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Tempo Smart Button
- What is the Tempo Smart Button?
The Tempo Smart Button™ is a data transmitter for your Tempo Pen™ that uses Bluetooth® wireless technology to send your dose-related data to your TempoSmart™ App. It comes ready to use. Simply attach the Tempo Smart Button to the Tempo Pen by following the instructions here. Please read the Instructions for Use included with the Tempo Smart Button.
To pair the Tempo Smart Button with the TempoSmart App:
- Make sure the dose indicator on your Tempo Pen is at “0.”
- Open the TempoSmart App on your mobile device in a location at least 9 feet (3 meters) away from other mobile devices actively in use. Warning: to help prevent others from accessing your data or settings, do not leave your Tempo Smart Button in an area that can be accessed by others.
- On the TempoSmart App, select the following:
- More
- Connections & Devices
- Tempo Smart Button
- Connect Tempo Smart Button
- Press and hold the Tempo Smart Button down for about 10 seconds until you see 1 green flash. Release the Tempo Smart Button after you see 1 green flash. This means that your Tempo Smart Button is ready to pair with your app.
- Follow your TempoSmart App’s onscreen prompts to finish pairing your Tempo Smart Button. You will receive confirmation in your app if pairing is successful.
- The light ring on the Tempo Smart Button will flash green 3 times when the Tempo Smart Button is connected (paired) with your app.
Please read the Instructions for Use included with the Tempo Smart Button in your Tempo™ Welcome Kit. You can also visit Setting Up Tempo.
- How do I safely store and travel with my Tempo Smart Button?
Place the Tempo Smart Button in a location where it cannot get pressed accidentally or repeatedly. This is to preserve the battery life of your Tempo Smart Button. You may keep the Tempo Smart Button attached to your Tempo Pen in between doses.
Further tips for storage and handling of the Tempo Smart Button:
- When attached to your Tempo Pen, store your Tempo Smart Button at room temperature below 86 °F (30 °C). Do not store your Tempo Smart Button in the refrigerator
- Keep your Tempo Smart Button away from excessive light, including sunlight
- Keep your Tempo Smart Button away from strong electromagnetic fields, such as magnetic resonance imaging (MRI). This may cause you harm or damage your Smart Button
- Avoid getting the Tempo Smart Button wet
- Please refer to the Instructions for Use
TempoSmart App
- How do I pair the TempoSmart App with the Tempo Smart Button?
- Make sure the dose indicator on your Tempo Pen is at “0.”
- Open the TempoSmart App on your mobile device in a location at least 9 feet (3 meters) away from other mobile devices actively in use. To help prevent others from accessing your data or settings, do not leave your Tempo Smart Button in an area that can be accessed by others.
- On the TempoSmart App, select the following:
- More
- Connections & Devices
- Tempo Smart Button
- Connect Tempo Smart Button
- Press and hold the Tempo Smart Button down for about 10 seconds until you see 1 green flash. Release the Tempo Smart Button after you see 1 green flash. This means that your Tempo Smart Button is ready to pair with your app.
- Follow your TempoSmart App’s onscreen prompts to finish pairing your Tempo Smart Button. You will receive confirmation in your app if pairing is successful.
- The light ring on the Tempo Smart Button will flash green 3 times when the Tempo Smart Button is connected (paired) with your app.
For further instructions, please read the Instructions for Use included with the Tempo Smart Button in your Tempo Welcome Kit. You can also visit Setting Up Tempo.
- How do I pair the TempoSmart App with my blood glucose meter (BGM) and/or Dexcom Continuous Glucose Monitoring (CGM) System?
Tap the More menu on the Home screen of your TempoSmart App and then tap Connections & Devices. From here you can select the options to pair your BGM and/or CGM.
Please visit your device manufacturer’s user guide for troubleshooting help.
Considerations for devices using Bluetooth® wireless technology:
- Make sure you know which Bluetooth® wireless device you are pairing with your TempoSmart App
- To ensure that data from your devices (eg, BGM, Tempo Smart Button) are sent wirelessly to the TempoSmart App, you must first pair your device with the TempoSmart App
- How do I change my TempoSmart App medication reminders?
On the Discover tab, you can set or change medication reminders based on your healthcare professional’s guidance for each medication added to your profile. Select:
- More
- Medications
- Medication Reminders
Then follow the onscreen instructions.
- How do I share a SMART Visit Report?
The SMART Visit Report helps you and your healthcare team keep track of and discuss your progress at office visits or between visits. All the information you enter, including your medication list, blood glucose values for the last 30 days, responses to health assessment surveys, notes, and other health information helps you and your healthcare team manage your diabetes.
