Betafact 250 Iu

Leaflet attached to the packaging: patient information

Powder and solvent for solution for injection

BETAFACТ 250 IU

Human coagulation factor IX
Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What is BETAFACТ 250 IU and what is it used for
2. Important information before using BETAFACТ 250 IU
3. How to use BETAFACТ 250 IU
4. Possible side effects
5. How to store BETAFACТ 250 IU
6. Package contents and other information

BETAFACТ 250 IU is a medicine belonging to the group of antihemorrhagic medicines.

The active substance is human coagulation factor IX. It is a protein that occurs naturally in the human body. The function of this protein is to ensure proper blood clotting and prevent prolonged bleeding.
BETAFACТ 250 IU is used to compensate for the lack of coagulation factor IX, and thus prevent and treat bleeding (hemorrhages) in patients with hemophilia B.
Hemophilia B is a hereditary disease associated with a lack of protein called coagulation factor IX.

2. Important information before using BETAFACТ 250 IU

The medicine should not be used in the following cases:

• if the patient is allergic to human coagulation factor IX or any other component of this medicine (see section 6).
• if the patient has hypersensitivity to human proteins.
• if the patient suffers from disseminated intravascular coagulation (DIC) syndrome.

Particular caution should be exercised when using BETAFACТ 250 IU:

• if the patient has liver or heart disease, as they may increase the risk of thromboembolic complications.
• if the patient is taking anticoagulant medicines (e.g., warfarin), as this may increase the risk of bleeding.

Using BETAFACТ 250 IU during pregnancy and breastfeeding– No studies have been conducted on the use of BETAFACТ 250 IU during pregnancy and breastfeeding. The medicine should be used during pregnancy and breastfeeding only if the potential benefits to the mother outweigh the potential risk to the fetus or child.
Driving and operating machinery– BETAFACТ 250 IU does not affect the ability to drive and operate machinery.

3. How to use BETAFACТ 250 IU

BETAFACТ 250 IU should be used in accordance with the doctor's recommendations.
Dosing depends on:

• the severity of the bleeding
• the location of the bleeding
• the patient's body weight
• the level of factor IX in the patient's plasma

BETAFACТ 250 IU is administered intravenously.

4. Possible side effects

Like any medicine, BETAFACТ 250 IU can cause side effects, although not everybody gets them.
Common side effects (may occur in 1 to 10 out of 100 patients):

• allergic reactions (e.g., rash, itching, hives)
• fever
• headache
• hypotension
• dizziness

Uncommon side effects (may occur in 1 to 10 out of 1,000 patients):

• anaphylactic reactions (severe allergic reactions)
• liver function disorders
• vein thrombosis

Rare side effects (may occur in 1 to 10 out of 10,000 patients):

• pulmonary embolism
• heart attack
• stroke

5. How to store BETAFACТ 250 IU

Store in a refrigerator at a temperature of 2°C to 8°C.
Do not freeze.
Store in the original packaging to protect from light.

6. Package contents and other information

The package contains: Powder and solvent for solution for injection.
Responsible entity: CSL Behring GmbH
To obtain further information, please contact the responsible entity.

When to exercise particular caution when using BETAFACТ 250 IU

Risk of blood clots forming in the blood
Due to the existing risk of improper blood clot formation (thromboembolic complications), the medicine should be evaluated for potential benefits of treatment with human coagulation factor IX in the following situations:

• in patients with signs of blood clot degradation (fibrinolysis),
• in patients who form numerous blood clots in the bloodstream (disseminated intravascular coagulation syndrome),
• in newborns,
• in patients shortly after surgery,
• in patients with high blood clotting,
• in patients with liver disease.

The doctor should refer the patient for a blood test to detect signs of these complications as soon as possible.
Risk of cardiovascular events
If the patient has cardiovascular risk factors, the doctor should evaluate the potential benefits of treatment with human coagulation factor IX.
Risk of allergic reaction
Due to the risk of allergic reaction (see section 4), the first injection of BETAFACТ 250 IU must be done under medical supervision, allowing for immediate treatment of allergic reactions if necessary.
The doctor must inform the patient about the possible symptoms of an allergic reaction (see section 4). If an allergic reaction occurs, treatment should be stopped immediately and the doctor should be contacted to start appropriate treatment, depending on the type and severity of the reaction.
After repeated treatment with BETAFACТ 250 IU, the patient's immune system may react to factor IX by producing inhibitors (antibodies against factor IX). The appearance of such inhibitors may reduce the effectiveness of treatment. The doctor must regularly perform blood tests to check for the presence of such inhibitors and to determine their quantity.
A connection has been shown between the presence of factor IX inhibitors and allergic reactions. If the patient experiences symptoms of an allergic reaction, treatment should be stopped immediately and the doctor should be consulted.
Interactions with other medicines
No studies have been conducted on the interaction of BETAFACТ 250 IU with other medicines. Caution should be exercised when administering anticoagulant medicines (e.g., warfarin, heparin) at the same time, as this may increase the risk of bleeding.
Pregnancy and breastfeeding
There is insufficient data on the use of BETAFACТ 250 IU during pregnancy and breastfeeding. The doctor should evaluate whether the potential benefits of using the medicine outweigh the potential risk to the mother and child.
Impact on ability to drive and operate machinery
BETAFACТ 250 IU does not affect the ability to drive and operate machinery.
Dosing and administration
The dose of BETAFACТ 250 IU is determined by the doctor individually for each patient, depending on:

