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x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from to
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Delaware
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94-3023969
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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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Title of Class
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Name of Exchange on which Registered
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Common Stock, par value $0.01 per share
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The NASDAQ Stock Market LLC
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Large accelerated filer
x
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Accelerated filer
¨
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Non-accelerated filer
¨
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Smaller reporting company
¨
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(Do not check if a smaller reporting company)
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PART I
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Item 1
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Item 1A
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Item 1B
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Item 2
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Item 3
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Item 4
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PART II
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Item 5
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Item 6
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Item 7
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Item 7A
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Item 8
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Item 9
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Item 9A
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Item 9B
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PART III
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Item 10
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Item 11
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Item 12
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Item 13
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Item 14
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PART IV
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Item 15
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Abbreviation/term
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Definition
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'216B Patent
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European Patent No. 0 451 216B
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'761 Patent
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U.S. Patent No. 5,693,761
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2012 Notes
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2.0% Convertible Senior Notes due February 15, 2012, fully retired at June 30, 2011
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Abbott
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Abbott Laboratories
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APIC
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Additional paid-in-capital
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ASU
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Accounting Standards Update
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AxoGen
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AxoGen, Inc.
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BioTransplant
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BioTransplant, Inc.
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Chugai
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Chugai Pharmaceutical Co., Ltd.
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Elan
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Elan Corporation, PLC
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EPO
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European Patent Office
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ex-U.S.-based Manufacturing and Sales
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Products that are both manufactured and sold outside of the United States
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Facet
|
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Facet Biotech Corporation. In April 2010, Abbott acquired Facet and later renamed the company Abbott Biotherapeutics Corp., and in January 2013, Abbott Biotherapeutics Corp. was renamed AbbVie Biotherapeutics, Inc. and spun off from Abbott as a subsidiary of AbbVie Inc.
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FASB
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Financial Accounting Standards Board
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FDA
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U.S. Food and Drug Administration
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February 2015 Notes
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2.875% Convertible Senior Notes due February 15, 2015
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GAAP
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U.S. Generally Accepted Accounting Principles
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Genentech
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Genentech, Inc.
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Genentech Products
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Avastin
®
, Herceptin
®
, Lucentis
®
, Xolair
®
, Perjeta
®
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Lilly
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Eli Lilly and Company
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May 2015 Notes
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3.75% Senior Convertible Notes due May 2015
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MedImmune
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MedImmune, LLC
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Merus Labs
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Merus Labs International, Inc.
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Non-Recourse Notes
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QHP PhaRMA
SM
Senior Secured Notes due March 15, 2015, issued through our wholly-owned subsidiary, QHP Royalty Sub LLC, in November 2009, fully repaid in September 2012
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Novartis
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Novartis AG
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PDL, we, us, our, the Company
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PDL BioPharma, Inc.
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Pfizer
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Pfizer, Inc.
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PLMA
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Patent licensing master agreement
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Queen et al. patents
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PDL's patents in the United States and elsewhere covering the humanization of antibodies
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Roche
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F. Hoffman LaRoche, Ltd.
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Royalty Agreement
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Revenue interests purchase agreement between PDL and AxoGen.
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SEC
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Securities and Exchange Commission
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Series 2012 Notes
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2.875% Series 2012 Convertible Senior Notes due February 15, 2015
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SPCs
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Supplementary Protection Certificates
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SPC Products
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Avastin
®
, Herceptin
®
, Lucentis
®
, Xolair
®
and Tysabri
®
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Spin-Off
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The spin-off by PDL of Facet
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T-DM1
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Trastuzumab-DM1
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U.S.-based Sales
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Products sold in the United States or manufactured in the United States and used or sold anywhere in the world
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UCB
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UCB Pharma S.A.
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VWAP
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Volume weighted average share price
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Wellstat Diagnostics
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Wellstat Diagnostics, LLC
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Application Number
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Filing Date
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Patent Number
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Issue Date
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Expiration Date
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08/477,728
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06/07/95
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5,585,089
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12/17/96
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06/25/13
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08/474,040
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06/07/95
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5,693,761
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12/02/97
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12/02/14
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08/487,200
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06/07/95
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5,693,762
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12/02/97
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06/25/13
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08/484,537
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06/07/95
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6,180,370
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01/30/01
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06/25/13
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Licensee
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Product Names
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Genentech
|
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Avastin
®
|
|
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Herceptin
®
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Xolair
®
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|
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Lucentis
®
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Perjeta
®
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Elan
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Tysabri
®
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Chugai
|
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Actemra
®
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Genentech Products Made or Sold in the U.S.
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Royalty Rate
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Net sales up to $1.5 billion
|
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3.0%
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Net sales between $1.5 billion and up to $2.5 billion
|
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2.5%
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Net sales between $2.5 billion and up to $4.0 billion
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2.0%
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Net sales exceeding $4.0 billion
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1.0%
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Genentech Products Made and Sold ex-U.S.
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Net sales
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3.0%
|
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Year Ended December 31,
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|||||||
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2012
|
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2011
|
|
2010
|
|||
Avastin
|
|
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|||
Ex-U.S.-based sales
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56
|
%
|
|
55
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%
|
|
50
|
%
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Ex-U.S.-based Manufacturing and Sales
|
29
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%
|
|
21
|
%
|
|
21
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%
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Herceptin
|
|
|
|
|
|
|||
Ex-U.S.-based sales
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69
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%
|
|
71
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%
|
|
70
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%
|
Ex-U.S.-based Manufacturing and Sales
|
37
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%
|
|
35
|
%
|
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44
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%
|
Lucentis
|
|
|
|
|
|
|||
Ex-U.S.-based sales
|
63
|
%
|
|
59
|
%
|
|
56
|
%
|
Ex-U.S.-based Manufacturing and Sales
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Perjeta
|
|
|
|
|
|
|||
Ex-U.S.-based sales
|
1
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%
|
|
0
|
%
|
|
0
|
%
|
Ex-U.S.-based Manufacturing and Sales
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Xolair
|
|
|
|
|
|
|||
Ex-U.S.-based sales
|
39
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%
|
|
40
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%
|
|
35
|
%
|
Ex-U.S.-based Manufacturing and Sales
|
39
|
%
|
|
40
|
%
|
|
35
|
%
|
Convertible Notes
|
|
Conversion Rate
per $1,000
Principal Amount
|
|
Approximate
Conversion Price Per Common Share
|
|
Effective Date
|
|||
Series 2012 Notes
|
|
169.525
|
|
|
$
|
5.90
|
|
|
December 5, 2012
|
May 2015 Notes
|
|
148.3827
|
|
|
$
|
6.74
|
|
|
December 5, 2012
|
February 2015 Notes
|
|
169.525
|
|
|
$
|
5.90
|
|
|
December 10, 2012
|
|
High
|
|
Low
|
||||
2012
|
|
|
|
||||
First Quarter
|
$
|
6.60
|
|
|
$
|
6.00
|
|
Second Quarter
|
$
|
6.68
|
|
|
$
|
6.03
|
|
Third Quarter
|
$
|
7.86
|
|
|
$
|
6.49
|
|
Fourth Quarter
|
$
|
8.43
|
|
|
$
|
6.95
|
|
2011
|
|
|
|
||||
First Quarter
|
$
|
6.40
|
|
|
$
|
4.66
|
|
Second Quarter
|
$
|
6.70
|
|
|
$
|
5.70
|
|
Third Quarter
|
$
|
6.44
|
|
|
$
|
5.40
|
|
Fourth Quarter
|
$
|
6.46
|
|
|
$
|
5.15
|
|
|
12/31/2007
|
|
12/31/2008
|
|
12/31/2009
|
|
12/31/2010
|
|
12/31/2011
|
|
12/31/2012
|
||||||||||||
PDL BioPharma, Inc.
|
$
|
100.00
|
|
|
$
|
71.29
|
|
|
$
|
112.61
|
|
|
$
|
120.03
|
|
|
$
|
132.10
|
|
|
$
|
163.53
|
|
Nasdaq Biotechnology Index
|
$
|
100.00
|
|
|
$
|
93.40
|
|
|
$
|
103.19
|
|
|
$
|
113.89
|
|
|
$
|
129.12
|
|
|
$
|
163.33
|
|
Nasdaq Composite Index
|
$
|
100.00
|
|
|
$
|
59.03
|
|
|
$
|
82.25
|
|
|
$
|
97.32
|
|
|
$
|
98.63
|
|
|
$
|
110.78
|
|
|
|
For the Years Ended December 31,
|
||||||||||||||||||
(In thousands, except per share data)
|
|
2012
|
|
2011
|
|
2010
|
|
2009
|
|
2008
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Royalties
|
|
$
|
374,525
|
|
|
$
|
351,641
|
|
|
$
|
343,475
|
|
|
$
|
305,049
|
|
|
$
|
278,713
|
|
License and other
|
|
—
|
|
|
10,400
|
|
|
1,500
|
|
|
13,135
|
|
|
15,483
|
|
|||||
Total revenues
|
|
374,525
|
|
|
362,041
|
|
|
344,975
|
|
|
318,184
|
|
|
294,196
|
|
|||||
General and administrative expenses
|
|
25,469
|
|
|
18,338
|
|
|
41,396
|
|
|
21,064
|
|
|
51,544
|
|
|||||
Accrued legal settlement expense
|
|
—
|
|
|
—
|
|
|
92,500
|
|
|
—
|
|
|
—
|
|
|||||
Operating income
|
|
349,056
|
|
|
343,703
|
|
|
211,079
|
|
|
297,120
|
|
|
242,652
|
|
|||||
Non-operating income (expense), net
|
|
(21,923
|
)
|
|
(36,275
|
)
|
|
(60,709
|
)
|
|
(16,835
|
)
|
|
682
|
|
|||||
Income from continuing operations before income taxes
|
|
327,133
|
|
|
307,428
|
|
|
150,370
|
|
|
280,285
|
|
|
243,334
|
|
|||||
Income tax expense
|
|
115,464
|
|
|
108,039
|
|
|
58,496
|
|
|
90,625
|
|
|
5,014
|
|
|||||
Income from continuing operations
|
|
211,669
|
|
|
199,389
|
|
|
91,874
|
|
|
189,660
|
|
|
238,320
|
|
|||||
Loss on discontinued operations, net of income taxes
(1)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(169,933
|
)
|
|||||
Net income
|
|
$
|
211,669
|
|
|
$
|
199,389
|
|
|
$
|
91,874
|
|
|
$
|
189,660
|
|
|
$
|
68,387
|
|
Net income per basic share:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Continuing operations
|
|
$
|
1.52
|
|
|
$
|
1.43
|
|
|
$
|
0.73
|
|
|
$
|
1.59
|
|
|
$
|
2.01
|
|
Net income
|
|
$
|
1.52
|
|
|
$
|
1.43
|
|
|
$
|
0.73
|
|
|
$
|
1.59
|
|
|
$
|
0.58
|
|
Net income per diluted share:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Continuing operations
|
|
$
|
1.45
|
|
|
$
|
1.15
|
|
|
$
|
0.54
|
|
|
$
|
1.07
|
|
|
$
|
1.48
|
|
Net income
|
|
$
|
1.45
|
|
|
$
|
1.15
|
|
|
$
|
0.54
|
|
|
$
|
1.07
|
|
|
$
|
0.47
|
|
Dividends per share:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash dividends declared and paid
|
|
$
|
0.60
|
|
|
$
|
0.60
|
|
|
$
|
1.00
|
|
|
$
|
2.67
|
|
|
$
|
4.25
|
|
Stock distribution in connection with the Spin-Off of Facet
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2.60
|
|
|
|
December 31,
|
||||||||||||||||||
(In thousands)
|
|
2012
|
|
2011
|
|
2010
|
|
2009
|
|
2008
|
||||||||||
Cash, cash equivalents, investments and restricted investments
|
|
$
|
168,689
|
|
|
$
|
227,946
|
|
|
$
|
248,229
|
|
|
$
|
303,227
|
|
|
$
|
147,527
|
|
Working capital
|
|
$
|
172,511
|
|
|
$
|
100,506
|
|
|
$
|
90,672
|
|
|
$
|
22,320
|
|
|
$
|
149,168
|
|
Total assets
|
|
$
|
279,966
|
|
|
$
|
269,471
|
|
|
$
|
316,666
|
|
|
$
|
338,411
|
|
|
$
|
191,142
|
|
Long-term obligations, less current portion
|
|
$
|
337,614
|
|
|
$
|
340,737
|
|
|
$
|
446,857
|
|
|
$
|
460,848
|
|
|
$
|
510,698
|
|
Retained earnings (accumulated deficit)
|
|
$
|
169,634
|
|
|
$
|
(42,035
|
)
|
|
$
|
(241,424
|
)
|
|
$
|
(333,298
|
)
|
|
$
|
(522,958
|
)
|
Total stockholders’ deficit
|
|
$
|
(68,122
|
)
|
|
$
|
(204,273
|
)
|
|
$
|
(324,182
|
)
|
|
$
|
(415,953
|
)
|
|
$
|
(352,569
|
)
|
(1)
|
The financial results for our former biotechnology, manufacturing and commercial operations have been presented as discontinued operations in our Consolidated Statements of Operations.
|
Convertible Notes
|
|
Conversion Rate
per $1,000 Principal Amount |
|
Approximate
Conversion Price Per Common Share |
|
Effective Date
|
|||
Series 2012 Notes
|
|
169.525
|
|
|
$
|
5.90
|
|
|
December 5, 2012
|
May 2015 Notes
|
|
148.3827
|
|
|
$
|
6.74
|
|
|
December 5, 2012
|
February 2015 Notes
|
|
169.525
|
|
|
$
|
5.90
|
|
|
December 10, 2012
|
•
|
Our net income for the years ended
December 31, 2012
,
2011
and
2010
was
$211.7 million
,
$199.4 million
and
$91.9 million
, respectively;
|
•
|
At
December 31, 2012
, we had cash, cash equivalents, investments and restricted investments of
$168.7 million
as compared with
$227.9 million
at
December 31, 2011
; and
|
•
|
At
December 31, 2012
, we had
$348.1 million
in total liabilities as compared with
$473.7 million
at
December 31, 2011
.
|
(Dollars in thousands)
|
|
2012
|
|
2011
|
|
Change from Prior Year %
|
|
2010
|
|
Change from Prior Year %
|
||||||||
Revenues
|
|
|
|
|
|
|
|
|
|
|
||||||||
Royalties
|
|
$
|
374,525
|
|
|
$
|
351,641
|
|
|
7
|
%
|
|
$
|
343,475
|
|
|
2
|
%
|
License and other
|
|
—
|
|
|
10,400
|
|
|
N/M
|
|
|
1,500
|
|
|
593
|
%
|
|||
Total revenues
|
|
$
|
374,525
|
|
|
$
|
362,041
|
|
|
3
|
%
|
|
$
|
344,975
|
|
|
5
|
%
|
Licensee
|
|
Product Names
|
Genentech
|
|
Avastin
|
|
|
Herceptin
|
|
|
Xolair
|
|
|
Lucentis
|
|
|
Perjeta
|
Elan
|
|
Tysabri
|
Chugai
|
|
Actemra
|
Genentech Products Made or Sold in the U.S.
|
|
Royalty Rate
|
Net sales up to $1.5 billion
|
|
3.0%
|
Net sales between $1.5 billion and up to $2.5 billion
|
|
2.5%
|
Net sales between $2.5 billion and up to $4.0 billion
|
|
2.0%
|
Net sales exceeding $4.0 billion
|
|
1.0%
|
|
Year Ended December 31,
|
|||||||
|
2012
|
|
2011
|
|
2010
|
|||
Avastin
|
|
|
|
|
|
|||
Ex-U.S.-based sales
|
56
|
%
|
|
55
|
%
|
|
50
|
%
|
Ex-U.S.-based Manufacturing and Sales
|
29
|
%
|
|
21
|
%
|
|
21
|
%
|
Herceptin
|
|
|
|
|
|
|||
Ex-U.S.-based sales
|
69
|
%
|
|
71
|
%
|
|
70
|
%
|
Ex-U.S.-based Manufacturing and Sales
|
37
|
%
|
|
35
|
%
|
|
44
|
%
|
Lucentis
|
|
|
|
|
|
|||
Ex-U.S.-based sales
|
63
|
%
|
|
59
|
%
|
|
56
|
%
|
Ex-U.S.-based Manufacturing and Sales
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Perjeta
|
|
|
|
|
|
|||
Ex-U.S.-based sales
|
1
|
%
|
|
0
|
%
|
|
0
|
%
|
Ex-U.S.-based Manufacturing and Sales
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Xolair
|
|
|
|
|
|
|||
Ex-U.S.-based sales
|
39
|
%
|
|
40
|
%
|
|
35
|
%
|
Ex-U.S.-based Manufacturing and Sales
|
39
|
%
|
|
40
|
%
|
|
35
|
%
|
•
|
Reported net sales of Herceptin increased $0.4 billion or 7% compared to the same period for the prior year.
|
•
|
Reported Lucentis sales increased $0.4 billion or 11% compared to the same period for the prior year.
|
•
|
Reported sales of Tysabri increased $0.1 billion or 8% compared to the same period for the prior year. Tysabri royalties are determined at a flat rate as a percent of the sales regardless of location of manufacture or sale.
|
•
|
Reported net sales of Avastin increased $0.1 billion or 1% compared to the same period for the prior year.
|
•
|
Reported net sales of Herceptin increased $0.7 billion or 13% compared to the same period for the prior year. While Herceptin net sales increased 13%, royalties on Herceptin only increased 5% due to a shift in site of manufacture: ex-U.S. manufactured and sold Herceptin declined to 35% compared to 44% for the same period in 2010.
|
•
|
Reported Lucentis sales increased $1.0 billion or 33% compared to the same period for the prior year. Reported sales in 2011 increased 27% in the United States and 38% internationally.
|
•
|
Reported sales of Tysabri increased $0.3 billion or 22% compared to the same period for the prior year. Tysabri royalties are determined at a flat rate as a percent of the sales regardless of location of manufacture or sale.
|
•
|
Reported net sales of Avastin decreased $0.1 billion or 2% compared to the same period for the prior year.
