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`15:48
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`INST FUR filSTHMifilEufllLL
`
`Informed Consent Form (Adults)
`CSLSBILEGOI f CSP Amendment 2 VIA), 30 March 2012
`
`INFORMED CONSENT FORM FOR ENROLLMENT
`FOR ADULTS
`
`Study Title:
`
`An open~iabel. cross-over, dose—ranging study to evaluate the
`pharmacokinetics, pharmacodynamics and safety of the
`subcutaneous administration of a human plasmauderived
`G‘l—esterase inhibitor in subjects with hereditary angioedeme
`
`Study
`Number:
`
`Center:
`
`csLsso_2oo-l
`
`H. Henry Li, MD.
`Institute for Asthma 5‘: Allergy PC
`5454 Wisconsin Avenue. Suite 7'00
`Chevy Chase, MD 20815
`
`301-985-9292 (24 Hour Number)
`
`Sponsor:
`
`CSL Behring GmbH
`
`Clinical Research and Development
`
`Emil—yon-Behringnsuesse 76
`
`D 35041 Marburg
`
`Germany
`
`Research Study Information
`
`We are asking you to be in a research study initiated and funded by CSL. Behring.
`Before you agree to be in this study, it is important that you read (or have read to you)
`and understand the information in this document.
`
`An independent Review Board (lRB) approved this clinical study. This is an
`independent group of experts who make sure that the rights. safety, and weli~belng of
`human subjects in a study are proteoted.
`
`A description of this clinical trial will be available on httdewwElinicalTrials.gov, as
`required by U.B. Law. This Web site will not include information that can identify you.
`At most, the Web site will include a summary of the results. You can search this Web
`site at any time.
`
`Being in this study is your choice. You should discuss any questions you have with '
`the study doctor. You must sign this document if you want to be in this study. By
`signing this document, you will not give up any of your legal rights that you may have
`
`
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`E13315
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`Informed Consent Form for Enrollmnnt (Adults)
`CSLSSILIOOI 1 C31" Amendment 2 v1.0, 30 March 2012
`(as a research subject) under federal or state laws and regulations. No study-specific
`procedures will be started before you sign this document.
`
`Introduction and Purpose of the Study
`
`is due to the lack of a working protein called Ci—esterase inhibitor (Ci—lNH). Therapy
`for HAE includes giving C'tniNH to treat an episode of svvelling, or to give it regularly
`to preVent these episodes from occurring. However. Ct—lNH currently has to be given
`directly into a vein (intravenously), and this can be impractical for some patients. A
`more convenient way of giving C'l-INH by an injection under the surface of the skin is
`being developed. We are asking you to be in a research study that will invastigate
`how the body handles Ct-lNH that is injected under the surface of the skin.
`
`Study Treatment and Procedures
`
`This is a global clinical research study that will be done at approximately 13 centers in
`the United States and Germany. Approximately 18 subjects with HAE will be in the
`study.
`
`You will be in the study for up to about 17 Weeks. This may include an interval
`between treatments (up to four weeks}; this may be granted in agreement with your
`study doctor and ESL Behring prior to starting the study.
`
`flew
`
`While you are in this study, you will get two forms of C‘I-lNi—l:
`- Berinert is an approved product for treatment of swelling episodes due to HAE
`in the United States and Germany. Berinert will be given to you once,
`intravenously, at the standard dose. The Berinert injection will last about 1t)
`minutes.
`- CSLBSU is a new formulation of Berinert that can be dissolved in a tenth the
`volume of liquid. CSLSBO is an inVestlgational medicine, which means that it
`has not been approved by the drug approval agency in your country. You will
`receive CSLBSO by needle injection under the skin in your abdomen at two of
`the following three doses:
`o 1500 international units (M) in 3 mL. given two times a Week for four
`weeks
`
`o 3000 IU in 6 mL. given Mo times a week for four weeks
`0 6000 It! in 12 mL. given two times a week for four weeks
`
`- The doses you receive and the sequence in which you receive them, will be
`determined by the order you enter the study. Allocation is not random (by
`chance) and sequences will be assigned so that experience with the lower
`doses can be gained before the higher doses are given. Depending on the
`dose given, the injection will last from a few seconds to a few minutes (less
`than ,five).
