Exhibit 10.1
Certain identified information has been omitted from this document because it is not material and would be competitively harmful if publicly disclosed, and has been marked with “[***]” to indicate where omissions have been made.
LICENSE AND COMMERCIALIZATION AGREEMENT
THIS LICENSE AND COMMERCIALIZATION AGREEMENT (“Agreement”) dated as of July 31, 2022 (“Signing Date”) is entered into between Bioprojet Société Civile de Recherche, an independent (privately owned) research company organized under the laws of France and having its principal place of business at 30, rue des Francs-Bourgeois, 75003 Paris, France (together with its Affiliates, including Bioprojet Pharma SAS and Bioprojet Europe Ltd., “Bioprojet”) and Harmony Biosciences, LLC, a limited liability company organized under the laws of Delaware and having its principal place of business at 630 W. Germantown Pike, Suite 215, Plymouth Meeting, Pennsylvania, USA (“Harmony”).
BACKGROUND
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
Article 1 | |
DEFINITIONS
In addition to the capitalized terms defined elsewhere in this Agreement, the following terms shall have the meanings set forth below, except as otherwise provided herein.
GRANT OF LICENSES
GOVERNANCE
Article 4 | |
DEVELOPMENT, CLINICAL, REGULATORY AND MEDICAL AFFAIRS ACTIVITIES
This exchange of information shall be governed by the Safety Data Exchange Agreement (“SDEA”) agreed between the Parties under the LCA, as amended by the Parties at the Effective Date or within [thirty (30) days] thereafter to incorporate the Product(s) and each Party agrees to the timely exchange of safety data as outlined in the SDEA.
Article 5 | |
COMMERCIALIZATION AND PROMOTION
PAYMENTS
[***].
Annual Net Sales |
| Royalty Rate (% of |
| |
[***] |
|
| [***] | |
[***] | | | [***] | |
[***] | | | [***] | |
[***] | | | [***] | |
Worked example: [***]
o | [***] |
and
(a) and (b) together the “Royalty Payments”.
In addition to the Royalty Payments and in consideration for the Trademark License, following the First Commercial Sale of a Product and for twenty (20) years thereafter, Harmony shall pay to Bioprojet royalties on Annual Net Sale of Products in the Harmony Territory at a rate equal to [***] (“Trademark Royalty Payments”).
PAYMENTS; BOOKS AND RECORDS
CERTAIN COVENANTS
Article 9 | |
PRODUCT SUPPLY AND DISTRIBUTION
CONFIDENTIALITY
Article 11 | |
PATENT PROSECUTION AND ENFORCEMENT
[***]
Article 12 | |
TRADEMARKS
[***] | | | | | | | | |
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TERM AND TERMINATION
EFFECT OF TERMINATION
REPRESENTATIONS, WARRANTIES AND COVENANTS
INDEMNIFICATION
Article 17 | |
CLOSING
Article 18 | |
EXCLUSIVITY
DISPUTE RESOLUTION
Article 20 | |
GENERAL PROVISIONS
To Bioprojet: |
| To Harmony: |
Bioprojet Société Civile de Recherche 75003 Paris, France Attention: [***] |
| Harmony Biosciences, LLC 630 W. Germantown Pike, Suite 215, Plymouth Meeting, Pennsylvania, USA |
With a copy to: |
| With a copy to: |
McDermott Will & Emery AARPI 23 rue de l’Université 75007 Paris, France Attention: Emmanuelle Trombe [***] |
| Hogan Lovells US LLP 100 International Drive Baltimore, Maryland 21208 USA Attention: William Intner [***] |
Any notice required or permitted to be given concerning this Agreement shall be effective upon receipt by the Party to whom it is addressed.
[Signature Page Follows]
IN WITNESS WHEREOF, the Parties have executed this License and Commercialization Agreement as of the date first set forth above.
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| Bioprojet Société Civile de Recherche | ||
| BY: | | /s/ Jeanne-Marie Lecomte | |
| NAME: |
| Jeanne-Marie Lecomte | |
| TITLE: |
| Chairman | |
| Harmony Biosciences, LLC | |||
| BY: |
| /s/ John Jacobs | |
| NAME: |
| John Jacobs | |
| TITLE: |
| President & CEO |
EXHIBIT 1.11
Bioprojet Patents
EXHIBIT 3.1(a)
Initial Development Plan
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