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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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LANTHEUS HOLDINGS, INC.
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(Exact name of registrant as specified in its charter)
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Delaware
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35-2318913
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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331 Treble Cove Road, North Billerica, MA
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01862
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(Address of principal executive offices)
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(Zip Code)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, $0.01 par value per share
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NASDAQ Global Market
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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Emerging growth company
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Our ability to continue to grow the appropriate use of DEFINITY in suboptimal echocardiograms in the face of segment competition from other echocardiography contrast agents, including Optison from GE Healthcare Limited (“GE Healthcare”) and Lumason from Bracco Diagnostics Inc. (“Bracco”), and potential generic competition as a result of future patent and regulatory exclusivity expirations;
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The instability of the global Moly supply, including outages at the NTP Radioisotopes (“NTP”) processing facility in South Africa from late November 2017 until mid-February 2018 and again from early June 2018 through mid-November 2018, resulting in our inability to fill all of the demand for our TechneLite generators on certain manufacturing days during those periods;
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Risks associated with revenues and unit volumes for Xenon in pulmonary studies as a result of increased competition from Curium;
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Our dependence upon third parties for the manufacture and supply of a substantial portion of our products, raw materials and components, including DEFINITY at JHS;
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Our dependence on key customers for our medical imaging products, and our ability to maintain and profitably renew our contracts with those key customers, including Cardinal Health (“Cardinal”), United Pharmacy Partners (“UPPI”), GE Healthcare and Jubilant Drax Image Radiopharmaceuticals (“JDI”) d/b/a Triad Isotopes, Inc. (“Triad”);
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Our inability to identify and acquire or in-license additional products, businesses or technologies to drive our future growth;
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Risks associated with the technology transfer programs to secure production of our products at additional contract manufacturer sites, including a modified formulation of DEFINITY at Samsung BioLogics (“SBL”) in South Korea;
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Risks associated with our lead agent in development, flurpiridaz F 18, which in 2017 we out-licensed to GE Healthcare, including:
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The ability to successfully complete the Phase 3 development program;
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The ability to obtain Food and Drug Administration (“FDA”) approval; and
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The ability to gain post-approval market acceptance and adequate reimbursement;
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Risks associated with the internal clinical development of DEFINITY for a left ventricular ejection fraction (“LVEF”) indication and LMI 1195 for patient populations that would benefit from molecular imaging of the norepinephrine pathway, including risk stratification of ischemic heart failure patients at risk of sudden cardiac death;
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Risks associated with the manufacturing and distribution of our products and the regulatory requirements related thereto;
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Risks associated with our investment in, and construction of, additional specialized manufacturing capabilities at our North Billerica, Massachusetts facility;
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The dependence of certain of our customers upon third-party healthcare payors and the uncertainty of third-party coverage and reimbursement rates;
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Uncertainties regarding the impact of on-going U.S. healthcare reform proposals on our business, including related reimbursements for our current and potential future products;
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Our being subject to extensive government regulation, our potential inability to comply with those regulations and the costs of compliance;
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Potential liability associated with our marketing and sales practices;
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The occurrence of any serious or unanticipated side effects with our products;
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Our exposure to potential product liability claims and environmental, health and safety liability;
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The extensive costs, time and uncertainty associated with new product development, including further product development relying on external development partners or potentially developed internally;
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Our inability to introduce new products and adapt to an evolving technology and medical practice landscape;
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Our inability to protect our intellectual property and the risk of claims that we have infringed on the intellectual property of others;
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Risks associated with prevailing economic or political conditions and events and financial, business and other factors beyond our control;
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Risks associated with our international operations;
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Our inability to adequately operate, maintain and protect our facilities, equipment and technology infrastructure;
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Our inability to hire or retain skilled employees and key personnel;
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Our inability to utilize, or limitations in our ability to utilize, net operating loss carryforwards to reduce our future tax liability;
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Risks related to our outstanding indebtedness and our ability to satisfy those obligations;
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Costs and other risks associated with the Sarbanes-Oxley Act and the Dodd-Frank Act, including in connection with potentially becoming a large accelerated filer;
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Risks related to the ownership of our common stock; and
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Other factors that are described in Part I, Item. 1A. “Risk Factors” of this Annual Report on Form 10-K.
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U.S. Segment
produces and markets our medical imaging agents and products throughout the U.S. In the U.S., we primarily sell our products to radiopharmacies, integrated delivery networks, hospitals, clinics and group practices.
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International Segment
operations consist of production and distribution activities in Puerto Rico and some direct distribution activities in Canada. Additionally, within our International Segment, we have established and maintain third-party distribution relationships under which our products are marketed and sold in Europe, Canada, Australia, Asia-Pacific and Latin America.
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Ultrasound contrast agents are compounds that are used in diagnostic procedures, such as cardiac ultrasounds or echocardiograms, to improve the clarity of the diagnostic image.
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Medical radiopharmaceuticals are radioactive pharmaceuticals used by clinicians to perform nuclear imaging procedures.
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In certain circumstances, a radioactive element, or radioisotope, is attached to a chemical compound to form the radiopharmaceutical. This act of attaching the radioisotope to the chemical compound is called radiolabeling, or labeling.
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In other circumstances, a radioisotope can be used as a radiopharmaceutical without attaching any additional chemical compound.
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Radioisotopes are most commonly manufactured in a nuclear research reactor, where a target is bombarded with subatomic particles, or in a cyclotron, which is a type of particle accelerator that also creates radioisotopes.
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Two common forms of nuclear imaging procedures are single-photon emission computed tomography (“SPECT”) which measures gamma rays emitted by a SPECT radiopharmaceutical, and positron emission tomography (“PET”) which measures positrons emitted by a PET radiopharmaceutical.
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Patents
- We continue to actively pursue additional patents in connection with DEFINITY, both in the U.S. and internationally. In the U.S., we have an Orange Book-listed method of use patent expiring in March 2037. This patent augments an Orange Book-listed composition of matter patent expiring in June 2019, and additional manufacturing patents that are not Orange Book-listed expiring in 2021, 2023 and 2037. Outside of the U.S., our DEFINITY patent protection or regulatory exclusivity currently expires in 2019.
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LVEF Indication
- We are currently conducting two well-controlled Phase 3 studies designed to demonstrate improved accuracy of LVEF measurements with DEFINITY-enhanced echocardiography versus unenhanced echocardiography. The truth standard in these studies is cardiac magnetic resonance imaging. The studies will be conducted at 20 U.S. sites and will eventually enroll a total of approximately 300 subjects. We believe DEFINITY could improve the accuracy of LVEF calculations, giving clinicians greater confidence in patient management decisions. An LVEF indication could substantially increase the addressable market for contrast-enhanced echocardiography. We believe that DEFINITY, as the market leader, would benefit from the expanded addressable market.
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Modified Formulation
- We are developing at SBL a modified formulation of DEFINITY. We believe this modified formulation will provide an enhanced product profile by enabling storage as well as shipment at room temperature (DEFINITY’s current formulation requires refrigerated storage), will give clinicians additional choice, and will allow for greater utility of this formulation in broader clinical settings. We were recently granted a composition of matter patent on the modified formulation which runs through December 2035. If the modified formulation is approved by the FDA, then this patent would be eligible to be listed in the Orange Book. We currently believe that, if approved by the FDA, the modified formulation could become commercially available in 2020, although that timing cannot be assured. Given its physical characteristics, the modified formulation may also be better suited for inclusion in kits requiring microbubbles for other indications and applications.
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New Applications
- As we continue to look for other opportunities to expand our microbubble franchise, we are evaluating new indications and applications beyond echocardiography and contrast imaging generally.
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In-House Manufacturing
- We are currently building specialized in-house manufacturing capabilities at our North Billerica, Massachusetts facility for DEFINITY and, potentially, other sterile vial products. We believe the investment in these efforts will allow us to better control DEFINITY manufacturing and inventory, reduce our costs in a potentially more price competitive environment, and provide us with supply chain redundancy. We currently expect to be in a position to use this in-house manufacturing capability by early 2021, although that timing cannot be assured.
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Xenon Xe 133 Gas
(“Xenon”) is a radiopharmaceutical gas that is inhaled and used to assess pulmonary function and also to image cerebral blood flow. Our Xenon is manufactured by a third party as a bi-product of Moly production and is processed and finished by us. We are currently the leading provider of Xenon in the U.S.
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Neurolite
is an injectable, Technetium-labeled imaging agent used with SPECT technology to identify the area within the brain where blood flow has been blocked or reduced due to stroke. We launched Neurolite in 1995.
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Cardiolite
, also known by its generic name sestamibi, is an injectable, Technetium-labeled imaging agent used in MPI procedures to assess blood flow to the muscle of the heart using SPECT. Cardiolite was approved by the FDA in 1990 and its market exclusivity expired in July 2008. Included in Cardiolite revenues are branded Cardiolite and generic sestamibi revenues.
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Thallium TI 201
is an injectable radiopharmaceutical imaging agent used in MPI studies to detect cardiovascular disease. We have marketed Thallium since 1977 and manufacture the agent using cyclotron technology.
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FDG
is an injectable, fluorine-18-radiolabeled imaging agent used with PET technology to identify and characterize tumors in patients undergoing oncologic diagnostic procedures. We manufacture and distribute FDG from our Puerto Rico radiopharmacy.
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Gallium (Ga 67)
is an injectable radiopharmaceutical imaging agent used to detect certain infections and cancerous tumors, especially lymphoma. We manufacture Gallium using cyclotron technology.
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Quadramet
, our only therapeutic product, is an injectable radiopharmaceutical used to treat severe bone pain associated with osteoblastic metastatic bone lesions. We serve as the direct manufacturer and supplier of Quadramet in the U.S.
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Cobalt (Co 57)
is a non-pharmaceutical radiochemical used in the manufacture of sources for the calibration and maintenance of SPECT imaging cameras.
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Product
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Approved Markets
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DEFINITY
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Australia, Canada, European Union, European Economic Area, Israel, India, Mexico, New Zealand, Singapore, South Korea, Taiwan, United States
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TechneLite
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Australia, Brazil, Canada, China, Colombia, Costa Rica, New Zealand, Panama, South Korea, Taiwan, United States
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Xenon
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Canada, United States
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Cardiolite
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Australia, Canada, Costa Rica, Hong Kong, Israel, Japan, New Zealand, Panama, Philippines, South Korea, Taiwan, Thailand, United States
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Neurolite
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Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Luxembourg, New Zealand, Philippines, Slovenia, South Korea, Spain, Taiwan, Thailand, United States
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Thallium Tl 201
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Australia, Canada, Colombia, New Zealand, Pakistan, Panama, South Korea, Taiwan, United States
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Gallium Ga 67
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Australia, Canada, Colombia, Costa Rica, New Zealand, Pakistan, Panama, South Korea, Taiwan, United States
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FDG
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United States
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Quadramet
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United States
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•
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Cardinal maintains approximately
131
radiopharmacies that are typically located in large, densely populated urban areas in the U.S. We estimate that Cardinal’s radiopharmacies distributed approximately
45%
of the aggregate U.S. SPECT doses sold in the first half of
2018
(the latest information currently available to us). Our written supply agreement with Cardinal relating to TechneLite, Xenon, Neurolite and other products expires on
December 31, 2019
. The agreement specifies pricing levels and requirements to purchase minimum percentages of certain products during certain periods. The agreement may be terminated upon the occurrence of specified events, including a material breach by the other party and certain force majeure events.
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UPPI is a cooperative purchasing group (roughly analogous to a group purchasing organization) of approximately
68
independently owned or smaller chain radiopharmacies located in the U.S. UPPI’s radiopharmacies are typically broadly dispersed geographically, with some urban presence and a substantial number of radiopharmacies located in suburban and rural areas of the country. We estimate that these independent radiopharmacies, together with approximately
33
unaffiliated, independent radiopharmacies, distributed approximately
24%
of the aggregate U.S. SPECT doses sold in the first half of
2018
. We currently have an agreement with UPPI for the distribution of TechneLite, Xenon and certain other products to radiopharmacies or families of radiopharmacies within the UPPI cooperative purchasing group. The agreement contains specified pricing levels based upon specified purchase amounts for UPPI. We are entitled to terminate the UPPI agreement upon 60 days written notice. The UPPI agreement expires on
December 31, 2019
.
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GE Healthcare maintains approximately
31
radiopharmacies in the U.S. that purchase our TechneLite generators. We estimate that GE Healthcare distributed approximately
13%
of the aggregate U.S. SPECT doses sold in the first half of
2018
. We currently have an agreement with GE Healthcare for the distribution of TechneLite, Xenon and other products. The agreement provides that GE Healthcare will purchase a minimum percentage of TechneLite generators as well as certain other products from us. Our agreement, which expires on
December 31, 2020
, may be terminated by either party upon the occurrence of specified events including a material breach by either party, bankruptcy by either party, certain irresolvable regulatory changes or economic circumstances, or force majeure events.
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Triad maintains approximately
56
radiopharmacies in the U.S. that purchase a range of our products. We estimate that Triad distributed approximately
12%
of the aggregate U.S. SPECT doses sold in the first half of
2018
. We currently have an agreement with Triad for the distribution of TechneLite, Xenon, Neurolite and other products. The agreement specifies pricing levels and percentage purchase requirements. The agreement will expire on
December 31, 2020
and may be terminated upon the occurrence of specified events, including a material breach by the other party.
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DEFINITY
—In February 2012, we entered into a Manufacturing and Supply Agreement with JHS, for the manufacture of DEFINITY. Under the agreement, JHS manufactured DEFINITY for us for an initial term of five years. In September 2016, we extended the agreement through January 2022. The agreement contains automatic renewals for additional one-year periods thereafter. The agreement allows for termination upon the occurrence of certain events such as a material breach or default by either party, or bankruptcy by either party. The agreement also requires us to place orders for a minimum percentage of our requirements for DEFINITY with JHS. Based on our current projections, we believe that we will have sufficient supply of DEFINITY from JHS to meet expected demand.
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Cardiolite
—In May 2012, we entered into a Manufacturing and Supply Agreement with JHS for the manufacture of Cardiolite products. In the third quarter of 2016, we completed the technology transfer process and received FDA approval to manufacture Cardiolite at JHS. Under the agreement, JHS has agreed to manufacture products for an initial term of five years from the effective date. On November 9, 2017, we extended the term until December 31, 2020, and the agreement can be further extended for three additional one-year periods thereafter so long as the parties, using good faith, reasonable efforts, agree to new pricing for the upcoming additional term. The agreement allows for termination upon the occurrence of specified events, including material breach or bankruptcy by either party. The agreement requires us to place orders for 100% of our requirements for Cardiolite products with JHS during such term. Based on our current projections, we believe that we will have sufficient supply of Cardiolite products from JHS to meet expected demand.
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Neurolite
—In May 2012, we entered into a Manufacturing and Supply Agreement with JHS for the manufacture of Neurolite, and in January 2015, the FDA granted approval to manufacture Neurolite at JHS. Under the agreement, JHS agreed to manufacture Neurolite for an initial term of five years from the effective date. On November 9, 2017, we extended the term of the agreement until December 31, 2020, and the agreement can be further extended for three additional one-year periods thereafter so long as the parties, using good faith, reasonable efforts, agree to new pricing for the upcoming additional term. The agreement allows for termination upon the occurrence of specified events, including material breach or bankruptcy by either party. The agreement also requires us to place orders for 100% of our requirements for Neurolite during such term. Based on our current projections, we believe that we will have sufficient supply of Neurolite from JHS to meet expected demand.
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Completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices regulations;
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Submission to the FDA of an IND which must become effective before human clinical studies may begin, including review and approval by any individual review board (“IRB”), serving any of the institutions participating in the clinical studies;
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Performance of adequate and well-controlled human clinical studies according to Good Clinical Practices and other requirements, to establish the safety and efficacy of the proposed drug product for its intended use;
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Submission to the FDA of a new drug application, or NDA, for a new drug;
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Satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug product is produced to assess compliance with current Good Manufacturing Practices (“cGMPs”) regulations; and
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FDA review and approval of the NDA.
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Phase 1.
The agent is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the agent may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients with those diseases.
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Phase 2.
Involves studies in a limited patient population to identify possible adverse effects and safety risks, to evaluate preliminarily the efficacy of the agent for specific targeted diseases and to determine dosage tolerance and optimal dosage and schedule.
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Phase 3.
Clinical studies are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These studies are intended to collect sufficient safety and efficacy data to support the NDA for FDA approval.
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increasing the presumed utilization rate for imaging equipment costing $1 million or more in the physician office and free-standing imaging facility setting which reduces the Medicare per procedure medical imaging reimbursement; which rate was further increased by subsequent legislation effective January 1, 2014;
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increasing drug rebates paid to state Medicaid programs under the Medicaid Drug Rebate Program for brand name prescription drugs and extending those rebates to Medicaid managed care organizations;
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imposing a non-deductible annual fee on pharmaceutical manufacturers or importers who sell brand name prescription drugs to specified federal government programs;
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imposing an excise tax on the sale of taxable medical devices, to be paid by the entity that manufactures or imports the device: (which tax applied to applicable sales made from January 1, 2013 through December 31, 2015, but is currently suspended for 2016 through 2019); and
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amending the federal self-referral laws to require referring physicians ordering certain diagnostic imaging services to inform patients under certain circumstances that the patients may obtain the services from other local and unaffiliated suppliers (which may affect the setting in which a patient obtains services).
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Limiting payments for imaging services in physician offices and free-standing imaging facility settings based upon rates paid to hospital outpatient departments;
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Reducing payments for certain imaging procedures when performed together with other imaging procedures in the same family of procedures on the same patient on the same day in the physician office and free-standing imaging facility setting;
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Making significant revisions to the methodology for determining the practice expense component of the Medicare payment applicable to the physician office and free-standing imaging facility setting which results in a reduction in payment;
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Revising payment policies and reducing payment amounts for imaging procedures performed in the hospital outpatient setting; and
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Reducing prospective payment levels for applicable diagnosis-related groups in the hospital inpatient setting.
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Substantial modifications to our business practices and operations;
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Significantly reduced demand for our products (if products become ineligible for reimbursement under federal and state healthcare programs);
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A total or partial shutdown of production in one or more of the facilities where our products are produced while the alleged violation is being remediated;
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Delays in or the inability to obtain future pre-market clearances or approvals; and
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Withdrawals or suspensions of our current products from the market.
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The availability of alternative products from our competitors;
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The breadth of indications in which alternative products from our competitors can be marketed;
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The price of our products relative to those of our competitors;
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The timing of our market entry;
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Our ability to market and distribute our products effectively;
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Market acceptance of our products; and
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Our ability to obtain adequate reimbursement.
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A reduction of our current financial resources;
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Incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions;
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Difficulty or inability to secure financing to fund development activities for those acquired or in-licensed technologies;
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Higher than expected acquisition and integration costs;
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Disruption of our business, customer base and diversion of our management’s time and attention to develop acquired products or technologies; and
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Exposure to unknown liabilities.
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We might not have been the first to make the inventions covered by each of our pending patent applications and issued patents, and we could lose our patent rights as a result;
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We might not have been the first to file patent applications for these inventions or our patent applications may not have been timely filed, and we could lose our patent rights as a result;
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Others may independently develop similar or alternative technologies or duplicate any of our technologies;
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It is possible that none of our pending patent applications will result in any further issued patents;
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Our issued patents may not provide a basis for commercially viable drugs, may not provide us with any protection from unauthorized use of our intellectual property by third parties, and may not provide us with any competitive advantages;
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Our patent applications or patents may be subject to interferences, oppositions, post-grant review, ex-parte re-examinations, inter-partes review or similar administrative proceedings;
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While we generally apply for patents in those countries where we intend to make, have made, use or sell patented products, we may not be able to accurately predict all of the countries where patent protection will ultimately be desirable and may be precluded from doing so at a later date;
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We may choose not to seek patent protection in certain countries where the actual cost outweighs the perceived benefit at a certain time;
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Patents issued in foreign jurisdictions may have different scopes of coverage than our U.S. patents and so our products may not receive the same degree of protection in foreign countries as they would in the U.S.;
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We may not develop additional proprietary technologies that are patentable; or
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The patents of others may have an adverse effect on our business.
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Less stable political and economic environments and changes in a specific country’s or region’s political or economic conditions, including the potential for an unnegotiated exit by the United Kingdom from the EU;
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Entering into, renewing or enforcing commercial agreements with international governments or provincial authorities or entities directly or indirectly owned or controlled by such governments or authorities, such as our Belgian, Australian and South African isotope suppliers, IRE, ANSTO and NTP, and our Chinese development and commercialization partner, Double-Crane Pharmaceutical Company;
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International customers which are agencies or institutions owned or controlled by foreign governments;
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Local business practices which may be in conflict with the U.S. Foreign Corrupt Practices Act and U.K. Bribery Act;
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Currency fluctuations;
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Unfavorable labor regulations;
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Greater difficulties in relying on non-U.S. courts to enforce either local or U.S. laws, particularly with respect to intellectual property;
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Greater potential for intellectual property piracy;
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Greater difficulties in managing and staffing non-U.S. operations;
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The need to ensure compliance with the numerous in-country and international regulatory and legal requirements applicable to our business in each of these jurisdictions and to maintain an effective compliance program to ensure compliance with these requirements, including in connection with the recently enacted GDPR in the EU;
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Changes in public attitudes about the perceived safety of nuclear facilities;
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Changes in trade policies, regulatory requirements and other barriers;
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Civil unrest or other catastrophic events; and
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Longer payment cycles of non-U.S. customers and difficulty collecting receivables in non-U.S. jurisdictions.
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Require us to dedicate a substantial portion of cash flow from operations to the payment of interest on and principal of our indebtedness, thereby reducing the funds available for other purposes;
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Make it more difficult for us to satisfy and comply with our obligations with respect to our outstanding indebtedness, namely the payment of interest and principal;
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Make it more difficult to refinance the outstanding indebtedness;
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Subject us to increased sensitivity to interest rate increases;
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Make us more vulnerable to economic downturns, adverse industry or company conditions or catastrophic external events;
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Limit our ability to withstand competitive pressures;
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Reduce our flexibility in planning for or responding to changing business, industry and economic conditions; and
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Place us at a competitive disadvantage to competitors that have relatively less debt than we have.
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Maintain net leverage above certain specified levels;
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Incur additional debt;
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Pay dividends or make other distributions;
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Redeem stock;
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Issue stock of subsidiaries;
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Make certain investments;
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Create liens;
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Enter into transactions with affiliates; and
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Merge, consolidate or transfer all or substantially all of our assets.
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Market conditions in the broader stock market;
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Actual or anticipated fluctuations in our quarterly financial and operating results;
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Issuance of new or changed securities analysts’ reports or recommendations;
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•
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Investor perceptions of us and the medical technology and pharmaceutical industries;
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Sales, or anticipated sales, of large blocks of our stock;
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Acquisitions or introductions of new products or services by us or our competitors;
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Additions or departures of key personnel;
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Regulatory or political developments;
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Loss of intellectual property protections;
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Litigation and governmental investigations; and
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Changing economic conditions.
