Case5:11-cv-04494-EJD Document189 Filed12/19/12 Page1 of 15
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`Gregory L. Diskant (admitted pro hac vice)
`Eugene M. Gelernter (admitted pro hac vice)
`PATTERSON BELKNAP WEBB & TYLER LLP
`1133 Avenue of the Americas
`New York, NY 10036
`Telephone: (212) 336-2000
`Facsimile: (212) 336-2222
`E-mail: g1diskantcpbwt.com
`erngelernter@pbwt.com
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`Richard Goetz (S.B. #115666)
`OMELVENY & MYERS LLP
`400 South Hope Street
`Los Angeles, CA 90071-2899
`Telephone: (213) 430-6000
`Facsimile: (213) 430-6407
`E-Mail: rgoetz(omm.com
`
`Sue Roeder (S.B. #160897)
`OMELVENY & MYERS LLP
`2765 Sand Hill Road
`Menlo Park, CA 94025
`Telephone: (650) 473-2600
`Facsimile: (650) 473-2601
`E-Mail: sroeder@omrn.com
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`Attorneys for Plaintiffs
`LIFESCAN, INC. and
`LIFESCAN SCOTLAND, LTD.
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`SAN JOSE
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`LIFES CAN, INC. and
`LIFESCAN SCOTLAND, LTD.,
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`Plaintiffs,
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`SHASTA TECHNOLOGIES, LLC,
`DECISION DIAGNOSTICS CORP.,
`PHARMATECH SOLUTIONS, INC., and
`CONDUCTIVE TECHNOLOGIES, INC.,
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`Defendants.
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`Case No. CV11-04494-EJD (PSG)
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`CORRECTED DECLARATION OF
`PETER MENZIUSO IN SUPPORT OF
`PLAINTIFFS' MOTION FOR A
`PRELIMINARY INJUNCTION
`(FED. R. CIV. P. 65)
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`Date: (cid:9)
`Time: (cid:9)
`Place: (cid:9)
`Judge: (cid:9)
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`March 13, 2013
`9:00 a.m.
`5th Floor, Courtroom 4
`Hon. Edward J. Davila
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`5806221v.]
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`MENZIUSO DECL. ISO LIFESCAN'S P.I. MOTION
`CASE NO. 11 -04494-EJD (PSG)
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`LIFESCAN SCOTLAND LTD. EXHIBIT 2002
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`(cid:9)
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`Case5:11-cv-04494-EJD Document189 Filed12/19/12 Page2 of 15
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`DECLARATION OF PETER MENZIUSO
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`1.
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`I am Vice President of U.S. Sales & Market Development for the
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`Diabetes Care Franchise at LifeScan, Inc. ("LifeScan"), in Milpitas, California. As part of
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`my responsibilities, I am in charge of sales for LifeScan's OneTouch® Ultra® blood glucose
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`monitoring systems, including OneTouch Ultra meters and OneTouch Ultra test strips. I am
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`fully familiar with the facts and circumstances set forth below.
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`2.
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`I submit this declaration in support of the motion by LifeScan and
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`LifeScan Scotland, Ltd. for a preliminary injunction barring Defendants from selling the
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`Shasta Genstrip or offering it for sale.
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`3.
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`If the court does not issue a preliminary injunction, the sale of the
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`Shasta Genstrip would have a devastating impact on LifeScan's business, causing harm that a
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`later award of money damages could not remedy.
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`LifeScan's OneTouch Ultra Blood Glucose Monitoring System
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`4.
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`Persons with diabetes use blood glucose monitoring systems to self-
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`monitor their blood glucose levels. This self-monitoring is one of the most important things
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`diabetic patients can do to manage their disease and prevent long term complications. Using
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`these systems, a person with diabetes can determine if his or her blood glucose is abnormally
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`low or abnormally high, requiring management.
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`5.