• the degree of factor IX deficiency,
• the type of bleeding,
• the location of the bleeding,
• the patient's body weight,
• the presence of factor IX inhibitors.

Usually, the single dose is 25-50 IU/kg body weight. In the case of severe bleeding, the dose may be increased to 100 IU/kg body weight.
BETAFACТ 250 IU is administered intravenously.
Overdose
Overdose of BETAFACТ 250 IU may cause excessive blood clotting, which can lead to thrombosis.
In case of suspected overdose, the doctor should be contacted immediately.
Side effects
The most common side effects are:

• allergic reactions (e.g., rash, itching, swelling, shortness of breath),
• fever,
• headache,
• nausea,
• vomiting.

Rare side effects include:

• hepatitis,
• thrombosis,
• anaphylactic reactions.

If any side effects occur, the doctor should be consulted.
Storage conditions
Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original packaging to protect from light.
The medicine should be used immediately after reconstitution. The unreconstituted powder can be stored in the refrigerator for up to 36 hours.
Expiration date
The expiration date is stated on the packaging. Do not use the medicine after the expiration date.
Pharmaceutical form and package contents
Powder for solution for injection or infusion.
The package contains 1 vial with 250 IU of factor IX.
Responsible entity
BÉTAFACT 250 IU
Powder for solution for injection or infusion
Manufacturer
Octapharma Pharmazeutika Produktionsgesellschaft mbH
Lindenplatz 5
83022 Rosenheim
Germany
Date of last update of the leaflet
2019-03-29

If the medicines are produced from human blood or plasma, certain safety measures must be taken to prevent the transmission of infections. These include:

• careful selection of blood and plasma donors based on tests and medical interviews, in order to exclude donors who are at risk of infection,
• testing each recovered blood sample and collected plasma for viruses and infectious agents.
• Including processes during the production of products from blood or plasma that inactivate or remove viruses.

Despite the use of preventive methods in the administration of medicinal products produced from human blood or plasma, it is not possible to completely exclude the risk of transmitting infectious agents. This applies to all unknown or newly emerging viruses and other types of infections.
Actions taken during the production of BETAFACТ 250 IU are considered effective against viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus.
Precautions may have limited application in the case of B19 virus, which can have a severe course in pregnant women (fetal infection) and in people with weakened or inadequate immunity or certain types of anemia (e.g., sickle cell anemia or hemolytic anemia).

Vaccinations

The doctor may recommend that the patient be vaccinated against hepatitis A or B if they regularly/repeatedly take products containing factor IX produced from human plasma.

Recording the batch number of the medicine

It is strongly recommended that when administering a dose of BETAFACТ 250 IU to a patient, the name and batch number of the medicine be recorded, so that the patient can be linked to a specific batch of the medicine.

Diaries

The warnings and precautions mentioned apply to both patients receiving single doses of BETAFACТ 250 IU and those receiving regular, chronic infusions.
It is necessary to keep accurate records of patients receiving BETAFACТ 250 IU, including information about the administered doses and batch numbers.

Procedure in case of infection symptoms

If symptoms of infection occur in a patient receiving BETAFACТ 250 IU, the administration of the medicine should be stopped immediately and the patient should undergo appropriate diagnostic tests.

Pharmacokinetic properties Pharmacokinetics of factor IX produced from plasma

BETAFACТ 250 IU contains factor IX produced from human plasma. The pharmacokinetics of factor IX produced from plasma is well understood.
After intravenous administration, factor IX is rapidly distributed in the circulation. The half-life is approximately 12 hours.
The clearance of factor IX is proportional to body weight and is approximately 50 ml/kg/hour.
Excretion of factor IX occurs mainly through hepatic metabolism.
Pharmacokinetics after administration during surgery
During surgery, the pharmacokinetics of factor IX may change due to increased blood loss and changes in circulation.
In such cases, it may be necessary to adjust the dose of the medicine to maintain an adequate level of factor IX.

