Item 1.01 Entry into a Material Definitive Agreement.
On
Pursuant to Amendment No. 3 the parties have agreed, among other things, to (i) manufacture veverimer for commercial use using a payment structure that, in addition to payment for delivery of commercial product on a per kilogram basis as established by the Agreement, provides an additional incremental payment to Patheon to cover certain manufacturing costs, (ii) maintain the existing cap on maximum compensation to Patheon for commercial manufacturing during the upcoming campaign, (iii) work on development of a second generation manufacturing process, and (iv) defer payment of certain costs to the fourth quarter of 2023.
The foregoing description of terms of the Amendment No. 3 does not purport to be
complete and is qualified in its entirety by reference to the full text of the
Amendment No. 3. A copy of the Amendment No. 3 will be filed with the
Item 7.01 Regulation FD Disclosure.
Amendment No. 3 does not impact
The information included under Item 7.01 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, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Forward Looking Statements
This Current Report on Form 8-K contains "forward-looking statements" within the
meaning of Section 27A of the Securities Act and Section 21E of the Exchange
Act. Forward-looking statements relate to expectations concerning matters that
are not historical facts. Words such as "projects," "believes," "anticipates,"
"plans," "expects," "intends," "may," "will," "could," "should," "would," and
similar words and expressions are intended to identify forward-looking
statements. These forward-looking statements include, but are not limited to,
statements related to deferral of certain costs until the fourth quarter of
2023, our financial resources being sufficient to fund our planned operations
into early in the second quarter of 2023, risks associated with our
manufacturer's commercial production capacity, risks associated with our
business prospects, financial results and business operations. These and other
factors that may affect our future business prospects, results and operations
are identified and described in more detail in our filings with the
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit Number Description Cover Page Interactive Data File (embedded within the Inline XBRL 104 document).
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