Note 8 - Commitments and Contingencies	6 Months Ended
Jun. 30, 2017
Notes to Financial Statements
Commitments and Contingencies Disclosure [Text Block]	Note 8. Commitments and Contingencies We are or may be from time to time involved in various other disputes, governmental and/or regulatory inspections, inquiries, investigations, and proceedings that could result in litigation, and other litigation matters that arise from time to time. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect us, our results of operations, financial condition, and cash flows. In each of the matters described in this filing or in Note 10. Commitments and Contingencies to our consolidated financial statements in our Annual Report on Form 10 -K for the year ended December 31, 2016, plaintiffs seek an award of a not -yet-quantified amount of damages or an amount that is not material. In addition, a number of the matters pending against us are at very early stages of the legal process (which in complex proceedings of the sort faced by us often extend for several years). As a result, none of the matters described in this filing, except for the former employee litigation, have progressed sufficiently through discovery and/or development of important factual information and legal issues to enable us to estimate a range of possible loss, if any, or such amounts are not material. While it is not possible to accurately predict or determine the eventual outcomes of these items, an adverse determination in one or more of these items currently pending could have a material adverse effect on our consolidated results of operations, financial position, or cash flows. Former Employee Litiga tion On January 4, 2017, we settled all claims against us under a federal action brought in 2010 by a former employee, where such former employee had complained that we had violated the anti-retaliation provisions of the Federal Sarbanes-Oxley law by terminating him. In connection with this settlement, we and the former employee exchanged mutual releases and we are to pay an aggregate sum of $4.0 million to the former employee and his attorneys. During the three months ended June 30, 2017, we paid $0.2 million of the aggregate sum to his attorneys resulting in a remaining balance of $3.8 million, which is included in accrued expenses on our consolidated balance sheet at June 30, 2017. We have $1.5 million held by the District Court in escrow and recorded as restricted cash in other current assets on our consolidated balance sheet at June 30, 2017. Abbreviated New Drug Application Litigations On October 7, 2015, we, Valeant, and Wyeth LLC (Valeant’s predecessor as licensee of RELISTOR) received notification of a Paragraph IV certification for certain patents for RELISTOR ® (methylnaltrexone bromide) subcutaneous injection, which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. The certification resulted from the filing by Mylan Pharmaceuticals, Inc. of an Abbreviated New Drug Application (“ANDA”) with the FDA, challenging such patents for RELISTOR subcutaneous injection and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire. On October 28, 2015, we, Valeant, and Wyeth LLC received a second notification of a Paragraph IV certification with respect to the same patents for RELISTOR subcutaneous injection from Actavis LLC as a result of Actavis LLC’s filing of an ANDA with the FDA, also challenging these patents and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire. In October 2016, we, Valeant, and Wyeth LLC received a notification of a Paragraph IV certification with respect to certain patents for RELISTOR Tablets. The certification accompanied the filing by Actavis LLC of an ANDA challenging such patents for RELISTOR Tablets and seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of these patents expire. In accordance with the Drug Price Competition and Patent Term Restoration Act (commonly referred to as the Hatch-Waxman Act), we and Valeant timely commenced litigation against each of the above-listed ANDA filers in order to obtain an automatic stay of FDA approval of the ANDA until the earlier of (i) 30 months from receipt of the notice or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed. In each of the above-described proceedings we and Valeant continue to cooperate closely to vigorously defend and enforce RELISTOR intellectual property rights. Pursuant to the RELISTOR license agreement between us and Valeant, Valeant has the first right to enforce the intellectual property rights at issue and is responsible for the costs of such enforcement. In addition to the above-described ANDA notifications, in October 2015, we received notices of opposition to three European patents relating to methylnaltrexone bromide. The oppositions were filed separately by each of Actavis Group PTC ehf. and Fresenius Kabi Deutschland GmbH. We are actively defending the European patents against these opposition challenges.

Note

Commitments and Contingencies

We are or

may

be from time to time involved in various other disputes, governmental and/or regulatory inspections, inquiries, investigations, and proceedings that could result in litigation, and other litigation matters that arise from time to time. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect us, our results of operations, financial condition, and cash flows.

In each of the matters described in this filing or in

Note

10.

Commitments and Contingencies

to our consolidated financial statements in our Annual Report on Form

-K for the year ended

December 31, 2016,

plaintiffs seek an award of a

not

-yet-quantified amount of damages or an amount that is

not

material. In addition, a number of the matters pending against us are at very early stages of the legal process (which in complex proceedings of the sort faced by us often extend for several years). As a result,

none

of the matters described in this filing, except for the former employee litigation, have progressed sufficiently through discovery and/or development of important factual information and legal issues to enable us to estimate a range of possible loss, if any, or such amounts are

not

material. While it is

not

possible to accurately predict or determine the eventual outcomes of these items, an adverse determination in

one

or more of these items currently pending could have a material adverse effect on our consolidated results of operations, financial position, or cash flows.

Former Employee Litiga

tion

January 4, 2017,

we settled all claims against us under a federal action brought in

2010

by a former employee, where such former employee had complained that we had violated the anti-retaliation provisions of the Federal Sarbanes-Oxley law by terminating him. In connection with this settlement, we and the former employee exchanged mutual releases and we are to pay an aggregate sum of

$4.0

million to the former employee and his attorneys. During the

three

months ended

June 30, 2017,

we paid

$0.2

million of the aggregate sum to his attorneys resulting in a remaining balance of

$3.8

million, which is included in accrued expenses on our consolidated balance sheet at

June 30, 2017.

We have

$1.5

million held by the District Court in escrow and recorded as restricted cash in other current assets on our consolidated balance sheet at

June 30, 2017.

Abbreviated New Drug Application Litigations

October 7, 2015,

we, Valeant, and Wyeth LLC (Valeant’s predecessor as licensee of RELISTOR) received notification of a Paragraph IV certification for certain patents for RELISTOR

(methylnaltrexone bromide) subcutaneous injection, which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. The certification resulted from the filing by Mylan Pharmaceuticals, Inc. of an Abbreviated New Drug Application (“ANDA”) with the FDA, challenging such patents for RELISTOR subcutaneous injection and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire.

October 28, 2015,

we, Valeant, and Wyeth LLC received a

second

notification of a Paragraph IV certification with respect to the same patents for RELISTOR subcutaneous injection from Actavis LLC as a result of Actavis LLC’s filing of an ANDA with the FDA, also challenging these patents and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire.

October 2016,

we, Valeant, and Wyeth LLC received a notification of a Paragraph IV certification with respect to certain patents for RELISTOR Tablets. The certification accompanied the filing by Actavis LLC of an ANDA challenging such patents for RELISTOR Tablets and seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of these patents expire.

In accordance with the Drug Price Competition and Patent Term Restoration Act (commonly referred to as the Hatch-Waxman Act), we and Valeant timely commenced litigation against each of the above-listed ANDA filers in order to obtain an automatic stay of FDA approval of the ANDA until the earlier of (i)

months from receipt of the notice or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or

not

infringed.

In each of the above-described proceedings we and Valeant continue to cooperate closely to vigorously defend and enforce RELISTOR intellectual property rights. Pursuant to the RELISTOR license agreement between us and Valeant, Valeant has the

first

right to enforce the intellectual property rights at issue and is responsible for the costs of such enforcement.

In addition to the above-described ANDA notifications, in

October 2015,

we received notices of opposition to

three

European patents relating to methylnaltrexone bromide. The oppositions were filed separately by each of Actavis Group PTC ehf. and Fresenius Kabi Deutschland GmbH. We are actively defending the European patents against these opposition challenges.