BETAFACТ 250 IU contains sodium

The medicine contains approximately 2.6 mg of sodium per 1 ml of product (13 mg per 5 ml vial). This should be taken into account if the patient is on a low-sodium diet.

BETAFACТ 250 IU contains heparin

The medicine may cause an allergic reaction and a decrease in blood cell count, which can affect blood clotting.

3. How to use BETAFACТ 250 IU

Treatment should be started by a doctor with experience in caring for patients with hemophilia B. This medicine should always be used in accordance with the doctor's recommendations. If you have any doubts, consult your doctor.

Dosing

• body weight,
• severity of hemophilia,
• location and severity of bleeding,
• general health condition,
• and in specific cases, the procedure to which the patient will be subjected (e.g., surgical procedure, tooth extraction, etc.).

The doctor will recommend blood tests for the patient during treatment to monitor:

• factor IX concentration,
• presence of factor IX inhibitors.

Based on the frequency of such tests, the doctor may decide to change the dose size and frequency of injections.
The appropriate dose is expressed in units (IU).
The doctor will inform the patient how often to administer BETAFACТ 250 IU.
The doctor will adjust the frequency of administration of the medicine based on the severity of the bleeding and the effectiveness of the treatment.
At the end of this leaflet, in the section for medical staff, there is a table describing the frequency of administration and duration of treatment in different situations.

Administration method and route

This medicine should be administered as an intravenous infusion after reconstitution using the supplied solvent.
The doctor will administer the recommended dose of BETAFACТ 250 IU

4. Possible side effects

Like any medicine, BETAFACТ 250 IU can cause side effects, although not everybody gets them.
Rarely, an allergic reaction may occur. In some cases, such reactions can lead to serious allergic conditions.
Allergic reactions may occur in the case of factor IX inhibitor formation and may affect kidney function (see section 2 "Risk of allergic reaction").
Possible symptoms of allergic reactions include:

• swelling of the face or throat,
• feeling of burning and tingling at the injection site,
• chills,
• itching and rash,
• low blood pressure,
• severe weakness (lethargy),
• feeling of nausea (nausea), vomiting,
• anxiety,
• rapid heartbeat (tachycardia),
• feeling of pressure in the chest,
• tingling and numbness,
• wheezing (similar to that occurring in asthma).

If any of these reactions occur, treatment should be stopped immediately and the doctor should be consulted to start appropriate treatment, depending on the type and severity of the reaction.
During clinical trials of BETAFACТ 250 IU, the following side effects were observed, which may occur rarely (may occur in 1 to 1,000 administrations of the medicine):

• hypersensitivity,
• headache,
• flushing,
• allergic swelling,
• feeling of nausea (nausea),
• reaction at the injection site (e.g., chest pain),
• allergic reaction at the injection site.

In the post-marketing period, two cases of adverse reactions – neutralizing antibodies (inhibitors) – were reported in one patient who had not been previously treated with BETIFACT 250 IU and in one patient who had been previously treated with BETIFACT 250 IU.

Side effects listed below were not observed during clinical trials of BETIFACT 250 IU, but were observed in patients taking a medicine from the same group as BETIFACT 250 IU:

• Blood clots may form during treatment with factor IX medicines with low purity.
• Blood clots may form during treatment with factor IX medicines with low purity.
• block blood flow and oxygen supply to the lungs, leading to a serious condition – pulmonary embolism.
• block the formation of blood clots in blood vessels (disseminated intravascular coagulation syndrome).

BETIFACT 250 IU is a medicine containing factor IX with high purity and is rarely associated with such an effect.

Inhibitor formation

1. Patients taking factor IX medicines may produce antibodies against factor IX (so-called inhibitors – see section 2).
2. During clinical trials of BETAFACТ 250 IU, no such antibodies were observed in 1 previously untreated patient.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
02-222 Warsaw, Al. Jerozolimskie 181C
tel: 22 4921 301
fax: 22 4921 309
email: działania.niepożądane@urpl.gov.pl

Manufacturer

BioPharma S.r.l., Via Bettinelli, 29/50058 Pontedera (PI) Italia
Date of leaflet approval: 2019-03-26
BETIFACT 250 IU, powder for solution for infusion
Read the entire leaflet carefully before using the medicine, as it contains important information about the medicine.
Keep the leaflet until the end of treatment.
This medicine is used to treat hemophilia A (factor VIII deficiency) in adults and children.
BETIFACT 250 IU contains factor VIII coagulation factor (factor VIII).
The medicine is prescription-only.