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`LifeScan sells a glucose monitoring system known as the OneTouch
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`Ultra system. To use LifeScan's OneTouch Ultra system, a person inserts a disposable
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`OneTouch Ultra test strip in the port of a OneTouch Ultra meter. The person then pricks his
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`or her finger or forearm with a lancet to obtain a small blood sample and places a drop of
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`blood on the test strip. The meter determines the blood glucose level in the sample by
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`measuring the flow of electrical current. Within seconds, the meter displays the person's
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`blood glucose level as a number on a digital display. Based on this reading, the person may
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`determine if his or her blood glucose level is within a satisfactory range or if some
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`intervention or treatment is required to raise or lower the blood glucose level.
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`5806221v.1
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`MENZIUSO DECL. ISO LIFESCAN'S P.I. MOTION
`CASE NO. 1 1-04494-EJD (PSG)
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`(cid:9)
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`Case5:11-cv-04494-EJD Document189 Filed12/19/12 Page3 of 15
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`1
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`6. (cid:9)
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`LifeScan and its affiliates and predecessor companies are pioneers in
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`2 the field of developing blood glucose monitoring systems. They have been developing new
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`3 and improved glucose monitoring systems since the mid-1990s. Their products, including
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`the OneTouch Ultra family of meters and test strips, allow for fast and accurate testing of
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`blood samples, while requiring little blood.
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`7. (cid:9)
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`LifeScan's OneTouch Ultra systems are the market-leading blood
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`glucose monitoring systems in the United States. Other major companies sell test strips,
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`8 including Abbott Diabetes Care, Bayer Diabetes Care and Roche Diagnostics. Each of these
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`9 companies distributes its own glucose meters and test strips that work with that particular
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`10 company's meters. Their test strips are not compatible with OneTouch Ultra meters and
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`11 cannot be used with them. Similarly, LifeScan's OneTouch Ultra test strips are not
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`12 compatible with those companies' blood glucose meters.
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`13 LifeScan's DoubleSureTM Technology
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`14
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`8. (cid:9)
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`An important feature of the OneTouch Ultra system is that it checks
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`15 each blood sample twice to promote accuracy in blood glucose measurements. LifeScan
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`16 refers to this feature in promotional materials and on its website as its "D oubleSureTM
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`17 Technology." This feature represents a key advantage of LifeScan's OneTouch Ultra system
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`18 over competitors' glucose monitoring systems.
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`19
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`9. (cid:9)
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`LifeScan emphasizes its DoubleSure Technology in its promotional
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`20 literature. For example, LifeScan tells customers on its website that its "Do
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`ubleSureTM
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`21 Technology automatically checks each blood sample twice." Ex. A. It tells customers:
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`22 "Don't just be sure. Be DoubleSureTM." Id. The example shown below appears on
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`23 LifeScan's website, Id.:
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`580622!v.1
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`MENZIUSO DECL. ISO LIFESCAN'S P.I. MOTION
`CASE NO. I 1-04494-EJD (PSG)
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`Case5:11-cv-04494-EJD Document189 Filed12/19/12 Page4 of 15
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`10.
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`LifeScan has invested heavily in print, electronic, and television
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`advertising to promote DoubleSure Technology as an advantage over competing systems.
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`Examples of print and electronic materials promoting LifeScan's DoubleSure Technology are
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`attached to this declaration as Exhibits B through K; storyboards of television advertisements
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`promoting DoubleSure are attached as Exhibits L and M.
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`LifeScan's Practice of Providing Meters Free of Charge or at Discount
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`11.
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`Over the years, LifeScan has had a policy and practice of providing
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`blood glucose test meters to patients and doctors either free of charge or at sharply
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`discounted prices.
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`12.
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`LifeScan does not realize a profit on its U.S. sales of its meters. More
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`than half of the meters that LifeScan distributes are given to patients and doctors free of
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`charge. This comes to more than one million meters per year. The remainder are sold at
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`sharply discounted prices.
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`13.
