Common use of Exclusion Criteria Clause in Contracts

Exclusion Criteria. Subjects fulfilling any of the following criteria are not eligible for participation in this study. 1. Any self-reported accommodative, binocular vision issues, or issues of eye alignment 2. Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wears as determined by the Investigator 3. Any use of systemic medications or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator, including use of any topical ocular medications and lubrication drops that would require instillation during contact lens wear 4. History of refractive surgery or irregular cornea 5. Ocular or intraocular surgery within the previous 12 months (excluding placement of punctal plugs) or during the study 6. Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher in either eye at screening 7. Current or history of pathologically dry eye in either eye 8. Current or history of herpetic keratitis in either eye 9. Eye injury within 12 weeks immediately prior to enrollment for the study 10. Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment 11. Monocular subjects (only one eye with functional vision 12. Known pregnancy at time of enrollment 13. Concurrent participation of the subject in a contact lens or contact lens care product clinical trial or within the previous 30 days 14. The Investigator, his/her staff, family members of the Investigator, family members of the Investigator’s staff, or individuals living in the households of the aforementioned persons may not participate in the study

Exclusion Criteria. Subjects fulfilling any of the following criteria are not eligible for participation in this study. 1. Any self-reported accommodative, binocular vision issues, or issues of eye alignment 2. Any anterior segment infection, inflammation, disease, or abnormality or disease (including systemic) that contraindicates contact lens wears wear, as determined by the Investigatorinvestigator 32. Any use of systemic medications or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator, including use of any topical ocular medications and lubrication drops that would require instillation during contact lens wearinvestigator. 43. History of refractive surgery or plan to have refractive surgery during the study or irregular corneacornea in either eye. 54. Ocular or intraocular surgery within the previous 12 months (excluding placement of punctal plugs) within the previous 12 months or planned during the study. 65. Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher in either eye at screeninghigher; presence of corneal infiltrates 76. Current or history of pathologically dry eye in either eyeeye that, in the opinion of the - nvestigator, would preclude contact lens wear. 87. Current or history of herpetic keratitis in either eye. 98. Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial. 9. Current or history of intolerance, hypersensitivity or allergy to any component of the study products. 10. Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear. 11. The investigator, his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of the aforementioned persons may not participate in the study. 1012. Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. 13. Monovision and multifocal contact lens wearers. 14. Daily Disposable contact lens wearers 15. Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent. 16. Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment 11. Monocular subjects (only one eye with functional vision 12. Known pregnancy at time of enrollment 13. Concurrent participation of the subject in a contact lens or contact lens care product clinical trial or within the previous 30 days 14. The Investigator, his/her staff, family members of the Investigator, family members of the Investigator’s staff, or individuals living in the households of the aforementioned persons may not participate in the study.

Exclusion Criteria. Subjects fulfilling any of the following criteria are not eligible for participation in this study. 1. Any self-reported accommodative, binocular vision issues, or issues of eye alignment 2. Any anterior segment infection, inflammation, disease, or abnormality or disease (including systemic) that contraindicates contact lens wears wear, as determined by the Investigator. 32. Any use of systemic medications or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator. 3. History of ocular or intraocular surgery, including use of any topical ocular medications and lubrication drops that would require instillation during contact lens wearrefractive surgery, and/or irregular cornea; 4. History of refractive surgery Current or irregular corneaprevious orthokeratology treatment or has worn rigid gas permeable lenses in the past 12 months. 5. Ocular or intraocular surgery within the previous 12 months (excluding placement of punctal plugs) or during the study 6. Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher in either eye at screeninghigher; presence of corneal infiltrates. 76. Current or history of pathologically dry eye in either eyeeye that, in the opinion of the Investigator, would preclude contact lens wear. 87. Current or history of herpetic keratitis in either eye. 98. Eye injury in either eye within 12 weeks immediately prior to enrollment for this study. 9. Current or history of intolerance, hypersensitivity, or allergy to any component of study lenses, lens care or associated materials for the study. 10. Wearing daily disposable lenses over the last 3 months prior to enrollment. 11. No prior experience with routine cleaning and disinfection. 12. Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment 11. Monocular subjects (only one eye with functional vision 12. Known pregnancy at time of enrollment. 13. Concurrent participation Any use of the subject in a habitual/prescribed topical ocular medications or artificial tear or rewetting drops (habitual) that would require instillation during study lens wear. 14. Monovision or multifocal contact lens or contact lens care product clinical trial or within the previous 30 dayswearers. 1415. The Investigator, his/her staff, family members of the Investigator, family members of the Investigator’s staff, or individuals living in the households of the aforementioned persons may not participate in the study. 16. Participation of the subject in a clinical study within the previous 30 days or currently enrolled in any clinical study. 17. Any habitual wear of Biofinity contact lenses. Women of childbearing potential or women who are pregnant at the time of study entry are not excluded from participation. Pregnancy should be included in the Medical History section of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant during the study. Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case-by-case basis.

