NON-EXCLUSIVE LICENSE AGREEMENT
This license agreement (“Agreement”) is entered into as of the date of the last party to sign below (“Effective Date”) between the Fred Hutchinson Cancer Research Center ("FHCRC"), a Washington non-profit corporation and [Enter Entity Name and Type i.e. Corporation, L.L.C. etc] ("LICENSEE") having a principal office at [Enter Entity Business Address], [Enter City][Enter State][Enter Zip] each of which are individually a “Party” and together are the “Parties”.
RECITALS
Whereas FHCRC possesses hybridoma cell line(s) as described in Appendix A;
Whereas FHCRC desires that such hybridoma cell line(s) and its products be developed and utilized in the public interest and is willing to enter into this Agreement for those purposes;
Whereas LICENSEE desires to obtain a non-exclusive worldwide license;
Whereas FHCRC is willing to grant such a license to LICENSEE subject to the terms and conditions of this Agreement.
NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants as set forth herein, the parties agree as follows:
ARTICLE 1 - DEFINITIONS
1.1 AFFILIATES means any present or future domestic or foreign corporation, partnership, or other entity in which LICENSEE owns or controls at least a fifty percent (50%) ownership interest or which directly or indirectly owns or controls more than a fifty percent (50%) ownership interest in LICENSEE or is under common control with a party to this Agreement. The term “control” as used in the preceding sentence means the possession of the power to direct or call for the direction of the management and policies of an entity, whether through ownership of a majority of the outstanding voting securities, by contract or otherwise.
1.2 LICENSED MATERIAL means the hybridoma cell line(s) as selected by LICENSEE in Appendix A of this agreement.
1.3 LICENSED PRODUCTS means any products, or portions or fragments therefrom, that are derived from, contain, result from or are produced by or for the LICENSEE from the LICENSED MATERIAL, including but not limited to monoclonal antibodies derived from the LICENSED MATERIAL.
1.4 FIELD means the production and sale of monoclonal antibody reagents for research use only. Field does not include any other diagnostic or therapeutic use or any use in humans.
1.5 TERM means the period of time commencing on the Effective Date and ending on the expiration Ten (10) years from the Effective Date unless sooner terminated in accordance with the provisions set forth in this Agreement.
1.6 NET SALES means the gross receipts of LICENSEE and its AFFILIATES from sales or leases of LICENSED PRODUCTS less:
(a) All trade, quantity or cash discounts and non-affiliated brokers' or agents' commissions actually allowed and taken;
(b) Amounts repaid or credited on sales of LICENSED PRODUCTS by reason of rejection, return, billing errors, or retroactive price reductions; and/or
(c) To the extent separately stated on purchase orders, invoices or other documents of sales, taxes levied on and/or other governmental charges made as to production, sale, transportation, delivery or use and paid by or on behalf of LICENSEE.
LICENSEE shall not accept any consideration other than cash, without authorization of FHCRC.
1.7 SIGNING FEE means a non-refundable, one-time fee equal to the cumulative
amount of the amounts indicated on Appendix A for each LICENSED MATERIAL selected by the LICENSEE as part of this Agreement
1.8 ROYALTY RATE means percentage rate indicated on Appendix A for each LICENSED MATERIAL selected by the LICENSEE as part of this Agreement.
ARTICLE 2 – LICENSE GRANT AND COMMERCIAL EFFORT
2.1 License Grant. FHCRC hereby grants to LICENSEE and LICENSEE accepts, subject to the terms and conditions hereof, a worldwide, non-exclusive license to use the LICENSED MATERIAL to make and have made, to sell, have sold and offer for sale the LICENSED PRODUCTS in the FIELD for the term of this Agreement (collectively, the "License"). LICENSEE shall have the right to convey any or all of its rights hereunder to an AFFILIATE and to third party distributors who sell under Licensee’s label, which conveyance shall not be considered a sublicense. LICENSEE shall not have the right to sell, have sold or transfer the LICENSED MATERIALS other than to its AFFILIATES or parties that LICENSEE engages for purposes of contract manufacturing or long-term off-site back-up storage on LICENSEE’s behalf. LICENSEE agrees that it will not make, use or sell or make available for sale LICENSED PRODUCTS for any diagnostic or in vivo human use; and any such manufacture, use, sale, lease or other disposition is unauthorized and constitutes a material breach by LICENSEE of the Agreement.