`
`204374_csr.sso_2om_usnfloroda ICFchrsion 4.0_12Apr2012
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`PflGE
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`
`Informed Consent Form lf‘or Enrollment (Adults)
`CSLSSCLEOM ICSP Amendment 2 v1.0, 30 Ms roll 2012‘.
`If you are joining the study as a replacement for a discontinued subject, your
`treatment sequence will be assigned by CSL Behring to match that missing from the
`subject you are replacing.
`in certain situations,
`this may mean that you will be
`allocated to a single CSLBSD dose and will only need to have a single fournwaek
`‘ CSL330 dosing period. Except for this difference, all other study procedures and visits
`will be as described below.
`
`This is an open—label study, which means that both you and the study doctor will know
`which treatment you are getting-
`
`Study Procggures
`
`The study procedures and study visits will be:
`
`a An initial screening visit to determine if you are suitable for the study;
`a A single, intravenous dose of Berinert followed by two visits to assess how
`your body handles Berinert;
`o Two fouruweek CSLSSQ dosing periods to assess the safety of the dose and
`how your body handles CSLBBD;
`o For each four-week dosing period, visits are two times a Week for the
`first three weeks, and daily on the fourth week;
`o Dyer each four-week dosing period, you will receive two injections of
`CSL830 under the skin every week, which will be an overall total of 16
`injections of CSLBBO;
`.
`o Between the two dosing periods, an interval of up to one month may be
`granted in agreement with your study doctor and ESL Behring prior to
`starting the study;
`o An exit visit one week. after the last CSLBSU dosing period.
`When you start the study, you Mil be asked to visit the study center approximately 30
`times during this study. These visits will take place over a period of up to about 17
`weeks and are described in more detail below.
`
`Screening visit
`
`Before you can start the study, your study doctor will need to make sure that you
`meet the entry criteria for this study. Your study doctor will check your medical
`records to do this. it the study doctor is not your regular doctor, he or she may contact
`your regular doctor.
`
`In addition, your study doctor will have to do some tests to make sure you should be
`in the study. This means that the study doctor will do the following:
`
`«- Ask you about your medical history and your use of any medicines;
`- Perform a physical examination that includes measuring your height, weight,
`temperature, pulse rate, blood preasure and breathing rate;
`. Collect blood and urine samples (including urine pregnancy test for females of
`childbearing potential};
`204374HCSL830_2001_USA_Mcdsl ICF_Version 4.0_12Apr2012
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`8132832815
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`15:48
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`38198??E|1Ei
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`INST FDR flSTHMflEflLL
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`PflGE
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`E’IEr’lEi
`
`Informed Consent Form for Enrollment (Adults)
`CSLBSOJUDI ICSP Amendment 2 v1.0, 30 March 2012
`
`o Assess risk of deep vein thrombosis (which may include arranging an
`ultrasound scan of your legs if your study doctor deems necessary).
`As your health status can affect the safety of your participation in this study, you must
`tell the study doctor:
`
`a Any illness or medical conditions that you have;
`a All medications that you are currently taking or have taken recently;
`-
`If you are participating in any other clinical studies;
`in
`if you are a woman, whether you are trying to become pregnant during the
`course of the study or are breastfeeding;
`a Any other information that can affect your suitability for this clinical study.
`
`After your study doctor has made sure you meet all the entry criteria. you can start the
`study. It can take up to a few days for the blood and urine results to be available.
`if
`necessary, you may need to have some of the blood tests repeated if the first results
`Were unclear.
`
`At your first visit (the screening visit), you will be provided with a diaryimemory aid to
`record any changes to your health and medications taken during the study.
