Item 1.01 Entry into a Material Definitive Agreement.
Collaboration and License Agreement
On
Collaboration and License. Under the Collaboration Agreement, upon the expiration or termination of applicable waiting periods and the receipt of any required approvals or clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (such date, the "Effective Date" and such clearance, "Antitrust Clearance"), the Company and Neurocrine have agreed to collaborate on the conduct of the Programs. Under the terms of the Collaboration Agreement, subject to the rights retained by the Company thereunder, the Company has also agreed to grant to Neurocrine, as of the Effective Date, an exclusive, royalty-bearing, sublicensable, worldwide license, under certain of the Company's intellectual property rights, to research, develop, manufacture and commercialize gene therapy products (the "New Collaboration Products") arising under the Programs.
Pursuant to mutually-agreed development plans (the "Development Plans"), during the period beginning on the Effective Date and ending on the third anniversary of the Effective Date, which period may be extended upon mutual written agreement of the Company and Neurocrine (the "Discovery Period"), and as overseen by the joint steering committee that oversees the Company's ongoing collaboration with Neurocrine (the "JSC"), the Company is responsible for identifying capsids meeting target criteria, producing development candidates, and conducting other non-clinical activities regarding the New Collaboration Products. Neurocrine has agreed to be responsible for all costs incurred by the Company in conducting non-clinical development activities for each Program, in accordance with an agreed budget. If the Company breaches its development responsibilities or, in certain circumstances, upon a change of control of the Company, Neurocrine has the right, but not the obligation, to assume the conduct of the Company's activities under such Program.
The Company has the option (a "Co-Co Option") to co-develop and co-commercialize
New Collaboration Products in the GBA1 Program in the
Governance. The Company's research and development activities under the Collaboration Agreement are to be conducted pursuant to plans agreed to by the parties, on a Program-by-Program basis, and overseen by the JSC, which is composed of an equal number of representatives from each of the Company and Neurocrine. The JSC may delegate matters within its authority to subcommittees of the JSC. In addition, the Collaboration Agreement establishes working groups to handle specified matters on a subject matter-by-subject matter basis. If a working group or subcommittee cannot agree on a matter within its purview within a specified time, such matter is to be referred sequentially to the JSC and then the executive officers of the parties. If the executive officers are not able to resolve the matter, then (i) with respect to the GBA1 Program, subject to specified exceptions, (a) Neurocrine has the right to resolve such matter prior to the Company's exercise of its Co-Co Option for the GBA1 Program or in the event the Company elects not to exercise its Co-Co Option, and (b) following the exercise by the Company of its Co-Co Option for the GBA1 Program, depending on the subject of such matter, either Neurocrine, in certain instances, or the parties jointly or the JSC, in other instances, would have the right to resolve such matter, and (ii) with respect to the New Discovery Programs, subject to specified exceptions, Neurocrine has the right to decide any unresolved matters relating to a New Discovery Program that are within the JSC's authority.
Candidate Selection.
Manufacturing. The parties have agreed that the Development Plans shall specify the allocation between the Company and Neurocrine of responsibilities for the manufacturing of Collaboration Candidates associated with the applicable Program . . .
Item 2.02 Results of Operations and Financial Condition
The Company is currently completing its reports of the Company's operational and
financial results for the year ended
The estimated cash and cash equivalent and marketable securities amounts as of
The information in Item 2.02 of this Current Report on Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 3.02 Unregistered Sales of
The information set forth in Item 1.01 above under the caption "2023 Stock Purchase Agreement" is incorporated herein by reference. Based in part upon the representations of Neurocrine in the 2023 Stock Purchase Agreement, the Company expects the Shares to be issued in reliance on the exemption from registration under Section 4(a)(2) of the Securities Act for a transaction by an issuer not involving any public offering within the meaning of Section 4(a)(2) and/or under Rule 506 of Regulation D promulgated under the Securities Act and corresponding provisions of state securities or "blue sky" laws.
Item 8.01 Other Events
On
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "might," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "undoubtedly," "target," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward-looking statements.
For example, all statements the Company makes regarding the consummation of the
collaboration with Neurocrine and the sale and issuance of Company common stock
to Neurocrine, the satisfaction of closing conditions and the receipt of
regulatory clearances necessary for the consummation of the collaboration and
the sale and issuance of Company common stock to Neurocrine, the Company's
entitlement to receive the Upfront Payment, milestone payments and royalties
from Neurocrine under the Collaboration Agreement, the creation of value and the
establishment of new opportunities that may arise as a result of the
collaboration, the ability of the Company and Neurocrine to perform under the
2019 Collaboration Agreement and the Collaboration Agreement, including the
Company's and Neurocrine's abilities to advance gene therapy product candidates
under this collaboration into, and successfully initiate, enroll and complete,
clinical trials, the ability of the Company and Neurocrine to perform their
obligations under the Amended and Restated Investor Agreement, the ability of
the Company to add new programs to its pipeline, the ability of the Company to
develop its pipeline programs including its new research efforts focused on
Huntington's disease, the ability of the Company to enter into new partnerships
or collaborations, the ability of the Company to continue to develop the TRACER
platform, the regulatory pathway of, and the timing or likelihood of its
regulatory filings and approvals for, any of the Company's product candidates,
the Company's preliminary unaudited cash and cash equivalent and marketable
securities amounts as of
All forward-looking statements are based on estimates and assumptions by the
Company's management that, although the Company believes them to be reasonable,
are inherently uncertain. All forward-looking statements are subject to risks
and uncertainties that may cause actual results to differ materially from those
that the Company expected. Such risks and uncertainties include, among others,
the expectations and decisions of regulatory authorities; the initiation and
conduct of preclinical studies and clinical trials; the availability of data
from clinical trials; the continued development of the Company's capsid and gene
therapy platforms; the availability or commercial potential of product
candidates under this collaboration; the willingness and ability of the
Company's collaboration partners to meet obligations under collaboration
agreements with the Company; and uncertainties as to the Company's preliminary
unaudited cash and cash equivalent and marketable securities amounts as of
These statements are also subject to a number of material risks and
uncertainties that are described in the Company's most recent Annual Report on
Form 10-K filed with the
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