Common use of Regulatory Documentation Clause in Contracts

Regulatory Documentation. With respect to the Lead Product, Dicerna and its Affiliates shall generate, prepare, maintain and retain all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information shall be true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” means: all (i) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (iii) supplements or changes to any of the foregoing following Regulatory Approval; and (iv) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((i), (ii), (iii) and (iv)) relating to the Lead Product Directed To an Initially Named Target.

Regulatory Documentation. With respect to the Lead Product, Dicerna Avidity and its Affiliates shall generatehave generated, prepareprepared, maintain maintained and retain retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information shall be is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” meansmeans all: all (ia) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (iib) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (iiic) supplements or changes to any of the foregoing following Regulatory Approval; and (ivd) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((ia), (iib), (iiic) and (ivd)) relating to the Lead Product a Collaboration Target and Compounds Directed To an Initially Named Against a Collaboration Target.

Regulatory Documentation. With respect to the Lead Product, Dicerna Precision and its Affiliates shall generatehave generated, prepareprepared, maintain maintained and retain retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information shall be is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” meansmeans all: all (ia) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (iib) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (iiic) supplements or changes to any of the foregoing following Regulatory Approval; and (ivd) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((i), (ii), (iii) and (iva)–(d)) relating to a Collaboration Target in the Lead Product Field and Licensed Products Directed To an Initially Named TargetAgainst a Collaboration Target in the Field.

Regulatory Documentation. With respect to the Lead Product, Dicerna Precision and its Affiliates shall generatehave generated, prepareprepared, maintain maintained and retain retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information shall be is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” meansmeans all: all (ia) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (iib) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (iiic) supplements or changes to any of the foregoing following Regulatory Approval; and (ivd) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((i), (ii), (iii) and (iva)–(d)) relating to a Licensed Product in the Lead Product Directed To an Initially Named TargetField.

Regulatory Documentation. With respect to the Lead Product, Dicerna Centrexion and its Affiliates shall generatehave generated, prepareprepared, maintain maintained and retain retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information shall be is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” meansmeans all: all (i) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (iii) supplements or changes to any of the foregoing following Regulatory Approval; and (iv) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((i), (ii), (iii) and (iv)) relating to the Lead Product Directed To an Initially Named Targeta Compound or Product.

Regulatory Documentation. With respect to the Lead Product, Dicerna Alnylam and its Affiliates shall generatehave generated, prepareprepared, maintain maintained and retain retained all Regulatory Documentation that is required to be maintained or retained retained, in all material respects, pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law Laws and all such information shall be is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” meansmeans all: all (i) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (iii) supplements or changes to any of the foregoing following Regulatory Approval; and (iv) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((i), (ii), (iii) and (iv)) relating to the Lead Product Directed To an Initially Named Target.a Product. ||