Common use of Females able to have children Clause in Contracts

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose of study drug. Please note that carbamazepine can make hormonal contraceptives less effective. It is suggested that a back-up method of birth control be utilized, such as a condom. You must not donate eggs for the purpose of reproduction for the duration of the study and for at least 28 days after the last dose of study drug. Low user dependency methods (methods that do not rely on you to remember to use them) • Copper Intrauterine device (IUD) • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Sexual abstinence – defined as refraining from heterosexual intercourse and is the preferred and usual lifestyle of the participant You must agree to the following during the study and for at least 28 days after the last dose of study drug. • Refrain from donating sperm • Be abstinent from heterosexual intercourse with a female able to have children as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent Must agree to use birth control/barrier as detailed below: • Agree to use a male condom when having sexual intercourse with a female able to have children who is not currently pregnant • In addition to male condom use, a highly effective method of birth control may be considered in female partners able to have children of male participants such as the methods detailed earlier in this document The effects of the study drug on the following are not known and may involve unforeseeable risks: • Sperm • Pregnancy • Unborn child • Breastfeeding child The effects of the study drug on reproduction are unknown. At this time, it is not known whether the study drug can cause harm to the fetus or whether it is secreted in human milk. Therefore, the study drug should not be administered to pregnant women or women who are breastfeeding. An appropriate method of birth control is required. Carbamazepine can cause harm to an unborn child. Even if you use birth control during the study, there is a chance you or your partner, could become pregnant. If you or your partner are pregnant or become pregnant, during the study, the study drugs or procedure may involve unforeseeable risks to the unborn child. \A pregnancy test is not always right, especially in the early stages of pregnancy. If you are currently pregnant, plan to become pregnant, or are breastfeeding a child, you should not join this study. If you are a man whose partner is currently pregnant or plan to father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigator

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose of study drugdosing. Please note that carbamazepine can make • Implantable progestogen-only hormonal contraceptives less effective. It is suggested that a back-up method of birth control be utilized, such as a condom. You must not donate eggs for the purpose of reproduction for the duration of the study and for at least 28 days after the last dose of study drug. Low user dependency methods (methods that do not rely on you to remember to use them) • Copper Intrauterine device (IUD) • Intrauterine hormone-releasing system • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Hormonal birth control (*See Note Below) • Sexual abstinence – defined as refraining from heterosexual intercourse and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must be used in addition to the hormonal birth control methods: • Male of female condom with or without spermicide • Cervical cap, diaphragm, or sponge with or without spermicide • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double-barrier method) You must agree to the following during the study and for at least 28 days after the last dose of study drug. : • Refrain from donating sperm • Be abstinent from heterosexual intercourse with a female able to have children as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent Must agree to use birth control/barrier as detailed below: • Agree Must agree to use a male condom when having sexual intercourse with a female woman who is able to have children who is not currently pregnant • In addition to male condom use, a female partners able to have children may consider an additional highly effective method of birth control may be considered in female partners able to have children of male participants such as the methods detailed earlier in this document The effects of the study drug on the following are not known and may involve unforeseeable risks: • Sperm • Pregnancy • Unborn child • Breastfeeding child The effects of the study drug on reproduction are unknown. At this time, it is not known whether the study drug can cause harm to the fetus or whether it is secreted in human milk. Therefore, the study drug should not be administered to pregnant women or women who are breastfeeding. An appropriate method of birth control is required. Carbamazepine can cause harm to an unborn child. Even if you use birth control during the study, there is a chance you or your partner, could become pregnant. If you or your partner are pregnant or become pregnant, during the study, the study drugs or procedure may involve unforeseeable risks to the unborn child. \A pregnancy test is not always right, especially in the early stages of pregnancy. If you are currently pregnant, plan to become pregnant, or are breastfeeding a child, you should not join this study. If you are a man whose partner is currently pregnant or plan to father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigatorabove.

