Common use of Regulatory Data Clause in Contracts

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. (ii) Ablynx shall support AbbVie, as may be reasonably necessary or appropriate, in obtaining Regulatory Approval for the Licensed Compound or Licensed Products, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and any applicable Development Plan.

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 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 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. (ii) Ablynx shall support AbbVie, as may be reasonably necessary or appropriate, in obtaining Regulatory Approval for the Licensed Compound or Licensed Products, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and any applicable Development Plan.