Master Alliance Provisions Guide (MAPGuide)

UC Berkeley, Therapeutics & Diagnostics, Exclusive License Agreement Template

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3.4 Entity Status. LICENSEE will have a continuing responsibility to keep REGENTS informed of the large/small entity status, as defined in 15 U.S.C. §632, of itself and its SUBLICENSEES.



4.6 LICENSEE will collect and guarantee payment of all monies and other consideration due REGENTS from SUBLICENSEES, and deliver all reports due REGENTS and received from SUBLICENSEES.



(a) If REGENTS (to the extent of the actual knowledge of the licensing professional responsible for administration of this case) or a third party discovers and notifies that licensing professional that the INVENTION is useful for an application covered by the LICENSED FIELD OF USE, but for which LICENSED PRODUCTS have not been developed or are not currently under development by LICENSEE, then REGENTS, as represented by the Office of Technology Licensing, will give written notice to LICENSEE, except for: 1) information that is subject to restrictions of confidentiality with third parties, and 2) information which originates with REGENTS’ personnel who do not assent to its disclosure to LICENSEE. LICENSEE will have ninety (90) days to give REGENTS written notice stating whether LICENSEE elects to develop LICENSED PRODUCTS for the application.

(b) If LICENSEE elects to develop and commercialize the proposed LICENSED PRODUCTS for the new application, LICENSEE will submit progress reports or royalty reports to REGENTS pursuant to Article 8 (Progress and Royalty Reports). If LICENSEE elects not to develop and commercialize the proposed LICENSED PRODUCTS for use in the new application, REGENTS may seek (a) third party(ies) to develop and commercialize the proposed LICENSED PRODUCTS for the new application. If REGENTS is successful in finding a third party, it will refer such third party to LICENSEE. If the third party requests a SUBLICENSE under this AGREEMENT, then LICENSEE will report the request to REGENTS within thirty (30) days from the date of such written request. If the request results in a SUBLICENSE, then LICENSEE will report it to REGENTS pursuant to Paragraph 4.3.

4.9 Affordable Access Plan. […] Within thirty (30) days of the REGENTS’ request (but no more often than once annually), LICENSEE agrees to confer with the REGENTS to review LICENSEE’S progress, and to consider in good faith any modifications suggested by the REGENTS, with respect to its Affordable Access Plan (“Progress Discussions”). For clarity, while the REGENTS may invite a designated entity to join either the Initial and/or Progress Discussions under this Paragraph 4.9, such discussions will at all times be made subject to the confidentiality obligations set forth in Article 25 (Confidentiality).


8.1 Progress Reports. For the period beginning [Date], LICENSEE will submit to REGENTS a semi-annual progress report covering LICENSEE’s activities related to the development and testing of all LICENSED PRODUCTS, LICENSED SERVICES and LICENSED METHODS and the obtaining of necessary governmental approvals, if any, for marketing in the United States. These progress reports will be made for all development activities until the first SALE occurs in the United States. Each progress report will be a sufficiently detailed summary of activities of LICENSEE and any SUBLICENSEES so that REGENTS may evaluate and determine LICENSEE’s progress in development of LICENSED PRODUCTS, LICENSED SERVICES, and LICENSED METHODS, and in meeting its diligence obligations under Article 7 (Diligence), and will include (but not be limited to) the following: summary of work completed and in progress; current schedule of anticipated events and milestones, including diligence milestones under Paragraph 7.2; anticipated market introduction dates for the LICENSED TERRITORIES; status of implementation of the Affordable Access Plan and SUBLICENSEE’s activities during the reporting period. LICENSEE also will report to REGENTS in its immediately subsequent progress and royalty reports, the date of first SALE.

8.2 Royalty Reports. After the first SALE anywhere in the world, LICENSEE will make quarterly royalty reports to REGENTS within sixty (60) days after the quarters ending March 31, June 30, September 30, and December 31, of each year. If no SALEs have occurred during the report period, a statement to this effect is required in the royalty report for that period. Each such royalty report will be substantially similar to APPENDIX A and include at least the following:

(a) The number of LICENSED PRODUCTS manufactured and the number SOLD;


(c) NET SALES pursuant to Paragraph 2.8;

(d) Total royalties due REGENTS; and

(e) Names and addresses of any new SUBLICENSEES along with a summary of the material terms of each new SUBLICENSE entered into during the reporting quarter.


9.1 Accounting. LICENSEE will keep, and will require its AFFILIATES and SUBLICENSEES to keep, accurate books and records showing all payments due REGENTS and all LICENSED PRODUCTS manufactured, used, offered for sale, imported, sold, and/or otherwise exploited under the terms of this AGREEMENT. Books and records may encompass data maintained on LICENSEE’s accounting and enterprise resource planning systems including, but not limited to production and manufacturing data, general ledger data, and data showing territory of sale, customer name and location, invoice number and date, ship date, part number and/or description, quantity sold, gross sales, deductions taken, and net sales. Books and records will be preserved for at least seven (7) years after the date of the payment to which they pertain.

9.2 Auditing. Books and records kept in accordance with Paragraph 9.1 will be open to inspection by representatives or agents of REGENTS at reasonable times to determine the completeness and accuracy of those payments and to assess the LICENSEE’s compliance with terms of this AGREEMENT. As necessary and reasonable, LICENSEE will make its personnel available to interpret documents, understand accounting methodologies employed, and to run reports from LICENSEE’s accounting and enterprise resource planning systems to permit REGENTS agents and representatives to verify the completeness and accuracy of LICENSEE’s payments due REGENTS. The agents or representatives of REGENTS may retain one copy of books and records supporting their findings until the matters identified during the course of the inspection are resolved. Notwithstanding any other provision of this AGREEMENT or any confidentiality agreement between LICENSEE and agents or representatives of REGENTS, such agents and representatives are permitted to disclose their findings regarding the completeness and accuracy of LICENSEE’s payments to REGENTS as well as the evidentiary bases therefore. REGENTS right to conduct an inspection will be preserved for one year following the later of the termination or expiration of this AGREEMENT. or the LICENSEE’s final report setting forth royalties due in connection with LICENSED PRODUCTS manufactured or in inventory at the expiration or termination of the AGREEMENT. The fees and expenses of representatives of REGENTS performing such an inspection will be borne by REGENTS. If, however, the payments made to REGENTS under this AGREEMENT by the LICENSEE are found after REGENTS initiate their inspection to be less than ninety-five percent (95%) of the total payments due to REGENTS under this AGREEMENT for any year, LICENSEE will bear the cost of the inspection. Should an overpayment by LICENSEE be discovered after REGENTS initiate their inspection, LICENSEE will be entitled to a credit equal to such excess payment, minus the expenses of such inspection, against the payment obligations next accruing under the AGREEMENT, provided such payments are due and payable.

9.3 LICENSEE Audit. LICENSEE will conduct an independent audit of SALEs and royalties at least every two (2) years if annual SALEs of LICENSED PRODUCT are over Five Million ($5,000,000) US Dollars. The audit will address, at a minimum, the amount of gross SALEs by or on behalf of LICENSEE during the audit period, the amount of funds owed to REGENTS under this AGREEMENT, and whether the amount owed has been paid to REGENTS and is reflected in the records of LICENSEE. LICENSEE will submit the auditor’s report promptly to REGENTS upon completion. LICENSEE will pay for the entire cost of the audit.