grants, sponsorships & charitable donations€¦ · pacific region for events/programs taking...

GRANTS, SPONSORSHIPS & CHARITABLE DONATIONS ASIA PACIFIC

BioMarin Pharmaceutical Inc.

Updated 10‐25‐2018

GRANTS, SPONSORSHIPS, AND CHARITABLE DONATIONS: ASIA PACIFIC

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TableofContentsOverview .............................................................................................................................................. 3

Welcome ........................................................................................................................................... 3

Areas of Focus for BioMarin .............................................................................................................. 4

Transparency .................................................................................................................................... 4

Funding Categories ........................................................................................................................... 4

Funding Criteria .................................................................................................................................. 5

Guidelines ............................................................................................................................................ 7

Before You Apply ............................................................................................................................... 7

Accessing the Portal, Review Process, Request Status, Payments .................................................. 8

Applying for a Grant – Step-by-step instructions................................................................................9

Frequently Asked Questions ........................................................................................................... 37

Contact Us ......................................................................................................................................... 40


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Overview Welcome

BioMarin is a fully integrated multinational organization with globally marketed products that provides innovative therapeutics to patients with rare diseases who have serious unmet medical needs. BioMarin is committed to patients, families and physicians in providing rapid access to treatments, disease education, and support services.

As part of its commitment, BioMarin supports programs and activities that foster excellence in patient care and provide valuable scientific, medical, and educational information to the medical and scientific communities as well as patient advocacy organizations.


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Areas of Focus for BioMarin Support

In alignment with BioMarin’s commitment to scientific innovation and addressing areas of unmet medical needs, BioMarin supports grants, sponsorships, and charitable donations in the following areas:

Rare Disease (Generally) Mucopolysaccharidosis (MPS) Phenylketonuria (PKU) Friedreich’s Ataxia CLN2 (Batten Disease) Achondroplasia Hemophilia Community Relations Giving

Transparency Reporting BioMarin complies with all applicable transparency reporting and disclosure obligations, both in the U.S. and around the world in the countries in which we operate. Accordingly, transfers of value provided to healthcare professionals and organizations will be reported as required. The definition of reportable transfer of value varies with each federal, state and regional law, local regulation, or industry code, but it typically includes speaker fees, grants, sponsorships and charitable donations, as well as spending on food, beverages, travel and lodging, among other categories. Any questions regarding these reporting requirements may be sent to: [email protected]. Funding Categories Grants

Grants provide funding to support non-clinical research (research that does not include human subjects) related to disease states or areas of scientific or medical interest to BioMarin. Grants assume no collaboration or sharing of data with BioMarin. No benefit may be given to BioMarin in return for support unless such benefit is incidental in nature, such as fair acknowledgement of BioMarin’s support. In instances of collaboration, BioMarin will seek to enter a duly executed Research agreement with the requestor and such collaborative requests would not be appropriate for processing through this eGrants portal.

Note: Requests for funding of independent research involving human subjects should be submitted through our Global Independent Research (IR) portal; http://www.biomarin.com/funding-and-support/guidelines-for-requesting-independent-research-ir-support/my-global-independent-research-applications/.


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Charitable Donations

Charitable donations provide funding for benevolent purposes such as improvement of healthcare, patient care or advocacy, civic projects, disaster relief, access to healthcare, or programs for children. The primary purpose of a program supported by a charitable donation should be fundraising or similar charitable activities. No benefit may be given to BioMarin in return for support unless such benefit is incidental in nature, such as fair recognition of BioMarin’s name on a list of donors, or a seat/table at the charitable event.

Note: Please use the Charitable Donation form if you are an organization seeking a donation for fundraising or similar charitable activities.

Sponsorships

Sponsorships provide funding for events and/or activities that further the education of healthcare professionals, patients or the public about important health topics of legitimate interest to BioMarin.

Note: Please use the Sponsorship form if you are seeking funding for an event or activity intended to further the education of healthcare professionals, patients, or the public.

Funding Criteria

As general guidance for grant requests, please note that BioMarin considers many factors including whether the request:

Promotes excellence in patient care Meets guidelines related to content, venue, and dissemination as applicable Is conducive to an effective and efficient meeting format Educates the broadest target audience at an appropriate and reasonable cost

Out of Scope Items generally outside the scope of BioMarin’s Asia Pacific Grants, Sponsorships and Donations Program include:

Requests for funding provided directly to an individual, an organization controlled by an HCP or practice group, or a political organization.