|
|
|
|
|
Year Ended December 31,
|
|||||||
Licensee
|
|
Product Name
|
|
2012
|
|
2011
|
|
2010
|
|||
Genentech
|
|
Avastin
|
|
32
|
%
|
|
31
|
%
|
|
34
|
%
|
|
|
Herceptin
|
|
34
|
%
|
|
33
|
%
|
|
33
|
%
|
|
|
Lucentis
|
|
12
|
%
|
|
15
|
%
|
|
13
|
%
|
Elan
|
|
Tysabri
|
|
13
|
%
|
|
12
|
%
|
|
10
|
%
|
(Dollars in thousands, except for percentages)
|
|
2012
|
|
2011
|
|
Change from Prior Year %
|
|
2010
|
|
Change from Prior Year %
|
||||||||
General and administrative
|
|
$
|
25,469
|
|
|
$
|
18,338
|
|
|
39
|
%
|
|
$
|
41,396
|
|
|
(56
|
)%
|
Percentage of total revenues
|
|
7
|
%
|
|
5
|
%
|
|
|
|
12
|
%
|
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||
Legal settlement
|
|
$
|
—
|
|
|
$
|
—
|
|
|
0
|
%
|
|
$
|
92,500
|
|
|
N/M
|
|
Percentage of total revenues
|
|
0
|
%
|
|
0
|
%
|
|
|
|
27
|
%
|
|
|
(Dollars in thousands)
|
|
2012
|
|
2011
|
|
Change from Prior Year %
|
|
2010
|
|
Change from Prior Year %
|
||||||||
Loss on retirement or conversion of convertible notes
|
|
$
|
—
|
|
|
$
|
(766
|
)
|
|
N/A
|
|
|
$
|
(17,648
|
)
|
|
(96
|
)%
|
Interest and other income, net
|
|
7,113
|
|
|
593
|
|
|
1,099
|
%
|
|
468
|
|
|
27
|
%
|
|||
Interest expense
|
|
(29,036
|
)
|
|
(36,102
|
)
|
|
(20
|
)%
|
|
(43,529
|
)
|
|
(17
|
)%
|
|||
Total non-operating expense, net
|
|
$
|
(21,923
|
)
|
|
$
|
(36,275
|
)
|
|
(40
|
)%
|
|
$
|
(60,709
|
)
|
|
(40
|
)%
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Net income per basic share
|
$
|
1.52
|
|
|
$
|
1.43
|
|
|
$
|
0.73
|
|
Net income per diluted share
|
$
|
1.45
|
|
|
$
|
1.15
|
|
|
$
|
0.54
|
|
•
|
During any fiscal quarter commencing after the fiscal quarter ending December 31, 2011, if the closing price of the Company’s common stock for at least 20 trading days in a period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter exceeds 130% of the conversion price for the Series 2012 Notes on the last day of such preceding fiscal quarter;
|
•
|
During the five business-day period immediately after any five consecutive trading-day period in which the trading price per $1,000 principal amount of the Series 2012 Notes for each trading day of that measurement period was less than 98% of the product of the closing price of the Company’s common stock and the conversion rate for the Series 2012 Notes for that trading day;
|
•
|
Upon the occurrence of certain corporate transactions as provided in the indenture; or
|
•
|
Anytime, at the holder’s option, beginning on August 15, 2014.
|
•
|
During any fiscal quarter ending after the quarter ending June 30, 2011, if the last reported sale price of our common stock for at least 20 trading days in a period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter exceeds 130% of the conversion price for the notes on the last day of such preceding fiscal quarter;
|
•
|
During the five business-day period immediately after any five consecutive trading-day period, which we refer to as the measurement period, in which the trading price per $1,000 principal amount of notes for each trading day of that measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate for the notes for each such day;
|
•
|
Upon the occurrence of specified corporate events as described further in the indenture; or
|
•
|
At any time on or after November 1, 2014.
|
|
|
|
|
|
|
December 31, 2012
|
|
December 31, 2011
|
||||||||||||
Euro Forward Contracts
|
|
|
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||
Currency
|
|
Settlement Price
($ per Euro)
|
|
Type
|
|
Notional Amount
|
|
Fair Value
|
|
Notional Amount
|
|
Fair Value
|
||||||||
Euro
|
|
1.400
|
|
Sell Euro
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
25,150
|
|
|
$
|
1,837
|
|
Euro
|
|
1.200
|
|
Sell Euro
|
|
—
|
|
|
—
|
|
|
117,941
|
|
|
(9,783
|
)
|
||||
Euro
|
|
1.230
|
|
Sell Euro
|
|
27,553
|
|
|
(2,036
|
)
|
|
—
|
|
|
—
|
|
||||
Euro
|
|
1.240
|
|
Sell Euro
|
|
10,850
|
|
|
(726
|
)
|
|
—
|
|
|
—
|
|
||||
Euro
|
|
1.270
|
|
Sell Euro
|
|
44,450
|
|
|
(1,950
|
)
|
|
—
|
|
|
—
|
|
||||
Euro
|
|
1.281
|
|
Sell Euro
|
|
36,814
|
|
|
(1,331
|
)
|
|
—
|
|
|
—
|
|
||||
Euro
|
|
1.300
|
|
Sell Euro
|
|
91,000
|
|
|
(1,538
|
)
|
|
—
|
|
|
—
|
|
||||
Total
|
|
|
|
|
|
$
|
210,667
|
|
|
$
|
(7,581
|
)
|
|
$
|
143,091
|
|
|
$
|
(7,946
|
)
|
|
|
|
|
|
|
December 31, 2012
|
|
December 31, 2011
|
||||||||||||
Euro Option Contracts
|
|
|
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||
Currency
|
|
Strike Price
($ per Euro)
|
|
Type
|
|
Notional Amount
|
|
Fair Value
|
|
Notional Amount
|
|
Fair Value
|
||||||||
Euro
|
|
1.510
|
|
Purchased call option
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
27,126
|
|
|
$
|
—
|
|
Euro
|
|
1.315
|
|
Purchased call option
|
|
—
|
|
|
—
|
|
|
129,244
|
|
|
5,001
|
|
||||
Total
|
|
|
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
156,370
|
|
|
$
|
5,001
|
|
(In thousands)
|
|
2013
|
|
2014
|
|
2015
|
|
Total
|
|
Fair Value
|
|
||||||||||
Convertible notes
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Fixed Rate
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
335,250
|
|
|
$
|
335,250
|
|
|
$
|
410,487
|
|
(1)
|
Average Interest Rate
|
|
3.28
|
%
|
|
3.28
|
%
|
|
3.28
|
%
|
|
|
|
|
|
(1)
|
The fair value of the remaining payments under our convertible notes was estimated based on the trading value of these notes at
December 31, 2012
.
|
|
December 31,
|
||||||
|
2012
|
|
2011
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
131,212
|
|
|
$
|
168,544
|
|
Restricted investment
|
20,000
|
|
|
—
|
|
||
Short-term investments
|
17,477
|
|
|
42,301
|
|
||
Receivables from licensees
|
366
|
|
|
600
|
|
||
Deferred tax assets
|
1,613
|
|
|
10,054
|
|
||
Notes receivable
|
7,504
|
|
|
—
|
|
||
Prepaid and other current assets
|
4,813
|
|
|
12,014
|
|
||
Total current assets
|
182,985
|
|
|
233,513
|
|
||
Property and equipment, net
|
59
|
|
|
22
|
|
||
Long-term investments
|
—
|
|
|
17,101
|
|
||
Notes and other long-term receivables
|
85,704
|
|
|
—
|
|
||
Long-term deferred tax assets
|
4,552
|
|
|
11,481
|
|
||
Other assets
|
6,666
|
|
|
7,354
|
|
||
Total assets
|
$
|
279,966
|
|
|
$
|
269,471
|
|
Liabilities and Stockholders' Deficit
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,074
|
|
|
$
|
528
|
|
Accrued legal settlement
|
—
|
|
|
27,500
|
|
||
Accrued liabilities
|
9,400
|
|
|
11,609
|
|
||
Current portion of non-recourse notes payable
|
—
|
|
|
93,370
|
|
||
Total current liabilities
|
10,474
|
|
|
133,007
|
|
||
Convertible notes payable
|
309,952
|
|
|
316,615
|
|
||
Other long-term liabilities
|
27,662
|
|
|
24,122
|
|
||
Total liabilities
|
348,088
|
|
|
473,744
|
|
||
Commitments and contingencies (Note 11)
|
|
|
|
||||
Stockholders' deficit:
|
|
|
|
||||
Preferred stock, par value $0.01 per share, 10,000 shares authorized; no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, par value $0.01 per share, 250,000 shares authorized; 139,816 and 139,680 shares issued and outstanding at December 31, 2012 and 2011, respectively
|
1,398
|
|
|
1,397
|
|
||
Additional paid-in capital
|
(234,066
|
)
|
|
(161,750
|
)
|
||
Accumulated other comprehensive loss
|
(5,088
|
)
|
|
(1,885
|
)
|
||
Retained earnings (accumulated deficit)
|
169,634
|
|
|
(42,035
|
)
|
||
Total stockholders' deficit
|
(68,122
|
)
|
|
(204,273
|
)
|
||
Total liabilities and stockholders' deficit
|
$
|
279,966
|
|
|
$
|
269,471
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Royalties
|
$
|
374,525
|
|
|
$
|
351,641
|
|
|
$
|
343,475
|
|
License and other
|
—
|
|
|
10,400
|
|
|
1,500
|
|
|||
Total revenues
|
374,525
|
|
|
362,041
|
|
|
344,975
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
General and administrative
|
25,469
|
|
|
18,338
|
|
|
41,396
|
|
|||
Legal settlement
|
—
|
|
|
—
|
|
|
92,500
|
|
|||
Total operating expenses
|
25,469
|
|
|
18,338
|
|
|
133,896
|
|
|||
Operating income
|
349,056
|
|
|
343,703
|
|
|
211,079
|
|
|||
Non-operating expense, net
|
|
|
|
|
|
||||||
Loss on retirement or conversion of convertible notes
|
—
|
|
|
(766
|
)
|
|
(17,648
|
)
|
|||
Interest and other income, net
|
7,113
|
|
|
593
|
|
|
468
|
|
|||
Interest expense
|
(29,036
|
)
|
|
(36,102
|
)
|
|
(43,529
|
)
|
|||
Total non-operating expense, net
|
(21,923
|
)
|
|
(36,275
|
)
|
|
(60,709
|
)
|
|||
Income before income taxes
|
327,133
|
|
|
307,428
|
|
|
150,370
|
|
|||
Income tax expense
|
115,464
|
|
|
108,039
|
|
|
58,496
|
|
|||
Net income
|
$
|
211,669
|
|
|
$
|
199,389
|
|
|
$
|
91,874
|
|
Net income per share
|
|
|
|
|
|
||||||
Basic
|
$
|
1.52
|
|
|
$
|
1.43
|
|
|
$
|
0.73
|
|
Diluted
|
$
|
1.45
|
|
|
$
|
1.15
|
|
|
$
|
0.54
|
|
Weighted average shares outstanding
|
|
|
|
|
|
||||||
Basic
|
139,711
|
|
|
139,663
|
|
|
126,578
|
|
|||
Diluted
|
146,403
|
|
|
177,441
|
|
|
178,801
|
|
|||
Cash dividends declared per common share
|
$
|
0.60
|
|
|
$
|
0.60
|
|
|
$
|
1.00
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Net income
|
$
|
211,669
|
|
|
$
|
199,389
|
|
|
$
|
91,874
|
|
Other comprehensive income (loss), net of tax
|
|
|
|
|
|
||||||
Unrealized gains (losses) on investments in available-for-sale securities
(a)
|
(22
|
)
|
|
30
|
|
|
(1
|
)
|
|||
Unrealized gains (losses) on cash flow hedges
(b)
|
(3,181
|
)
|
|
(5,134
|
)
|
|
3,220
|
|
|||
Total other comprehensive income (loss), net of tax
|
(3,203
|
)
|
|
(5,104
|
)
|
|
3,219
|
|
|||
Comprehensive income
|
$
|
208,466
|
|
|
$
|
194,285
|
|
|
$
|
95,093
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Cash flows from operating activities
|
|
|
|
|
|
||||||
Net income
|
$
|
211,669
|
|
|
$
|
199,389
|
|
|
$
|
91,874
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
||||||
Amortization of convertible notes offering costs
|
12,481
|
|
|
5,386
|
|
|
1,682
|
|
|||
Amortization of non-recourse notes offering costs
|
1,226
|
|
|
4,533
|
|
|
7,238
|
|
|||
Other amortization and depreciation expense
|
946
|
|
|
1,405
|
|
|
330
|
|
|||
Loss on retirement or conversion of convertible notes
|
—
|
|
|
766
|
|
|
17,648
|
|
|||
Hedge adjustment - ineffectiveness and reclassifications from OCI for transactions not probable to occur
|
(257
|
)
|
|
—
|
|
|
—
|
|
|||
Stock-based compensation expense
|
937
|
|
|
387
|
|
|
662
|
|
|||
Tax benefit (expense) from stock-based compensation arrangements
|
—
|
|
|
(120
|
)
|
|
12,818
|
|
|||
Net excess tax benefit from stock-based compensation
|
(27
|
)
|
|
—
|
|
|
(12,924
|
)
|
|||
Deferred income taxes
|
11,338
|
|
|
31,217
|
|
|
(5,677
|
)
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Receivables from licensees
|
234
|
|
|
(131
|
)
|
|
581
|
|
|||
Prepaid and other current assets
|
4,138
|
|
|
(199
|
)
|
|
1,445
|
|
|||
Notes receivable
|
(2,882
|
)
|
|
—
|
|
|
—
|
|
|||
Other assets
|
(1,162
|
)
|
|
(6,639
|
)
|
|
182
|
|
|||
Accounts payable
|
546
|
|
|
(2,012
|
)
|
|
2,170
|
|
|||
Accrued legal settlement
|
(27,500
|
)
|
|
(37,500
|
)
|
|
65,000
|
|
|||
Accrued liabilities
|
62
|
|
|
239
|
|
|
(26,229
|
)
|
|||
Other long-term liabilities
|
(1,533
|
)
|
|
(26,939
|
)
|
|
27,500
|
|
|||
Net cash provided by operating activities
|
210,216
|
|
|
169,782
|
|
|
184,300
|
|
|||
Cash flows from investing activities
|
|
|
|
|
|
||||||
Purchases of investments
|
(29,898
|
)
|
|
(74,744
|
)
|
|
(46,668
|
)
|
|||
Maturities of investments
|
50,831
|
|
|
50,696
|
|
|
9,772
|
|
|||
Issuance of notes receivable
|
(95,300
|
)
|
|
—
|
|
|
—
|
|
|||
Repayment of notes receivable
|
5,000
|
|
|
—
|
|
|
—
|
|
|||
Purchase of property and equipment
|
(51
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash used in investing activities
|
(69,418
|
)
|
|
(24,048
|
)
|
|
(36,896
|
)
|
|||
Cash flows from financing activities
|
|
|
|
|
|
||||||
Retirement of convertible notes
|
—
|
|
|
(133,851
|
)
|
|
(108,247
|
)
|
|||
Repayment of non-recourse notes
|
(93,370
|
)
|
|
(110,900
|
)
|
|
(95,730
|
)
|
|||
Payment of debt issuance costs
|
(845
|
)
|
|
—
|
|
|
—
|
|
|||
Net proceeds from the issuance of convertible notes
|
—
|
|
|
149,712
|
|
|
82,039
|
|
|||
Purchase of call options
|
—
|
|
|
(20,765
|
)
|
|
—
|
|
|||
Proceeds from issuance of warrants
|
—
|
|
|
10,868
|
|
|
—
|
|
|||
Cash dividends paid
|
(83,942
|
)
|
|
(83,828
|
)
|
|
(130,043
|
)
|
|||
Excess tax benefit from stock-based compensation
|
27
|
|
|
—
|
|
|
12,924
|
|
|||
Net cash used in financing activities
|
(178,130
|
)
|
|
(188,764
|
)
|
|
(239,057
|
)
|
|||
Net decrease in cash and cash equivalents
|
(37,332
|
)
|
|
(43,030
|
)
|
|
(91,653
|
)
|
|||
Cash and cash equivalents at beginning of the year
|
168,544
|
|
|
211,574
|
|
|
303,227
|
|
|||
Cash and cash equivalents at end the year
|
$
|
131,212
|
|
|
$
|
168,544
|
|
|
$
|
211,574
|
|
|
Year Ended December 31,
|
||||||||||
|
2012
|
|
2011
|
|
2010
|
||||||
Supplemental cash flow information
|
|
|
|
|
|
||||||
Cash paid for income taxes
|
$
|
99,000
|
|
|
$
|
83,000
|
|
|
$
|
69,000
|
|
Cash paid for interest
|
$
|
15,754
|
|
|
$
|
25,627
|
|
|
$
|
40,622
|
|
Supplemental disclosures of non-cash financing activities
|
|
|
|
|
|
||||||
Conversion of convertible notes
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
111,680
|
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Retained Earnings (Accumulated Deficit)
|
|
Accumulated
Other Comprehensive
Income (Loss)
|
|
Total
Stockholders' Deficit |
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance at December 31, 2009
|
119,522,885
|
|
|
$
|
1,195
|
|
|
$
|
(83,850
|
)
|
|
$
|
(333,298
|
)
|
|
$
|
—
|
|
|
$
|
(415,953
|
)
|
Issuance of common stock for convertible debt
|
19,969,069
|
|
|
200
|
|
|
112,675
|
|
|
—
|
|
|
—
|
|
|
112,875
|
|
|||||
Issuance of common stock under employee benefit plans
|
148,198
|
|
|
1
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation expense for employees
|
—
|
|
|
—
|
|
|
662
|
|
|
—
|
|
|
—
|
|
|
662
|
|
|||||
Tax benefit from employee stock options
|
—
|
|
|
—
|
|
|
12,818
|
|
|
—
|
|
|
—
|
|
|
12,818
|
|
|||||
Dividends declared
|
—
|
|
|
—
|
|
|
(129,677
|
)
|
|
—
|
|
|
—
|
|
|
(129,677
|
)
|
|||||
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
91,874
|
|
|
—
|
|
|
91,874
|
|
|||||
Change in unrealized gains and losses on investments in available-for-sale securities, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
(1
|
)
|
|||||
Change in unrealized gains on cash flow hedges, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,220
|
|
|
3,220
|
|
|||||
Total comprehensive income
|
|
|
|
|
|
|
|
|
|
|
95,093
|
|
||||||||||
Balance at December 31, 2010
|
139,640,152
|
|
|
1,396
|
|
|
(87,373
|
)
|
|
(241,424
|
)
|
|
3,219
|
|
|
(324,182
|
)
|
|||||
Issuance of common stock under employee benefit plans
|
39,600
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|||||
Issuance of convertible debt
|
—
|
|
|
—
|
|
|
11,870
|
|
|
—
|
|
|
—
|
|
|
11,870
|
|
|||||
Purchase of purchased call options, net of tax
|
—
|
|
|
—
|
|
|
(13,522
|
)
|
|
—
|
|
|
—
|
|
|
(13,522
|
)
|
|||||
Proceeds from the sale of warrants
|
—
|
|
|
—
|
|
|
10,868
|
|
|
—
|
|
|
—
|
|
|
10,868
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
387
|
|
|
—
|
|
|
—
|
|
|
387
|
|
|||||
Tax expense from stock options
|
—
|
|
|
—
|
|
|
(120
|
)
|
|
—
|
|
|
—
|
|
|
(120
|
)
|
|||||
Dividends declared
|
—
|
|
|
—
|
|
|
(83,860
|
)
|
|
—
|
|
|
—
|
|
|
(83,860
|
)
|
|||||
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
199,389
|
|
|
—
|
|
|
199,389
|
|
|||||
Change in unrealized gains and losses on investments in available-for-sale securities, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
30
|
|
|
30
|
|
|||||