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`LifeScan makes this investment in the expectation and intent that
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`customers will use its OneTouch Ultra meters with LifeScans OneTouch Ultra test strips,
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`from which LifeScan does derive a profit, in their ongoing course of therapy.
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`15806221v.]
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`MENZIUSO DECL. ISO LIFESCAN'S P.I. MOTION
`CASE NO. 1 1-04494-EJD (PSG)
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`(cid:9)
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`Case5:11-cv-04494-EJD Document189 Filed12/19/12 Page5 of 15
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`The Notice on LifeScan's Packaging
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`14. (cid:9)
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`LifeScan's glucose monitors are packaged in boxes that feature the
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`following notice:
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`"Use of the monitoring device included here is protected under
`one or more of the following U.S. patents: 7,250,105,
`6,413,410, 6,733,655, 6,468,125. Purchase of this device does
`not act to grant a use license under these patents. Such a license
`is granted only when the device is used with [LifeScan's]
`OneTouch® Ultra® Test Strips. No test strip supplier other than
`LifeScan is authorized to grant such a license.
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`"The accuracy of results generated with LifeScan meters using
`test strips manufactured by anyone other than LifeScan has not
`been evaluated by LifeScan..
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`ri
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`10 Exhibit N to this declaration is a copy of the front and bottom panels of the package for the
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`11 OneTouch UltraMini, with this notice.
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`12
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`15. (cid:9)
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`The User Guide for OneTouch Ultra meters, which is included in the
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`13 package, features the same notice. See Ex. 0.
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`14
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`16. (cid:9)
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`The User Guide for OneTouch Ultra test strips, a copy of which is
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`15 attached to this declaration as Exhibit P, has a similar notice:
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`"Use of these test strips and associated monitoring device is
`protected under the following U.S. patents: 6,413,410,
`5,733,655, 7,250,105. Purchase of the associated monitoring
`device does not act to grant a use license under these patents.
`Such a license is granted only when the associated monitoring
`device is used with [LifeScan's] OneTouch® Ultra® Blue Test
`Strips. No test strip supplier other than LifeScan is authorized to
`grant such a license. The accuracy of results generated with
`LifeScan meters using test strips manufactured by anyone other
`than LifeScan has not been evaluated by LifeScan."
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`The Introduction of Defendants' Shasta GenStrip Product
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`17. (cid:9)
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`On November 30, 2012, the U.S. Food & Drug Administration
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`("FDA") cleared Defendants' Shasta GenStrip product for sale in the United States for certain
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`uses in connection with glucose meters sold by LifeScan before July 2010. A copy of the
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`FDA clearance letter, from the website of Defendant Decision Diagnostics Corp. ("DDC,"
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`formerly known as Instacare Corp.), is attached to this declaration as Exhibit Q.
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`5806221v.1 (cid:9)
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`MENZIUSODECL. ISO LIFESCAN'S P.I. MOTION
`CASE NO. I I-04494-EJD (PSG)
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`Case5:11-cv-04494-EJD Document189 Filed12/19/12 Page6 of 15
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`18.
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`The "Indications for Use' document that accompanies the FDA's
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`November 30 letter states: "GenStripTM Test Strips with calibration codes 4, 10, and 13 are
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`for use with [LifeScan's] OneTouch® Ultra®, Ultra®2 and UltraMini® Meters purchased
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`before July 2010." Id.
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`19.
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`As of December 13, 2012, Defendant DDC stated on its website:
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`Introducing Gen strip
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`Blood Glucose Test Strip
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`For use with Lifescan One Touch® Ultra®, Ultra 2®, Ultra
`Smart® and Ultra Mini® meters
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`Exhibit R hereto. DDC's website also states that the GenStrip "will be comparable to the
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`existing consumable provided by the platform manufacturer [LifeScan], but priced
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`significantly (50%) lower." Id. The website of Defendant PharmaTech Solutions, Inc.