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Date
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Lantheus Holdings, Inc. (“LNTH”)
|
|
Russell 2000 Index (“^RUT”)
|
|
NASDAQ US Small Cap Index (“^NQUSS”)
|
||||||
06/25/15
|
|
$
|
100.00
|
|
|
$
|
100.00
|
|
|
$
|
100.00
|
|
12/31/15
|
|
$
|
49.93
|
|
|
$
|
88.26
|
|
|
$
|
88.24
|
|
12/31/16
|
|
$
|
127.03
|
|
|
$
|
105.45
|
|
|
$
|
107.67
|
|
12/31/17
|
|
$
|
302.07
|
|
|
$
|
119.31
|
|
|
$
|
122.28
|
|
12/31/18
|
|
$
|
231.17
|
|
|
$
|
104.79
|
|
|
$
|
107.62
|
|
Period
|
|
Total Number of Shares Purchased
|
|
Average Price Paid per Share
|
|
Total Number of Shares Purchased as Part of Publicly Announced Programs
|
|
Approximate Dollar Value of Shares that May Yet Be Purchased Under the Program
|
|||
October 2018 **
|
|
737
|
|
|
$
|
13.27
|
|
|
*
|
|
*
|
November 2018 **
|
|
439
|
|
|
$
|
17.65
|
|
|
*
|
|
*
|
December 2018 **
|
|
236
|
|
|
$
|
16.28
|
|
|
*
|
|
*
|
Total
|
|
1,412
|
|
|
|
|
*
|
|
|
|
Year Ended
December 31,
|
||||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Statements of Operations
|
(in thousands, except per share data)
|
||||||||||||||||||
Revenues
|
$
|
343,374
|
|
|
$
|
331,378
|
|
|
$
|
301,853
|
|
|
$
|
293,461
|
|
|
$
|
301,600
|
|
Cost of goods sold
|
168,489
|
|
|
169,243
|
|
|
164,073
|
|
|
157,939
|
|
|
176,081
|
|
|||||
Sales and marketing
|
43,159
|
|
|
42,315
|
|
|
36,542
|
|
|
34,740
|
|
|
35,116
|
|
|||||
General and administrative
|
50,167
|
|
|
49,842
|
|
|
38,832
|
|
|
43,894
|
|
|
37,313
|
|
|||||
Research and development
|
17,071
|
|
|
18,125
|
|
|
12,203
|
|
|
14,358
|
|
|
13,673
|
|
|||||
Gain on sales of assets
|
—
|
|
|
—
|
|
|
6,385
|
|
|
—
|
|
|
—
|
|
|||||
Operating income
|
64,488
|
|
|
51,853
|
|
|
56,588
|
|
|
42,530
|
|
|
39,417
|
|
|||||
Interest expense
|
17,405
|
|
|
18,410
|
|
|
26,618
|
|
|
38,715
|
|
|
42,288
|
|
|||||
Debt retirement costs
|
—
|
|
|
—
|
|
|
1,896
|
|
|
—
|
|
|
—
|
|
|||||
Loss on extinguishment of debt
|
—
|
|
|
2,442
|
|
|
—
|
|
|
15,528
|
|
|
—
|
|
|||||
Other income (expense)
|
(2,465
|
)
|
|
(8,638
|
)
|
|
(220
|
)
|
|
65
|
|
|
(505
|
)
|
|||||
Income (loss) before income taxes
|
49,548
|
|
|
39,639
|
|
|
28,294
|
|
|
(11,778
|
)
|
|
(2,366
|
)
|
|||||
Income tax expense (benefit)
(a)
|
9,030
|
|
|
(83,746
|
)
|
|
1,532
|
|
|
2,968
|
|
|
1,195
|
|
|||||
Net income (loss)
|
$
|
40,518
|
|
|
$
|
123,385
|
|
|
$
|
26,762
|
|
|
$
|
(14,746
|
)
|
|
$
|
(3,561
|
)
|
Net income (loss) per common share:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
$
|
1.06
|
|
|
$
|
3.31
|
|
|
$
|
0.84
|
|
|
$
|
(0.60
|
)
|
|
$
|
(0.20
|
)
|
Diluted
|
$
|
1.03
|
|
|
$
|
3.17
|
|
|
$
|
0.82
|
|
|
$
|
(0.60
|
)
|
|
$
|
(0.20
|
)
|
Weighted-average common shares:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
38,233
|
|
|
37,276
|
|
|
32,044
|
|
|
24,440
|
|
|
18,081
|
|
|||||
Diluted
|
39,501
|
|
|
38,892
|
|
|
32,656
|
|
|
24,440
|
|
|
18,081
|
|
(a)
|
The 2017 amount reflects the release of our valuation allowance of
$141.1 million
against its deferred tax assets offset by a provision of
$45.1 million
for remeasuring the Company’s deferred tax assets for the change in tax rates enacted under the Tax Cuts and Jobs Act of 2017.
|
|
Year Ended
December 31,
|
||||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Statements of Cash Flows Data
|
(in thousands)
|
||||||||||||||||||
Net cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
||||||||||
Operating activities
|
$
|
61,193
|
|
|
$
|
54,777
|
|
|
$
|
49,642
|
|
|
$
|
21,762
|
|
|
$
|
11,590
|
|
Investing activities
|
$
|
(19,132
|
)
|
|
$
|
(16,309
|
)
|
|
$
|
3,281
|
|
|
$
|
(13,151
|
)
|
|
$
|
(7,682
|
)
|
Financing activities
|
$
|
(4,668
|
)
|
|
$
|
(13,450
|
)
|
|
$
|
(30,217
|
)
|
|
$
|
999
|
|
|
$
|
(2,297
|
)
|
Capital expenditures
|
$
|
20,132
|
|
|
$
|
17,543
|
|
|
$
|
7,398
|
|
|
$
|
13,151
|
|
|
$
|
8,137
|
|
|
December 31,
|
||||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Balance Sheet Data
|
(in thousands)
|
||||||||||||||||||
Cash and cash equivalents
|
$
|
113,401
|
|
|
$
|
76,290
|
|
|
$
|
51,178
|
|
|
$
|
28,596
|
|
|
$
|
19,739
|
|
Total assets
|
$
|
439,831
|
|
|
$
|
383,858
|
|
|
$
|
255,898
|
|
|
$
|
242,379
|
|
|
$
|
243,153
|
|
Long-term debt, net
|
$
|
263,709
|
|
|
$
|
265,393
|
|
|
$
|
274,460
|
|
|
$
|
349,858
|
|
|
$
|
392,863
|
|
Total liabilities
|
$
|
368,829
|
|
|
$
|
360,567
|
|
|
$
|
362,414
|
|
|
$
|
427,668
|
|
|
$
|
482,423
|
|
Total stockholders’ equity (deficit)
|
$
|
71,002
|
|
|
$
|
23,291
|
|
|
$
|
(106,516
|
)
|
|
$
|
(185,289
|
)
|
|
$
|
(239,270
|
)
|
•
|
U.S. Segment
produces and markets our medical imaging agents and products throughout the U.S. In the U.S., we primarily sell our products to radiopharmacies, integrated delivery networks, hospitals, clinics and group practices.
|
•
|
International Segment
operations consist of production and distribution activities in Puerto Rico and some direct distribution activities in Canada. Additionally, within our International Segment, we have established and maintain third-party distribution relationships under which our products are marketed and sold in Europe, Canada, Australia, Asia-Pacific and Latin America.
|
•
|
DEFINITY
is a microbubble contrast agent used in ultrasound exams of the heart, also known as echocardiography exams. DEFINITY contains perflutren-containing lipid microspheres and is indicated in the U.S. for use in patients with suboptimal echocardiograms to assist in imaging the left ventricular chamber and left endocardial border of the heart in ultrasound procedures.
|
•
|
TechneLite
is a Technetium generator that provides the essential nuclear material used by radiopharmacies to radiolabel Cardiolite, Neurolite and other Technetium-based radiopharmaceuticals used in nuclear medicine procedures. TechneLite uses Moly as its active ingredient.
|
|
Year Ended
December 31,
|
|||||||||||||||||||
(in thousands)
|
2018
|
|
% of
Revenues
|
|
2017
|
|
% of
Revenues
|
|
2016
|
|
% of
Revenues
|
|||||||||
DEFINITY
|
$
|
183,073
|
|
|
53.3
|
%
|
|
$
|
157,268
|
|
|
47.5
|
%
|
|
$
|
131,612
|
|
|
43.6
|
%
|
TechneLite
|
98,858
|
|
|
28.8
|
%
|
|
104,644
|
|
|
31.6
|
%
|
|
99,217
|
|
|
32.9
|
%
|
|||
Other*
|
61,443
|
|
|
17.9
|
%
|
|
69,466
|
|
|
20.9
|
%
|
|
71,024
|
|
|
23.5
|
%
|
|||
Total revenues
|
$
|
343,374
|
|
|
100.0
|
%
|
|
$
|
331,378
|
|
|
100.0
|
%
|
|
$
|
301,853
|
|
|
100.0
|
%
|
•
|
Patents -
We continue to actively pursue additional patents in connection with DEFINITY, both in the U.S. and internationally. In the U.S., we have an Orange Book-listed method of use patent expiring in March 2037. This patent augments an Orange Book-listed composition of matter patent expiring in June 2019, and additional manufacturing patents that are not Orange Book-listed expiring in 2021, 2023 and 2037. Outside of the U.S., our DEFINITY patent protection or regulatory exclusivity currently expires in 2019.
|
•
|
LVEF Indication
- We are currently conducting two well-controlled Phase 3 studies designed to demonstrate improved accuracy of LVEF measurements with DEFINITY-enhanced echocardiography versus unenhanced echocardiography. The truth standard in these studies is cardiac magnetic resonance imaging. The studies will be conducted at 20 U.S. sites and will eventually enroll a total of approximately 300 subjects. We believe DEFINITY could improve the accuracy of LVEF calculations, giving clinicians greater confidence in patient management decisions. An LVEF indication could substantially
|
•
|
Modified Formulation
- We are developing at SBL a modified formulation of DEFINITY. We believe this modified formulation will provide an enhanced product profile enabling storage as well as shipment at room temperature (DEFINITY’s current formulation requires refrigerated storage), will give clinicians additional choice, and will allow for greater utility of this formulation in broader clinical settings. We were recently granted a composition of matter patent on the modified formulation which runs through December 2035. If the modified formulation is approved by the FDA, then this patent would be eligible to be listed in the Orange Book. We currently believe that, if approved by the FDA, the modified formulation could become commercially available in 2020, although that timing cannot be assured. Given its physical characteristics, the modified formulation may also be better suited for inclusion in kits requiring microbubbles for other indications and applications.
|
•
|
New Applications
- As we continue to look for other opportunities to expand our microbubble franchise, we are evaluating new indications and applications beyond echocardiography and contrast imaging generally.
|
•
|
In-House Manufacturing
- We are currently building specialized in-house manufacturing capabilities at our North Billerica, Massachusetts facility for DEFINITY and, potentially, other sterile vial products. We believe the investment in these efforts will allow us to better control DEFINITY manufacturing and inventory, reduce our costs in a potentially more price competitive environment, and provide us with supply chain redundancy. We currently expect to be in a position to use this in-house manufacturing capability by early 2021, although that timing cannot be assured.
|
•
|
increased revenues for DEFINITY in the suboptimal echocardiogram segment as a result of our continued focused sales efforts which has also resulted in increased gross profit;
|
•
|
decreased revenues for TechneLite in the U.S. segment primarily as a result of a temporary supplier disruption;
|
•
|
increased revenues for TechneLite in the International segment primarily driven by increased volume as a result of temporary incremental demand which has also resulted in increased gross profit;
|
•
|
decreased revenues in other revenue due to the recognition of $5.0 million during the prior year from GE Healthcare in exchange for rights to the continued Phase 3 development and worldwide commercialization of flurpiridaz F 18;
|
•
|
decreased depreciation expense as a result of the decommissioning of certain long-lived assets during the prior year period;
|
•
|
decreases in other income due to a $5.5 million decrease in tax indemnification income as a result
of the impact of the reduction in the U.S. federal corporate tax rate pursuant to the Tax Cuts and Jobs Act enacted on December 22, 2017; and
|
•
|
increased tax expense due to the profit generated during the year ended December 31, 2018 and the fact that we no longer record a valuation allowance against our domestic deferred tax assets offset by the release of our valuation allowance against our Canada deferred tax assets.
|
|
Year Ended
December 31,
|
|
2018 vs. 2017
|
|
2017 vs. 2016
|
||||||||||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
|
Change
$
|
|
Change
%
|
|
Change
$
|
|
Change
% |
||||||||||||
Revenues
|
$
|
343,374
|
|
|
$
|
331,378
|
|
|
$
|
301,853
|
|
|
$
|
11,996
|
|
|
3.6
|
%
|
|
$
|
29,525
|
|
|
9.8
|
%
|
Cost of goods sold
|
168,489
|
|
|
169,243
|
|
|
164,073
|
|
|
(754
|
)
|
|
(0.4
|
)%
|
|
5,170
|
|
|
3.2
|
%
|
|||||
Gross profit
|
174,885
|
|
|
162,135
|
|
|
137,780
|
|
|
12,750
|
|
|
7.9
|
%
|
|
24,355
|
|
|
17.7
|
%
|
|||||
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Sales and marketing
|
43,159
|
|
|
42,315
|
|
|
36,542
|
|
|
844
|
|
|
2.0
|
%
|
|
5,773
|
|
|
15.8
|
%
|
|||||
General and administrative
|
50,167
|
|
|
49,842
|
|
|
38,832
|
|
|
325
|
|
|
0.7
|
%
|
|
11,010
|
|
|
28.4
|
%
|
|||||
Research and development
|
17,071
|
|
|
18,125
|
|
|
12,203
|
|
|
(1,054
|
)
|
|
(5.8
|
)%
|
|
5,922
|
|
|
48.5
|
%
|
|||||
Total operating expenses
|
110,397
|
|
|
110,282
|
|
|
87,577
|
|
|
115
|
|
|
0.1
|
%
|
|
22,705
|
|
|
25.9
|
%
|
|||||
Gain on sales of assets
|
—
|
|
|
—
|
|
|
6,385
|
|
|
—
|
|
|
—
|
%
|
|
(6,385
|
)
|
|
(100.0
|
)%
|
|||||
Operating income
|
64,488
|
|
|
51,853
|
|
|
56,588
|
|
|
12,635
|
|
|
24.4
|
%
|
|
(4,735
|
)
|
|
(8.4
|
)%
|
|||||
Interest expense
|
17,405
|
|
|
18,410
|
|
|
26,618
|
|
|
(1,005
|
)
|
|
(5.5
|
)%
|
|
(8,208
|
)
|
|
(30.8
|
)%
|
|||||
Debt retirement costs
|
—
|
|
|
—
|
|
|
1,896
|
|
|
—
|
|
|
—
|
%
|
|
(1,896
|
)
|
|
(100.0
|
)%
|
|||||
Loss on extinguishment of debt
|
—
|
|
|
2,442
|
|
|
—
|
|
|
(2,442
|
)
|
|
(100.0
|
)%
|
|
2,442
|
|
|
100.0
|
%
|
|||||
Other income
|
(2,465
|
)
|
|
(8,638
|
)
|
|
(220
|
)
|
|
6,173
|
|
|
(71.5
|
)%
|
|
(8,418
|
)
|
|
3,826.4
|
%
|
|||||
Income before income taxes
|
49,548
|
|
|
39,639
|
|
|
28,294
|
|
|
9,909
|
|
|
25.0
|
%
|
|
11,345
|
|
|
40.1
|
%
|
|||||
Income tax expense (benefit)
|
9,030
|
|
|
(83,746
|
)
|
|
1,532
|
|
|
92,776
|
|
|
(110.8
|
)%
|
|
(85,278
|
)
|
|
(5,566.4
|
)%
|
|||||
Net income
|
$
|
40,518
|
|
|
$
|
123,385
|
|
|
$
|
26,762
|
|
|
$
|
(82,867
|
)
|
|
(67.2
|
)%
|
|
$
|
96,623
|
|
|
361.0
|
%
|
|
Year Ended
December 31, |
|
2018 vs. 2017
|
|
2017 vs. 2016
|
||||||||||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
|
Change
$ |
|
Change
% |
|
Change
$ |
|
Change
% |
||||||||||||
U.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
DEFINITY
|
$
|
178,440
|
|
|
$
|
153,581
|
|
|
$
|
128,677
|
|
|
$
|
24,859
|
|
|
16.2
|
%
|
|
$
|
24,904
|
|
|
19.4
|
%
|
TechneLite
|
74,042
|
|
|
90,489
|
|
|
85,412
|
|
|
(16,447
|
)
|
|
(18.2
|
)%
|
|
5,077
|
|
|
5.9
|
%
|
|||||
Other
|
36,098
|
|
|
45,932
|
|
|
43,331
|
|
|
(9,834
|
)
|
|
(21.4
|
)%
|
|
2,601
|
|
|
6.0
|
%
|
|||||
Total U.S. Revenues
|
288,580
|
|
|
290,002
|
|
|
257,420
|
|
|
(1,422
|
)
|
|
(0.5
|
)%
|
|
32,582
|
|
|
12.7
|
%
|
|||||
International
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
DEFINITY
|
4,633
|
|
|
3,687
|
|
|
2,935
|
|
|
946
|
|
|
25.7
|
%
|
|
752
|
|
|
25.6
|
%
|
|||||
TechneLite
|
24,816
|
|
|
14,155
|
|
|
13,805
|
|
|
10,661
|
|
|
75.3
|
%
|
|
350
|
|
|
2.5
|
%
|
|||||
Other
|
25,345
|
|
|
23,534
|
|
|
27,693
|
|
|
1,811
|
|
|
7.7
|
%
|
|
(4,159
|
)
|
|
(15.0
|
)%
|
|||||
Total International Revenues
|
54,794
|
|
|
41,376
|
|
|
44,433
|
|
|
13,418
|
|
|
32.4
|
%
|
|
(3,057
|
)
|
|
(6.9
|
)%
|
|||||
Total Revenues
|
$
|
343,374
|
|
|
$
|
331,378
|
|
|
$
|
301,853
|
|
|
$
|
11,996
|
|
|
3.6
|
%
|
|
$
|
29,525
|
|
|
9.8
|
%
|
(in thousands)
|
Rebates and
Allowances |
||
Balance, January 1, 2016
|
$
|
2,303
|
|
Provision related to current period revenues
|
7,255
|
|
|
Adjustments relating to prior period revenues
|
(452
|
)
|
|
Payments or credits made during the period
|
(6,809
|
)
|
|
Balance, December 31, 2016
|
2,297
|
|
|
Provision related to current period revenues
|
9,568
|
|
|
Adjustments relating to prior period revenues
|
(654
|
)
|
|
Payments or credits made during the period
|
(8,351
|
)
|
|
Balance, December 31, 2017
|
2,860
|
|
|
Provision related to current period revenues
|
13,202
|
|
|
Adjustments relating to prior period revenues
|
(361
|
)
|
|
Payments or credits made during the period
|
(11,047
|
)
|
|
Balance, December 31, 2018
|
$
|
4,654
|
|
|
Year Ended
December 31, |
|
2018 vs. 2017
|
|
2017 vs. 2016
|
||||||||||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
|
Change
$ |
|
Change
% |
|
Change
$ |
|
Change
% |
||||||||||||
U.S.
|
$
|
161,760
|
|
|
$
|
154,671
|
|
|
$
|
128,350
|
|
|
$
|
7,089
|
|
|
4.6
|
%
|
|
$
|
26,321
|
|
|
20.5
|
%
|
International
|
13,125
|
|
|
7,464
|
|
|
9,430
|
|
|
5,661
|
|
|
75.8
|
%
|
|
(1,966
|
)
|
|
(20.8
|
)%
|
|||||
Total Gross profit
|
$
|
174,885
|
|
|
$
|
162,135
|
|
|
$
|
137,780
|
|
|
$
|
12,750
|
|
|
7.9
|
%
|
|
$
|
24,355
|
|
|
17.7
|
%
|
|
Year Ended
December 31, |
|
2018 vs. 2017
|
|
2017 vs. 2016
|
||||||||||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
|
Change
$ |
|
Change
% |
|
Change
$ |
|
Change
% |
||||||||||||
U.S.
|
$
|
40,579
|
|
|
$
|
39,471
|
|
|
$
|
32,919
|
|
|
$
|
1,108
|
|
|
2.8
|
%
|
|
$
|
6,552
|
|
|
19.9
|
%
|
International
|
2,580
|
|
|
2,844
|
|
|
3,623
|
|
|
(264
|
)
|
|
(9.3
|
)%
|
|
$
|
(779
|
)
|
|
(21.5
|
)%
|
||||
Total Sales and marketing
|
$
|
43,159
|
|
|
$
|
42,315
|
|
|
$
|
36,542
|
|
|
$
|
844
|
|
|
2.0
|
%
|
|
$
|
5,773
|
|
|
15.8
|
%
|
|
Year Ended
December 31, |
|
2018 vs. 2017
|
|
2017 vs. 2016
|
||||||||||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
|
Change
$ |
|
Change
% |
|
Change
$ |
|
Change
% |
||||||||||||
U.S.
|
$
|
15,705
|
|
|
$
|
16,692
|
|
|
$
|
11,574
|
|
|
$
|
(987
|
)
|
|
(5.9
|
)%
|
|
$
|
5,118
|
|
|
44.2
|
%
|
International
|
1,366
|
|
|
1,433
|
|
|
629
|
|
|
(67
|
)
|
|
(4.7
|
)%
|
|
804
|
|
|
127.8
|
%
|
|||||
Total Research and development
|
$
|
17,071
|
|
|
$
|
18,125
|
|
|
$
|
12,203
|
|
|
$
|
(1,054
|
)
|
|
(5.8
|
)%
|
|
$
|
5,922
|
|
|
48.5
|
%
|
|
Year Ended
December 31, |
|
2018 vs. 2017
|
|
2017 vs. 2016
|
|||||||||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
|
Change
$ |
|
Change
% |
|
Change
$ |
|
Change
% |
|||||||||||
Income tax expense (benefit)
|
$
|
9,030
|
|
|
$
|
(83,746
|
)
|
|
$
|
1,532
|
|
|
$
|
92,776
|
|
|
(110.8
|
)%
|
|
$
|
(85,278
|
)
|
|
< (1,000)%
|
|
Year Ended
December 31, |
||||
|
2018
|
|
2017
|
|
2016
|
Effective tax rate
|
18.2%
|
|
(211.3)%
|
|
5.4%
|
|
|
Year Ended
December 31, |
||||||||||
(in thousands)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Net cash provided by operating activities
|
|
$
|
61,193
|
|
|
$
|
54,777
|
|
|
$
|
49,642
|
|
Net cash (used in) provided by investing activities
|
|
$
|
(19,132
|
)
|
|
$
|
(16,309
|
)
|
|
$
|
3,281
|
|
Net cash used in financing activities
|
|
$
|
(4,668
|
)
|
|
$
|
(13,450
|
)
|
|
$
|
(30,217
|
)
|
2017 Facility Financial Covenants
|
|
Period
|
Consolidated
Leverage Ratio |
Q1 2019
|
4.75 to 1.00
|
Thereafter
|
4.50 to 1.00
|
•
|
The costs of acquiring or in-licensing new products, businesses or technologies, together with the costs of pursuing opportunities that are not eventually consummated;
|
•
|
The pricing environment and the level of product sales of our currently marketed products, particularly DEFINITY and any additional products that we may market in the future;
|
•
|
Revenue mix shifts and associated volume and selling price changes that could result from contractual status changes with key customers and additional competition;
|
•
|
Our investment in the further clinical development and commercialization of existing products and development candidates;
|
•
|
The costs of investing in our facilities, equipment and technology infrastructure;
|
•
|
The costs and timing of establishing manufacturing and supply arrangements for commercial supplies of our products and raw materials and components;
|
•
|
Our ability to have product manufactured and released from JHS and other manufacturing sites in a timely manner in the future;
|
•
|
The costs of further commercialization of our existing products, particularly in international markets, including product marketing, sales and distribution and whether we obtain local partners to help share such commercialization costs;
|
•
|
The extent to which we choose to establish collaboration, co-promotion, distribution or other similar arrangements for our marketed products;
|
•
|
The legal costs relating to maintaining, expanding and enforcing our intellectual property portfolio, pursuing insurance or other claims and defending against product liability, regulatory compliance or other claims; and
|
•
|
The cost of interest on any additional borrowings which we may incur under our financing arrangements.
|
|
Payments Due by Period
|
||||||||||||||||||
(in thousands)
|
Total
|
|
Less than
1 Year
|
|
1 - 3 Years
|
|
3 -5 Years
|
|
More than
5 Years
|
||||||||||
Debt obligations (principal)
|
$
|
270,187
|
|
|
$
|
2,750
|
|
|
$
|
5,500
|
|
|
$
|
261,937
|
|
|
$
|
—
|
|
Interest on debt obligations
(a)
|
57,705
|
|
|
17,101
|
|
|
33,724
|
|
|
6,880
|
|
|
—
|
|
|||||
Operating lease obligations
(b)
|
1,521
|
|
|
391
|
|
|
476
|
|
|
476
|
|
|
178
|
|
|||||
Purchase obligations
(c)
|
1,750
|
|
|
1,750
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Capital lease obligations
|
144
|
|
|
123
|
|
|
21
|
|
|
—
|
|
|
—
|
|
|||||
Other long-term liabilities
(d)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Asset retirement obligations
(e)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total contractual obligations
|
$
|
331,307
|
|
|
$
|
22,115
|
|
|
$
|
39,721
|
|
|
$
|
269,293
|
|
|
$
|
178
|
|
(a)
|
Amount relates to the minimum interest under our 2017 Term Facility.
|
(b)
|
Operating leases include minimum payments under leases for our facilities and certain equipment.
|
(c)
|
Excludes purchase orders for inventory in the normal course of business.
|
(d)
|
Our other long-term liabilities in the consolidated balance sheet include unrecognized tax benefits and related interest and penalties. As of
December 31, 2018
, we had unrecognized tax benefits of
$40.2 million
, which included interest and penalties, classified as noncurrent liabilities. At this time, we are unable to make a reasonably reliable estimate of the timing of payments in individual years in connection with these tax liabilities; therefore, such amounts are not included in the above contractual obligation table.
|
(e)
|
We have excluded asset retirement obligations from the table above due to the uncertainty of the timing of the future cash outflows related to the decommissioning of our radioactive operations. As of
December 31, 2018
, the liability, which was approximately
$11.6 million
, was measured at the present value of the obligation expected to be incurred of approximately
$26.9 million
.
|
|
Page
|
/s/ Deloitte & Touche LLP
|
Boston, Massachusetts
|
February 20, 2019
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
113,401
|
|
|
$
|
76,290
|
|
Accounts receivable, net
|
43,753
|
|
|
40,259
|
|
||
Inventory
|
33,019
|
|
|
26,080
|
|
||
Other current assets
|
5,242
|
|
|
5,221
|
|
||
Total current assets
|
195,415
|
|
|
147,850
|
|
||
Property, plant and equipment, net
|
107,888
|
|
|
92,999
|
|
||
Intangibles, net
|
9,133
|
|
|
11,798
|
|
||
Goodwill
|
15,714
|
|
|
15,714
|
|
||
Deferred tax assets, net
|
81,449
|
|
|
87,010
|
|
||
Other long-term assets
|
30,232
|
|
|
28,487
|
|
||
Total assets
|
$
|
439,831
|
|
|
$
|
383,858
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Current portion of long-term debt
|
$
|
2,750
|
|
|
$
|
2,750
|
|
Revolving line of credit
|
—
|
|
|
—
|
|
||
Accounts payable
|
17,955
|
|
|
17,464
|
|
||
Accrued expenses and other liabilities
|
32,050
|
|
|
26,536
|
|
||
Total current liabilities
|
52,755
|
|
|
46,750
|
|
||
Asset retirement obligations
|
11,572
|
|
|
10,412
|
|
||
Long-term debt, net
|
263,709
|
|
|
265,393
|
|
||
Other long-term liabilities
|
40,793
|
|
|
38,012
|
|
||
Total liabilities
|
368,829
|
|
|
360,567
|
|
||
Commitments and contingencies (see Note 15)
|
|
|
|
||||
Stockholders’ equity
|
|
|
|
||||
Preferred stock ($0.01 par value, 25,000 shares authorized; no shares issued and outstanding)
|
—
|
|
|
—
|
|
||
Common stock ($0.01 par value, 250,000 shares authorized; 38,466 and 37,765 shares issued and outstanding, respectively)
|
385
|
|
|
378
|
|
||
Additional paid-in capital
|
239,865
|
|
|
232,960
|
|
||
Accumulated deficit
|
(168,140
|
)
|
|
(209,013
|
)
|
||
Accumulated other comprehensive loss
|
(1,108
|
)
|
|
(1,034
|
)
|
||
Total stockholders’ equity
|
71,002
|
|
|
23,291
|
|
||
Total liabilities and stockholders’ equity
|
$
|
439,831
|
|
|
$
|
383,858
|
|
|
Year Ended
December 31, |
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Revenues
|
$
|
343,374
|
|
|
$
|
331,378
|
|
|
$
|
301,853
|
|
Cost of goods sold
|
168,489
|
|
|
169,243
|
|
|
164,073
|
|
|||
Gross profit
|
174,885
|
|
|
162,135
|
|
|
137,780
|
|
|||
Operating expenses
|
|
|
|
|
|
||||||
Sales and marketing
|
43,159
|
|
|
42,315
|
|
|
36,542
|
|
|||
General and administrative
|
50,167
|
|
|
49,842
|
|
|
38,832
|
|
|||
Research and development
|
17,071
|
|
|
18,125
|
|
|
12,203
|
|
|||
Total operating expenses
|
110,397
|
|
|
110,282
|
|
|
87,577
|
|
|||
Gain on sales of assets
|
—
|
|
|
—
|
|
|
6,385
|
|
|||
Operating income
|
64,488
|
|
|
51,853
|
|
|
56,588
|
|
|||
Interest expense
|
17,405
|
|
|
18,410
|
|
|
26,618
|
|
|||
Debt retirement costs
|
—
|
|
|
—
|
|
|
1,896
|
|
|||
Loss on extinguishment of debt
|
—
|
|
|
2,442
|
|
|
—
|
|
|||
Other income
|
(2,465
|
)
|
|
(8,638
|
)
|
|
(220
|
)
|
|||
Income before income taxes
|
49,548
|
|
|
39,639
|
|
|
28,294
|
|
|||
Income tax expense (benefit)
|
9,030
|
|
|
(83,746
|
)
|
|
1,532
|
|
|||
Net income
|
$
|
40,518
|
|
|
$
|
123,385
|
|
|
$
|
26,762
|
|
Net income per common share:
|
|
|
|
|
|
||||||
Basic
|
$
|
1.06
|
|
|
$
|
3.31
|
|
|
$
|
0.84
|
|
Diluted
|
$
|
1.03
|
|
|
$
|
3.17
|
|
|
$
|
0.82
|
|
Weighted-average common shares outstanding:
|
|
|
|
|
|
||||||
Basic
|
38,233
|
|
|
37,276
|
|
|
32,044
|
|
|||
Diluted
|
39,501
|
|
|
38,892
|
|
|
32,656
|
|
|
Year Ended
December 31, |
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Net income
|
$
|
40,518
|
|
|
$
|
123,385
|
|
|
$
|
26,762
|
|
Other comprehensive (loss) income:
|
|
|
|
|
|
||||||
Reclassification adjustment for gains on sales of assets included in net income
|
—
|
|
|
—
|
|
|
435
|
|
|||
Foreign currency translation
|
(74
|
)
|
|
(87
|
)
|
|
603
|
|
|||
Total other comprehensive (loss) income
|
(74
|
)
|
|
(87
|
)
|
|
1,038
|
|
|||
Comprehensive income
|
$
|
40,444
|
|
|
$
|
123,298
|
|
|
$
|
27,800
|
|
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Deficit
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Total
Stockholders’
Equity
(Deficit)
|
|||||||||||||
|
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balance, January 1, 2016
|
|
30,365
|
|
|
$
|
303
|
|
|
$
|
175,553
|
|
|
$
|
(359,160
|
)
|
|
$
|
(1,985
|
)
|
|
$
|
(185,289
|
)
|
Issuance of common stock, net of $2,080 issuance costs
|
|
6,200
|
|
|
62
|
|
|
48,758
|
|
|
—
|
|
|
—
|
|
|
48,820
|
|
|||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
26,762
|
|
|
—
|
|
|
26,762
|
|
|||||
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,038
|
|
|
1,038
|
|
|||||
Stock option exercises
|
|
41
|
|
|
1
|
|
|
230
|
|
|
—
|
|
|
—
|
|
|
231
|
|
|||||
Vesting of restricted stock awards
|
|
214
|
|
|
2
|
|
|
(2
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Shares withheld to cover taxes
|
|
(64
|
)
|
|
(1
|
)
|
|
(601
|
)
|
|
—
|
|
|
—
|
|
|
(602
|
)
|
|||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
2,524
|
|
|
—
|
|
|
—
|
|
|
2,524
|
|
|||||
Balance, December 31, 2016
|
|
36,756
|
|
|
367
|
|
|
226,462
|
|
|
(332,398
|
)
|
|
(947
|
)
|
|
(106,516
|
)
|
|||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
123,385
|
|
|
—
|
|
|
123,385
|
|
|||||
Other comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(87
|
)
|
|
(87
|
)
|
|||||
Stock option exercises and employee stock plan purchases
|
|
478
|
|
|
5
|
|
|
3,429
|
|
|
—
|
|
|
—
|
|
|
3,434
|
|
|||||
Vesting of restricted stock awards
|
|
744
|
|
|
8
|
|
|
(8
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Shares withheld to cover taxes
|
|
(214
|
)
|
|
(2
|
)
|
|
(2,851
|
)
|
|
—
|
|
|
—
|
|
|
(2,853
|
)
|
|||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
5,928
|
|
|
—
|
|
|
—
|
|
|
5,928
|
|
|||||
Balance, December 31, 2017
|
|
37,765
|
|
|
378
|
|
|
232,960
|
|
|
(209,013
|
)
|
|
(1,034
|
)
|
|
23,291
|
|
|||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
40,518
|
|
|
—
|
|
|
40,518
|
|
|||||
Forfeiture of dividend equivalent right
|
|
—
|
|
|
—
|
|
|
—
|
|
|
355
|
|
|
—
|
|
|
355
|
|
|||||
Other comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(74
|
)
|
|
(74
|
)
|
|||||
Stock option exercises and employee stock plan purchases
|
|
223
|
|
|
2
|
|
|
1,578
|
|
|
—
|
|
|
—
|
|
|
1,580
|
|
|||||
Vesting of restricted stock awards
|
|
672
|
|
|
7
|
|
|
(7
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Shares withheld to cover taxes
|
|
(194
|
)
|
|
(2
|
)
|
|
(3,384
|
)
|
|
—
|
|
|
—
|
|
|
(3,386
|
)
|
|||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
8,718
|
|
|
—
|
|
|
—
|
|
|
8,718
|
|
|||||
Balance, December 31, 2018
|
|
38,466
|
|
|
$
|
385
|
|
|
$
|
239,865
|
|
|
$
|
(168,140
|
)
|
|
$
|
(1,108
|
)
|
|
$
|
71,002
|
|
|
Year Ended
December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Operating activities
|
|
|
|
|
|
||||||
Net income
|
$
|
40,518
|
|
|
$
|
123,385
|
|
|
$
|
26,762
|
|
Adjustments to reconcile net income to net cash flows from operating activities:
|
|
|
|
|
|
||||||
Depreciation, amortization and accretion
|
13,929
|
|
|
19,231
|
|
|
18,263
|
|
|||
Amortization of debt related costs
|
1,279
|
|
|
1,361
|
|
|
1,603
|
|
|||
Provision for bad debt
|
321
|
|
|
136
|
|
|
53
|
|
|||
Provision for excess and obsolete inventory
|
2,875
|
|
|
1,215
|
|
|
1,342
|
|
|||
Stock-based compensation
|
8,718
|
|
|
5,928
|
|
|
2,524
|
|
|||
Gain on sales of assets
|
—
|
|
|
—
|
|
|
(6,385
|
)
|
|||
Loss on impairment of land
|
—
|
|
|
912
|
|
|
—
|
|
|||
Loss on extinguishment of debt and debt retirement costs
|
—
|
|
|
2,442
|
|
|
1,896
|
|
|||
Deferred taxes
|
5,762
|
|
|
(86,946
|
)
|
|
(155
|
)
|
|||
Long-term income tax receivable
|
(2,855
|
)
|
|
(8,413
|
)
|
|
(200
|
)
|
|||
Long-term income tax payable and other long-term liabilities
|
3,219
|
|
|
2,793
|
|
|
565
|
|
|||
Other
|
1,399
|
|
|
1,049
|
|
|
1,284
|
|
|||
Increases (decreases) in cash from operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(3,985
|
)
|
|
(3,407
|
)
|
|
(1,059
|
)
|
|||
Inventory
|
(8,690
|
)
|
|
(9,620
|
)
|
|
(3,626
|
)
|
|||
Other current assets
|
(661
|
)
|
|
(388
|
)
|
|
(155
|
)
|
|||
Accounts payable
|
(2,886
|
)
|
|
604
|
|
|
5,700
|
|
|||
Accrued expenses and other liabilities
|
2,250
|
|
|
4,495
|
|
|
1,230
|
|
|||
Net cash provided by operating activities
|
61,193
|
|
|
54,777
|
|
|
49,642
|
|
|||
Investing activities
|
|
|
|
|
|
||||||
Capital expenditures
|
(20,132
|
)
|
|
(17,543
|
)
|
|
(7,398
|
)
|
|||
Proceeds from sale of assets
|
1,000
|
|
|
1,234
|
|
|
10,605
|
|
|||
Other
|
—
|
|
|
—
|
|
|
74
|
|
|||
Net cash (used in) provided by investing activities
|
(19,132
|
)
|
|
(16,309
|
)
|
|
3,281
|
|
|||
Financing activities
|
|
|
|
|
|
||||||
Proceeds from issuance of common stock
|
428
|
|
|
187
|
|
|
50,900
|
|
|||
Payments for public offering costs
|
—
|
|
|
(74
|
)
|
|
(2,006
|
)
|
|||
Proceeds from issuance of long-term debt
|
—
|
|
|
274,313
|
|
|
—
|
|
|||
Payments on long-term debt
|
(2,862
|
)
|
|
(286,694
|
)
|
|
(78,729
|
)
|
|||
Deferred financing costs
|
—
|
|
|
(1,576
|
)
|
|
(11
|
)
|
|||
Proceeds from stock option exercises
|
1,152
|
|
|
3,247
|
|
|
231
|
|
|||
Payments for minimum statutory tax withholding related to net share settlement of equity awards
|
(3,386
|
)
|
|
(2,853
|
)
|
|
(602
|
)
|
|||
Net cash used in financing activities
|
(4,668
|
)
|
|
(13,450
|
)
|
|
(30,217
|
)
|
|||
Effect of foreign exchange rates on cash and cash equivalents
|
(282
|
)
|
|
94
|
|
|
(124
|
)
|
|||
Net increase in cash and cash equivalents
|
37,111
|
|
|
25,112
|
|
|
22,582
|
|
|||
Cash and cash equivalents, beginning of year
|
76,290
|
|
|
51,178
|
|
|
28,596
|
|
|||
Cash and cash equivalents, end of year
|
$
|
113,401
|
|
|
$
|
76,290
|
|
|
$
|
51,178
|
|
|
Year Ended
December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Supplemental disclosure of cash flow information
|
|
|
|
|
|
||||||
Cash paid during the period for:
|
|
|
|
|
|
||||||
Interest
|
$
|
15,869
|
|
|
$
|
16,653
|
|
|
$
|
24,441
|
|
Income taxes, net of refunds of $35, $17 and $82, respectively
|
$
|
90
|
|
|
$
|
106
|
|
|
$
|
265
|
|
Schedule of non-cash investing and financing activities
|
|
|
|
|
|
||||||
Additions of property, plant and equipment included in liabilities
|
$
|
7,395
|
|
|
$
|
2,738
|
|
|
$
|
4,990
|
|
Receivable in connection with sale of Australian subsidiary
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,479
|
|
•
|
DEFINITY is a microbubble contrast agent used in ultrasound exams of the heart, also known as echocardiography exams. DEFINITY contains perflutren-containing lipid microspheres and is indicated in the U.S. for use in patients with suboptimal echocardiograms to assist in imaging the left ventricular chamber and left endocardial border of the heart in ultrasound procedures
|
•
|
TechneLite is a Technetium generator that provides the essential nuclear material used by radiopharmacies to radiolabel Cardiolite, Neurolite and other Technetium-based radiopharmaceuticals used in nuclear medicine procedures. TechneLite uses Moly as its active ingredient.
|
|
Year Ended
December 31,
|
||||
|
2018
|
|
2017
|
|
2016
|
DEFINITY
|
53.3%
|
|
47.5%
|
|
43.6%
|
TechneLite
|
28.8%
|
|
31.6%
|
|
32.9%
|
Class
|
|
Range of Estimated Useful Lives
|
Buildings
|
|
10 - 50 years
|
Land improvements
|
|
15 - 40 years
|
Machinery and equipment
|
|
3 - 15 years
|
Furniture and fixtures
|
|
15 years
|
Leasehold improvements
|
|
Lesser of lease term or 15 years
|
Computer software
|
|
3 - 5 years
|
|
Years Ended
December 31,
|
||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
||||||
Foreign currency losses (gains)
|
$
|
557
|
|
|
$
|
(253
|
)
|
|
$
|
853
|
|
Tax indemnification income
|
(2,855
|
)
|
|
(8,367
|
)
|
|
(1,055
|
)
|
|||
Other income
|
(167
|
)
|
|
(18
|
)
|
|
(18
|
)
|
|||
Total other income
|
$
|
(2,465
|
)
|
|
$
|
(8,638
|
)
|
|
$
|
(220
|
)
|
Standard
|
Description
|
Effective Date
for Company
|
Effect on the
Consolidated Financial
Statements
|
Recently Issued Accounting Standards Not Yet Adopted
|
|||
ASU 2016-02, Leases (Topic 842)
|
This ASU supersedes existing guidance on accounting for leases in Leases (Topic 840) and generally requires all leases to be recognized on the balance sheet. The provisions of ASU 2016-02 are effective for annual reporting periods beginning after December 15, 2018; early adoption is permitted. In July 2018, an amendment was made that allows companies the option of using the effective date of the new standard as the initial application date (at the beginning of the period in which it is adopted, rather than at the beginning of the earliest comparative period).
|
January 1, 2019
|
The Company has completed its assessment on the impact of the standard, including optional practical expedients and transition methods that the Company will elect upon adoption. The implementation plan included identifying the Company’s lease population, assessing significant leases under the new guidance and identifying changes to processes and controls. The Company concluded that upon adoption of this standard there will not be a significant impact to its Balance Sheet. The Company will utilize the prospective approach of adopting this standard. The Company has identified and implemented appropriate changes to its business processes and controls to support recognition and disclosure under this standard.
|
Standard
|
Description
|
Effective Date
for Company
|
Effect on the
Consolidated Financial
Statements
|
Accounting Standards Adopted During the Year Ended December 31, 2018
|
|||
ASU 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting
|
This ASU clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, vesting conditions or classification of the award (as equity or liability) changes as a result of the change in terms or conditions.
The new guidance will be applied prospectively to awards modified on or after the adoption date. The guidance is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017 for all entities. |
January 1, 2018
|
The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
|
ASU 2014-09, Revenue from Contracts with Customers (Topic 606) and related amendments
|
This ASU and related amendments affect any entity that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets, unless those contracts are within the scope of other standards. The guidance in this ASU supersedes the revenue recognition requirements in Topic 605, Revenue Recognition and most industry-specific guidance. The core principle of the guidance is that an entity should recognize revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.
|
January 1, 2018
|
See Note 3, "Revenue from Contracts with Customers" for the required disclosures related to the impact of adopting this standard.
The adoption of this standard did not have a material impact on the Company’s consolidated balance sheets and statements of operations.
|
|
|
Year Ended December 31, 2018
|
||||||||||
Major Products/Service Lines (in thousands)
|
|
U.S.
|
|
International
|
|
Total
|
||||||
Product revenue, net
(1)
|
|
$
|
288,580
|
|
|
$
|
52,556
|
|
|
$
|
341,136
|
|
License and royalty revenues
|
|
—
|
|
|
2,238
|
|
|
2,238
|
|
|||
Total revenues
|
|
$
|
288,580
|
|
|
$
|
54,794
|
|
|
$
|
343,374
|
|
(1)
|
The Company’s principal products include DEFINITY and TechneLite and are categorized within product revenue, net. The Company applies the same revenue recognition policies and judgments for all of its principal products.
|
(in thousands)
|
Rebates and
Allowances |
||
Balance, January 1, 2018
|
2,860
|
|
|
Provision related to current period revenues
|
13,202
|
|
|
Adjustments relating to prior period revenues
|
(361
|
)
|
|
Payments or credits made during the period
|
(11,047
|
)
|
|
Balance, December 31, 2018
|
$
|
4,654
|
|
(in thousands)
|
Year Ended December 31, 2018
|
||
Amounts included in the contract liability at the beginning of the period
|
$
|
33
|
|
Performance obligations satisfied (or partially satisfied) in previous periods
|
$
|
—
|
|
•
|
Level 1
— Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
|
•
|
Level 2
— Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).
|
•
|
Level 3
— Unobservable inputs that reflect a Company’s estimates about the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.
|
|
December 31, 2018
|
||||||||||||||
(in thousands)
|
Total Fair
Value |
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Money market
|
$
|
61,391
|
|
|
$
|
61,391
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
61,391
|
|
|
$
|
61,391
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
December 31, 2017
|
||||||||||||||
(in thousands)
|
Total Fair
Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Money market
|
$
|
8,700
|
|
|
$
|
8,700
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
8,700
|
|
|
$
|
8,700
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Year Ended
December 31,
|
||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
||||||
U.S.
|
$
|
46,945
|
|
|
$
|
39,559
|
|
|
$
|
23,736
|
|
International
|
2,603
|
|
|
80
|
|
|
4,558
|
|
|||
Income before income taxes
|
$
|
49,548
|
|
|
$
|
39,639
|
|
|
$
|
28,294
|
|
|
Year Ended
December 31,
|
||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
||||||
Current
|
|
|
|
|
|
||||||
Federal
|
$
|
(21
|
)
|
|
$
|
(58
|
)
|
|
$
|
(91
|
)
|
State
|
3,424
|
|
|
3,242
|
|
|
1,689
|
|
|||
International
|
(135
|
)
|
|
16
|
|
|
(49
|
)
|
|||
|
3,268
|
|
|
3,200
|
|
|
1,549
|
|
|||
Deferred
|
|
|
|
|
|
||||||
Federal
|
7,821
|
|
|
(71,742
|
)
|
|
—
|
|
|||
State
|
1,411
|
|
|
(15,220
|
)
|
|
—
|
|
|||
International
|
(3,470
|
)
|
|
16
|
|
|
(17
|
)
|
|||
|
5,762
|
|
|
(86,946
|
)
|
|
(17
|
)
|
|||
Income tax expense (benefit)
|
$
|
9,030
|
|
|
$
|
(83,746
|
)
|
|
$
|
1,532
|
|
|
Year Ended
December 31,
|
||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
||||||
U.S. statutory rate
|
$
|
10,405
|
|
|
$
|
13,873
|
|
|
$
|
9,903
|
|
Permanent items
|
505
|
|
|
(1,916
|
)
|
|
(570
|
)
|
|||
Write-off of foreign tax and research credits
|
—
|
|
|
—
|
|
|
7,125
|
|
|||
Foreign tax credits
|
—
|
|
|
—
|
|
|
(319
|
)
|
|||
Uncertain tax positions
|
3,227
|
|
|
3,128
|
|
|
1,529
|
|
|||
Other tax credits
|
(742
|
)
|
|
(175
|
)
|
|
90
|
|
|||
State and local taxes
|
2,125
|
|
|
1,252
|
|
|
433
|
|
|||
Impact of rate change on deferred taxes
|
—
|
|
|
45,129
|
|
|
(383
|
)
|
|||
True-up of prior year tax
|
—
|
|
|
7
|
|
|
(2,751
|
)
|
|||
Foreign tax rate differential
|
30
|
|
|
97
|
|
|
(242
|
)
|
|||
Valuation allowance
|
(4,073
|
)
|
|
(141,094
|
)
|
|
(13,292
|
)
|
|||
Benefit of windfall related to stock compensation
|
(1,760
|
)
|
|
(2,723
|
)
|
|
—
|
|
|||
Increase in indemnification deferred tax asset
|
(731
|
)
|
|
(1,055
|
)
|
|
—
|
|
|||
Other
|
44
|
|
|
(269
|
)
|
|
9
|
|
|||
Income tax expense (benefit)
|
$
|
9,030
|
|
|
$
|
(83,746
|
)
|
|
$
|
1,532
|
|
|
December 31,
|
||||||
(in thousands)
|
2018
|
|
2017
|
||||
Deferred Tax Assets
|
|
|
|
||||
Federal benefit of state tax liabilities
|
$
|
7,809
|
|
|
$
|
7,510
|
|
Reserves, accruals and other
|
11,005
|
|
|
9,251
|
|
||
Inventory obsolescence
|
428
|
|
|
239
|
|
||
Capitalized research and development
|
7,491
|
|
|
9,941
|
|
||
Amortization of intangibles other than goodwill
|
2,809
|
|
|
3,903
|
|
||
Net operating loss carryforwards
|
55,938
|
|
|
63,202
|
|
||
Depreciation
|
—
|
|
|
972
|
|
||
Deferred tax assets
|
85,480
|
|
|
95,018
|
|
||
Deferred Tax Liabilities
|
|
|
|
||||
Reserves, accruals and other
|
(1,078
|
)
|
|
(1,346
|
)
|
||
Customer relationships
|
(986
|
)
|
|
(1,294
|
)
|
||
Depreciation
|
(727
|
)
|
|
—
|
|
||
Deferred tax liability
|
(2,791
|
)
|
|
(2,640
|
)
|
||
Less: valuation allowance
|
(1,240
|
)
|
|
(5,368
|
)
|
||
|
$
|
81,449
|
|
|
$
|
87,010
|
|
Recorded in the accompanying consolidated balance sheets as:
|
|
|
|
||||
Noncurrent deferred tax assets
|
$
|
81,449
|
|
|
$
|
87,010
|
|
(in thousands)
|
Amount
|
||
Balance, January 1, 2017
|
$
|
140,915
|
|
Charged to income tax expense (benefit)
|
2,305
|
|
|
Adoption of ASU 2016-09
|
2,929
|
|
|
Foreign currency
|
313
|
|
|
Release valuation allowance
|
(141,094
|
)
|
|
Balance, December 31, 2017
|
5,368
|
|
|
Charged to income tax expense (benefit)
|
(103
|
)
|
|
Foreign currency
|
(56
|
)
|
|
Release valuation allowance
|
(3,969
|
)
|
|
Balance, December 31, 2018
|
$
|
1,240
|
|
(in thousands)
|
Amount
|
||
Balance of uncertain tax positions as of January 1, 2017
|
$
|
10,441
|
|
Additions related to current year tax positions
|
—
|
|
|
Reductions related to prior year tax positions
|
(506
|
)
|
|
Settlements
|
—
|
|
|
Lapse of statute of limitations
|
(69
|
)
|
|
Balance of uncertain tax positions as of December 31, 2017
|
9,866
|
|
|
Additions related to current year tax positions
|
—
|
|
|
Reductions related to prior year tax positions
|
(4
|
)
|
|
Settlements
|
—
|
|
|
Lapse of statute of limitations
|
(74
|
)
|
|
Balance of uncertain tax positions as of December 31, 2018
|
$
|
9,788
|
|
|
December 31,
|
||||||
(in thousands)
|
2018
|
|
2017
|
||||
Land
|
$
|
13,450
|
|
|
$
|
13,450
|
|
Buildings
|
64,444
|
|
|
76,059
|
|
||
Machinery, equipment and fixtures
|
69,298
|
|
|
71,870
|
|
||
Computer software
|
19,266
|
|
|
20,271
|
|
||
Construction in progress
|
24,169
|
|
|
7,622
|
|
||
|
190,627
|
|
|
189,272
|
|
||
Less: accumulated depreciation and amortization
|
(82,739
|
)
|
|
(96,273
|
)
|
||
Total property, plant and equipment, net
|
$
|
107,888
|
|
|
$
|
92,999
|
|
(in thousands)
|
Amount
|
||
Balance, January 1, 2018
|
$
|
10,412
|
|
Accretion expense
|
1,160
|
|
|
Balance, December 31, 2018
|
$
|
11,572
|
|
|
December 31, 2018
|
||||||||||||
(in thousands)
|
Amortization
Method |
|
Cost
|
|
Accumulated Amortization
|
|
Net
|
||||||
Trademarks
|
Straight-Line
|
|
$
|
13,540
|
|
|
$
|
(9,856
|
)
|
|
$
|
3,684
|
|
Customer relationships
|
Accelerated
|
|
98,912
|
|
|
(93,463
|
)
|
|
5,449
|
|
|||
Patents
|
Straight-Line
|
|
6,570
|
|
|
(6,570
|
)
|
|
—
|
|
|||
Total
|
|
|
$
|
119,022
|
|
|
$
|
(109,889
|
)
|
|
$
|
9,133
|
|
|
December 31, 2017
|
||||||||||||
(in thousands)
|
Amortization
Method |
|
Cost
|
|
Accumulated Amortization
|
|
Net
|
||||||
Trademarks
|
Straight-Line
|
|
$
|
13,540
|
|
|
$
|
(9,304
|
)
|
|
$
|
4,236
|
|
Customer relationships
|
Accelerated
|
|
99,133
|
|
|
(92,072
|
)
|
|
7,061
|
|
|||
Patents
|
Straight-Line
|
|
42,780
|
|
|
(42,279
|
)
|
|
501
|
|
|||
Total
|
|
|
$
|
155,453
|
|
|
$
|
(143,655
|
)
|
|
$
|
11,798
|
|
(in thousands)
|
Amount
|
||
2019
|
$
|
1,803
|
|
2020
|
1,568
|
|
|
2021
|
1,309
|
|
|
2022
|
1,173
|
|
|
2023
|
579
|
|
|
2024 and thereafter
|
2,701
|
|
|
Total
|
$
|
9,133
|
|
|
December 31,
|
||||||
(in thousands)
|
2018
|
|
2017
|
||||
Compensation and benefits
|
$
|
15,962
|
|
|
$
|
14,469
|
|
Freight, distribution and operations
|
7,721
|
|
|
3,604
|
|
||
Accrued rebates, discounts and chargebacks
|
4,654
|
|
|
2,860
|
|
||
Accrued professional fees
|
1,673
|
|
|
2,852
|
|
||
Other
|
2,040
|
|
|
2,751
|
|
||
Total accrued expenses and other liabilities
|
$
|
32,050
|
|
|
$
|
26,536
|
|
(in thousands)
|
Amount
|
||
2019
|
2,750
|
|
|
2020
|
2,750
|
|
|
2021
|
2,750
|
|
|
2022
|
261,937
|
|
|
Total principal outstanding
|
270,187
|
|
|
Unamortized debt discount
|
(1,584
|
)
|
|
Unamortized debt issuance costs
|
(2,144
|
)
|
|
Total
|
266,459
|
|
|
Less: current portion
|
(2,750
|
)
|
|
Total long-term debt
|
$
|
263,709
|
|
|
Year Ended
December 31,
|
||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
||||||
Cost of goods sold
|
$
|
1,140
|
|
|
$
|
1,692
|
|
|
$
|
359
|
|
Sales and marketing
|
1,244
|
|
|
640
|
|
|
339
|
|
|||
General and administrative
|
4,990
|
|
|
2,964
|
|
|
1,438
|
|
|||
Research and development
|
1,344
|
|
|
632
|
|
|
388
|
|
|||
Total stock-based compensation expense
|
$
|
8,718
|
|
|
$
|
5,928
|
|
|
$
|
2,524
|
|
|
|
Total
Stock
Options
|
|
Weighted-
Average
Exercise
Price
|
|
Weighted-
Average
Remaining
Contractual
Term
(Years)
|
|
Aggregate
Intrinsic
Value
|
||||
Balance at January 1, 2018
|
|
565,425
|
|
|
$
|
13.65
|
|
|
|
|
|
|
Options granted
|
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
Options exercised
|
|
(192,550
|
)
|
|
$
|
5.98
|
|
|
|
|
|
|
Options cancelled and expired
|
|
(15,800
|
)
|
|
$
|
20.44
|
|
|
|
|
|
|
Outstanding at December 31, 2018
|
|
357,075
|
|
|
$
|
17.50
|
|
|
4.4
|
|
535,427
|
|
Vested and expected to vest at December 31, 2018
|
|
357,075
|
|
|
$
|
17.50
|
|
|
4.4
|
|
535,427
|
|
Exercisable at December 31, 2018
|
|
353,049
|
|
|
$
|
17.56
|
|
|
4.4
|
|
522,423
|
|
|
|
Year Ended December 31,
|
|
|
|
2018
|
|
Expected volatility
|
|
84.3
|
%
|
Risk-free interest rate
|
|
2.4
|
%
|
Expected life (in years)
|
|
2.8
|
|
Expected dividend yield
|
|
—
|
|
|
Year Ended
December 31, |
||||||||||
(in thousands, except per share amounts)
|
2018
|
|
2017
|
|
2016
|
||||||
Net income
|
$
|
40,518
|
|
|
$
|
123,385
|
|
|
$
|
26,762
|
|
|
|
|
|
|
|
||||||
Basic weighted-average common shares outstanding
|
38,233
|
|
|
37,276
|
|
|
32,044
|
|
|||
Effect of dilutive stock options
|
61
|
|
|
288
|
|
|
612
|
|
|||
Effect of dilutive restricted stock
|
1,207
|
|
|
1,328
|
|
|
—
|
|
|||
Diluted weighted-average common shares outstanding
|
39,501
|
|
|
38,892
|
|
|
32,656
|
|
|||
|
|
|
|
|
|
||||||
Basic income per common share
|
$
|
1.06
|
|
|
$
|
3.31
|
|
|
$
|
0.84
|
|
Diluted income per common share
|
$
|
1.03
|
|
|
$
|
3.17
|
|
|
$
|
0.82
|
|
|
|
|
|
|
|
||||||
Antidilutive securities excluded from diluted net income per common share
|
424
|
|
|
604
|
|
|
1,563
|
|
(in thousands)
|
Amount
|
||
2019
|
$
|
2,264
|
|
2020
|
259
|
|
|
2021
|
238
|
|
|
2022
|
238
|
|
|
2023
|
238
|
|
|
2024 and thereafter
|
178
|
|
|
Total
|
$
|
3,415
|
|
|
Year Ended
December 31, |
||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2016
|
||||||
Revenues from external customers
|
|
|
|
|
|
||||||
U.S.