Changes in unrealized gains and losses on cash flow hedges, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(5,134
|
)
|
|
(5,134
|
)
|
|||||
Total comprehensive income
|
|
|
|
|
|
|
|
|
|
|
194,285
|
|
||||||||||
Balance at December 31, 2011
|
139,679,752
|
|
|
1,397
|
|
|
(161,750
|
)
|
|
(42,035
|
)
|
|
(1,885
|
)
|
|
(204,273
|
)
|
|||||
Issuance of common stock under employee benefit plans
|
136,507
|
|
1
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of convertible debt
|
—
|
|
|
—
|
|
|
10,692
|
|
|
—
|
|
|
—
|
|
|
10,692
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
937
|
|
|
—
|
|
|
—
|
|
|
937
|
|
|||||
Dividends declared
|
—
|
|
|
—
|
|
|
(83,944
|
)
|
|
—
|
|
|
—
|
|
|
(83,944
|
)
|
|||||
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
211,669
|
|
|
—
|
|
|
211,669
|
|
|||||
Change in unrealized gains and losses on investments in available-for-sale securities, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(22
|
)
|
|
(22
|
)
|
|||||
Changes in unrealized gains and losses on cash flow hedges, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,181
|
)
|
|
(3,181
|
)
|
|||||
Total comprehensive income
|
|
|
|
|
|
|
|
|
|
|
208,466
|
|
||||||||||
Balance at December 31, 2012
|
139,816,259
|
|
|
$
|
1,398
|
|
|
$
|
(234,066
|
)
|
|
$
|
169,634
|
|
|
$
|
(5,088
|
)
|
|
$
|
(68,122
|
)
|
Licensee
|
|
Product Names
|
Genentech
|
|
Avastin
®
|
|
|
Herceptin
®
|
|
|
Xolair
®
|
|
|
Lucentis
®
|
|
|
Perjeta
®
|
Elan
|
|
Tysabri
®
|
Chugai
|
|
Actemra
®
|
Leasehold improvements
|
|
Shorter of asset life or term of lease
|
Computer and office equipment
|
|
3 years
|
Furniture and fixtures
|
|
7 years
|
|
Year Ended December 31,
|
||||||||||
(In thousands, except per share amounts)
|
2012
|
|
2011
|
|
2010
|
||||||
Numerator
|
|
|
|
|
|
||||||
Net income
|
$
|
211,669
|
|
|
$
|
199,389
|
|
|
$
|
91,874
|
|
Add back interest expense for convertible notes, net of estimated tax of $25,000, $3.0 million and $2.7 million, for the years ended December 31, 2012, 2011 and 2010, respectively (see Note 12)
|
46
|
|
|
5,544
|
|
|
5,087
|
|
|||
Income used to compute net income per diluted share
|
$
|
211,715
|
|
|
$
|
204,933
|
|
|
$
|
96,961
|
|
Denominator
|
|
|
|
|
|
||||||
Total weighted-average shares used to compute net income per basic share
|
139,711
|
|
|
139,663
|
|
|
126,578
|
|
|||
Effect of dilutive stock options
|
95
|
|
|
13
|
|
|
9
|
|
|||
Restricted stock outstanding
|
17
|
|
|
25
|
|
|
103
|
|
|||
Assumed conversion of Series 2012 notes
|
4,944
|
|
|
—
|
|
|
—
|
|
|||
Assumed conversion of 2012 notes
|
—
|
|
|
9,790
|
|
|
29,870
|
|
|||
Assumed conversion of February 2015 notes
|
631
|
|
|
27,950
|
|
|
4,229
|
|
|||
Assumed conversion of May 2015 notes
|
1,005
|
|
|
—
|
|
|
—
|
|
|||
Assumed conversion of 2023 notes
|
—
|
|
|
—
|
|
|
18,012
|
|
|||
Shares used to compute net income per diluted share
|
146,403
|
|
|
177,441
|
|
|
178,801
|
|
|||
Net income per basic share
|
$
|
1.52
|
|
|
$
|
1.43
|
|
|
$
|
0.73
|
|
Net income per diluted share
|
$
|
1.45
|
|
|
$
|
1.15
|
|
|
$
|
0.54
|
|
|
|
December 31, 2012
|
|
December 31, 2011
|
||||||||||||||||||||
(In thousands)
|
|
Level 1
|
|
Level 2
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Total
|
||||||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Money market funds
|
|
$
|
121,095
|
|
|
$
|
—
|
|
|
$
|
121,095
|
|
|
$
|
163,368
|
|
|
$
|
—
|
|
|
$
|
163,368
|
|
Certificates of deposit
|
|
—
|
|
|
26,128
|
|
|
26,128
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Corporate debt securities
|
|
—
|
|
|
13,572
|
|
|
13,572
|
|
|
—
|
|
|
44,877
|
|
|
44,877
|
|
||||||
Commercial paper
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8,996
|
|
|
8,996
|
|
||||||
U.S. government sponsored agency bonds
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,015
|
|
|
—
|
|
|
2,015
|
|
||||||
U.S. treasury securities
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,513
|
|
|
—
|
|
|
5,513
|
|
||||||
Foreign currency hedge contracts
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,838
|
|
|
6,838
|
|
||||||
Total
|
|
$
|
121,095
|
|
|
$
|
39,700
|
|
|
$
|
160,795
|
|
|
$
|
170,896
|
|
|
$
|
60,711
|
|
|
$
|
231,607
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Foreign currency hedge contracts
|
|
$
|
—
|
|
|
$
|
7,581
|
|
|
$
|
7,581
|
|
|
$
|
—
|
|
|
$
|
9,783
|
|
|
$
|
9,783
|
|
|
|
December 31, 2012
|
|
December 31, 2011
|
||||||||||||||||||||
|
|
Carrying Value
|
|
Level 2
|
|
Level 3
|
|
Carrying Value
|
|
Level 2
|
|
Level 3
|
||||||||||||
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Wellstat Diagnostics note receivable
|
|
$
|
41,098
|
|
|
$
|
—
|
|
|
$
|
41,098
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Merus Labs note receivable
|
|
30,000
|
|
|
30,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
AxoGen note receivable
|
|
22,110
|
|
|
—
|
|
|
22,110
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Total
|
|
$
|
93,208
|
|
|
$
|
30,000
|
|
|
$
|
63,208
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Series 2012 Notes
|
|
$
|
165,528
|
|
|
$
|
227,187
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
May 2015 Notes
|
|
143,433
|
|
|
182,031
|
|
|
—
|
|
|
138,952
|
|
|
156,123
|
|
|
—
|
|
||||||
February 2015 Notes
|
|
991
|
|
|
1,269
|
|
|
—
|
|
|
177,663
|
|
|
191,475
|
|
|
—
|
|
||||||
Non-recourse Notes
|
|
—
|
|
|
—
|
|
|
—
|
|
|
93,370
|
|
|
95,237
|
|
|
—
|
|
||||||
Total
|
|
$
|
309,952
|
|
|
$
|
410,487
|
|
|
$
|
—
|
|
|
$
|
409,985
|
|
|
$
|
442,835
|
|
|
$
|
—
|
|
Summary of Cash and Available-For-Sale Securities
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
|
Cash and Cash Equivalents
|
|
Restricted Investment
|
|
Short-Term Marketable Securities
|
|
Long-Term Marketable Securities
|
||||||||||||||||
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
December 31, 2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Cash
|
|
$
|
7,894
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,894
|
|
|
$
|
7,894
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Money market funds
|
|
121,095
|
|
|
—
|
|
|
—
|
|
|
121,095
|
|
|
121,095
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Certificates of deposit
|
|
26,128
|
|
|
—
|
|
|
—
|
|
|
26,128
|
|
|
2,223
|
|
|
20,000
|
|
|
3,905
|
|
|
—
|
|
||||||||
Corporate debt securities
|
|
13,562
|
|
|
10
|
|
|
—
|
|
|
13,572
|
|
|
—
|
|
|
—
|
|
|
13,572
|
|
|
—
|
|
||||||||
Total
|
|
$
|
168,679
|
|
|
$
|
10
|
|
|
$
|
—
|
|
|
$
|
168,689
|
|
|
$
|
131,212
|
|
|
$
|
20,000
|
|
|
$
|
17,477
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
December 31, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Cash
|
|
$
|
3,177
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,177
|
|
|
$
|
3,177
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Money market funds
|
|
163,368
|
|
|
—
|
|
|
—
|
|
|
163,368
|
|
|
163,368
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Corporate debt securities
|
|
44,863
|
|
|
57
|
|
|
(43
|
)
|
|
44,877
|
|
|
—
|
|
|
—
|
|
|
27,776
|
|
|
17,101
|
|
||||||||
Commercial paper
|
|
8,997
|
|
|
—
|
|
|
(1
|
)
|
|
8,996
|
|
|
1,999
|
|
|
—
|
|
|
6,997
|
|
|
—
|
|
||||||||
U.S. government sponsored agency bonds
|
|
2,003
|
|
|
12
|
|
|
—
|
|
|
2,015
|
|
|
—
|
|
|
—
|
|
|
2,015
|
|
|
—
|
|
||||||||
U.S. treasury securities
|
|
5,494
|
|
|
19
|
|
|
—
|
|
|
5,513
|
|
|
—
|
|
|
—
|
|
|
5,513
|
|
|
—
|
|
||||||||
Total
|
|
$
|
227,902
|
|
|
$
|
88
|
|
|
$
|
(44
|
)
|
|
$
|
227,946
|
|
|
$
|
168,544
|
|
|
$
|
—
|
|
|
$
|
42,301
|
|
|
$
|
17,101
|
|
Cash and Available-For-Sale Securities by Contractual Maturity
|
|
December 31,
2012 |
|
December 31,
2011 |
||||||||||||
(In thousands)
|
|
Amortized Cost
|
|
Fair Value
|
|
Amortized Cost
|
|
Fair Value
|
||||||||
Less than one year
|
|
$
|
168,679
|
|
|
$
|
168,689
|
|
|
$
|
210,807
|
|
|
$
|
210,845
|
|
Greater than one year but less than five years
|
|
—
|
|
|
—
|
|
|
17,095
|
|
|
17,101
|
|
||||
Total
|
|
$
|
168,679
|
|
|
$
|
168,689
|
|
|
$
|
227,902
|
|
|
$
|
227,946
|
|
Euro Forward Contracts
|
|
|
|
December 31, 2012
|
|
December 31, 2011
|
||||||||||||||
|
|
|
|
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
Currency
|
|
Settlement Price
($ per Euro)
|
|
Type
|
|
Notional Amount
|
|
Fair Value
|
|
Notional Amount
|
|
Fair Value
|
||||||||
Euro
|
|
1.400
|
|
Sell Euro
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
25,150
|
|
|
$
|
1,837
|
|
Euro
|
|
1.200
|
|
Sell Euro
|
|
—
|
|
|
—
|
|
|
117,941
|
|
|
(9,783
|
)
|
||||
Euro
|
|
1.230
|
|
Sell Euro
|
|
27,553
|
|
|
(2,036
|
)
|
|
—
|
|
|
—
|
|
||||
Euro
|
|
1.240
|
|
Sell Euro
|
|
10,850
|
|
|
(726
|
)
|
|
—
|
|
|
—
|
|
||||
Euro
|
|
1.270
|
|
Sell Euro
|
|
44,450
|
|
|
(1,950
|
)
|
|
—
|
|
|
—
|
|
||||
Euro
|
|
1.281
|
|
Sell Euro
|
|
36,814
|
|
|
(1,331
|
)
|
|
—
|
|
|
—
|
|
||||
Euro
|
|
1.300
|
|
Sell Euro
|
|
91,000
|
|
|
(1,538
|
)
|
|
—
|
|
|
—
|
|
||||
Total
|
|
|
|
|
|
$
|
210,667
|
|
|
$
|
(7,581
|
)
|
|
$
|
143,091
|
|
|
$
|
(7,946
|
)
|
Euro Option Contracts
|
|
|
|
December 31, 2012
|
|
December 31, 2011
|
||||||||||||||
|
|
|
|
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
Currency
|
|
Strike Price
($ per Euro)
|
|
Type
|
|
Notional Amount
|
|
Fair Value
|
|
Notional Amount
|
|
Fair Value
|
||||||||
Euro
|
|
1.510
|
|
Purchased call option
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
27,126
|
|
|
$
|
—
|
|
Euro
|
|
1.315
|
|
Purchased call option
|
|
—
|
|
|
—
|
|
|
129,244
|
|
|
5,001
|
|
||||
Total
|
|
|
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
156,370
|
|
|
$
|
5,001
|
|
|
|
|
|
December 31,
|
||||||
Cash Flow Hedge
|
|
Location
|
|
2012
|
|
2011
|
||||
(In thousands)
|
|
|
|
|
|
|
||||
Euro contracts
|
|
Prepaid and other current assets
|
|
$
|
—
|
|
|
$
|
1,837
|
|
Euro contracts
|
|
Accrued liabilities
|
|
$
|
3,574
|
|
|
$
|
4,134
|
|
Euro contracts
|
|
Other long-term liabilities
|
|
$
|
4,007
|
|
|
$
|
648
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2012
|
|
2011
|
|
2010
|
||||||
(In thousands)
|
|
|
|
|
|
|
||||||
Net gain (loss) recognized in OCI, net of tax
(1)
|
|
$
|
(5,040
|
)
|
|
$
|
(4,470
|
)
|
|
$
|
5,134
|
|
Gain (loss) reclassified from accumulated OCI into royalty revenue, net of tax
(2)
|
|
$
|
(1,859
|
)
|
|
$
|
664
|
|
|
$
|
1,914
|
|
Net loss recognized in interest and other income, net -- cash flow hedges
(3)
|
|
$
|
(169
|
)
|
|
$
|
(19
|
)
|
|
$
|
—
|
|
Net gain recognized in interest and other income, net -- non-designated contracts
(4)
|
|
$
|
391
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Amount excluded from effectiveness testing
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
December 31,
|
||||||
(In thousands)
|
|
2012
|
|
2011
|
||||
Non-recourse Notes issuance costs
|
|
$
|
—
|
|
|
$
|
1,226
|
|
Foreign currency exchange
|
|
—
|
|
|
1,837
|
|
||
Prepaid income taxes
|
|
3,351
|
|
|
8,297
|
|
||
Other
|
|
1,462
|
|
|
654
|
|
||
Total
|
|
$
|
4,813
|
|
|
$
|
12,014
|
|
|
|
December 31,
|
||||||
(In thousands)
|
|
2012
|
|
2011
|
||||
Leasehold improvements
|
|
$
|
127
|
|
|
$
|
112
|
|
Computer and office equipment
|
|
8,993
|
|
|
8,989
|
|
||
Furniture and fixtures
|
|
38
|
|
|
38
|
|
||
Total
|
|
9,158
|
|
|
9,139
|
|
||
Less accumulated depreciation and amortization
|
|
(9,131
|
)
|
|
(9,117
|
)
|
||
Construction in progress
|
|
32
|
|
|
—
|
|
||
Property and equipment, net
|
|
$
|
59
|
|
|
$
|
22
|
|
|
|
December 31,
|
||||||
(In thousands)
|
|
2012
|
|
2011
|
||||
Compensation
|
|
$
|
594
|
|
|
$
|
1,341
|
|
Interest
|
|
2,925
|
|
|
3,351
|
|
||
Deferred revenue
|
|
—
|
|
|
1,713
|
|
||
Foreign currency hedge
|
|
3,574
|
|
|
4,134
|
|
||
Dividend payable
|
|
53
|
|
|
52
|
|
||
Legal
|
|
2,020
|
|
|
673
|
|
||
Other
|
|
234
|
|
|
345
|
|
||
Total
|
|
$
|
9,400
|
|
|
$
|
11,609
|
|
(In thousands)
|
|
|
||
2013
|
|
$
|
285
|
|
2014
|
|
84
|
|
|
Total
|
|
$
|
369
|
|
(In thousands)
|
|
2012
Notes
|
|
Series
2012
Notes
|
|
May
2015
Notes
|
|
February
2015
Notes
|
|
Non-recourse
Notes
|
|
Total
|
||||||||||||
Balance at December 31, 2010
|
|
$
|
133,464
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
176,964
|
|
|
$
|
204,270
|
|
|
$
|
514,698
|
|
Issuance
|
|
—
|
|
|
—
|
|
|
136,313
|
|
|
—
|
|
|
—
|
|
|
136,313
|
|
||||||
Payment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(110,900
|
)
|
|
(110,900
|
)
|
||||||
Repurchase
|
|
(133,464
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(133,464
|
)
|
||||||
Discount amortization
|
|
—
|
|
|
—
|
|
|
2,639
|
|
|
699
|
|
|
—
|
|
|
3,338
|
|
||||||
Balance at December 31, 2011
|
|
—
|
|
|
—
|
|
|
138,952
|
|
|
177,663
|
|
|
93,370
|
|
|
409,985
|
|
||||||
Issuance and exchange
|
|
—
|
|
|
176,679
|
|
|
—
|
|
|
(176,679
|
)
|
|
—
|
|
|
—
|
|
||||||
Payment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(93,370
|
)
|
|
(93,370
|
)
|
||||||
Non-cash discount
|
|
—
|
|
|
(16,833
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,833
|
)
|
||||||
Discount amortization
|
|
—
|
|
|
5,682
|
|
|
4,481
|
|
|
7
|
|
|
—
|
|
|
10,170
|
|
||||||
Balance at December 31, 2012
|
|
$
|
—
|
|
|
$
|
165,528
|
|
|
$
|
143,433
|
|
|
$
|
991
|
|
|
$
|
—
|
|
|
$
|
309,952
|
|
•
|
During any fiscal quarter commencing after the fiscal quarter ending December 31, 2011, if the closing price of the Company’s common stock for at least 20 trading days in a period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter exceeds 130% of the conversion price for the Series 2012 Notes on the last day of such preceding fiscal quarter;
|
•
|
During the five business-day period immediately after any five consecutive trading-day period in which the trading price per $1,000 principal amount of the Series 2012 Notes for each trading day of that measurement period was less than 98% of the product of the closing price of the Company’s common stock and the conversion rate for the Series 2012 Notes for that trading day;
|
•
|
Upon the occurrence of certain corporate transactions as provided in the indenture; or
|
•
|
Anytime, at the holder’s option, beginning on August 15, 2014.
|
|
|
December 31,
|
||||||
(In thousands)
|
|
2012
|
|
2011
|
||||
Principal amount of the Series 2012 Notes
|
|
$
|
179,000
|
|
|
$
|
—
|
|
Unamortized discount of liability component
|
|
(13,472
|
)
|
|
—
|
|
||
Net carrying value of the Series 2012 Notes
|
|
$
|
165,528
|
|
|
$
|
—
|
|
|
|
Year ended December 31,
|
||||||||||
(In thousands)
|
|
2012
|
|
2011
|
|
2010
|
||||||
Contractual coupon interest
|
|
$
|
5,122
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Amortization of debt issuance costs
|
|
1,107
|
|
|
—
|
|
|
—
|
|
|||
Amortization of debt discount
|
|
5,682
|
|
|
—
|
|
|
—
|
|
|||
Total
|
|
$
|
11,911
|
|
|
$
|
—
|
|
|
$
|
—
|
|
•
|
During any fiscal quarter ending after the quarter ending June 30, 2011, if the last reported sale price of our common stock for at least 20 trading days in a period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter exceeds 130% of the conversion price for the notes on the last day of such preceding fiscal quarter;
|
•
|
During the five business-day period immediately after any five consecutive trading-day period, which we refer to as the measurement period, in which the trading price per $1,000 principal amount of notes for each trading day of that measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate for the notes for each such day;
|
•
|
Upon the occurrence of specified corporate events as described further in the indenture; or
|
•
|
At any time on or after November 1, 2014.