Support for general operating expenses or staffing (e.g., office equipment/staff, computer hardware/software, medical library resources, organizational overhead)

Funding that provides a direct or indirect discount on the purchase of BioMarin products


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Funding that influences BioMarin customers in contract negotiations relating to the prescription, purchase, or reimbursement of BioMarin products

Funding that influences clinical trial decisions Funding that will be used to pay personal expenses that have no benefit to patient care (e.g.,

personal travel expenses, funding for travel costs of non-faculty, medical conferences, or grants for holiday parties).

Clinical grants, including Investigator-Sponsored Trials (ISTs) Capital campaigns/building funds Religious programs Entertainment for HCPs (e.g., class reunions, retirement dinners) Textbooks and journal subscriptions Requests originating outside the Asia Pacific region, and/or requests originating outside the Asia

Pacific region for events/programs taking place in the Asia Pacific region (contact your local BioMarin office if you are outside of the Asia Pacific region)


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Guidelines for Requesting Funding Before You Apply

For sufficient time to review and process your funding request, please submit your application at least 30 days prior to the date of a planned event or activity.

To expedite processing of your funding request, the BioMarin Grants Committee suggests the following: Collect all necessary information prior to beginning the application process. Complete the funding request form in full, including all required fields and attachments. Respond promptly to any requests for additional information from the BioMarin Grants

Administrator. Required Information:

Name of the requestor and requesting organization Requesting organization contact information Total amount of funding requested Bank details (must match the entity/individual

requesting funding)

Required Documentation (as applicable):

Detailed program/project description, including a description of how the funding will be used, activity justification, intended audience

A detailed line item budget (excluding charitable donation requests) Program agenda (including venue), if applicable Learning objectives, if applicable W-8 BEN Form Letter showing designation of a charity, if applicable

Per company policy, BioMarin will not accept any grant requests after the program date has passed. BioMarin will deny, without consideration, any grant request submitted by an organization named on a debarment or exclusion list, including but not limited to, the U.S. Office of Inspector General's List of Excluded Individual/Entities (OIG LEIE) or the U.S. General Services Administration Excluded Parties List System (GSA EPLS).

All requests are considered in accordance with local and international legislation and internal policies. We reserve the right to refuse requests for any reason. There is no appeal process to contest funding decisions.


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Accessing the Portal (“eGrants”) BioMarin’s Grant, Sponsorship, and Charitable Donation request process is automated through an online tool known as eGrants. It is accessible at: www.biomarin.com/funding-and-support-overview

All Asia Pacific funding requests must be submitted using eGrants. Before creating an eGrants account, please review the information provided in this brochure regarding registration, required documentation, review timing, and decision notification.

Due to BioMarin’s year-end close out activities, all requests requiring funding prior to year-end must be submitted on or before November 1. Note: If you are using a MAC computer, please use either Firefox or Google Chrome when using the online portal.

Review Process

BioMarin’s Grants Committee meets regularly to review each submitted request and all accompanying attachments. BioMarin will inform you of its decision regarding the funding request as quickly as possible after the receipt of all required documentation. Please provide complete and accurate documentation in a timely manner to minimize the review timeline.

Request Status

To check the status of a funding request, log into the online portal. Due to company policy and industry standards, the local BioMarin field representative will not have access to this information. The BioMarin Grants Committee will notify applicants directly of its final decision. Please do not consider any request approved or denied until an email notification from the BioMarin Grants Committee has been received.

Payments

Payments are sent to the “Payee” contact provided in your application. This process can take up to 2 weeks after an approval is received. If you have questions about your payment, please contact [email protected].


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Applying for a Grant (Step by Step Submission Instructions)

Please review the Guidelines for Requesting Funding (Page 7 above) prior to starting your application. The Guidelines set forth the definitions of each type of funding, the process for committee review and general criteria considered when the committee reviews each funding request.

Accessing the Online Portal The Login Screen is your entry point for BioMarin’s eGrants portal. To access the portal:

1. Visit www.biomarin.com/funding-and-support-overview

2. Choose the region where your event or program will take place and your preferred language

Click on the region where you are located, and then find your preferred language below and click on the “Grants” link to access the Guidelines for your chosen region.


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3. Clicking on the Grants link will take you to the Grants Guidelines page. Use the left navigation to view

information regarding the grants process, how to apply, the eGrants portal (“My Grants”), frequently asked questions, and contact information. See below.


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4. The eGrants portal link, “My Grants”, is located to the right of the Guidelines Page and in the left navigation menu. There are links to register for a new account to access the system for the first time or login under an existing account for returning users.


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New User Registration

5. On the “Guidelines” page, click “Register” as pictured above.

6. After clicking “Register,” you will be directed to the “New User Registration” page in the eGrants portal.

All fields on the New User Registration page are required and must be completed in order to register. When asked to choose which site you are registering for, check “Grants, and Charitable Donations” as indicated in the picture below. Once the form is complete, click “Register”. Note: You will only be required to register once.


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7. Once you have completed the registration form, a confirmation window will pop up. A confirmation email

will also be sent to the email address that was provided during registration. Please remember to keep your email address and password for future access.

For New or Return Users - Logging In

8. On the “Guidelines” page, click “Login” as pictured above in Step 4.

9. Fill in your registered user name (email address) and password. If you have forgotten your password, you can click “change password” to reset. Click “Sign in” to enter the eGrants portal.


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Applying for a Grant, Sponsorship or Charitable Donation (for all requestors):

10. Once you have successfully logged in, you may begin your application by selecting, “Apply for a New Grant, Sponsorship, or Donation.”

11. Next hover over the drop-down button for country. A list of countries will appear. Please select a country within the region where the event/activity you are seeking funding for will take place. The request type definitions for that region will appear on the screen. Next, hover over the drop-down button for Request Type. A list of funding categories will appear. Please select the type of request you wish to submit.


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Charitable Donations:

Use this form to request grant funding for benevolent purposes such as improvement of healthcare, patient care or advocacy, civic projects, disaster relief, access to healthcare, or programs for children. The primary purpose of a program supported by a charitable donation should be fundraising or similar charitable activities, but can also be provided in support of charitable efforts that have an educational component. All requests for medical education programs (e.g., medical or nursing conference) should be made through the Grants or Sponsorship forms.

No benefit may be given to BioMarin in return for the Charitable Donation unless such benefit is incidental in nature, such as fair recognition of company name on a list of donors, or a seat/table at the charitable event. Please note BioMarin cannot provide Charitable Donations to individuals.

Grants:

Use this form to request grant funding to support research or specific projects related to disease states or areas of science that are of interest to BioMarin (“Grants”). A Grant may or may not include a material transfer (e.g., investigational drug). Grants assume no collaboration or sharing of data with BioMarin. In instances of collaboration, BioMarin will seek to enter a duly executed Research Agreement with the requestor. Grants differ from Investigator-Sponsored Trials (ISTs) in that the research does not include human subjects and may not be subject to a formalized protocol.

Click the drop down for Request Type and choose the type of funding you are seeking. (See definitions below)


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Sponsorships:

Use this form to request funding for healthcare related events or activities, or if you are a healthcare professional or a healthcare-related professional requesting support to attend a third party event (“Sponsorships”). Sponsorships will only be approved if connected to scientific and/or educational events (“Events”). Sponsorships may provide BioMarin with a public relations opportunity to promote our company and raise awareness for the diseases and products that BioMarin supports. Regardless of potential benefits to BioMarin from funded Sponsorships, Events funded by BioMarin must be controlled and managed exclusively by the sponsored organization without input from BioMarin. Please note BioMarin cannot provide Sponsorships to individuals or medical practices.

12. Once you’ve selected the type of request, then click “Next.”


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CHARITABLE DONATION FORM If you are submitting a request for a Charitable Donation, you will need to fill out the Charitable Donation application – including the Applicant Information tab, Request Information tab and Attachments tab.

13. Applicant Information Tab: Under the Applicant Information tab, fill out the Requestor

Information section. Fields marked with an asterisk are required and MUST be completed.


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14. Applicant Information Tab (continued): Under the Applicant Information tab, fill out the Organization

Information section. Fields marked with an asterisk are required and MUST be completed.

