certain identified information CONTAINED IN THIS EXHIBIT, MARKED BY [***], HAS BEEN EXCLUDED FROM THIS EXHIBIT because it is both not material and is the type that the registrant treats as private or confidential.
EXECUTION VERSION
CONFIDENTIAL
Exhibit 10.30
LICENSE AGREEMENT
This License Agreement (“Agreement”) is made and entered into this 11th day of December 2023 (“Effective Date”).
BY AND BETWEEN
and
Background
WHEREAS, Mereo owns certain intellectual property rights with respect to the Product in the Territory; and
WHEREAS, subject to the terms and conditions of this Agreement, ReproNovo desires to develop, distribute, market and sell the Product in the Territory; and
WHEREAS, ReproNovo has access to market information, experience in business practices and expert knowledge in relation to the registration/development, marketing, distribution and sales of pharmaceutical products within the Territory; and
WHEREAS, Mereo wishes to grant to ReproNovo, and ReproNovo wishes to take, an exclusive license in and to Mereo's intellectual property in the Product, in the Field, in the Territory, subject to and in accordance with the terms of this Agreement.
Terms
NOW, THEREFORE, in consideration of the foregoing and the respective representations, warranties, covenants and agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Mereo and ReproNovo hereby agree to be legally bound as follows:
EXECUTION VERSION
CONFIDENTIAL
“Accounting Standards” means, with respect to a Party, that such Party shall maintain records and books of accounts in accordance with (a) United States Generally Accepted Accounting Principles or (b) to the extent applicable, International Financial Reporting Standards as issued by the International Accounting Standards Board, in each case, consistently applied;
“Acquired Affiliates” means those entities which become Mereo Affiliates after the Effective Date through merger or acquisition with, by or of a Third Party(ies);
“Applicable Laws” means all applicable federal, state, local, foreign, national or multinational laws, statutes, ordinances, rules, regulations and/or any orders, rules, regulations, regulatory guidelines or other requirements of any court, regulatory agency or other governmental authority, any
Page 2 of 48
EXECUTION VERSION
CONFIDENTIAL
major national securities exchange or listing organisation or any similar provision having the force or effect of law that may be in effect from time to time during the Term and which is applicable to an activity or a Party under this Agreement, including all applicable regulatory laws;
“Blocking 3rd Party Patent” with respect to any country, a Patent in such country controlled by a Third Party that covers and would be infringed by the Exploitation of the Product;
“Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to January 1, 2023 and the last Calendar Quarter shall end on the last day of the Term;
“Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31, 2023 and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term;
Page 3 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 4 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 5 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 6 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 7 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 8 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 9 of 48
EXECUTION VERSION
CONFIDENTIAL
If a Product is sold as part of a Combination Product (as defined below), Net Sales will be the product of (i) Net Sales of the Combination Product calculated as above (i.e., calculated as for a non-Combination Product) and (ii) the fraction (A/(A+B)), where:
“A” is the gross invoice price in such country during the period to which the Net Sales calculation relates of the Product comprising the API as the sole therapeutically active ingredient; and
“B” is the gross invoice price in such country during the period to which the Net Sales calculation relates of the
Page 10 of 48
EXECUTION VERSION
CONFIDENTIAL
other therapeutically active ingredients contained in the Combination Product.
If “A” or “B” cannot be determined by reference to non-Combination Product sales as described above, then Net Sales will be calculated as above, but the gross invoice price in the above equation shall be determined by mutual agreement reached in good faith by the Parties prior to the end of the accounting period in question based on an equitable method of determining the same that takes into account, in the applicable country, variation in dosage units and the relative fair market value of each therapeutically active ingredient in the Combination Product. As used in this definition of “Net Sales,” “Combination Product” means a Product that contains one or more additional active ingredients (whether co-formulated or co-packaged);
Page 11 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 12 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 13 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 14 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 15 of 48
EXECUTION VERSION
CONFIDENTIAL
[***].