|
|
|
December 31,
|
||||||
(In thousands)
|
|
2012
|
|
2011
|
||||
Principal amount of the May 2015 Notes
|
|
$
|
155,250
|
|
|
$
|
155,250
|
|
Unamortized discount of liability component
|
|
(11,817
|
)
|
|
(16,298
|
)
|
||
Net carrying value of the May 2015 Notes
|
|
$
|
143,433
|
|
|
$
|
138,952
|
|
|
|
Year Ended December 31,
|
||||||||||
(In thousands)
|
|
2012
|
|
2011
|
|
2010
|
||||||
Contractual coupon interest
|
|
$
|
5,822
|
|
|
$
|
3,639
|
|
|
$
|
—
|
|
Amortization of debt issuance costs
|
|
1,193
|
|
|
727
|
|
|
—
|
|
|||
Amortization of debt discount
|
|
4,481
|
|
|
2,639
|
|
|
—
|
|
|||
Total
|
|
$
|
11,496
|
|
|
$
|
7,005
|
|
|
$
|
—
|
|
(In thousands)
|
|
Series
2012
Notes
|
|
May
2015
Notes
|
|
February
2015
Notes
|
|
Total
|
||||||||
2013
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
2014
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
2015
|
|
179,000
|
|
|
155,250
|
|
|
1,000
|
|
|
335,250
|
|
||||
Total
|
|
$
|
179,000
|
|
|
$
|
155,250
|
|
|
$
|
1,000
|
|
|
$
|
335,250
|
|
|
|
December 31,
|
||||||
(In thousands)
|
|
2012
|
|
2011
|
||||
Accrued lease liability
|
|
$
|
10,700
|
|
|
$
|
10,700
|
|
Uncertain tax position
|
|
12,955
|
|
|
12,774
|
|
||
Foreign currency hedge
|
|
4,007
|
|
|
648
|
|
||
Total
|
|
$
|
27,662
|
|
|
$
|
24,122
|
|
|
|
Year Ended December 31,
|
||||||||||
Stock-based Compensation
|
|
2012
|
|
2011
|
|
2010
|
||||||
(In thousands)
|
|
|
|
|
|
|
||||||
Employees and directors
|
|
$
|
650
|
|
|
$
|
337
|
|
|
$
|
662
|
|
Non-employees
|
|
287
|
|
|
50
|
|
|
—
|
|
|||
Total
|
|
$
|
937
|
|
|
$
|
387
|
|
|
$
|
662
|
|
Title of Plan
|
|
Total Shares of Common Stock Authorized
|
|
Total Shares of Common Stock Issued
|
|
Total Shares of Common Stock
Subject to
Outstanding Awards
|
|
Total Shares of Common Stock Available for Grant
|
||||
2005 Equity Incentive Plan
(1)
|
|
5,200,000
|
|
|
610,579
|
|
|
—
|
|
|
4,589,421
|
|
2002 Outside Directors Stock Option Plan
(2)
|
|
157,000
|
|
|
140,750
|
|
|
16,250
|
|
|
—
|
|
1999 Non-statutory Stock Option Plan
(2)
|
|
5,072,683
|
|
|
4,966,183
|
|
|
106,500
|
|
|
—
|
|
1999 Stock Option Plan
(2)
|
|
3,726,719
|
|
|
3,653,150
|
|
|
73,569
|
|
|
—
|
|
(1)
|
As of
December 31, 2012
, there were
120,436
shares of unvested restricted stock awards outstanding.
|
(2)
|
Plan terminated in 2009, subject to options outstanding under the plan.
|
|
|
2012
|
|
|
|
2011
|
|
|
|
2010
|
|
|
|||||||||
|
|
Number of shares
(in thousands)
|
|
Weighted-Average Exercise Price
|
|
Number of shares
(in thousands)
|
|
Weighted-Average Exercise Price
|
|
Number of shares
(in thousands)
|
|
Weighted-Average Exercise Price
|
|||||||||
Outstanding at beginning of year
|
|
231
|
|
|
$
|
16.62
|
|
|
274
|
|
|
$
|
17.25
|
|
|
1,564
|
|
|
$
|
19.82
|
|
Expired
|
|
(35
|
)
|
|
$
|
18.83
|
|
|
(43
|
)
|
|
$
|
20.67
|
|
|
(1,290
|
)
|
|
$
|
20.36
|
|
Outstanding at end of year
|
|
196
|
|
|
$
|
16.22
|
|
|
231
|
|
|
$
|
16.62
|
|
|
274
|
|
|
$
|
17.25
|
|
Exercisable at end of year
|
|
196
|
|
|
$
|
16.22
|
|
|
231
|
|
|
$
|
16.62
|
|
|
274
|
|
|
$
|
17.25
|
|
|
2012
|
|
|
|
2011
|
|
|
|
2010
|
|
|
|||||||||
|
Number of shares
(in thousands)
|
|
Weighted-average grant-date fair value per share
|
|
Number of shares
(in thousands)
|
|
Weighted-average grant-date fair value per share
|
|
Number of shares
(in thousands)
|
|
Weighted- average grant-date fair value per share
|
|||||||||
Nonvested at beginning of year
|
137
|
|
|
$
|
6.09
|
|
|
40
|
|
|
$
|
5.05
|
|
|
148
|
|
|
$
|
6.54
|
|
Awards granted
|
139
|
|
|
$
|
6.49
|
|
|
155
|
|
|
$
|
6.15
|
|
|
40
|
|
|
$
|
5.05
|
|
Awards vested
|
(137
|
)
|
|
$
|
6.09
|
|
|
(40
|
)
|
|
$
|
5.05
|
|
|
(148
|
)
|
|
$
|
6.54
|
|
Forfeited
|
(19
|
)
|
|
$
|
6.35
|
|
|
(18
|
)
|
|
$
|
6.59
|
|
|
—
|
|
|
|
||
Nonvested at end of year
|
120
|
|
|
$
|
6.51
|
|
|
137
|
|
|
$
|
6.09
|
|
|
40
|
|
|
$
|
5.05
|
|
|
|
Year Ended December 31,
|
||||||||||
(In thousands)
|
|
2012
|
|
2011
|
|
2010
|
||||||
Current income tax expense
|
|
|
|
|
|
|
||||||
Federal
|
|
$
|
104,152
|
|
|
$
|
83,569
|
|
|
$
|
91,325
|
|
State
|
|
1
|
|
|
1
|
|
|
11
|
|
|||
Total current
|
|
104,153
|
|
|
83,570
|
|
|
91,336
|
|
|||
Deferred income tax expense (benefit)
|
|
11,311
|
|
|
24,469
|
|
|
(32,840
|
)
|
|||
Total provision
|
|
$
|
115,464
|
|
|
$
|
108,039
|
|
|
$
|
58,496
|
|
|
|
Year Ended December 31,
|
||||||||||
(In thousands)
|
|
2012
|
|
2011
|
|
2010
|
||||||
Tax at U.S. statutory rate on income before income taxes
|
|
$
|
114,496
|
|
|
$
|
107,600
|
|
|
$
|
52,630
|
|
Change in valuation allowance
|
|
—
|
|
|
—
|
|
|
296
|
|
|||
State taxes
|
|
1
|
|
|
1
|
|
|
11
|
|
|||
Non-deductible loss on retirement or conversion of convertible notes
|
|
—
|
|
|
—
|
|
|
4,960
|
|
|||
Other
|
|
967
|
|
|
438
|
|
|
599
|
|
|||
Total
|
|
$
|
115,464
|
|
|
$
|
108,039
|
|
|
$
|
58,496
|
|
|
|
December 31,
|
||||||
(In thousands)
|
|
2012
|
|
2011
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Net operating loss carryforwards
|
|
$
|
6,686
|
|
|
$
|
7,308
|
|
Research and other tax credits
|
|
15,205
|
|
|
5,743
|
|
||
Intangible assets
|
|
5,487
|
|
|
7,403
|
|
||
Stock-based compensation
|
|
222
|
|
|
273
|
|
||
Reserves and accruals
|
|
229
|
|
|
10,087
|
|
||
Deferred revenue
|
|
—
|
|
|
600
|
|
||
Unrealized loss on foreign currency hedge contracts
|
|
2,740
|
|
|
1,031
|
|
||
Other
|
|
227
|
|
|
974
|
|
||
Total deferred tax assets
|
|
30,796
|
|
|
33,419
|
|
||
Valuation allowance
|
|
(20,392
|
)
|
|
(10,930
|
)
|
||
Total deferred tax assets, net of valuation allowances
|
|
10,404
|
|
|
22,489
|
|
||
Deferred tax liabilities:
|
|
|
|
|
||||
Deferred gain on repurchase of convertible notes
|
|
(954
|
)
|
|
(954
|
)
|
||
Debt modifications
|
|
(3,285
|
)
|
|
—
|
|
||
Total deferred tax liabilities
|
|
(4,239
|
)
|
|
(954
|
)
|
||
Net deferred tax assets
|
|
$
|
6,165
|
|
|
$
|
21,535
|
|
|
|
December 31,
|
||||||
(In thousands)
|
|
2012
|
|
2011
|
||||
Balance at the beginning of the year
|
|
$
|
23,061
|
|
|
$
|
23,061
|
|
Increases related to tax positions from prior fiscal years
|
|
4,029
|
|
|
—
|
|
||
Increases related to tax positions taken during current fiscal year
|
|
5,557
|
|
|
—
|
|
||
Expiration of statute of limitations for the assessment of taxes
|
|
—
|
|
|
—
|
|
||
Balance at the end of the year
|
|
$
|
32,647
|
|
|
$
|
23,061
|
|
|
|
Unrealized gain
(loss) on
available-for-
sale securities
|
|
Unrealized
gain (loss) on
cash flow
hedges
|
|
Total Accumulated
Other
Comprehensive
Income (Loss)
|
||||||
(In thousands)
|
|
|
|
|
|
|
||||||
Beginning Balance at December 31, 2009
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Activity for the year ended December 31, 2010
|
|
(1
|
)
|
|
3,220
|
|
|
3,219
|
|
|||
Balance at December 31, 2010
|
|
(1
|
)
|
|
3,220
|
|
|
3,219
|
|
|||
|
|
|
|
|
|
|
||||||
Activity for the year ended December 31, 2011
|
|
30
|
|
|
(5,134
|
)
|
|
(5,104
|
)
|
|||
Balance at December 31, 2011
|
|
29
|
|
|
(1,914
|
)
|
|
(1,885
|
)
|
|||
|
|
|
|
|
|
|
||||||
Activity for the year ended December 31, 2012
|
|
(22
|
)
|
|
(3,181
|
)
|
|
(3,203
|
)
|
|||
Ending Balance at December 31, 2012
|
|
$
|
7
|
|
|
$
|
(5,095
|
)
|
|
$
|
(5,088
|
)
|
|
|
2012 Quarter Ended
|
||||||||||||||
(In thousands, except per share data)
|
|
December 31
|
|
September 30
|
|
June 30
|
|
March 31
|
||||||||
Revenues
|
|
$
|
86,046
|
|
|
$
|
85,231
|
|
|
$
|
125,904
|
|
|
$
|
77,344
|
|
Net income
|
|
$
|
49,408
|
|
|
$
|
48,575
|
|
|
$
|
73,502
|
|
|
$
|
40,184
|
|
Net income per basic share
|
|
$
|
0.35
|
|
|
$
|
0.35
|
|
|
$
|
0.53
|
|
|
$
|
0.29
|
|
Net income per diluted share
|
|
$
|
0.34
|
|
|
$
|
0.32
|
|
|
$
|
0.52
|
|
|
$
|
0.29
|
|
|
|
2011 Quarter Ended
|
||||||||||||||
(In thousands, except per share data)
|
|
December 31
|
|
September 30
|
|
June 30
|
|
March 31
|
||||||||
Revenues
|
|
$
|
72,808
|
|
|
$
|
83,770
|
|
|
$
|
122,127
|
|
|
$
|
83,336
|
|
Net income
|
|
$
|
38,942
|
|
|
$
|
45,916
|
|
|
$
|
69,986
|
|
|
$
|
44,545
|
|
Net income per basic share
|
|
$
|
0.28
|
|
|
$
|
0.33
|
|
|
$
|
0.50
|
|
|
$
|
0.32
|
|
Net income per diluted share
|
|
$
|
0.24
|
|
|
$
|
0.28
|
|
|
$
|
0.38
|
|
|
$
|
0.25
|
|
|
|
/s/ ERNST & YOUNG LLP
|
|
|
|
/s/ ERNST & YOUNG LLP
|
|
(a)
|
The following documents are filed as part of this report:
|
(1)
|
Index to financial statements
|
Item
|
Page
|
(2)
|
The financial statement schedules are omitted because the information is inapplicable or presented in our Consolidated Financial Statements or notes.
|
(3)
|
Index to Exhibits
|
Exhibit
Number
|
Exhibit Title
|
|
|
2.1
|
Separation and Distribution Agreement, dated December 17, 2008, between the Company and Facet Biotech Corporation (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed December 23, 2008)
|
|
|
2.2
|
Amendment No. 1 to Separation and Distribution Agreement, dated January 20, 2009, between the Company and Facet Biotech Corporation (incorporated by reference to Exhibit 2.2 to Annual Report on Form 10-K filed March 2, 2009)
|
|
|
3.1
|
Restated Certificate of Incorporation effective March 23, 1993 (incorporated by reference to Exhibit 3.1 to Annual Report on Form 10-K filed March 31, 1993)
|
|
|
3.2
|
Certificate of Amendment of Certificate of Incorporation effective August 21, 2001 (incorporated by reference to Exhibit 3.3 to Annual Report on Form 10-K filed March 14, 2002)
|
|
|
3.3
|
Certificate of Amendment of Certificate of Incorporation effective January 9, 2006 (incorporated by reference to Exhibit 99.1 to Current Report on Form 8-K filed January 10, 2006)
|
|
|
3.4
|
Certificate of Designation, Preferences and Rights of the Terms effective August 25, 2006 (incorporated by reference to Exhibit 3.4 to Registration Statement on Form 8-A filed September 6, 2006)
|
|
|
3.5
|
Amended and Restated Bylaws effective June 4, 2009 (incorporated by reference to Exhibit 99.1 to Current Report on Form 8-K filed June 10, 2009)
|
|
|
4.1
|
Indenture between the Company and J.P. Morgan Trust Company, National Association, dated February 14, 2005 (incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed February 16, 2005)
|
|
|
4.2
|
Indenture between wholly-owned subsidiary QHP Royalty Sub LLC and U.S. Bank National Association, dated November 2, 2009 (incorporated by reference to Exhibit 99.1 to Current Report on Form 8-K filed November 6, 2009)
|
|
|
4.3
|
Indenture between the Company and The Bank of New York Mellon, N.A., dated November 1, 2010 (incorporated by reference to Exhibit 4.1 to Quarterly Report on Form 10-Q filed November 9, 2010)
|
|
|
4.4
|
Indenture between the Company and The Bank of New York Mellon, N.A., dated May 16, 2011 (incorporated by reference to Exhibit 4.1 to Quarterly Report on Form 10-Q filed July 29, 2011)
|
|
|
4.5
|
Supplemental Indenture between the Company and The Bank of New York Mellon, N.A., dated May 16, 2011 (incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed May 16, 2011)
|
|
|
4.6
|
Indenture between the Company and The Bank of New York Mellon, N.A., dated January 5, 2012 (incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed January 6, 2012)
|
|
|
10.1*
|
1999 Stock Option Plan (incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed August 9, 2006)
|
|
|
10.2*
|
1999 Nonstatutory Stock Option Plan, as amended through February 20, 2003 (incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed August 9, 2006)
|
|
|
10.3*
|
Form of Notice of Grant of Stock Option under the 1999 Stock Option Plan (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed August 14, 2002)
|
|
|
10.4*
|
Form of Stock Option Agreement (incentive stock options) under the 1999 Stock Option Plan (incorporated by reference to Exhibit 10.4 to Quarterly Report on Form 10-Q filed August 9, 2006)
|
|
|
10.5*
|
Form of Stock Option Agreement (nonstatutory stock options) under the 1999 Stock Option Plan (incorporated by reference to Exhibit 10.5 to Quarterly Report on Form 10-Q filed August 9, 2006)
|
|
|
10.6*
|
Form of Notice of Grant of Stock Option under the 1999 Nonstatutory Stock Option Plan (incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q/A filed November 14, 2007)
|
10.7*
|
Form of Stock Option Agreement under the 1999 Nonstatutory Stock Option Plan (incorporated by reference to Exhibit 10.6 to Quarterly Report on Form 10-Q filed August 9, 2006)
|
|
|
10.8*
|
2002 Outside Directors Stock Option Plan, as amended June 8, 2005 (incorporated by reference to Exhibit 99.2 to Current Report on Form 8-K filed June 14, 2005)
|
|
|
10.9*
|
Form of Nonqualified Stock Option Agreement under the 2002 Outside Directors Plan (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q/A filed November 14, 2007)
|
|
|
10.10*
|
Amended and Restated 2005 Equity Incentive Plan effective June 4, 2009 (incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed July 31, 2009)
|
|
|
10.11*
|
Form of Notice of Grant of Stock Option under the 2005 Equity Incentive Plan (incorporated by reference to Exhibit 10.7 to Quarterly Report on Form 10-Q filed August 9, 2006)
|
|
|
10.12*
|
Form of Stock Option Agreement under the 2005 Equity Incentive Plan (incorporated by reference to Exhibit 10.8 to Quarterly Report on Form 10-Q filed August 9, 2006)
|
|
|
10.13*
|
Form of Notice of Grant of Restricted Stock Award under the 2005 Equity Incentive Plan (incorporated by reference to Exhibit 10.9 to Quarterly Report on Form 10-Q filed August 9, 2006)
|
|
|
10.14*
|
Form of Restricted Stock Agreement under the 2005 Equity Incentive Plan (for the officers of the Company) (incorporated by reference to Exhibit 10.10 to Quarterly Report on Form 10-Q filed August 9, 2006)
|
|
|
10.15*
|
Form of Director and Officer Indemnification Agreement (incorporated by reference to Exhibit 10.1 to Registration Statement on Form S-1 filed December 16, 1991)
|
|
|
10.16*
|
Offer Letter between the Company and John McLaughlin, dated November 4, 2008 (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed November 10, 2008)
|
|
|
10.17*
|
Offer Letter between the Company and Christine Larson, dated December 15, 2008 (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed December 19, 2008)
|
|
|
10.18
|
Tax Sharing and Indemnification Agreement, dated December 18, 2008, between the Company and Facet Biotech Corporation (incorporated by reference to Exhibit 10.3 to Current Report on Form 8-K filed December 23, 2008)
|
|
|
10.19
|
Patent Licensing Master Agreement between the Company and Genentech, Inc., dated September 25, 1998 (incorporated by reference to Exhibit 10.10 to Quarterly Report on Form 10-Q filed November 16, 1998)†
|
|
|
10.20
|
Amendment No. 1 to Patent Licensing Master Agreement between the Company and Genentech, Inc., dated September 18, 2003 (incorporated by reference to Exhibit 10.45 to Annual Report on Form 10-K filed
March 8, 2004)†
|
|
|
10.21
|
Amendment No. 2 to Patent Licensing Master Agreement between the Company and Genentech, Inc., dated December 18, 2003 (incorporated by reference to Exhibit 10.45 to Annual Report on Form 10-K filed March 2, 2009)
|
|
|
10.22
|
Amendment No. 1 to the Herceptin
®
License Agreement between the Company and Genentech, Inc., dated December 18, 2003 (incorporated by reference to Exhibit 10.47 to Annual Report on Form 10-K filed March 8, 2004)
|
|
|
10.23
|
Patent License Agreement, dated July 17, 1997, between the Company and MedImmune Inc. (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed January 24, 2011)†
|
|
|
10.24
|
Patent License Agreement, dated April 24, 1998, between the Company and Elan International Services Ltd. (incorporated by reference to Exhibit 10.45 to Annual Report on Form 10-K filed March 2, 2009) †
|
|
|
10.25*
|
Offer Letter between the Company and Christopher Stone, dated December 30, 2008 (incorporated by reference to Exhibit 10.29 to Annual Report on Form 10-K filed March 1, 2010)
|
|
|
10.26
|
Purchase and Sale Agreement, dated November 2, 2009, between PDL and wholly-owned subsidiary QHP Royalty Sub LLC (incorporated by reference to Exhibit 99.2 to Current Report on Form 8-K filed November 6, 2009)
|
|
|
10.27
|
Pledge and Security Agreement, dated November 2, 2009, between PDL and wholly-owned subsidiary QHP Royalty Sub LLC (incorporated by reference to Exhibit 99.3 to Current Report on Form 8-K filed November 6, 2009)