`If you
`experience any swelling episodes due to HAE during the study. you will need to
`record details of the episode and any medications used to treat it.
`
`Study visits associated with Berinert injection
`
`Before the start of your first CSL830 dosing period, you will have three visits over
`three days to see how your body handles a standard dose of Berinert that is given to
`you intravenously.
`
`These three visits will be scheduled betWeen two to seven days before the start of the
`first CSLBSG dosing period. (However, the three visits will be postponed if you have
`recently experienced swelling that Was caused by HAE and that required treatment.
`Please let your study doctor know if you experience any swelling episodes prior to this
`visit.)
`
`On the first day, which will be the day of the Bennett injection. you will have a review
`of your health status and any medications taken. Your doctor will also review the
`inciusioniexclusion criteria for the study and your lab results from the screening visit.
`You and your doctor will then discuss the study drug treatment schedule. You will
`then be given Berinert intravenously. The injection takes about 10 minutes. You will
`be monitored at the study center for at leastao minutes afterwards in case of any
`immediate reactions. Two blood samples will be taken: before Berinert is given to you
`and also at the end of this visit.
`
`On each of the two days following the Berinert injection, you will have a review of your
`health status and any medications taken. A blood sample will also be taken each day.
`
`if the visit for the second day following Bennett injection coincides with the visit at the
`
`2043 r4_cspssom2001_usA_Moct-J ICF_Version 4.D_122Apr2012
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`8132832815
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`38198??E|1E’l
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`INST FDR rfiiSTHMrfiiEufiiLL
`
`PrfiiGE
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`E’IErt’lEr
`
`Informed Consent Form for Enrollment (A delta)
`(33148312001 fCSI’ Amendment 2 111,0, 3-0 March 2012
`start of the CSLBSD dosing period detailed below, thenthe study procedures will not
`be duplicated.
`
`(2:51.830 dosing perfo ols
`
`There are two, four-Week CSLSBO dosing periods. During each of the two, four—week
`dosing periods, you will receive two injections per week of CSL330 under the skin,
`which will be an total of 16 injections of CSLBSO- Depending on the dose given, the
`injections will last from a few seconds to a few minutes {less than five).
`Two different doses of CSLSSO will be given to you during each four*Week period. The
`first dosing period will be scheduled to start within 30 days of the screening visit.
`During each of the four-week dosing periods, visits will be twice a week for the first
`three weeks and daily on the fourth Week.
`
`At each of the twice-weekly visits during the first three weeks of each dosing period,
`you will have
`
`a A review of your health status and any medications taken,
`A blood sample drawn
`a An injection of CSLBSO under the skin in your abdomen by a study center staff
`member.
`
`After receiving CSLBBD on the first day of each dosing period, you will be monitored
`by the study staff for at least 30 minutes in case of any immediate reactions.
`
`At the daily visits during the fourth week of each dosing period. you will have:
`
`a A review of your healthstatus and any medications taken.
`A blood sample will be drawn.
`. An injection of CSLHSU under your skin by a study center staff member (on two
`of these visits only).
`
`Urine samples will be collected once on Day 1 and once during.Week 3 (Day 15) of
`each dosing period. Your temperature, pulse rate. blood pressure and respiratory rate
`will be measured before and after CSLBSO injection on Day 1 and Day 4 in the first
`week, and during two visits (Day 22 and Day 25} in the fourth week. A physical
`examination will also be conducted on Day 25. During each dosing period, there will
`be a weekly assessment (Day 3, Day 15, and Day 22) for the risk of deep vein
`thrombosis, which may include arranging an ultrasound scan of your legs if your study
`doctor deems necessary.
`
`If an intervai of up to four weeks between both dosing periods has been agreed to
`with the study doctor and CSL Behring, you will need to continue to record your health
`status and medications taken during this lntenral.
