Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omissions.
Exhibit 10.2
AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT
THIS AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT (“AGREEMENT”) is made and entered into the date of last signature (“A/R EFFECTIVE DATE”), by and between THE CURATORS OF THE UNIVERSITY OF MISSOURI, a public corporation of the State of Missouri (“UNIVERSITY”) and DECIBEL THERAPEUTICS, INC., a Delaware for-profit corporation having offices at 1325 Boylston Street, Suite 500, Boston, MA 02215 (“LICENSEE”). UNIVERSITY and LICENSEE may sometimes be referred to herein as a “PARTY” or “PARTIES” as the case may be.
WHEREAS, UNIVERSITY has an ownership interest in certain PATENT RIGHTS as defined herein related to UM Disclosure No. [**]; and
WHEREAS, the PATENT RIGHTS were developed under a research program sponsored by National Institutes of Health. Therefore, this AGREEMENT is subject to the terms and conditions of the Bayh-Dole Act, Public Law 96-517 and 98-620 as amended; and
WHEREAS, UNIVERSITY and LICENSEE previously entered into an EXCLUSIVE LICENSE AGREEMENT dated August 26, 2019 (the “ORIGINAL LICENSE AGREEMENT”) whereby the UNIVERSITY licensed PATENT RIGHTS to LICENSEE; and
WHEREAS, UNIVERSITY and LICENSEE previous to the A/R EFFECTIVE DATE entered into certain amendments of the ORIGINAL LICENSE AGREEMENT; and
WHEREAS, as indicated in this AGREEMENT, as of the A/R EFFECTIVE DATE LICENSEE has made certain payments called for in the ORIGINAL LICENSE AGREEMENT.
WHEREAS, through this AGREEMENT LICENSEE desires to obtain and maintain the license to practice the PATENT RIGHTS granted under the terms and conditions of the ORIGINAL LICENSE AGREEMENT, but modify those certain due diligence and regulatory milestones related to royalty payment as set forth in the ORIGINAL LICENSE AGREEMENT; and
WHEREAS, UNIVERSITY is willing to amend the ORIGINAL LICENSE AGREEMENT in accordance with the terms and conditions of this AGREEMENT.
NOW, THEREFORE, in consideration of the foregoing premises and the covenants, representations and warranties contained herein, the PARTIES agree as follows:
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In calculating NET SALES, no deductions shall be made for commissions paid to individuals whether they are with independent sales agencies or regularly employed by LICENSEE and on its payroll, or for cost of collections. In the event LICENSEE SELLS a LICENSED PRODUCT to a third party in a bona fide arm’s length transaction, for consideration, in whole or in part, other than cash, then the NET SALES price for such LICENSED PRODUCT shall be deemed to be the standard invoice price then being invoiced by LICENSEE in an arm’s length transaction with similar entities and in the absence of such standard invoice price, then the reasonable fair market value of the LICENSED PRODUCT. For the purposes of calculating NET SALES, LICENSEE’S SALES to a SUBLICENSEE or to an AFFILIATE under this AGREEMENT for end use (but not resale) by the SUBLICENSEE or the AFFILIATE shall be treated as SALES by LICENSEE at the greater of the (i) billed/invoiced price of LICENSEE the SUBLICENSEE or AFFILIATE or (ii) the billed/invoiced price that LICENSEE would have charged a third party in a bona fide arm’s length transaction. For the purposes of calculating NET SALES, LICENSEE’S SALES to a SUBLICENSEE or to an AFFILIATE under this AGREEMENT for resale to end users by the SUBLICENSEE or an AFFILIATE shall be treated as SALES at the billed/invoiced price to the end users of SUBLICENSEE or AFFILIATE.
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The SALES ROYALTY and the MANUFACTURING ROYALTY are each a “ROYALTY.”
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For each LICENSED PRODUCT, in the event that a milestone is met and a prior milestone has not been met, then, the later and all prior unpaid milestone amounts will be combined and will be due upon the occurrence of the later milestone. For example, if a LICENSED PRODUCT in the OTOFERLIN LICENSED SUBFIELD had [**], LICENSEE would owe [**] dollars ($[**]) due upon [**].
For clarity, for each LICENSED PRODUCT in the OTOFERLIN LICENSED SUBFIELD achieving regulatory approval in the US, LICENSEE will owe UNIVERSITY a total amount in Regulatory Milestone Payments of seven hundred eighty thousand dollars ($780,000.00) for such LICENSED PRODUCT. Furthermore, for each LICENSED PRODUCT in the [**] LICENSED SUBFIELD achieving regulatory approval in the US, LICENSEE will owe UNIVERSITY a total amount in Regulatory Milestone Payments of seven hundred eighty thousand dollars ($772,500.00) for such LICENSED PRODUCT.