|
10.28
|
Bill of Sale, dated November 2, 2009, between PDL and wholly-owned subsidiary QHP Royalty Sub LLC (incorporated by reference to Exhibit 99.4 to Current Report on Form 8-K filed November 6, 2009)
|
|
|
10.29*
|
Company 2010 Annual Bonus Plan (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on April 19, 2010)
|
|
|
10.30
|
Settlement Agreement between the Company and Genentech, Inc., dated December 18, 2003 (incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed November 9, 2010) †
|
|
|
10.31
|
Amended and Restated Patent Licensing master Agreement between the Company and Genentech, Inc., dated July 27, 2009 (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed November 9, 2010) †
|
|
|
10.32
|
Amendments to Product Licenses and Settlement Agreement between the Company and Genentech, Inc. dated July 27, 2009 (incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed November 9, 2010)
|
|
|
10.33
|
Form of Exchange Agreement between the Company and certain holders of the Company’s 2.75% Convertible Subordinated Notes due 2023 (incorporated by reference to Exhibit 10.1 to Current Report Form 8-K filed August 5, 2010)
|
|
|
10.34
|
Form of Exchange Agreement between the Company and certain holders of the Company’s 2.00% Convertible Senior Notes due 2012 (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed October 27, 2010)
|
|
|
10.35
|
Form of Purchase Agreement between the Company and certain holders of the Company’s 2.00% Convertible Senior Notes due 2012 (incorporated by reference to Exhibit 10.2 to Current Report on Form 8-K filed October 27, 2010)
|
|
|
10.36
|
Form of Exchange and Purchase Agreement between the Company and certain holders of the Company’s 2.00% Convertible Senior Notes due 2012 (incorporated by reference to Exhibit 10.3 to Current Report on Form 8-K filed October 27, 2010)
|
|
|
10.37*
|
Offer Letter between the Company and Caroline Krumel, dated January 6, 2011 (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed January 25, 2011)
|
|
|
10.38*
|
Company 2011 Annual Bonus Plan (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed January 26, 2011)
|
|
|
10.39*
|
Offer Letter between the Company and Danny Hart, dated January 11, 2010 (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed April 18, 2011)
|
|
|
10.40*
|
Form of Executive Officer Severance Agreement (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed May 26, 2011)
|
|
|
10.41*
|
2012 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed July 29, 2011)
|
|
|
10.42*
|
Separation Agreement between the Company and Christine Larson, dated December 9, 2011 (incorporated by reference to Exhibit 10.46 to Annual Report on Form 10-K filed February 23, 2012)
|
|
|
10.43*
|
2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.47 to Annual Report on Form 10-K filed February 23, 2012)
|
|
|
10.44*
|
2012 Annual Bonus Plan (Incorporated by reference to Exhibit 10.48 to Annual Report on Form 10-K filed February 23, 2012)
|
|
|
10.45
|
Form of Exchange Agreement between the Company and certain holders of the Company's 2.875% Convertible Senior Notes due February 15, 2015 (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed February 2, 2012)
|
10.46
|
Lease Agreement between 932936, LLC and the Company, dated April 17, 2012 (incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed May 3, 2012)
|
|
|
10.47*
|
Offer Letter between the Company and Bruce Tomlinson, dated April 20, 2012 (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed April 27, 2012)
|
|
|
10.48
|
Credit Agreement between the Company and Merus Labs International, Inc., dated July 10, 2012 (incorporated by reference to Exhibit 10.1 to Quarterly Report on form 10Q filed August 2, 2012)†
|
|
|
10.49#
|
Revenue Interests Purchase Agreement between the Company and AxoGen, Inc., dated October 5, 2012†
|
|
|
10.50#
|
Credit Agreement between the Company and Wellstat Diagnostics, LLC, dated November 2, 2012†
|
|
|
10.51*#
|
Separation Agreement between the Company and Bruce Tomlinson, dated November 30, 2012
|
|
|
12.1#
|
Ratio of Earnings to Fixed Charges
|
|
|
14.1#
|
Code of Business Conduct
|
|
|
21.1#
|
Subsidiaries of the Registrant
|
|
|
23.1#
|
Consent of Independent Registered Public Accounting Firm
|
|
|
31.1#
|
Certification of Principal Executive Officer and Acting Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
|
32.1#
|
Certification by the Principal Executive Officer and the Acting Principal Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934, as amended, and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350)
|
|
|
101.INS
|
XBRL Instance Document
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase
|
#
|
Filed herewith.
|
|
|
*
|
Management contract or compensatory plan or arrangement.
|
|
|
†
|
Certain information in this exhibit has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request under 17 C.F.R. Sections 200.80(b)(4) and 24b-2.
|
|
PDL BIOPHARMA, INC. ( REGISTRANT)
|
|
|
|
|
|
|
By:
|
|
/S/ JOHN P. MCLAUGHLIN
|
|
|
|
John P. McLaughlin
|
|
|
|
President, Chief Executive Officer, Acting Chief Financial Officer and Acting Principal Accounting Officer
|
|
|
|
|
|
Date:
|
March 1, 2013
|
|
Signature
|
Title
|
Date
|
|
|
|
/S/ JOHN P. MCLAUGHLIN
|
President and Chief Executive Officer (Principal Executive Officer, Acting Chief Financial Officer and Acting Principal Accounting Officer)
|
March 1, 2013
|
(John P. McLaughlin)
|
|
|
|
|
|
/S/ JODY S. LINDELL
|
Director
|
March 1, 2013
|
(Jody S. Lindell)
|
|
|
|
|
|
/S/ PAUL W. SANDMAN
|
Director
|
March 1, 2013
|
(Paul W. Sandman)
|
|
|
|
|
|
/S/ HAROLD E. SELICK
|
Director
|
March 1, 2013
|
(Harold E. Selick)
|
|
|
|
|
Page
|
|
ARTICLE I DEFINITIONS
|
|
1
|
|
ARTICLE II PURCHASE OF INTERESTS
|
|
13
|
|
Section 2.01
Purchase
.
|
|
13
|
|
Section 2.02
Payments by the Company
.
|
|
14
|
|
Section 2.03
Closing; Payment Purchase Price; Closing Deliveries
.
|
|
14
|
|
Section 2.04
No Assumed Obligations
.
|
|
15
|
|
ARTICLE III REPRESENTATIONS AND WARRANTIES OF COMPANY
|
|
15
|
|
Section 3.01
Organization
.
|
|
15
|
|
Section 3.02
Authorization
.
|
|
15
|
|
Section 3.03
Governmental Authorization
.
|
|
15
|
|
Section 3.04
Ownership
.
|
|
16
|
|
Section 3.05
Financial Statements
.
|
|
17
|
|
Section 3.06
No Undisclosed Liabilities
.
|
|
17
|
|
Section 3.07
Solvency
.
|
|
17
|
|
Section 3.08
Litigation
.
|
|
17
|
|
Section 3.09
Compliance with Laws
.
|
|
17
|
|
Section 3.10
Conflicts
.
|
|
18
|
|
Section 3.11
Subordination
.
|
|
18
|
|
Section 3.12
Intellectual Property
.
|
|
18
|
|
Section 3.13
Regulatory Approval
.
|
|
20
|
|
Section 3.14
Material Contracts
.
|
|
21
|
|
Section 3.15
Place of Business
.
|
|
21
|
|
Section 3.16
Broker's Fees
.
|
|
21
|
|
Section 3.17
Other Information
.
|
|
22
|
|
Section 3.18
Insurance
.
|
|
22
|
|
Section 3.19
Taxes
.
|
|
22
|
|
ARTICLE IV REPRESENTATIONS AND WARRANTIES OF PURCHASER
|
|
22
|
|
Section 4.01
Organization
.
|
|
22
|
|
Section 4.02
Authorization
.
|
|
23
|
|
Section 4.03
Broker's Fees
.
|
|
23
|
|
Section 4.04
Conflicts
.
|
|
23
|
|
ARTICLE V COVENANTS
|
|
23
|
|
Table of Contents
|
|||
(continued)
|
|||
|
|
|
|
|
|
Page
|
|
Section 5.01
Consents and Waivers
.
|
|
23
|
|
Section 5.02
Access; Information
.
|
|
24
|
|
Section 5.03
Material Contracts
.
|
|
25
|
|
Section 5.04
Confidentiality; Public Announcement
.
|
|
25
|
|
Section 5.05
Guarantee and Collateral Agreement
.
|
|
26
|
|
Section 5.06
Efforts; Further Assurance
.
|
|
26
|
|
Section 5.07
Change of Control; Put Option
.
|
|
27
|
|
Section 5.08
Remittance to Deposit Account
.
|
|
28
|
|
Section 5.09
Intellectual Property
.
|
|
30
|
|
Section 5.10
Negative Covenants
.
|
|
31
|
|
Section 5.11
Insurance
.
|
|
31
|
|
Section 5.12
Notice
.
|
|
32
|
|
Section 5.13
Use of Proceeds
.
|
|
32
|
|
Section 5.14
Taxes
.
|
|
32
|
|
Section 5.15
Board Designee.
|
|
32
|
|
Section 5.16
Rights to Future Stock Issuances.
|
|
33
|
|
ARTICLE VI TERMINATION
|
|
34
|
|
Section 6.01
Termination Date
.
|
|
34
|
|
Section 6.02
Effect of Termination
.
|
|
34
|
|
ARTICLE VII MISCELLANEOUS
|
|
35
|
|
Section 7.01
Survival
.
|
|
35
|
|
Section 7.02
Specific Performance; Limitations on Damages
.
|
|
35
|
|
Section 7.03
Notices
.
|
|
35
|
|
Section 7.04
Successors and Assigns
.
|
|
36
|
|
Section 7.05
Indemnification
.
|
|
36
|
|
Section 7.06
No Implied Representations and Warranties
.
|
|
38
|
|
Section 7.07
Independent Nature of Relationship
.
|
|
39
|
|
Section 7.08
Federal Tax.
|
|
39
|
|
Section 7.09
Entire Agreement
.
|
|
39
|
|
Section 7.10
Amendments; No Waivers
.
|
|
39
|
|
Table of Contents
|
|||
(continued)
|
|||
|
|
|
|
|
|
Pages
|
|
Section 7.11
Interpretation
.
|
|
39
|
|
Section 7.12
Headings and Captions
.
|
|
40
|
|
Section 7.13
Counterparts; Effectiveness
.
|
|
40
|
|
Section 7.14
Severability
.
|
|
40
|
|
Section 7.15
Expenses
.
|
|
40
|
|
Section 7.16
Governing Law; Jurisdiction
.
|
|
40
|
|
Section 7.17
Waiver of Jury Trial
.
|
|
41
|
|
COMPANY:
|
AxoGen, Inc.
By:
/s/ Karen Zaderej
_
Name:Karen Zaderej
Title:Chief Executive Officer
|
PURCHASER:
|
PDL BIOPHARMA, INC.
By
: /s/ John P. McLaughlin
_
Name:John P. McLaughlin
Title: President and Chief Executive Officer
|
TABLE OF CONTENTS
|
|||
|
|
|
|
|
|
Page
|
|
Section 1. Definitions
|
|
1
|
|
1.01. Definition of Terms Used Herein Generally
|
|
1
|
|
1.02. Definition of Certain Terms Used Herein
|
|
1
|
|
1.03. Rules of Interpretation
|
|
2
|
|
Section 2. Guarantee
|
|
2
|
|
2.01. Guarantee
|
|
2
|
|
2.02. Right of Contribution
|
|
3
|
|
2.03. Subrogation
|
|
3
|
|
2.04. Amendments, etc. with respect to the Secured Obligations
|
|
4
|
|
2.05. Guarantee Absolute and Unconditional
|
|
4
|
|
2.06. Reinstatement
|
|
5
|
|
2.07. Payments
|
|
5
|
|
2.08. Waiver of Subrogation
|
|
5
|
|
Section 3. Grant of Security Interest
|
|
7
|
|
Section 4. Authorization to File Financing Statements
|
|
7
|
|
Section 5. Reserved
|
|
8
|
|
Section 6. Representations and Warranties
|
|
8
|
|
6.01. Grantors’ Legal Status
|
|
8
|
|
6.02. Grantors’ Legal Names
|
|
8
|
|
6.03. Grantors’ Locations
|
|
8
|
|
6.04. Representations in the Purchase Agreement
|
|
8
|
|
6.05. Title to Collateral
|
|
8
|
|
6.06. Nature of Collateral
|
|
8
|
|
6.07. Compliance with Laws
|
|
9
|
|
6.08. Validity of Security Interest
|
|
9
|
|
6.09. Reserved
|
|
9
|
|
6.10. Investment Property in lieu of Payment
|
|
9
|
|
6.11. Account Receivables
|
|
9
|
|
6.12. Accounts
|
|
9
|
|
6.13. Reserved
|
|
9
|
|
Section 7. Covenants.
|
|
9
|
|
7.01. Grantors’ Legal Status
|
|
10
|
|
TABLE OF CONTENTS
|
|||
(continued)
|
|||
|
|
|
|
|
|
Page
|
|
7.02. Grantors’ Names
|
|
10
|
|
7.03. Grantors’ Organizational Numbers
|
|
10
|
|
7.04. Reserved
|
|
10
|
|
7.05. Covenants in Purchase Agreement
|
|
10
|
|
7.06. Promissory Notes and Tangible Chattel Paper
|
|
10
|
|
7.07. Deposit Accounts
|
|
10
|
|
7.08. Pledged Stock
|
|
10
|
|
7.09. Reserved
|
|
10
|
|
7.10. Reserved
|
|
11
|
|
7.11. Reserved
|
|
11
|
|
7.12. Reserved
|
|
11
|
|
7.13. Reserved
|
|
11
|
|
7.14. Maintenance of Collateral; Compliance with Laws
|
|
11
|
|
7.15. Reserved
|
|
11
|
|
7.17. Periodic Certification
|
|
11
|
|
7.18. Other Actions as to any and all Collateral
|
|
11
|
|
Section 8. Reserved
|
|
12
|
|
Section 9. Collateral Protection Expenses; Preservation of Collateral
|
|
12
|
|
9.01. Expenses Incurred by the Purchaser
|
|
12
|
|
9.02. Purchaser’s Obligations and Duties
|
|
12
|
|
9.03. Reserved
|
|
13
|
|
Section 10. Deposits
|
|
13
|
|
Section 11. Notification to Account Debtors and Other Persons Obligated on Collateral
|
|
13
|
|
Section 12. Power of Attorney
|
|
14
|
|
12.01. Appointment and Powers of Purchaser
|
|
14
|
|
12.02. Failure of Grantor to Perform
|
|
15
|
|
12.03. Expenses of Attorney-in-Fact
|
|
15
|
|
12.04. Ratification by Grantor
|
|
15
|
|
12.05. No Duty on Purchaser
|
|
15
|
|
Section 13. Remedies
|
|
15
|
|
13.01. Default
|
|
15
|
|
13.02. Remedies Upon Default
|
|
15
|
|
TABLE OF CONTENTS
|
|||
(continued)
|
|||
|
|
|
|
|
|
Page
|
|
13.03. Reserved
|
|
17
|
|
13.04. Waivers by Grantors
|
|
17
|
|
13.05. Application of Proceeds
|
|
17
|
|
13.06. Surplus, Deficiency
|
|
17
|
|
13.07. Information Related to the Collateral
|
|
18
|
|
13.08. Sale Exempt from Registration
|
|
18
|
|
13.09. Rights and Remedies Cumulative
|
|
18
|
|
13.10. Reserved
|
|
18
|
|
Section 14. Standards for Exercising Remedies
|
|
18
|
|
14.01. Commercially Reasonable Manner
|
|
18
|
|
14.02. Standard of Care
|
|
19
|
|
Section 15. Waivers by Grantor; Obligations Absolute
|
|
19
|
|
15.01. Specific Waivers
|
|
19
|
|
15.02. Obligations Absolute
|
|
19
|
|
Section 16. Marshalling
|
|
19
|
|
Section 17. Interest
|
|
20
|
|
Section 18. Reinstatement
|
|
20
|
|
Section 19. Miscellaneous
|
|
20
|
|
19.01. Notices
|
|
20
|
|
19.02. GOVERNING LAW; CONSENT TO JURISDICTION; SERVICE OF PROCESS
|
|
20
|
|
19.03. WAIVER OF JURY TRIAL, ETC
|
|
21
|
|
19.04. Counterparts
|
|
21
|
|
19.05. Headings
|
|
21
|
|
19.06. No Strict Construction
|
|
21
|
|
19.07. Severability
|
|
21
|
|
19.08. Survival of Agreement
|
|
21
|
|
19.09. Fees and Expenses; Indemnification
|
|
21
|
|
19.10. Binding Effect; Several Agreement
|
|
22
|
|
19.11. Waivers; Amendment
|
|
22
|
|
19.12. Set-Off
|
|
22
|
|
19.13. Integration
|
|
23
|
|
19.14. Acknowledgments
|
|
23
|
|
TABLE OF CONTENTS
|
|||
(continued)
|
|||
|
|
|
|
|
|
Page
|
|
19.15. Additional Grantors and Guarantors
|
|
23
|
|
1.
|
Guarantee and Collateral Agreement
. By executing and delivering this Assumption Agreement, the Additional Grantor, as provided in
Section 19.15
of the Guarantee and Collateral Agreement, hereby becomes a party to the Guarantee and Collateral Agreement as a Grantor and Guarantor thereunder with the same force and effect as if originally named therein as a Grantor and Guarantor and, without limiting the generality of the foregoing, hereby expressly assumes all obligations and liabilities of a Grantor and Guarantor thereunder. The information set forth in Annex I-A hereto is hereby added to the information set forth in the update to the Schedules to the Purchase Agreement most recently delivered pursuant to the terms of the Guarantee and Collateral Agreement. The Additional Grantor hereby represents and warrants that each of the representations and warranties as to the Additional Grantor contained in
Section 6
of the Guarantee and Collateral Agreement is true and correct on and as the date hereof (after giving effect to this Assumption Agreement) as if made on and as of such date.
|
2.
|
GOVERNING LAW
. THIS ASSUMPTION AGREEMENT SHALL BE GOVERNED BY, AND CONSTRUED AND INTERPRETED IN ACCORDANCE WITH, THE LAW OF THE STATE OF
|
Guarantor
|
Bank
|
Account Number
|
AxoGen, Inc.
|
Silicon Valley Bank
|
***
|
AxoGen Corporation
|
Silicon Valley Bank
|
***
|
1.
|
The Company does hereby sell, assign, transfer, convey, deliver and vest in Purchaser, its successors and assigns forever, all of its right, title and interest in and to the Assigned Interests.
|
2.
|
The Company hereby covenants that, from time to time after the delivery of this instrument, at Purchaser's request, the Company will do, execute, acknowledge and deliver, or will cause to be done, executed, acknowledged and delivered such further acts, conveyances, transfers, assignments, powers of attorney and assurances as Purchaser may reasonably require to convey, transfer to and vest in Purchaser, and to put Purchaser in possession of, any of the Assigned Interests.
|
3.
|
Nothing in this Assignment of Interests shall alter any liability or obligation of the Company or Purchaser arising under the Revenue Purchase Agreement, which shall govern the representations, warranties and obligations of the parties with respect to the Assigned Interests.
|
4.
|
This Assignment of Interests shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns.
|
5.
|
This Assignment of Interests shall be governed by, and construed in accordance with, the internal laws of the State of New York, without giving effect to the principles of conflicts of law thereof.
|
6.
|
This Assignment of Interests may be executed in counterparts, each of which shall be deemed an original and all of which, when taken together, shall constitute one and the same instrument.