`If the interval is longer than seven
`days, then the study staff will contact you approximately seven days into this interval
`to see how you are doing.
`
`204374_cstssq_2ooi_usA_Mm-el roam-em: 4.0g12Aprsorz
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`8132832815
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`15:48
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`38198??E|1El
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`INST FDR lfilSTHMlfilEllfilLL
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`PlfllGE
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`EWIIE
`
`Informed Consent Form for Enrollment (Adults)
`CSLSBLZOM rCSP Amendment 2 v1.0, 3|} March 2012
`Exit visit
`
`Approximately one week after the end of the last (281.830 dosing period. you will have
`a renew of your health status and any medications taken. a physical examination
`(including measurement of your temperature. pulse rate. blood pressure and
`respiratory rate). Blood and urine samples {including a urine pregnancy test for
`women of childbearing potential) will be taken.
`
`Possible Benefits and Risks
`
`This study will help us learn more about how the medicine CSLBBU is handled by your
`body and how safe it is when given to patients with HAE by injection under the skin.
`This information will help in the development of a convenient and effective therapy in
`preventing swelling episodes caused by HAE.
`
`You may or may not benefit from this study. Your condition is not expected to get
`better or worse because of your participation in this study.
`
`is approved for use in the treatment of HAE in a number of countries
`Berinert
`worldwide. The most common adverse reactions reported with Bennett use were
`those related to the HAE illness, and have included HAE attacks. headache.
`abdominal pain, nausea. muscle spasm. pain, diarrhea and Vomiting.
`in addition.
`other events such as injection-site pain. injection-site redness. chills and fever have
`also been reported.
`
`CSLBSD has not been previously studied in humans. Becauae CSLBSO contains
`the same active ingredient as Berinert (i.e., C1-[NH), adverse reactions observed with
`Berineit can also be expected with GSLBBG.
`
`Screening blood donors for viral infections;
`- Testing all their blood samples for viruses;
`-
`Inactivating and removing viruses from the blood samples.
`
`Despite this. such products may still potentially contain infections agents. including
`some not yet known or identified. Thus. the risk of transmission of infectious agents
`cannot be totally eliminated. You will be monitored for the development of certain viral
`infections during the study.
`
`Berinert and CSLBBD contain proteins from human plasma. Like any other protein
`molecules. they can cause development of antibodies. Antibodies are substances that
`your immune system produces to help your body fight diseases. Such antibodies can
`theoretically reduce the effectiveness of Berinert or GSLBBD that is given to you.
`Although development of these antibodies has not been observed with the clinical use
`
`20437d_CSL$30"200I_USA_Modcl IC‘F_Vcrsion 4.0;]2Apr20l2
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`8132832815
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`INST FDR lfiISTHMIfiIEHfiILL
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`PflGE
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`EiBr’l
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`E
`
`Informed Consent Form for Enrollment (Adults)
`CSMBOhlflUI 1' CS]? Amendment 2 v1.0, 30 March 2012
`off Eerinert, we will monitor you for development of antibodies to Ci—iNH during this
`
`s u y.
`
`‘l ) after your Berinert injection and
`
`2) after you receive your first dose of CSLSBD at the start of each of the two dosing
`periods.
`
`Formation of blood clots is a potential risk with all Ct—lNH products (both Berlnert and
`CSLBSO}. Although this risk is low, your risk of having a blood slot will be revieWed
`regularly by your study doctor. If there is a chance that you may have developed a
`blood clot, additional tests such as an ultrasound of your legs will be arranged to
`confirm if a blood clot has occurred and to help determine if any other appropriate
`therapy is required.
`
`this injection is
`As CSL83O will be administered under the surface of the skin,
`expected to be associated with local reactions such as irritation, swelling and bruising.
`Such reactions Were reported in a previous study with Berinert injections under the
`skin and were reported to be mild, with the patients recovering completely. Any soch
`reactions developing during this study will be closely monitored by the study doctor.
