Grant by Jerini. During the Term, Jerini will provide to Kos access during regular business hours and at mutually agreeable times to all other data (including pre-clinical and clinical data and data) and all filings (including IND and NDA dossiers) with respect to Icatibant and Licensed Product applicable to the Licensed Field and that are Controlled by Jerini. Further, Jerini hereby grants Kos the right to use and reference all data (including pre-clinical and clinical data) and regulatory filings and approvals Controlled by Jerini relating to Licensed Product in the Licensed Field (including any NDAs or M▇▇▇) for the purpose of developing and commercializing Licensed Product in the Licensed Field and in the Territory in accordance with the terms of this Agreement (including in Kos’s regulatory filings for the Licensed Product in the Territory). Such right of reference will be transferable to Kos’s Affiliates and Sublicensees. To the extent that any such data or regulatory filings are held by a Third Party, Jerini will arrange direct access to the portions of such data and regulatory filings that are relevant to the activities of Kos contemplated by this Agreement. Further, upon request of Kos, Jerini will make available necessary personnel to participate in meetings with regulatory authorities within the Territory as may be required by Kos in connection with the development and obtaining Marketing Approval of Licensed Products in the Territory in the R/A Field;* * *. Any information obtained by Kos pursuant to this Section 4.2.2 will be deemed Confidential Information of Jerini.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Kos Pharmaceuticals Inc), Collaboration and License Agreement (Kos Pharmaceuticals Inc)