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`("PharmaTech"), which is linked to DDC's website, has the same text. Ex. S at 1.
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`20.
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`The packaging for the GenStrip shown on the websites of Defendants
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`PharmaTech and Shasta show the GenStrip being used with a LifeScan OneTouch UltraMini
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`meter:
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`(C
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`8 Wit AW
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`bIu
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`so
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`See id. at 2; Ex. T at 1-2 (Shasta website).
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`5806221v.]
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`MENZIUSO DECL. ISO LIFESCAN'S P.I. MOTION
`CASE NO. 1 1-04494-EJD (PSG)
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`Case5:11-cv-04494-EJD Document189 Filed12/19/12 Page7 of 15
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`21. (cid:9)
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`There is no suggestion that the Shasta GenStrip could be used with
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`2 meters supplied by any company other than LifeScan, and the FDA has not cleared the
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`3 GenStrip for use with other companies' meters.
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`4 The GenStrip's Impact on LifeScan's OneTouch Ultra Sales
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`22. Defendant DDC has made clear that it expects to achieve substantial
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`sales of the Shasta GenStrip. According to a May 24, 2011 memorandum published on
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`DDC's website in 2011, DDC projects sales of $173.5 million in the United States in the
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`GenStrip's first full year on the market, with sales increasing sharply afterward. See Ex.
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`U at 2 (total sales minus international sales); see also D.E. 1 ¶ 32.
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`23. (cid:9)
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`This estimate is not unrealistic. Competition in the market for glucose
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`11 test strips is intense, and the market is increasingly sensitive to price considerations. A test
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`12 strip that can be used as a substitute for LifeScan's OneTouch Ultra test strips for half the
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`13 price would substantially reduce LifeScan's sales. It would have a devastating and
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`14 catastrophic effect on LifeScan's business.
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`15
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`24. (cid:9)
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`Because Defendants plan to sell the GenStrip at half the price of
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`16 LifeScan's OneTouch Ultra test strips, it is safe to conclude that LifeScan's lost sales would
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`17 be significantly greater than the sales made by Defendants.
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`18
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`25. (cid:9)
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`This loss of sales would destroy LifeScan's position as the market
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`19 leader, jeopardizing or destroying brand equity that LifeScan has worked hard for many years
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`20 to create and maintain.
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`21 Doubts as to Defendants' Ability to Pay a Damage Award
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`22
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`26. (cid:9)
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`If this court does not issue an injunction, Defendants likely would be
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`23 unable to compensate LifeScan for its lost profits. DDC stated in its most recent 10-K
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`24 Report, filed with the Securities and Exchange Commission ("S.E.C."), that it had suffered a
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`25 net loss of more than $2 million in 2011. Ex. V at F-6. For the period ending September 30,
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`26 2012, DDC reported to the SEC that it was operating at a net loss and had just over $7,000 in
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`MENZIUSO DECL. ISO LIFESCAN'S P.I. MOTION
`CASE NO. I I-04494-EJD (PSG)
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`1 net cash. See Ex. W at 5. I understand that Defendant PharmaTech Solutions, Inc. is a
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`2 wholly owned subsidiary of DDC, formerly known as InstaCare. Ex. V at F-7.
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`Im Customers Could Blame LifeScan for Problems with the Shasta GenStri
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`27. (cid:9)
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`LifeScan's OneTouch Ultra test strips have been on the market for
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`5
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`years and have a proven track record for safety and reliability. A study summarizing nine
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`6 years of accuracy data with OneTouch Ultra test strips is attached to this declaration as
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`7 Exhibit X.
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`8
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`28. (cid:9)
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`In contrast, the Shasta GenStrip has no track record in the marketplace.
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`9 If there were defects or problems with Shasta GenStrip test strips, then inserting those strips
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`10 into LifeScan OneTouch meters could result in inaccurate readings of patients' blood glucose
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`11 levels. The consequences for patients could be serious, and customers are likely to blame
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`12 LifeScan for any problems, harming its good will. This is particularly so since the packaging
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`13 of the Shasta GenStrip prominently features a picture of a LifeScan One Touch meter,
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`14 implying that LifeScan has endorsed and licensed the Shasta GenStrip.