2.2 No Grant for Sublicense. LICENSEE shall have no right to grant sublicenses under this Agreement.
2.3 Reserved Rights. This Agreement is subject to any rights reserved to the United States Government and others under 35 US Code Section 200 et seq. and its implementing regulations.
2.4 The parties have agreed that their principal purpose in entering into this Agreement is solely for FHCRC to provide LICENSEE with the use of LICENSED MATERIAL, and it is not the transfer of tangible property by FHCRC to LICENSEE in a sales transaction. Title to the LICENSED MATERIAL shall remain with FHCRC during the term of this Agreement. The transfer of the LICENSED MATERIAL shall be considered to be a bailment and with respect to such property LICENSEE shall be a bailee. Notwithstanding the above:
A) Should any court or other administrative body construe this Agreement as involving the sale of any tangible property by FHCRC to LICENSEE, because for example, tangible property originally bailed to LICENSEE is consumed in its use, the parties agree that such transfer is purely ancillary or incidental to the license of the intangible rights.
B) Further, in the event it is so found that this Agreement, nevertheless, involves a sale of tangible property, the parties agree that its value is less than $10,000 and that the first $10,000 of any consideration paid under this Agreement shall constitute full consideration for any and all tangible property which may transfer ancillary to the licensing of the intangible rights.
2.5 Notwithstanding the license grant to LICENSEE, FHCRC retains a non-exclusive and non-transferable right to use the LICENSED MATERIAL and its LICENSED PRODUCTS for educational and research purposes. FHCRC further reserves the right to supply the LICENSED MATERIAL and its LICENSED PRODUCTS to academic researchers, subject to a research only limitation and a restriction on further distribution. FHCRC also retains all rights not granted under Article 2, paragraph 2.1 above and the right to grant licenses under these rights.
2.6 The license granted herein shall terminate upon the termination of this Agreement in accordance with Article 6.
2.7 LICENSEE recognizes that as a non-profit institution, FHCRC has an obligation that may include an obligation to the Federal Government to ensure that LICENSED PRODUCT(S) benefit society. LICENSEE agrees that LICENSED PRODUCT(S) for distribution in the United States will be manufactured substantially in the United States. Accordingly, LICENSEE shall use its best efforts to effect commercial sales of LICENSED PRODUCT(S) as soon as practicable and to maximize these sales, consistent with sound and reasonable business practices and judgment. “Best efforts” under this clause shall mean commenced offer for LICENSED PRODUCT(S) for sale within 180 (one hundred eighty) days of the effective date of this Agreement.
2.8 LICENSEE shall sell LICENSED PRODUCT(S) at a fair and reasonable price and refrain from making any extravagant claims in its advertising or otherwise.
2.9 LICENSEE and its AFFILIATES shall alone have the obligation to ensure that any LICENSED PRODUCTS they sell is not defective and that any LICENSED PRODUCTS satisfies all applicable government regulations.
ARTICLE 3 - DELIVERY OF LICENSED MATERIALS
3.1 Delivery of Materials. In consideration of the license granted hereunder and upon execution of this Agreement, LICENSEE shall pay FHCRC the Signing Fee, as specified in Section 5.2. Under receipt of payment, FHCRC shall provide to LICENSEE of LICENSED MATERIAL that will produce antibodies when appropriately grown in tissue culture or as ascites fluid in animals. If said LICENSED MATERIAL are not viable/do not produce antibody LICENSEE may request replacement of such LICENSED MATERIAL within thirty (30) days from receipt of materials, in which case FHCRC shall use reasonable endeavors to supply replacement LICENSED MATERIAL to LICENSEE within thirty (30) days after LICENSEE's notice delivered in accordance with section 12 of this Agreement, provided that LICENSEE reimburses FHCRC for its reasonable costs and expenses. If upon second shipment, LICENSED MATERIAL are still not viable/do not produce antibody LICENSEE must notify FHCRC within (30) days from receipt of materials (“Final Notice”). If FHCRC is not able to arrange for replacement of the LICENSED MATERIAL, FHCRC shall so advise LICENSEE. Upon such advise by FHCRC, or Final Notice from LICENSEE, this Agreement shall be immediately terminated and be of no further effect, and only in such instance, FHCRC shall fully refund the Signing Fee to LICENSEE. Termination of the Agreement and return of the license upfront fee will be LICENSEE's sole remedy if adequate LICENSED MATERIAL is never received by LICENSEE.