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By way of example, should LICENSEE develop two LICENSED PRODUCTS (i.e., two different commercial products), then each of the foregoing milestones shall be payable for each of LICENSED PRODUCTS. Milestone fees are non-refundable. Royalty payments in a given license year shall not be creditable against any milestone fees.
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By way of example, if LICENSEE enters into a sublicense agreement [**] in which a SUBLICENSEE later pays LICENSEE a [**] percent ([**]%) royalty on NET SALES for LICENSED PRODUCTS SOLD in the LICENSED TERRITORY and a [**] dollar ($[**]) milestone payment based on sales made by SUBLICENSEE, then LICENSEE shall pay UNIVERSITY the [**] percent ([**]%) SALES ROYALTY pursuant to Section 3.01(c)(i) and Section 3.02(a) and $[**] pursuant to Section 3.02(b)(i)1).
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If no payment is due, LICENSEE shall so report to UNIVERSITY. An exemplary report format is set forth in Appendix D. This report shall identify the issued patents and/or patent applications under the PATENT RIGHTS that cover the particular LICENSED PRODUCT being reported. LICENSEE shall direct its authorized representative to certify that reports required hereunder are correct to the best of LICENSEE’s knowledge and information. Failure to provide reports as required under this Article shall be a material breach of this AGREEMENT.
LICENSEE shall provide sufficient data for UNIVERSITY to verify the royalty calculations and any reasonable additional information UNIVERSITY requires to determine LICENSEE’S satisfaction of the reporting requirements hereunder or to clarify the information contained in reports provided by LICENSEE. LICENSEE shall provide such additional information to UNIVERSITY within [**] of receiving a request from UNIVERSITY. Simultaneously with the delivery of each report, LICENSEE must pay to UNIVERSITY the amount, if any, due for the period of each report.
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LICENSEE shall also promptly provide any reasonable additional information UNIVERSITY requested to evaluate LICENSEE’S performance under this AGREEMENT. An exemplary report format is set forth in Appendix E.
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LICENSEE shall maintain such commercial general liability insurance beyond the expiration or termination of this AGREEMENT during (i) the period that any product, process, or service, relating to, or developed pursuant to this AGREEMENT is being commercially SOLD by LICENSEE or its SUBLICENSEE and (ii) a reasonable period after the period referred to in (i) above which in no event shall be less than [**].
LICENSEE shall provide Workers’ Compensation in accordance with applicable state statutes or provide evidence of monopolistic state coverage. LICENSEE shall also purchase Employers Liability insurance with the following limits: $[**] each accident, disease each employee and disease policy limit.
LICENSEE shall provide UNIVERSITY with written evidence of the insurance requirements of this Section 6.02 within [**] after such insurance becomes necessary pursuant to this AGREEMENT. LICENSEE shall provide UNIVERSITY with written notice at least [**] prior to the cancellation, non-renewal or material change in such insurance; if LICENSEE does not obtain replacement insurance providing comparable coverage within such [**] period, UNIVERSITY shall have the right to terminate this AGREEMENT effective at the end of such [**] period without notice or any additional waiting periods. It is agreed that the insurance required is required in the public interest and UNIVERSITY does not assume any liability for acts of LICENSEE, their officers, agents, and employees or of a SUBLICENSEE, their officers, agents, and employees, in connection with the granting of this AGREEMENT.
If LICENSEE elects to self-insure all or part of the limits described above, such self-insurance program must be acceptable to UNIVERSITY’S Risk and Insurance Management department.
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However, failure to so mark or label any material shall neither exclude that material from the scope of COMMON INTEREST INFORMATION nor constitute a waiver of any privilege or a waiver of any right or obligation created by this AGREEMENT.
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Specific information shall not be deemed to be within the foregoing exceptions merely because it is embraced by more general information within the exceptions. In addition, any combination of the features shall not be deemed to be within the foregoing exception merely because individual features may be within the exceptions.
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Nothing in this section shall be construed as limiting in any way UNIVERSITY’S rights or remedies that UNIVERSITY may otherwise have, either in law or in equity.
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If to UNIVERSITY:
Technology Advancement Office
Mizzou North, Room 706
115 Business Loop 70 West
Columbia, Missouri 65211-8375, USA
Attention: Director TAO
If to LICENSEE:
Decibel Therapeutics, Inc.
Boylston St, Suite 500
Boston, MA 02215, USA
ATTN: VP Legal
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IN WITNESS WHEREOF, the PARTIES hereto have executed this AGREEMENT by their duly authorized officers or representatives.
THE CURATORS OF THE |
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UNIVERSITY OF MISSOURI |
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BY: | /s/ Lisa Lorenzen |
| BY: | /s/ Laurence Reid |
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NAME: | Lisa Lorenzen, PhD |
| NAME: | Laurence Reid |
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TITLE: | Assistant Vice Chancellor, TA |
| TITLE: | Chief Executive Officer |
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DATE | March 10, 2023 |
| DATE | March 10, 2023 |
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