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`15
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`29. (cid:9)
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`If there were defects or other problems related to the Shasta GenStrip,
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`16 it is likely, if not inevitable, that customers would contact LifeScan to complain and to seek
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`17 information, refunds and assurances - which LifeScan would not be able to provide. This
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`18 would further injure the good will that LifeScan has worked hard to develop.
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`19
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`30. (cid:9)
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`These concerns are heightened because the FDA has cleared the Shasta
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`20 GenStrip only for limited purposes. As discussed above, the Shasta GenStrip is cleared only
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`21 with three calibration codes - "calibration codes 4, 10, and 13" - out of 49 possible codes.
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`22 Ex. Q at 4. Moreover, the GenStrip is cleared only "for use with [LifeScan's] OneTouch®
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`23 Ultra®, Ultra®2 and UltraMini® Meters purchased before July 2010."
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`Id.
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`31. (cid:9)
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`But the test strips LifeScan has sold in the United States since 2009
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`have a calibration code - calibration code 25 - that is different from the calibration code for
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`26 which the GenStrip is cleared. Moreover, for the past three years all of the OneTouch Ultra
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`Case5:11-cv-04494-EJD Document189 Filed12/19/12 Page9 of 15
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`1 meters distributed by LifeScan have been pre-set to calibration code
`I results.
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`25 to get accurate
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`32. (cid:9)
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`If a customer uses strips with a calibration code other than calibration
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`4 code 25 (for example, the calibration codes for which the GenStrip has received clearance)
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`5 without resetting his or her OneTouch Ultra meter to the strips' calibration code, there would
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`6 be a mismatch between calibration codes for the meter and the strips.
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`7
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`33. (cid:9)
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`Because customers have become accustomed to a single, preset
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`8 calibration code and to the ease and convenience of not having to reset it, they would have to
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`9 be trained and reminded to calibrate when using the Shasta GenStrip. If they were not
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`10 trained to do so, they could blame LifeScan for any resulting problems, further injuring the
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`11 good will associated with LifeScans products.
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`12
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`34. (cid:9)
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`Closely related to these issues, sale of the GenStrip is likely to cause
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`13 customer confusion. LifeScan would have to devote considerable resources to helping
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`14 consumers understand the respective roles of LifeScan and the Defendants. This would
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`15 distract LifeScan from its core business and be costly to implement, diverting precious and
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`16 limited resources from LifeScan's other competitive selling activities.
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`17
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`35. (cid:9)
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`Any such consumer education effort, coupled with the confusion and
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`18 inconvenience resulting from the GenStrip and its calibration code, could cause customers to
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`19 perceive LifeScan's products as difficult to use and undesirable to buy. They could abandon
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`20 LifeScan's meters entirely and switch to those made by LifeScan's current competitors,
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`21 particularly Roche, Bayer, and Abbot, most of which require no calibration at all. This loss
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`22 of customers is further evidence of the irreparable harm that LifeScan would suffer from the
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`entry of the GenStrip.
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`Sale of the Shasta GenStrip Would Cause Price Erosion and Related Harms
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`25
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`36. (cid:9)
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`In addition, LifeScan would have to dramatically lower its prices to
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`26 compete with a supposedly "comparable" test strip that is sold at a much lower price. As
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`5806221v.]
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`MENZIUSO DECL. ISO LIFESCAN'S P.I. MOTION
`CASE NO. I l-04494-EJD (PSG)
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`1 indicated above, DDC's website states that the GenStrip will be "priced significantly
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`(50%)
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`2 lower" than LifeScan's OneTouch Ultra test strips.