Table of contents

1. What is BETIFACT 250 IU and what is it used for
2. Important information about BETIFACT 250 IU
3. How to use BETIFACT 250 IU
4. Possible side effects
5. How to store BETIFACT 250 IU
6. Package contents and other information

1. What is BETIFACT 250 IU and what is it used for

BETIFACT 250 IU is a medicine containing factor VIII coagulation factor (factor VIII). It is used to treat and prevent bleeding in patients with hemophilia A.
Hemophilia A is a genetic disease that causes blood to not clot properly. This happens because there is a lack or insufficient amount of factor VIII.
BETIFACT 250 IU helps control bleeding by supplementing the missing factor VIII.

2. Important information about BETIFACT 250 IU

Do not use BETIFACT 250 IU:

• if the patient is allergic to factor VIII of human origin or any other component of this medicine.

Warnings and precautions:
Before starting treatment with BETIFACT 250 IU, consult your doctor or pharmacist.
The formation of inhibitors (antibodies neutralizing factor VIII) is a known complication of factor VIII treatment. The risk of inhibitor formation depends on several factors, such as the intensity of treatment, patient age, genetics, and type of hemophilia A.
Caution should be exercised when using the medicine in patients with heart or kidney disease.
Patients treated with factor IX medicines may experience allergic reactions, including anaphylactic reactions.

3. How to use BETIFACT 250 IU

The medicine will be administered by a doctor or nurse in a hospital or clinic.
The dose of the medicine depends on several factors, such as the patient's weight, type of bleeding, severity of hemophilia A, and overall health condition.
The medicine will be administered intravenously.

4. Possible side effects

Like any medicine, BETIFACT 250 IU can cause side effects, although not everybody gets them.
Common side effects (may occur in less than 1 in 10 patients):

• allergic reactions, such as rash, itching, hives
• headache
• fever

Uncommon side effects (may occur in less than 1 in 100 patients):

• anaphylactic reactions (severe allergic reactions)
• shortness of breath
• chest pain
• dizziness
• nausea
• vomiting

5. How to store BETIFACT 250 IU

Store in a refrigerator at a temperature of 2°C to 8°C.
Do not freeze.
Store in the original packaging to protect from light.

6. Package contents and other information

The package contains: 1 vial with powder for solution for infusion (250 IU) and 1 ampoule syringe with water for injection.

6. Contents of BETAFACТ 250 IU

What BETAFACТ 250 IU contains
The active substance of the medicine is human coagulation factor IX at a concentration of 50 IU/ml after reconstitution. After reconstitution, one vial contains 250 IU/ml of human coagulation factor IX.
The specific activity of BETAFACТ 250 IU is approximately 110 IU/mg of total protein.
The other ingredients are:

• in the powder: sodium chloride, sodium heparin, lysine hydrochloride, arginine, sodium citrate, and
• in the solvent: water for injection (see section 2).

What BETAFACТ 250 IU looks like and what the package contains

BETAFACТ 250 IU comes in the form of powder and solvent for solution for injection (in vials of 250 IU/ml) with a reconstitution set and a filter needle. BETAFACТ 250 IU is available in single packages.

Responsible entity and manufacturer

LFB BIOMEDICAMENTS
ZA de Courtaboeuf
91940 Les Ulis
FRANCE
Phone: +33 (1) 69 82 70 10

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

• Austria, Netherlands: BЕТАFACT 50 IU/ml
• Czech Republic, Greece, Slovakia: BЕТАFACT 250 IU/ml
• France, Portugal: BЕТАFACT 50 IU/ml, BЕТАFACT 250 IU/ml
• Spain: BЕТАFACT 250 IU/ml, BЕТАFACT 50 IU/ml
• Germany: BЕТАFACT 250 IU
• Poland: BЕТАFACT 250 IU
• Romania: BЕТАFACT 250 IU
• Hungary: BЕТАFACT 250 IU
• Italy: BЕТАFACT 250 IU

Date of last update of the leaflet: May 2023
Information about this medicine can be found on the website of the Agency for Medicinal Products: https://www.urpl.gov.pl

Monitoring treatment

During treatment, it is recommended to regularly determine the factor IX levels to determine the administered dose and frequency of infusion. In individual patients, the response to factor IX may vary. The biological half-life and recovery time may also vary. The dose determined based on body weight may need to be adjusted in patients who are underweight or overweight. The risk of thromboembolic complications increases in the case of major surgical procedures, and careful monitoring of substitution therapy based on coagulation analysis (factor IX activity in plasma) is necessary.

Dosing

The dose and duration of substitution therapy depend on the degree of factor IX deficiency, location and severity of bleeding, and the patient's clinical condition.
The number of units of factor IX administered is expressed in international units (IU), which refer to the current World Health Organization (WHO) standard for factor IX products. Factor IX activity in plasma is expressed as a percentage value (relative to normal human plasma values) or in international units (relative to the International Standard for factor IX in plasma).
One international unit (IU) of factor IX activity corresponds to the amount of factor IX in one milliliter of normal human plasma.

Treatment as needed

The calculation of the required dose of factor IX is based on the empirical finding that one international unit (IU) of factor IX per kilogram of body weight increases the factor IX activity in plasma by 1.08% relative to the normal value. The required dose is determined using the formula:
Number of units to be administered =
Administered dose and frequency of administration should be determined individually for each patient, depending on the clinical effectiveness in individual cases.
In the case of the following complications, repeated bleeding will be stabilized by administering a factor IX activity level of ≥ 80%. In the case of urgent bleeding, it is recommended to re-administer a factor IX activity level of ≥ 100%. Monitoring of factor IX levels should be performed regularly.
Table 1. Guideline doses of factor IX based on body weight and type of bleeding

• Body weight (kg)
• Type of bleeding
• Dose (IU)

Note:The given doses are guideline doses and should be adjusted to the individual needs of the patient.
In the case of severe bleeding, such as bleeding in the head, higher doses of factor IX may be necessary.
In the case of lack of response to treatment, it may be necessary to administer additional doses of factor IX or use other treatment methods.
In the case of side effects, treatment should be stopped and the doctor should be consulted.

Life-threatening bleeding

60-100

Repeat infusion every 8-24 hours, until the risk has passed.

Surgical procedure

30-60

Every 24 hours, for at least one day, until adequate wound healing. Then repeat infusion every 8-24 hours, until adequate wound healing.

Minor surgical procedure, including tooth extraction
Major surgical procedure
80-100
(before surgery, factor IX activity level of 30-60% (IU/dl) and after)
In some cases, it may be necessary to use higher doses than calculated, especially for the initial dose.

Prophylaxis

In the case of long-term antihemorrhagic prophylaxis in patients with severe hemophilia B, the usual doses of factor IX are 20-40 IU/kg body weight, administered at intervals of 3-4 days.
In some cases, especially in younger patients, it may be necessary to shorten the dosing intervals or use higher doses.

Previously untreated patients

Currently available data are described in section 4.8, but no dosing recommendations can be provided.

Children and adolescents

In a clinical trial, 13 children under the age of six were administered the medicinal product BETAFACТ, using doses similar to those administered to adult patients (see also sections 4.4, 5.1, and 5.2).

Reconstitution:

The product should be dissolved using water for injection, as described below.

• If necessary, warm both vials (powder and solvent) to room temperature.
• Wash your hands thoroughly using soap and warm water.

• Remove the protective cap from the vial and powder and solvent.

• Disinfect the surface of each stopper. Place the vials on a flat, clean surface.

• Remove the semi-transparent cover from the reconstitution set and insert the needle into the end of the set through the hole in the center of the stopper of the vial with the solvent, while turning the needle.

• Remove the second cover from the other end of the reconstitution set.

• Holding the vials horizontally (the puncture hole should be facing upwards), quickly insert the free end of the needle into the center of the stopper of the vial with the powder.

• Make sure the needle remains immersed in the solvent to avoid premature loss of vacuum.

• Immediately position the set vertically, holding the vial with the solvent directly above the vial with the powder. This will allow the entire solvent to be transferred to the vial with the powder.

• During the transfer of the solvent, direct the stream to the entire surface of the powder. Ensure that all the solvent has been transferred.

• The vacuum will disappear at the end of the transfer (sterile air).

• Remove the empty vial (solvent) from the reconstitution set.

• For a few minutes, gently rotate the vial in a rotational motion to prevent foam formation, until the powder is completely dissolved.

The powder dissolves quickly and should be completely dissolved within less than 5 minutes.
The solution should be clear.
Do not use a cloudy solution or one containing particles.
Do not mix with other medicinal products.
Do not dilute the already dissolved product.

Storage after reconstitution

Use immediately. However, the chemical and physical stability of the reconstituted solution has been demonstrated for up to 3 hours at 25°C.

Administration method:

Draw the product into a sterile syringe using the filter needle provided with the kit.

Remove the needle from the syringe.

Connect the syringe to the intravenous needle; remove the air from the syringe, disinfect the skin at the injection site, and insert the needle into the vein.
Administer intravenously as a single dose, not exceeding a flow rate of 4 ml/minute.

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