|
$
|
288,580
|
|
|
$
|
290,002
|
|
|
$
|
257,420
|
|
International
|
54,794
|
|
|
41,376
|
|
|
44,433
|
|
|||
Total revenues from external customers
|
$
|
343,374
|
|
|
$
|
331,378
|
|
|
$
|
301,853
|
|
|
|
|
|
|
|
||||||
Revenues by product
|
|
|
|
|
|
||||||
DEFINITY
|
$
|
183,073
|
|
|
$
|
157,268
|
|
|
$
|
131,612
|
|
TechneLite
|
98,858
|
|
|
104,644
|
|
|
99,217
|
|
|||
Other
|
61,443
|
|
|
69,466
|
|
|
71,024
|
|
|||
Total revenues
|
$
|
343,374
|
|
|
$
|
331,378
|
|
|
$
|
301,853
|
|
|
|
|
|
|
|
||||||
Geographical revenues
|
|
|
|
|
|
||||||
U.S.
|
$
|
288,580
|
|
|
$
|
290,002
|
|
|
$
|
257,420
|
|
All other
|
54,794
|
|
|
41,376
|
|
|
44,433
|
|
|||
Total revenues
|
$
|
343,374
|
|
|
$
|
331,378
|
|
|
$
|
301,853
|
|
|
|
|
|
|
|
||||||
Operating income
|
|
|
|
|
|
||||||
U.S.
|
$
|
56,327
|
|
|
$
|
49,239
|
|
|
$
|
46,909
|
|
International
|
8,161
|
|
|
2,614
|
|
|
9,679
|
|
|||
Operating income
|
64,488
|
|
|
51,853
|
|
|
56,588
|
|
|||
Interest expense
|
17,405
|
|
|
18,410
|
|
|
26,618
|
|
|||
Debt retirement costs
|
—
|
|
|
—
|
|
|
1,896
|
|
|||
Loss on extinguishment of debt
|
—
|
|
|
2,442
|
|
|
—
|
|
|||
Other income
|
(2,465
|
)
|
|
(8,638
|
)
|
|
(220
|
)
|
|||
Income before income taxes
|
$
|
49,548
|
|
|
$
|
39,639
|
|
|
$
|
28,294
|
|
|
|
|
|
|
|
||||||
Depreciation and amortization
|
|
|
|
|
|
||||||
U.S.
|
$
|
12,278
|
|
|
$
|
17,672
|
|
|
$
|
15,995
|
|
International
|
491
|
|
|
517
|
|
|
1,335
|
|
|||
Total depreciation and amortization
|
$
|
12,769
|
|
|
$
|
18,189
|
|
|
$
|
17,330
|
|
|
December 31,
|
||||||
(in thousands)
|
2018
|
|
2017
|
||||
Long-lived assets
|
|
|
|
||||
U.S.
|
$
|
106,755
|
|
|
$
|
91,537
|
|
International
|
1,133
|
|
|
1,462
|
|
||
Total long-lived assets
|
$
|
107,888
|
|
|
$
|
92,999
|
|
(in thousands)
|
|
Balance at Beginning of Year
|
|
Charged to Income
|
|
Deductions from Reserves
(1)
|
|
Other Adjustments
|
|
Balance at End of Year
|
||||||||||
Allowance for doubtful accounts
|
||||||||||||||||||||
Year ended December 31, 2018
|
|
$
|
977
|
|
|
$
|
321
|
|
|
$
|
(179
|
)
|
|
$
|
—
|
|
|
$
|
1,119
|
|
Year ended December 31, 2017
|
|
$
|
969
|
|
|
$
|
136
|
|
|
$
|
(128
|
)
|
|
$
|
—
|
|
|
$
|
977
|
|
Year ended December 31, 2016
|
|
$
|
881
|
|
|
$
|
53
|
|
|
$
|
(30
|
)
|
|
$
|
65
|
|
|
$
|
969
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Rebates and allowances
|
||||||||||||||||||||
Year ended December 31, 2018
|
|
$
|
2,860
|
|
|
$
|
13,202
|
|
|
$
|
(11,047
|
)
|
|
$
|
(361
|
)
|
|
$
|
4,654
|
|
Year ended December 31, 2017
|
|
$
|
2,297
|
|
|
$
|
9,568
|
|
|
$
|
(8,351
|
)
|
|
$
|
(654
|
)
|
|
$
|
2,860
|
|
Year ended December 31, 2016
|
|
$
|
2,303
|
|
|
$
|
7,255
|
|
|
$
|
(6,809
|
)
|
|
$
|
(452
|
)
|
|
$
|
2,297
|
|
(1)
|
Amounts charged to deductions from allowance for doubtful accounts represent the write-off of uncollectible balances and represent payments for rebates and allowances.
|
|
Quarterly Periods During the Year Ended
December 31, 2018 |
||||||||||||||
|
Q1
|
|
Q2
|
|
Q3
|
|
Q4
|
||||||||
|
(in thousands, except per share data)
|
||||||||||||||
Revenues
|
$
|
82,630
|
|
|
$
|
85,573
|
|
|
$
|
88,900
|
|
|
$
|
86,271
|
|
Gross profit
|
$
|
42,309
|
|
|
$
|
43,846
|
|
|
$
|
44,885
|
|
|
$
|
43,845
|
|
Net income
|
$
|
8,211
|
|
|
$
|
9,745
|
|
|
$
|
9,269
|
|
|
$
|
13,293
|
|
Basic income per weighted-average share
(b)
|
$
|
0.22
|
|
|
$
|
0.25
|
|
|
$
|
0.24
|
|
|
$
|
0.35
|
|
Diluted income per weighted-average share
(b)
|
$
|
0.21
|
|
|
$
|
0.25
|
|
|
$
|
0.24
|
|
|
$
|
0.34
|
|
|
|
|
|
|
|
|
|
||||||||
|
Quarterly Periods During the Year Ended
December 31, 2017 |
||||||||||||||
|
Q1
|
|
Q2
|
|
Q3
|
|
Q4
|
||||||||
|
(in thousands, except per share data)
|
||||||||||||||
Revenues
|
$
|
81,359
|
|
|
$
|
88,837
|
|
|
$
|
79,941
|
|
|
$
|
81,241
|
|
Gross profit
|
$
|
39,762
|
|
|
$
|
45,947
|
|
|
$
|
38,527
|
|
|
$
|
37,899
|
|
Net income
(a)
|
$
|
4,138
|
|
|
$
|
13,595
|
|
|
$
|
8,526
|
|
|
$
|
97,126
|
|
Basic income per weighted-average share
(b)
|
$
|
0.11
|
|
|
$
|
0.37
|
|
|
$
|
0.23
|
|
|
$
|
2.58
|
|
Diluted income per weighted-average share
(b)
|
$
|
0.11
|
|
|
$
|
0.35
|
|
|
$
|
0.22
|
|
|
$
|
2.47
|
|
(a)
|
Net income for the fourth quarter of 2017 reflects the income tax benefit due to the release of the Company’s valuation allowance of
$141.1 million
against its deferred tax assets offset by a provision of
$45.1 million
for remeasuring the Company’s deferred tax assets for the change in tax rates enacted under the Tax Cuts and Jobs Act of 2017.
|
(b)
|
Quarterly and annual computations are prepared independently. Accordingly, the sum of each quarter may not necessarily total the fiscal year period amounts noted elsewhere within this Annual Report on Form 10-K.
|
▪
|
Exemption from the auditor attestation requirement on the effectiveness of our system of internal control over financial reporting;
|
▪
|
Exemption from compliance with any new requirements adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report in which the auditor would be required to provide additional information about the audit and the financial statements of the issuer;
|
▪
|
Exemption from the requirement to seek non-binding advisory votes on executive compensation and golden parachute arrangements; and
|
▪
|
Reduced disclosure about executive compensation arrangements.
|
|
Page
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit
Number
|
|
Description of Exhibits
|
|
Form
|
|
File Number
|
|
Exhibit
|
|
Filing Date
|
2.1†
|
|
|
10-Q/A
|
|
001-36569
|
|
2.1
|
|
August 25, 2016
|
|
2.2†
|
|
|
10-Q
|
|
001-36569
|
|
10.1
|
|
November 1, 2016
|
|
3.1
|
|
|
8-K
|
|
001-36569
|
|
3.1
|
|
April 27, 2018
|
|
3.2
|
|
|
8-K
|
|
001-36569
|
|
3.2
|
|
April 27, 2018
|
|
4.1
|
|
|
8-K
|
|
001-36569
|
|
4.1
|
|
June 30, 2015
|
|
10.4†
|
|
|
S-4
|
|
333-169785
|
|
10.9
|
|
December 23, 2010
|
|
10.5†
|
|
|
S-4
|
|
333-169785
|
|
10.10
|
|
December 1, 2010
|
|
10.6†
|
|
|
10-Q
|
|
333-169785
|
|
10.1
|
|
May 13, 2011
|
|
10.9†
|
|
|
S-4
|
|
333-169785
|
|
10.26
|
|
December 1, 2010
|
|
10.10†
|
|
|
S-4
|
|
333-169785
|
|
10.14
|
|
December 23, 2010
|
|
10.11†
|
|
|
S-4
|
|
333-169785
|
|
10.16
|
|
December 29, 2010
|
|
10.12†
|
|
|
S-4
|
|
333-169785
|
|
10.17
|
|
December 1, 2010
|
|
10.13+
|
|
|
S-4
|
|
333-169785
|
|
10.18
|
|
October 6, 2010
|
|
10.14+
|
|
|
S-4
|
|
333-169785
|
|
10.19
|
|
October 6, 2010
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit
Number
|
|
Description of Exhibits
|
|
Form
|
|
File Number
|
|
Exhibit
|
|
Filing Date
|
10.15+
|
|
|
S-4
|
|
333-169785
|
|
10.20
|
|
October 6, 2010
|
|
10.16+
|
|
|
S-4
|
|
333-169785
|
|
10.21
|
|
October 6, 2010
|
|
10.17+
|
|
|
S-4
|
|
333-169785
|
|
10.24
|
|
October 6, 2010
|
|
10.18†
|
|
|
10-Q
|
|
333-169785
|
|
10.1
|
|
May 15, 2012
|
|
10.19†
|
|
|
10-Q
|
|
333-169785
|
|
10.2
|
|
May 15, 2012
|
|
10.20†
|
|
|
10-Q
|
|
333-169785
|
|
10.1
|
|
August 14, 2012
|
|
10.22†
|
|
|
10-Q
|
|
001-36569
|
|
10.53
|
|
May 2, 2018
|
|
10.23†
|
|
|
10-K
|
|
333-169785
|
|
10.54
|
|
March 29, 2013
|
|
10.25†
|
|
|
10-Q
|
|
333-169785
|
|
10.1
|
|
May 10, 2013
|
|
10.26+
|
|
|
8-K
|
|
333-169785
|
|
10.1
|
|
May 6, 2013
|
|
10.27+
|
|
|
8-K
|
|
333-169785
|
|
10.2
|
|
May 6, 2013
|
|
10.28+
|
|
|
8-K
|
|
333-169785
|
|
10.3
|
|
May 6, 2013
|
|
10.33+
|
|
|
10-K
|
|
333-169785
|
|
10.48
|
|
March 11, 2014
|
|
10.37+
|
|
|
S-1
|
|
333-196998
|
|
10.37
|
|
June 24, 2015
|
|
10.38+
|
|
|
S-1
|
|
333-196998
|
|
10.38
|
|
June 24, 2015
|
|
10.39+
|
|
|
S-1
|
|
333-196998
|
|
10.39
|
|
June 24, 2015
|
|
10.40+
|
|
|
S-1
|
|
333-196998
|
|
10.40
|
|
June 24, 2015
|
|
10.41+
|
|
|
S-1
|
|
333-196998
|
|
10.41
|
|
June 24, 2015
|
|
10.42+
|
|
|
10-Q
|
|
333-169785
|
|
10.1
|
|
May 5, 2015
|
|
10.47
|
|
|
8-K
|
|
001-36569
|
|
10.5
|
|
June 30, 2015
|
|
10.49+
|
|
|
8-K
|
|
001-36569
|
|
10.7
|
|
June 30, 2015
|
|
10.50+
|
|
|
8-K
|
|
001-36569
|
|
10.8
|
|
June 30, 2015
|
|
10.52+
|
|
|
10-Q
|
|
001-36569
|
|
10.2
|
|
November 4, 2015
|
|
10.53†
|
|
|
10-K
|
|
001-36569
|
|
10.53
|
|
March 2, 2016
|
|
10.57+
|
|
|
8-K
|
|
001-36569
|
|
10.1
|
|
April 28, 2016
|
|
10.58†
|
|
|
10-Q
|
|
001-36569
|
|
10.2
|
|
November 1, 2016
|
|
10.59+
|
|
|
8-K
|
|
001-36569
|
|
10.1
|
|
April 28, 2017
|
|
10.60+
|
|
|
8-K
|
|
001-36569
|
|
10.2
|
|
April 28, 2017
|
|
10.61
|
|
|
10-Q
|
|
001-36569
|
|
10.1
|
|
May 2, 2017
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit
Number
|
|
Description of Exhibits
|
|
Form
|
|
File Number
|
|
Exhibit
|
|
Filing Date
|
10.62†
|
|
|
10-Q
|
|
001-36569
|
|
10.1
|
|
August 1, 2017
|
|
10.63†
|
|
|
10-Q
|
|
001-36569
|
|
10.2
|
|
August 1, 2017
|
|
10.64†
|
|
|
10-K
|
|
001-36569
|
|
10.64
|
|
February 7, 2018
|
|
10.65†
|
|
|
10-K
|
|
001-36569
|
|
10.65
|
|
February 7, 2018
|
|
10.66
|
|
|
10-Q
|
|
001-36569
|
|
10.1
|
|
October 30, 2018
|
|
10.67
|
|
|
10-Q
|
|
001-36569
|
|
10.2
|
|
October 30, 2018
|
|
10.68*+
|
|
|
|
|
|
|
|
|
|
|
10.69*+
|
|
|
|
|
|
|
|
|
|
|
10.70*+
|
|
|
|
|
|
|
|
|
|
|
10.71*+
|
|
|
|
|
|
|
|
|
|
|
21.1*
|
|
|
|
|
|
|
|
|
|
|
23.1*
|
|
|
|
|
|
|
|
|
|
|
24.1*
|
|
|
|
|
|
|
|
|
|
|
31.1*
|
|
|
|
|
|
|
|
|
|
|
31.2*
|
|
|
|
|
|
|
|
|
|
|
32.1**
|
|
|
|
|
|
|
|
|
|
|
101.INS*
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
101.SCH*
|
|
XBRL Taxonomy Extension Schema
|
|
|
|
|
|
|
|
|
101.CAL*
|
|
XBRL Taxonomy Extension Calculation
|
|
|
|
|
|
|
|
|
101.DEF*
|
|
XBRL Taxonomy Extension Definition
|
|
|
|
|
|
|
|
|
101.LAB*
|
|
XBRL Taxonomy Extension Labels
|
|
|
|
|
|
|
|
|
101.PRE*
|
|
XBRL Taxonomy Extension Presentation
|
|
|
|
|
|
|
|
|
*
|
Filed herewith.
|
**
|
Furnished herewith.
|
+
|
Indicates management contract or compensatory plan or arrangement.
|
†
|
Confidential treatment requested as to certain portions, which portions have been filed separately with the Securities and Exchange Commission
|
LANTHEUS HOLDINGS, INC.
|
|
|
|
By:
|
/S/ MARY ANNE HEINO
|
Name:
|
Mary Anne Heino
|
Title:
|
President and Chief Executive Officer
|
Date:
|
February 20, 2019
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/S/ MARY ANNE HEINO
|
|
Chief Executive Officer, President and Director
(Principal Executive Officer) |
|
February 20, 2019
|
Mary Anne Heino
|
|
|
|
|
|
|
|
|
|
/S/ ROBERT J. MARSHALL, JR.
|
|
Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer) |
|
February 20, 2019
|
Robert J. Marshall, Jr.
|
|
|
|
|
|
|
|
|
|
/S/ BRIAN MARKISON
|
|
Chairman of the Board of Directors
|
|
February 20, 2019
|
Brian Markison
|
|
|
|
|
|
|
|
|
|
/S/ JAMES C. CLEMMER
|
|
Director
|
|
February 20, 2019
|
James C. Clemmer
|
|
|
|
|
|
|
|
|
|
/S/ SAMUEL R. LENO
|
|
Director
|
|
February 20, 2019
|
Samuel R. Leno
|
|
|
|
|
|
|
|
|
|
/S/ JULIE H. MCHUGH
|
|
Director
|
|
February 20, 2019
|
Julie H. McHugh
|
|
|
|
|
|
|
|
|
|
/S/ GARY J. PRUDEN
|
|
Director
|
|
February 20, 2019
|
Gary J. Pruden
|
|
|
|
|
|
|
|
|
|
/S/ KENNETH J. PUCEL
|
|
Director
|
|
February 20, 2019
|
Kenneth J. Pucel
|
|
|
|
|
|
|
|
|
|
/S/ DR. FREDERICK A. ROBERTSON
|
|
Director
|
|
February 20, 2019
|
Dr. Frederick A. Robertson
|
|
|
|
|
|
|
|
|
|
/S/ DR. DERACE L. SCHAFFER
|
|
Director
|
|
February 20, 2019
|
Dr. Derace L. Schaffer
|
|
|
|
|
|
|
|
|
|
/S/ DR. JAMES H. THRALL
|
|
Director
|
|
February 20, 2019
|
Dr. James H. Thrall
|
|
|
|
1.
|
At-Will Employment.
Executive’s employment with the Company commenced as of April 15, 2013. Such employment shall be “at-will” employment. Subject to the terms of this Agreement, the Company may terminate Executive’s employment and this Agreement for any reason at any time, with or without prior notice and with or without Cause (as defined herein), but subject to certain terms set forth in Section 8 below. Similarly, subject to the terms of this Agreement, Executive may terminate her employment at any time, subject to Section 8 below.
|
2.
|
Position.
|
(a)
|
Executive shall serve as the Company’s President and Chief Executive Officer and as a member of the Board of Directors of Lantheus Holdings, Inc. (the “
Board
”). In such capacities, Executive shall report to the Board, and Executive shall have such duties and responsibilities as are consistent with such titles and positions and/or such other duties and responsibilities as may be assigned from time to time by the Board. If requested, Executive shall serve as an officer or a member of the Board of Directors of any of the Company’s subsidiaries or affiliates without additional compensation.
|
(b)
|
Executive will devote Executive’s full business time and best efforts to the performance of Executive’s duties hereunder and will not engage in any other business, profession or occupation for compensation or otherwise which would conflict or interfere with the rendition of such services either directly or indirectly, without the prior written consent of the Board;
provided
that nothing herein shall preclude Executive, subject to the prior approval of the Board, from accepting appointment to or continuing to serve on any board of directors or trustees of any business corporation or any charitable organization;
provided
in each case, and in the aggregate, that such activities do not conflict or interfere with the performance of Executive’s duties hereunder or conflict with Section 9.
|
3.
|
Base Salary
. During Executive’s employment hereunder, the Company shall pay Executive a base salary at the annualized rate of $675,000, payable in regular installments in accordance with the Company’s payment practices from time to time. Executive shall be entitled to annual performance and salary review, and any increase in base salary shall be in the sole discretion of the Compensation Committee of the Board. Executive’s annual base salary, as in effect from time to time, is hereinafter referred to as the “
Base Salary
”.
|
4.
|
Annual Bonus
. With respect to each full fiscal year ending during Executive’s employment hereunder, Executive shall be eligible to earn an annual bonus award of eighty-five percent (85%) of Executive’s Base Salary (the “
Target
”) based upon achievement of annual EBITDA and/or other performance targets established by the Compensation Committee of the Board within the first three months of each fiscal year (the “
Annual Bonus
”). Annual Bonuses, if any, are generally paid in March of the year following the year to which such Annual Bonus relates, by the 15th of that month; provided, that Executive is an active employee in good standing with the Company on such date of payment.
|
5.
|
Equity
. Executive shall be eligible to receive future equity awards from time to time pursuant to the Lantheus MI Holdings, Inc. 2015 Equity Incentive Plan, commensurate with Executive’s level of responsibilities and the level of awards for similarly situated executives, as determined by the Compensation Committee of the Board in its sole discretion. The terms and conditions of any such equity awards shall be set forth in a separate award agreement.
|
6.
|
Employee Benefits
. During Executive’s employment hereunder, Executive shall be entitled to participate in the Company’s health, life and disability insurance, and retirement and fringe employee benefit plans as in effect from time to time (collectively “
Employee Benefits
”), on the same basis as those benefits are generally made available to other similarly situated executives of the Company.
|
7.
|
Business Expenses
. During Executive’s employment hereunder, reasonable business expenses incurred by Executive in the performance of Executive’s duties hereunder shall be reimbursed by the Company in accordance with Company policies.
|
8.
|
Termination of Employment
.
|
(a)
|
Termination By the Company Without Cause. If Executive’s employment is terminated by the Company without Cause or Executive terminates for Good Reason, executive shall receive the following, subject to Section 8(g):
|
(i)
|
an amount equal to the sum of (A) one times (1x) the Executive’s annual base salary and (B) a pro-rata portion of Executive’s target annual bonus (prorated based on the percentage of the fiscal year that shall have elapsed through the Separation Date), in each case, as in effect on the Separation Date (or, if a reduction in Executive’s annual base salary gave rise to Good Reason under this Agreement, as in effect immediately prior to such reduction) (the “
Severance Payment
”);
|
(ii)
|
provided that Executive timely and properly elects to purchase continued healthcare coverage under COBRA, a monthly amount equal to the employer portion of the monthly premiums paid under the Company’s group health plans as of the Separation Date, for the period ending on the earliest of (i) the one-year anniversary of the Separation Date, (ii) the date on which Executive becomes covered under another employer’s health plan and (iii) the expiration of the maximum COBRA continuation coverage period for which Executive is eligible under federal law. For the avoidance of doubt, Executive will be responsible for paying the applicable COBRA premiums directly to the Company’s COBRA administrator (the “
COBRA Payment
”);
|
(iii)
|
a lump sum amount equal to any earned, but unpaid, Annual Cash Bonus, if any, for the year prior to the year of termination, less taxes and withholdings, which shall be payable on the 60th day following Executive’s termination of employment;
|
(iv)
|
a lump sum amount equal to any earned, but unpaid, Base Salary, if any, through the date of Executive’s termination of employment, less taxes and withholdings, which shall be payable with the Company’s first payroll after Executive’s termination of employment; and
|
(v)
|
a lump sum amount equal to any unreimbursed business expenses, if any, pursuant to and in accordance with Section 7, incurred through the date of Executive’s termination of employment.
|
(b)
|
Termination Without Cause or For Good Reason following a Change of Control. If, within 12 months following the occurrence of a Change of Control, Executive terminates her employment for Good Reason or the Company terminates Executive’s employment with the Company without Cause, Executive shall receive the following, subject to Section 8(g) and in lieu of the payments described in Section 8(a):
|
(i)
|
an amount equal to two times (2x) the sum of Executive’s annual base salary and target annual bonus, in each case, as in effect on the Separation Date (or, if a reduction in Executive’s annual base salary gave rise to Good Reason under this Agreement, as in effect immediately prior to such reduction);
|
(ii)
|
an aggregate amount equal to the employer portion of the monthly premiums paid under the Company’s group health plans as of the Separation Date multiplied by twenty four (24) (the sum of (i) and (ii), “
Change in Control Severance Payment
”);
|
(iii)
|
a lump sum amount equal to any earned, but unpaid, Annual Cash Bonus, if any, for the year prior to the year of termination, less taxes and withholdings, which shall be payable on the 60th day following Executive’s termination of employment;
|
(iv)
|
a lump sum amount equal to any earned, but unpaid, Base Salary, if any, through the date of Executive’s termination of employment, less taxes and withholdings, which shall be payable on the first payroll date after Executive’s termination of employment;
|
(v)
|
a lump sum amount equal to any unreimbursed business expenses, if any, pursuant to and in accordance with Section 7, incurred through the date of Executive’s termination of employment. Executive acknowledges and agrees that, in connection with any Change of Control transaction, except as otherwise provided in a separate agreement, Executive shall not be entitled to receive, and shall not be paid, any transaction, success, sale or similar bonus or payment; and
|
(vi)
|
any stock options or other equity-based award that Executive holds on the Separation Date, to the extent then-unvested, shall vest in full, with performance-based awards vesting at target, and, in the case of stock options, shall remain exercisable as provided in the equity plan or award agreement under which they were granted.
|
(c)
|
Termination Due to Death or Permanent Disability. Executive’s employment with the Company shall terminate automatically on Executive’s death. In the event of Executive’s Permanent Disability, the Company shall be entitled to terminate her employment.
|
(i)
|
a lump sum amount equal to any earned, but unpaid, Annual Cash Bonus, if any, for the year prior to the year of termination, less taxes and withholdings, payable on the sixtieth (60th) day following Executive’s termination of employment;
|
(ii)
|
a lump sum amount equal to any earned, but unpaid, Base Salary, if any, through the date of Executive’s termination of employment, less taxes and withholdings, which shall be payable on the first payroll date after Executive’s termination of employment;
|
(iii)
|
a lump sum amount equal to any unreimbursed business expenses, if any, pursuant to and in accordance with Section 7, incurred through the date of Executive’s termination of employment; and
|
(iv)
|
a pro rata portion of Executive’s target annual bonus for the year of termination, based on the percentage of the fiscal year that shall have elapsed through the Separation Date, payable in a lump sum on the Company’s first regular payroll date following the date that the Separation Agreement becomes fully effective and irrevocable (and will include all amounts that would have been paid on the regular payroll dates of the Company following the Separation Date prior to such date).
|
(d)
|
Other Terminations.
Executive shall not be entitled to the post-termination benefits set forth in Section 8(a), Section 8(b) or Section 8(c) above if her employment with the Company ceases for any reason other than her termination by the Company without Cause, her resignation for Good Reason or her termination as a result of her death or Permanent Disability; it being understood that if Executive’s employment with the Company ceases or terminates for any other reason, he will not be entitled to any severance or post-termination benefits or payments, whether hereunder or pursuant to any policy of the Company, other than a lump sum amount equal to any earned, but unpaid, Base Salary, if any, through the date of Executive’s termination of employment, less taxes and withholdings (payable on the first payroll date after Executive’s termination of employment), and a lump sum amount equal to any unreimbursed business expenses, if any, pursuant to and in accordance with Section 3(e), incurred through the date of Executive’s termination of employment; provided, that this paragraph shall not alter Executive’s rights or obligations he may have or be subject to in connection with or with respect to her equity interests in Holdings, and Executive’s indemnification rights shall continue to be governed in accordance with any Directors and Officers Liability Insurance Policy that the Company may maintain and/or with the Company’s certificate of incorporation or by-bylaws or similar governing document, and otherwise in accordance with Section 7.
|
(e)
|
Cause Definition
. For purposes of this Agreement, “
Cause
” means (i) material failure by Executive to perform Executive’s employment duties (other than as a consequence of any illness, accident or disability), (ii) continued, willful failure of Executive to carry out any reasonable lawful direction of the Company, (iii) material failure of Executive to comply with any of the applicable rules of the Company contained in its Employee Handbook or any other Company policy, (iv) fraud, willful malfeasance, gross negligence or recklessness of Executive in the performance of employment duties, (v) willful failure of Executive to comply with any of the material terms of this Agreement, (vi) other serious, willful misconduct of Executive which causes material injury to the Company or its reputation, including, but not limited to, willful or gross misconduct toward any of the Company’s other employees, and (vii) conviction of a crime (or a pleading of guilty or
nolo contendere
), other than one which in the opinion of the Board does not affect Executive’s position as an employee of the Company.
|
(f)
|
Good Reason Definition
. For purposes of this Agreement, “
Good Reason
” means, without the Executive’s consent (i) a material decrease in Executive’s base salary or failure to pay salary when due; (ii) a material diminution in Executive’s duties or responsibilities (provided however, that a mere change in Executive’s title or reporting relationship alone shall not constitute “Good Reason”); (iii) the failure of the Company to cause the transferee or successor to all or substantially all of the assets of the Company or line of business to which Executive’s employment principally relates to assume by operation of law or contractually the Company’s obligations hereunder; or (iv) the relocation of Executive’s principal work location to a location more than fifty (50) miles from its current location; provided, in each case, that (A) Executive provides written notice to the Company, setting forth in reasonable detail the event giving rise to Good Reason within thirty (30) days following the initial occurrence of such event, (B) such event is not cured by the Company within thirty (30) days following its receipt of such written notice, and (C) Executive actually terminates Executive’s employment not later than thirty (30) days following the expiration of such cure period.
|
(g)
|
Separation Agreement and General Release
. The payments and benefits set forth in Sections 8(a), 8(b) and 8(c) above shall be expressly conditioned upon Executive’s (or her estate or legal representatives, in the case of Section 4(c)) execution and delivery to the Company of a Separation Agreement and General Release in a form that is acceptable to the Company (the “
Separation Agreement
”) and such Separation Agreement becoming irrevocable within sixty (60) days following Executive’s termination of employment. For the avoidance of doubt, the payments and benefits set forth in Sections 8(a), 8(b) and 8(c) above shall be forfeited if such Separation Agreement has not been executed, delivered and become irrevocable within such sixty (60) day period. Such Separation Agreement shall contain release language substantially similar to the language set forth in Exhibit A attached hereto.
|
(h)
|
Board/Committee Resignation.
Upon termination of Executive’s employment for any reason, Executive agrees to resign, as of the date of such termination and to the extent applicable, from the Board (and any committees thereof) and the Board of Directors (and any committees thereof) of any of the Company’s subsidiaries or affiliates.
|
(i)
|
Beneficial Owner Definition
. For purposes of this Agreement, “
Beneficial Owner
” has the meaning ascribed to such term in Rule 13d-3 under the Securities Exchange Act of 1934, as amended.
|
(j)
|
Change of Control Definition
. For purposes of this Agreement,
“
Change in Control
”
means any of the following:
|
(i)
|
Any Person becomes the Beneficial Owner, directly or indirectly, of more than fifty percent (50%) of the combined voting power, excluding any Person who is the Beneficial Owner of fifty percent (50%) or more of the voting power on the date this Agreement is accepted and agreed to by Executive, of the then outstanding voting securities of the Company entitled to vote generally in the election of its directors (the “
Outstanding Company Voting Securities
”), including by way of merger, consolidation or otherwise;
provided
,
however
, that for purposes of this definition, the following acquisitions shall not constitute a Change in Control: (i) any acquisition of Outstanding Company Voting Securities directly from the Company, including, without limitation, in a public offering of securities, or (ii) any acquisition of Outstanding Company Voting Securities by the Company or any of its subsidiaries, including, without limitation, an acquisition by any employee benefit plan or related trust sponsored or maintained by the Company or any of its subsidiaries.
|
(ii)
|
Consummation of a reorganization, merger, or consolidation to which the Company is a party or a sale or other disposition of all or substantially all of the assets of the Company or the line of business to which Executive’s employment principally relates (a “
Business Combination
”), unless, following such Business Combination: (i) any Persons who were the Beneficial Owners of Outstanding Company Voting Securities immediately prior to such Business Combination are the Beneficial Owners, directly or indirectly, of more than fifty percent (50%) of the combined voting power of the outstanding voting securities entitled to vote generally in the election of directors (or election of members of a comparable governing body) of the entity resulting from the Business Combination (including, without limitation, an entity which, as a result of such transaction, owns all or substantially all of the Company or all or substantially all of the Company’s assets, either directly or through one or more subsidiaries) (the “
Successor Entity
”) in substantially the same proportions as their ownership immediately prior to such Business Combination; or (ii) no Person (excluding any Successor Entity or any employee benefit plan or related trust of the Company, any of its subsidiaries, such Successor Entity or any of its subsidiaries) is the Beneficial Owner, directly or indirectly, of more than fifty percent (50%) of the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors (or comparable governing body) of the Successor Entity, except to the extent that such ownership of the Company existed prior to the Business Combination.
|
(iii)
|
Approval by the shareholders of the Company of a complete liquidation or dissolution of the Company.
|
(k)
|
Separation Date Definition
. For purposes of this Agreement, “
Separation Date
” means the date Executive’s employment with the Company terminates.
|
9.
|
Non-Competition
.
|
(a)
|
Executive acknowledges and recognizes the highly competitive nature of the businesses of the Company and its affiliates and accordingly agrees as follows:
|
(i)
|
During Executive’s employment with the Company and, for a period of one year following the date Executive ceases to be employed by the Company (the
“Restricted Period
”), Executive will not, whether on Executive’s own behalf or on behalf of or in conjunction with any person, firm, partnership, joint venture, association, corporation or other business organization, entity or enterprise whatsoever (“
Person
”), directly or indirectly solicit or assist in soliciting in competition with the Company, the business of any client or prospective client:
|
(1)
|
with whom Executive had personal contact or dealings on behalf of the Company during the one-year period preceding Executive’s termination of employment;
|
(2)
|
with whom employees reporting to Executive had personal contact or dealings on behalf of the Company during the one year immediately preceding the Executive’s termination of employment; or
|
(3)
|
for whom Executive had direct or indirect responsibility during the one year immediately preceding Executive’s termination of employment.
|
(ii)
|
During the Restricted Period, Executive will not directly or indirectly:
|
(1)
|
engage in any business that competes with the business or businesses of the Company or any of its affiliates, namely in the testing, development and manufacturing services for the development, manufacture, distribution, marketing or sale of radiopharmaceutical products, contrast imaging agents and/or radioactive generators for the global medical imaging and pharmaceutical industries, and including, without limitation, businesses which the Company or its affiliates have specific plans to conduct in the future and as to which Executive is aware of such planning (a
“Competitive Business
”);
|
(2)
|
enter the employ of, or render any services to, any Person (or any division or controlled or controlling affiliate of any Person) who or which engages in a Competitive Business;
|
(3)
|
acquire a financial interest in, or otherwise become actively involved with, any Competitive Business, directly or indirectly, as an individual, partner, shareholder, officer, director, principal, agent, trustee or consultant; or
|
(4)
|
interfere with, or attempt to interfere with, business relationships (whether formed before, on or after the date of this Agreement) between the Company or any of its affiliates and customers, clients, suppliers, partners, members or investors of the Company or its affiliates.
|
(iii)
|
Notwithstanding anything to the contrary in this Agreement, Executive may, directly or indirectly, own, solely as an investment, securities of any Person engaged in the business of the Company or its affiliates which are publicly traded on a national or regional stock exchange or on the over-the-counter market if Executive (i) is not a controlling person of, or a member of a group which controls, such Person and (ii) does not, directly or indirectly, own 5% or more of any class of securities of such Person.
|
(iv)
|
During the Restricted Period, Executive will not, whether on Executive’s own behalf or on behalf of or in conjunction with any Person, directly or indirectly:
|
(1)
|
solicit or encourage any employee or consultant of the Company or its affiliates to leave the employment of, or cease providing services to, the Company or its affiliates; or
|
(2)
|
hire any such employee or consultant who was employed by or providing services to the Company or its affiliates as of the date of Executive’s termination of employment with the Company or who left the employment of or ceased providing services to the Company or its affiliates coincident with, or within one year prior to or after, the termination of Executive’s employment with the Company.
|
(3)
|
It is expressly understood and agreed that although Executive and the Company consider the restrictions contained in this Section 9 to be reasonable, if a final judicial determination is made by a court of competent jurisdiction that the time or territory or any other restriction contained in this Agreement is an unenforceable restriction against Executive, the provisions of this Agreement shall not be rendered void but shall be deemed amended to apply as to such maximum time and territory and to such maximum extent as such court may judicially determine or indicate to be enforceable. Alternatively, if any court of competent jurisdiction finds that any restriction contained in this Agreement is
|
(b)
|
The provisions of this Section 9 shall survive the termination of this Agreement and Executive’s employment for any reason.
|
10.
|
Non-Disparagement.
The Executive shall not at any time (whether during or after Executive’s employment with the Company) make, or cause to be made, any statement or communicate any information (whether oral or written) that disparages or reflects negatively on the Company or any of its affiliates, except for truthful statements that may be made pursuant to legal process, including without limitation in litigation, arbitration or similar dispute resolution proceedings. This Section 10 shall survive the termination of this Agreement and Executive’s employment for any reason.
|
11.
|
Confidentiality; Intellectual Property
.
|
(a)
|
Confidentiality
.
|
(i)
|
Executive will not at any time (whether during or after Executive’s employment with the Company) (x) retain or use for the benefit, purposes or account of Executive or any other Person; or (y) disclose, divulge, reveal, communicate, share, transfer or provide access to any Person outside the Company (other than its professional advisers who are bound by confidentiality obligations), any non-public, proprietary or confidential information - including, without limitation, trade secrets, know-how, research and development, software, databases, inventions, processes, formulae, technology, designs and other intellectual property, information concerning finances, investments, profits, pricing, costs, products, services, vendors, customers, clients, partners, investors, personnel, compensation, recruiting, training, advertising, sales, marketing, promotions, government and regulatory activities and approvals - concerning the past, current or future business, activities and operations of the Company, its subsidiaries or affiliates and/or any third party that has disclosed or provided any of same to the Company on a confidential basis
(“Confidential Information”)
without the prior written authorization of the Board.
|
(ii)
|
Confidential Information shall not include any information that is (A) generally known to the industry or the public other than as a result of Executive’s breach of this covenant or any breach of other confidentiality obligations by third parties; (B) made legitimately available to Executive by a third party without breach of any confidentiality obligation; or (C) required by law to be disclosed; provided that Executive shall give prompt written notice to the Company of such requirement, disclose no more information than is so required, and cooperate with any attempts by the Company to obtain a protective order or similar treatment.
|
(iii)
|
Except as required by law, Executive will not disclose to anyone, other than Executive’s immediate family and legal or financial advisors, the existence or contents of this Agreement; provided that Executive may disclose to any prospective future employer the provisions of Sections 9, 10 and 11 of this Agreement provided they agree to maintain the confidentiality of such terms.
|
(iv)
|
Upon termination of Executive’s employment with the Company for any reason, Executive shall (x) cease and not thereafter commence use of any Confidential Information or intellectual property (including without limitation, any patent, invention, copyright, trade secret, trademark, trade name, logo, domain name or other source indicator) owned or used by the Company, its subsidiaries or affiliates; (y) immediately return to the Company all Company property and destroy, delete, or return to the Company, at the Company’s option, all originals and copies in any form or medium (including memoranda, books, papers, plans, computer files, letters and other data) in Executive’s possession or control (including any of the foregoing stored or located in Executive’s office, home, laptop or other computer, whether or not Company property) that contain Confidential Information or otherwise relate to the business of the Company, its affiliates and subsidiaries, except that Executive may retain only those portions of any personal notes, notebooks and diaries that do not contain any Confidential Information; and (z) notify and fully cooperate with the Company regarding the delivery or destruction of any other Confidential Information of which Executive is or becomes aware and promptly return any other Company property in Executive’s possession.
|
(b)
|
Intellectual Property.
|
(i)
|
If Executive has created, invented, designed, developed, contributed to or improved any works of authorship, inventions, intellectual property, materials, documents or other work product (including without limitation, research, reports, software, databases, systems, applications, presentations, textual works, content, or audiovisual materials) (“
Works
”), either alone or with third parties, prior to Executive’s employment by the Company, that are relevant to or implicated by such employment (“
Prior Works
”), Executive hereby grants the Company a perpetual, nonexclusive, royalty-free, worldwide, assignable, sublicensable license under all rights and intellectual property rights (including rights under patent, industrial property, copyright, trademark, trade secret, unfair competition and related laws) therein for all purposes in connection with the Company’s current and future business. A list of all such material Works as of the date hereof is attached hereto as
Exhibit B
.
|
(ii)
|
If Executive creates, invents, designs, develops, contributes to or improves any Works, either alone or with third parties, at any time during Executive’s employment by the Company and within the scope of such employment and/or with the use of any Company resources (“
Company Works
”), Executive shall promptly and fully disclose such works to the Company and hereby irrevocably assigns, transfers and conveys, to the maximum extent permitted by applicable law, all rights and intellectual property rights therein (including rights under patent, industrial property, copyright, trademark, trade secret, unfair competition and related laws) to the Company to the extent ownership of any such rights does not vest originally in the Company.
|
(iii)
|
Executive agrees to keep and maintain adequate and current written records (in the form of notes, sketches, drawings, and any other form or media requested by the Company) of all Company Works. The records will be available to and remain the sole property and intellectual property of the Company at all times.
|
(iv)
|
Executive shall take all requested actions and execute all requested documents (including any licenses or assignments required by a government contract) at the Company’s expense (but without further remuneration) to assist the Company in validating, maintaining, protecting, enforcing, perfecting, recording, patenting or registering any of the Company’s rights in the Prior Works and Company Works. If the Company is unable for any other reason to secure Executive’s signature on any document for this purpose, then Executive hereby irrevocably designates and appoints the Company and its duly authorized officers and agents as Executive’s agent and attorney-in-fact, to act for and on Executive’s behalf to execute any documents and to do all other lawfully permitted acts in connection with the foregoing.
|
(v)
|
Executive shall not improperly use for the benefit of, bring to any premises of, divulge, disclose, communicate, reveal, transfer or provide access to, or share with the Company any confidential, proprietary or non-public information or intellectual property relating to a former employer or other third party without the prior written permission of such third party. Executive hereby indemnifies, holds harmless and agrees to defend the Company and its officers, directors, partners, employees, agents and representatives from any breach of the foregoing covenant. Executive shall comply with all relevant policies and guidelines of the Company, including regarding the protection of confidential information and intellectual property and potential conflicts of interest. Executive acknowledges that the Company may amend any such policies and guidelines from time to time, and that Executive remains at all times bound by their most current version.
|
(c)
|
The provisions of this Section 11 shall survive the termination of this Agreement and Executive’s employment for any reason.
|
12.
|
Specific Performance
. ·Executive acknowledges and agrees that the Company’s remedies at law for a breach or threatened breach of any of the provisions of Section 9, Section 10 or Section 11 would be inadequate and the Company would suffer irreparable damages as a result of such breach or threatened breach. In recognition of this fact, Executive agrees that, in the event of such a breach or threatened breach, in addition to any remedies at law, the Company, without posting any bond, shall be entitled to cease making any payments or providing any benefit otherwise required by this Agreement and obtain equitable relief in the form of specific performance, temporary restraining order, temporary or permanent injunction or any other equitable remedy which may then be available.
|
13.
|
Miscellaneous.
|
(a)
|
Governing Law.
This Agreement shall be governed by, construed and interpreted in all respects, in accordance with the laws of the State of New York, without regard to conflicts of laws principles thereof.
|
(b)
|
Entire Agreement/Amendments
. This Agreement contains the entire understanding of the parties with respect to the employment of Executive by the Company and supersedes all prior agreements, understandings, discussions, negotiations and undertakings, whether written or oral between the Executive and the Company or any of its affiliates with respect to the Executive’s employment. There are no restrictions, agreements, promises, warranties, covenants or undertakings between the parties with respect to the subject matter herein other than those expressly set forth herein. This Agreement may not be altered, modified, or amended except by written instrument signed by the parties hereto.
|
(c)
|
No Waiver
. The failure of a party to insist upon strict adherence to any term of this Agreement on any occasion shall not be considered a waiver of such party’s rights or deprive such party of the right thereafter to insist upon strict adherence to that term or any other term of this Agreement.
|
(d)
|
Severability.
In the event that any one or more of the provisions of this Agreement shall be or become invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions of this Agreement shall not be affected thereby.
|
(e)
|
Assignment.
This Agreement, and all of Executive’s rights and duties hereunder, shall not be assignable or delegable by Executive. Any purported assignment or delegation by Executive in violation of the foregoing shall be null and void
ab initio
and of no force and effect. This Agreement may be assigned by the Company to a person or entity which is an affiliate or a successor in interest to substantially all of the business operations of the Company. Upon such assignment, the rights and obligations of the Company hereunder shall become the rights and obligations of such affiliate or successor person or entity.
|
(f)
|
Set Off.
The Company’s obligation to pay Executive the amounts provided and to make the arrangements provided hereunder shall be subject to set-off, counterclaim or recoupment of amounts owed by Executive to the Company or its affiliates.
|
(g)
|
Dispute Resolution.
Except with respect to Sections 9, 10, 11 and 12 hereof, any controversy or claim arising out of or related to any provision of this Agreement that cannot be mutually resolved by the parties hereto shall be settled by final, binding and nonappealable arbitration in New York, NY by a single mutually-acceptable arbitrator. Subject to the following provisions, the arbitration shall be conducted in accordance with the applicable rules of American Arbitration Association then in effect. Any award entered by the arbitrator shall be final, binding and nonappealable and judgment may be entered thereon by either party in accordance with applicable law in any court of competent jurisdiction. This arbitration provision shall be specifically enforceable. The arbitrator shall have no authority to modify any provision of this Agreement or to award a remedy for a dispute involving this Agreement other than a benefit specifically provided under or by virtue of the Agreement. Each party shall be responsible for its own expenses relating to the conduct of the arbitration or litigation (including attorney’s fees and expenses) and shall share the fees of the American Arbitration Association and the arbitrator equally.
|
(h)
|
Compliance with Section 409A of the Code.
|
(i)
|
The intent of the parties is that the payments and benefits under this Agreement comply with or be exempt from Section 409A of the Internal Revenue Code of 1986, as amended (the “
Code
”) and, accordingly, to the maximum extent permitted, this Agreement shall be interpreted to be in compliance therewith. To the extent that any provision hereof is modified in order to comply with or be exempt from Section 409A, such modification shall be made in good faith and shall, to the maximum extent reasonably possible, maintain the original intent and economic benefit to Executive and the Company of the applicable provision without violating the provisions of Code Section 409A (“
Section 409A
”).
|
(ii)
|
If any payment, compensation or other benefit provided to Executive under this Agreement in connection with Executive’s “separation from service” (within the meaning of Section 409A) is determined, in whole or in part, to constitute “nonqualified deferred compensation” (within the
|
(iii)
|
A termination of employment shall not be deemed to have occurred for purposes of any provision of this Agreement providing for the payment of any amounts or benefits subject to Section 409A upon or following a termination of employment unless such termination is also a “separation from service” (within the meaning of Section 409A), and for purposes of any such provision of this Agreement, references to a “resignation,” “termination,” “terminate,” “termination of employment” or like terms shall mean separation from service (within the meaning of Section 409A).
|
(iv)
|
All expenses or other reimbursements as provided herein shall be payable in accordance with the Company’s policies in effect from time to time, but in any event shall be made on or prior to the last day of the taxable year following the taxable year in which such expenses were incurred by Executive. With regard to any provision herein that provides for reimbursement of costs and expenses or in-kind benefits, except as permitted by Section 409A: (i) the right to reimbursement or in-kind benefits shall not be subject to liquidation or exchange for another benefit; and (ii) the amount of expenses eligible for reimbursements or in-kind benefits provided during any taxable year shall not affect the expenses eligible for reimbursement or in-kind benefits to be provided in any other taxable year.
|
(v)
|
For purposes of Section 409A, Executive’s right to receive any installment payments pursuant to this Agreement shall be treated as a right to receive a series of separate and distinct payments. Whenever a payment under this Agreement specifies a payment period with reference to a number of days (e.g., payment shall be made within 30 days following the date of termination), the actual date of payment within the specified period shall be within the sole discretion of the Company.
|
(vi)
|
To the extent required to comply with Section 409A, a Change in Control will not be deemed to occur for purposes of this Agreement unless it is a “change in control event” as defined in Section 1.409A-3(i)(5)(i) of the Treasury Regulations, and if it is not a “change in control event,” payment of the severance described in Section 8(b) of this Agreement shall instead be paid as provided under Section 8(a) of this Agreement (unless the severance, or portion thereof, could be paid earlier without resulting in adverse tax consequences under Section 409A).
|
(i)
|
Successors; Binding Agreement.
This Agreement shall inure to the benefit of and be binding upon personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees of the parties hereto.
|
(j)
|
Notice
. For the purpose of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be deemed to have been duly given when delivered by hand or overnight courier or three days after it has been mailed by United States registered mail, return receipt requested, postage prepaid, addressed to the respective addresses set forth below in this Agreement, or to such other address as either party may have furnished to the other in writing in accordance herewith, except that notice of change of address shall be effective only upon receipt,
|
(k)
|
Executive Representation
. Executive hereby represents to the Company that (i) Executive has been provided with sufficient opportunity to review this Agreement and has been advised by the Company to conduct such review with an attorney of her choice, and (ii) the execution and delivery of this Agreement by Executive and the Company and the performance by Executive of Executive’s duties hereunder shall not constitute a breach of, or otherwise contravene, the terms of any employment agreement or other agreement or policy to which Executive is a party or otherwise bound.
|
(l)
|
Cooperation.
Executive shall provide Executive’s reasonable cooperation in connection with any action or proceeding (or any appeal from any action or proceeding) which relates to events occurring during Executive’s employment hereunder. This provision shall survive any termination of this Agreement or Executive’s employment.
|
(m)
|
Withholding Taxes
. The Company may withhold from any amounts payable under this Agreement such Federal, state and local taxes as may be required to be withheld pursuant to any applicable law or regulation.
|
(n)
|
Counterparts.