1. Under the Applicant Information tab in the Payee Information section - Fill in the fields marked with an asterisk.


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15. Applicant Information Tab (continued): Under the Applicant Information tab, fill out the Payee

Information section. If the Payee Information is the same as the Organization, click the box titled, “Same As Organization” and this information will be filled in. If the Accounting Contact information is the same as the Requestor, click the box titled, “Same As Requestor.” Fields marked with an asterisk are required and MUST be completed. Once all information is completed, click “Next.”


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16. Request Information Tab: Under the Request Information tab, fill out the General Information section.

Fields marked with an asterisk are required and MUST be completed.

17. Request Information Tab (continued): Under the Request Information tab, fill out the Funding section. Once all information is completed, click “Next.”

Remember to click, Review & Submit when you have completed filling out the application.


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18. Attachments Tab: Under the Attachments tab, attach any and all supporting documentation [Program

or Event agenda, Description, and Budget. Fields marked with an asterisk are required and MUST be completed, but if a section is not applicable, you may indicate that with “N/A” in the field.

19. Once your application is complete, click the “Review and Submit” button (see above screenshot in step #18). A pop-up will appear which says, “Success!” Be sure to click the “Ok” button. You will be contacted by BioMarin’s Grant Administrator if more information is needed for your application.


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GRANT FORM If you are submitting a request for a Grant, you will need to fill out the Grant application – including the Applicant Information tab, Request Information tab and Attachments tab.

20. Applicant Information Tab: Under the Applicant Information tab, fill out the Requestor Information

section. Fields marked with an asterisk are required and MUST be completed.


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21. Applicant Information Tab (continued): Under the Applicant Information tab, fill out the Organization Information section. Fields marked with an asterisk are required and MUST be completed.


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22. Applicant Information Tab (continued): Under the Applicant Information tab, fill out the Payee Information section. If the Payee Information is the same as the Organization, click the box titled, “Same As Organization” and this information will be filled in. If the Accounting Contact information is the same as the Requestor, click the box titled, “Same As Requestor.” Fields marked with an asterisk are required and MUST be completed. Once all information is completed, click “Next” to move to the Request Information tab.


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23. Request Information Tab: Under the Request Information tab, fill out the Project Details section. Fields

marked with an asterisk are required and MUST be completed.


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24. Request Information Tab (continued): Under the Request Information tab, fill out the Presentation/Publications (if applicable) section. Fields marked with an asterisk are required and MUST be completed.

25. Request Information Tab (continued): Under the Request Information tab, fill out the Funding section. Fields marked with an asterisk are required and MUST be completed.


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26. Attachments Tab: Under the Attachments tab, attach any and all supporting documentation [e.g., Proposed Budget]. Fields marked with an asterisk are required and MUST be completed, but if a section is not applicable, you may indicate that with “N/A” in the field.

27. Once your application is complete and you are ready to submit it, click the “Review and Submit” button. A pop-up will appear which says, “Success!” Be sure to click the “Ok” button. You will be contacted if more information is needed for your application.


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SPONSORSHIP FORM If you are submitting a request for a Sponsorship, you will need to fill out the Sponsorship application – including the Applicant Information tab, Request Information tab and Attachments tab.

28. Applicant Information Tab: Under the Applicant Information tab, fill out the Requestor Information

section. Fields marked with an asterisk are required and MUST be completed.

29. Applicant Information Tab: Further down under the Applicant Information tab, fill out the Organization Information section. Fields marked with an asterisk are required and MUST be completed.


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30. Applicant Information Tab (continued): Under the Applicant Information tab, fill out the Payee

Information section. If the Payee Information is the same as the Organization, click the box titled, “Same As Organization” and this information will be filled in. If the Accounting Contact information is the same as the Requestor, click the box titled, “Same As Requestor.” Fields marked with an asterisk are required and MUST be completed. Once all information is completed, click “Next.”


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31. On the Request Information tab, fill out the General Information section. Fields marked with an asterisk are required and MUST be completed.


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32. Request Information tab (continued), fill out the Funding section. Fields marked with an asterisk are required and MUST be completed.


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33. On the Attachments tab, attach any and all supporting documentation [Program or event agenda,

description, and budget; All fields marked with a red asterisk are required but if a section is not applicable, you may indicate that in the field by typing “N/A”.