`Eierinert has been used during pregnancy with no evidence of harm: however there is
`no information about
`the risks of pregnancy during treatment with CSLBSD.
`In
`addition, pregnancy can affect the way your body handles CSLBBD. Therefore, you
`are not allowed to get pregnant while being in this study. If you are sexually active,
`you must use contraception while in this study- Your study doctor will tell you about
`appropriate contraceptive methods.
`
`if you become pregnant, you must tell your study doctor and we will take you out of
`the study. Your study doctor will tell you about the possible risks and inconveniences
`to you during the pregnancy and, if applicable, to an embryo, fetus or nursing infant.
`Your study doctor may need to contact your obstetrician.
`
`If you are a male who is sexually active, you must inform your partnerts), if they are
`able to have children, that the effects of the investigationai product on sperm are
`unknown. You or your partnerts) muot use methods of birth control, so your
`partneris) doesl'do not become pregnant.
`
`Blood samples will be taken froma vein in your arm during the study. This may lead
`to pain at the needle site, bruising, bleeding, swelling or fainting. and (rarely) infection.
`The maximum amount of blood that will be taken on any day of the study is about
`4?.5 mL (3.2 tablespoons). The total amount of blood that will be taken over the entire
`study is about 29? mi. (approximately 1 1/1 cups). This compares to a standard blood
`donation of 2 cups (500 mL}.
`
`2543T4__CSL$30_20QI_USA_Model ICFLVm'sion 4.0_12Apr2012
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`E11328? 2015
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`15:48
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`30190??E|1Ei
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`INST FDR fiSTHMflEflLL
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`PflGE
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`E’IEIr’lEi
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`
`
`Informed Consent Form for Enrollment (Adults)
`CSLBBI‘LIOII! HIS!" Amendment 2 v1.0, .30 March 2012
`
`When assessing your vital signs, your blood pressure and heart rate will be
`measured. An inflatable cuff will be placed on your arm, and a machine will measure
`your blood pressure and heart rate after you have been sitting down for at least five
`minutes. You may eXperience mild discomfort in your arm while the cuff is inflated.
`
`There may be other risks and discomforts associated with administration of Berinert
`or CSLBBD that are not yet known.
`
`New Findings
`
`tell you right away if there is new information that could be
`Your study doctor will
`important to your decision to be in the study.
`
`Espenses and Compensation
`
`Costs to you
`
`You will not have to pay for the study medicine (Berinert or CSLBBO), hospital stays,
`and any tests or procedures which are required only as a result of being in the study
`(for example any additional blood tests or ultrasound scans). GSL Behring will pay for
`these. You or your heaith insurance company will be responsible for paying all other
`medical costs that are not related to this study. This includes any routine or standard
`treatment for HAE that you Wouid haVe received if you had not been in the study.
`
`Compensation
`
`There is no charge to you for participating in this research study. The study sponsor
`pays all the study costs.
`Institute for Asthma a Allergy PC will receive payment from
`the sponsor for the time spent on this study.
`
`For your participation in this study, you may be compensated up to a total of
`$1,570.00. Your compensation will be broken down as follows:
`
`Dosing Period 1
`
`Visit 1
`Visit 2
`Visit 3
`Visit 4
`Visit 5
`Visit 0
`Visit 7’
`Visit 5
`Visit a
`Visit 10
`Visit 11
`Visit 12
`Visit 13
`
`Screening
`1V Berinert infusion
`
`Day 1
`Day 4
`Day a
`Day 11
`Day 15
`Day 18
`Day 22
`Day 25
`Day 23
`
`$120.00
`$90.00
`$50.00
`$50.00
`$95.00
`$55.00
`$55.00
`$55.00
`$70.00
`$45.00
`$55.00
`$55.00
`$45.00
`
`204374_CSL830_2001_USA_Modei ICF‘Ver-sion 4.0_12Apr2012
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`8132832015
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`15: 4B
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`30190??E|1El
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`INST FDR IfiISTHMIfiIEHflILL
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`F'ifiiGE
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`lE’lr’lEi
`
`Informed Consent Form for Enrollment (Adults)
`CSLSSCLZOIJJ. ICSP Amendment 2 vi .0, 30 March 2012
`
`Visit 14
`.Visit 15
`Visit 10
`Visit 17
`Visit 18
`
`Day 24
`Day 26
`Day 2?
