Regulatory Documentation. Avidity and its Affiliates have generated, prepared, maintained and 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 is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” means all: (a) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (b) 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; (c) supplements or changes to any of the foregoing following Regulatory Approval; and (d) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((a), (b), (c) and (d)) relating to a Collaboration Target and Compounds Directed Against a Collaboration Target.
Regulatory Documentation. The Administrative Agent shall have received (i) all documentation and other information required by regulatory authorities under applicable “know your customer” and anti-money laundering rules and regulations, including without limitation, the PATRIOT Act and (ii) to the extent the Borrower or the Company constitute a legal entity customer under 31 C.F.R. § 1010.230, a certification regarding beneficial ownership required by 31 C.F.R. § 1010.230, in each case, that has been requested prior to the Amendment No. 5
Regulatory Documentation. The term “
Regulatory Documentation. On the Reseller’s reasonable request, 3B shall supply the Reseller with all documentation that the Reseller requires to comply with the regulatory requirements of all Governmental Authorities in the Territory.
Regulatory Documentation. From and after the Effective Date, Cerulean shall own, and Calando hereby assigns to Cerulean all right, title and interest in and to, all Regulatory Documentation regarding the Licensed Product and all intellectual property rights therein.
Regulatory Documentation. Subject to Section 3.1(g), as soon as practicably possible after the Effective Date but in no event later than [***] after the Effective Date, Merck will transfer and assign to Urovant all Regulatory Documentation in Merck’s possession or control (including, Subject to Section 8.3, the transfer to Urovant of a database that contains all relevant information regarding adverse events that have been observed during any clinical trials or studies with respect to the Compound prior to the Effective Date). Urovant shall, at its own costs and expenses, make and prepare any and all other regulatory documentation necessary for submission to the applicable Governmental Agency in the Territory for the Regulatory Approvals with the goal of obtaining at least one Marketing Authorization in the Territory. Upon completion of the activities outlined in Section 3.1(g), Merck shall be under no obligation to provide Urovant with regulatory assistance in fulfilling the necessary regulatory activities to achieve Marketing Authorization in the Territory. Notwithstanding anything in this Agreement to the contrary, during the Term and upon reasonable advance request by Urovant, Merck agrees, to the extent readily available, to provide, or otherwise provide access to Urovant with respect to, all raw data underlying or referenced in, any Regulatory Documentation, to the extent not provided as part of the transfer contemplated under Section 3.1(g) and this Section 4.4; provided, however, that if Merck is not able under Applicable Laws to provide access to Urovant to such raw data, and if such data is required or requested by any Governmental Agency, Merck shall provide such raw data to such Governmental Agency, upon request of Urovant; provided, further, that, to the extent available, Merck shall provide such raw data as-is, and is under no obligation to do any further analysis or computation with such data.
Regulatory Documentation. Inovio and its Affiliates have generated, prepared, maintained and retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with good laboratory and clinical practice and Applicable Law and all such information is true, complete and correct and what it purports to be. Inovio has made (and will make) available to MedImmune all Regulatory Documentation, Know-How and other information in its possession or Control related to the Products, Delivery Device and Enabling Technologies and all such Regulatory Documentation, Know-How and other information are (and, if made available after the Effective Date, will be) true, complete and correct.
Regulatory Documentation. Any PROTEON requests for documents or other work product that do not exist as of the date of such request or other substantive requests for assistance in compiling any Regulatory Filing shall constitute Additional Services, and LONZA shall notify PROTEON of the same, and, if PROTEON authorizes such services, LONZA shall prepare a Change Order and invoice PROTEON for such Additional Services in accordance with the Project Rates.
Regulatory Documentation. The status of Marketing Authorizations in each country or other jurisdiction in the Territory as of the Effective Date is accurately reflected on Appendix 1.167 and each of them is in full force and effect. To the Knowledge of ARIAD US, ARIAD US and its Affiliates have generated, prepared, maintained, and retained all material records that are required to be maintained or retained pursuant to and in accordance with good laboratory practice and cGMP and Applicable Law, and all such information is true, complete and correct. Neither ARIAD US nor its Affiliates have received any written notice that any Regulatory Authority with jurisdiction in the Territory over the Products has commenced or will commence any action: (i) to suspend, revoke, not renew or materially amend any Marketing Authorization held by ARIAD US or its Affiliates; or (ii) prohibit production, development, marketing or sale of the Product in the Territory.
Regulatory Documentation. MedImmune hereby assigns to Kolltan all of MedImmune’s right, title and interest in and to any Regulatory Documentation relating to the Licensed Antibody or Licensed Products Controlled by MedImmune as of the Effective Date, including the Existing IND. Promptly after the Effective Date, MedImmune shall (a) transfer and/or disclose to Kolltan all such Regulatory Documentation and (b) provide Kolltan with an executed copy of a letter notifying the FDA of the assignment of the Existing IND to Kolltan. MedImmune shall submit such assignment letter to the FDA as soon as reasonably possible following the Effective Date and shall promptly notify Kolltan of MedImmune’s correspondence with the FDA with respect to such assignment. Promptly (but in no event more than [**] Business Days) thereafter, Kolltan shall submit to the FDA its acceptance of such transfer and provide MedImmune with written notice of such acceptance. The transfers and disclosures described in clause (a) above shall be made (x) in any manner or form reasonably requested by Kolltan and (y) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense.
