Note 7 - Contingencies | 6 Months Ended |
Jun. 30, 2014 |
Commitments and Contingencies Disclosure [Abstract] | ' |
Commitments and Contingencies Disclosure [Text Block] | ' |
7. Contingencies |
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Legal Matters |
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General Litigation and Disputes |
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From time to time, in the normal course of our operations, we are a party to litigation and other dispute matters and claims. Currently such litigation includes proceedings to which Insys Therapeutics, Inc. and our wholly owned subsidiary, Insys Pharma, Inc., is a party. Litigation can be expensive and disruptive to normal business operations. Moreover, the results of complex legal proceedings are difficult to predict and our view of these matters may change in the future as the litigation and events related thereto unfold. An unfavorable outcome to any legal matter, if material, could have a materially adverse effect on our operations or our financial position, liquidity or results of operations. Following is a brief description of such litigation and dispute proceedings. |
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Kottayil vs. Insys Pharma, Inc. On September 29, 2009, Insys Pharma, Inc., our wholly owned subsidiary, and certain of our officers and the five directors who comprised the Insys Pharma board of directors as of June 2009, as well as their spouses, were named as defendants in a lawsuit in the Superior Court of the State of Arizona, Maricopa County, or the Arizona Superior Court, brought by Santosh Kottayil, Ph.D., certain of his family members and a trust of which Dr. Kottayil is the trustee. |
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Dr. Kottayil formerly served as President, Chief Scientific Officer and a director of Insys Pharma, among other positions. The complaint brought a cause of action for statutory and common law appraisal of Dr. Kottayil’s Insys Pharma common stock. The cause of action for appraisal relates to a reverse stock split that Insys Pharma effected in June 2009, which resulted in Dr. Kottayil’s ownership position becoming a fractional share of Insys Pharma common stock. Following the reverse stock split, Insys Pharma cancelled all resulting fractional shares, including the fractional share held by Dr. Kottayil, and offered a cash payment in lieu of the fractional shares. The complaint also brought causes of action for breach of fiduciary duty, fraud and negligent misrepresentation in the defendants’ dealings with Dr. Kottayil on the subject of his compensation and stock ownership in Insys Pharma. In January 2010, the plaintiffs added claims seeking to rescind Dr. Kottayil’s assignment to Insys Pharma of his interest in all of the fentanyl and dronabinol patent applications previously assigned to Insys Pharma and to recover the benefits of those interests. Dr. Kottayil is seeking, among other relief, the fair value of his Insys Pharma common stock as of June 2, 2009, compensatory and punitive damages, and rescission of all assignments to Insys Pharma of his interest in the patent applications, as well as attorneys’ fees, costs and interest. |
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In February 2010, Insys Pharma and the other defendants answered and filed counter-claims to Dr. Kottayil’s amended complaint. The counter-claims include actions for breach of fiduciary duty, fraud and negligent misrepresentations and omissions with respect to the time during which Dr. Kottayil was employed at Insys Pharma. The counter-claims, among other relief, seek compensatory and punitive damages. |
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Discovery on all of the foregoing claims was completed and a trial was scheduled to commence on January 27, 2014; however, on January 22, 2014, the court vacated the trial and granted plaintiffs leave to file an amended complaint to add Insys Therapeutics, Inc. as a defendant. |
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On January 29, 2014, the plaintiffs filed a second amended complaint in the Arizona Superior Court in which Insys Therapeutics, Inc. was also named as defendant in this lawsuit. This amended complaint filed by plaintiffs re-alleges substantially the same claims set forth in the prior complaint, except that plaintiffs now allege that they are entitled to rescissory damages, plaintiffs have also added our majority stockholder, a private trust, as a defendant to the breach of fiduciary duty claim and plaintiffs have revised their fraud claim against the Insys Pharma director defendants. |
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On February 25, 2014, we filed a Motion to Dismiss the Kottayil Plantiffs’ claims for a statutory and common law appraisal. The motion was denied on May 2, 2014. |
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The court has set the case for trial commencing on December 1, 2014. |
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Although there has been some discovery into the range of potential loss or any potential recovery from the counter-claims, that range is very broad and we are not able to provide a reasonable estimate of these figures at this time, nor are we able to predict the outcome of this litigation. If the patent assignments are successfully rescinded, we may not have exclusive patent rights covering our fentanyl and dronabinol product candidates, and such patent rights may not be available to us on acceptable terms, if at all, which would have a material adverse effect on our business. We intend to vigorously defend against the plaintiffs’ claims and pursue our counter-claims. |