ARTICLE 4 - ROYALTIES
4.1 Signing Fee and Royalty. For the license granted hereunder, LICENSEE shall pay to FHCRC a non-refundable SIGNING FEE and a ROYALTY RATE for each of the LICENSED MATERIAL(S) selected by the LICENSEE. Royalties shall be paid on NET SALES of LICENSED PRODUCT(S) sold by LICENSEE and/or its AFFILIATES. LICENSEE shall be responsible to FHCRC for the payment of running royalties due with respect to sales made by AFFILIATES as though they were sales by LICENSEE.
ARTICLE 5 - PAYMENTS AND RECORDS
5.1 First Sales. LICENSEE shall report to FHCRC the date of first sale of LICENSED PRODUCTS within thirty (30) days of occurrence.
5.2. Payment of Signing Fee. LICENSEE shall submit to FHCRC within sixty (60) days of the Effective Date of this Agreement, the Signing Fee due under Section 4.1.
5.3 Reports and Payments. Reports and earned royalty payments are due on February 28 of each year (the “Payment Due Date”) during the TERM for sales during the previous calendar year. Upon effective termination of this Agreement, a final payment and report will be due within sixty (60) days of the termination date. Each such report will identify the amount of the LICENSED PRODUCTS sold by LICENSEE and its AFFILIATE(S), the sales volume and NET SALES, and the amount of royalty due to FHCRC together with payment of such royalty amount. Such report shall be certified as correct by an officer of LICENSEE. If no royalties are due to FHCRC for any reporting period, the written report shall so state. All payments due hereunder shall be payable in United States dollars. When a LICENSED PRODUCT is sold for compensation for other than United States dollars, conversion of foreign currency to United States dollars will be made in the same manner as the Licensee converts all of its other revenues, provided that (a) such manner is consistent with United States generally accepted accounting principles, and (b) the exchange rates employed are those quoted by a reputable source, such as a recognized money center bank such as JP Morgan, Bank of America or an equivalent, OANDA.com, or the Wall Street Journal. Such payments will be without deduction of exchange, collection or other charges.
5.4 Confidentiality of Reports. All such reports shall be maintained in confidence by FHCRC, except as otherwise required by law, including 35 US Code Section 200 et seq. and its implementing regulations.
5.5 Record Keeping. LICENSEE and its AFFILIATES, shall maintain complete and accurate books of account and records showing all sales of LICENSED PRODUCTS and all NET SALES in sufficient detail to allow verification of the accuracy of royalties paid under this agreement. For purposes of verifying the accuracy of the royalties paid by LICENSEE pursuant to this Agreement or verifying performance of LICENSEE of any other obligation to FHCRC hereunder, such books and records shall be open to inspection and copying, during usual business hours and not more frequently than once per twelve (12) month period, by an independent certified public accountant. In the event that any such inspection shows any underreporting and underpayment by LICENSEE in excess of five thousand dollars ($5,000.00 USD) for any twelve (12) month period, then LICENSEE shall pay the cost of such examination. In the event that any such inspection shows overpayment by LICENSEE, such overpaid amount shall be credited against future royalties. Such books and records shall be maintained for at least three (3) full years after the creation of such books and records. In connection with, and prior to the commencement of, an audit, if the LICENSEE so requests in writing to FHCRC, the LICENSEE, the FHCRC and the auditor shall enter into an agreement prohibiting the auditor and FHCRC from disclosing the LICENSEE’s non-public, proprietary information to any third party without the LICENSEE’s prior written consent; provided, however, that consistent with generally accepted auditing standards and the auditor’s professional judgment, the auditor may disclose such information to FHCRC and its agents, counsel, or consultants. The LICENSEE acknowledges that such an agreement is adequate to protect its legitimate interests, and the parties agree that there shall be no additional non-disclosure agreement demanded as a condition to the commencement of an audit and FHCRC’s exercising its rights under this subsection.