Commitments and Contingencies Disclosure | 15 . Commitments and C ontingencies (a) Leases Future minimum lease payments under operating leases as of March 31, 2016 are presented below: Operating leases $’M _____________ 2016 1 36.5 2017 1 39.8 2018 1 33.5 2019 1 30.7 2020 1 30.8 2021 29.2 Thereafter 1 156.5 111 _____________ 357.0 _____________ The Company leases land, facilities, motor vehicles and certain equipment under operating leases expiring through 20 32 . Lease and rental expense amounted to $ 7.5 million and $ 14.2 million for the three months ended March 31, 2016 and 2015 respectively , which is predominately included in SG&A expenses in the Company's Unaudited Consolidated Statement of Income . (b) Letters of credit and guarantees At March 31 , 2016 , the Company had irrevocable standby letters of credit and guarantees with various banks and insurance companies totaling $ 6 0 .0 m illion (being the contractual amounts) , providing security for the C ompany's performance of various obligations. These obligations are primarily in respect of the recoverability of insurance claims, lease obligations and supply comm itments. (c) Collaborative and other licensing arrangements Details of significant updates in other licensing arrangements are included below: L icensing arrangements The Company ha s entered into various collabora tive and licensing arrangements where it has licensed certain product or intellectual property rights for consideration such as up-front payments, development milestones, sales milestones and/or royalty payments. In some of these arrangements Shire and the licensee are both actively involved in the development and commercialization of the licensed product and have exposure to risks and rewards dependent on its commercial success. Under the terms of these collaborative and licensing arrangements, the Company may receive development milestone payments up to an aggregate amount of $ 3 2 million and sales milestones up to an aggregate amount of $ 4 2 million . The receipt of these substantive milestones is uncertain and contingent on the achievement of certain development milestones or the achievement of a specified level of annual net sales by the licensee . In the three months ended March 31, 2016 the Company received cash related to up-front and milestone payments of $ 0.5 million (2015 : $ 12 . 6 million ). In the three months ended March 31, 2016 the Company recognized milestone income of $ 1 . 3 million (2015 : $ 0.5 million) in o ther revenues and $ 15 . 1 million (2015 : $ 9 . 2 million ) in p roduct sales for shipment of product to the relevant licensee. (d) Commitments ( i ) Clinical testing At March 31, 2016 the Company had committed to pay approximately $ 584 million (December 31, 2015 : $ 490 million) to contract vendors for administering and executing clinical trials. The timing of these payments is dependent upon actual services performed by the organizations as determined by patient enrollment levels and related activities. (ii) Contract manufacturing At March 31, 2016 the Company had committed to pay approximately $ 334 million (December 31, 2015 : $ 325 million) in respect of contract manufacturing. The Company expects to pay $ 159 million of these commitments in 201 6 . (iii) Other purchasing commitments At March 31, 2016 the Company had committed to pay approximately $ 581 million (December 31, 2015 : $ 485 million) for future purchases of goods and services, predominantly relating to active pharmaceutical ingredients sourcing. The Company expects to pay $ 575 million of these commitments in 201 6 . (iv) Investment commitments At March 31, 2016 the Company had outstanding commitments to purchase common stock and interests in companies and partnerships , respectively, for amounts totaling $ 22 million (December 31, 2015 : $ 22 million) which may all be payable in 201 6 , depending on the timing of capital calls. The investment commitments include additional funding to certain VIE s that Shire is not the primary beneficiary. (v) Capital commitments At March 31, 2016 the Company had committed to spend $ 43 million (December 31, 2015 : $ 60 million) on capital projects. (e) L egal and other proceedings The Company expenses legal costs when incurred. The Company recognizes loss contingency provisions for probable losses when management is able to reasonably estimate the loss. When the estimated loss lies within a range, the Company records a loss contingency provision based on its best estimate of the probable loss. If no particular amount within that range is a better estimate than any other amount, the minimum amount is recorded. Estimates of losses may be developed before the ultimate loss is known, and are therefore refined each accounting period as additional information becomes known. In instances where the Company is unable to develop a reasonable estimate of loss, no loss contingency provision is recorded at that time. As information becomes known a loss contingency provision is recorded when a reasonable estimate can be made. The estimates are reviewed quarterly and changed when expectations are revised. An outcome that deviates from the Company's estimate may result in an additional expense or release in a future accounting period. At March 31, 2016 , reserve for litigation losses, insurance claims and other disputes totaled $ 25.0 million ( December 31, 2015 : $ 9.9 million) . The Company's principal pending legal and other proceedings are disclosed below. The outcomes of these proceedings are not always predictable and can be affected by various factors. For those legal and other proceedings for which it is considered at least reasonably possible that a loss has been incurred, the Company discloses the possible loss or range of possible loss in excess of the recorded loss contingency provision, if any, where such excess is both material and estimable. VYVANSE In May and June 2011, Shire was notified that six separate Abbreviated New Drug Applications ("ANDAs") were submitted under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of VYVANSE. The notices were from Sandoz, Inc. ("Sandoz"); Amneal Pharmaceuticals LLC (" Amneal "); Watson Laboratories, Inc .; Roxane Laboratories, Inc. ("Roxane"); Mylan Pharmaceuticals, Inc. (“ Mylan ”); and Actavis Elizabeth LLC and Actavis Inc. (collectively, " Actavis "). Since filing suit against these ANDA filers, along with API suppliers Johnson Matthey Inc. and Johnson Matthey Pharmaceuticals Materials (collectively “Johnson Matthey”), Shire has been engaged in a consolidated patent infringement litigation in the US District Court for the District of New Jersey against the aforementioned parties (except Watson, who withdrew their ANDA). On June 23, 2014, the US District Court for the District of New Jersey granted Shire's summary judgment motion holding that 18 claims of the patents-in-suit were both infringed and valid. On September 24, 2015, the US Court of Appeals of the Federal Circuit (“CAFC”) affirmed that ruling against all of the ANDA filers and remanded the case to the trial court for further proceedings in which Shire expects the court to impose an injunction preventing all of the ANDA filers (Sandoz, Roxane, Amneal , Actavis and Mylan ) from launching generic versions of VYVANSE until the expiration of these patents in 2023. The CAFC ruling overturned the infringement ruling against Johnson Matthey and the case against Johnson Matthey has been dismissed. On March 24, 2016, Shire received a Notice of Allegation (“NOA”) from Apotex Inc. (“ Apotex ”) informing us that Apotex filed an Abbreviated New Drug Submission (“ANDS”) with Health Canada seeking approval to market a generic version of VYVANSE in Canada. Shire is reviewing the contents of the NOA and if Shire applies for an order of prohibition within 45 days of the NOA, a 24-month stay of approval of the ANDS will be put into effect . On April 14, 2016, Shire prevailed in upholding its European patent for ELVANSE. Shire initially prevailed in an opposition to its patent lodged by Jo hnson Matthey plc, Generics [UK] Limited (trading as Mylan ) and Hexal AG and on April 14, 2016 Shire prevailed in the appeal. The decision by the appeals board of the European Patent Office is final and cannot be further appealed. LIALDA In M a y 2010 , S h ire w as no t if i e d t h at Z ydu s Ph a rm ac eu tica l s U SA , I n c. ( “ Zydus ”) h ad subm itted an A N D A und er t h e Hat ch-Waxm an Ac t s e ekin g p e rm i ss ion to m a rk et a g e n e r ic v e rs ion o f LI A LDA . W i th in t h e re quis ite 45-da y p e r i od , S h ire f iled a l awsu it i n th e US Di s trict Cou rt fo r t h e Di s tr i ct o f Del aw a r e a g a ins t Z ydu s a n d C a d ila H eal th care L im it ed , do i n g busin ess a s Z ydu s C a d i l a . A Ma rkm an h ear in g to o k p lace o n J a nu a r y 2 9, 201 5 a n d a Mar kma n ru ling wa s issu ed o n Ju ly 2 8, 2015 . A trial took place between March 28 , 2016 and April 1 , 2016 and a decision is not expected before September 2016. In Fe b r u a r y 2012 , S h ire wa s no ti f ied t h at Osmot ica Ph a rm a c e u tical Co r po rati o n (“ Osmotica ”) h ad subm itted a n AND A und er th e Hat ch-Waxm an A ct s e ekin g p e rm i ss ion t o m a rk et a gen e r ic v e rs ion o f LI A LDA . W i thi n th e re qu i sit e 45-d ay p e r io d , S h ire f iled a lawsui t in th e US D i s trict Cou rt fo r t h e N o rt h e r n D i s trict o f Ge o r g ia ag a ins t Osmot ica . A Mar kma n h earing to o k p lace o n A ugus t 2 2, 201 3 a n d a Mar km an r u l in g wa s issu ed o n S e p t emb er 2 5, 2014 . Th e c ou rt i ssu ed an Or d er o n Fe b r u a r y 2 7, 201 5 in wh ich all d ates i n th e schedu ling o r d er h a v e b een s t ay e d . In March 2012 , S h ire w as no ti f ied th at W atson L a bo rat o ries I n c . —Florida h ad submi tt e d an AND A und er t h e Hatc h-W a xma n A ct s e ek ing p e rmiss ion to m a rk et a gen e r ic v e rs ion o f LI A LDA . W it hi n the re qu i s ite 45-da y p e r io d , S h i r e f iled a l awsu it i n t h e US Di s trict Cou rt fo r t h e So u t h e r n Di st rict o f Florida a g ai ns t W atson L a bo rat o ries I n c . —Florida a n d W atson Ph a rm ac eu tica ls , I n c., W atson Ph a rm a, I n c. a n d W atson L a bo rat o ries, I n c. (c o llecti v e l y “ Watson ”) w e r e subs e qu e ntl y a dd ed as d e f e nd a n t s . A trial to o k p lace in Ap ril 201 3 a n d o n May 9, 201 3 th e trial c ou rt i ssu ed a d eci s ion find ing t h at t h e p r opos ed g e n e r ic produ ct i nf rin g es th e p ate nt-in - sui t a n d t h at t h e p ate n t is no t i nv ali d . W atson a pp ealed t h e trial c ou r t 's r u ling to th e C AFC an d a h earing to o k p lace o n Dec emb er 2, 2013 . Th e r u l in g o f th e CAF C wa s i ssu ed o n March 2 8, 201 4 ov e r r u li n g th e trial c ou rt o n t h e in ter p ret a tion o f tw o cla i m te rm s an d r em a ndin g th e c as e fo r f u r th er p r o cee d i ngs . S h ire p etitio n ed t h e S up r em e Cou rt fo r a wr it o f certiora r i wh i c h w as g r an ted o n J a nu a r y 2 6, 2015 . Th e S up r em e Cou rt also v acated th e C AFC d eci s i o n a n d r emand ed t h e ca s e to t h e CAF C fo r fu r th er c ons ide r ati o n in l igh t o f t h e Sup r em e Cou r t' s rece n t d eci s ion i n T e v a v S ando z. On Jun e 3, 2015 , t h e CAF C re af f irm ed t h eir p re v io u s d eci s ion t o re v e rs e th e D is trict Cou r t' s cl a im s c ons tr u cti on a nd remanded the case to the US District Court for the Southern District of Florida. A trial was held on January 25-27 , 2016. A ruling was issued on March 28 , 2016 upholding the validity of the patent and finding that Watson's proposed ANDA product infringes the patent-in-suit. Watson appealed the ruling to the CAFC. In Ap ril 2012 , S h ire w as no ti f ied th at My l a n h ad subm itted an A N D A und er th e Hatc h-W a xma n A ct s e ek ing p e rm i ss ion to m a rk et a gen e r ic v e rs ion o f LI A LDA . W it hi n the re qu i s ite 45-da y p e r io d , S h i r e f iled a l awsu it i n th e US D ist rict Cou rt fo r th e Mi dd le D is t r ict o f Florida a g a ins t My l an . A Mar km an h ear in g to o k p la c e o n Dece mb er 2 2, 2014 . A Mar kma n ru ling wa s i ssu ed o n March 2 3, 2015 . A trial is scheduled to take place starting on September 6, 2016 . In March 2015, Shire was notified that Amneal had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA. Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the District of New Jersey against Amneal , Amneal Pharmaceuticals of New York, LLC and Amneal Pharmaceuticals Co. India Pvt. Ltd. No trial date has been set. In September 2015, Shire was notified that Lupin Ltd. had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA . Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the District of Maryland against Lupin Ltd., Lupin Pharmaceuticals Inc., Lupin Inc. and Lupin Atlantis Holdings SA. No trial date has been set. A Markman hearing is scheduled to take place on August 22, 2016. On October 7, 2015 the Patent Trial and Appeals Board (“PTAB”) of the United States Patent Office instituted an inter partes review (“IPR”) of US Patent 6,773,720 which is the patent-in-suit in the litigations referred to above. The IPR process is designed to re-assess the patentability of the claims of the patent. A decision from the PTAB is expected in October 2016. Investigation related to DERMAGRAFT The Department of Justice, including the US Attorney's Office for the Middle District of Florida, Tampa Division and the US Attorney's Office for Washington, DC, is conducting civil and criminal investigations into the sales and marketing practices of Advanced BioHealing Inc. (“ABH”) relating to DERMAGRAFT. Following the disposal of the DERMAGRAFT business in January 2014, Shire has retained certain legacy liabilities including any liability that may arise from this investigation. Shire is cooperating fully with these investigations. Shire is not in a position at this time to predict the scope, duration or outcome of these investigations. Civil Investigative Demand relating to VANCOCIN On April 6, 2012, ViroPharma Incorporated (“ ViroPharma ”) received a notification that the United States Federal Trade Commission (“FTC”) is conducting an investigation into whether ViroPharma had engaged in unfair methods of competition with respect to VANCOCIN. On August 3, 2012, and September 8, 2014, ViroPharma and Shire respectively received Civil Investigative Demands from the FTC requesting additional information related to this matter. Shire has fully cooperate d with the FTC 's investigation. At this time, Shire is unable to predict the outcome or duration of this investigation. Lawsuit related to supply of ELAPRASE to certain patients in Brazil On September 24, 2014 Shire's Brazilian affiliate, Shire Farmaceutica Brasil Ltda , was served with a lawsuit brought by the State of Sao Paulo and in which the Brazilian Public Attorney's office has intervened alleging that Shire is obligated to provide certain medical care including ELAPRASE for an indefinite period at no cost to patients who participated in ELAPRASE clinical trials in Brazil, and seeking recoupment to the Brazilian government for amounts paid for these patients to date, and moral damages associated with these claims. Shire intends to defend itself against these allegations but is not able to predict the outcome or duration of this case . |