Exclusive License Agreement (PBGM01), dated July 31, 2024, by and between the Registrant and Gemma Biotherapeutics, Inc
Execution Version
Confidential
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT PASSAGE BIO, INC. TREATS AS PRIVATE OR CONFIDENTIAL.
EXCLUSIVE LICENSE AGREEMENT
by and between
Passage Bio, Inc.
and
Gemma Biotherapeutics, INC.
July 31, 2024
Confidential
TABLE OF CONTENTS
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Confidential
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (this “Agreement”) is entered into as of July 31, 2024 (the “Effective Date”), by and between Passage Bio, Inc., a corporation organized under the laws of Delaware (“Passage”), with offices at 2005 Market St., 39th Floor, Philadelphia, PA 19103, and Gemma Biotherapeutics, Inc., a Delaware corporation (“Gemma”), with offices at 1831 Delancey Place, Philadelphia, PA 19103. Passage and Gemma may be referred to in this Agreement individually as a “Party” or collectively as the “Parties.”
BACKGROUND
WHEREAS, Passage is a biopharmaceutical company with expertise in the development, manufacture and commercialization of human therapeutic products for the treatment of genetic disorders;
WHEREAS, concurrently with the execution of this Agreement, Passage and The Trustees of the University of Pennsylvania (“Penn”) are also entering into that certain Second Amended and Restated Research, Collaboration & License Agreement, effective as of September 18, 2018, and amended and restated as of the Effective Date (as amended and restated, the “UPenn Agreement”);
WHEREAS, concurrently with the execution of this Agreement, Passage and Gemma are also entering into (a) that certain Exclusive License Agreement, pursuant to which Passage will grant to Gemma a license under certain intellectual property rights relating to the development, manufacture and commercialization of certain products for Krabbe disease (globoid cell leukodystrophy), and (b) that certain Exclusive License Agreement, pursuant to which Passage will grant to Gemma a license under certain intellectual property rights relating to the development, manufacture and commercialization of certain products for Metachromatic leukodystrophy;
WHEREAS, the programs contemplated by this Agreement are of mutual interest to Passage and Gemma, and may benefit Passage and Gemma through the creation or discovery of new inventions and the development and commercialization of Licensed Products (as defined herein) for the Indication (as defined herein);
WHEREAS, Gemma wishes to obtain from Passage worldwide, exclusive and non-exclusive licenses to rights granted to Passage under the UPenn Agreement and certain other intellectual property rights owned or controlled by Passage, to develop, manufacture and commercialize Licensed Products for the Indication, and Passage is willing to grant such licenses to Gemma in accordance with the terms and conditions set forth herein; and
WHEREAS, concurrently with the execution of this Agreement, Passage and Gemma are also entering into the Transition Services Agreement (as defined herein);
NOW THEREFORE, in consideration of the various promises and undertakings set forth herein, the Parties agree as follows:
DEFINITIONS & INTERPRETATION
Whenever used in this Agreement with an initial capital letter, the terms defined in this Article 1 and elsewhere in this Agreement, whether used in the singular or plural, shall have the meanings specified.
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For the purpose of this definition of Change of Control, (x) “person” and “group” have the meanings given such terms under Sections 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term “group” includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the aforesaid Act; (y) a “beneficial owner” shall be determined in accordance with Rule 13d-3 under the aforesaid Act; and (z) the terms “beneficially owned” and “beneficially own” shall have meanings correlative to that of “beneficial owner.”
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Even if there is overlap between any of the deductions described above, each individual item shall only be deducted once in the overall Net Sales calculation.
In the case of a Combination Product, the Parties shall negotiate in good faith, at the latest [*] before the expected launch of such Combination Product, an allocation of Net Sales of such Combination Product to the respective Licensed Product components and other component(s) thereof, as the case may be, based on the fair market value of such components for the purposes of determining a product-specific allocation of such Net Sales. Payments related to such Combination Product under this Agreement, including Royalties and milestone payments, will be calculated, due and payable based only on the portion of such Net Sales so allocated to a Licensed Product’s components.
In case of disagreement and failure by the Parties to agree upon an allocation of Net Sales of such Combination Product to the respective Licensed Product components and other component(s) thereof, [*].
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LICENSE
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Any Sublicense that does not include all of the terms and conditions set forth in this Section 2.3.2 or which is not issued in accordance with the terms and conditions set forth in this Section 2.3, shall be considered null and void with no further notice from Passage unless separately approved by Passage in writing.