34. Once your application is complete, click the “Review and Submit” button (see above screenshot in step #34). A pop-up will appear which says, “Success!” Be sure to click the “Ok” button. You will be contacted by BioMarin’s Grant Administrator if more information is needed for your application.


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35. A request ID number will be assigned automatically to your application. Please refer to this number when

asking questions about your application. Any request you have submitted will be listed under the “My Grant Activity” section. You can see view section after you login.

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36. You will receive an email telling you, your request has been successfully submitted (see picture below).


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37. When Additional Information is required:

If additional information is required for BioMarin to review and assess your application, you

will receive an email notice that more information is required for your application. You will receive instructions on what additional information to provide.

Open your application for funding from the “My Grant Activity” link on the eGrants home page.

On the top of the page click on “Edit” to edit your application.

Provide the additional information requested and then click the “Submit” button. A pop-up window will appear which says, “Success!” be sure to click the “OK” button.


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38. Reclassifying your request:

If you are asked to re-classify the type of funding you are requesting, you will need to amend the funding type in your application. Follow these instructions.

Open your application for funding from the “My Grant Activity” link on the eGrants home page.

On the top of the page click on “Edit” to edit your application.

Click the arrow next to the request type to bring up the drop-down list of funding types. Select the appropriate request type.


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Fill in the application fields for the new request type. Some information will pre-populate from your original application. However, depending on the type of funding, you may be required to answer additional questions or provide additional information.

Click on “Review & Submit” button at the end of the page.

After reviewing all the information click on Submit at the end of the review page. A pop-up window will appear which says, “Success!” be sure to click the “OK” button.


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Frequently Asked Questions

The Questions and Answers within this section are broken down into the following topic areas: Process Technical Contracts Reconciliation

If you need further assistance after reading this section, please contact BioMarin at [email protected].

Process Related Questions

1. When does BioMarin accept grant requests? Grant requests are accepted for review all year. Due to BioMarin’s year-end close out activities, all requests requiring funding prior to year-end must be submitted on or before November 1.

2. How long does the APAC grant request process take? APAC: A minimum of 30 calendar days is required to process any grant request; please

plan accordingly.

3. What is BioMarin’s review and decision process regarding grant requests? BioMarin has a centralized grant review and decision-making process. Grant committees consist of cross- functional representatives to ensure each grant request is meritorious, consistent with BioMarin’s goals and policies, and is not excessive or duplicative. BioMarin grants are never in any way tied to, or intended as an inducement or reward for, the past, present, or future purchase, prescription, or recommendation of any BioMarin product.

4. Can I submit my grant request via paper and/or through my BioMarin field representative?

No. All grant requests must be submitted online by the requesting organization. BioMarin employees cannot fill out grant requests or submit them on behalf of requesting organizations.

5. Can an organization submit multiple grant requests? Yes. However, grant requests are reviewed individually. Funding of a grant request is not contingent upon previous activity nor does previous funding guarantee future support.

6. Can I request funding for an activity that has already occurred?

No. BioMarin does not fund activities that have already occurred.

7. Can I complete part of the request form and complete the rest later? Yes. If you are unable to complete your request form in one session, you may save the partially completed request form and complete the rest later by clicking “Save Draft” at the bottom of the page. You will have the opportunity to come back and make changes to the request form at any time before the submission of a request.


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8. How will I be notified of the status of my grant request?

An email to confirm BioMarin’s receipt of the grant request will be sent upon submission and another email notification of approval or denial will be sent to the requestor after the grants committee has reviewed the request. At any point in the process, the requestor will receive notification if an application is missing required documentation or further information is needed to complete committee review of the grant request.

9. What is a “Request for Additional Information” and how much time do I have for

completion? A “Request for Additional Information” is made when more information is needed to consider and process your grant request. ”Requests for Additional Information” will be sent by email. Requestors are asked to respond to “Requests for Additional Information” within 10 business days. If BioMarin has not received all necessary information within 10 business days, the grant request may be denied.

10. I received an email “Request for Additional Information.” May I fax, mail, or email the

information? No. All updates to your grant request must be made directly to your application in the online portal. Log into the online portal, click the edit button and make the edits required or attach the additional information requested. When attaching additional documentation, be sure to select the appropriate document type from the drop down menu. Once you are finished, click the submit button and a window will open with the message, “Success!” Click the OK button and your updated request will be submitted.

