Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Exhibit 4.4
CLINICAL SUPPLY AGREEMENT
by and between
Seagen Inc.
and
LAVA THERAPEUTICS N.V.
JANUARY 27, 2023
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
CLINICAL SUPPLY AGREEMENT
This Clinical Supply Agreement (this “Agreement”) is entered into as of January 27, 2023 (the “Effective Date”), by and between Seagen Inc., a Delaware corporation, having a place of business at 21823 30th Drive S.E., Bothell, WA 98021, United States (“Seagen”), and Lava Therapeutics N.V., a Netherlands public limited company (naamloze vennootschap) having an address at Yalelaan 60, 3584 CM Utrecht, the Netherlands (“Lava”). Seagen and Lava are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”
BACKGROUND
WHEREAS, Lava and Seagen have entered into that certain Exclusive License Agreement dated as of September 23, 2022 (the “License Agreement”), pursuant to which Seagen obtained an exclusive license to Develop, Manufacture and Commercialize Licensed Compounds and Licensed Products in the Field in the Territory; and
WHEREAS, pursuant to the terms of the License Agreement, Seagen and Lava have agreed to enter into this Agreement in order to establish certain Manufacture and supply obligations of Lava with respect to GMP Drug Product and GMP Diluent in the form of fully released bulk unlabeled vials as further described on Exhibit A (collectively, “Product”) as well as, upon Seagen’s request, GMP Drug Substance; and
WHEREAS, Lava desires to have Manufactured and supply to Seagen Product and, upon Seagen’s request, GMP Drug Substance, and Seagen desires to be supplied Product and, upon Seagen’s request, GMP Drug Substance from Lava, in each case, subject to the applicable terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:
Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below. Capitalized terms used herein but not defined shall have the meaning set forth in the License Agreement.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
If to Seagen: | Seagen Inc. |
21823 30th Drive SE
Bothell, WA 98021
Fax: [***]
Email: [***]
Attention: General Counsel
If to Lava: | LAVA Therapeutics N.V. |
520 Walnut Street, Suite 1120
Philadelphia, PA 19106 USA
Email: [***]
Attention: General Counsel
With a copy (which shall not constitute notice) to:
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
[***]
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
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Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
SEAGEN INC.
By:/s/ Todd Simpson
Name: Todd Simpson
Title: CFO
LAVA THERAPEUTICS N.V.
By:/s/ Steve Hurly
Name: Steve Hurly
Title: CEO
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Product
Material | ID | Manuf. | Required amount of vials filled | Vial content | Currently anticipated amount of vials filled |
GMP Drug Product, unlabeled | [***] | [***] | [***] | [***] | [***] |
GMP Diluent, unlabeled | [***] | [***] | [***] | [***] | [***] |
To be delivered to Seagen at the following locations:
GMP Drug Substance | [***] | [***] |
| | |
GMP Drug Product and GMP Diluent | [***] |
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Exhibit B
Supply Price
[***]
Certain portions of this exhibit (indicated by “[***]”) have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
Exhibit C
[***]
[***]