`Day 28
`
`‘
`
`Total for Period 1
`
`$1.110.00
`
`Dosing Period 2
`
`Visit 3
`Visit 4
`Visit 5
`Visit 5 ‘
`Visit 7
`Visit 0
`Visit 9
`Visit 10
`1u’isit 11
`Visit 12
`Visit 13
`Visit 14
`Visit 15
`Visit 10
`Visit 17
`Visit 13
`
`Day 1
`Day 4
`Day a
`Day 11
`Day 15
`Day 13
`Day 22
`Day 25
`Day 23
`Day 24'
`Day as
`Day 27
`Day 28
`
`$45.00
`$45.00
`$45.00
`$45.00
`$90.00
`
`$50.00
`$50.00
`$05.00
`$45.00
`$40.00
`$40.00
`$70.00
`$45.00
`$55.00
`$55.00
`$45.00
`$45.00
`$45.00
`$45.00
`$45.00
`$90.00
`
`Total for Period 1
`
`$300.00
`
`If you do not complete the study. you will be compensated for the Visits you hays
`completed.
`
`Researc vriei'atedm'u deformed
`
`about nsurance
`
`if you get hurt or sick as a result of being in the study, you should immediately contact
`your study doctor and seek medical treatment.
`
`Dr. H. Henry Li
`
`Telephone Number: 301-930-9292 (24 Hour Number)
`
`If you experience a study—related injury. necessary andavaiiable medical care
`(including hospitalization) will be provided. A study-related injury is a physical injury or
`illness that is directly caused by any procedure or treatment used in this study and
`that is different from the treatment you would receive if you were not in this study.
`If
`you are physically injured because of any substance or procedure properly giVen
`under the plan of this study, we will pay for the reasonable costs of the treatment of
`that injury that are not covered by any other responsible third party.
`if your health
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`38198??E|1El
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`INST FDR flSTHMflEflLL
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`PflGE
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`llr’lEi
`
`Informed Consent Form for Enrollment (Adults)
`CSLSSLEDD‘I ICSP Amendm cut 2. v1.0, 30 March 26.12
`
`insurance plan has a cost—sharing system (for example ecu—payments or deductibles},
`you may still have to pay these.
`
`.
`
`You will not get any money for medical treatment of an injury or illness that is not the
`result of getting Berinert or CSLBBD as part of this study. You will not get any money
`for wages lost. You will not get any money for the costs of reoeiving physical therapy
`or other recovery services. You will not get any money for pain andi'or suffering that
`may occur during the study or for injuries or problems related to your underlying
`medical canditionls).
`
`Alternative Treatments
`
`You do not have to be in this study to get treatment for your condition.
`
`Your study doctor will tell you about benefits and risks of alternative procedures and
`treatments for the prevention of swelling episodes due to 'HAE. Alternative treatment
`options may include oral steroids or intravenous CHNH injection.
`
`Treatment after the End of the Study
`
`Berinert and GSLBSO will not be provided to you after the study is completed. More
`information will need to be collected before it is decided if CSLSSD injection under the
`skin can be used to prevent swelling episodes in HAE.
`
`After this study is completed. you may return to your prior treatment as prescribed by
`your doctor.
`
`Voluntary Participation and Right to Withdraw
`
`Your participation in this study is completely voluntary. You may refuse to be in the
`study. You may also stop the study at any time. In either case, there will not be a
`penalty or loss of benefits to which you have a right. If you choose to stop the study,
`you will be asked to see your study doctor for a final study visitlexamination. This is
`important to make an orderly and to your study treatment and to tell you about other
`treatment options.