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Insys Therapeutics, Inc. vs. Mylan Pharmaceuticals. On or around May 30, 2013, we filed a lawsuit against Mylan Pharmaceuticals, or Mylan, seeking a declaration that the parties’ Supply and Distribution Agreement dated May 20, 2011, or the Distribution Agreement, had been terminated because of Mylan’s material breach of the Distribution Agreement. Mylan removed the action to the United States District Court for the District of Arizona, or the District Court, as Case No. 2:13-cv-01112-DGC, and moved to compel arbitration and sought a preliminary injunction. The District Court compelled arbitration and issued a preliminary injunction requiring that the Distribution Agreement continue in full force and effect pending the outcome of arbitration. The District Court then dismissed the lawsuit. |
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On May 31, 2013, Mylan filed a demand with the American Arbitration Association, Case No. 55 122 00119 13. Mylan’s demand alleged that we were in breach of the Distribution Agreement. On July 10, 2013, we filed a response to Mylan’s demand, denying we were in breach of the Distribution Agreement, and asserting counterclaims based on Mylan’s material breach of the Distribution Agreement and the duty of good faith and fair dealing. On January 13, 2014, the three-member arbitration panel held a preliminary hearing, where it ordered Mylan to submit an amended and detailed demand by February 3, 2014, to which we responded and submitted amended counterclaims on February 4, 2014. The panel has set an arbitration hearing for August 5-8, 2014. We anticipate that the arbitration will resolve: (1) whether Mylan materially breached the Distribution Agreement by failing to accept delivery of a conforming shipment of product in October 2012; (2) whether Mylan has materially breached the parties Distribution Agreement by failing to use commercially reasonable efforts to market and sell the product; and (3) whether the Distribution Agreement has been terminated because of the parties dispute over floor pricing. We anticipate seeking damages and attorneys’ fees as part of the arbitration. |
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On January 21, 2014, Mylan filed a new lawsuit against us with the District Court, as Case No. 2:14-cv-00119-GMS, asserting a claim for declaratory judgment and seeking a temporary restraining order and preliminary injunction relating to our notice of termination of the Distribution Agreement with respect to the parties’ failure to agree on floor pricing. On January 24, 2014, Insys responded in opposition to the application for temporary restraining order and preliminary injunction, or Application. A hearing was initially set for April 3, 2014. After stipulation of the parties to postpone the hearing, the Court denied all pending motions as moot on April 2, 2014. We intend to seek attorneys’ fees incurred in responding to Mylan’s lawsuit. The Application was dismissed by the Court with prejudice on June 2, 2014. |
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Because of the remaining uncertainty as to the claims (if any) made by Mylan against us, as well as the uncertainty relating to the total damages incurred by us because of Mylan’s breaches, we are not able to predict the outcome of this dispute or make a reasonable estimate of possible losses. |
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Federal Securities Litigation. Between May 15 and May 19, 2014, two complaints (captioned Larson v. Insys Therapeutics, Inc., Case No. 14-cv-01043-GMS) and (Li vs. Insys Therapeutics, Inc., Case No 14-cv-01077-DGC) were filed in the U.S. District Court for the District of Arizona (“Court”) against us and certain of our current officers. The complaints were brought as purported class actions, on behalf of purchasers of our common stock. In general, they allege that the defendants violated federal securities laws by making intentionally false and misleading statements regarding our business and operations, therefore artificially inflating the price of our common stock. The plaintiffs seek unspecified monetary damages and other relief. On July 14, 2014, several purported shareholders filed motions to consolidate the two cases, appoint a lead plaintiff, and appoint lead counsel. The Court has not yet ruled on these motions. In both cases, the parties stipulated to extending defendants’ deadline to respond to the complaint until after the Court consolidates the actions and appoints lead plaintiff and lead counsel. In the Li case, the Court instructed defendants to respond to the initial complaint by August 29th, 2014 or to propose a specific schedule for responding to the complaint. |
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We plan to vigorously defend these claims. Because of the uncertainty and early stage of these matters, we are not able to predict the outcome of this dispute or make a reasonable estimate of possible liability. |
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Government Proceedings |
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Like other companies in the pharmaceutical industry, we are subject to extensive regulation by national, state and local government agencies in the United States. As a result, interaction with government agencies occurs in the normal course of our operations. Following is a brief description of a pending, potentially material, governmental investigation. It is possible that criminal charges and substantial fines and/or civil penalties or damages could result from any government investigation or proceeding. |
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Department of Health and Human Services Investigation. We received a subpoena, dated December 9, 2013, from the Office of Inspector General of the Department of Health and Human Services, or HHS, in connection with an investigation of potential violations involving HHS programs. The subpoena was issued in connection with an investigation by the U.S. Attorney’s Office for the Central District of California. The subpoena requests documents regarding our business, including the commercialization of Subsys. We are cooperating with this investigation and have produced documents in response to the subpoena and have provided other requested information. |