PIRS CoDev Option Notice. Subject to Section 4.3.6.2, and pursuant to the applicable guidelines set forth in Section 4.4.2.3, for applicable Collaboration Products, SGEN may or shall (depending on the Collaboration Product) issue a written notice (“Option Notice”) triggering a PIRS CoDev Option after Key Data from the Clinical Study preceding the first Pivotal Clinical Study is available and prior to initiating such Pivotal Clinical Study with respect to such Collaboration Product (the “CoDev Decision Point”). Concurrently with the Option Notice, to the extent not already provided to PIRS, SGEN shall provide to PIRS: (a) all material clinical Data to be included in the clinical study report (CSR), but in no case less than Key Data, for all Clinical Studies conducted prior to initiation of the first Pivotal Study in the form then available (i.e., even if a final CSR may not yet be available for all Clinical Studies, but including the final CSR for Clinical Studies, for which it is available), including, upon PIRS’ reasonable request, providing PIRS with access to the underlying raw data (which may require a PIRS employee to travel to Clinical Study sites), (b) all material preclinical Data as well as all material Data related to CMC Development work conducted on such Collaboration Product (including, upon PIRS’ reasonable request, providing PIRS with access to the underlying raw data), (c) documentation of all substantive interactions with Competent Authorities as well as Regulatory Materials (e.g. the IND/IMPD), (d) a written report on the market potential for such Collaboration Product, including the competitive landscape with a form and content as decided by SGEN, but no less detailed than the report that SGEN has prepared for its internal use, (e) a Development plan and related budget for the Collaboration Product including a regulatory strategy for obtaining Marketing Approval from the FDA for the United States and the EMA for the EU[***] Markets for the Collaboration Product (the “CoDev Product Plan” and corresponding budget, the “Joint Development Budget”), provided that such initial CoDev Product Plan shall not contain Pivotal Clinical Studies in more than [***] Indication and not more than [***] Pivotal Clinical Studies in such Indication for such Collaboration Product, and (f) an accounting of the Reimbursable [***]. The initial CoDev Product Plan shall also include an estimate of the number of field sales representatives and medical science liaisons required for the conti...