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
US Patent 6,972,168 (UFRF)
|
Licensed
|
Patent -8/13/2021 Agreement - See UFRF License Agreement Below
|
Yes
|
AxoGen Corporation
|
US Patent 7,402,319 (UTA)
|
Licensed
|
Patent -9/26/2023 Agreement - See UFRF License Agreement Below
|
Yes
|
AxoGen Corporation
|
US Patent 7,732,200 (UFRF)
|
Licensed
|
Patent -12/21/2022 Agreement - See UFRF License Agreement Below
|
Yes
|
AxoGen Corporation
|
US Published Patent Application 20080299536 (UFRF)
|
Licensed
|
Patent Application-N/A Agreement - See UFRF License Agreement Below
|
Yes
|
AxoGen Corporation
|
US Published Patent Application 20090030269 (UTA)
|
Licensed
|
Patent Application -N/A Agreement - See UTA License Agreement Below
|
Yes
|
AxoGen Corporation
|
Canada Patent Application 2,455,827 (UFRF)
|
Licensed
|
Patent Application-N/A Agreement - See UFRF License Agreement Below
|
Yes
|
AxoGen Corporation
|
European Patent No. EP1425390 (UFRF)
|
Licensed
|
Patent -8/12/2022 Agreement - See UFRF License Agreement Below
|
Yes
|
AxoGen Corporation
|
Japanese Patent No. 4,749,667 (UFRF)
|
Licensed
|
Patent-8/13/2022 Agreement - See UFRF License Agreement Below
|
Yes
|
AxoGen Corporation
|
Mexico Patent No. 296009 (UFRF)
|
Licensed
|
Patent - 2/13/2012 Agreement - See UFRF License Agreement Below
|
Yes
|
AxoGen Corporation
|
Mexico Patent No. 296020 (UFRF)
|
Licensed
|
Patent -2/13/2012 Agreement - See UFRF License Agreement Below
|
Yes
|
AxoGen Corporation
|
Mexico Patent No. 296021 (UFRF)
|
Licensed
|
Patent - 2/13/2012 Agreement - See UFRF License Agreement Below
|
No
|
AxoGen Corporation
|
Mexico Patent No. 296019 (UFRF)
|
Licensed
|
Patent Application-2/13/2012 Agreement - See UFRF License Agreement Below
|
No
|
AxoGen Corporation
|
US Published Patent Application 20090264871 (AxoGen)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
Canada Patent Application 2,721,945 (AxoGen)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
European Patent Application EP2276410 (AxoGen)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
US Patent 6,696,575 (UTA)
|
Licensed
|
Patent -3/27/2021 Agreement - See UTA License Agreement Below
|
No
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
US Patent 7,851,447 (UFRF)
|
Licensed
|
Patent -11/18/2023 Agreement - See UFRF License Agreement Below
|
No
|
AxoGen Corporation
|
US Published Patent Application US-20110082482 (UFRF)
|
Licensed
|
Patent Application-N/A Agreement - See UFRF License Agreement Below
|
No
|
AxoGen Corporation
|
US 7,772,185 (Emory)
|
Licensed
|
Patent -11/18/2023 Agreement - See Emory License Agreement Below
|
No
|
AxoGen Corporation
|
US Published Patent Application US-201000268336 (Emory)
|
Licensed
|
Patent Application -N/A Agreement - See Emory License Agreement Below
|
No
|
AxoGen Corporation
|
Japanese Patent No. 4,773,976 (Emory)
|
Licensed
|
Patent -1/31/2025 Agreement - See Emory License Agreement Below
|
No
|
AxoGen Corporation
|
European Patent Application EP1737476 (Emory)
|
Licensed
|
Patent Application -N/A Agreement - See Emory License Agreement Below
|
No
|
AxoGen Corporation
|
Canada Patent Application 2,556,161 (Emory)
|
Licensed
|
Patent Application -N/A Agreement - See Emory License Agreement Below
|
No
|
AxoGen Corporation
|
AxoGen Nerve Regeneration -Nerve Recovery Training Video (Copyright)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
LB-122 AVANCE 70 AG-T-1 Instructions for Use: AxoGen Product (Copyright)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
LB-123 AxoGuard Nerve Connector Instructions for Use (Copyright)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
LB-124 AxoGuard Nerve Protector Instructions for Use (Copyright)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
(Canada Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AXOGUARD (Canada Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AxoGen (Canada Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AVANCE NERVE GRAFT (Canada Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
(European Trademark)
|
Owned
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
AVANCE NERVE GRAFT (European Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AXOGEN NERVE REGENERATION (Japan Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AVANCE NERVE GRAFT (Japan Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AVANCE NERVE GRAFT (Mexico Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AXOGEN NERVE REGENERATION (Mexico Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AXOGEN NERVE REGENERATION (Mexico Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AXOGEN NERVE REGENERATION (Mexico Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AXOGUARD (U.S. Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
(U.S. Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AXOGEN (U.S. Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AXOGEN (U.S. Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
(U.S. Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
(U.S. Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
AVANCE (U.S. Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
(U.S. Trademark)
|
Owned
|
N/A
|
Yes
|
AxoGen Corporation
|
RANGER (U.S. Trademark)
|
Owned
|
N/A
|
No
|
AxoGen Corporation
|
RANGER (U.S. Trademark)
|
Owned
|
N/A
|
NO
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
License Agreement-University of Florida Research Foundation (UFRF)
|
N/A
|
The expiration date of the agreement is until the earlier of the date that no Licensed Patent remains enforceable or the payment of earned royalties ceases for more than four (4) calendar quarters on all Licensed Products and Processes.
|
Yes
|
AxoGen Corporation
|
License Agreement-Emory University (Emory)
|
N/A
|
Expires on the last to expire Valid Claim.
|
No
|
AxoGen Corporation
|
License Agreement-University of Texas at Austin (UTA)
|
N/A
|
Expires on the last to expire of the Licensed Patents.
|
Yes
|
AxoGen, Inc.
|
Patent Application- US 11/535,214
|
Owned
|
Patent Application - not pursuing
|
No
|
AxoGen, Inc.
|
Patent Application PCT-US-2009-001407
|
Owned
|
Patent Application -N/A
|
No
|
AxoGen, Inc.
|
Patent Application- US 12/921,253
|
Owned
|
Patent Application -N/A
|
No
|
AxoGen, Inc.
|
Patent Application- US 61/409,786
|
Owned
|
Patent Application -N/A
|
No
|
AxoGen, Inc.
|
Patent Application- US 13/035,535
|
Owned
|
Patent Application -N/A
|
No
|
AxoGen, Inc.
|
Patent Application PCT-US-2011-026319
|
Owned
|
Patent Application -N/A
|
No
|
AxoGen, Inc.
|
Patent Application US 61/705,251
|
Owned
|
Patent Application - N/A
|
No
|
AxoGen, Inc.
|
US Patent - 7,288,265
|
Owned
|
1-2023
|
No
|
AxoGen, Inc.
|
US Patent - 6,830,758
|
Owned
|
4-2021
|
No
|
AxoGen, Inc.
|
US Patent - 6,495,158
|
Owned
|
1-2019
|
No
|
AxoGen, Inc.
|
US Patent - 6,469,227
|
Owned
|
5-2020
|
No
|
AxoGen, Inc.
|
US Patent - 6,455,065
|
Owned
|
5-2019
|
No
|
AxoGen, Inc.
|
US Patent - 6,406,712
|
Owned
|
6-2019
|
No
|
AxoGen, Inc.
|
US Patent - 6,348,212
|
Owned
|
5-2019
|
No
|
AxoGen, Inc.
|
US Patent - 6,090,403
|
Owned
|
8-2018
|
No
|
AxoGen, Inc.
|
US Patent - 5,804,213
|
Owned
|
9-2015
|
No
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Domain name -ABOUTNERVE.BIZ
|
Owned
|
6/8/2012
|
No
|
AxoGen Corporation
|
Domain name -ABOUTNERVE.COM
|
Owned
|
6/9/2012
|
No
|
AxoGen Corporation
|
Domain name -ABOUTNERVE.INFO
|
Owned
|
6/9/2012
|
No
|
AxoGen Corporation
|
Domain name -ABOUTNERVE.MOBI
|
Owned
|
6/9/2012
|
No
|
AxoGen Corporation
|
Domain name -ABOUTNERVE.NET
|
Owned
|
6/9/2012
|
No
|
AxoGen Corporation
|
Domain name -ABOUTNERVE.ORG
|
Owned
|
6/9/2012
|
No
|
AxoGen Corporation
|
Domain name -ABOUTNERVE.US
|
Owned
|
6/8/2012
|
No
|
AxoGen Corporation
|
Domain name - AVANCENERVEGRAFT.BIZ
|
Owned
|
4/8/2015
|
No
|
AxoGen Corporation
|
Domain name - AVANCENERVEGRAFT.CO
|
Owned
|
4/9/2015
|
No
|
AxoGen Corporation
|
Domain name - AVANCENERVEGRAFT.COM
|
Owned
|
4/9/2015
|
No
|
AxoGen Corporation
|
Domain name - AVANCENERVEGRAFT.INFO
|
Owned
|
4/9/2015
|
No
|
AxoGen Corporation
|
Domain name - AVANCENERVEGRAFT.MOB I
|
Owned
|
4/9/2015
|
No
|
AxoGen Corporation
|
Domain name - AVANCENERVEGRAFT.NET
|
Owned
|
4/9/2015
|
No
|
AxoGen Corporation
|
Domain name - AVANCENERVEGRAFT.ORG
|
Owned
|
4/9/2015
|
No
|
AxoGen Corporation
|
Domain name - AVANCENERVEGRAFT.US
|
Owned
|
4/8/2015
|
No
|
AxoGen Corporation
|
Domain name - AXGN.BIZ
|
Owned
|
2/21/2014
|
No
|
AxoGen Corporation
|
Domain name - AXGN.CO
|
Owned
|
2/21/2014
|
No
|
AxoGen Corporation
|
Domain name - AXGN.INFO
|
Owned
|
2/22/2014
|
No
|
AxoGen Corporation
|
Domain name - AXGN.ORG
|
Owned
|
2/22/2014
|
No
|
AxoGen Corporation
|
Domain name - AXGN.US
|
Owned
|
2/21/2014
|
No
|
AxoGen Corporation
|
Domain name - AXOGEN.BIZ
|
Owned
|
8/5/2012
|
No
|
AxoGen Corporation
|
Domain name - AXOGEN.INFO
|
Owned
|
8/6/2012
|
No
|
AxoGen Corporation
|
Domain name - AXOGEN.ME
|
Owned
|
8/6/2012
|
No
|
AxoGen Corporation
|
Domain name - AXOGEN.NET
|
Owned
|
11/13/2011
|
No
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Domain name - AXOGEN.ORG
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Domain name - AXOGEN.US
|
Owned
|
8/5/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGENINC.BIZ
|
Owned
|
8/5/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGENINC.COM
|
Owned
|
11/13/2017
|
Yes
|
AxoGen Corporation
|
Domain name -AXOGENINC.INFO
|
Owned
|
8/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGENINC.ME
|
Owned
|
8/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGENINC.MOBI
|
Owned
|
8/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGENINC.NAME
|
Owned
|
8/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGENINC.NET
|
Owned
|
7/20/2014
|
No
|
AxoGen Corporation
|
Domain name -AXOGENINC.ORG
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGENINC.US
|
Owned
|
3/7/2013
|
No
|
AxoGen Corporation
|
Domain name -AXOGENINC.WS
|
Owned
|
8/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGUARD.BIZ
|
Owned
|
10/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGUARD.COM
|
Owned
|
10/6/2012
|
Yes
|
AxoGen Corporation
|
Domain name -AXOGUARD.INFO
|
Owned
|
10/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGUARD.ME
|
Owned
|
10/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGUARD.MOBI
|
Owned
|
10/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGUARD.NET
|
Owned
|
10/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGUARD.ORG
|
Owned
|
10/6/2012
|
No
|
AxoGen Corporation
|
Domain name -AXOGUARD.US
|
Owned
|
10/5/2011
|
No
|
AxoGen Corporation
|
Domain name -NERVEGRAFT.BIZ
|
Owned
|
5/21/2015
|
No
|
AxoGen Corporation
|
Domain name -NERVEGRAFT.COM
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEGRAFT.INFO
|
Owned
|
5/22/2014
|
No
|
AxoGen Corporation
|
Domain name -NERVEGRAFT.MOBI
|
Owned
|
5/22/2014
|
No
|
AxoGen Corporation
|
Domain name -NERVEGRAFT.NET
|
Owned
|
7/20/2012
|
No
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Domain name -NERVEGRAFT.ORG
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEINJURY.NET
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEINJURY.ORG
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEREGENERATION.NET
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEREGENERATION.ORG
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEREPAIR.BIZ
|
Owned
|
8/5/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEREPAIR.INFO
|
Owned
|
8/6/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEREPAIR.ME
|
Owned
|
8/6/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEREPAIR.NET
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEREPAIR.ORG
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Domain name -NERVEREPAIR.US
|
Owned
|
8/5/2012
|
No
|
AxoGen Corporation
|
Domain name -PERIPHERALNERVE.BIZ
|
Owned
|
5/21/2015
|
No
|
AxoGen Corporation
|
Domain name -PERIPHERALNERVE.NET
|
Owned
|
7/21/2012
|
No
|
AxoGen Corporation
|
Domain name -PROSTATECTOMY.NET
|
Owned
|
7/20/2012
|
No
|
AxoGen Corporation
|
Non-clinical data -VP-001-Installation Qualification Protocol for the ACCU-SEAL Model 730-3B6E Medical Sealer (SN 37443)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-002-Operation Qualification Protocol for the ACCU-SEAL Model 730-3B6E Medical Sealer (SN 37443)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-003-ACCU-SEAL Model 730-3B6E Medical Sealer (SN 37443) Validation Report
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-004-Seal Parameters for ACCU-SEAL Model 730 Next Generation Medical Sealer (SN 37443) and Mangar RM48WLAM and DT 1073UC Pouches
|
Owned*
|
N/A
|
Yes
|
AxoGen
|
Non-clinical Data -RD-001-
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
Corporation
|
AGT-1 Nerve Graft Small Animal Study: Axon Regeneration and Functional Recovery following Rat Sciatic Nerve Defect Repair using 14mm and 28mm Grafts
|
|
|
|
AxoGen Corporation
|
Non-clinical data -RD-002-AG-T-1 Nerve Graft Large Animal Study: Evaluation of Regeneration Across Long Nerve (70 mm) Autografts compared to Allografts in Sheep
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-003-Preparation of Suffolk Sheep Nerve Grafts using the AG-T-1 Nerve Graft Processing Method
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-004-Evaluation of CS56 Staining of AG-T-1 processed Mouse, Rat and Sheep Tissue
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-005-Summary of AG-T-1-UT Development Project: Evaluation and development of a detergent treatment process for human peripheral nerve
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-006-AG-T-1 Process Improvement Project
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-007-Evaluation of Label Adherence to AG-T-1 Packaging Components following Gamma Irradiation and Frozen Storage
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-008-Results of EM Investigation of Particulate on AG-T-1 Grafts
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-009-Examination of Histological Processing Parameters
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-012-Assessment of AxoGuard Nerve Protector and Nerve Connector Sizing
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -RD-013-AxoGuard Handling Benchtop Test for Optimal Hydration Time
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-014-Histological Processing of Explant Samples from RD-001 Using Historical Methods
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-015-Justification for the potential for revascularization across nerve graft length and diameter
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-018-Muir Sensory vs. Motor vs. Mixed versions of Autograft and Avance
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-019-Muir Restablished CPSG
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-020-Graft Processing and Histology summary of rabbit Sciatic Nerve using the Alpha Process
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-021-Processing and Histology results of rabbit Peroneal Nerve Study
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-022-Evaluation of a 7cm AG-T-1 Processed Nerve Allograft: A morphometric and function study in the rabbit peroneal nerve model
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-023-Testing of Cryoembedding/ Sectioning of AVANCE™ Nerve Grafts
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-024-Avance Nerve Graft Working Expiration Time Study
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-025-Preliminary Evaluation of the Effects of Decreased ChABC Concentrations on Peripheral Nerve CSPG Clearance
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-026-Evaluation of scarring, inflammation, and nerve function following nerve wrapping
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -RD-027-Vacuum Filtration of Enzyme A with Nerve Tissue II
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-028-Avance Handling Equivalency Study
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-029-Avance Handling Equivalency Study II
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-031-Detergent and CSPG relationship -Avance
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-032-SEM Microphotographs of Nerve Grafts
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-033-Collagen 1 immunostaining of AVANCE samples
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-034-Investigation of CSPG in processed and unprocessed human skin
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-036-Vacuum Filtration of Enzyme A w/ Nervous Tissue
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-037-Avance Suture Retention Strength Method
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-038-Avance Suture Retention Strength
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-039-Post-hoc investigation of neurite recruitment by Avance in an ectopic muscle implant
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-040-Validation of the Gel Clot Method Bacterial Endotoxin Test for Nerve
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-041-Effects of detergent processing on the growth-promoting properties of nerve basal lamina and laminin
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-045-Vacuum Filtration of Enzyme A and the Effect on CSPG Removal from Nerve Tissue II
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -RD-048-Histological Testing of CSPG Clearance
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -RD-049-Clearance of NGF by Detergent Processing
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-005-Validation of the Corporate Quality Folder Security
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-007-Evaluation of Mediatech Data on 20 L Plastic Film used for Processing Solution Storage
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-008-Stability Study on Mediatech Solutions A, B and D
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-009-CS56 Staining Effectiveness Test Run Summary
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-012-Determination of Foil/Mylar Pouch Sealing Parameters and Integrity Testing Regimen
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-013-Determination of Burst Criteria for Tyvek/Mylar Pouch Integrity Testing Regimen
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-014-Qualification Protocol and Final Report of Sanyo Pharmaceutical Refrigerator SN 6081303 ID AX-027
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-015-Qualification Protocol and Final Report of Shel Lab Orbital Shaking Incubator SN# 10099606, ID# AX-021
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-016-Qualification Protocol and Final Report of Shel Lab Orbital Shaking Incubator SN# 10099806, ID# AX-023
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-017-Qualification Protocol and Final Report of Shel Lab Orbital Shaking Incubator SN# 04004206, ID# AX-001
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-018-Qualification Protocol and Final Report of Sanyo -86oC Freezer SN# 60812908, ID# AX-004
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-019-Qualification Protocol and Final Report of Sanyo -86oC Freezer SN# 60812909, ID# AX-005
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-020-Qualification Protocol and Final Report of Sanyo -86oC Freezer SN# 60812913, ID# AX-003
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-021-Initial Biocompatibility Testing for AG-T-1 Nerve Grafts
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-022-Comparative Muscle Implantation Study with Negative Control - 6 weeks -Product Code AG-T-1
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-023-AxoGuard Handling Equivalency Study
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-025-Qualification Protocol and Final Report of Shel Lab Orbital Shaking Incubator SN# 10099506, ID# AX-022
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-026-1, 2, & 3 Year Shelf-Life Package Validation Testing AG-T-1 Nerve Graft Packaging
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-027-Biocompatibility Testing of the Avance Peripheral Nerve Graft
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-029-AG-T-1 Debridement Process Performance Qualification
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-030-
AppTec-Biological Safety Cabinet IQ/OQ/PQ for AX-026
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-031-AppTec-B iological Safety Cabinet IQ/OQ/PQ for AX-025
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-032-Evaluation of Thawing AVANCE Peripheral Nerve Grafts
