Exhibit 10.1
Certain identified information has been redacted from this exhibit because it is both (i) not material and (ii) a type that the registrant treats as private or confidential. Information that has been omitted has been identified in this document with a placeholder identified by the mark “[***].”
AMENDED AND RESTATED LICENSE AGREEMENT
by and between
ALS THERAPY DEVELOPMENT FOUNDATION, INC.
and
ANELIXIS THERAPEUTICS, INC.
dated FEBRUARY 18, 2020
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Exhibit 10.1
TABLE OF CONTENTS
Page
1. | DEFINITIONS | 1 |
2. | GRANT OF RIGHTS | 7 |
3. | COMPANY DILIGENCE OBLIGATIONS. | 8 |
4. | ROYALTIES AND PAYMENT TERMS | 8 |
5. | REPORTS AND RECORDS | 12 |
6. | PATENT PROSECUTION | 13 |
7. | INFRINGEMENT | 14 |
8. | INDEMNIFICATION AND INSURANCE. | 15 |
9. | NO REPRESENTATIONS OR WARRANTIES | 16 |
10. | GENERAL COMPLIANCE WITH LAWS | 17 |
11. | TERMINATION | 17 |
12. | DISPUTE RESOLUTION | 19 |
13. | CONFIDENTIALITY | 20 |
14. | MISCELLANEOUS | 21 |
| APPENDIX A | 1 |
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Exhibit 10.1
AMENDED AND RESTATED LICENSE AGREEMENT
This Amended and Restated License Agreement, dated as of February 18, 2020, (this “Agreement”) amends and restates the May 20, 2015 License Agreement, as amended by a First Amendment dated December 5, 2017 and effective as of June 1, 2017, a Second Amendment dated and effective as of December 17, 2018, and a Third Amendment dated September 17, 2019 (collectively, the “Original License Agreement”), each by and between ALS Therapy Development Foundation, Inc., d/b/a ALS Therapy Development Institute, Inc., a Massachusetts non-profit corporation (“ALSTDI”) and Anelixis Therapeutics, Inc., f/k/a Anelixis Pharmaceuticals, Inc., a Delaware corporation (“Company”) (each referred to as a “Party”, and together the “Parties”). This Agreement is a restatement of, and replaces in its entirety, the Original License Agreement and all prior amendments. In the event of any conflict between this Agreement and the Original License Agreement or the prior amendments, the terms contained in this Agreement will prevail.
R E C I T A L S
WHEREAS, ALSTDI is the owner of certain Licensed Patent Rights (as later defined herein);
WHEREAS, ALSTDI and Company have entered into a Research Services Agreement related to a certain Contract # W81XWH-17-1-0057 issued by the U.S. Army Medical Research Acquisition Activity, U.S. Department of Defense under which certain Inventions (as defined in the Research Services Agreement) are being assigned to ALSTDI.
WHEREAS, ALSTDI desires to have the Licensed Patent Rights developed and commercialized to benefit the public and is willing to grant a license thereunder;
WHEREAS, Company has represented to ALSTDI, to induce ALSTDI to enter into this Agreement, that Company shall commit itself to a diligent program of exploiting the Licensed Patent Rights so that public utilization shall result therefrom; and
WHEREAS, Company desires to obtain an amended license under the Licensed Patent Rights upon the terms and conditions hereinafter set forth.
NOW, THEREFORE, ALSTDI and Company hereby agree as follows:
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any comparable application filed with regulatory authorities in or for a country or group of countries other than the United States.
(ii) the Know-How set forth in Exhibit 1.15(ii) that is owned and Controlled by ALSTDI and necessary for the research, development or commercialization of Licensed Products, excluding in each case (i) and (ii) any patents, patent applications or other patent rights (or foreign equivalents thereof) that describe, claim or cover such Know-How.
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offices, and any judicial or other appeals of the foregoing. Cognates of the word “Prosecution” have their correlative meanings.
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(a) Exclusive Patent License. Subject to the terms of this Agreement, ALSTDI hereby grants to Company (including its Affiliates) an exclusive license under ALSTDI’ s interest in the Licensed IP solely to make, have made, use, sell, offer for sale, import, perform and practice Licensed Products in the Field in the Territory during the Term.
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Exhibit 10.1
Agreement for any reason, any Sublicensee not then in default may seek a license from ALSTDI. ALSTDI agrees to negotiate such licenses in good faith under reasonable terms and conditions.