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose of study drug. Please note that carbamazepine ritonavir can make hormonal contraceptives estradiol-containing birth control less effective. It is suggested that a back-up A barrier method or other nonhormonal method of birth control must also be utilized, such as a condomused if you are using estradiol-containing birth control. You must not donate eggs for the purpose of reproduction for the duration of the study and for at least 28 days after the last dose of study drug. Low user dependency methods (methods that do not rely on you to remember to use them) • Copper  Implantable progestogen-only hormone birth control  Intrauterine device (IUD) •  Intrauterine hormone-releasing system  Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) •  Partner has a vasectomy (absence of sperm confirmed) •  Hormonal birth control* (See Note below)  Sexual abstinence – defined as refraining from heterosexual intercourse during the study and for 28 days after the last dose of study drug, and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must be used in addition to the use of hormonal birth control methods:  Male or female condom with or without spermicide  Cervical cap, diaphragm, or sponge with spermicide  A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double barrier method) You must agree to the following during the study and for at least 28 days after the last dose of study drug. • :  Refrain from donating sperm •  Be abstinent from heterosexual intercourse with a female able to have children as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent Must agree to use birth control/barrier as detailed below: •  Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of birth control as a condom may break or leak when having sexual intercourse with a female able to have children who is not currently pregnant •  In addition to male condom use, a highly effective method of birth control may be considered in female partners able to have children of male participants such as the methods detailed earlier in this document The effects of the study drug taken with ritonavir on the following are not known and may involve unforeseeable risks: • Sperm •  Fertility  Pregnancy •  Unborn child •  Breastfeeding child The effects of the study drug on reproduction are unknowntaken with ritonavir has not been studied in pregnant or lactating women. At this time, It is unknown if it is not known whether the study drug can cause harm to the fetus an unborn child or whether if it is secreted in human milk. Therefore, Animal studies with the study drug have not shown a harmful effect on fetal (unborn) development. Animal studies with ritonavir have shown a harmful effect on reproduction. In a large study of pregnant women who received ritonavir during pregnancy, there was no increase in birth defects. Therefore, until more is known about the study drug, if you are pregnant, planning to become pregnant during the study, or breastfeeding a child, you should not be administered to pregnant women or women who are breastfeedingtake part in this study. An appropriate method of birth control is required. Carbamazepine can cause harm to an unborn child. Even if you use birth control during the study, there is a chance you or your partner, partner could become pregnant. If you or your partner are pregnant or become pregnant, pregnant during the study, the study drugs drug or procedure may involve unforeseeable risks to the unborn child. \A A pregnancy test is not always right, especially in the early stages of pregnancy. If you are currently pregnant, plan to become pregnant, or are breastfeeding a child, you should not join this study. If you are a man whose partner is currently pregnant or plan to father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigator

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose of study drugvaccine. Please note that carbamazepine can make hormonal contraceptives less effective. It is suggested that a back• Implantable progestogen-up method of only hormone birth control be utilized, such as a condom. You must not donate eggs for the purpose of reproduction for the duration of the study and for at least 28 days after the last dose of study drug. Low user dependency methods (methods that do not rely on you to remember to use them) • Copper Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Hormonal birth control • Sexual abstinence – defined as refraining from heterosexual intercourse and is the preferred and usual lifestyle of the participant • Male of female condom, with or without spermicide • Cervical cap, diaphragm, or sponge with spermicide • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double-barrier method) You must agree to the following during the study and for at least 28 days after the last dose of study drug. vaccine: • Refrain from donating sperm • Be abstinent from heterosexual intercourse with a female able to have children as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent Must You must agree to use birth control/barrier as detailed below: • Agree to use a male condom when having sexual intercourse with a female able to have children who is not currently pregnant • In addition to male condom useHave had a vasectomy, a highly effective method with the absence of birth control may be considered in female partners able to have children of male participants such as the methods detailed earlier in this document sperm having been confirmed The effects of the study drug vaccine on the following are not known and may involve unforeseeable risks: • Sperm • Pregnancy • Unborn child • Breastfeeding child The effects of the study drug on reproduction are unknown. At this time, it is not known whether the study drug can cause harm to the fetus or whether it is secreted in human milk. Therefore, the study drug should not be administered to pregnant women or women who are breastfeeding. An appropriate method of birth control is required. Carbamazepine can cause harm to an unborn child. Even if you use birth control during the study, there is a chance you or your partner, partner could become pregnant. If you or your partner are is pregnant or become pregnant, becomes pregnant during the study, the study drugs vaccine or procedure may involve unforeseeable risks to the unborn child. \A A pregnancy test is not always right, especially in the early stages of pregnancy. If you You cannot participate in this study if: • You are currently pregnant, plan planning to become pregnant, or are breastfeeding a child, you should not join this study. If you child • You are a man whose female partner is currently pregnant or plan planning to father a child, you cannot join this study. become pregnant If you want to stop your required birth control during the study, you should tell the study investigator