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`3
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`37. (cid:9)
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`Once Life Scan lowered its price to compete with the GenStrip, it
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`4 would be difficult or impossible to raise the price to earlier levels, even if the GenStrip
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`5
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`eventually is removed from the market. Trying to raise prices to earlier levels would cause
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`6 consumer anger and resentment. Thus, any reduction in price to meet competition from the
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`7 GenStrip would cause a long-lasting drop in prices for OneTouch Ultra strips.
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`8
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`38. (cid:9)
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`Sales of a compatible test strip for a much lower price also would
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`9 undermine the goodwill with consumers that LifeScan has worked hard to develop. The
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`III harm to LifeScan would be difficult or impossible to quantify. This harm would occur even
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`11 if LifeScan reduces the price of OneTouch Ultra strips in response to the introduction of the
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`12 Shasta GenStrip.
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`13
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`39. (cid:9)
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`These factors would harm LifeScan's good will with customers. It
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`14 would be difficult or impossible to effectively communicate to customers that LifeScan needs
`
`15 to maintain higher prices because it invests heavily in research & development and generates
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`16 no profit from its OneTouch Ultra blood glucose meters. As discussed above, LifeScan
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`17 distributes its meters to customers free of charge or at sharply reduced or rebated prices in the
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`18 expectation that customers will use the meters with LifeScan's OneTouch Ultra test strips -
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`19 an expectation that would be frustrated by the sale of the GenStrip.
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`20 DenvinLy an Injunction Would Undermine the Incentives for Innovation
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`21
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`40. (cid:9)
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`LifeScan and other Johnson & Johnson companies sell some of the
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`22 world's most advanced medical devices and pharmaceutical products. LifeScan and these
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`23 other Johnson & Johnson companies follow a business model that is based on efforts to
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`24 develop innovative medical/diagnostic products that can make a significant contribution to
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`25
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`26
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`27
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`28
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`patient care.
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`41. (cid:9)
`Developing such products is an expensive, time-consuming and risky
`I endeavor. Developing a new medical device or pharmaceutical product can take many years
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`5806221v.]
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`1 and cost hundreds of millions of dollars. For every project that succeeds, there are many that
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`2 never result in a commercially available product.
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`3
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`42. (cid:9)
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`LifeScan and other Johnson & Johnson companies invest time and
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`4 money in developing innovative medical products with the expectation that, when these
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`5
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`efforts succeed, courts will protect their patented technology by enjoining the sale of
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`6 products that infringe their patents. If other companies can effectively ride on an innovator's
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`7
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`coattails by selling an infringing product and merely paying a reasonable royalty on
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`8 infringing sales, there would be less incentive to spend time and money on the risky venture
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`9 of trying to develop new medical products. The result would be that technology-based
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`10 companies such as LifeScan and other Johnson & Johnson companies would have less of an
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`11 incentive to engage in the risky and expensive endeavor of trying to develop new medical
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`12 products, and their ability to carry on their core business and attract investors would be
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`13 seriously impaired.
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`14
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`43. (cid:9)
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`In 2011, LifeScan's ultimate parent company, Johnson & Johnson,
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`15 invested approximately $7 billion in research and development. LifeScan and its affiliates
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`16 also have a history of making large investments in research and development.
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`17
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`44. (cid:9)
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`The risks and expense associated with trying to develop new medical
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`18 technologies make it important for innovator companies to have some assurance that their
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`19 patents will be fully protected when their investment leads to a new product. Any other
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`20 result will reduce the incentive to engage in the risky and expensive process of developing
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`21 new medical technologies.
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`22
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`45. (cid:9)
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`It would be unfair to allow Defendants to use LifeScan's and LifeScan
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`23 Scotland's patented technology to compete against us. If sales of the Shasta GenStrip are not
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`24 enjoined, Defendants would, in effect, be riding on our coattails and using our patented
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`25
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`26
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`27
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`28 (cid:9)
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`technology to do so.