You can share a SMART Visit Report with your healthcare professional or another person in your support system. To send a SMART Visit Report, select:
- More
- Health Information
- SMART Visit Report (which will create a summary of your data)
You can send it to yourself (it goes to your inbox on the Home screen) or click on Add Another Person. This will send your summary by email or fax to your healthcare professional or another person in your support system.
You can also schedule a report to be sent on a regular basis by clicking on Schedule a Report. Then you can choose when you would like to have the report sent to your healthcare professional or another person in your support system.
IMPORTANT: The SMART Visit Report is intended to supplement, not replace, medical expertise, research, judgment, or diabetes treatment provided by the health care providers. The report provides information that can be used to identify trends to help inform health care providers’ treatment decisions. Decisions regarding diagnosis or treatment of patients will be made solely by the health care providers.
- How do I change my password?
To change your password, click on Forgot Password and follow the onscreen instructions. For additional assistance, you can also call Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983) Monday to Friday, 8 ᴀᴍ to 8 ᴘᴍ ET, and Saturday, 9 ᴀᴍ to 5 ᴘᴍ ET.
- How will my data be handled?
Data handling is done in accordance with Lilly policy. For more information, please read Lilly’s Privacy Statement.
Tempo Pen
- Which insulins are compatible with Tempo?
The insulins that work with the Tempo Smart Button are Lyumjev® (insulin lispro-aabc) injection 100 units/mL, BASAGLAR® (insulin glargine) injection 100 units/mL, and Humalog® (insulin lispro injection) 100 units/mL. To use these insulins, you must have a Lyumjev® Tempo Pen, BASAGLAR® Tempo Pen, or Humalog® Tempo Pen.
- Can I use the Tempo Pen without the Tempo Smart Button?
The Tempo Pen functions in a similar way to the prefilled insulin KwikPen® and is modified to work with the Tempo Smart Button.
You can use the Tempo Pen to give your insulin injection without the Tempo Smart Button. However, if used independently, the dose-related data from the Tempo Pen will not be captured by the Tempo Smart Button. This will make the data within the TempoSmart App incomplete until each dose taken without a Tempo Smart Button connection is accurately logged manually.
- Can I use the insulin I already have?
Not using a Tempo Pen is possible but is not recommended. Each dose of non-Tempo Pen insulin must be manually and accurately logged into the TempoSmart App. Access to the TempoSmart App is only available for 6 months if the Tempo Smart Button is not used.
Other
- Do I need a prescription for Tempo?
Tempo Welcome Kit: Prescription required
Tempo Pen prefilled with Lilly insulin: Prescription required
Tempo Refill Kit: Prescription required
A prescription is not required to download the TempoSmart App.
- Can I individually order replacement devices or components?
Once you have received the Tempo Welcome Kit, your healthcare professional can prescribe you a Tempo Refill Kit. The Tempo Smart Button can also be prescribed again individually as a replacement when the battery runs out.
The Tempo™ Welcome Kit includes*:
- Tempo Smart Button™
- Tempo™ Blood Glucose Monitoring System
- Tempo™ Lancets (Quantity: 100)
- Tempo™ Blood Glucose Test Strips (Quantity: 100)
- Pen needles (Quantity: 100)
The Tempo™ Refill Kit includes*:
- Tempo™ Lancets (Quantity: 100)
- Tempo™ Blood Glucose Test Strips (Quantity: 100)
- Pen needles (Quantity: 100)
- Tempo kits do not include insulin. Welcome Kit and Refill Kit are prescribed separately.
- How much does Tempo cost?
The TempoSmart App is available at no charge and can be used without a prescribed compatible device, with limited features, for up to 180 days. To learn the cost of your Tempo Welcome Kit, Tempo Refill Kit, and Tempo Pen, please call your insurance plan’s customer service line.
If you have commercial drug insurance, you may also be eligible for the Tempo Savings Card.
If you don’t have insurance and need help paying for your care, you may have another option available to you.
- Can I use any BGM and/or CGM with the Tempo Platform?
Not all BGMs and CGMs are compatible with the Tempo Platform. Tempo is compatible with the Dexcom CGM System and the following BGMs:
- Tempo Blood Glucose Meter
- Accu-Chek® Aviva Connect
- Accu-Chek® Guide
- Accu-Chek® Instant
- CONTOUR®NEXT ONE
- OneTouch Verio Flex®
- OneTouch Verio Reflect®
- TRUE METRIX® AIR
Warning: Do not make dosing decisions based on CGM data from the TempoSmart App. Follow instructions on your CGM system.
- How do I get started with my Tempo Platform?
Once you have received the prescription from your healthcare professional and picked up your Tempo Welcome Kit and Tempo Pens from the pharmacy, you can start using the Tempo Platform.
To get started, download the TempoSmart App onto your smartphone. You can use the link provided by your healthcare professional to create your user ID and password and complete your registration. Then you can pair the TempoSmart App with your Tempo Smart Button and compatible BGM or CGM.
Follow these steps to connect your TempoSmart App with your Tempo Smart Button:
- Make sure the dose indicator on your Tempo Pen is at “0.”
- Open the TempoSmart App on your mobile device in a location at least 9 feet (3 meters) away from other mobile devices actively in use. Warning: to help prevent others from accessing your data or settings, do not leave your Tempo Smart Button in an area that can be accessed by others.
- On the TempoSmart App, select the following:
- More
- Connections & Devices
- Tempo Smart Button
- Connect Tempo Smart Button
- Press and hold the Tempo Smart Button down for about 10 seconds until you see 1 green flash. Release the Tempo Smart Button after you see 1 green flash. This means that your Tempo Smart Button is ready to pair with your app.
- Follow your TempoSmart App’s onscreen prompts to finish pairing your Tempo Smart Button.
- The light ring on the Tempo Smart Button will flash green 3 times when the Tempo Smart Button is connected (paired) with your app.
For further instructions, please read the Instructions for Use included with the Tempo Smart Button in your Tempo Welcome Kit. You can also visit Setting Up Tempo.
Still Have Questions?
Contact Lilly Tempo Support at
1-855-LILLY-TEMPO
(1-855-545-5983)
Monday to Friday, 8 ᴀᴍ to 8 ᴘᴍ ET, and Saturday, 9 ᴀᴍ to 5 ᴘᴍ ET.
Tempo Smart Button™ Intended Use
The Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application (App). The Smart Button is indicated for single-patient use by patients 18 years or older who are diagnosed with type 1 or type 2 diabetes mellitus, using prefilled insulin Tempo Pens, and using a compatible App.
TempoSmart™ and Tempo Insights™ Indications and Contraindications
TempoSmart is indicated for use by healthcare providers (HCPs) and their patients—aged 18 years and older—who have type 1 or type 2 diabetes. TempoSmart is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. TempoSmart analyzes and reports glucose test results and supports medication adherence. In addition, TempoSmart provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
TempoSmart is not intended to replace the care provided by a licensed healthcare provider, including prescriptions, diagnosis, or treatment.
Tempo Insights is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart is not indicated for people with gestational diabetes or who use an insulin pump.
Important Safety Information for Tempo™ Personalized Diabetes Management Platform
DO NOT start over, skip, or repeat your injection when using the Tempo Personalized Diabetes Management Platform if you are not sure you took your insulin or if you are not sure your insulin dosing information is correct. Instead, monitor your blood glucose and consult your Healthcare Provider. Call 911 if you are experiencing a medical emergency. Ensure you work with your Healthcare Provider on a backup diabetes management plan if your Tempo Smart Button or TempoSmart App stops working. Having a backup plan and supplies can help avoid severe low and high glucose. Keep the Tempo Smart Button away from children. For product and safety information, including Warnings and Cautions, read the Tempo Smart Button Instructions for Use, TempoSmart App User Guides and Tempo Welcome Kit and Tempo Refill Kit Instructions.
INDICATION AND SAFETY SUMMARY
Lyumjev® (LOOM-jehv) (insulin lispro-aabc) injection 100 units/mL and Humalog® (HU-ma-log) (insulin lispro injection) 100 units/mL
- Lyumjev is a fast-acting insulin used to control high blood sugar in adults and children with diabetes. Humalog is a fast-acting insulin. Humalog is used to control high blood sugar in adults and children with diabetes.
- Lyumjev comes in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter). Lyumjev U-200 contains 2 times as much insulin in 1 milliliter as Lyumjev U-100. Humalog U-100 contains 100 units of insulin per milliliter. The dose window of the pen shows the number of insulin units to be delivered.
- It is not known if Humalog is safe and effective for children with type 2 diabetes or for children younger than 3 years of age with type 1 diabetes as there were no studies done with Humalog in these groups of children. If your doctor decides to give your child any insulin products, he or she may give you special instructions.
All Lyumjev and Humalog products contain insulin lispro.