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-033-Thermal Performance Qualification of the ThermoSafe® Insulated Shipper Model # 615
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-034-Thermal Performance Qualification of the ThermoSafe® Insulated Shipper Model # 326
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-035-AG-T-1 Processing and Packaging Performance Qualification
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-036-Evaluation of Enzyme A from Alternative Manufacturers for Use in Production
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-037-Sterilization Validation for the Avance Product Family
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-038-IQ/OQ for AccuSeal Impulse Sealer AX-020-AppTec St. Paul Facility
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-039-Process Qualification of Final AG-T-1 Product Packaging
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-040-IQ/OQ for BT_1000 Burst Tester AX-048-AppTec St. Paul Facility
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-041-User Handling Qualification of AG-T-1
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-042-Thermal Performance Qualification of the ThermoSafe® Insulated
Shipper Model # E186
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-043-Incubator AX-001 Empty Chamber Thermal Mapping
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-044-Incubator AX-021 Empty Chamber Thermal Mapping
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-045-Evaluation of AG-T-1 Nerve Grafts from Processing Performance Qualification
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-046-AG-T-1 Pilot Production Run Report
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-047-System Validation Master Plan: Microsoft Dynamics GP 9.00.0281 Implementation
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-048-Validation of an Analytical Method for Triton X-200 using HPLC-MS
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-049-IQ/OQ for Zebra Printer AX-066
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-050-Validation of Zebra Printer AX-066
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-051-Validation of Sandwich ELISA for Detection of Chondroitinase ABC (EN-026) Residuals
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-052-AG-T-1 2009 Gamma Irradiation Yearly Dose Re-Mapping
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-053-Sanyo Freezer Final Report AX-068
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-054-Sanyo Freezer Final Report AX-069
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-055-Sanyo Freezer Final Report AX-070
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-056-Sanyo Freezer Final Report AX-073
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-057-AG-T-1 Labeling Process
Performance Qualification
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-058-IQ/OQ for Zebra Printer AX-071
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-059-Summary Report: Non-Immunogenicity of AG-T-1 Nerve Graft
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-060-Residual Enzyme Validation: Chondroitinase ABC and AG-T-1 Nerve Grafts
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-061-Dose Map Report AG-T-1 in SCA Thermosafe E-186 Shipping Container
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-062-AppTec Cleaning Practices, Isolette L-145 Qualification and Isolette L-145 Environmental Monitoring Report
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-063-Washington University Handling Report
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-064-Bioburden Equivalency Investigation -AG-T-1 XXXX70 product codes
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-065-AG-T-1 Risk Management -FMEA [Application, Design and Process]
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-066-Validation of Labeling Software
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-067-Summary Report: Functional Recovery Support for AG-T-1 Nerve Graft
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-068-AG-T-1 Processing: Detergent Virucidal Effects
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-069-1, 2, & 3 Year Real Time Shelf-Life Study of AG-T-1 Peripheral Nerve Graft
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-070-AxoGaurd Receiving, Releasing, Ordering and Shipping Qualification
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-071-Sanyo Freezer Loss of Power Study
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-072-Validation of Labeling Software PS-001 R02
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-073-Installation and Operational Qualification of Accu-Seal Model 730 [AX-076] Next Generation Medical Sealer
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-074-Process Qualification Protocol for the ACCU-SEAL Model 730-1B6E (AX-076) Medical Sealer (SN 42487)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-075-Installation and Certification of AX-083 Labconco Purifier Delta Class II, Type A2 Safety Cabinet
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-076-Installation and Certification of AX-084 Labconco Purifier Delta Class II, Type A2 Safety Cabinet
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-077-Installation and Qualification of AX-085 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-078-Installation and Qualification of AX-086 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-079-Installation and Qualification of AX-087 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-080-Installation and Qualification of AX-
088 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-081-IQ/OQ for ELPRO ECOLOG “LP4” Datalogger Installation in Sid Martin Biotechnology Building Room 137 and 170 (Linked to AX-091)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-082-PQ for ELPRO ECOLOG “LP4” Datalogger Installation in Sid Martin Biotechnology Building Room 137 and 170
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-083-AG-T-1 2007 3rd Quarterly Gamma Irradiation Dose Audit
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-085-EN-004 Solution C Lot 98198013: Filtered versus Manual Comparison
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-086-Summary Report: Support for 5 cm AG-T-1 Nerve Grafts
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-088-5 Year Accelerated and Real Time Aging for AG-T-1 Product
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-089-Installation and Qualification of AX-093 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-090-Installation and Qualification of AX-094 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-091-Installation and Qualification of AX-095 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-092-Installation and Qualification of AX-096 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-093-AG-T-1 2007 4th Quarterly Gamma
Irradiation Dose Audit
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-094-SI6R Orbital Shaking Incubator Temperature Mapping Report
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-095-Re-Qualification Protocol and Final Report of Sanyo -80oC Freezer SN# 60812913, ID# AX-003
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-097-Requalification of AX-048 BT-1000 Burst Tester
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-098-LifeNet: AG-T-1 Debridement Process Performance Qualification
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-099-Installation and Operational Qualification of Sanyo -86oC Freezer SN# 70611640, ID# AX-092
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-100-Installation, Operational and Process Qualification of Accu-Seal Model 730 Next Generation Medical Sealer
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-101-Validation of Labeling Program - PS-001 R04
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-102-Burst Tester 1 Qualificationat LifeNet (BT-1000 Burst Tester)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-104-AG-T-1 Processing and Packaging Performance Qualification LifeNet Ward Court Facility
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-105-Installation and Qualification of SN#11022307, ID# LNH2 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-106-Installation and Qualification of SN#01016208, ID# LNH4 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-107-Installation and Qualification of SN#11022207, ID# LNH3 Shel Lab
SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-108-Installation and Qualification of SN#01016108, ID# LNH1 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-109-Installation and Qualification ofSN#01015508 LNH7 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-110-Installation and Qualification of SN 01015908 LNH6 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-111-Installation and Qualification of SN#11022507, ID# LNH5 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-112-Installation and Qualification of SN# 11022607 LNH 8 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-113-Sterilization Validation for the AVANCE Product Family: LifeNet Facility
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-114-Installation and Qualification of SN#01015408 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-115-Installation and Qualification of SN#01015708 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-116-Installation and Qualification of SN#01015808 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-117-Installation and Qualification of SN#01016308 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-118-
Installation and Qualification of SN#01015608 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-119-Installation and Qualification of SN#01015208 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-120-Installation and Qualification of SN#01015308 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-121-Installation and Qualification of SN#01016008 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-122-Installation and Qualification of SN#01015108 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-123-Installation and Qualification of SN#01015008 Shel Lab SI6R Orbital-Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-124-Interim Report: 1-Year Real-Time Package Validation Testing for the AG-T-1 Nerve Graft
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-125-AG-T-1 2008 1st Quarterly Gamma Irradiation Dose Audit
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-126-Requalification of the Sandwich ELISA for Chondroitinase ABC Residuals in Nerve Grafts
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-127-Qualification Protocol and Final Report of Sanyo-86*C Freezer SN#08020041, ID#AX-099
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-128-Qualification Protocol and Final Report of Sanyo-86*C Freezer SN#08020044, ID#AX-090
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-129-
Chamber Thermal Mapping: Sanyo -86ºC Freezer SN# 70611640, ID# AX-092
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-130-AG-T-1 Process Improvement #1 Processing and Packaging Qualification
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-131-AxoGuard User Handling
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-132-Process Bioburden Investigation Protocol
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-133-Process Cytotoxicity Protocol
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-134-Process Residual Enzyme Protocol
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-135-Process Handling Equivalency Protocol
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-136-Qualification of the Hyclone-Thermofisher Solution C Reagent
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-137-AG-T-1 2008 2nd Quarterly Gamma Irradiation Dose Audit
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-138-AG-T-1 2008 2
nd
Quarterly Gamma Irradiation Dose Audit for LifeNet Processing
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-140-2007-2008 Histology Summary Report
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-141-EN-004 Solution C Analysis
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-142-Installation, Operational, and Performance Qualification of the Sanyo -80 C Freezer
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-143-Installation, Operational, and Performance Qualification of the Sanyo Pharmaceutical Refrigerator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -
VP-144-Installation, Operational, and Performance Qualification of the Shel Lab Orbital Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-145-AG-T-1 2008 3nd Quarterly Gamma Irradiation Dose Audit for WuXi AppTec Processing
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-146-AG-T-1 2008 3
nd
Quarterly Gamma Irradiation Dose Audit for LifeNet
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-147-AG-T-1 Process Improvement #1 Operations Qualification, LifeNet
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-148-Stability Study for Hyclone Solutions A, B, C, D and F
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-149-Packaging User Qualification for AxoGuard
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-150-Shipper Qualification of AxoGuard Finished Product
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-152-September 2008 Steris Isomedix Dose Mapping
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-153-Verifying the use of Tissue Tek VIP processor for processing of histology samples at Histology Tech Services, Inc.
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-154-Mini Pak'R Air Cushion Machine Validation Protocol
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-155-AxoGuard Nerve Wrap Distribution FMEA
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-156-AG-T-1 2008 4th Quarterly Gamma Irradiation Dose Audit for LifeNet
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-157-Validation of Donor Database PS-002 R00
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-158-AxoGen Dose Confirmation Study for AVANCE Nerve Graft (CAPA 08-005)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-159-AX-004 Qualification Report
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-160-1, 2, & 3 Yr RT Shelf-Life Study of AG-T-1 Peripheral Nerve Graft, 1 week Process
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-161-Determination of Ethylene Oxide Residuals for Processing Tubing
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-162-BioStorage Shipping Qualification
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-163-AG-T-1 2009 1st Quarterly Gamma Irradiation Dose Audit for LifeNet
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-165-Inspection Report Review BSC 7 (120868013108) Nuaire Hood (NU-425-500)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-166-Inspection Report Review BSC 6 (120874013108) Nuaire Hood (NU-425-500)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-167-Inspection Report Review BSC 4 (121151021308) Nuaire Hood (NU-425-500)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-168-Inspection Report Review BSC 5 (102906020408) Nuaire Hood (NU-425-500)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-169-IQ/OQ Report BSC 1 (071179035) Labconco Hood (3460001)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-170-IQ/OQ Report BSC 2 (071178797) Labconco Hood (3460001)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -
VP-171-IQ/OQ Report BSC 3 (071179045) Labconco Hood (3460001)
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-172-Validation of Labeling Program - 5 year expiration date
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-173-Re-Qualification of the Sanyo -80 C Freezer
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-174-Re-Qualification of the Sanyo Pharmaceutical Refrigerator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-175-Re-Qualification of the Shel Lab Orbital Shaking Incubator
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-176-Vacuum Filtration of Enzyme A
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-177-IQ/OQ/PQ Report of the Shel Lab Orbital Shaking Incubator S/N 03003409 (IN-19)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-178-Preventive Maintenance Report of the Shel Lab Orbital Shaking Incubator S/N 01015008 (IN-15)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-179-AG-T-1 2009 2nd Quarterly Gamma Irradiation Dose Audit for LifeNet
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-180-AG-T-1 2010 1st Quarterly Gamma Irradiation Dose Audit for LifeNet
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-181-Dose Map Report for Quarterly Dose Audits
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-184-Detergent Dilution Calculation
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-185-Meta-Analysis of Reported Two-Point Discrimination Outcomes from the use of Nerve Cuffs and Avance
®
Nerve Graft for the Reconstruction of Digital Nerve Discontinuities of the Hand of 5 mm or Greater
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -VP-186-Product Dose Mapping for Off Carrier Processing for AxoGen AG-T-1 Product -Steris Isomedix Libertyville IL
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-187-Process Re-Qualification, Lifenet
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-188-LifeNet Incubators Qualifications
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-190-AG-T-1 2010 3rd Quarterly Gamma Irradiation Dose Audit
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-192-Product Dose Re-Mapping Report for AxoGen AG-T-1 Product -Steris North Libertyville IL
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-193-AG-T-1 2011 1Q Quarterly Gamma Irradiation Dose Audit
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-194-Determination of Ethylene Oxide Residuals for Processing Tubing: 2011
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-195-AG-T-1 2011 2Q Quarterly Gamma Irradiation Dose Audit
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-196-Meta-Analysis of Reported Outcomes for NeuraGen Nerve Guide and Avance Nerve Graft for the Reconstruction of Nerve Discontinuities
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-197-IQ/OQ/PQ Houston
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-198-AG-T-1 2011 3Q Quarterly Gamma Irradiation Dose Audit
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -VP-199-2011 Product Dose Re-Mapping Report for AxoGen AG-T-1 Product
-Steris North Libertyville IL
|
Owned*
|
N/A
|
Yes
|
Owner or Licensee of IP
|
Type of IP (e.g., patent, TM, ©, mask work) or License Agreement(1)
|
Owned or Licensed?
|
Anticipated Expiration Date (if a License, expiration of License and Licensed Property)
|
Material IP?
|
AxoGen Corporation
|
Non-clinical data -AGD-CF-01-Early Customer Feedback from Implantation of AxoGuard Nerve Connector and AxoGuard Nerve Protector
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -AXGN CP-003-A pilot study to assess the technical feasibility of robotic assisted Laparoscopic Interpositioning of the AVANCE Nerve Graft for Reconstruction of the Neurovascular Bundle, with a twenty-four month follow-up term to assess efficacy
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -ANG-CP-004-A multicenter, prospective, randomized, comparative study of Hollow Nerve Conduit a,d Avance Nerve Graft evauating recovery outcomes of Nerve Repair in the hand. (Change)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Non-clinical data -ANG-CP-005 -A multicenter, retropective study of Avance Nerve Graft utilization, evaluations and outcomes in peripheral nerve injury repair (RANGER)
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Clinical data -
A Multicenter Retrospective Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair (RANGER)
. The Ranger study, the Avance® Nerve Graft registry, has completed the first data milestone and continues to enroll additional cases.
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Clinical data -
A Multicenter, Prospective, Randomized, Comparative Study of Hollow Nerve Conduit and Avance® Nerve Graft Evaluation Recovery Outcomes of the Nerve Repair in the Hand (CHANGE)
. The CHANGE study is being run as a pilot comparative study and enrollment is still in process.
|
Owned*
|
N/A
|
Yes
|
AxoGen Corporation
|
Clinical data -
Cavernous Nerve Reconstruction Using Avance® Nerve Graft in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer.