Exclusion Criteria. Subjects fulfilling any of the following criteria are not eligible for participation in this study. 1. Any self-reported accommodative, binocular vision issues, or issues of eye alignment 2. Any anterior segment infection, inflammation, disease, or abnormality or disease (including systemic) that contraindicates contact lens wears wear, as determined by the Investigator 32. Any use of systemic medications or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator, including use of any topical ocular medications and lubrication drops that would require instillation during contact lens wear. 43. History of refractive surgery or plan to have refractive surgery during the study or irregular corneacornea in either eye. 54. Ocular or intraocular surgery within the previous 12 months (excluding placement of punctal plugs) within the previous 12 months or planned during the study. 65. Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher in either eye at screeninghigher, and/or any infiltrate. 76. Current or history of pathologically dry eye in either eyeeye that, in the opinion of the Investigator, would preclude contact lens wear. 87. Current or history of herpetic keratitis in either eye. 98. Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial. 9. Current or history of intolerance, hypersensitivity or allergy to any component of the studystudy products. 10. Wearing habitual Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollmentlens wear. 11. Monocular subjects (only one eye with functional vision 12. Known pregnancy at time of enrollment 13. Concurrent participation of the subject in a contact lens or contact lens care product clinical trial or within the previous 30 days 14. The Investigator, his/her staff, family members of the Investigator, family members of the Investigator’s staff, or individuals living in the households of the aforementioned persons may not participate in the study. 12. Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. 13. Monocular subjects (only one eye with functional vision) or subjects fit with only one contact lens. 14. Known pregnancy or lactating.

Exclusion Criteria. Subjects fulfilling any of the following criteria are not eligible for participation in this study.: 1. Any self-reported accommodative, binocular vision issues, or issues of eye alignment 2. Any anterior segment infection, inflammation, disease, or abnormality or disease (including systemic) that contraindicates contact lens wears wear, as determined by the Investigator. 32. Any use of systemic medications or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator. 3. History of ocular or intraocular surgery, including use of any topical ocular medications and lubrication drops that would require instillation during refractive surgery for which contact lens wearextended wear could be contraindicated, as determined by the Investigator and/or history of irregular cornea. 4. History of refractive surgery Current or irregular corneaprevious orthokeratology treatment or has worn RGP lenses in the past 12 months. 5. Ocular or intraocular surgery within the previous 12 months (excluding placement of punctal plugs) or during the study 6. Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher in either eye at screeninghigher; or presence of corneal infiltrate(s). 76. Current or history of pathologically dry eye in either eyeeye that, in the opinion of the Investigator, would preclude contact lens wear. 87. Current or history of herpetic keratitis in either eye. 98. Eye injury in either eye within 12 weeks immediately prior to enrollment for the studythis trial. 9. Current or history of intolerance, hypersensitivity or allergy to any component of study lenses, 10. Wearing Any habitual wear of Biofinity contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollmentlenses. 11. Monocular subjects Any use of habitual/prescribed topical ocular medications or artificial tear or rewetting drops (only one eye with functional visionhabitual) that would require instillation during study lens wear. 12. Known pregnancy at time of enrollmentCurrently pregnant or breast-feeding. 13. Concurrent participation of the subject in a contact lens or contact lens care product clinical trial or within the previous 30 days 14. The Investigator, his/her staff, family members of the Investigator, family members of the Investigator’s staff, or individuals living in the households of the aforementioned persons may not participate in the study. 14. Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. 15. Monovision contact lens wearers.