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 60 days after the last dose of study drugdose. Please note that carbamazepine can make hormonal contraceptives less effective. It is suggested that a back• Implantable progesterone-up method of only hormone birth control be utilized, such as a condom. You must not donate eggs for the purpose of reproduction for the duration of the study and for at least 28 days after the last dose of study drug. Low user dependency methods (methods that do not rely on you to remember to use them) • Copper Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Combined (estrogen- and progestogen-containing) hormonal birth control o Oral* o Intravaginal* o Transdermal* • Progestogen-containing hormonal contraception o Oral* o Injectable* • Sexual abstinence – defined as refraining from heterosexual intercourse and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must be used in addition to the hormonal birth control methods: • Male or female condom with or without spermicide • Cervical cap, diaphragm, or sponge with spermicide • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double-barrier method) You must agree to the following during the study and for at least 28 60 days after the last dose of study drug. : • Refrain from donating sperm • Be abstinent from heterosexual intercourse with a female able to have children as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent Must agree to use birth control/barrier as detailed below: • Agree Must agree to use a male condom when having sexual intercourse with a female woman able to have children who is not currently pregnant • In addition to male condom use, a highly effective method of birth control may be considered in for female partners able to have children of male participants children, such as the methods detailed earlier in this document document. The effects of the study drug on the following are not known and may involve unforeseeable risks: • Sperm • Ova • Pregnancy • Unborn child • Breastfeeding child The effects of the study drug on reproduction are unknown. At this time, it is not known whether the study drug can cause harm to the fetus or whether it is secreted in human milk. Therefore, the study drug should not be administered to pregnant women or women who are breastfeeding. An appropriate method of birth control is required. Carbamazepine can cause harm to an unborn child. Even if you use birth control during the study, there is a chance that you or your partner, partner could become pregnant. If you or your partner are pregnant or become pregnant, pregnant during the study, the study drugs drug or procedure procedures may involve unforeseeable risks to the unborn child. \A A pregnancy test is not always right, especially in the early stages of pregnancy. If you You cannot participate in this study if: • You are currently pregnant, plan planning to become pregnant, or are breastfeeding a child, you should not join this study. If you child • You are a man whose female partner is currently pregnant or plan planning to father a child, you cannot join this study. become pregnant If you want to stop your required birth control during the study, you should tell the study investigator

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose of study drug. Please note that carbamazepine ritonavir can make hormonal contraceptives estradiol-containing birth control less effective. It is suggested that a back-up A barrier method or other nonhormonal method of birth control must also be utilized, such as a condomused if you are using estradiol-containing birth control. You must not donate eggs for the purpose of reproduction for the duration of the study and for at least 28 days after the last dose of study drug. Low user dependency methods (methods that do not rely on you to remember to use them) • Copper Implantable progestogen-only hormone birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Hormonal birth control* (See Note below) • Sexual abstinence – defined as refraining from heterosexual intercourse during the study and for 28 days after the last dose of study drug, and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must be used in addition to the use of hormonal birth control methods: • Male or female condom with or without spermicide • Cervical cap, diaphragm, or sponge with spermicide • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double barrier method) You must agree to the following during the study and for at least 28 days after the last dose of study drug. : • Refrain from donating sperm • Be abstinent from heterosexual intercourse with a female able to have children as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent Must agree to use birth control/barrier as detailed below: • Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of birth control as a condom may break or leak when having sexual intercourse with a female able to have children who is not currently pregnant • In addition to male condom use, a highly effective method of birth control may be considered in female partners able to have children of male participants such as the methods detailed earlier in this document The effects of the study drug taken with ritonavir on the following are not known and may involve unforeseeable risks: • Sperm Fertility • Pregnancy • Unborn child • Breastfeeding child The effects of the study drug on reproduction are unknowntaken with ritonavir has not been studied in pregnant or lactating women. At this time, It is unknown if it is not known whether the study drug can cause harm to the fetus an unborn child or whether if it is secreted in human milk. Therefore, Animal studies with the study drug have not shown a harmful effect on fetal (unborn) development. Animal studies with ritonavir have shown a harmful effect on reproduction. In a large study of pregnant women who received ritonavir during pregnancy, there was no increase in birth defects. Therefore, until more is known about the study drug, if you are pregnant, planning to become pregnant during the study, or breastfeeding a child, you should not be administered to pregnant women or women who are breastfeedingtake part in this study. An appropriate method of birth control is required. Carbamazepine can cause harm to an unborn child. Even if you use birth control during the study, there is a chance you or your partner, partner could become pregnant. If you or your partner are pregnant or become pregnant, pregnant during the study, the study drugs drug or procedure may involve unforeseeable risks to the unborn child. \A A pregnancy test is not always right, especially in the early stages of pregnancy. If you are currently pregnant, plan to become pregnant, or are breastfeeding a child, you should not join this study. If you are a man whose partner is currently pregnant or plan to father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigator