Participant Informed Consent Form And

STUDY: New Formulation of Glatiramer Acetate (GA) PROTOCOL NO: PM033 STERLING IRB ID: DATE OF IRB REVIEW:

PARTICIPANT INFORMED CONSENT FORM AND AUTHORIZATIONTEMPLATE TO USE AND DISCLOSE MEDICAL INFORMATION STUDY TITLE: An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection

PROTOCOL NO: PM033

STUDY DOCTOR: ,

STUDY SITE:

TELEPHONE:

SPONSOR: Teva Neuroscience, Inc.

Please read this document carefully before you sign it.

You are being asked to participate in a medical research study. Your participation in this research study is strictly voluntary, meaning that you may or may not choose to take part. In order to make an informed decision about the medical research study, the risks and benefits should be explained to you. This process is known as informed consent. This consent form describes the purpose, procedures, possible benefits, and risks of the study. This form will also explain how your medical

of 11 Version: 1 dated 18 June 2009 Participant's Initials

STUDY: New Formulation of Glatiramer Acetate (GA) PROTOCOL NO: PM033 STERLING IRB ID: DATE OF IRB REVIEW: information will be used and who may see it. Once the study has been explained to you, you will be asked to sign this form if you wish to participate. You will receive a copy of this form to review at your leisureTEMPLATE or to ask advice from others. The study doctor or staff will answer any questions you may have about this form or about the study. Please read this document carefully and ask any questions you have about this information. This form may contain words that you do not understand. Please ask the study doctor or staff to explain the words or information that you do not understand. You will be given ample time to review and ask questions.

The sponsor of this research, Teva Neuroscience, Inc., is paying the study doctor to conduct this study.

BACKGROUND INFORMATION

7 Glatiramer acetate (marketed as Copaxone ) is a drug that is currently approved by the United States Food and Drug Administration (FDA) for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). This is a type of MS where patients have Aattacks@ or Aflare-ups@ followed by

7 times when they get completely or partially better. Copaxone is not approved as a cure for MS, but research studies have shown that patients who take the drug have fewer flare-ups.

7 Research studies conducted with Copaxone have shown that the drug is well tolerated. The most 7 frequently reported side effect in patients using Copaxone is injection-site reaction. The symptoms associated with this side effect include redness, a lump under the skin where the drug is injected, pain, itching, swelling, inflammation, and allergic reaction.

PURPOSE OF THE STUDY

The sponsorTEMPLATE of this study has developed a new formulation of glatiramer acetate (GA). This new formulation is investigational, which means that it has not been approved by the FDA, but is 7 available in research studies like this one. Both the approved formulation of GA (Copaxone ) and the investigational form of GA are given as an injection under the skin (subcutaneous).

The purpose of this study is to compare injection-site reactions and pain associated with injections of the approved formulation of GA with the investigational formulation of GA. In addition, the investigators will evaluate the side effects of the two formulations of GA.

If you agree to take part in this study, you will be assigned by chance, like flipping a coin, to one of two study drug groups. You will have an equal chance of being assigned to either of these two groups.

This study is divided into three periods:

$ the Run-In Period $ Study Drug Period 1 $ Study Drug Period 2

During the Run-In period, both study groups will administer injections of the approved formulation for seven (7) days. The purpose of the Run-In period is to allow you time to practice the manual injection technique and to get used to recording information in your study diary. During Study Drug Period 1, one group of participants will receive the investigational formulation and the other group will receive the approved formulation. During Study Drug Period 2, each group will receive

STUDY: New Formulation of Glatiramer Acetate (GA) PROTOCOL NO: PM033 STERLING IRB ID: DATE OF IRB REVIEW: injections of the study drug that they did not receive during the first period. Both you and your study doctor will know to which study drug group you have been assigned.

DURATION TEMPLATE

Your participation in this study is expected to last up to five weeks, and will involve four (4) study visits. The first study visit will take about 1- hours and the other 3 visits will take about 1 hour each to complete.

NUMBER OF PARTICIPANTS

Approximately 132 men and women ages 18 or older with RRMS will take part in this study at approximately 20 research centers across the United States of America. PROCEDURES

Visit 1

The study doctor or staff will explain the study to you. If you decide to participate, you will be asked to sign and date this informed consent form before any study-related procedures are performed. The following study procedures will be performed at this visit:

$ A review of your medical history, including your RRMS history. $ A review of the medications you are taking now and the medications you have taken in the last 30 days. $ A physical examination. This examination will not include a pelvic, rectal, or breast exam. $ A neurological examination. These examinations will include mental status, eye reflexes, coordination reflexes, sensory function, and motor examination.

$ Your vital signs (blood pressure, heart rate, temperature), height, and weight will be measured. $ Blood (approximately 1 2 tablespoons) will be collected for hematology (red blood cells, whiteTEMPLATE blood cells, platelets) and blood chemistry (sodium, potassium, liver function tests). $ You will be asked to provide a urine sample for a urinalysis. If you are a woman who is not post-menopausal for at least one year or surgically sterilized, a urine pregnancy test will be done. If the pregnancy test is positive or you become pregnant during the study, you will be withdrawn from the study.

You will be given instructions on the following:

$ How to perform a manual injection of GA. You will be taught how to rotate your injection site, using five, six or seven different locations (sites) on your body each week. $ How to record the time and date of each injection. $ How to complete the study diary after each injection.

If you agree to follow the study directions and qualify for the study, you will begin the Run-In Period. During this period, you will give yourself an injection of the approved formulation of GA for seven (7) days. During this period of the study, you will practice giving yourself the manual injections and rotating your injection sites (7 different injection locations). You will also practice recording information in a daily study diary.

The study doctor or staff will provide you with the study drug and a study diary. If possible, the study doctor or staff will observe your first manual injection of the study drug and then review the study diary pages you completed. If it is not possible to observe your first manual injection of the study drug, you will start the study drug and Run-In Period the next day or the day after that, at home.

Run - In Period B (7 days)

During this period,TEMPLATE you will give yourself a manual injection of the approved formulation of GA and complete the study diary. This period may start on the same day as Visit 1 or within two days following that visit. At home you will perform the following:

$ Use the study drug labeled ARun-In Period@ and manually inject the approved formulation of GA at your regularly scheduled time, following the injection instructions provided with the study drug. $ Complete the study diary immediately after the injection and before the next dose on the following day.

Repeat this procedure for 7 consecutive days and return to the clinic for Visit 2.

Visit 2

You will return to the study clinic for Visit 2 and the following procedures will be performed:

$ Your vital signs (blood pressure, heart rate and temperature) will be recorded. $ Your study diary from the Run-In Period will be collected and reviewed. $ Unused study drug from the Run-In Period will be collected and reviewed. $ Any changes in your medications will be recorded. $ Any changes in your health will be recorded.

You will be provided with the study drug and diary for Study Drug Period 1 at this visit.

If possible, the study doctor or staff will observe your injection of the first dose of the study drug for Period 1 and then review the study diary pages you completed. If it is not possible to observe the injection TEMPLATEof the first dose of the study drug, you will start the study drug and Study Drug Period 1 the next day, or the day after that, at home.

At home for Study Drug Period 1 (14-day duration)

At home you will perform the following:

$ Use the study drug labeled APeriod 1@ and manually inject GA at your regularly scheduled time, following the injection instructions provided with the study drug. $ Complete the study diary immediately after the injection and before the next dose on the following day.

You will repeat this procedure for 14 consecutive days and return to the clinic for Visit 3.

Visit 3

You will return to the study clinic for Visit 3 and the following procedures will be performed:

$ Your vital signs (blood pressure, heart rate, and temperature) will be recorded. $ Blood (approximately 1 2 tablespoons) will be collected for hematology (red blood cells, white blood cells, platelets) and blood chemistry (sodium, potassium, liver function tests). $ You will be asked to provide a urine sample for a urinalysis. $ Your study diary from Study Drug Period 1 will be collected and reviewed. $ Unused study drug from Study Drug Period 1 will be collected and reviewed.

$ Any changes in your medications will be recorded. $ Any changes in your health will be recorded.

You will alsoTEMPLATE be provided with the study drug and diary for Study Drug Period 2 at this visit.

If possible, the study doctor or staff will observe your injection of the first dose of the study drug for Period 2 and then review the study diary pages you completed. If it is not possible to observe injection of the first dose of the study drug, you will start the study drug the next day, or the day after that, at home.

At home for Study Drug Period 2 (14-day duration)

At home you will perform the following:

$ You will use the study drug labeled APeriod 2@ and manually inject glatiramer acetate at your regularly scheduled time following the injection instructions provided with the study drug. $ Complete the study diary immediately after the injection and before the next dose on the following day.

You will repeat this procedure for 14 consecutive days and return to the clinic for Visit 4.

Visit 4 (Final Visit)

You will return to the study clinic for Visit 4 (Final Visit). The following procedures will be performed:

$ A physical examination. This examination will not include a pelvic, rectal, or breast exam. $ A neurological examination including eye reflexes, coordination reflexes, sensory function and motor examination. $ Vital TEMPLATEsigns including blood pressure, heart rate, temperature and weight will be recorded. $ Blood (approximately 1 2 tablespoons) will be collected for hematology (red blood cells, white blood cells, platelets) and blood chemistry (sodium, potassium, liver function tests). $ You will be asked to provide a urine sample for a urinalysis. $ Your study diary from Study Drug Period 2 will be collected and reviewed. $ Unused study drug from Period 2 will be collected and reviewed. $ Any changes in your medications will be recorded. $ Any changes in your health will be recorded.

PREGNANCY AND BIRTH CONTROL

If you are pregnant, planning to become pregnant, or are breast-feeding, you may not participate in this study.

If you are a woman who is not postmenopausal for at least one year or surgically sterilized and are sexually active, you should use medically acceptable forms of birth control while in the study. Acceptable birth-control methods include abstinence, intrauterine device (IUD), birth-control pills, hormone patch, long-acting injectable hormone, partner=s vasectomy, or a condom or diaphragm used with a cream or foam that kills sperm (double-barrier method). If you have any questions about birth-control options, please ask your study doctor.

The effect of glatiramer acetate on an unborn baby (fetus) is unknown. If you become pregnant, continuing the study drug may not be safe for your unborn baby and for you. Therefore, you must report the pregnancy immediately to the study site staff and your participation in the study will be

STUDY: New Formulation of Glatiramer Acetate (GA) PROTOCOL NO: PM033 STERLING IRB ID: DATE OF IRB REVIEW: stopped. You will be required to consult with your study doctor regarding the risks to your unborn baby, including the possibility of termination of your pregnancy. In the event that you decide not to terminate your pregnancy, the study doctor will ask for your permission to monitor your pregnancy and the healthTEMPLATE of your baby.

POSSIBLE HAZARDS, RISKS, AND DISCOMFORTS OF PARTICIPATING IN THE STUDY

Injecting a needle to administer the study drug or for blood draws may cause fainting, bruising of the skin, or pain at the puncture site. In some people, lightheadedness or nausea may occur. There is also a possibility of infection at the site where the needle is inserted.

POSSIBLE RISKS RELATED TO STUDY DRUG

As with all medications, you should be aware that you may develop some side effects to the study drugs. You will be watched carefully for any side effects and you must report changes in your condition to your study doctor.

The most frequent side effects reported with glatiramer acetate are pain, bleeding, bruising, or lump at the site of injection. These reactions can be partially prevented by using the correct injection technique. You will be trained how to correctly perform the manual injections at Visit 1.

In previous studies, some participants reported symptoms which appeared soon after the injection, which may be signs of an allergic reaction. These symptoms include redness, swelling, itching, flushing (feeling of heat in the face and body), chest tightness, rapid heartbeat, and/or difficulty breathing. The majority of these symptoms go away immediately without any lasting effect, but may last up to 30 minutes. Sometimes some of the symptoms may last for over an hour. You should contact your study doctor immediately if any of these symptoms do not stop within 30 minutes or

STUDY: New Formulation of Glatiramer Acetate (GA) PROTOCOL NO: PM033 STERLING IRB ID: DATE OF IRB REVIEW: they become severe. If you think you are having a severe allergic reaction, call 9-1-1 and seek medical attention immediately.

A permanentTEMPLATE dent (depression) at the injection sites may occur because the fat tissue under the skin may be destroyed.

You should let the study staff know right away if you have any of the above-listed problems, or any other problem that concerns you.

You may not have any side effects, but you should know there is a possibility of risks that are not known. With any drug, unusual, unexpected, or previously unreported side effects could occur. You could also have an allergic reaction to the study drug. It is important that you report all symptoms and side effects that you experience as soon as they occur, whether or not you think they are caused by the study drug. The study drugs must only be taken by you, the study participant (the person for whom it was intended). The study drugs must be kept out of the reach of children or persons with limited ability to read and understand.

POTENTIAL BENEFITS OF THE STUDY

You may or may not benefit from taking part in this study. Your RRMS symptoms may improve, worsen, or stay the same.

You may benefit from the physical and neurological examinations, instruction on the 7-site injection rotation and close monitoring from your study doctor. Also, your participation in this study will provide information that may help RRMS patients in the future.

ALTERNATIVES

You do not have to participate in this study to receive treatment for your RRMS. This study is for research purposesTEMPLATE only. You can choose not to participate in this study. The approved formulation 7 of glatiramer acetate (Copaxone ), is available by prescription from your doctor. The study doctor will explain the risks and benefits of alternative treatments with you.

NEW INFORMATION

Any new information that becomes available during this study that may affect your willingness to continue to participate will be provided to you.

COST FOR BEING IN THE STUDY

There is no cost to you for your participation in this study. During the study you will receive the study visits and study drugs at no cost to you. The study visits are for participation in the study only and do not take the place of your regular doctor visits. You will be responsible for the cost of medicines and/or treatments unrelated to this study.

COMPENSATION TO YOU

To help with your expenses for participation in this study, you will receive $25.00 for each of the scheduled office visits, up to a total of $100.00. You will be paid at the end of the study. If you do not complete the entire study, you will be paid for the visits that you complete.

COMPENSATION FOR RESEARCH-RELATED INJURY

Every effort to prevent a study-related injury will be taken by the study doctor and staff. Medical care will be made available to you to treat any physical injury that happens as a direct result of the study procedures. In the event that you are injured as a direct result of following the study doctor's instructionsTEMPLATE and the study protocol, you should immediately contact Dr. at and emergency treatment will be provided.

You agree to cooperate in obtaining any proceeds from insurance or other third-party coverage that may be available. No financial payments or other forms of compensation (such as lost wages, physical therapy or other recovery needs, other loss of income or pain or suffering or discomfort) will be offered to you for such injuries. However, you do not waive any of your legal rights or release anyone from liability for negligence by signing this document.

VOLUNTARY PARTICIPATION/WITHDRAWAL

Your decision to participate is entirely voluntary. You may decide not to take part or you may leave the study at any time without penalty or loss of benefits. Your regular treatment for your RRMS and the attitudes of your study doctor and staff towards you will not be affected should you decide not to take part in this study. Refusal to participate will not affect any benefits to which you are otherwise entitled.

Your participation may be stopped without your consent by the study doctor, the sponsor, the Institutional Review Board (IRB) or the FDA for any reason. For example, your participation may be stopped if it is deemed to be in the best interest of your health and welfare, if you fail to follow instructions or to cooperate, or the study is stopped for any reason. If you withdraw consent or are withdrawn from the study, you will be asked to have a final visit for your safety.