In addition to the foregoing general diligence obligation, Company shall, or shall cause its Sublicensee to, use Commercially Reasonable Efforts to meet its obligations pursuant to a written development plan, as mutually agreed by the parties.
one-time Milestone Payments for the first occurrence of each milestone event for the first Licensed
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Exhibit 10.1
Product:
Milestone Event | Payment |
Dosing of first subject in first toxicity study in non-human primates | $1,000,000 |
Dosing of first patient in a Phase I Clinical Trial | $1,000,000 |
Dosing of first patient in Phase IIB Clinical Trial | $ 200,000 |
Dosing of first patient in a Phase III Clinical Trial | $ 300,000 |
First completion of a Phase III Clinical Trial with a positive clinical endpoint |
$ 500,000 |
First Regulatory Approval in the US | $1,000,000 |
First Regulatory Approval in the European Union | $1,000,000 |
First Regulatory Approval in Asia | $1,000,000 |
First Commercial Sale in the Territory | $1,000,000 |
The parties acknowledge that the issuance to ALSTDI of 555,555 shares of the Company’s non-voting common stock pursuant to that certain Non-Voting Common Stock Purchase Agreement dated on or about June 1, 2017 fully satisfies the Company’s obligation to make that certain Milestone Payment for the dosing of the first subject in the first toxicity study in non- human primates pursuant to Section 4.1(a) of the Agreement.
Each Milestone Event may be achieved only once and each Milestone Payment shall be due only once following upon the first achievement of the corresponding Milestone Event. For the avoidance of doubt, in no event shall Company be obligated to pay to ALSTDI Milestone Payments exceeding $7,000,000.
The first five Milestone Events above (the “Clinical Trial Milestones”) are intended to be successive; if any of the Clinical Trial Milestones is reached without achieving a preceding Clinical Trial Milestone, then the amount which would have been payable on achievement of the preceding Clinical Trial Milestone shall be payable upon achievement of the next successive Clinical Trial Milestone. For purposes of the above Milestone Events, the “completion” of a pre- clinical or clinical study means the date of the last examination or intervention of the last research subject for the purpose of data collection for the primary endpoint in that trial.
In the event that the Company develops a second Licensed Product for disease indications different than the first Licensed Product, Company shall notify ALSTDI within ten (10) days of the first achievement of any of the following milestones for the second Licensed Product by Company or any of its Sublicensees. At the time of such notification, Company shall pay to
ALSTDI the following one-time Milestone Payments for the first occurrence of each milestone
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event for the second Licensed Product for a disease indication different than the first Licensed Product:
First completion of a Phase III Clinical Trial with a positive clinical endpoint |
$ 500,000 |
First Regulatory Approval in the US | $ 500,000 |
First Regulatory Approval in the European Union | $ 500,000 |
First Regulatory Approval in Asia | $ 500,000 |
First Commercial Sale in the Territory | $ 500,000 |
Notwithstanding the foregoing, ALSTDI may, in its sole discretion, defer receipt or acceptance of any Milestone Payment to any later date that it selects.
Milestone Event | Payment |
$500 million in aggregate Net Sales of Licensed Products in one calendar year, across all indications and uses | $15,000,000 |
$1 billion in aggregate Net Sales of Licensed Products in one calendar year, across all indications and uses | $30,000,000 |
Notwithstanding the foregoing, ALSTDI may, in its sole discretion, defer receipt or acceptance of any Milestone Payment to any later date that it selects.
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If no amounts are due to ALSTDI for any Reporting Period, the report shall so state.
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(i) where such underpayment is in excess of five percent (5%) for any twelve (12) month period, Company shall bear the full cost of such audit, and (ii) Company shall remit any amounts due to ALSTDI within thirty (30) days of receiving notice thereof from ALSTDI. In the event that any audit performed under this Section 5.4 reveals an overpayment, ALSTDI shall deliver written notice to Company within thirty (30) days of acquiring knowledge of such overpayments, and shall remit any amounts due to Company as a result of such overpayment along with delivery of such notice.
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Prior to commencing any such action, Company shall consult with ALSTDI and shall consider the views of ALSTDI regarding the advisability of the proposed action and its effect on the public interest. ALSTDI may participate in any such action with counsel of its choosing at its own expense.
7.2 or 7.4 shall be distributed as follows: (a) each party shall be reimbursed for any expenses incurred in the action, (b) as to ordinary damages, Company shall receive an amount equal to its lost profits or a reasonable royalty on the infringing sales, or whichever measure of damages the court shall have applied, and Company shall pay to ALSTDI based upon such amount a reasonable
approximation of the royalties and other amounts that Company would have paid to ALSTDI if Company had sold the infringing products, processes and services rather than the infringer, and
(c) as to special or punitive damages, the parties shall share equally in any award.