This Agreement may be signed in counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument.
|
14.
|
|
(a)
|
Anything in this Agreement to the contrary notwithstanding, in the event that the receipt of all payments or distributions by the Company in the nature of compensation to or for the Executive’s benefit, whether paid or payable pursuant to this Agreement or otherwise (a “
Payment
”), would subject the Executive to the excise tax under Section 4999 of the Code, the accounting firm which audited the Company prior to the corporate transaction which results in the application of such excise tax (the “
Accounting Firm
”) shall determine whether to reduce any of the Payments to the Reduced Amount (as defined below). The Payments shall be reduced to the Reduced Amount only if the Accounting Firm determines that the Executive would have a greater Net After-Tax Receipt (as defined below) of aggregate Payments if the Executive’s Payments were reduced to the Reduced Amount. If such a determination is not made by the Accounting Firm, the Executive shall receive all Payments to which the Executive is entitled.
|
(b)
|
If the Accounting Firm determines that aggregate Payments should be reduced to the Reduced Amount, the Company shall promptly give the Executive notice to that effect and a copy of the detailed calculation thereof. All determinations made by the Accounting Firm under this Section 14 shall be made as soon as reasonably practicable and in no event later than sixty (60) days following the date of termination or such earlier date as requested by the Company. For purposes of reducing the Payments to the Reduced Amount, such reduction shall be implemented by determining the Parachute Payment Ratio (as defined below) for each Payment and then reducing the Payments in order beginning with the Payment with the highest Parachute Payment Ratio. For Payments with the same Parachute Payment Ratio, such Payments shall be reduced based on the time of payment of such Payments, with amounts having later payment dates being reduced first. For Payments with the same Parachute Payment Ratio and the same time of payment, such Payments shall be reduced on a pro rata basis (but not below zero) prior to reducing Payments with a lower Parachute Payment Ratio. In all cases, the reduction of Payments shall be implemented in a manner that complies with Section 409A of the Code. All other provisions of any agreement embodying the Payments shall remain in full force and effect. All fees and expenses of the Accounting Firm shall be borne solely by the Company.
|
(c)
|
As a result of the uncertainty in the application of Section 4999 of the Code at the time of the initial determination by the Accounting Firm hereunder, it is possible that amounts will have been paid or distributed by the Company to or for the benefit of the Executive pursuant to this Agreement or otherwise which should not have been so paid or distributed (the “
Overpayment
”) or that additional amounts which will have not been paid or distributed by the Company to or for the benefit of the Executive pursuant to this Agreement or otherwise could have been so paid or distributed (the “
Underpayment
”), in each case, consistent with the calculation of the Reduced Amount hereunder. In the event that the Accounting Firm, based upon the assertion of a deficiency by the Internal Revenue Service against either the Company or the Executive which the Accounting Firm believes has a high probability of success, determines that an Overpayment has been made, the Executive shall pay any such Overpayment to the Company together with
|
(d)
|
For purposes hereof, the following terms have the meanings set forth below: (i) “
Reduced Amount
” shall mean the greatest amount of Payments that can be paid that would not result in the imposition of the excise tax under Section 4999 of the Code if the Accounting Firm determines to reduce Payments pursuant to this Section 14, (ii) “
Net After-Tax Receipt
” shall mean the present value (as determined in accordance with Sections 280G(b)(2)(A)(ii) and 280G(d)(4) of the Code) of a Payment net of all taxes imposed on the Executive with respect thereto under Sections 1 and 4999 of the Code and under applicable state and local laws, determined by applying the highest marginal rate under Section 1 of the Code and under state and local laws which applied to the Executive’s taxable income for the immediately preceding taxable year, or such other rate(s) as the Executive certifies, in the Executive’s sole discretion, as likely to apply to the Executive in the relevant tax year(s), and (iii) “
Parachute Payment Ratio
” shall mean a fraction the numerator of which is the present value (as determined in accordance with Sections 280G(b)(2)(A)(ii) and 280G(d)(4) of the Code) of the applicable Payment for purposes of Section 280G and the denominator of which is the intrinsic value of such Payment.
|
1.
|
Executive agrees to and does waive any claims Executive may have for employment by the Company. Executive, on her own behalf and on behalf of Executive’s heirs, estate and beneficiaries, further does hereby release the Company, and in those capacities, any of its Affiliates, and each of their respective past, present and future officers, directors, agents, employees, shareholders, investors, employee benefit plans and their administrators, trustees or fiduciaries, insurers of any of those entities, and its and their successors and assigns and others related to those entities (collectively, the “
Released Parties
”) from any and all claims made, to be made, or which might have been made of whatever nature, whether known or unknown, from the beginning of time, including those that arose as a consequence of Executive’s employment with the Company, or arising out of the termination of Executive’s employment with the Company, or any act committed or omitted during or after the existence of that employment relationship, all up through and including the date on which this Release is executed, including, but not limited to, those which were, could have been or could be the subject of an administrative or judicial proceeding filed by Executive or on her behalf under federal, state or local law, whether by statute, regulation, in contract or tort, and including, but not limited to, for front pay, back pay, wages, bonus, fringe benefit, any form of discrimination, wrongful termination, tort, emotional distress, pain and suffering, breach of contract, fraud, defamation, compensatory or punitive damages, interest, attorney’s fees, reinstatement or reemployment, and any rights or claims under the Civil Rights Act of 1866, the Age Discrimination in Employment Act of 1967, 29 U.S.C. sec. 621, et seq., the Older Workers Benefit Protection Act, the Americans with Disabilities Act, the Family and Medical Leave Act, the Civil Rights Act of 1964, Title VII, the Civil Rights Act of 1991, the Employee Retirement Income Security Act of 1974, the Equal Pay Act, the Worker Adjustment and Retraining Notification Act, the Massachusetts Fair Employment Practices Act (M.G.L. c.151B), the Massachusetts Civil Rights Act, the Massachusetts Equal Pay and Maternity Benefits Law, the Massachusetts Equal Rights for Elderly and Disabled Law, the Massachusetts Small Necessities Leave Act, the Massachusetts Age Discrimination Law, the Massachusetts Wage Payment Statutes (M.G.L. c.149, 148, 150), the Massachusetts Earned Sick Tim Law (MGL Ch. 149, Section 148C) and any other federal, state or local law, in each case, as amended, relating to employment, discrimination in employment, termination of employment, wages, benefits or otherwise. Executive acknowledges and agrees that even though claims and facts in addition to those now known or believed by her to exist may subsequently be discovered, it is Executive’s intention to fully settle and release all claims she may have against the Company and the Released Parties, whether known, unknown or suspected. The Released Parties who are not party to this Release will be third-party beneficiaries of this Section 1.
|
2.
|
Notwithstanding the generality of the foregoing, Executive does not waive her right to (i) have a complaint, charge or related lawsuit filed with the Equal Employment Opportunity Commission (“
EEOC
”) or any similar state or local governmental agency by her or by anyone on her behalf or to participate in an investigation conducted by the EEOC or any similar state or local governmental agency; however, Executive expressly waives her right to recover any personal relief, recovery or monies should Executive or anyone on her behalf pursue any of those complaints, claims or related lawsuits; or (ii) pursue a claim that cannot be waived by law, such as a claim for unemployment benefit rights.
|
3.
|
The Company and Executive acknowledge and agree that the release contained in Section 1 above does not, and will not be construed to, release or limit the scope of any existing obligation of the Company and/or any of its Affiliates (i) if and as applicable, to indemnify Executive for her acts as an officer or director of the Company and/or its Affiliates in accordance with their respective charters or bylaws or under an indemnification agreement to which Executive and the Company or any of its Affiliates are parties or under any applicable Directors and Officers insurance policies or under any applicable law; or (ii) to Executive and her eligible, participating dependents or
|
4.
|
The Executive acknowledges and agrees that before entering into this Release, she has had the opportunity to consult with any attorney or other advisor of her choice, and Executive is hereby advised to consult with an attorney. Executive further acknowledges and agrees that by signing this Release, Executive does so of her own free will and act, that it is her intention to be legally bound by its terms, and that no promises or representations have been made to her by any person to induce her to enter into this Release other than the express terms set forth herein. Executive further acknowledges and agrees that Executive has carefully read this Release, know and understand its contents and its binding legal effect, including the waiver and release of claims set forth in Section 1 above.
|
5.
|
The Executive acknowledges that she has been provided at least 21 days to review the Release. In the event the Executive elects to sign this Release prior to this 21 day period, she agrees that it is a knowing and voluntary waiver of her right to wait the full 21 days. The Executive further understand that she has 7 days after the signing hereof to revoke this Release by so notifying the Company, Lantheus Medical Imaging, Inc., 331 Treble Cove Rd., Bldg. 600-2, N. Billerica, MA 01862, Attention: General Counsel in writing, such notice to be received by the Company within the 7 day period. This Release shall not become effective or enforceable, and no payments or benefits under Sections 8(a), (b) or (c) of the Employment Agreement, as applicable, shall be made or provided, until this seven (7) day revocation period expires without the Executive having revoked this Release.
|
1.
|
At-Will Employment.
Executive's employment with the Company commenced as of January 15, 2008. This agreement was subsequently put in place as of November 22, 2013 (the
"Effective Date")
and supersedes the prior Executive Agreement between the parties dated March 16, 2008. Such employment shall be "at-will" employment. Subject to the terms of this Agreement, the Company may terminate Executive's employment and this Agreement for any reason at any time, with or without prior notice and with or without Cause (as defined herein), but subject to certain terms set forth in Section 8 below. Similarly, subject to the terms of this Agreement, Executive may terminate his employment at any time, subject to Section 8 below.
|
2.
|
Position.
|
(a)
|
Commencing as of the Effective Date, Executive shall serve as the Company's Vice President, General Counsel and Secretary and shall report to the Chief Executive Officer of the Company (the
"CEO")
or such CEO's designee. Executive shall have such duties and responsibilities as are consistent with such title and position and/or such other duties and responsibilities as may be assigned from time to time by the CEO or the Board of Directors of Lantheus MI Holdings, Inc. (the
"Board").
If requested, Executive shall serve as an officer or a member of the Board of Directors of any of the Company's subsidiaries or affiliates without additional compensation.
|
(b)
|
Executive will devote Executive's full business time and best efforts to the performance of Executive's duties hereunder and will not engage in any other business, profession or occupation for compensation or otherwise which would conflict or interfere with the rendition of such services either directly or indirectly, without the prior written consent of the Board;
provided
that nothing herein shall preclude Executive, subject to the prior approval of the Board, from accepting appointment to or continuing to serve on any board of directors or trustees of any business corporation or any charitable organization;
provided
in each case, and in the aggregate, that such activities do not conflict or interfere with the performance of Executive's duties hereunder or conflict with Section 9.
|
3.
|
Base Salary.
During Executive's employment hereunder, the Company shall pay Executive a base salary at the annualized rate of $315,000, payable in regular installments in accordance with the Company's payment practices from time to time. Executive shall be entitled to annual performance and salary review, and any increase in base salary shall be in the sole discretion of the Compensation Committee of the Board. Executive's annual base salary, as in effect from time to time, is hereinafter referred to as the
"Base Salary".
|
4.
|
Annual Bonus
. With respect to each full fiscal year ending during Executive's employment hereunder, Executive shall be eligible to earn an annual bonus award of fourty percent (40%) of Executive's Base Salary (the
"Target")
based upon achievement of annual EBITDA and/or other performance targets established by the Compensation Committee of the Board within the first three months of each fiscal year (the
"Annual Bonus").
The Annual Bonus, if any, shall be paid to Executive at the same time as an annual bonus is paid to other similarly situated executives;
provided,
that Executive is an active employee in good standing with the Company on such date of payment.
|
5.
|
Equity
. Executive shall be Executive shall be eligible to receive future equity awards from time to time pursuant to the Lantheus MI Holdings, Inc. 2013 Equity Incentive Plan, commensurate with Executive's level of responsibilities and
|
6.
|
Employee Benefits
. During Executive's employment hereunder, Executive shall be entitled to participate in the Company's health, life and disability insurance, and retirement and fringe employee benefit plans as in effect from time to time (collectively
"Employee Benefits"),
on the same basis as those benefits are generally made available to other similarly situated executives of the Company.
|
7.
|
Business Expenses
. During Executive's employment hereunder, reasonable business expenses incurred by Executive in the performance of Executive's duties hereunder shall be reimbursed by the Company in accordance with Company policies.
|
8.
|
Termination of Employment
.
|
(a)
|
Termination By the Company Without Cause. If Executive's employment is terminated by the Company without Cause, executive shall receive the following, subject to Section 8(g):
|
(i)
|
an amount equal to Executive's Base Salary on the date of termination, less taxes and withholdings, payable in substantially equal installments over a period of 12 months in accordance with the Company's normal payroll practices, with payments commencing with the Company's first payroll after the sixtieth (60th) day following Executive's termination of employment, and such first payment shall include any such amounts that would otherwise be due prior thereto;
|
(ii)
|
a pro rata portion of the Target Annual Bonus amount that Executive would have been eligible to receive pursuant to Section 4 hereof in such year of termination based upon the percentage of the fiscal year that shall have elapsed through the date of Executive's termination of employment, less taxes and withholdings, payable in substantially equal installments over a period of 12 months in accordance with the Company's normal payroll practices, with payments commencing with the Company's first payroll after the sixtieth (60th) day following Executive's te1mination of employment, and such first payment shall include any such amounts that would be otherwise due prior thereto;
|
(iii)
|
provided that Executive elects to purchase continued healthcare coverage under COBRA, group medical coverage and continued life insurance during the Severance Period for Executive and Executive's eligible dependents upon the same terms as provided to similarly situated executive officers of the Company and at the same coverage levels as in effect for active employees during the Severance Period; provided that such continued life insurance and/or group medical coverage shall cease upon Executive becoming eligible for life insurance and/or medical coverage, as applicable, from a prior employer or Executive becoming employed by another employer and eligible for life insurance and/or medical coverage, as applicable, with such other employer.
|
(iv)
|
a lump sum amount equal to any earned, but unpaid, Annual Cash Bonus, if any, for the year prior to the year of termination, less taxes and withholdings, which shall be payable on the 60th day following Executive's termination of employment;
|
(v)
|
a lump sum amount equal to any earned, but unpaid, Base Salary, if any, through the date of Executive's termination of employment, less taxes and withholdings, which shall be payable with the Company's first payroll after Executive's termination of employment; and
|
(vi)
|
a lump sum amount equal to any unreimbursed business expenses, if any, pursuant to and in accordance with Section 7, incurred through the date of Executive's termination of employment.
|
(b)
|
Termination Without Cause or For Good Reason following a Change of Control. If, within 12 months following the occurrence of a Change of Control (as defined in the Shareholders Agreement) of Holdings, Executive terminates his employment for Good Reason or the Company terminates Executive's employment with the Company without Cause, Executive shall receive the following, subject to Section 8(g):
|
(i)
|
an amount equal to the Executive's Base Salary on the date of termination, less taxes and withholdings, payable in substantially equal installments over a period of 12 months in accordance with the Company's normal payroll practices, with payments .commencing with the Company's first payroll after the sixtieth (60th) day following Executive's termination of employment, and such first payment shall include any such amounts that would otherwise be due prior thereto;
|
(ii)
|
an amount equal to the full Target Bonus for the year of termination, less taxes and withholdings, payable in substantially equal installments over a period of 12 months in accordance with the Company's normal payroll practices, with payments commencing with the Company's first payroll after the sixtieth (60th) day following Executive's termination of employment, and such first payment shall include any such amounts that would otherwise be due prior thereto;
|
(iii)
|
provided that Executive elects to purchase continued healthcare coverage under COBRA, group medical coverage and continued life insurance during the Severance Period for Executive and Executive's eligible dependents upon the same .terms as provided to similarly situated executive officers of the Company and at the same coverage levels as in effect for active employees during the Severance Period; provided that such continued life insurance and/or group medical coverage shall cease upon Executive becoming eligible for life insurance and/or medical coverage, as applicable, from a prior employer or Executive becoming employed by another employer and eligible for life insurance and/or medical coverage, as applicable, with such other employer.
|
(iv)
|
a lump sum amount equal to any earned, but unpaid, Annual Cash Bonus, if any, for the. year prior to the year of termination, less taxes and withholdings, which shall be payable on the 60th day following Executive's termination of employment;
|
(v)
|
a lump sum amount equal to any earned, but unpaid, Base Salary, if any, through the date of Executive's termination of employment, less taxes and withholdings, which shall be payable on the first payroll date after Executive's termination of employment; and
|
(vi)
|
a lump sum amount equal to any unreimbursed business expenses, if any, pursuant to and in accordance with Section 7, incurred through the date of Executive's termination of employment. Executive acknowledges and agrees that, in connection with any Change of Control transaction, except as otherwise provided in a separate agreement, Executive shall not be entitled to receive, and shall not be paid, any transaction, success, sale or similar bonus or payment.
|
(c)
|
Termination Due to Death or Permanent Disability. Executive's employment with the Company shall terminate automatically on Executive's death. In the event of Executive's Permanent Disability, the Company shall be entitled to terminate his employment.
|
(i)
|
a lump sum amount equal to any earned, but unpaid, Annual Cash Bonus, if any, for the year prior to the year of termination, less taxes and withholdings, payable on the sixtieth (60th) day following Executive's termination of employment;
|
(ii)
|
a lump sum amount equal to any earned, but unpaid, Base Salary, if any, through the date of Executive's termination of employment, less taxes and withholdings, which shall be payable on the first payroll date after Executive's termination of employment;
|
(iii)
|
a lump sum amount equal to any unreimbursed business expenses, if any, pursuant to and in accordance with Section 7, incurred through the date of Executive's termination of employment; and
|
(iv)
|
a pro rata portion of any Annual Cash Bonus, to the extent earned based on actual performance by the Company, that Executive would have been eligible to receive hereunder in the year of termination, based on the percentage of the fiscal year that shall have elapsed through the date of Executive's termination of employment, payable at such time as any such Annual Cash Bonuses are paid to active senior executives of the Company.
|
(d)
|
Other Terminations.
Executive shall not be entitled to the post-termination benefits set forth in Section 8(a), Section 8(b) or Section 8(c) above if his employment with the Company ceases for any reason other than his termination by the Company without Cause, his resignation for Good Reason or his termination as a result of his death or Permanent Disability; it being understood that if Executive's employment with the Company ceases or terminates for any other reason, he will not be entitled to any severance or post-termination benefits or payments, whether hereunder or pursuant to any policy of the Company, other than a lump sum amount equal to any earned, but unpaid, Base Salary, if any, through the date of Executive's termination of employment, less taxes and withholdings (payable on the first payroll date after Executive's termination of employment), and a lump sum amount equal to any unreimbursed business expenses, if any, pursuant to and in accordance with Section 3(e), incurred through the date of Executive's termination of employment; provided, that this paragraph shall not alter Executive's rights or obligations he may have or be subject to in connection with or with respect to his equity interests in Holdings, and Executive's indemnification rights shall continue to be governed in accordance with any Directors and Officers Liability Insurance Policy that the Company may maintain and/or with the Company's certificate of incorporation or by-bylaws or similar governing document, and otherwise in accordance with section 7.
|
(e)
|
Cause Definition
. For purposes of this Agreement,
"Cause"
means (i) material failure by Executive to perform Executive's employment duties (other than as a consequence of any illness, accident or disability), (ii) continued, willful failure of Executive to carry out any reasonable lawful direction of the Company, (iii) material failure of Executive to comply with any of the applicable rules of the Company contained in its Employee Handbook or any other Company policy, (iv) fraud, willful malfeasance, gross negligence or recklessness of Executive in the performance of employment duties, (v) willful failure of Executive to comply with any of the material terms of this Agreement, (vi) other serious, willful misconduct of Executive which causes material injury to the Company or its reputation, including, but not limited to, willful or gross misconduct toward any of the Company's other employees, and (vii) conviction of a crime (or a pleading of guilty or nolo contendere), other than one which in the opinion of the Board does not affect Executive's position as an employee of the Company.
|
(f)
|
Good Reason Definition
. For purposes of this Agreement, "Good Reason" shall mean, without the Executive's Consent, (A) the failure of the Company to pay, or cause to be paid, Executive's Base Salary or Bonus, as the case may be, when due, (B) a permanent decrease in the Executive's Base Salary, or a failure by the Company to pay material compensation or provide material benefits due and payable to the Executive under his Employment Agreement, (C) the Company requiring the Executive to be based at any office or location that is more than 50 miles from the Company's current headquarters in Billerica, Massachusetts, or (D) the failure of the Company to cause the transferee or successor to all or substantially all of the assets of the Company to assume by operation of law or contractually the Company's obligations hereunder, and provided further that any of the events described in clauses (A) or (D) of this section shall constitute Good Reason only if the Company fails to cure such event within 30 days after receipt from Executive of written notice of the event which constitutes Good Reason, and provided further, that Good Reason shall cease to exist for an event on the 30th day following the later of its occurrence or Executive's knowledge thereof, unless Executive has given the Company written notice thereof prior to such date; For the avoidance of doubt, (x) a change in Executive's reporting relationships, including but not limited to a change in the number of direct or indirect reports to Executive, shall not constitute a material and adverse reduction in Executive's responsibilities, and (y) commensurate with Executive performing his duties Executive will be expected to work at the Company's headquarters in North Billerica, Massachusetts, as necessitated by business demands or as reasonably requested by the Company.
|
(g)
|
Separation Agreement and General Release
. The payments and benefits set forth in Sections 8(a), 8(b) and 8(c) above shall be expressly conditioned upon Executive's (or his estate or legal representatives, in the case of Section 4(c)) execution and delivery to the Company of a Separation Agreement and General Release in·a form that is acceptable to the Company (the
"Separation Agreement")
and such Separation Agreement becoming irrevocable within sixty (60) days following Executive's termination of employment; provided, that any payments or benefits otherwise due prior to such sixtieth (60th) day shall be paid on such sixtieth (60th)
|
(h)
|
Board/Committee Resignation.
Upon termination of Executive's employment for any reason, Executive agrees to resign, as of the date of such termination and to the extent applicable, from the Board (and any committees thereof) and the Board of Directors (and any committees thereof) of any of the Company's subsidiaries or affiliates.
|
9.
|
Non-Competition
.
|
(a)
|
Executive acknowledges and recognizes the highly competitive nature of the businesses of the Company and its affiliates and accordingly agrees as follows:
|
(i)
|
During Executive's employment with the Company and, for a period of one year following the date Executive ceases to be employed by the Company (the
"Restricted Period"),
Executive will not, whether on Executive's own behalf or on behalf of or in conjunction with any person, firm, partnership, joint venture, association, corporation or other business organization, entity or enterprise whatsoever
("Person"),
directly or indirectly solicit or assist in soliciting in competition with the Company, the business of any client or prospective client:
|
(1)
|
with whom Executive had personal contact or dealings on behalf of the Company during the one-year period preceding Executive's termination of employment;
|
(2)
|
with whom employees reporting to Executive had personal contact or dealings on behalf of the Company during the one year immediately preceding the Executive's termination of employment; or
|
(3)
|
for whom Executive had direct or indirect responsibility during the one year immediately preceding Executive's termination of employment.
|
(ii)
|
During the Restricted Period, Executive will not directly or indirectly:
|
(1)
|
engage in any business that competes with the business or businesses of the Company or any of its affiliates, namely in the testing, development and manufacturing services for the development, manufacture, distribution, marketing or sale of radiopharmaceutical products, contrast imaging agents and/or radioactive generators for the global medical imaging and pharmaceutical industries, and including, without limitation, businesses which the Company or its affiliates have specific plans to conduct in the future and as to which Executive is aware of such planning (a
"Competitive Business");
|
(2)
|
enter the employ of, or render any services to, any Person (or any division or controlled or controlling affiliate of any Person) who or which engages in a Competitive Business;
|
(3)
|
acquire a financial interest in, or otherwise become actively involved with, any Competitive Business, directly or indirectly, as an individual, partner, shareholder, officer, director, principal, agent, trustee or consultant; or
|
(4)
|
interfere with, or attempt to interfere with, business relationships (whether formed before, on or after the date of this Agreement) between the Company or any of its affiliates and customers, clients, suppliers, partners, members or investors of the Company or its affiliates.
|
(iii)
|
Notwithstanding anything to the contrary in this Agreement, Executive may, directly or indirectly, own, solely as an investment, securities of any Person engaged in the business of the Company or its affiliates which are publicly traded on a national or regional stock exchange or on the over-the-counter market if Executive (i) is not a controlling person of, or a member of a group which
|
(iv)
|
During the Restricted Period, Executive will not, whether on Executive’s own behalf or on behalf of or in conjunction with any Person, directly or indirectly:
|
(1)
|
solicit or encourage any employee or consultant of the Company or its affiliates to leave the employment of, or cease providing services to, the Company or its affiliates; or
|
(2)
|
hire any such employee or consultant who was employed by or providing services to the Company or its affiliates as of the date of Executive's termination of employment with the Company or who left the employment of or ceased providing services to the Company or its affiliates coincident with, or within ·one year prior to or after, the termination of Executive's employment with the Company.
|
(3)
|
It is expressly understood and agreed that although Executive and the Company consider the restrictions contained in this Section 9 to be reasonable, if a final judicial determination is made by a court of competent jurisdiction that the time or territory or any other restriction contained in this Agreement is an unenforceable restriction against Executive, the provisions of this Agreement shall not be rendered void but shall be deemed amended to apply as to such maximum time and territory and to such maximum extent as such court may judicially determine or indicate to be enforceable. Alternatively, if any court of competent jurisdiction finds that any restriction contained in this Agreement is unenforceable, and such restriction cannot be amended so .as to make it enforceable, such finding shall not affect the enforceability of any of the other restrictions contained herein.
|
(b)
|
The provisions of this Section 9 shall survive the termination of this Agreement and Executive’s employment for any reason.
|
10.
|
Non-Disparagement.