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`Sale of the Shasta GenStrip Would Deprive LifeScan of Funds for R&D
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`46. (cid:9)
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`To the extent the Shasta GenStrip takes sales that otherwise would
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`have gone to LifeScan, then LifeScan will be deprived of revenues it otherwise could invest
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`in research and development ("R&D").
`
`47. (cid:9)
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`The resulting harm to LifeScan - and to the public in general - is
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`5
`6 impossible to quantify. No one ever will know what life-saving products could have been
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`1
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`2
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`3
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`4
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`developed if LifeScan and affiliated companies had additional funds available to invest in
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`research and development.
`
`48. (cid:9)
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`Moreover, investment in R&D means investment in people -
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`scientists, physicians, engineers and technical assistants. A reduction in R&D spending
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`would necessary mean a reduction in LifeScan's R&D staff. Once these personnel are
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`11
`12 discharged, institutional knowledge and company-specific know-how are irretrievably lost,
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`7
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`8
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`9
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`10
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`13
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`14
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`15
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`and LifeScan's ability to compete in the marketplace would be significantly impaired.
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`Reduced Sales Could Force LifeScan to Lay Off Employees
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`49. (cid:9)
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`Sales of the Shasta GenStrip could harm LifeScan's employees, as well
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`as the company itself. Those sales might force LifeScan to lay off sales, marketing and R&D
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`16
`17 personnel, with many people losing their jobs, particularly in the Northern District of
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`25
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`26
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`27
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`28 (cid:9)
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`California.
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`50. (cid:9)
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`These dangers are not speculative. Because of recent changes in the
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`way the U.S. Government reimburses diabetes testing supplies used by Medicare patients,
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`and the resulting decline in the amount that LifeScan will be able to charge its biggest
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`customer for OneTouch Ultra products (i.e., the U.S. Government), LifeScan recently
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`reduced its workforce by several hundred positions, separate and apart from the introduction
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`of the GenStrip.
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`51. (cid:9)
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`A reduction in sales and prices resulting from the introduction of the
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`GenStrip will necessitate further layoffs. And as with R&D personnel, a company's ability to
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`compete effectively depends on the experience, depth, and strength of its sales and marketing
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`teams. If the GenStrip is introduced and garners substantial sales at LifeScan's expense,
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`5806221v.1
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`1 there is no doubt that LifeScan would be forced to lay off sales and marketing personnel, as
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`2 well as R&D personnel. The impact on LifeScan cannot be overstated. Simply put, it will
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`3 threaten LifeScan's viability as an ongoing concern. Clearly, damages flowing from such an
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`4
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`event would be difficult to calculate and impossible to compensate through an award of
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`5 money damages.
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`6 Reduced Contributions to Diabetes Education and Advocacy
`7
`To the extent the Shasta GenStrip takes sales that otherwise would
`52. (cid:9)
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`8 have gone to LifeScan, LifeScan also will be deprived of revenues that it could devote to
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`9 diabetes education and to other charitable and advocacy efforts aimed at helping diabetics.
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`10 That injury would be felt by other organizations and by the broader community of persons
`11 (cid:9)
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`with diabetes.
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`12
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`53. (cid:9)
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`LifeScan participates extensively in non-commercial, humanitarian
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`13 efforts to improve the quality of life for persons with diabetes. In this regard, LifeScan
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`14 provides assistance to the diabetes community in four areas: (i) legislative advocacy; (ii)
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`15 professional associations; (iii) corporate philanthropy; and (iv) local community efforts.
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`16 Relevant portions of LifeScan's website discussing these activities are attached to this
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`17 Declaration as Exhibit Y. See Being a Responsible Corporate Citizen, LifeScan,
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`18 http://www.lifescan.com/responsibility/giving (last visited Dec. 13, 2012).
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`19
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`54. (cid:9) With respect to legislative advocacy, LifeScan works with the
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`20 Diabetes Access to Care Coalition to assist diabetes organizations in the passage of laws that
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`21 increase insurance coverage and medical rights for people with diabetes.