Within [*] after the execution of a Sublicense Document, Gemma shall provide a complete and accurate copy of such Sublicense Document to Passage, in the English Language. Passage’s receipt of a Sublicense Document, however, will constitute neither an approval nor disapproval of the Sublicense Document nor a waiver of any right of Passage or obligation of Gemma under this Agreement.
Gemma and its Sublicensees shall provide an annual Sublicense Development Report on or before [*] of each year during the Term (“SDR Report”), a form of which is attached hereto as Exhibit B.
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the performance of all Subcontractors to the same extent as if such activities were conducted by such Party. Any Party engaging a Subcontractor hereunder will remain responsible and obligated for such activities and will not grant rights to such Subcontractor that interfere with the rights of the other Party under this Agreement.
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EXCLUSIVITY
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GOVERNANCE
PAYMENTS
Development Milestone Event | Development Milestone Payment (USD) |
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[*] | [*] |
[*] | [*] |
Total | [*] |
If any of the above Development Milestone Events are skipped (such that a later Development Milestone Payment becomes due and payable before an earlier Development Milestone Payment), then the skipped Development Milestone Event(s) will be deemed to have been achieved upon the achievement of the subsequent Development Milestone Event, and the Development Milestone Payment(s) corresponding to such skipped Development Milestone Event(s) shall be due and payable at the same time as the subsequent Development Milestone Event.
Sales Milestone Event | Sales Milestone Payment (USD) |
[*] | [*] |
[*] | [*] |
[*] | [*] |
Total | [*] |
Each of the foregoing Sales Milestone Payments in this Section 5.3 shall be payable a maximum of one (1) time hereunder regardless of the number of times the applicable Sales Milestone Event is achieved. For the avoidance of doubt, the aggregate maximum amount payable by Gemma under this Agreement pursuant to this Section 5.3 is [*]. In the event that in a given Calendar Year more than one (1) Sales Milestone Event is achieved, Gemma shall pay to Passage the Sales Milestone Payment with respect to each such Sales Milestone Event.
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Each Financial Report shall be in the form of the sample report attached hereto as Exhibit C.
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exercise of its rights under this Agreement. Gemma shall pay such amounts to Passage in accordance with this Article 5 (unless otherwise directed by Passage in writing to make payments directly to such licensor), in each case, no later than [*] prior to the date on which the applicable amount is due and payable by Passage under the UPenn Agreement. Without limiting the foregoing, Gemma shall promptly (but in any event not more than [*] thereafter) provide notice to Passage upon the achievement (by Gemma, its Affiliates or Sublicensees) of any of the third party milestones set forth in Exhibit D and pay the corresponding milestone amount owed under the UPenn Agreement, as provided by Passage to Gemma, to Passage (unless otherwise directed by Passage in writing to make payments directly to Penn) no later than [*] following the achievement of such milestone. At the request of Gemma, Passage shall use Commercially Reasonable Efforts to seek applicable and available reductions of any royalties owed under the UPenn Agreement.
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DEVELOPMENT AND COMMERCIALIZATION
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a separate clinical trial budget prior to initiation of such Clinical Study; provided that any such study shall be at Gemma’s cost and expense.
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CONFIDENTIALITY
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Party) discloses or otherwise makes available to the other Party (or to an Affiliate or representative of the other Party) in connection with this Agreement. The Passage Technology shall be the Confidential Information of Passage, and the terms and conditions of this Agreement shall be the Confidential Information of both Parties.
Any combination of features shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the receiving Party.
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provided that in each of the cases of Sections 7.3.1-7.3.3 such Person is subject to a written agreement containing obligations of confidentiality and non-use at least as stringent as those herein (or without such agreement for recipients that are financial or legal advisors under a professional code of conduct giving rise to an expectation of confidentiality and non-use at least as restrictive as those set forth in this Agreement).
Notwithstanding the foregoing, in the event that a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Sections 7.3.1 and 7.3.3, it will, except where impracticable, promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations, and, if requested by the other Party, cooperate in all reasonable respects with the other Party’s efforts to obtain confidential treatment or a protective order with respect to any such disclosure, at the other Party’s expense. In any such event, each Party agrees to take all reasonable actions to minimize disclosure of the other Party’s Confidential Information. Any information disclosed pursuant to this Section 7.3 shall remain, subject to Section 7.2, the Confidential Information of the disclosing Party and subject to the restrictions set forth in this Agreement, including the foregoing provisions of this Article 7.
