definiens: ( as defined in 21 CFR314.3(b ) and comparable regulations outside the United States ) with respect to Analytical Data as necessary forAbbott and its permitted assigns and sublicensees to prepare and submit submissions to Regulatory Authorities andmaintain Regulatory Approvals related to a PCR assay to detect MDY88 L265P mutations and related matters . ARTICLE 3COMMERCIALIZATION3.1 Commercialization Plan . [COMPANY], with Idera ’s cooperation, shall commercialize the Diagnostic Test for theDiagnostic Test Intended Use pursuant to the provisions of a commercialization plan, which shall include thefollowing:(a ) the activities to be performed by each Party and the deliverables related thereto;(b ) the timelines for each activity under the Commercialization Plan;(c ) the overarching commercial goals including the availability and distribution of the Diagnostic Test;(d ) customer service;(e ) responsibilities for and restrictions on public relations activity / Direct - To - Consumer and other promotionaladvertising activity;(f ) coordination of the pre - launch / launch and post launch of [COMPANY] / Idera sales teams and scientific teams;(g ) forecasting and measurement of sales and distribution data, including reporting of sales units of theDiagnostic Test to Idera and the Idera Product to Abbott;(h ) the establishment of for each market . Such launch success factors shall beagreed upon by the Parties prior to any launch;(i ) activities to be performed post - launch with respect to the Diagnostic Test Intended Use, including fulfillingany commitment(s ) imposed by Regulatory Authorities;(j ) plans for manufacturing and supplying the Diagnostic Test ; and(k ) plans for maintaining acceptable levels of regulatory and GMP / GLP compliance during development, manufacture and marketing of the Diagnostic Test, including responsibility for timely and comprehensive resolution ofany compliance findings or actions of Regulatory Authorities during audits ( pre and post - approval)(as amended from time to time, the ) . The initial Commercialization Plan is attached heretoas Exhibit D. The Parties acknowledge that the initial Commercialization Plan does not address all of the items setforth above, but the Parties agree that, as soon as practicable following the Effective Date, the initialCommercialization Plan will be modified andmade more comprehensive pursuant to the provisions of this Agreement . Thereafter, as may be necessary from time - to - time, in particular as the Diagnostic Test gets closer to commercialization, the Commercialization Team Lead shallsuggest appropriate revisions to the Commercialization Plan to the JSC for its prior written review and approval . If theJSC approves such revisions, and the Parties consent in writing to such revisions, then the JSC shall revise theCommercialization Plan accordingly without need for amending this Agreement . The revised Commercialization Planshall thereafter be the Commercialization Plan for all purposes of this Agreement . The Parties shall each use theirCommercially Reasonable Efforts to perform all of their obligations under the Commercialization Plan in accordancewith generally accepted ethical, good sales and marketing practices and in compliance with Applicable Law, providedhowever that [COMPANY] shall have the right to delay First Commercial Sale in accordance with Section 7.9