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`22
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`55. (cid:9)
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`To further the goal of diabetes education, LifeScan also supports
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`23 diabetes organizations and awards that focus on educating health care professionals in
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`24 diabetes-related field to provide the highest quality of care for people with diabetes. Support
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`25
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`26
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`for these organizations provides a wide range of support for the diabetes community.
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`56. (cid:9)
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`As part of these efforts, LifeScan has partnerships with leading
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`27 organizations in the diabetes field, including the American Diabetes Association ("ADA"),
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`28
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`1 the American Association of Diabetes Educators ("AADE'), the Diabetes Exercise and
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`2 Sports Association ("DESA"), the National Diabetes Education Program, the American
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`3 Association of Clinical Endocrinologists, the American Diabetes Association, the European
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`4 Association for the Study of Diabetes, the Federation of European Nurses for Diabetes, the
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`5
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`International Diabetes Federation, the International Society for Pediatric and Adolescent
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`6 Diabetes, and the Juvenile Diabetes Research Foundation ("JDRF").
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`7
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`57. (cid:9)
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`In addition, LifeScan sponsors awards, including: (a) an annual award
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`8 given by the AADE to the Diabetes Educator of the Year, an individual who has made a
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`9 special contribution to diabetes education through dedication and innovation in the practice
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`10 of patient care; (b) an annual award given by the Canadian Diabetes Association to the
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`11 Canadian Educator of the Year; (c) the DESA LifeScan Prize for Athletic Achievement; and
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`12 (d) the American Diabetic Association's Distinguished Service Award in Diabetes Care and
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`13 Education. LifeScan also is a sponsor of the Diabetes Education and Camping Association,
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`14 which provides leadership and education for diabetes camps that serve children affected with
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`diabetes.
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`15
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`16
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`58. (cid:9)
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`As part of its philanthropic efforts, LifeScan also donates testing
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`17 supplies to camp programs nationwide so that thousands of children with diabetes can
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`18 experience the camaraderie of summer camps. In addition, LifeScan sponsors educational
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`19 programs for patients and health care professionals. It also provides sponsorship for diabetes
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`20 fundraising events such as ADA's Tour to Cure and JDRF's Walk to Cure Diabetes.
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`21
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`59. (cid:9)
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`In addition, LifeScan contributes to the Johnson & Johnson Diabetes
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`22 Institute LLC, which provides healthcare professionals with education, training and a space
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`23 for collaboration with the aim of enhancing the understanding of diabetes and helping to
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`24 improve patient outcomes. The Institute aims to ensure that diabetes specialists are able to
`
`25
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`receive skills training and education customized to reflect the needed of patients and
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`26 providers in the region, as well as supporting proven guideline implementation and an
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`27 efficient use of resources within diabetes care. Relevant pages from the Institute's website
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`28
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`are attached to this Declaration as Exhibit Z. See also Johnson & Johnson Diabetes Institute,
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`LLC, http://\\/w\v.iidi.com/(Iast visited Dec. 13,2012).
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`60.
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`To the extent the Shasta GenStrip takes sales that otherwise would
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`have gone to LifeScan, LifeScan would have substantially less funds available to devote to
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`these philanthropic and humanitarian causes.
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`2
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`3
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`4
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`5
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`6 Conclusion
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`7
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`10
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`11
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`14
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`15
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`18
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`22
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`23
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`26
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`27
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`28
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`61.
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`As discussed above, the introduction of the Shasta Genstrip would
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`irreparably harm LifeScan in ways that could not be remedied through an award of money
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`damages.
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`I declare under penalty of perjury that the foregoing is true and correct.
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`Executed: December 19,2012
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`BY~\ha 1:~
`
`Peter
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`enzlUSp
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`OneTouch®GI13l3a®Blltrell/ITBdt4SMi-}lt§.J-[1DnE‘5E1E1nI11il®nt176-4