Page 16 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 17 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 18 of 48
EXECUTION VERSION
CONFIDENTIAL
General Milestones (subject to Section 4.4.5 below):
No. | General Milestone Trigger by ReproNovo, its Affiliates or their Sublicensees:
| Milestone Payment |
|
|
|
1 | [***] | [***] |
2 | [***] | [***] |
3 | [***] | [***] |
4 | [***] | [***] |
5 | [***] | [***] |
6 | [***] | [***] |
7 | [***] | [***] |
8 | [***] | [***] |
9 | [***] | [***] |
Sales Milestones (subject to Section 4.4.5 below):
No. | Sales Milestones Achieved by ReproNovo, or its Affiliates:
| Milestone Payment |
1 | [***] | [***] |
2 | [***] | [***] |
3 | [***] | [***] |
Page 19 of 48
EXECUTION VERSION
CONFIDENTIAL
Portion of Annual Net Sales for the Product in the Territory (USD) | Royalty Rate |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Royalties shall be payable, on a country-by-country basis, commencing upon the first occurrence of a royalty-bearing commercial sale, namely a First Commercial Sale or a sale made prior to receipt of all Regulatory Approvals for such Product such as so-called “treatment IND sales”, “named patient sales” and “compassionate use sales” of the Product in such country ("Royalty-Bearing Commercial Sale") and ending upon the latest of (i) the expiration of the last-to-expire Valid Claim in the Patents within the Mereo Intellectual Property that Covers the Product in such country; (ii) the expiration of all Regulatory Exclusivity and data exclusivity for such Product in such country, and (iii) the tenth (10th) anniversary of the First Commercial Sale of the Product in such country (the “Royalty Term”). Within forty-five (45) days after the end of each Calendar Quarter commencing with the first Royalty-Bearing Commercial Sale of the Product in the Territory, ReproNovo shall provide Mereo with a Net Sales Report. ReproNovo shall pay to Mereo the royalty amounts due with respect to a given Calendar Quarter within forty-five (45) days after the end of such Calendar Quarter.
Page 20 of 48
EXECUTION VERSION
CONFIDENTIAL
(a) ReproNovo shall pay to Mereo, within thirty (30) days following receipt, [***] of all royalties and other payments received from such Third Party expressly based upon the sales of the Product in the applicable countries (in no event to include Sublicense Milestone Income) in accordance with the definitive agreement for such Third Party Sublicense; and
(b) during the Royalty Term with respect to the applicable country covered by such Third Party Sublicense (and for so long thereafter as such Third Party has the right to commercialise the Product in such country during the Royalty Term), no payments shall be due or owing pursuant to (i) Section 4.2 with respect to the payments described in the “Sales Milestones” table (if such applicable country is the United States) or (ii) pursuant to Section 4.3 with respect to royalties for sales by such Sublicensee of Product in the applicable country. For clarity the obligation of ReproNovo to pay the Milestone Payments 1-9 for the "General Milestones" table in Section 4.2 shall continue in force notwithstanding the grant of any such Third Party Sublicense, subject to Section 4.4.5(d) below; and
(c) ReproNovo shall pay to Mereo, within thirty (30) days following receipt, the following percentages of all Sublicense Milestone Income received from such Third Party in accordance with the definitive agreement for such Third Party Sublicense: (i) in the case of any such Third Party Sublicense entered into prior to initiation of any Phase III trial, [***] of all Sublicense Milestone Income paid pursuant to such Third
Page 21 of 48
EXECUTION VERSION
CONFIDENTIAL
Party Sublicense; and (ii) in the case of any such Third Party Sublicense entered into after initiation of any Phase III trial but before any Regulatory Approval in the United States, any Major European Country or any Major Asian Country for any Indication, [***] of all Sublicense Milestone Income paid pursuant to such Third Party Sublicense; and (iii) in the case of any such Third Party Sublicense entered into after any Regulatory Approval in the United States, any Major European Country or any Major Asian Country for any Indication, [***] of all Sublicense Milestone Income paid pursuant to such Third Party Sublicense; and
(d) all such amounts described in clause (c) of this Section 4.4.5 above shall be fully creditable against the payments described in the “General Milestones” table above in Section 4.2 which have not been previously paid; and
(e) ReproNovo shall not, and shall not permit its Affiliates to, intentionally and for the purpose of avoiding or decreasing any sums payable pursuant to this Section 4.4.5, enter into any agreement with a Third Party sublicensee involving a Third Party Sublicense under which the payments thereunder are (a) not reasonably consistent with the types of payment structures typically included in sublicenses in the pharmaceutical industry for the applicable country or group of countries to be covered by such Third Party Sublicense, and (b) designed intentionally by ReproNovo to minimize the allocation of payments thereunder to be eligible to be subject to the payment obligations under this Section 4.4.5 relative to other types of payments made under such Third Party Sublicense such that the payment structure including royalty rates would wholly or partly deprive Mereo of monies that it would otherwise be entitled to receive under this Section 4.4.5.
