OrionMacroMed’s ability to supply to Licensee Dexmedetomidine API that meets cGMP standardsknowledge, no suspension, revocation, cancellation or withdrawal of any such regulatory approval is threatened and no cause exists such suspension, revocation, cancellation or withdrawal.