Item 1.01. Entry into a Material Definitive Agreement.
On
Under the Purchase Agreement, and in connection with its sale of the Royalty, the Company has agreed to specified negative covenants with respect to the exercise of its rights under the License Agreement, including the Company's right to amend, assign and terminate the License Agreement. In addition, the Company has agreed not to commence or join any action for infringement of the Company's intellectual property rights to the extent such infringement is competitive with the Product without RPI's prior written consent. The Company has also agreed to enforce the License Agreement at RPI's direction with respect to any Celgene breach related to the Product, payments of the Royalty and the Company's intellectual property rights related to the Product. The Purchase Agreement also contains representations and warranties, other covenants, indemnification obligations and other provisions customary for transactions of this nature.
The Purchase Agreement will terminate 60 days following the date on which Celgene is no longer obligated to make any payments of the Royalty pursuant to the License Agreement. Upon termination of the License Agreement by Celgene for convenience or by the Company for Celgene's material breach or bankruptcy, the Company has the right to negotiate with RPI for the right to commercialize the Product and has otherwise agreed to license the intellectual property rights that it controls under the License Agreement related to the Product to a third party selected by RPI at RPI's direction and expense.
The foregoing description of the Purchase Agreement does not purport to be
complete and is qualified in its entirety by reference to the complete text of
the Purchase Agreement, which will be filed as an exhibit to the Company's
quarterly report on Form 10-Q for the fiscal quarter ending
Item 8.01. Other Events.
The full text of the press release announcing the consummation of the
transactions contemplated by the Purchase Agreement on
On
Cautionary Note Regarding Forward-Looking Statements
Statements in this Current Report on Form 8-K, Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3 hereto contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding: Agios' use of proceeds from the transaction with RPI, developments regarding Agios' collaboration agreement with Celgene, the potential benefits of mitapivat, Agios' plans for the further clinical development of mitapivat and Agios' strategic plans and prospects. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all
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forward-looking statements contain these identifying words. Such statements are
subject to numerous important factors, risks and uncertainties that may cause
actual events or results to differ materially from Agios' current expectations
and beliefs. For example, there can be no guarantee that any product candidate
Agios or its collaborators is developing will successfully commence or complete
necessary preclinical and clinical development phases, or that development of
any of Agios' product candidates will successfully continue. There can be no
guarantee that any positive developments in Agios' business will result in stock
price appreciation. Management's expectations and, therefore, any
forward-looking statements in this press release could also be affected by risks
and uncertainties relating to a number of other important factors, including,
without limitation: risks and uncertainties related to the impact of the
COVID-19 pandemic to Agios' business, operations, strategy, goals and
anticipated milestones, including its ongoing and planned research activities,
ability to conduct ongoing and planned clinical trials, clinical supply of
current or future drug candidates, commercial supply of current or future
approved products, and launching, marketing and selling current or future
approved products; Agios' results of clinical trials and preclinical studies,
including subsequent analysis of existing data and new data received from
ongoing and future studies; the content and timing of decisions made by the
Item 9.01. Financial Statements and Exhibits.
Exhibit No. Description 99.1 Press release issuedJune 12, 2020 (Purchase Agreement) 99.2 Press release issuedJune 12, 2020 (mitapivat for thalassemia) 99.3 Press release issuedJune 12, 2020 (mitapivat for sickle cell disease) 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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