ITEM 1.01 ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
Pursuant to the Agreement, the Parties will develop a collaboration and jointly administer activities under a product development plan that will include identifying at least one acceptable third party marketer (a "Marketer"). Each Marketer would enter into an agreement with Capsugel to further develop, market and distribute the Marketer's consumer health nature identical synthetic astaxanthin products that are formulated with Capsugel's technologies. The terms and conditions of an agreement with a Marketer and Capsugel will be subject to the Company's reasonable approval.
The Agreement provides that Capsugel shall share revenues with
Capsugel will, among other matters, perform the development work necessary to formulate, analytically develop and take all other developmental actions necessary or required to develop the synthetic axtaxanthin product and manufacture pre-clinical and clinical batches for use by the parties.
The Agreement establishes the respective obligations of the Parties for, among other matters, obtaining regulatory approval of product candidates, developing manufacturing processes, performing animal and human studies and the allocation and sharing of costs that will be incurred for such studies. The Agreement also includes customary indemnification provisions. The term of the Agreement is for an initial stated period, subject to specified renewal provisions, subject to earlier termination if the mutually agreed commercial milestones are not achieved.
The foregoing description of the Agreement does not purport to be complete, and is qualified in its entirety by reference to the Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K. Portions of Exhibit 10.1 to this Current Report on Form 8-K have been omitted and filed separately with the
ITEM 7.01 REGULATION FD DISCLOSURE
In accordance with General Instruction B.2 of Form 8-K, the information set forth herein and in the press release is deemed to be "furnished" and shall not be deemed to be "filed" for purposes of the Exchange Act. The information set forth in Item 7.01 of this Current Report on Form 8-K shall not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely to satisfy the requirements of Regulation FD.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS
(d) Exhibits Exhibit No. Description 10.1 Collaboration Agreement, dated as of
August 18, 2014, by and between Capsugel US, LLCand its affiliates and Cardax, Inc.and its affiliates* 99.1 Press Release, dated August 19, 2014
* Confidential treatment has been requested for this exhibit, and confidential portions have been filed separately with the