Memorandum of Understanding and Supply & Services Agreement between Corcept Inc. and [Supplier] for API 1073
Contract Categories:
Business Operations
›
Supply Agreements
Summary
This agreement is between Corcept Inc. and a supplier for the development and manufacturing of API 1073, which Corcept will study 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. Both parties will share costs for technology transfer and development, with Corcept committing to a minimum annual purchase after product launch. Key project milestones and payment terms are outlined, with some details confidential.
EX-10.11 6 dex1011.txt MEMORANDUM OF UNDERSTANDING, DATED JUNE 12, 2000 EXHIBIT 10.11 *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