This study is being conducted to assess the technical feasibility of robotic assisted implantation of Avance® Nerve Graft and the long term outcomes for continence and potency in men undergoing radical prostatectomy. Enrollment is still in process.
|
Owned*
|
N/A
|
Yes
|
Policy
|
Carrier
|
Policy #
|
Period
|
Amount
|
Deductible
|
Workers Compensation Employers Liability
|
Travelers
|
UB7A746705
|
10/31/11-10/31/12
|
$1,000,000
|
—
|
Auto Liability
|
Travelers
|
BA5A90456A
|
10/31/11-10/31/12
|
$1,000,000
|
$1,000
|
General Liability
|
Marine Travelers
|
TT06306983
|
10/31/11-10/31/12
|
$1M/$2M
|
$1,000
|
Umbrella
|
St Paul Fire & Marine Travelers
|
TT06306983
|
10/31/11-10/31/12
|
$4,000,000
|
$1,000
|
Property
|
St Paul Fire & Marine Travelers
|
TT06306983
|
10/31/11-10/31/12
|
$6,091,500
|
$500
|
Product Liability
|
St Paul Fire & Marine Travelers
|
TT06306984
|
10/31/11-10/31/12
|
$5,000,000
|
$50,000
|
Directors & Officers
|
SH Smith & Co.
|
11053901
|
9/30/12-9/30/13
|
$3,000,000
|
$75,000
|
Employment Practices
|
SH Smith & Co.
|
82244603
|
9/30/12-9/30/13
|
$1,000,000
|
$10,000
|
TABLE OF CONTENTS
|
|||
|
|
|
|
|
|
Page
|
|
Section 1.
|
Definitions; Interpretation.
|
1
|
|
1.1.
|
Definitions
|
1
|
|
1.2.
|
Interpretation
|
12
|
|
Section 2.
|
Credit Facilities.
|
13
|
|
2.1.
|
Loan
|
13
|
|
2.1.1.
|
Loan
|
13
|
|
2.1.2.
|
General
|
13
|
|
2.2.
|
Loan Accounting
|
13
|
|
2.2.1.
|
Recordkeeping
|
13
|
|
2.2.2.
|
Notes
|
13
|
|
2.3.
|
Interest
|
13
|
|
2.3.1.
|
Interest Rate
|
13
|
|
2.3.2.
|
Interest Payments
|
14
|
|
2.3.3.
|
Computation of Interest
|
14
|
|
2.4.
|
Prepayment
|
14
|
|
2.4.1.
|
Voluntary Prepayment
|
14
|
|
2.4.2.
|
Payments in Respect of the Assigned Interests
|
14
|
|
2.5.
|
Payment Upon Maturity
|
14
|
|
2.6.
|
Making of Payments
|
15
|
|
2.7.
|
Application of Payments and Proceeds
|
15
|
|
2.8.
|
Payment Dates
|
15
|
|
2.9.
|
Set-off
|
15
|
|
2.10.
|
Currency Matters
|
15
|
|
Section 3.
|
Yield Protection.
|
15
|
|
3.1.
|
Taxes
|
15
|
|
3.2.
|
Increased Cost
|
16
|
|
3.3.
|
Mitigation of Circumstances
|
18
|
|
3.4.
|
Conclusiveness of Statements; Survival
|
18
|
|
Section 4.
|
Conditions Precedent.
|
18
|
|
4.1.
|
Loan
|
18
|
|
4.1.1.
|
Delivery of Loan Documents
|
18
|
|
4.1.2.
|
Payment of Fees, Expenses and Existing Obligations
|
19
|
|
4.1.3.
|
Representations and Warranties
|
19
|
|
TABLE OF CONTENTS
(continued)
|
|||
|
|
|
|
|
|
Page
|
|
4.1.4.
|
No Default
|
20
|
|
4.1.5.
|
No Material Adverse Change
|
20
|
|
4.1.6.
|
Surviving Debt Subordination Agreement and Acknowledgment
|
20
|
|
4.1.7.
|
Execution and Delivery of Letter Agreement
|
20
|
|
Section 5.
|
Representations and Warranties.
|
20
|
|
5.1.
|
Organization
|
20
|
|
5.2.
|
Authorization; No Conflict
|
20
|
|
5.3.
|
Validity; Binding Nature
|
21
|
|
5.4.
|
Financial Condition
|
21
|
|
5.5.
|
No Material Adverse Change
|
21
|
|
5.6.
|
Litigation
|
21
|
|
5.7.
|
Ownership of Properties; Liens
|
21
|
|
5.8.
|
Capitalization; Subsidiaries
|
22
|
|
5.9.
|
Pension Plans
|
22
|
|
5.10.
|
Compliance with Law; Investment Company Act; Other Regulated Entities
|
22
|
|
5.11.
|
Margin Stock
|
23
|
|
5.12.
|
Taxes
|
23
|
|
5.13.
|
Solvency
|
23
|
|
5.14.
|
Environmental Matters
|
23
|
|
5.15.
|
Insurance
|
24
|
|
5.16.
|
Information
|
24
|
|
5.17.
|
Intellectual Property
|
24
|
|
5.18.
|
Labor Matters
|
25
|
|
5.19.
|
No Default
|
25
|
|
5.20.
|
Foreign Assets Control Regulations and Anti-Money Laundering
|
25
|
|
5.20.1.
|
OFAC
|
25
|
|
5.20.2.
|
Patriot Act
|
25
|
|
Section 6.
|
Affirmative Covenants.
|
26
|
|
6.1.
|
Information
|
26
|
|
6.1.1.
|
Annual Report
|
26
|
|
6.1.2.
|
Quarterly Reports
|
26
|
|
6.1.3.
|
Reserved
|
26
|
|
6.1.4.
|
Compliance Certificate
|
26
|
|
TABLE OF CONTENTS
(continued)
|
|||
|
|
|
|
|
|
Page
|
|
6.1.5.
|
Monthly Net Revenue Report
|
26
|
|
6.1.6.
|
Notice of Default; Litigation; ERISA Matters
|
26
|
|
6.1.7.
|
Reserved
|
27
|
|
6.1.8.
|
Budgets
|
27
|
|
6.1.9.
|
Other Information
|
27
|
|
6.2.
|
Books; Records; Inspections
|
27
|
|
6.3.
|
Maintenance of Property; Insurance
|
28
|
|
6.4.
|
Compliance with Laws and Contractual Obligations; Payment of Taxes and Liabilities
|
29
|
|
6.5.
|
Maintenance of Existence
|
29
|
|
6.6.
|
Environmental Matters
|
29
|
|
6.7.
|
Further Assurances
|
30
|
|
6.8.
|
Post-Closing Obligations
|
31
|
|
6.9.
|
Assigned Interests Payments
|
31
|
|
Section 7.
|
Negative Covenants.
|
31
|
|
7.1.
|
Debt
|
31
|
|
7.2.
|
Liens
|
32
|
|
7.3.
|
Restricted Payments
|
33
|
|
7.4.
|
Mergers; Consolidations; Asset Sales
|
33
|
|
7.5.
|
Modification of Organizational Documents or Surviving Debt Subordination Agreement and Acknowledgment
|
34
|
|
7.6.
|
Use of Proceeds
|
35
|
|
7.7.
|
Transactions with Affiliates
|
35
|
|
7.8.
|
Inconsistent Agreements
|
35
|
|
7.9.
|
Business Activities
|
36
|
|
7.10.
|
Investments
|
36
|
|
7.11.
|
Fiscal Year
|
36
|
|
7.12.
|
Deposit Accounts and Securities Accounts
|
36
|
|
7.13.
|
Sale-Leasebacks
|
36
|
|
7.14.
|
Hazardous Substances
|
36
|
|
7.15.
|
ERISA Liability
|
37
|
|
Section 8.
|
Events of Default; Remedies.
|
37
|
|
8.1.
|
Events of Default
|
37
|
|
TABLE OF CONTENTS
(continued)
|
|||
|
|
|
|
|
|
Page
|
|
8.1.1.
|
Non-Payment of Credit
|
37
|
|
8.1.2.
|
Default Under Other Debt.
|
37
|
|
8.1.3.
|
Bankruptcy; Insolvency
|
37
|
|
8.1.4.
|
Non-Compliance with Loan Documents.
|
38
|
|
8.1.5.
|
Representations; Warranties
|
38
|
|
8.1.6.
|
Judgments.
|
38
|
|
8.1.7.
|
Invalidity of Collateral Documents
|
39
|
|
8.1.8.
|
Invalidity of Subordination Provisions
|
39
|
|
8.1.9.
|
Change of Control
|
39
|
|
8.1.10.
|
Invalidity of Subordination Provisions
|
39
|
|
8.2.
|
Remedies
|
39
|
|
Section 9.
|
The Agent.
|
40
|
|
9.1.
|
Appointment; Authorization
|
40
|
|
9.2.
|
Delegation of Duties
|
40
|
|
9.3.
|
Limited Liability
|
40
|
|
9.4.
|
Successor Agent
|
40
|
|
9.5.
|
Collateral Matters
|
41
|
|
Section 10.
|
Miscellaneous.
|
41
|
|
10.1.
|
Waiver; Amendments
|
41
|
|
10.2.
|
Notices
|
41
|
|
10.3.
|
Costs; Expenses
|
42
|
|
10.4.
|
Indemnification by the Borrower
|
42
|
|
10.5.
|
Marshaling; Payments Set Aside
|
43
|
|
10.6.
|
Nonliability of the Lender
|
43
|
|
10.7.
|
Confidentiality
|
43
|
|
10.8.
|
Captions
|
44
|
|
10.9.
|
Nature of Remedies
|
44
|
|
10.10.
|
Counterparts
|
44
|
|
10.11.
|
Severability
|
44
|
|
10.12.
|
Entire Agreement
|
44
|
|
10.13.
|
Successors; Assigns
|
44
|
|
10.14.
|
Governing Law
|
44
|
|
10.15.
|
Forum Selection; Consent to Jurisdiction; Service of Process
|
45
|
|
10.16.
|
Waiver of Jury Trial
|
45
|
|
10.17.
|
Collateral Agent
|
45
|
|
Annex I
|
Internal Rate of Return Calculation
|
Annex II
|
Addresses
|
Exhibit A
|
Compliance Certificate
|
Schedule 5.7
|
Real Property
|
Schedule 5.10
|
Authorizations, Permits, Licenses and Approvals
|
Schedule 5.15
|
Insurance
|
Schedule 5.18
|
Labor Matters
|
Schedule 7.1
|
Existing Debt
|
Schedule 7.2
|
Permitted Liens
|
Schedule 7.10
|
Existing Investments
|
Schedule 7.12
|
Bank Accounts
|
Section 1.
|
Definitions; Interpretation
.
|
•
|
Long term note payable to Bioveris (Roche) -
|
•
|
Total debt owed to Samuel and Nadine Wohlstadter as of September 30, 2012 -
|
Bank
|
Description
|
Account Number
|
Wells Fargo Bank N.A.
|
Payroll Account
|
|
Wells Fargo Bank N.A.
|
Operating Account
|
|
|
|
For the Years Ended December 31,
|
||||||||||||||||||||||
|
|
2007
|
|
2008
|
|
2009
|
|
2010
|
|
2011
|
|
2012
|
||||||||||||
Earnings:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Income before income taxes
|
|
$
|
191,073
|
|
|
$
|
243,334
|
|
|
$
|
280,285
|
|
|
$
|
150,370
|
|
|
$
|
307,428
|
|
|
$
|
327,133
|
|
Add: fixed charges
|
|
16,267
|
|
|
14,285
|
|
|
19,430
|
|
|
43,578
|
|
|
36,153
|
|
|
29,097
|
|
||||||
Earnings
|
|
$
|
207,340
|
|
|
$
|
257,619
|
|
|
$
|
299,715
|
|
|
$
|
193,948
|
|
|
$
|
343,581
|
|
|
$
|
356,230
|
|
Fixed Charges:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Interest expense
1
|
|
$
|
16,200
|
|
|
$
|
14,219
|
|
|
$
|
19,357
|
|
|
$
|
43,529
|
|
|
$
|
36,102
|
|
|
$
|
29,036
|
|
Estimated interest portion of rent expense
2
|
|
67
|
|
|
66
|
|
|
73
|
|
|
49
|
|
|
51
|
|
|
61
|
|
||||||
Fixed charges
|
|
$
|
16,267
|
|
|
$
|
14,285
|
|
|
19,430
|
|
|
$
|
43,578
|
|
|
$
|
36,153
|
|
|
$
|
29,097
|
|
|
Ratio of earnings to fixed charges
|
|
12.75
|
|
|
18.03
|
|
|
15.43
|
|
|
4.45
|
|
|
9.50
|
|
|
12.24
|
|
•
|
Am I following the spirit, as well as the letter, of any law or Company policy?
|
•
|
Would I want my actions reported in the media?
|
•
|
What would my family, friends or neighbors think of my actions?
|
•
|
Will there be any direct or indirect negative consequences for the Company?
|
•
|
access to assets is permitted, and receipts and expenditures are made, only in accordance with management’s general or specific authorization;
|
•
|
transactions are executed only in accordance with management’s general or specific authorization;
|
•
|
transactions are recorded so as to permit preparation of financial statements in conformity with GAAP or any other criteria applicable to those statements, and to maintain accountability for assets;
|
•
|
the recorded accountability for assets will be compared with the existing assets at reasonable intervals and appropriate action may be taken with respect to any differences, all to permit prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on the Company’s financial statements.
|
•
|
perform his or her duties in an honest and ethical manner;
|
•
|
handle all actual or apparent conflicts of interest between his or her personal and professional relationships in an ethical manner;
|
•
|
take all necessary actions to ensure full, fair, accurate, timely, and understandable disclosure in reports and documents that the Company files with, or submits to, government agencies and in other public communications;
|
•
|
comply with all applicable laws, rules and regulations of federal, state and local governments; and
|
•
|
proactively promote and be an example of ethical behavior in the work environment.
|
•
|
you, or a member of your family, receive improper personal benefits as a result of your position in the Company;
|
•
|
you, or a member of your family, use Company property for your personal benefit;
|
•
|
you engage in activities that interfere with your loyalty to the Company or your ability to perform Company duties or responsibilities effectively;
|
•
|
you, or a member of your family, work simultaneously (whether as an employee or a consultant) for a licensee or supplier;
|
•
|
you, or a member of your family, have a financial interest in a licensee, which is significant enough to cause divided loyalty with the Company or the appearance of divided loyalty (the significance of a financial interest depends on many factors, such as size of investment in relation to your income, net worth and/or financial needs, your potential to influence decisions that could impact your interests, and the nature of the business;
|
•
|
you, or a member of your family, acquire an interest in property (such as real estate, patent or other intellectual property rights or securities) in which you have reason to know the Company has, or might have, a legitimate interest;
|
•
|
you, or a member of your family, receive a loan or a guarantee of a loan from a licensee (other than a loan from a financial institution made in the ordinary course of business and on an arm’s length basis);
|
•
|
you divulge or use the Company’s confidential information – such as financial data, or research or development plans – for your own personal or business purposes;
|
•
|
you make gifts or payments, or provide special favors, to licensees or suppliers (or their immediate family members) with a value significant enough to cause the licensee or supplier to make a purchase or to take or forego any other action, which is beneficial to the Company and which the licensee or supplier would not otherwise have taken; or
|
•
|
you are given the right to buy stock in other companies or you receive cash or other payments in return for promoting the services of an advisor or vendor to the Company.
|
•
|
bribery or payoffs to induce business or breaches of contracts by others;
|
•
|
acquiring a competitor’s trade secrets through bribery or theft;
|
•
|
making false, deceptive or disparaging claims or comparisons about competitors or their products or services; or
|
•
|
mislabeling products or services.
|
•
|
If you believe a violation of this Code, or a violation of applicable laws and/or governmental regulations has occurred or you have observed or become aware of conduct which appears to be contrary to this Code, promptly report the situation to the Compliance Officer.
|
•
|
If you have a complaint or concern or receive notice of a complaint or concern regarding the Company’s financial disclosure, accounting practices, internal accounting controls, auditing, or questionable accounting or auditing matters, you
must
promptly advise the Compliance Officer.
|
•
|
If you wish to report any complaints or concerns anonymously or confidentially, then you may do so as described on our website at www.pdl.com, Investor Relations, Corporate Governance at the bottom of the page “Communication of Potential Issues or Concerns”.
|
•
|
Compliance
. You are expected to become familiar with and understand the requirements of this Code. Most importantly, you must comply with it. By accepting a position as a director, officer or employee of the Company, you are agreeing to abide by the Code. You will be required to certify annually that during the preceding year, you have complied with, and have reported any violations of, the Code.
|
•
|
CEO Responsibility
. The Company’s CEO is responsible for ensuring that this Code is established and effectively communicated to all employees, officers and directors. Although the day-to-day compliance issues are the responsibility of the Company’s managers, the CEO is ultimately accountable for the overall implementation of the Code and successful compliance with this Code.
|
•
|
Corporate Compliance Management
. The Board of Directors shall select an employee to act as the Compliance Officer. The Compliance Officer’s charter is to ensure communication, training, monitoring, and overall compliance with this Code. The Compliance Officer will, with the assistance and cooperation of the Company’s officers, directors and managers, foster an atmosphere where employees are comfortable in communicating and/or reporting concerns and possible Code violations.
|
•
|
Internal Reporting of Violations
. The Company’s efforts to ensure observance of, and adherence to, the goals and policies outlined in this Code mandate that all employees, officers and directors of the Company report suspected violations in accordance with Section XIV of this Code.
|
•
|
Internal Investigation
.
|
◦
|
When an alleged violation of this Code is reported, the Company shall take appropriate action in accordance with the law and regulations and otherwise consistent with good business practice.
|
◦
|
If the suspected violation appears to involve either a possible violation of law or an issue of significant corporate interest, or if the report involves a complaint or concern of any person, whether an employee, a stockholder or another interested person regarding the
|
◦
|
If the suspected violation involves any director or executive officer or if the suspected violation concerns any fraud, whether or not material, involving management or other employees who have a significant role in the Company’s internal controls, any person who received the report should promptly report the alleged violation to the Compliance Officer, if appropriate, the Chief Executive Officer and/or Chief Financial Officer, and, in every such case, the Chairperson of the Audit Committee. The Compliance Officer or the Chairperson of the Audit Committee, as applicable, shall assess the situation and determine the appropriate course of action.
|
◦
|
A person who is suspected of a violation shall be apprised of the alleged violation at a point in the process consistent with the need not to compromise the investigation and shall have an opportunity to provide a response to the investigator.
|
NAME OF SUBSIDIARY OR ORGANIZATION
|
|
STATE OF INCORPORATION OR FORMATION
|
QHP Royalty Sub LLC
|
|
Delaware
|
BTI Acquisition I Corp.
|
|
Delaware
|
BioTransplant Incorporated
|
|
Delaware
|
(1)
|
|
Registration Statement (Form S-3 no. 333-36708) of PDL BioPharma, Inc.,
|
(2)
|
|
Registration Statement (Form S-3 No. 333-122760) of PDL BioPharma, Inc.,
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(3)
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Registration Statement (Form S-3 No. 333-123958) of PDL BioPharma, Inc.,
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(4)
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Registration Statement (Form S-3 No. 333-128644) of PDL BioPharma, Inc.,
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(5)
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Registration Statement (Form S-3ASR No. 333-174052) of PDL BioPharma, Inc.,
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(6)
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Registration Statement (Form S-8 No. 333-87957) pertaining to the 1999 Stock Option Plan and 1999 Nonstatutory Stock Option Plan of PDL BioPharma, Inc.,
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(7)
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Registration Statement (Form S-8 No. 333-68314) pertaining to the 1999 Stock Option Plan and 1999 Nonstatutory Stock Option Plan of PDL BioPharma, Inc.,
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(8)
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Registration Statement (Form S-8 No. 333-104170) pertaining to the 1999 Nonstatutory Stock Option Plan of PDL BioPharma, Inc.,
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(9)
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Registration Statement (Form S-8 No. 333-125906) pertaining to the 2005 Equity Incentive Plan of PDL BioPharma, Inc., and
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(10)
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Registration Statement (Form S-8 No. 333-145262) pertaining to the 2005 Equity Incentive Plan.
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/s/ JOHN P. MCLAUGHLIN
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John P. McLaughlin
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President, Chief Executive Officer and Acting Chief Financial Officer
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(Principal Executive Officer and Acting Principal Financial Officer)
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By:
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/s/ JOHN P. MCLAUGHLIN
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John P. McLaughlin
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President, Chief Executive Officer and Acting Chief Financial Officer
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(Principal Executive Officer and Acting Principal Financial Officer)
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