11. May I change the content of my grant request once it has been submitted?

Changes to the topic, target audience, or other material aspect of a submitted grant request will be reviewed on a case-by-case basis. If you need to make such a change, email the request to BioMarin at [email protected].

12. If my grant request is denied, may I appeal the decision?

No. Decisions to deny grant requests are final. There is no appeal process.

13. My grant request was denied but I do not understand the reason. Can I find out why? BioMarin reserves the right to deny funding for a particular request, at its sole discretion. Please review the Grant Request Guidelines for eligibility criteria. There are numerous reasons why a grant request may be denied. For example, budgetary allocations may change, grant requests may not reflect BioMarin educational strategies, or similar activities may have already been funded.

Technical Questions

14. What if I don’t remember my username and password? Please email BioMarin at [email protected]. The grants administrator can help you reset your password or retrieve your username.


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15. Why was I prevented from registering? Common reasons include:

1. Some of the information entered as part of your registration may be invalid - please see the error message and re-enter the required information.

2. You may be using an email address or username during your registration that has already been registered with the online portal. Please choose a different username or email address.

- If you have registered previously, please request that your username be emailed to you so you can sign-in under your existing account (see "What if I cannot remember my Username or Password?" above for details).

- If you have not registered previously, please email BioMarin at [email protected].

3. A mandatory field may be missing information. Review your registration form to ensure all mandatory fields are complete.

16. Why was I unable to log-in?

Common reasons include: 1. Your account may have been disabled due to inactivity. Please email BioMarin at

[email protected] and request that your account be reactivated. 2. Your account may have been temporarily disabled due to repeated unsuccessful log-in

attempts. Please wait 30 minutes before you try to log-in again.

17. What if my program description does not fit into the allotted space? You will have the opportunity to upload additional supporting documentation at the end of the request form.

Contracts Questions

Certain grant requests (depending on the type of request and amount of funding) may require the requestor to enter into a written Grant Agreement with BioMarin.

18. How will I receive the Grant Agreement?

The Grant Agreement will be sent to you via email. Instructions on how to sign and return the signed agreement to BioMarin will be included. You will receive a pdf copy of the fully executed agreement for your files.

19. Who should sign the Grant Agreement?

Grant Agreements should only be signed by persons duly authorized by the organization to enter into contractual agreements on its behalf.

20. Will I get a copy of the Grant Agreement from BioMarin?

Once BioMarin receives the signed Grant Agreement from an organization, it can take up to 2 weeks to obtain all required signatures at BioMarin and provide a copy of the fully executed document to the grant requestor. It is to your advantage to return the Grant Agreement in a timely manner to avoid delays.


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21. I sent the Grant Agreement executed by my organization back to BioMarin. How do I know

if BioMarin received it? Once BioMarin receives the Grant Agreement signed by an organization, BioMarin will confirm receipt. If you do not receive a confirmation email within a reasonable amount of time, please email BioMarin at [email protected].

22. What if I do not wish to enter into a grant agreement?

Per company policy, BioMarin cannot process funding for those grants requiring a written contract, until the grant agreement is fully executed.

Reconciliations

Is a reconciliation required if all the grant funds were spent exactly as stated in the application? Yes. A reconciliation is required for all grants. Failure to submit a reconciliation within 90 days of the Program End Date may result in denial of future funding. The format of the reconciliation form/report may vary according to each region. For more information on that regard, please consult the terms and conditions of the agreement you entered into with BioMarin or e-mail BioMarin with questions. All reconciliations should be sent to [email protected].

Contact Us For any questions or comments related to your grant request, please send your inquiry to [email protected]. You can also submit an inquiry from the web portal by clicking on the “Contact Us” link. For all inquiries, be sure to provide your contact information. The information you provide will be maintained in accordance with our privacy policy. For more information about BioMarin’s privacy policy, please click on the link at the bottom of the web portal. Please note that BioMarin cannot accept any medical questions through its Grants, Sponsorships, and Charitable Donations online portal. Questions pertaining to your medical condition or the medical condition of a family member should be directed to your healthcare provider.

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