CONFIDENTIAL TREATMENT
AGREEMENT
This Agreement, dated as of July 30, 2001, (the "Effective Date") is by and, between Albany Molecular Research, Inc., a Delaware corporation, located at 21 Corporate Circle, P. O. Box 15098, Albany, New York 15098 ("AMRI"), and CUBIST Pharmaceuticals, Inc., a Delaware corporation with a place of business at 24 Emily Street, Cambridge, Massachusetts 02139 ("CUBIST").
NOW, THEREFORE, in consideration of the mutual promises and other good and valuable consideration, the parties agree as follows:
SECTION 1.- Definitions.
The terms used in this Agreement have the following meaning:
1.1 "Affiliate" with respect to any Party, shall mean any Person whether de jure or de facto, controlling, controlled by, or under common control with, such Party. For these purposes, "control" shall refer to (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract or otherwise or (b) the ownership, directly or indirectly, of at least 50% (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction of the voting securities or other ownership interest of a Person).
1.2 "AMRI Background Patents" means claims of any and all patents and patent applications anywhere in the world that are owned by AMRI as of the Effective Date and that claim a [*] that was used by AMRI in producing AMRI Derivatives pursuant to the Research Program.
1.3 "AMRI Derivative" means (i) a compound (s) prepared by AMRI pursuant to the Research Program and that is either a derivative of [*] created utilizing [*] or bio catalysis technology developed or practiced by AMRI, or a derivative of any such derivative created utilizing [*] or bio catalysis technology developed or practiced by AMRI, and/or (ii) compound (s) prepared by CUBIST or its Affiliates or sublicensees that are [*] in (i).
1.4 "AMRI Process Technology" means the data, know-how and information that is required to produce [*] used by AMRI in the Research Program, whether patented or not.
1.5 "Biocatalytic process" means Biocatalytic procedure or bio catalysis used by AMRI to prepare derivatives of [*] and, without limitation, any process or procedure using [*] under this Agreement.
1.6 "Combination Product" shall mean a CUBIST Product that includes an AMRI Derivative or a CUBIST Derivative and one or more additional active agents.
1.7 "CUBIST Derivative" means a compound prepared by CUBIST or its Affiliates or sublicensees or any of their agents, consultants or collaborators that is directly based upon or directly derived from an AMRI Derivative.
1.8 "CUBIST Product" means either an (a) "AMRI Derivative Product" which is a product (i) the making, using, selling, offering for sale, or import of which would, but for the licenses granted herein, infringe a valid claim of a Research Patent or (ii) that includes an AMRI Derivative; or (b)"CUBIST Derivative Product" which is a product containing a CUBIST Derivative.
1.9 "FDA" means the United States Food and Drug Administration, or the successor thereto.
1.10 "FTE" means a full time equivalent person year of scientific or technical work, working forty hours per week for at least 48 weeks.
1.11 "First Commercial Sale" means, with respect to any CUBIST Product in a country of the Territory, the first sale of a CUBIST Product by CUBIST, its Affiliates, distributors or sublicensees to a Third Party, in such country anywhere in the Territory, after all required marketing and pricing approvals have been granted, or otherwise permitted, by the governing health authority of such country. "First Commercial Sale" shall not include the sale of any CUBIST Product for use in clinical trials or for compassionate use prior to the grant of regulatory approval.
1.12 "IND" shall mean an investigation a l new drug application filed with the FDA for approval to commence human clinical trials, or the equivalent application in other countries or regulatory jurisdictions.
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