CONFIDENTIALITY AND AUTHORIZATION TO COLLECT, USE AND DISCLOSE YOUR MEDICAL INFORMATION

As a part ofTEMPLATE this research, the study staff will collect and use records that contain information or data about you and your health. These records may identify you and will be kept as confidential as possible. This is required by law. The study staff will use this information about you to complete this research.

Under the privacy laws, you have the right to decide who can use your protected health information (PHI). When you sign this form, you are saying that you will allow the use of your information for this study.

The Information that will be collected about you as a part of this research includes:

$ Initials $ Birth date $ Race $ Gender $ Allergies $ Medications you take (current and past) $ Medical conditions (current and past)

Information collected about you for this research study will be kept in a research file that is separate from your medical chart. You have a right to see your records. However, you will not be able to see your study records until after the study is ended.

The staff will know your identity. However, they may label your records with your initials or a code assigned to you. The study staff are the only people who will have this code and its key. The following groups may review and may request your information. They may review the study information toTEMPLATE make sure it is correct. They may also review how the team(s) and staff completed the study to make sure they conducted the study correctly.

$ The study sponsor, representatives of the sponsor (Clinical Research Organization), and the people who work with them on the study. $ These people include: " The U.S. Food and Drug Administration (FDA) " Sterling Institutional Review Board " The Department of Health and Human Services " Other government agencies in other countries

We may need to release your information to the groups listed above. If your health information is reviewed by these people, they may need to see your entire medical record. Because of this, we cannot promise your privacy will always be protected. It is possible that your information may be shared (re-disclosed) in a way that it would no longer be protected.

Your information may also be presented at meetings or in articles written about the study (publications). You will not be identified by name in any presentation or publication that uses your research or health information.

This permission (authorization) will expire at the end of the study and/or following expiration of any required record retention period.

You may also take away (withdraw) your permission for us to use your health information at any

STUDY: New Formulation of Glatiramer Acetate (GA) PROTOCOL NO: PM033 STERLING IRB ID: DATE OF IRB REVIEW: time. If you choose to take away your permission, you must write your study staff a letter.

The study staff=s mailing address is , , . The study staff will still be able to use the information collected aboutTEMPLATE you before you withdrew your permission. Information that has already been sent to the Sponsor of the study cannot be taken back.

If you withdraw your permission after you have entered the study, you will be discontinued from the study.

If you do not give permission to use your health information, you cannot be in this study. If you refuse to give permission, your medical care or your relationship with your health care providers will not be affected.

QUESTIONS

You will be given a copy of this informed consent document and may ask for additional information at any time TEMPLATEduring the study from Dr. at . Please call Dr. if you have any questions about the study, or if you experience any medical problems.

If you have questions, concerns, or complaints about the research or questions regarding your rights as a research participant, you may contact Sally P. Green, M.D., Sterling Institutional Review Board, 6300 Powers Ferry Road, Suite 600-351, Atlanta, Georgia 30339 (mailing address) at telephone number 1-888-636-1062 (toll free).

PARTICIPANT STATEMENT AND AUTHORIZATION:

I have read the Participant Informed Consent Form and Authorization to Use and Disclose Medical Information forTEMPLATE this study. I have received an explanation of the nature, purpose, duration, and foreseeable effects and risks of the study and what I will be expected to do. My questions have been answered to my satisfaction.

I agree to take part in this study. I agree to cooperate fully with the study staff and will contact the study doctor or staff right away if I suffer any unexpected or unusual symptoms during the study.

My participation in the study is voluntary and I may refuse to participate or may withdraw from the study at any time, without penalty or loss of benefits to which I am otherwise entitled. I have been informed that any information that becomes available during the course of the study that may affect my willingness to take part will be made known to me as soon as possible.

I agree that results of the study may be passed on to the appropriate authorities and to the sponsor (Teva Neuroscience). My name and address will be kept private. Representatives of the sponsor, Sterling Institutional Review Board, or local or foreign regulatory authorities may wish to examine my medical records to verify the information collected. By signing this document, I give permission for this review of my records while I am a participant.

I give my permission to the study doctor or staff to use and reveal my personal health information as described in this consent form.