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INTELLECTUAL PROPERTY
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REPRESENTATIONS, WARRANTIES, AND COVENANTS
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INDEMNIFICATION
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Gemma shall (and shall cause its Affiliates and Sublicensees to) maintain such insurance (including in the amounts set forth above) during the Term and for [*] thereafter. Passage may
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review periodically the adequacy of the minimum amounts of insurance for each coverage required by this Section, and has the right to require Gemma to adjust the limits in Passage’s reasonable discretion.
TERM AND TERMINATION
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Agreement in and for such country), perpetual, and irrevocable for such Licensed Product in and for such country. Upon the expiration of the Term, the License shall become non-exclusive, fully paid-up and royalty-free (subject to any payments owed under the UPenn Agreement), perpetual, and irrevocable in its entirety.
(a) Gemma may, at its convenience, terminate this Agreement in its entirety or terminate a Licensed Product for the Indication in the Field of Use, upon providing at least [*] prior written notice to Passage of such intention to terminate, provided that upon termination of a Licensed Product, except as set forth in Section 11.7.3, Gemma shall cease using the License for making, using, or selling the affected Licensed Product for the Indication in the Field of Use; provided further, that Gemma may not terminate this Agreement in its entirety or terminate a Licensed Product for the Indication in the Field of Use, in either case for convenience prior to the first anniversary of the Effective Date and full payment of the amounts due to Passage under Section 5.1.
(b) Each Party shall have the right to terminate this Agreement immediately in its entirety upon written notice to the other Party if such other Party materially breaches this Agreement and does not cure such breach within [*] (or within [*] with respect to a breach of any payment obligation) following receipt of written notice of such breach from the non-breaching Party; provided however, that if the breach is capable of being cured, but cure of such breach cannot reasonably be effected within such [*] period, then the cure period shall be extended an additional [*] (for a total of [*] following receipt of written notice of such breach from the non-breaching Party). Additionally, Passage shall have the right to terminate this Agreement in its entirety (i) upon [*] written notice if Gemma fails to comply with any Laws that apply to its activities or obligations under this Agreement, which failure(s) can be remedied, and Gemma fails to remedy such lack of compliance within such [*] period, and (ii) upon written notice, with immediate effect, if Gemma grants a security interest in any Licensed UPenn Patents.
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during such period, even if the due date of such payment comes after the effective date of termination.
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MISCELLANEOUS
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This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement.
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If to Passage: |
|
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With a copy to (which shall not constitute notice):
Passage Bio, Inc.
2005 Market St
39th Floor
Philadelphia, PA 19103
ATTN: General Counsel
If to Gemma: |
|
1831 Delancey Place
Philadelphia, PA 19103
ATTN: Chief Executive Officer
With a copy to (which shall not constitute notice):
McDermott Will & Emery LLP
200 Clarendon Street, Floor 58
Boston, MA 02116
ATTN: Brian Bunn
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or agreement or instrument was transmitted or communicated through the use of Electronic Delivery as a defense to the formation of a contract, and each Party forever waives any such defense, except to the extent that such defense relates to lack of authenticity.
[Signature page follows]
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IN WITNESS WHEREOF, the Parties intending to be legally bound have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
Passage Bio, Inc. | Gemma Biotherapeutics, Inc. |
By: _/s/ Will Chou_______________ | By: _/s/ Annalisa Jenkins__________ |
Name: Will Chou, M.D. | Name: Annalisa Jenkins |
Title: Chief Executive Officer | Title: President |
List of Schedules:
Schedule 1.60: Licensed Compound
Schedule 1.119: UPenn Patents (existing as of the Effective Date)
List of Exhibits:
Exhibit A: Specified Obligations
Exhibit B: Form of SDR Report
Exhibit C: Form of Financial Report
Exhibit D: Third Party Milestones
Exhibit E: Diligence Events
[Signature Page to Exclusive License Agreement (GM1)]
SCHEDULE 1.60
LICENSED COMPOUND
[*]
SCHEDULE 1.119
UPENN PATENTS
[*]
EXHIBIT A
SPECIFIED OBLIGATIONS
[*]
EXHIBIT B
FORM OF SDR REPORT
[*]
EXHIBIT C
FORM OF FINANCIAL REPORT
[*]
EXHIBIT D
THIRD PARTY MILESTONES
[*]
EXHIBIT E
DILIGENCE EVENTS
[*]