Item 2.01 Completion of Acquisition or Disposition of Assets.
As previously disclosed, on December 19, 2019, Jazz Pharmaceuticals Ireland
Limited (the "Company"), a subsidiary of Jazz Pharmaceuticals plc ("Jazz
Pharmaceuticals"), entered into an exclusive license agreement (the "Agreement")
with Pharma Mar, S.A. ("PharmaMar") pursuant to which PharmaMar granted to the
Company an exclusive license under PharmaMar's patents and know-how to develop
and commercialize lurbinectedin in the United States. The effectiveness of the
Agreement was subject to the expiration or early termination of the applicable
waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976,
as amended (the "HSR Act"). The applicable waiting period under the HSR Act
expired on January 21, 2020, and the Agreement became effective.
Under the Agreement, PharmaMar is responsible for continuing ongoing clinical
trials of lurbinectedin. PharmaMar is also responsible for conducting any
post-approval commitment studies that are required by the U.S. Food and Drug
Administration with respect to any regulatory approval of lurbinectedin in small
cell lung cancer. Under a separate agreement to be executed by the parties
within a specified time period, PharmaMar will supply the Company with launch
quantities of lurbinectedin drug product and on an ongoing basis will supply the
Company with the active pharmaceutical ingredient for lurbinectedin.
Pursuant to the terms of the Agreement, the Company will pay PharmaMar an
upfront payment of $200 million and will be obligated to pay PharmaMar up to
$250 million in regulatory milestone payments based on the achievement of
accelerated and/or full regulatory approval of lurbinectedin in small cell lung
cancer in the United States within specified timeframes. PharmaMar is also
eligible to receive tiered royalties from the high teens percentage up to 30% on
net sales of lurbinectedin in the United States, subject to customary royalty
reductions, and commercial milestone payments of up to $550 million once certain
sales levels have been achieved in the United States. The Company may also be
obligated to pay additional milestone payments upon receipt of regulatory
approval of lurbinectedin in additional indications, with any such milestone
payments creditable against the Company's commercial milestone payment
obligations.
The term of the Agreement will extend until the latest of: (i) expiration of the
last PharmaMar patent covering lurbinectedin in the United States (subject to
certain exclusions), (ii) expiration of regulatory exclusivity for lurbinectedin
in the United States and (iii) 12 years after the first commercial sale of
lurbinectedin in the United States. The Company also has the right to terminate
the Agreement at will upon a specified notice period, provided that the
effective date of such termination is not within one year of the signing of the
Agreement. Either party can terminate the Agreement for the other party's
uncured material breach or bankruptcy.
The foregoing summary of certain terms of the Agreement does not purport to be
complete and is subject to, and qualified in its entirety by, the full text of
the Agreement, a copy of which is filed as Exhibit 2.1 hereto and incorporated
herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
Number Description
2.1* License Agreement, dated as of December 19, 2019, between Pharma
Mar, S.A. and Jazz Pharmaceuticals Ireland Limited
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
* Pursuant to Item 601(b)(2) of Regulation S-K, certain portions of this
agreement have been omitted because the omitted portions are both not material
and would likely cause competitive harm if publicly disclosed.
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