Page 22 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 23 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 24 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 25 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 26 of 48
EXECUTION VERSION
CONFIDENTIAL
EXCEPT AS OTHERWISE SPECIFICALLY STATED IN THIS AGREEMENT, NEITHER PARTY GIVES ANY OTHER REPRESENTATIONS OR WARRANTIES, COVENANT OR AGREEMENT (WHETHER EXPRESS OR IMPLIED). ANY REPRESENTATION, WARRANTY, COVENANT OR AGREEMENT SET FORTH IN THIS AGREEMENT IS EXCLUSIVE AND IN LIEU OF ANY OTHER WARRANTIES, WRITTEN OR ORAL, DIRECT, OR IMPLIED OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, EXPRESS OR IMPLIED WARRANTIES FOR MERCHANTIBILITY, QUALITY OR FITNESS FOR A PARTICULAR PURPOSE. FOR THE SAKE OF CLARITY, MANDATORY STATUTORY WARRANTIES ARE NOT EXCLUDED.
Page 27 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 28 of 48
EXECUTION VERSION
CONFIDENTIAL
In the event the indemnifying Party assumes the defense of a Third Party claim made against the Indemnified Party hereunder: (a) with respect to any Losses relating solely to the payment of money damages in connection with such Third Party claim (i.e. that shall not result in the Indemnified Party becoming subject to injunctive or other relief), the indemnifying Party shall have the sole right to enter into any settlement or otherwise dispose of such claim so long as the Indemnified Party is not subject to any liability or obligation to pay any amounts (the “Litigation Condition”); and (b) in respect of any other Losses, the indemnifying Party shall not enter into a settlement or otherwise dispose of the claim without obtaining the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed). If the indemnifying Party does not assume and conduct the defense of a Third Party Claim as provided above, the Indemnified Party may defend against such Third Party Claim, provided that the Indemnified Party may not admit any liability with respect to, or settle, compromise or dispose of, any Third Party claim without the prior written consent of the indemnifying Party, which consent shall not be unreasonably withheld, conditioned or delayed.
The failure to deliver written notice to the indemnitor within a reasonable time after the commencement of any action with respect to a Third Party claim shall only relieve the indemnitor of its indemnification obligations under this Section 8 if and to the extent the indemnitor is actually prejudiced thereby.
Page 29 of 48
EXECUTION VERSION
CONFIDENTIAL
Each Party will at all times during the Term of this Agreement, and for [***] thereafter, maintain adequate product liability insurance in respect of any claims which may be brought against it in relation to the performance of its activities hereunder, including, in the case of ReproNovo, development and commercialisation of the Products in the Territory, and the Parties will each supply the other Party with a copy of the relevant insurance certificate on request. Such insurance shall not be construed to create a limit of a Party’s liability with respect to its indemnification obligations under Section 8. Each Party shall provide the other with prompt written notice of cancellation, non-renewal or material change in such insurance or self-insurance that could materially adversely affect the rights of such other Party hereunder, and shall provide such notice within thirty (30) days after any such cancellation, non‑renewal or material change.
Each Party will take such precautions as it normally takes with its own confidential or proprietary information to prevent the improper disclosure of Confidential Information disclosed to it pursuant to this Agreement, such precautions to be at a minimum commercially reasonable precautions.
Page 30 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 31 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 32 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 33 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 34 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 35 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 36 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 37 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 38 of 48
EXECUTION VERSION
CONFIDENTIAL
To Mereo: | Mereo BioPharma 2 Limited [***]
With a copy to: Email: [***]
With a further copy to [***]
|
To ReproNovo: | ReproNovo SA
With a copy to: [***]
|
All notices shall be deemed given and received (a) if delivered by hand, immediately, (b) if sent by mail, ten (10) Business Days after posting, or (c) if delivered by express courier service, three (3) Business Days in the jurisdiction of the recipient.
Page 39 of 48
EXECUTION VERSION
CONFIDENTIAL
Page 40 of 48
EXECUTION VERSION
CONFIDENTIAL
[Signature Page Follows]
Page 41 of 48
EXECUTION VERSION
CONFIDENTIAL
IN WITNESS WHEREOF, the Parties have signed this Agreement as of the Effective Date.
REPRONOVO SA
By: [***]
Name: [***]
Title: [***]
By: [***]
Name: [***]
Title: [***]
MEREO BIOPHARMA 2 LIMITED
By: [***]
Name: [***]
Title: [***]
Page 42 of 48
EXECUTION VERSION
CONFIDENTIAL
[***]
[THIS PAGE AND THE FOLLOWING 7 PAGES OF THIS EXHIBIT HAVE BEEN EXCLUDED FROM THIS EXHIBIT because it is both not material and is the type that the registrant treats as private or confidential]
Page 43 of 48