The Executive shall not at any time (whether during or after Executive’s employment with the Company) make, or cause to be made, any statement or communicate any information (whether oral or written) that disparages or reflects negatively on the Company or any of its affiliates, except for truthful statements that may be made pursuant to legal process, including without limitation in litigation, arbitration or similar dispute resolution proceedings. This Section 10 shall survive the termination of this Agreement and Executive’s employment for any reason.
|
11.
|
Confidentiality; Intellectual Property
.
|
(a)
|
Confidentiality
.
|
(i)
|
Executive will not at any time (whether during or after Executive’s employment with the Company) (x) retain or use for the benefit, purposes or account of Executive or any other Person; or (y) disclose, divulge, reveal, communicate, share, transfer or provide access to any Person outside the Company (other than its professional advisers who are bound by confidentiality obligations), any non-public, proprietary or confidential information - including, without limitation, trade secrets, know-how, research and development, software, databases, inventions, processes, formulae, technology, designs and other intellectual property, information concerning finances, investments, profits, pricing, costs, products, services, vendors, customers, clients, partners, investors, personnel, compensation, recruiting, training, advertising, sales, marketing, promotions, government and regulatory activities and approvals - concerning the past, current or future business, activities and operations of the Company, its subsidiaries or affiliates and/or any third party that has disclosed or provided any of same to the Company on a confidential basis
(“Confidential Information”)
without the prior written authorization of the Board.
|
(ii)
|
Confidential Information shall not include any information that is (A) generally known to the industry or the public other than as a result of Executive’s breach of this covenant or any breach of other confidentiality obligations by third parties; (B) made legitimately available to Executive by a third party without breach of any confidentiality obligation; or (C) required by law to be disclosed; provided that Executive shall give prompt written notice to the Company of such requirement,
|
(iii)
|
Except as required by law, Executive will not disclose to anyone, other than Executive’s immediate family and legal or financial advisors, the existence or contents of this Agreement; provided that Executive may disclose to any prospective future employer the provisions of Sections 9, 10 and 11 of this Agreement provided they agree to maintain the confidentiality of such terms.
|
(iv)
|
Upon termination of Executive’s employment with the Company for any reason, Executive shall (x) cease and not thereafter commence use of any Confidential Information or intellectual property (including without limitation, any patent, invention, copyright, trade secret, trademark, trade name, logo, domain name or other source indicator) owned or used by the Company, its subsidiaries or affiliates; (y) immediately return to the Company all Company property and destroy, delete, or return to the Company, at the Company’s option, all originals and copies in any form or medium (including memoranda, books, papers, plans, computer files, letters and other data) in Executive’s possession or control (including any of the foregoing stored or located in Executive’s office, home, laptop or other computer, whether or not Company property) that contain Confidential Information or otherwise relate to the business of the Company, its affiliates and subsidiaries, except that Executive may retain only those portions of any personal notes, notebooks and diaries that do not contain any Confidential Information; and (z) notify and fully cooperate with the Company regarding the delivery or destruction of any other Confidential Information of which Executive is or becomes aware and promptly return any other Company property in Executive’s possession.
|
(a)
|
Intellectual Property.
|
(i)
|
If Executive has created, invented, designed, developed, contributed to or improved any works of authorship, inventions, intellectual property, materials, documents or other work product (including without limitation, research, reports, software, databases, systems, applications, presentations, textual works, content, or audiovisual materials) (“
Works
”), either alone or with third parties, prior to Executive’s employment by the Company, that are relevant to or implicated by such employment (“
Prior Works
”), Executive hereby grants the Company a perpetual, nonexclusive, royalty-free, worldwide, assignable, sublicensable license under all rights and intellectual property rights (including rights under patent, industrial property, copyright, trademark, trade secret, unfair competition and related laws) therein for all purposes in connection with the Company’s current and future business. A list of all such material Works as of the date hereof is attached hereto as
Exhibit B
.
|
(ii)
|
If Executive creates, invents, designs, develops, contributes to or improves any Works, either alone or with third parties, at any time during Executive’s employment by the Company and within the scope of such employment and/or with the use of any Company resources (“
Company Works
”), Executive shall promptly and fully disclose such works to the Company and hereby irrevocably assigns, transfers and conveys, to the maximum extent permitted by applicable law, all rights and intellectual property rights therein (including rights under patent, industrial property, copyright, trademark, trade secret, unfair competition and related laws) to the Company to the extent ownership of any such rights does not vest originally in the Company.
|
(iii)
|
Executive agrees to keep and maintain adequate and current written records (in the form of notes, sketches, drawings, and any other form or media requested by the Company) of all Company Works. The records will be available to and remain the sole property and intellectual property of the Company at all times.
|
(iv)
|
Executive shall take all requested actions and execute all requested documents (including any licenses or assignments required by a government contract) at the Company’s expense (but without further remuneration) to assist the Company in validating, maintaining, protecting, enforcing, perfecting, recording, patenting or registering any of the Company’s rights in the Prior Works and Company Works. If the Company is unable for any other reason to secure Executive’s signature on any document for this purpose, then Executive hereby irrevocably designates and appoints the Company and its duly authorized officers and agents as Executive’s agent and attorney-in-fact, to act
|
(v)
|
Executive shall not improperly use for the benefit of, bring to any premises of, divulge, disclose, communicate, reveal, transfer or provide access to, or share with the Company any confidential, proprietary or non-public information or intellectual property relating to a former employer or other third party without the prior written permission of such third party. Executive hereby indemnifies, holds harmless and agrees to defend the Company and its officers, directors, partners, employees, agents and representatives from any breach of the foregoing covenant. Executive shall comply with all relevant policies and guidelines of the Company, including regarding the protection of confidential information and intellectual property and potential conflicts of interest. Executive acknowledges that the Company may amend any such policies and guidelines from time to time, and that Executive remains at all times bound by their most current version.
|
(b)
|
The provisions of this Section 11 shall survive the termination of this Agreement and Executive’s employment for any reason.
|
12.
|
Specific Performance
. ·Executive acknowledges and agrees that the Company’s remedies at law for a breach or threatened breach of any of the provisions of Section 9, Section 10 or Section 11 would be inadequate and the Company would suffer irreparable damages as a result of such breach or threatened breach. In recognition of this fact, Executive agrees that, in the event of such a breach or threatened breach, in addition to any remedies at law, the Company, without posting any bond, shall be entitled to cease making any payments or providing any benefit otherwise required by this Agreement and obtain equitable relief in the form of specific performance, temporary restraining order, temporary or permanent injunction or any other equitable remedy which may then be available.
|
13.
|
Miscellaneous.
|
(a)
|
Governing Law.
This Agreement shall be governed by, construed and interpreted in all respects, in accordance with the laws of the State of New York, without regard to conflicts of laws principles thereof.
|
(b)
|
Entire Agreement/Amendments
. This Agreement contains the entire understanding of the parties with respect to the employment of Executive by the Company and supersedes all prior agreements, understandings, discussions, negotiations and undertakings, whether written or oral between the Executive and the Company or any of its affiliates with respect to the Executive’s employment. There are no restrictions, agreements, promises, warranties, covenants or undertakings between the parties with respect to the subject matter herein other than those expressly set forth herein. This Agreement may not be altered, modified, or amended except by written instrument signed by the parties hereto.
|
(c)
|
No Waiver
. The failure of a party to insist upon strict adherence to any term of this Agreement on any occasion shall not be considered a waiver of such party’s rights or deprive such party of the right thereafter to insist upon strict adherence to that term or any other term of this Agreement.
|
(d)
|
Severability.
In the event that any one or more of the provisions of this Agreement shall be or become invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions of this Agreement shall not be affected thereby.
|
(e)
|
Assignment.
This Agreement, and all of Executive’s rights and duties hereunder, shall not be assignable or delegable by Executive. Any purported assignment or delegation by Executive in violation of the foregoing shall be null and void
ab initio
and of no force and effect. This Agreement may be assigned by the Company to a person or entity which is an affiliate or a successor in interest to substantially all of the business operations of the Company. Upon such assignment, the rights and obligations of the Company hereunder shall become the rights and obligations of such affiliate or successor person or entity.
|
(f)
|
Set Off.
The Company’s obligation to pay Executive the amounts provided and to make the arrangements provided hereunder shall be subject to set-off, counterclaim or recoupment of amounts owed by Executive to the Company or its affiliates.
|
(g)
|
Dispute Resolution.
Except with respect to Sections 9, 10, 11 and 12 hereof, any controversy or claim arising out of or related to any provision of this Agreement that cannot be mutually resolved by the parties hereto
|
(h)
|
Compliance with Section 409A of the Code.
The parties acknowledge and agree that the interpretation of Section 409 A of the Code and its application to the terms of this Agreement is uncertain and may be subject to change as additional guidance and interpretations become available. Anything to the contrary herein notwithstanding, all benefits or payments provided by the Company to the Executive that would be deemed to constitute "nonqualified deferred compensation" within the meaning of Section 409A of the Code are intended to comply with Section 409A of the Code. If, however, any such benefit or payment is deemed to not comply with Section 409A of the Code, the Company and the Executive agree to renegotiate in good faith any such benefit or payment (including, without limitation, as to the timing of any severance payments payable hereunder), if possible, so that either (i) Section 409A of the Code will not apply or (ii) compliance with Section 409A of the Code will be achieved. The Company shall consult with Executive in good faith regarding the implementation of the provisions of this Section 13(h);
provided
that neither the Company nor any of its employees or representatives shall have any liability to Executive with respect to thereto.
|
(i)
|
Successors; Binding Agreement.
This Agreement shall inure to the benefit of and be binding upon personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees of the parties hereto.
|
(a)
|
Notice
. For the purpose of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be deemed to have been duly given when delivered by hand or overnight courier or three days after it has been mailed by United States registered mail, return receipt requested, postage prepaid, addressed to the respective addresses set forth below in this Agreement, or to such other address as either party may have furnished to the other in writing in accordance herewith, except that notice of change of address shall be effective only upon receipt,
|
(j)
|
Executive Representation
. Executive hereby represents to the Company that (i) Executive has been provided with sufficient opportunity to review this Agreement and has been advised by the Company to conduct such review with an attorney of his choice, and (ii) the execution and delivery of this Agreement by Executive and the Company and the performance by Executive of Executive’s duties hereunder shall not constitute a breach of, or otherwise contravene, the terms of any employment agreement or other agreement or policy to which Executive is a party or otherwise bound.
|
(k)
|
Cooperation.
Executive shall provide Executive’s reasonable cooperation in connection with any action or proceeding (or any appeal from any action or proceeding) which relates to events occurring during Executive’s employment hereunder. This provision shall survive any termination of this Agreement or Executive’s employment.
|
(l)
|
Withholding Taxes
. The Company may withhold from any amounts payable under this Agreement such Federal, state and local taxes as may be required to be withheld pursuant to any applicable law or regulation.
|
(m)
|
Counterparts.
This Agreement may be signed in counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument.
|
/s/ Jeffrey Bailey
|
/s/ Michael P. Duffy
|
By: Jeffrey Bailey
|
Michael Duffy
|
1.
|
Executive agrees to and does waive any claims he may have for employment by the Company and agrees not to seek such employment or reemployment by the Company in the future. The Executive, on his own behalf and on behalf of his heirs, estate and beneficiaries, further does hereby release the Company, and in such capacities, any of its subsidiaries or affiliates, and each of their respective past, present and future. officers, directors, agents, employees, shareholders, investors, employee benefit plans and their administrators or fiduciaries, insurers of any such entities, and its and their successors and assigns and others related to such entities from any and all claims made, to be made, or which might have been made of whatever nature, whether known or unknown; from the .beginning of time, .including those that arose as a consequence of his employment with the Company, or arising_ out of the separation from the Company, the severance of such employment relationship, or any act committed or omitted during or after the existence of such employment relationship, all up through and including the date on which this Release is executed, including, but not limited to, those which were, could have been or could be the subject of an administrative or judicial proceeding filed by the Executive or on his behalf under federal, state or local law, .whether by statute, regulation, in contract or tort, and including, but not limited to, every claim for front pay, back pay, wages, bonus, fringe benefit, any form of discrimination, wrongful termination, tort, emotional distress, pain and suffering, breach of contract, fraud, defamation, compensatory or punitive damages, interest, attorney's fees, reinstatement or reemployment, and any rights or claims under the Civil Rights Act of 1866, the Age Discrimination in Employment Act of 1967, as amended, 29 U.S.C. sec. 621, et seq., the Americans with Disabilities Act, the Family and Medical Leave Act, the Civil Rights Act of 1964, Title VII, as amended, the Civil Rights Act of 1991, the Employee Retirement Income Security Act of 1974, as amended, the Equal Pay Act, the· Worker Adjustment and Retraining Notification Act, the New York State Human Rights Law, the New York City Human Rights Law, the Massachusetts Civil Rights Act, the Massachusetts Equal Pay and Maternity Benefits Law, the Massachusetts Equal Rights for Elderly and Disabled Law, the Massachusetts Small Necessities Leave Act, the Massachusetts Age Discrimination Law, or any other federal, state or local law relating to employment, discrimination in employment, termination of employment, wages, benefits or otherwise. The Executive acknowledges and agrees that even though claims and facts in addition to those now known or believed by him to exist may subsequently be discovered, it is his intention to fully settle and release all claims he may have against the Company and the persons and entities described above, whether known, unknown or suspected. Employee does not waive his right to have a charge filed with the Equal Employment Opportunity Commission
("EEOC")
or any state civil rights agency or to participate in an investigation conducted by the EEOC or any state civil rights agency; however, Employee expressly waives his right to recover any monetary relief should any administrative agency, including but not limited to the EEOC, pursue any claim on Employee's behalf.
|
2.
|
The Company and the Executive acknowledge and agree that the release contained in Paragraph 1 does not, and shall not be construed to, release or limit the scope of any existing obligation of the Company and/or any of its subsidiaries or affiliates (i) to indemnify the Executive for his acts as an officer or director of the Company and/or its subsidiaries or affiliates in accordance with their respective charters or bylaws or under an indemnification agreement to which the Executive arid the Company or any of its subsidiaries are parties or under any applicable Directors and Officers insurance policies or under any applicable law or (ii) to the Executive and his eligible, pa1iicipating dependents or beneficiaries under any existing group welfare (excluding severance), equity, or retirement plan of the Company in which the Executive and/or such dependents are participants.
|
3.
|
The Executive acknowledges that before entering into this Release, he has had the opportunity to consult with any attorney or other advisor of the Executive's choice, and the Executive is hereby advised to consult with an attorney. The Executive further acknowledges that by signing this Release, he does so of his own free will and act, that it is his intention to be legally bound by its terms, and that no promises or representations have been made to the Executive by any person to induce the Executive to enter into this Release other than the express terms set forth herein. The Executive further acknowledges that he has carefully read this Release, knows and understands its contents and its binding legal effect, including the waiver and release of claims set forth in Paragraph 1 above.
|
4.
|
The Executive acknowledges that he has been provided at least 21 days to review the Release. In the event the Executive elects to sign this Release prior to this 21 day period, he agrees that it is a knowing and voluntary waiver of his right to wait the full 21 days. The Executive further understand that he has 7 days after the signing hereof to revoke this Release by so notifying the Company, Lantheus Medical Imaging, Inc., 331 Treble Cove Rd., Bldg. 600-2, N. Billerica, MA 01862, Attention: Michael Duffy in writing, such notice to be received by the Company within the 7 day period. This Release shall not become effective or enforceable, and no payments or benefits under Sections 8(c)(ii)(B),(C) and (D) of the Employment Agreement, as applicable, shall be made or provided, until this seven (7) day revocation period expires without the Executive having revoked this Release.
|
1.
|
Severance Payments.
|
(a)
|
Non-Change in Control Severance.
If your employment with the Company is terminated in a Qualifying Termination other than on or within twelve (12) months following a Change in Control, then, subject to terms and conditions of this Agreement, the Company will:
|
i.
|
pay you an amount equal to the sum of (A) one times (1x) your annual base salary and (B) a pro rata portion of your target annual bonus (prorated based on the percentage of the fiscal year that shall have elapsed through the Separation Date), in each case, as in effect on the Separation Date (or, if a reduction in your annual base salary gave rise to Good Reason under this Agreement, as in effect immediately prior to such reduction) (the “
Severance Payment
”); and
|
ii.
|
provided that you timely and properly elect to purchase continued healthcare coverage under COBRA, pay you a monthly amount equal to the employer portion of the monthly premiums paid under the Company’s group health plans as of the Separation Date, for the period ending on the earliest of (i) the one-year anniversary of the Separation Date, (ii) the date on which you become covered under another employer’s health plan and (iii) the expiration of the maximum COBRA continuation coverage period for which you are eligible under federal law. For the avoidance of doubt, you will be responsible for paying the applicable COBRA premiums directly to the Company’s COBRA administrator (the “
COBRA Payment
”).
|
(b)
|
Change in Control Severance.
If your employment with the Company is terminated in a Qualifying Termination on or within twelve (12) months following a Change in Control, then, in lieu of the payments described in Section 1(a) above and subject to terms and conditions of this Agreement, the Company will provide you with the following benefits:
|
i.
|
pay you an amount equal to two times (2x) the sum of your annual base salary and target annual bonus, in each case, as in effect on the Separation Date (or, if a reduction in your annual base salary gave rise to Good Reason under this Agreement, as in effect immediately prior to such reduction);
|
ii.
|
pay you an aggregate amount equal to the employer portion of the monthly premiums paid under the Company’s group health plans as of the Separation Date multiplied by twenty four (24) (the sum of (i) and (ii), “
Change in Control Severance Payment
”); and
|
iii.
|
any stock options or other equity-based award that you hold on the Separation Date, to the extent then-unvested, shall vest in full, with performance-based awards vesting at target, and, in the case of stock options, shall remain exercisable as provided in the equity plan or award agreement under which they were granted.
|
(c)
|
Death or Permanent Disability Severance
. If your employment with the Company is terminated due to your death or by the Company due to your Permanent Disability, then, in lieu of the payments described in Sections 1(a) or 1(b) above and subject to terms and conditions of this Agreement, the Company will provide you with the following benefits:
|
i.
|
a pro rata portion of your target annual bonus for the year of termination, based on the percentage of the fiscal year that shall have elapsed through the Separation Date, payable in a lump sum on the Company’s first regular payroll date following the date that the Separation Agreement becomes fully effective and irrevocable (and will include all amounts that would have been paid on the regular payroll dates of the Company following the Separation Date prior to such date) (the “
Death/Disability Payment
”).
|
(d)
|
Certain Definitions.
For purposes of this Agreement, the following terms shall have the following meanings:
|
i.
|
“
Beneficial Owner
” shall have the meaning ascribed to such term in Rule 13d-3 under the Securities Exchange Act of 1934, as amended.
|
ii.
|
“
Cause
” means any of the following: (i) your material failure to perform your employment duties (other than as a consequence of any illness, accident or disability); (ii) your continued, willful failure to carry out any reasonable lawful direction of the Company; (iii) your material failure to comply with any of the applicable rules of the Company contained in its Employee Handbook or any other Company policy; (iv) your fraud, willful malfeasance, gross negligence or recklessness in the performance of your employment duties; (v) your willful failure to comply with any of the material terms of any agreement between you and the Company; (vi) your other serious willful misconduct which causes material injury to the Company or its reputation, including, but not limited to, willful or gross misconduct toward any of the Company’s other employees, or (vii) your conviction of a crime (or a pleading of guilt or nolo contendere), other than one which in the opinion of the board of directors of the Company does not affect your position as an employee of the Company.
|
iii.
|
“Change in Control”
means any of the following:
|
a.
|
Any Person becomes the Beneficial Owner, directly or indirectly, of more than fifty percent (50%) of the combined voting power, excluding any Person who is the Beneficial Owner of fifty percent (50%) or more of the voting power on the date this Agreement is accepted and agreed to by you, of the then outstanding voting securities of the Company entitled to vote generally in the election of its directors (the “
Outstanding Company Voting Securities
”), including by way of merger, consolidation or otherwise;
provided
,
however
, that for
|
b.
|
Consummation of a reorganization, merger, or consolidation to which the Company is a party or a sale or other disposition of all or substantially all of the assets of the Company or the line of business to which your employment principally relates (a “
Business Combination
”), unless, following such Business Combination: (i) any Persons who were the Beneficial Owners of Outstanding Company Voting Securities immediately prior to such Business Combination are the Beneficial Owners, directly or indirectly, of more than fifty percent (50%) of the combined voting power of the outstanding voting securities entitled to vote generally in the election of directors (or election of members of a comparable governing body) of the entity resulting from the Business Combination (including, without limitation, an entity which, as a result of such transaction, owns all or substantially all of the Company or all or substantially all of the Company’s assets, either directly or through one or more subsidiaries) (the “
Successor Entity
”) in substantially the same proportions as their ownership immediately prior to such Business Combination; or (ii) no Person (excluding any Successor Entity or any employee benefit plan or related trust of the Company, any of its Subsidiaries, such Successor Entity or any of its subsidiaries) is the Beneficial Owner, directly or indirectly, of more than fifty percent (50%) of the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors (or comparable governing body) of the Successor Entity, except to the extent that such ownership of the Company existed prior to the Business Combination.
|
c.
|
Approval by the shareholders of the Company of a complete liquidation or dissolution of the Company.
|
iv.
|
“
Good Reason
” means, without your consent: (i) a material decrease in your base salary or failure to pay salary when due; (ii) a material diminution in your duties or responsibilities (provided however, that a mere change in your title or reporting relationship alone shall not constitute “Good Reason”); (iii) the failure of the Company to cause the transferee or successor to all or substantially all of the assets of the Company or line of business to which your employment principally relates to assume by operation of law or contractually the Company’s obligations hereunder; or (iv) the relocation of your principal work location to a location more than fifty (50) miles from its current location; provided, in each case, that (A) you provide written notice to the Company, setting forth in reasonable detail the event giving rise to Good Reason within thirty (30) days following the initial occurrence of such event, (B) such event is not cured by the Company within thirty (30) days following its receipt of such written notice, and (C) you actually terminate your employment not later than thirty (30) days following the expiration of such cure period.
|
v.
|
“
Permanent Disability
” means your inability, because of mental or physical illness or incapacity, whether total or partial, to perform one or more of the material functions of your position with or without reasonable accommodation, for a period of: (i) ninety (90) consecutive calendar days or (ii) an aggregate of one hundred and twenty (120) days out of any consecutive twelve (12)-month period, and which entitles you to receive benefits under a disability plan provided by the Company.
|
vi.
|
“
Person
” means an individual, entity, or organization, including a government or political subdivision, department, or agency of a government.
|
vii.
|
“
Qualifying Termination
” means a termination of your employment by the Company without Cause or your resignation from the Company for Good Reason. “Qualifying Termination” does not include a termination of your employment due to your death or Permanent Disability.
|
viii.
|
“
Separation Date
” means the date your employment with the Company terminates.
|
ix.
|
“
Subsidiary
” means an entity (whether or not a corporation) that is wholly or majority owned or controlled, directly or indirectly, by the Company or any other affiliate of the Company that is so designated, from time to time, by the Company, during the period of such affiliated status.
|
2.
|
Conditions to Payment
. Any obligation of the Company to pay you the Cash Severance Payment, the COBRA Payment, the Change in Control Severance Payment or the Death/Disability Payment is conditioned upon (i) your continued compliance with all confidentiality, non-solicitation, no-hire, non-disparagement, invention assignment, cooperation and other similar obligations to, and other restrictive covenants in favor of, the Company or any of its subsidiaries or affiliates to which you are currently obligated, including, without limitation, those restrictive covenants included in the Employment Agreement, which shall remain in full force and effect in accordance with their terms (the “
Restrictive Covenants
”), and (ii) your (or your estate’s or legal representative’s, in the event of your death or Permanent Disability) execution and delivery to the Company of a separation agreement that includes a non-competition covenant that applies for one year following your termination of employment and general release and waiver in favor of the Company in a form reasonably acceptable to the Company (a “
Separation Agreement
”) and such Separation Agreement becoming fully effective and irrevocable by the date specified therein, but in no event more than sixty (60) days following the Separation Date.
|
3.
|
No Other Severance Benefits
. The payments provided by this Agreement are in lieu of any severance or similar payments or benefits that you may otherwise be entitled to upon termination of employment with the Company or any of its subsidiaries or affiliates, including, without limitation, under any severance policy of the Company or any of its subsidiaries or affiliates.
|
4.
|
Withholding
. The Company may withhold from all amounts payable under this Agreement any taxes or other amounts required by law to be withheld with respect to such payments, as determined by the Company in its sole discretion.
|
5.
|
Scope of Agreement
. Nothing in this Agreement will be deemed to entitle you to continued employment with the Company or any of its subsidiaries or affiliates, limit the Company’s right to terminate your employment at any time for any reason or alter the at-will nature of your employment with the Company.
|
6.
|
Section 409A
. All amounts payable under this Agreement are intended to be exempt from, or comply with, the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (the “
Code
”), and the regulations thereunder (collectively, “
Section 409A
”). To the extent required to comply with or be exempt from Section 409A, you will not be considered to have terminated employment with the Company for purposes of this Agreement, and no payment will be due to you under this Agreement, until you have incurred a “separation from service” from the Company within the meaning of Section 409A (after giving effect to the presumptions set forth therein). If you are determined to be a “specified employee” at the time of your separation from service then, to the extent necessary to prevent any accelerated or additional tax under Section 409A, payment of the amounts payable under this Agreement will be delayed until the earlier of (i) the date that is six months and one day following your separation from service or (ii) your death. Each amount paid to you pursuant to this Agreement shall be treated as a separate payment for purposes of Section 409A and the right to a series of installment payments under this Agreement shall be treated as the right to a series of separate payments. To the extent required to comply with Section 409A, if the period available to execute (and not revoke) the Separation Agreement spans two calendar years, the Cash Severance Payment, the COBRA Payment, the Change in Control Severance Payment or the Death/Disability Payment will be paid in the second calendar year. To the extent required to comply with Section 409A, a Change in Control will not be deemed to occur for purposes of this Agreement unless it is a “change in control event” as defined in Section 1.409A-3(i)(5)(i) of the Treasury Regulations, and if it is not a “change in control event,” payment of the severance described in Section 1(b) of this Agreement shall instead be paid as provided under Section 1(a) of this Agreement (unless the severance, or portion thereof, could be paid earlier without resulting in adverse tax consequences under Section 409A). Any reimbursement payable under this Agreement that is subject to Section 409A is subject to the following additional rules: (A) the amount of expenses eligible for reimbursement during any taxable year shall not affect the amount of expenses eligible for reimbursement in any other taxable year; (B) reimbursement of the expense shall be made, if at all, promptly, but not later than the end of the calendar year following the calendar year in which the expense was incurred, and (C) the right to reimbursement shall not be subject to liquidation or exchange for any other benefit. Notwithstanding the foregoing or anything to the contrary in this Agreement, neither the Company nor any other person will be liable to you by reason of any acceleration of income, or any additional tax (including any interest and penalties), asserted with respect to any of the payments under this Agreement, including by reason of the failure of this Agreement to satisfy the applicable requirements of Section 409A in form or in operation.
|
7.
|
Section 280G
. If all, or any portion, of the payments or benefits provided under this Agreement, either alone or together with any other payment or benefit that you receive or are entitled to receive from the Company or any of its subsidiaries or affiliates, would constitute an “excess parachute payment” within the meaning of Section 280G of the Code, then, notwithstanding anything in this Agreement or any other agreement or plan to the contrary, you will be entitled to receive: (A) the amount of such payments or benefits, reduced such that no portion thereof shall fail to be tax deductible under Section 280G of the Code (the “
Limited Amount
”), or (B) if the amounts otherwise payable hereunder and under any other agreements and plans of the Company and its subsidiaries and affiliates (without regard to clause (A)), reduced by all taxes applicable thereto (including, for the avoidance of doubt, the excise tax imposed by Section 4999 of the Code) would be greater than the Limited Amount reduced by all taxes applicable thereto, the amounts otherwise payable hereunder and thereunder. All determinations under this Section 7 will be made by an accounting, consulting, or valuation firm selected, and paid for, by the Company.
|
8.
|
Assignment
. Neither the Company nor you may assign any rights or obligations under this Agreement, by operation of law or otherwise, without the prior written consent of the other, except that the Company may assign its rights and obligations under this Agreement without your consent in the event that you are transferred to a position with any of the Company’s subsidiaries or affiliates, and the Company will assign its rights and obligations under this Agreement in the event of a reorganization, consolidation, or merger involving the Company or any of its subsidiaries or affiliates in which the Company is not the surviving entity, or a transfer of all or substantially all of the Company’s assets or line of business to which your employment principally relates. This Agreement shall inure to the benefit of and be binding upon you and the Company and your and its respective successors, executors, administrators, heirs and permitted assigns.
|
9.
|
Governing Law; Validity
. The laws of the Commonwealth of Massachusetts will govern all questions concerning the relative rights of you and the Company and all other questions concerning the construction, validity and interpretation of this Agreement, without giving effect to any choice of law or conflict of law provision or rule that would cause the application of the laws of any jurisdiction. The invalidity or unenforceability of any provision of this Agreement will not affect the validity or enforceability of any other provisions of this Agreement, which other provisions will remain in full force and effect.
|
10.
|
Notice
. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be deemed to have been duly given when delivered by hand or overnight courier or three days after it has been mailed by United States registered mail, return receipt requested, postage prepaid, addressed to the respective addresses set forth below in this Agreement, or to such other address as either party may have furnished to the other in writing in accordance herewith, except that notice of change of address shall be effective only upon receipt.
|
11.
|
Miscellaneous
. This letter agreement (and those Restrictive Covenants, which shall remain in full force and effect in accordance with their terms) is the entire agreement between you and the Company, and replaces all prior and contemporaneous communications, agreements, and understandings, whether written or oral, with respect to the subject matter described herein. No modification or amendment of this Agreement will be valid unless such modification or amendment is agreed to in writing and signed by you and by a duly authorized officer of the Company.
|
12.
|
Counterparts
. This Agreement may be executed in two or more counterparts, each of which will be an original and all of which together will constitute the same instrument.
|
|
|
LANTHEUS MEDICAL IMAGING, INC.
|
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By:
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Name: [Name]
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Title: [Title]
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1.
|
Severance Payments.
|
(a)
|
Non-Change in Control Severance.