`
`You may be taken out of the study without your agreement. This decision can be
`made by your study doctor, by CSL Behring or by the lECIlRB for the following
`reasons:
`.
`
`.
`-
`.
`s
`
`If your study doctor feels that it is in your best medical interest.
`if you do not follow the study instructions.
`If ESL Behring decides to stop the study.
`In the case of safety concerns.
`
`If you stop the study (or if you are taken out of the study) you will not get any
`additional study treatment. You will be asked to return for a final visit so that the study
`doctor can assess your safety.
`
`204374_CSL33 ti__2oot_usauMadcl ICF_Vorsion 4.o_12Apr2012
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`I
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`Informed Consent Form for Enrollment (Adults)
`CSL850_2001 .' CS]? Amendment 2 v1.0, 30 March 2012
`
`if you withdraw your consent or if you are taken out of the study, the Sponsor or their
`representatives may still use study data collected before you withdrew your consent
`or were taken out of the study.
`
`Confidentiality
`
`During this clinical study, We will collect personal data about you. This data may be
`sensitive, such as your date of birth, race, gender, and medical findings. We will keep
`your identity and your personal records confidential during and after the study.
`To be in this study, you must allow your regular doctor and your other health care
`providers to give your health information to the study doctor and other study
`personnel. You must also allow CSL Behring representatives,
`the IRB, and the
`regulatory authorityfies) access to your health information to monitor the clinical study
`and as required by law. Your identity will remain confidential, as allowed by the
`applicable laws and regulations.
`
`Results from this study may be published in medical journals and presented at
`scientific meetings. Study results may also be posted in a public database on the
`internet. However, your identity will not be disclosed.
`
`This section of the informed Consent describes what sponsor and its representativas
`may do with the study data, which include all of your health information obtained
`during the course of the study. The Sponsor and its representatives may use and
`disclose this data:
`
`. To conduct, monitor, and/or audit the research and to confirm the research
`results.
`-
`
`- To evaluate the performance of 081,330.
`
`. To assure the safety, effectiveness, and quality of research and of medical
`produots and therapies, which may include, but is not limited to. the collection
`and reporting of adverse event information as permitted by law.
`
`. To conduct new medical research and develop proposals for new medical
`products or therapies.
`
`4- As required by law.
`
`Individuals from the Institute for Asthma a Allergy PC, MidLands Independent Review
`Board, Clinical Trials Office, the US Food and Drug Administration and other US and
`foreign government agencies, data safety monitoring boards, and-representatives of
`the sponsor including those from PAREXEL International and contracted laboratories
`may look at and copy the health information created or collected about you as part of
`this study,
`to assure quality control.
`to analyze the information and as otherwise
`permitted bylaw.
`
`You understand that once your health information has been disclosed to a third party,
`federal law: may no longer protect the information from further disclosure.
`
`104374_CSL330_2001_USA_Model ICF_Version 4.D_12Apr20]2
`MLIRB Version 2
`Approved by MidLnnds [RB an 04!! 7/12
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`Informed Consent Form for Enrollment (Adults)
`CSLSSILEOOI HOSP Amendment 2 v1.0, 30 March 2012
`
`The results of this study conducted by the study investigator(s) and sponsor may be
`published or presented at meetings but will not include your name or reveal your
`identity.
`
`Use of Blood Samples for Future HAE Research
`
`After 'we complete our tests, GSL Behring would like to save any left-over blood for
`future research on HAE. Your blood sample will be frozen and will be stored with a
`number assigned to it instead of your name. The number will be linked to your name,
`which means you can withdraw permission for use of your blood sample at any time.
`Your consent to have your samples saved for future HAE research is independent of
`your participation in the current study, and your decision on the future use of your
`blood sample for HAE research does not affect whether you can participate in the
`current study.