Warnings - Do not take Lyumjev or Humalog if you have:
- symptoms of low blood sugar (hypoglycemia)
- an allergy to insulin lispro-aabc, Humalog, or any of the ingredients in Lyumjev or Humalog.
Do not reuse needles or share your insulin injection supplies with other people. This includes your:
- prefilled pen for use by a single patient
- cartridges
- reusable pen that works with Lilly 3mL cartridges available for Humalog
- needles
- syringes
You or the other person can get a serious infection. This can happen even if you change the needle.
Do not change the type of insulin you take or your dose unless your doctor tells you to. This could cause low or high blood sugar, which could be serious.
Do not use a syringe to remove Lyumjev or Humalog from your prefilled pen. This can cause you to take too much insulin. Taking too much insulin can lead to severe low blood sugar. This may result in seizures or death.
Lyumjev and Humalog may cause serious side effects. Some of these can lead to death. The possible serious side effects are:
- Low blood sugar. This can cause:
- dizziness or lightheadedness
- headache
- shakiness
- irritability
- sweating
- blurred vision
- fast heartbeat
- mood change
- confusion
- slurred speech
- anxiety
- hunger
If you are at risk of having severely low blood sugar, your doctor may prescribe a glucagon emergency kit. These are used when your blood sugar becomes too low and you are unable to take sugar by mouth. Glucagon helps your body release sugar into your bloodstream. - Low potassium in your blood. This can lead to severe breathing problems, irregular heartbeat, and death.
- Severe allergic reaction.
Get emergency help right away if you have:- a rash over your whole body
- sweating
- extreme drowsiness
- swelling of your face, tongue, or throat
- trouble breathing
- a faint feeling
- dizziness
- a fast heartbeat
- shortness of breath
- confusion
- Heart failure. Taking diabetes pills called thiazolidinediones (thIE-uh-zOH-li-dEEn-dIE-OHns), or “TZDs,” with Lyumjev or Humalog may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with Lyumjev or Humalog. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. Some symptoms of heart failure include shortness of breath, swelling of ankles and feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and your insulin lispro product.
- Sudden onset of high blood sugar and high amounts of ketones in your blood or urine. You can have these serious side effects when your insulin pump or infusion set is not working the right way, if there are handling errors, or if your insulin is no longer effective. For these reasons, you may not get the right amount of insulin, so always keep extra insulin and injection supplies with you.
Common side effects
The most common side effects of Lyumjev and Humalog are:
- low blood sugar
- reactions or pain at the injection or infusion site with insulin pump use
- itching
- weight gain
- allergic reactions
- skin thickening or pits at the injection or infusion site
- rash
Other most common side effects with Humalog include swelling of your hands or feet.
These are not all of the possible side effects. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before using
Talk with your doctor about low blood sugar and how to manage it. Also tell your doctor:
- about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
- about any other prescription medicines you take, especially ones called TZDs.
- about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems.
- if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed.
How to take
Read the Instructions for Use that come with your Lyumjev or Humalog. Be sure to take your Lyumjev or Humalog and check your blood sugar levels exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or physical activity level. He or she may also tell you to change the amount or time of your dose because of other medicines or different types of insulin you take.
Before injecting your Lyumjev or Humalog
You can inject your insulin dose yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:
- Check the insulin label before each injection. This will help you make sure that you are taking the correct insulin.
- Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you reuse needles.
- Change (rotate) where you inject your insulin with each dose. This can reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin. Do not inject your insulin into the exact same spot or where the skin has pits or lumps. Avoid injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.
- Monitor injection and infusion sites closely when initiating therapy with Lyumjev in children. Contact a healthcare provider if persistent injection or infusion site reactions occur.
When you are ready to inject
- Inject Lyumjev under your skin at the beginning of a meal or within 20 minutes after you start eating a meal.
- Inject Humalog under your skin within 15 minutes before or right after you eat a meal.
Staying safe while taking your Lyumjev or Humalog
To stay safe while taking your insulin, be sure to never inject Lyumjev U-200 in your vein, muscle, or with an insulin pump. Also be sure not to:
- mix Lyumjev with other insulins or liquids.
- drive or use heavy machinery until you know how your Lyumjev or Humalog affects you.
- drink alcohol or use other medicines that contain alcohol when taking your Lyumjev or Humalog.
Learn more
Lyumjev and Humalog are prescription medicines. For more information, call 1-800-545-5979 or go to www.Lyumjev.com or www.humalog.com.
This summary provides basic information about Lyumjev and Humalog. It does not include all information known about these medicines. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about your insulin lispro product and how to take it. Your doctor is the best person to help you decide if these medicines are right for you.
UR HI CON BS 14OCT2022
Lyumjev® and Humalog® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
INDICATION AND SAFETY SUMMARY
BASAGLAR® (bāz-a-glar) (insulin glargine) injection 100 units/mL
BASAGLAR is a long-acting insulin used to control high blood sugar in:
- adults with type 1 or type 2 diabetes
- children with type 1 diabetes
It is not known if BASAGLAR is safe and effective in children with type 2 diabetes or in children younger than 6 years with type 1 diabetes. There were no studies done with BASAGLAR in these groups of children. If your doctor decides to give your child BASAGLAR, he or she may give you special instructions.
BASAGLAR is not used to treat diabetic ketoacidosis.
Warnings - Do not take BASAGLAR if you have:
- symptoms of low blood sugar (hypoglycemia)
- an allergy to BASAGLAR or any of its ingredients
Do not reuse needles or share your BASAGLAR prefilled pen with other people. You or the other person can get a serious infection. This can happen even if you change the needle.
Do not change the insulin you use or your dose, unless your doctor tells you to. This could cause low or high blood sugar, which could be serious.
BASAGLAR may cause serious side effects. Some of these can lead to death. The possible serious side effects of BASAGLAR are:
- Low blood sugar. This can lead to:
- dizziness or light-headedness
- headache
- shakiness
- irritability
- sweating
- blurred vision
- fast heartbeat
- mood change
- confusion
- slurred speech
- anxiety
- hunger
- Severe allergic reaction.
Get emergency help right away if you have:- a rash over your whole body
- swelling of your face, tongue, or throat
- extreme drowsiness, dizziness, or confusion
- trouble breathing
- sweating
- a fast heartbeat
- shortness of breath
- Low potassium in your blood. This can lead to severe breathing problems, irregular heartbeat, and death.
- Heart failure. Taking diabetes pills called thiazolidinediones /thIE-uh-zOH-li-dEEn-dIE-OHns/ (TZDs) with BASAGLAR may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with BASAGLAR. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. These are: shortness of breath, swelling of the ankles or feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and BASAGLAR.
Common side effects
The most common side effects of BASAGLAR are:
- low blood sugar
- minor reactions where you have injected BASAGLAR
- itching
- swelling
- allergic reactions
- changes in fat tissue where you have injected BASAGLAR
- rash
- weight gain
These are not all of the possible side effects. Tell your doctor if you have any side effects.
You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before using
Talk with your doctor about low blood sugar and how to manage it. Tell your doctor:
- about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
- about any other prescription medicines you take, especially ones called TZDs.
- about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems. If you have heart failure, it may get worse while you take TZDs with BASAGLAR.
- if you are pregnant, breastfeeding, or plan to become pregnant. It is not known if BASAGLAR may harm your unborn or breastfeeding baby.
How to take
The BASAGLAR prefilled pen is a disposable insulin delivery device for use by a single patient to inject BASAGLAR. Read the Instructions for Use that come with your BASAGLAR prefilled pen. These instructions provide details on how to prepare and inject a dose of BASAGLAR, and how to throw away used BASAGLAR prefilled pens and needles.
Be sure to check your blood sugar levels and use BASAGLAR exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or level of physical activity or exercise. He or she may also tell you to change your dose because of other medicines you take.
Before injecting your BASAGLAR
You can inject BASAGLAR yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:
- Check your insulin label each time you give your injection. This will help you make sure that you are using the correct insulin.
- Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you re-use needles.
When you are ready to inject
- Take BASAGLAR once a day, at the same time each day.
- Change (rotate) where you inject your insulin with each dose. This can help reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin. Do not inject your insulin into the exact same spot or where the skin has pits or lumps. Avoid injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.
Staying safe while taking your BASAGLAR
To stay safe while taking BASAGLAR, be sure you only use BASAGLAR that is clear and colorless and does not have any particles.
Be sure you do not:
- mix BASAGLAR with any other type of insulin or solution.
- drive or use heavy machinery until you know how BASAGLAR affects you.
- drink alcohol or use other medicines that contain alcohol when taking BASAGLAR.
Learn more
BASAGLAR is a prescription medicine. For more information, call 1-800-545-5979 or go to BASAGLAR.com.
This summary provides basic information about BASAGLAR but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other health care provider about BASAGLAR and how to take it. Your doctor is the best person to help you decide if BASAGLAR is right for you.
BV CON BS 14SEP2022
BASAGLAR® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.