If your employment with the Company is terminated in a Qualifying Termination other than on or within twelve (12) months following a Change in Control, then, subject to terms and conditions of this Agreement, the Company will:
|
i.
|
pay you an amount equal to the sum of (A) one times (1x) your annual base salary and (B) a pro rata portion of your target annual bonus (prorated based on the percentage of the fiscal year that shall have elapsed through the Separation Date), in each case, as in effect on the Separation Date (or, if a reduction in your annual base salary gave rise to Good Reason under this Agreement, as in effect immediately prior to such reduction) (the “
Severance Payment
”); and
|
ii.
|
provided that you timely and properly elect to purchase continued healthcare coverage under COBRA, pay you a monthly amount equal to the employer portion of the monthly premiums paid under the Company’s group health plans as of the Separation Date, for the period ending on the earliest of (i) the one-year anniversary of the Separation Date, (ii) the date on which you become covered under another employer’s health plan and (iii) the expiration of the maximum COBRA continuation coverage period for which you are eligible under federal law. For the avoidance of doubt, you will be responsible for paying the applicable COBRA premiums directly to the Company’s COBRA administrator (the “
COBRA Payment
”).
|
(b)
|
Change in Control Severance.
If your employment with the Company is terminated in a Qualifying Termination on or within twelve (12) months following a Change in Control, then, in lieu of the payments described in Section 1(a) above and subject to terms and conditions of this Agreement, the Company will provide you with the following benefits:
|
i.
|
pay you an amount equal to two times (2x) the sum of your annual base salary and target annual bonus, in each case, as in effect on the Separation Date (or, if a reduction in your annual base salary gave rise to Good Reason under this Agreement, as in effect immediately prior to such reduction);
|
ii.
|
pay you an aggregate amount equal to the employer portion of the monthly premiums paid under the Company’s group health plans as of the Separation Date multiplied by twenty four (24) (the sum of (i) and (ii), “
Change in Control Severance Payment
”); and
|
iii.
|
any stock options or other equity-based award that you hold on the Separation Date, to the extent then-unvested, shall vest in full, with performance-based awards vesting at target, and, in the case of stock options, shall remain exercisable as provided in the equity plan or award agreement under which they were granted.
|
(c)
|
Death or Permanent Disability Severance
. If your employment with the Company is terminated due to your death or by the Company due to your Permanent Disability, then, in lieu of the payments described in Sections 1(a) or 1(b) above and subject to terms and conditions of this Agreement, the Company will provide you with the following benefits:
|
i.
|
a pro rata portion of your target annual bonus for the year of termination, based on the percentage of the fiscal year that shall have elapsed through the Separation Date, payable in a lump sum on the Company’s first regular payroll date following the date that the Separation Agreement becomes fully effective and irrevocable (and will include all amounts that would have been paid on the regular payroll dates of the Company following the Separation Date prior to such date) (the “
Death/Disability Payment
”).
|
(d)
|
Certain Definitions.
For purposes of this Agreement, the following terms shall have the following meanings:
|
i.
|
“
Beneficial Owner
” shall have the meaning ascribed to such term in Rule 13d-3 under the Securities Exchange Act of 1934, as amended.
|
ii.
|
“
Cause
” means any of the following: (i) your material failure to perform your employment duties (other than as a consequence of any illness, accident or disability); (ii) your continued, willful failure to carry out any reasonable lawful direction of the Company; (iii) your material failure to comply with any of the applicable rules of the Company contained in its Employee Handbook or any other Company policy; (iv) your fraud, willful malfeasance, gross negligence or recklessness in the performance of your employment duties; (v) your willful failure to comply with any of the material terms of any agreement between you and the Company; (vi) your other serious willful misconduct which causes material injury to the Company or its reputation, including, but not limited to, willful or gross misconduct toward any of the Company’s other employees, or (vii) your conviction of a crime (or a pleading of guilt or nolo contendere), other than one which in the opinion of the board of directors of the Company does not affect your position as an employee of the Company.
|
iii.
|
“Change in Control”
means any of the following:
|
a.
|
Any Person becomes the Beneficial Owner, directly or indirectly, of more than fifty percent (50%) of the combined voting power, excluding any Person who is the Beneficial Owner of fifty percent (50%) or more of the voting power on the date this Agreement is accepted and agreed to by you, of the then outstanding voting securities of the Company entitled to vote generally in the election of its directors (the “
Outstanding Company Voting Securities
”), including by way of merger, consolidation or otherwise;
provided
,
however
, that for purposes of this definition, the following acquisitions shall not constitute a Change in Control: (i) any acquisition of Outstanding Company Voting Securities directly from the Company, including, without limitation, in a public offering of securities, or (ii) any acquisition of Outstanding Company Voting Securities by the Company or any of its Subsidiaries, including, without limitation, an acquisition by any employee benefit plan or related trust sponsored or maintained by the Company or any of its Subsidiaries.
|
b.
|
Consummation of a reorganization, merger, or consolidation to which the Company is a party or a sale or other disposition of all or substantially all of the assets of the Company or the line of business to which your employment principally relates (a “
Business
|
c.
|
Approval by the shareholders of the Company of a complete liquidation or dissolution of the Company.
|
iv.
|
“
Good Reason
” means, without your consent: (i) a material decrease in your base salary or failure to pay salary when due; (ii) a material diminution in your duties or responsibilities (provided however, that a mere change in your title or reporting relationship alone shall not constitute “Good Reason”); (iii) the failure of the Company to cause the transferee or successor to all or substantially all of the assets of the Company or line of business to which your employment principally relates to assume by operation of law or contractually the Company’s obligations hereunder; or (iv) the relocation of your principal work location to a location more than fifty (50) miles from its current location; provided, in each case, that (A) you provide written notice to the Company, setting forth in reasonable detail the event giving rise to Good Reason within thirty (30) days following the initial occurrence of such event, (B) such event is not cured by the Company within thirty (30) days following its receipt of such written notice, and (C) you actually terminate your employment not later than thirty (30) days following the expiration of such cure period.
|
v.
|
“
Permanent Disability
” means your inability, because of mental or physical illness or incapacity, whether total or partial, to perform one or more of the material functions of your position with or without reasonable accommodation, for a period of: (i) ninety (90) consecutive calendar days or (ii) an aggregate of one hundred and twenty (120) days out of any consecutive twelve (12)-month period, and which entitles you to receive benefits under a disability plan provided by the Company.
|
vi.
|
“
Person
” means an individual, entity, or organization, including a government or political subdivision, department, or agency of a government.
|
vii.
|
“
Qualifying Termination
” means a termination of your employment by the Company without Cause or your resignation from the Company for Good Reason. “Qualifying Termination” does not include a termination of your employment due to your death or Permanent Disability.
|
viii.
|
“
Separation Date
” means the date your employment with the Company terminates.
|
ix.
|
“
Subsidiary
” means an entity (whether or not a corporation) that is wholly or majority owned or controlled, directly or indirectly, by the Company or any other affiliate of the Company that is so designated, from time to time, by the Company, during the period of such affiliated status.
|
2.
|
Conditions to Payment
. Any obligation of the Company to pay you the Cash Severance Payment, the COBRA Payment, the Change in Control Severance Payment or the Death/Disability Payment is conditioned upon (i) your continued compliance with all confidentiality, non-solicitation, no-hire, non-disparagement, invention assignment, cooperation and other similar obligations to, and other restrictive covenants in favor of, the Company or any of its subsidiaries or affiliates to which you are currently obligated, as well as those set forth on
Exhibit A
(the “
Restrictive Covenants
”), and (ii) your (or your estate’s or legal representative’s, in the event of your death or Permanent
|
3.
|
No Other Severance Benefits
. The payments provided by this Agreement are in lieu of any severance or similar payments or benefits that you may otherwise be entitled to upon termination of employment with the Company or any of its subsidiaries or affiliates, including, without limitation, under any severance policy of the Company or any of its subsidiaries or affiliates.
|
4.
|
Withholding
. The Company may withhold from all amounts payable under this Agreement any taxes or other amounts required by law to be withheld with respect to such payments, as determined by the Company in its sole discretion.
|
5.
|
Scope of Agreement
. Nothing in this Agreement will be deemed to entitle you to continued employment with the Company or any of its subsidiaries or affiliates, limit the Company’s right to terminate your employment at any time for any reason or alter the at-will nature of your employment with the Company.
|
6.
|
Section 409A
. All amounts payable under this Agreement are intended to be exempt from, or comply with, the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (the “
Code
”), and the regulations thereunder (collectively, “
Section 409A
”). To the extent required to comply with or be exempt from Section 409A, you will not be considered to have terminated employment with the Company for purposes of this Agreement, and no payment will be due to you under this Agreement, until you have incurred a “separation from service” from the Company within the meaning of Section 409A (after giving effect to the presumptions set forth therein). If you are determined to be a “specified employee” at the time of your separation from service then, to the extent necessary to prevent any accelerated or additional tax under Section 409A, payment of the amounts payable under this Agreement will be delayed until the earlier of (i) the date that is six months and one day following your separation from service or (ii) your death. Each amount paid to you pursuant to this Agreement shall be treated as a separate payment for purposes of Section 409A and the right to a series of installment payments under this Agreement shall be treated as the right to a series of separate payments. To the extent required to comply with Section 409A, if the period available to execute (and not revoke) the Separation Agreement spans two calendar years, the Cash Severance Payment, the COBRA Payment, the Change in Control Severance Payment or the Death/Disability Payment will be paid in the second calendar year. To the extent required to comply with Section 409A, a Change in Control will not be deemed to occur for purposes of this Agreement unless it is a “change in control event” as defined in Section 1.409A-3(i)(5)(i) of the Treasury Regulations, and if it is not a “change in control event,” payment of the severance described in Section 1(b) of this Agreement shall instead be paid as provided under Section 1(a) of this Agreement (unless the severance, or portion thereof, could be paid earlier without resulting in adverse tax consequences under Section 409A). Any reimbursement payable under this Agreement that is subject to Section 409A is subject to the following additional rules: (A) the amount of expenses eligible for reimbursement during any taxable year shall not affect the amount of expenses eligible for reimbursement in any other taxable year; (B) reimbursement of the expense shall be made, if at all, promptly, but not later than the end of the calendar year following the calendar year in which the expense was incurred, and (C) the right to reimbursement shall not be subject to liquidation or exchange for any other benefit. Notwithstanding the foregoing or anything to the contrary in this Agreement, neither the Company nor any other person will be liable to you by reason of any acceleration of income, or any additional tax (including any interest and penalties), asserted with respect to any of the payments under this Agreement, including by reason of the failure of this Agreement to satisfy the applicable requirements of Section 409A in form or in operation.
|
7.
|
Section 280G
. If all, or any portion, of the payments or benefits provided under this Agreement, either alone or together with any other payment or benefit that you receive or are entitled to receive from the Company or any of its subsidiaries or affiliates, would constitute an “excess parachute payment” within the meaning of Section 280G of the Code, then, notwithstanding anything in this Agreement or any other agreement or plan to the contrary, you will be entitled to receive: (A) the amount of such payments or benefits, reduced such that no portion thereof shall fail to be tax deductible under Section 280G of the Code (the “
Limited Amount
”), or (B) if the amounts otherwise payable hereunder and under any other agreements and plans of the Company and its subsidiaries and affiliates (without regard to clause (A)), reduced by all taxes applicable thereto (including, for the avoidance of doubt, the excise tax imposed by Section 4999 of the Code) would be greater than the Limited Amount reduced by all taxes applicable thereto, the amounts otherwise payable hereunder and thereunder. All determinations under this Section 7 will be made by an accounting, consulting, or valuation firm selected, and paid for, by the Company.
|
8.
|
Assignment
. Neither the Company nor you may assign any rights or obligations under this Agreement, by operation of law or otherwise, without the prior written consent of the other, except that the Company may assign its rights and obligations under this Agreement without your consent in the event that you are transferred to a position with any of the Company’s subsidiaries or affiliates, and the Company will assign its rights and obligations under this Agreement in the event of a reorganization, consolidation, or merger involving the Company or any of its subsidiaries or affiliates in which the Company is not the surviving entity, or a transfer of all or substantially all of the Company’s assets or line of business to which your employment principally relates. This Agreement shall inure to the benefit of and be binding upon you and the Company and your and its respective successors, executors, administrators, heirs and permitted assigns.
|
9.
|
Governing Law; Validity
. The laws of the Commonwealth of Massachusetts will govern all questions concerning the relative rights of you and the Company and all other questions concerning the construction, validity and interpretation of this Agreement, without giving effect to any choice of law or conflict of law provision or rule that would cause the application of the laws of any jurisdiction. The invalidity or unenforceability of any provision of this Agreement will not affect the validity or enforceability of any other provisions of this Agreement, which other provisions will remain in full force and effect.
|
10.
|
Specific Performance
. ·You acknowledge and agree that the Company’s remedies at law for a breach or threatened breach of any of the provisions of
Exhibit A
would be inadequate and the Company would suffer irreparable damages as a result of such breach or threatened breach. In recognition of this fact, you agree that, in the event of such a breach or threatened breach, in addition to any remedies at law, the Company, without posting any bond or proving damages, shall be entitled to cease making any payments or providing any benefit otherwise required by this Agreement and obtain equitable relief in the form of specific performance, temporary restraining order, temporary or permanent injunction or any other equitable remedy which may then be available.
|
11.
|
Notice
. For purposes of this Agreement, notices and all other communications provided for in the Agreement shall be in writing and shall be deemed to have been duly given when delivered by hand or overnight courier or three days after it has been mailed by United States registered mail, return receipt requested, postage prepaid, addressed to the respective addresses set forth below in this Agreement, or to such other address as either party may have furnished to the other in writing in accordance herewith, except that notice of change of address shall be effective only upon receipt.
|
12.
|
Miscellaneous
. This letter agreement (including
Exhibit A
) is the entire agreement between you and the Company, and replaces all prior and contemporaneous communications, agreements, and understandings, whether written or oral, with respect to the subject matter described herein. No modification or amendment of this Agreement will be valid unless such modification or amendment is agreed to in writing and signed by you and by a duly authorized officer of the Company.
|
13.
|
Counterparts
. This Agreement may be executed in two or more counterparts, each of which will be an original and all of which together will constitute the same instrument.
|
|
|
LANTHEUS MEDICAL IMAGING, INC.
|
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|
||
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|
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By:
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Name: [Name]
|
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||
|
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Title: [Title]
|
|
|
1.
|
Non-Solicitation and Non-Compete.
|
(a)
|
During your employment with the Company and for a period of one year following the date on which you cease to be employed by the Company (the “
Non-Solicitation Period
”), you will not, whether on your own behalf or on behalf of or in conjunction with any person, firm, partnership, joint venture, association, corporation or other business organization, entity or enterprise whatsoever (“
Person
”), directly or indirectly solicit or assist in soliciting for purposes of offering or accepting goods or services similar to or competitive with those offered by or to the Company or any of its affiliates, to or from any of the Company’s or any of its affiliates’ Business Partners:
|
(i)
|
with whom you or any employee reporting directly or indirectly to you had personal contact or dealings on behalf of the Company during the two years preceding your termination of employment;
|
(ii)
|
for whom you had direct or indirect responsibility during the two years immediately preceding your termination of employment.
|
(b)
|
During the Non-Solicitation Period, you will not, whether on your own behalf or on behalf of or in conjunction with any Person, directly or indirectly:
|
(i)
|
solicit or encourage any employee or contractor of the Company or its affiliates to leave the employment of, or cease providing services to, the Company or its affiliates; or
|
(ii)
|
hire any such employee or contractor who was employed by or providing services to the Company or its affiliates as of the date of your termination of employment with the Company or who left the employment of or ceased providing services to the Company or its affiliates coincident with, or within one year prior to or after, the termination of your employment with the Company.
|
(c)
|
During your employment with the Company (the “
Non-Competition Period
”), you will not, directly or indirectly:
|
(i)
|
engage in or undertake any planning to engage in any business that competes with the business or businesses of the Company or any of its affiliates, namely in the testing, development and manufacturing services for the development, manufacture, distribution, marketing or sale of radiopharmaceutical products, contrast imaging agents and/or radioactive generators for the global medical and pharmaceutical industries (or any businesses which the Company or its affiliates has specific plans to conduct in the future and as to which you are aware of such planning) (each, a
“Competitive Business
”), including any of the services that you provided to the Company or its affiliates at any time (collectively, the “
Restricted Services
”), in each case, in any geographic area in which the Company or any of its affiliates does business (or has specific plans to conduct business in the future and as to which you are aware of such planning) or in any geographic area in which you at any time provided services or had a material presence or influence (collectively, the “
Restricted Geography
”); or
|
(ii)
|
render any of the Restricted Services to any Person (or any division or controlled or controlling affiliate of any Person) who or which engages in a Competitive Business in the Restricted Geography, whether directly or indirectly, as an employee, contractor, individual, partner, shareholder, officer, director, principal, agent, trustee or consultant.
|
(d)
|
Notwithstanding anything to the contrary in this Agreement, you may, directly or indirectly, own, solely as an investment, securities of any Person engaged in the business of the Company or its affiliates which are publicly traded on a national or regional stock exchange or on the over-the-counter market if you (i) are not a controlling person of, or a member of a group which controls, such Person and (ii) does not, directly or indirectly, own 5% or more of any class of securities of such Person.
|
(e)
|
It is expressly understood and agreed that although you and the Company consider the restrictions contained in this Section 1 to be reasonable, if a final judicial determination is made by a court of competent jurisdiction that the time or territory or any other restriction contained in this Agreement is an unenforceable restriction against you, the provisions of this Agreement shall not be rendered void but shall be deemed amended to apply as to such maximum time and territory and to such maximum extent as such court may judicially determine or indicate to be enforceable. Alternatively, if any court of competent jurisdiction finds that any restriction contained in this Agreement is unenforceable, and such restriction cannot be amended so as to make it enforceable, such finding shall not affect the enforceability of any of the other provisions contained herein.
|
(f)
|
The provisions of this Section 1 shall survive the termination of this Agreement and your employment for any reason.
|
2.
|
Non-Disparagement.
Subject to Section 3(a)(iii), neither you nor the Company will at any time (whether during or after your employment with the Company) make, publish or communicate to any person or entity or in any public forum any defamatory, maliciously false or disparaging remarks, comments, or statements concerning the other party, except for truthful statements that may be made pursuant to legal process, including without limitation in litigation, arbitration or similar dispute resolution proceedings. This Section 2 will survive the termination of the Agreement and your employment for any reason.
|
3.
|
Confidentiality; Intellectual Property
.
|
(a)
|
Confidentiality
.
|
(i)
|
You will not at any time (whether during or after your employment with the Company) (x) retain or use for the benefit, purposes or account of you or any other Person; or (y) disclose, divulge, reveal, communicate, share, transfer or provide access to any Person outside the Company (other than its professional advisers who are bound by confidentiality obligations), any non-public, proprietary or confidential information - including, without limitation, trade secrets, know-how, research and development, software, databases, inventions, processes, formulae, technology, designs and other intellectual property, information concerning finances, investments, profits, pricing, costs, products, services, vendors, customers, clients, partners, investors, personnel, compensation, recruiting, training, advertising, sales, marketing, promotions, government and regulatory activities and approvals - concerning the past, current or future business, activities and operations of the Company, its subsidiaries or affiliates and/or any third party that has disclosed or provided any of same to the Company on a confidential basis (“
Confidential Information
”)
without the prior written authorization of the Board.
|
(ii)
|
Confidential Information shall not include any information that is (A) generally known to the industry or the public other than as a result of your breach of this covenant or any breach of other confidentiality obligations by third parties; (B) made legitimately available to you by a third party without breach of any confidentiality obligation; or (C) required by law, regulation or legal process to be disclosed; provided that you will give prompt written notice to the Company of such requirement, disclose no more information than is so required, and cooperate with any attempts by the Company to obtain a protective order or similar treatment.
|
(iii)
|
Nothing in this Agreement limits, restricts or in any other way affects your communicating with any governmental agency or entity, or communicating with any official or staff person of a governmental
|
(iv)
|
Except as required by law, you will not disclose to anyone, other than your immediate family and legal or financial advisors, the existence or contents of this Agreement; provided that you may disclose to any prospective future employer the provisions of Sections 1, 2 and 3 of this Agreement provided they agree to maintain the confidentiality of such terms.
|
(v)
|
Upon termination of your employment with the Company for any reason, you will (x) cease and not thereafter commence use of any Confidential Information or intellectual property (including without limitation, any patent, invention, copyright, trade secret, trademark, trade name, logo, domain name or other source indicator) owned or used by the Company, its subsidiaries or affiliates; (y) immediately return to the Company all Company property and destroy, delete, or return to the Company, at the Company’s option, all originals and copies in any form or medium (including memoranda, books, papers, plans, computer files, letters and other data) in your possession or control (including any of the foregoing stored or located in your office, home, laptop or other computer, whether or not Company property) that contain Confidential Information or otherwise relate to the business of the Company, its affiliates and subsidiaries, except that you may retain only those portions of any personal notes, notebooks and diaries that do not contain any Confidential Information; and (z) notify and fully cooperate with the Company regarding the delivery or destruction of any other Confidential Information of which you are or become aware and promptly return any other Company property in your possession.
|
(b)
|
Intellectual Property.
|
(i)
|
If you have created, invented, designed, developed, contributed to or improved any works of authorship, inventions, intellectual property, materials, documents or other work product (including without limitation, research, reports, software, databases, systems, applications, presentations, textual works, content, or audiovisual materials) (“
Works
”), either alone or with third parties, prior to your employment by the Company, that are relevant to or implicated by such employment (“
Prior Works
”), except with respect to the Prior Works listed on
Schedule A
, you hereby grant the Company a perpetual, nonexclusive, royalty-free, worldwide, assignable, sublicensable license under all rights and intellectual property rights (including rights under patent, industrial property, copyright, trademark, trade secret, unfair competition and related laws) therein for all purposes in connection with the Company’s current and future business.
|
(ii)
|
If you create, invent, design, develop, contribute to or improve any Works, either alone or with third parties, at any time during your employment by the Company and within the scope of such employment and/or with the use of any Company resources (“
Company Works
”), you will promptly and fully disclose such Works to the Company and you hereby irrevocably assign, transfer and convey, to the maximum extent permitted by applicable law, all rights and intellectual property rights therein (including rights under patent, industrial property, copyright, trademark, trade secret, unfair competition and related laws) to the Company to the extent ownership of any such rights does not vest originally in the Company.
|
(iii)
|
You agree to keep and maintain adequate and current written records (in the form of notes, sketches, drawings, and any other form or media requested by the Company) of all Company Works. The records will be available to and remain the sole property and intellectual property of the Company at all times. All Company Works are the Confidential Information of Company
|
(iv)
|
You will take all requested actions and execute all requested documents (including any licenses or assignments required by a government contract) at the Company’s expense (but without further remuneration) to assist the Company in validating, maintaining, protecting, enforcing, perfecting, recording, patenting or registering any of the Company’s rights in the Prior Works and Company Works. If the Company is unable for any other reason to secure your signature on any document for this purpose, then you hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as your agent and attorney-in-fact, to act for and on your behalf to execute any documents and to do all other lawfully permitted acts in connection with the foregoing.
|
(v)
|
You will not improperly use for the benefit of, bring to any premises of, divulge, disclose, communicate, reveal, transfer or provide access to, or share with the Company any confidential, proprietary or non-public information or intellectual property relating to a former employer or other third party without the prior written permission of such third party. You hereby indemnify, hold harmless and agree to defend the Company and its officers, directors, partners, employees, agents and representatives from any breach of the foregoing covenant. You will comply with all relevant policies and guidelines of the Company, including regarding the protection of confidential information and intellectual property and potential conflicts of interest. You acknowledge that the Company may amend any such policies and guidelines from time to time, and that you remain at all times bound by their most current version.
|
(c)
|
The provisions of this Section 3 shall survive the termination of this Agreement and your employment for any reason.
|
4.
|
Each of the On-Going Obligations is an individual right, separately enforceable by the Company and/or its applicable affiliate(s), notwithstanding any conflict or other inconsistency among any provisions (or any parts of any provisions) of any of the On-Going Obligations, and no such conflict or other inconsistency will have the effect of superseding, restricting or otherwise limiting any of the On-Going Obligations. The obligation of the Company to make payments and provide the benefits described under the Agreement, and your right to retain those payments and benefits, are expressly conditioned upon your continued full performance of your obligations under this Agreement and of the On-Going Obligations.
|
Subsidiary
|
State or Other Jurisdiction of Organization
|
Lantheus Medical Imaging, Inc.
|
Delaware
|
Lantheus MI Canada, Inc.
|
Ontario, Canada
|
Lantheus MI Real Estate, LLC
|
Delaware
|
Lantheus MI Radiopharmaceuticals, Inc.
|
Commonwealth of Puerto Rico
|
Lantheus MI UK Limited
|
England and Wales
|
Lantheus EU Limited
|
Ireland
|
1.
|
I have reviewed this Annual Report on Form 10-K of Lantheus Holdings, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s fourth fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
February 20, 2019
|
/s/ M
ARY
A
NNE
H
EINO
|
|
|
|
Name:
|
Mary Anne Heino
|
|
|
Title:
|
President and Chief Executive Officer
|
1.
|
I have reviewed this Annual Report on Form 10-K of Lantheus Holdings, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s fourth fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
February 20, 2019
|
/S/ ROBERT J. MARSHALL, JR.
|
|
|
|
Name:
|
Robert J. Marshall, Jr.
|
|
|
Title:
|
Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer) |
1.
|
The Annual Report on Form 10-K for the fiscal year ended
December 31, 2018
(the “Report”) of the Company fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date:
|
February 20, 2019
|
/
S
/ M
ARY
A
NNE
H
EINO
|
|
|
|
Name:
|
Mary Anne Heino
|
|
|
Title:
|
President and Chief Executive Officer
|
Date:
|
February 20, 2019
|
/s/ ROBERT J. MARSHALL, JR.
|
|
|
|
Name:
|
Robert J. Marshall, Jr.
|
|
|
Title:
|
Chief Financial Officer and Treasurer (Principal Financial Officer and Principal Accounting Officer)
|