CONFIDENTIAL
EXECUTION VERSION
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Exhibit 10.2
first amended and restated
Evaluation AGREEMENT
BY AND BETWEEN
FIBROGEN, INC.
AND
FORTIS Therapeutics, INC.
JUNE 6, 2024
FIRST AMENDED AND RESTATED
EVALUATION AGREEMENT
This First Amended and Restated Evaluation Agreement (this “Agreement”) is entered into as of June 6, 2024 (the “Restatement Effective Date”) by and between FIBROGEN, INC., a Delaware corporation, with its principal place of business at 409 Illinois Street, San Francisco, California 94158 (“FibroGen”), and FORTIS THERAPEUTICS, INC., having an address at 11099 North Torrey Pines Road, Suite 290, La Jolla, CA 92037 (“Fortis”). FibroGen and Fortis may be referred to herein individually as a “Party”, or collectively as the “Parties”.
RECITALS
Whereas, FibroGen and Fortis are parties to an Option Agreement and Plan of Merger dated as of May 5, 2023, as amended and restated concurrently with the amendment and restatement of this Agreement (the “Option and Merger Agreement”) pursuant to which Fortis granted to FibroGen an option to consummate the Merger (as defined below), pursuant to the terms of the Option and Merger Agreement;
Whereas, in order to evaluate whether FibroGen will exercise its Option (as defined below), FibroGen and Fortis entered into an evaluation agreement (the “Original Agreement”) dated May 5, 2023 (the “Effective Date”), pursuant to which the Parties agreed to conduct certain activities for the development of certain drug candidates, including FOR46, and for the evaluation by FibroGen of existing Fortis assets including the Products, pursuant to the terms and conditions of this Agreement;
Whereas, as of the Effective Date, Fortis and UCSF (as defined below) have entered into the Fourth UCSF Amendment (as defined below) to amend certain terms of the UCSF License (as defined below) as they apply with respect to this Agreement; and
Whereas, the Parties desire to amend and restate the Original Agreement to clarify the Parties’ understanding regarding certain data transfer and regulatory obligations of FibroGen by entering into this Agreement, which shall supersede and replace the Original Agreement in its entirety effective upon the Restatement Effective Date.
Now, therefore, in consideration of the foregoing and the mutual agreements set forth below, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
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Under this Agreement, (a) the Parties will collaborate for the purpose of the Development of FOR46 [*], and (b) FibroGen will conduct certain evaluation and exploratory research activities with respect to the Products to determine whether FibroGen will exercise the Option pursuant to and in accordance with the Option and Merger Agreement, in each case ((a) and (b)), through the performance of activities set forth in the Study Plan.
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provided that, in each case ((ii) and (iii)), notwithstanding anything to the contrary set forth in this Agreement, neither Party will have the authority to make any final decision that: (1) [*]; or (2) would reasonably be expected to require the other Party to take any action that the other Party reasonably believes would require the other Party to (x) violate any Applicable Law, including the requirements of any Regulatory Authority, (y) breach or otherwise violate any agreement with any Third Party entered into by the other Party (including, with respect to Fortis, the UCSF License), or (z) infringe or misappropriate any intellectual property rights of any Third Party.
In addition, and notwithstanding anything to the contrary in this Agreement, the JSC will not have the right to decide matters that are not expressly within the authority of the JSC, including the right to resolve disputes involving the breach or alleged breach of diligence obligations (which will be instead resolved in accordance with Article 12), modifications to final decision-making rights of the JSC, or amendments to this Agreement (other than amendments to the Study Plan in accordance with this Agreement).
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Date | Development Fee Payment |
[*] | $1,250,000 |
[*] | $1,250,000 |
[*] | $1,250,000 |
[*] | $1,250,000 |
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If and whenever any Confidential Information of the disclosing Party is disclosed in accordance with this Section 10.3, such disclosure will not cause any such information to cease to be Confidential Information of the disclosing Party except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement). Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to clauses (a) through (d) of this Section 10.3, it will, except where impracticable, give reasonable advance notice to the other Party of such disclosure and use not less than the same efforts to secure confidential treatment of such information as it would to protect its own confidential information from disclosure.
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and such term, the “Term”.
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If the above insurance is written on a claims-made form, it will continue for [*]. The insurance will have a retroactive date of placement prior to or coinciding with the Effective Date of this Agreement; and
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if to FibroGen:
[*]
with a copy to:
[*]
[*]
if to Fortis:
[*]
with a copy to:
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[*]
All notices and communications under this Agreement will be deemed to have been duly given (a) when delivered by hand, if personally delivered, (b) upon receipt when delivered by a courier (such date of receipt being evidenced by the courier’s service records) or (c) upon return acknowledgment by email, if delivered by email.
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[SIGNATURE PAGE FOLLOWS]
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CONFIDENTIAL
EXECUTION VERSION
In Witness Whereof, the Parties have caused this Agreement to be signed by their respective officers thereunto duly authorized as of the Restatement Effective Date.
FIBROGEN, INC.
By:/s/ [*]
Name: [*]
Title: [*]
FORTIS Therapeutics, INC.
