DEVELOPMENT STAGE PRODUCT. Notwithstanding any other provision of this AGREEMENT, the DEVELOPMENT STAGE PRODUCT shall not be an HMR NEWLY DEVELOPED PRODUCT for purposes of this AGREEMENT, and is not subject to the MEDICIS RIGHT OF FIRST OFFER. The parties have agreed to certain matters, rights and obligations pertaining to the DEVELOPMENT STAGE PRODUCT as set forth on Schedule 5.1 hereto, the terms of which are incorporated herein by reference.
DEVELOPMENT STAGE PRODUCT. Notwithstanding any other provision of this AGREEMENT or any provision of the other TRANSACTION DOCUMENTS, and except to the extent that rights or information are lawfully available to a third party (which is not HMR or their AFFILIATES, or their successors, assigns, licensees or sublicensees), for such purposes as are utilized by MEDICIS, its AFFILIATES, their successors and assigns and their licensees and sublicensees, under applicable U.S. Federal statutes or the regulations or rules promulgated thereunder (including those rights that any such third party would have under the U.S. Federal Food, Drug and Cosmetic Act, the U.S. Freedom of Information Act or any other U.S. Federal statute, but excluding (A) rights triggered or provided by any contractual or license rights granted to any such third party by HMR or their AFFILIATES or their successors and assigns or their licensees and sublicensees or (B) information which enters the public domain due to, by or pursuant to the action or inaction, directly or indirectly, of MEDICIS, its AFFILIATES, their successors and assigns and their licensees and sublicensees), MEDICIS, its AFFILIATES, their successors and assigns and their licensees and sublicensees shall not directly or indirectly access, review, disclose, reference or utilize the Drug Master Files, the NDAs or the INTELLECTUAL PROPERTY (including but not limited to New Drug Applications for the MEDICIS NEWLY DEVELOPED PRODUCTS, any IMPROVEMENTS, the HMR NEWLY DEVELOPED PRODUCTS, the DEVELOPMENT STAGE PRODUCT, or the additional Loprox PRODUCT discussed in Schedule 13 hereto, or any other regulatory approval based upon, arising out of or related to the Drug Master Files, the NDAs, such New Drug Applications or the INTELLECTUAL PROPERTY (other than the TRADEMARKS) or any information contained therein) (i) for the development, regulatory approval and/or commercialization of a COMPETING NAIL TOPICAL PRODUCT, or (ii) that relate to the ACTIVE INGREDIENTS; provided, however, that in no event or circumstance whatsoever shall the existence of such information in the public domain be deemed a release, modification or waiver of the restrictions on rights of reference specified in this paragraph (c) or in paragraph 2.5(b) hereof unless a third party (which is not HMR, their AFFILIATES, or their successors and assigns or their licensees or sublicensees) would have rights of reference to such information (except to the extent (A) such rights are triggered or provide...