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Company shall require any Sublicensee(s) to indemnify, hold harmless and defend the ALSTDI Indemnitees under the same terms set forth in this Section 8.1.
$2,000,000 per incident and $5,000,000 annual aggregate and naming ALSTDI Indemnitees as additional insureds. Such commercial general liability insurance must provide (a) product liability coverage and (b) broad form contractual liability coverage for Company’s indemnification under Section 8.1 of this Agreement. The minimum amounts of insurance coverage required under these provisions may not be construed to create a limit of Company’s liability with respect to its indemnification obligation under Section 8.1 of this Agreement. Company shall provide ALSTDI with written evidence of such insurance upon request..
Company shall require any Sublicensee(s) to maintain insurance in favor of ALSTDI Indemnitees under the same terms set forth in Section 8.2 above.
INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGES OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER SUCH PARTY SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING;
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PROVIDED THAT NOTHING IN THIS SECTION 9.2 SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS UNDER SECTION 8.1.
to ALSTDI, such notice to state the date at least ninety (90) days in the future upon which termination is to be effective, and (ii) upon payment of all amounts due to ALSTDI through such termination effective date.
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termination; provided, however, that each Party may keep one copy of such Confidential Information in its legal files solely for the purpose of enabling it to comply with the provisions of
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this Agreement, and shall not be required to remove such Confidential Information from its back- up or archive electronic records, including its electronic laboratory notebook and laboratory information management systems.
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overnight courier, or registered or certified mail, postage prepaid, return receipt requested, to the following addresses of the parties:
If to ALSTDI: | ALSTDI [***] |
If to Company: | Anelixis Therapeutics, Inc. [***] |
All notices under this Agreement shall be deemed effective upon receipt. A party may change its contact information immediately upon written notice to the other party in the manner provided in this Section 14.1.
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will be construed to refer to sections, attachments, appendices, exhibits or the like of this
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Agreement, and references to this Agreement include all attachments, appendices, exhibits or the like attached hereto, (h) references to any law, rule or regulation, or article, section or other division thereof, will be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof and (i) the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or.”
[Signatures Follow]
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Exhibit 10.1
IN WITNESS WHEREOF, the parties have caused this Amended and Restated License Agreement to be executed by their duly authorized representatives as of the date first written above.
ALS THERAPY DEVELOPMENT FOUNDATION INC.
By: /s/ Paul Sallaberry
Name: Paul A. Sallaberry
Title: Authorized Director
ANELIXIS THERAPEUTICS, INC.
By: /s/ Steven Perrin
Name: Steven Perrin
Title: President
[Signature Page to LicenseAgreement}
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Exhibit 10.1
APPENDIX A LICENSED PATENT RIGHTS
Methods for the treatment of Neurodegenerative Disease | |||||
Country | Application No. | Filing date | Publication or Patent Number | Publication or Issue Date | Status |
[***] | [***] | [***] | [***] | [***] | [***] |
PCT | PCT/US2009/066715 | 12/4/2009 | W02010/065819 | 6/10/2012 | Nationalized |
US | 13/858667 | 8/18/2011 | 8,435,514 | 5/7/2013 | Issued |
US (Divisional) | 13/858,667 | 4/8/2013 | 9,044,459 | 6/2/2015 | Issued |
[***] | [***] | [***] | [***] | [***] | [***] |
Japan | 2011-539720 | 12/4/2009 | JP201211014 | 5/17/2012 | Abandoned |
[***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] |
| |||||
Anti-CD40L Antibodies And Method For Treating | |||||
[***] | [***] | [***] | [***] | [***] | [***] |
PCT | PCT/US2016/016165 | 2/2/2016 | WO/2016/126702 | 11/8/2016 | Nationalized |
[***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] |
| |||||
Therapeutic Anti-CD40 Ligand Antibodies | |||||
[***] | [***] | [***] | [***] | [***] | [***] |
PCT | PCT/US2018/034172 | 5/23/18 | WO2018/217918 | 11/29/2018 | Nationalized |
Any patents, patent applications or other patent rights (or foreign equivalents thereof) owned and Controlled by ALSTDI that arise or result directly from the conduct of the activities set forth in Exhibit 1.15(ii), in each case to the extent necessary for the research, development or commercialization of Licensed Products.
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Exhibit 10.1
Exhibit 1.15(i)
Licensed Know-How includes the following Know-How to the extent it is actually provided by ALSTDI to Company:
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Exhibit 1.15(ii)
Licensed Know-How includes Know-How to the extent it arises or results directly from:
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Exhibit 1.29
Provided Materials means the following materials, to the extent they are actually provided by ALSTDI to Company:
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