By: /s/ [*]
Name: [*]
Title: [*]
CONFIDENTIAL
EXECUTION VERSION
Exhibit A Current Study Plan
[*]
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CONFIDENTIAL
EXECUTION VERSION
Schedule 1.12: CD46 Agent
[*]
CONFIDENTIAL
EXECUTION VERSION
Schedule 1.64: FOR46
[*]
CONFIDENTIAL
EXECUTION VERSION
Schedule 1.74: Fortis In-Licenses
[*]
CONFIDENTIAL
EXECUTION VERSION
Schedule 1.117: PET46
[*]
CONFIDENTIAL
EXECUTION VERSION
Schedule 1.149: YS5 (YS5FL)
[*]
CONFIDENTIAL
EXECUTION VERSION
Schedule 5.5: Fortis Existing Subcontractors
[*]
CONFIDENTIAL
EXECUTION VERSION
Schedule 9.2: Disclosure Schedule
[*]
CONFIDENTIAL
EXECUTION VERSION
Schedule 9.2(b): Fortis Patent Rights
[*]
Schedule 9.2(g)
[*]
Schedule 9.2(l)
[*]
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Schedule 10.5: Press Release
FibroGen Enters into Exclusive License for FOR46 with Fortis Therapeutics
SAN FRANCISCO, CA and LA JOLLA, CA May 8, 2023 (GLOBE NEWSWIRE) – FibroGen, Inc. (Nasdaq: FGEN) and Fortis Therapeutics announced that FibroGen has entered into an exclusive license with Fortis Therapeutics for FOR46, a potential first-in-class Phase 1 antibody-drug conjugate (ADC) targeting a novel epitope on CD46. FOR46 is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and is being explored for use in other CD46 expressing cancers. As part of the clinical development strategy, FibroGen will continue Fortis Therapeutics’ work to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody (PET46) for patient selection.
“The agreement with Fortis Therapeutics bolsters FibroGen’s clinical pipeline in a capital-efficient manner, providing a product candidate with the potential to address a significant unmet medical need in oncology,” said Enrique Conterno, Chief Executive Officer, FibroGen. “FOR46 is a natural fit with our R&D capabilities and expertise. The flexibility of the agreement gives us the opportunity to clinically develop FOR46, and ultimately acquire it as a Phase 3-ready asset, potentially delivering a therapy that may transform the treatment of patients with mCRPC and other CD46 expressing cancers.”
“We are pleased to partner with the team at FibroGen, who are experienced in advancing novel drug candidates in the clinic for life-threatening diseases,” said Jay Lichter, Ph.D., President and CEO of Fortis and Managing Partner of Avalon Bioventures. “We believe that FOR46 is a novel and unique antibody drug conjugate therapy that could help patients with prostate cancer and other cancers, where currently approved treatments have failed.”
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Under the terms of the agreement, there is no upfront consideration. FibroGen will conduct and fund future research, development, and manufacturing of FOR46 and PET46. During the four-year evaluation period, FibroGen has the option to acquire Fortis Therapeutics for $80 million. In addition, Fortis is eligible to receive up to a total of $200 million based on various regulatory approvals.
About FOR46
FOR46 is an antibody drug conjugate that binds a specific conformational epitope of CD46 that is highly expressed in various cancer types, including multiple myeloma and prostate and colorectal tumors, with limited reactivity against normal tissues. FOR46 is a fully human antibody conjugated to MMAE, a potent cytotoxic payload utilized in a variety of approved ADCs. Early clinical data show FOR46 to be generally well tolerated with demonstrated monotherapy activity in multiple myeloma and mCRPC.
About FibroGen
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in connective tissue growth factor (CTGF) biology and hypoxia-inducible factor (HIF) to advance innovative medicines for the treatment of unmet needs. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), metastatic pancreatic cancer, and Duchenne muscular dystrophy (DMD). Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in clinical development for anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA). FibroGen recently expanded its research and development portfolio to include product candidates in the immuno-oncology space. For more information, please visit www.fibrogen.com.
About Fortis Therapeutics
Fortis Therapeutics is an immuno-oncology biotech developing a novel antibody-drug conjugate for late-stage multiple myeloma and metastatic castration-resistant prostate cancer. Fortis was founded based on technology exclusively licensed from UCSF and developed in the laboratory of Bin Liu, Ph.D. Fortis is located in Avalon Bioventures’s Community of Innovation, in San Diego. FOR46 is Fortis’ sole pharmaceutical asset. For more information, please visit www.fortistx.com.
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Forward-Looking Statements
This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, and the timing of potential events, including statements regarding the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of its product candidates, and timelines for our clinical programs. These forward-looking statements include, but are not limited to, statements about FibroGen’s plans and objectives and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the Securities and Exchange Commission (SEC) on February 27, 2023, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
Contacts:
FibroGen, Inc.
Investors:
Michael Tung, M.D.
Corporate Strategy / Investor Relations
415.978.1434
mtung@fibrogen.com
Media:
Meichiel Jennifer Keenan
Investor Relations/Corporate Communications
mkeenan@fibrogen.com
Fortis Therapeutics
Media:
Jessica Yingling
858.344.8091
jessica@litldog.com
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