Memorandum of Understanding and Supply and Services Agreement between Corcept Inc. and [Supplier] for API Development

Summary

Corcept Inc. and a supplier have agreed that the supplier will develop and manufacture the active pharmaceutical ingredient (API) for Corcept’s product, ****1073, which will be studied for psychiatric and cognitive disorders. The supplier will provide both non-GMP and CGMP materials for pre-clinical, clinical, and commercial use, and will also help Corcept connect with dosage form manufacturers. Corcept guarantees a minimum annual purchase after product launch, and both parties will share certain development costs. The agreement outlines project timelines, cost-sharing, and purchase commitments.

EX-10.9 15 dex109.txt MEMORANDUM OF UNDERSTANDING, SUPPLY AND SERVICES AGREEMENT EXHIBIT 10.9 *CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS Memorandum of Understanding Supply and Services Agreement for ****1073 Summary - ------- **** will provide API development and manufacturing functions for ****1073 API to Corcept. This will include Non-GMP, as well as CGMP products for pre-clinical, clinical and commercial requirements. ****1073 will be studied by Corcept for treating patients with psychiatric and cognitive disorders only. In addition, **** is willing to act as a consultant to introduce Corcept to reputable dosage form manufacturers in **** for formulation development and manufacturing. Project Plan - ------------ 1. **** and Corcept will jointly invest in the acquisition of starting materials, equipment and manpower to complete the technology transfer, process development and scale-up studies. The target date to deliver total of **** Non-GMP materials for the planned toxicology study will be August/September, 2000, with smaller quantities (****) possibly available in July/August. 2. Produce **** of CGMP material by year-end of 2000 for clinical studies. 3. Prepare and submit DMF including all processing and analytical information for product registration. 4. Introduce Corcept CMC representative(s) to **** dosage form manufacturers and assist in selecting and establishing a direct working relationship between Corcept and the selected manufacturer. Development Out of Pocket Cost - ------------------------------ Starting material/reagents etc. **** Equipment & other supplies **** **** Manpower **** **** --------------------------------------------------------- Total **** (1) (1) At **** shared costs, Corcept will pay $150,000 Product Costs - ------------- Non-GMP Materials **** GMP Materials **** **** Reduction to be negotiated. Quantities - ---------- 1. Corcept will guarantee minimum purchase of 1 million dollars per year following product launch. 2. **** 1073 volume purchase in calendar year 2001 could be in the range of **** 3. **** 1073 purchase forecast, commencing calendar year 2003, will be between **** annual requirements. ****, Ltd. Corcept Inc. By /s/ **** By Joseph Belanoff Title President Title CEO Date June 1, 2000 Date June 8, 2000 **** By /s/ **** Title President Date June 12, 2000 2