Regulatory Data. It shall store and provide the other Party access to source data supporting all Regulatory Filings and Regulatory Approvals for the longer of (i) [**] or (ii) the time period required by any applicable Regulatory Authority in the Territory.
Regulatory Data. In accordance with procedures established by the JDC, each Party shall provide to the other Party on a timely basis access to or copies of all material pre-clinical and clinical data generated or compiled pursuant to the Development Plan with respect to Regulatory Materials maintained by such Party (via electronic copies of such data in a form that may be analyzed and manipulated by the other Party).
Regulatory Data. (i) Licensee will obligate each and every Sublicensee to disclose and make available to Licensee in a timely fashion all Regulatory Data in such Sublicensee’s possession and allow Licensee to disclose such Regulatory Data to MTI and allow further disclosures to any Other Licensees. For clarity, the Sublicensee will be obligated to disclose to Licensee (A) any final study report containing Regulatory Data upon the completion of such final study report, and (B) the underlying raw data supporting such final study report, but only to the extent that such raw data or any sub-analysis of such data are reasonably deemed necessary or appropriate to be directly submitted to a Regulatory Authority.
Regulatory Data. Upon early termination of this Agreement for any reason (but not expiration), and for a period of [*] after the effective date of such termination (or for such other period of time mutually agreed to by the parties in writing), EMORY shall have the right to review, and/or have a third party review on its behalf, subject to EMORY entering into a confidentiality agreement with such third party containing provisions at least as restrictive as those contained in this Agreement (hereinafter referred to as the “3rd Party CDA”) and subject to EMORY being responsible and liable to ALIMERA for any breaches of the terms of confidentiality under the 3rd Party CDA by such third party, [*] (the “Summary Development Information”). For the avoidance of doubt, the parties acknowledge and agree that the Summary Development Information does not contain all [*]. The Summary Development Information shall be made available by ALIMERA for review at a location to be designated by ALIMERA and for a reasonable period of time. In the event that EMORY enters into a license agreement with a third party covering a Licensed Product(s) after EMORY or the third party has reviewed the Summary Development Information, and Emory or such third party requests that ALIMERA provide all [*] (the “Development Information”), ALIMERA shall use reasonable efforts to provide EMORY or such third party with full and complete copies of all Development Information in its possession or control, which EMORY or such third party may use and * Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. CONFIDENTIAL TREATMENT REQUESTED reference, only after (x) EMORY or such third party reimburses ALIMERA for all the documentable costs incurred by ALIMERA and ALIMERA’s Affiliates and sublicensees in connection with the clinical development, regulatory approval process and commercialization with respect to such Licensed Product(s) and (y) ALIMERA and EMORY and/or such third party, as applicable, agree to reasonable terms related to the use of the Development Information, including an agreement by EMORY and/or such third party, as applicable, to indemnify ALIMERA in connection with EMORY’s or such third party’s use of the Development Information. For the purpose of clarity, the 3rd Party CDA will expire upon the fulfillment of Subarticles 12.7(x) and 12.7(y) herein by EMORY and/or such third party.
Regulatory Data. Centogene will maintain and store all regulatory data relating to Contract DBS Test Kits, such as results of experimentation and testing, processes, laboratory records, clinical, analytical and quality control data, data analyses, reports, manufacturing data, techniques, processes and summaries, other information contained in the technical files of the Contract DBS Test Kits and any updates thereof.
Regulatory Data. Each Party shall provide to the other Party on a timely basis copies of all material pre-clinical and clinical data generated or compiled pursuant to a Global Development Plan, Annual Development Plan or U.S. Commercialization Plan (via electronic copies of such data in a form that may be analyzed and manipulated by the other Party).
Regulatory Data. (i) Subject to Section 3.7.3, each Party shall promptly provide to the other Party copies of or access to all non-clinical data, Clinical Data and other Information, results and analyses with respect to any Party Development Activities that are Controlled by such Party or any of its Affiliates, including any such data, results and analysis Controlled by such Party or any of its Affiliates and resulting from or relating to Unilateral Activities of such Party or any of its Affiliates (collectively “Regulatory Data”), when and as such Regulatory Data becomes available. Use of such Regulatory Data shall be subject to Section 3.7.3.
Regulatory Data. Each Party shall promptly provide to the other Party copies of or access to all non-clinical data and clinical data, and other information, results, and analyses with respect to any development activities that are controlled by such Party or any of its Affiliates, collaborators or licensees (collectively, “Regulatory Data”), when and as such Regulatory Data becomes available. At the very least, CELSION shall provide IMPATIENTS with the GMP certificate of the manufacturing site, if applicable the Product’s GMP certificate, the Manufacturer’s manufacturing license for the Product, Product stability data and certificate of analysis, and all other Know How that IMPATIENTS is required to include, or may need to include, in its Early Access Approval applications.
Regulatory Data. (i) Each Party shall promptly provide to the other Party access to, pursuant to Section 2.2.2(v), or copies of all non-clinical data and Clinical Data, and other Information, results, and analyses with respect to any Development activities that are Controlled by such Party or any of its Affiliates (collectively, “Regulatory Data”) when and as such Regulatory Data becomes available. Without limiting the foregoing, Ablynx shall, within […***…] Days of the Effective Date, provide to AbbVie, in such form and format as AbbVie may reasonably request, (a) copies of all correspondence, as of the Effective Date, to and from any Regulatory Authority that relates to the Licensed Compound or Licensed Product, and (b) all Regulatory Documentation then in Ablynx’s possession or under Ablynx’s Control. CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Regulatory Data. The regulatory data it provides to the other Party shall be complete and accurate in all material respects.
