Risk Factors.
−Removed: Our material risk factors are disclosed in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020.
−Removed: There have been no material changes from the risk factors previously disclosed in such filing, except as follows:
+Added: Our material risk factors are disclosed in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.
+Added: There have been no material changes from the risk factors previously disclosed in such filings, except as follows:
Risks Related to Third Parties
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Moreover, an unsuccessful outcome in any clinical trial for which our licensee or collaborator is responsible could be harmful to the public perception and prospects of our NAV Technology Platform or product candidates.
+Added: In September 2021, we entered into a Collaboration and License Agreement with AbbVie Global Enterprises Ltd.
+Added: (AbbVie), a subsidiary of AbbVie Inc., to develop and commercialize RGX-314 (the AbbVie Collaboration and License Agreement).
+Added: The transaction is contingent upon the satisfaction of customary closing conditions, including the expiration or termination of the applicable waiting or suspension period under the Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended, and any other applicable competition laws.
+Added: If the transaction contemplated by the AbbVie Collaboration and License Agreement is not consummated or is delayed, our expectations regarding future revenues, research and development costs, other operating expenses and operating cash flows associated with the development and commercialization of RGX-314 would be materially affected.
+Added: For additional information regarding the AbbVie Collaboration and License Agreement, please refer to Note 8, “License and Royalty Revenue—Collaboration and License Agreement with AbbVie” to the accompanying unaudited consolidated financial statements.
Any current or future licensing agreements or future collaborations we enter into may pose additional risks, including the following:
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Each of our licensees and collaborators is subject to similar risks with respect to product development, regulatory approval and commercialization, and any such risk could result in its business being harmed, which could adversely affect our collaboration.
−Removed: For example, we were in arbitration with Abeona Therapeutics Inc.
−Removed: (Abeona) regarding a dispute under the License Agreement dated November 4, 2018 between the Company and Abeona, as amended on November 4, 2019.
−Removed: For information regarding our legal proceedings with Abeona, please refer to Note 8, “License and Royalty Revenue—Abeona Therapeutics Inc.,” to the accompanying unaudited consolidated financial statements.
We may in the future decide to partner or collaborate with pharmaceutical and biotechnology companies for the development and potential commercialization of our product candidates.
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If we elect to fund development or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms or at all.
−Removed: Unregistered Sales of Equity Securities and Use of Proceeds.
+Added: Unregistered Sales of Equit y Securities and Use of Proceeds.
Defaults Upon Senior Securities.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.