`
`The future use of your blood in HAE research may result in new products, tests or
`discoveries that may have potential commercial value. Donors of tissue (such as
`blood) do not retain property rights to the materials. As such. you would not share in
`any financial benefits from these products, tests or discoveries.
`
`The results of the study of your samples will be used for research purposes only, and
`you will not be told the results of the tests.
`
`AUTHORIZATION TO USE AND DISCLOSE HEALTH INFORMATION
`
`This Authorization governs how your health information will be used and disclosed
`(released) by your health care providers and study investigator(s) as part of the study.
`Your health information that may be used and disclosed includes all
`information
`collected during the study, as well as any health information in your medical records
`that is relevant to the study, including certain personal data, which may be sensitive,
`such as you date of birth, race, and gender.
`
`this
`if you do not cancel
`This authorization does not have an expiration date.
`this
`indefinitely.
`To cancel
`authorization in writing,
`then it will remain in effect
`authorization you must notify your study doctor in Writing at the address listed on page
`1 of this document.
`
`YOU AGREE TO PERMIT INSTITUTE FOR ASTHMA a ALLERGY PC, AND YOUR
`HEALTH CARE PROVIDERS TO DISCLOSE HEALTH INFORMATION IN YOUR
`MEDICAL RECORDS TO THE STUDY INVESTIGATORl’S) AND ITS STAFF, AND
`OTHER PERSONS WHO EXAMINE OR PROCESS INFORMATION AS PART OF
`THE STUDY (TOGETHER "RESEARCHERS’jl, AS WELL AS TO THE SPONSOR.
`YOU ALSO AGREE TO PERMIT YOUR PROVIDERS TO DISCLOSE YOUR
`HEALTH INFORMATION AS REQUIRED BY LAW AND TO REPRESENTATIVES
`OF
`FOREIGN AND DOMESTIC
`GOVERNMENT AND
`REGULATORY
`ORGANIZATIONS, REVIEW BOARDS, AND OTHER PERSONS WHO WATCH
`OVER THE SAFETY AND EFFECTIVENESS OF MEDICAL DRUGS AND
`
`2043 TAHCSLEB 0_2001_USA_Mode] ICFHVcrsion 4.G_12Apr2012
`MLIRB Version 2
`
`Approved by Midlands IKE on. 04W. 7112
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`Informed Consent Form for Enrollment (Adults)
`CSLSSILZHIDI ICSP Amendment 2. v1.0, .30 March 2012.
`
`THERAPIES AND THE CONDUCT OF RESEARCH TO MONITOR THE STUDY
`AND AS REQUIRED BY LAW.
`
`YOU ALSO AGREE TO PERMIT THE RESEARCHERS TO DISCLOSE YOUR
`HEALTH INFORMATION TO THE SPONSOR AND ITS REPRESENTATIVES TO
`CONFIRM THE RESEARCH RESULTS;
`TO ASSURE
`THE
`SAFE-TAT;
`EFFECTIVENESS, AND QUALITY OE RESEARCH AND OF MEDICAL PRODUCTS
`AND THERAPIES, INCLUDING DEVELOPING PROPOSALS FOR NEW MEDICAL
`PRODUCTS OR THERAPIES,‘ TO COMPLY WITH APPLICABLE LAWS; AND AS
`OTHERWISE PROVIDED FOR IN THE INFORMED CONSENT.
`
`PERSONS TO CONTACT FOR QUESTIONS, CONCERNS, OR COMPLAINTS
`
`If you have any questions, concerns or complaints about this study, call Dr. H. Henry
`Li at 301-935-9292 (24 Hour Number).
`
`if you have questions about your rights, general questions, complaints or concerns
`about this research, or questions about your rights as a person taking part in this
`study, call the MidLands Independent Review Board (RE) at (913) 335-1414 or (800)
`636-4445. If. at any tirne during or after your participation in this research, you would
`like information or offer input about your research experience, you can call the
`MidLands IRB