OMJSA Educational Grant Submission Process

Rev. 5/2010

p. 2

Objectives

Provide an overview of the OMJSA Medical Education Department and scientific areas of interest

Review the required elements for educational grant applications Provide an overview of our submission process and required

documents for the following companies: Janssen®

McNeil Pediatrics™Ortho-McNeil®Ortho-McNeil Neurologics® PRICARA™Ortho Women's Health & Urology®

Eligibility Requirements Requirements and New Updates

p. 3

Our Mission

To support educational programs with qualified organizations, that: are clinically relevant within scientific and medical areas of interest meet the needs of our customers comply with industry standards, regulatory and corporate

guidelines improve patient care and outcomes

To recognize the need for education at all levels, including national, regional and local activities.

p. 4

Scientific Areas of Interest

Janssen – www.janssen.com Schizophrenia Schizoaffective Disorder Bipolar Disorder

McNeil Pediatrics – www.mcneilpediatrics.net ADHD

Ortho-McNeil Neurologics – www.ortho-mcneilneurologics.com Epilepsy

Ortho Women’s Health and Urology

www.ortho-mcneilpharmaceutical.com Hormonal Contraception Interstitial Cystitis

p. 5

Scientific Areas of Interest (Con’t) PRICARA – www.pricara.com

Infectious Diseases • Multi-drug Resistance Organisms• Antimicrobial Stewardship• Antimicrobial Resistance

Pain• Acute and Chronic

Gastroenterology • Acid Reflux/GERD

ORTHO-MCNEIL – www.ortho-mcneil.com Cardiovascular

• VTE Prevention (Orthopedics)• Stroke Prevention in Atrial Fibrillation• Thromboembolic Disease (Other)

p. 6

Scientific Areas of Interest (Con’t) ORTHO-MCNEIL – www.ortho-mcneil.com

Infectious Diseases • Multi-drug Resistance Organisms• Antimicrobial Stewardship• Antimicrobial Resistance

p. 7

Medical Education ScopeActivities we CAN Support

Certified Continuing Education (CME/CPE/CEU) Non-certified educational activities Development of materials for patient or provider education Fellowships Travel Scholarships

Activities we CANNOT Support Education outside our therapeutic areas of interest Programs that have already occurred Promotional activities related to products of Operating

Companies supported by OMJSA Charitable contributions (Send Request to: contributions@its.jnj.com)

Advisory boards

p. 8

Things to Consider When Requesting an Educational Grant

Normal organizational overhead, e.g., purchase of computer equipment, staff training

Reimbursement for the cost of obtaining CME credits incurred by attendees/learners

Funds used to pay for travel, lodging, conference expenses or honorarium for a customer presenting a poster or paper

Food and beverage expenses at non-accredited programs (exception for grand rounds “modest” food/beverage)

Applicant’s business expensesCommercial display feesCorporate sponsorship/membership fees

Examples of Line Items We Cannot Support

p. 9

Required Documents (see Forms link on company websites)

Letter of Request (LOR) Budget Template AgendaNew in 2009 A signed Eligibility Questionnaire from the Accredited

Provider and Educational Partner (if applicable) A signed Payee’s W-9 Form from the requested Payee

p. 10

Required Document (see Forms link on company websites)

Eligibility QuestionnaireRequired application component for all proposed educational

activities that will have credit/contact hoursNEW in 2009! Effective immediately, this document replaces the CE Provider

Questionnaire and Certification of Separation templates and is required for CME activities

Must be completed and signed by the Accredited Provider and uploaded within the “CE Provider Questionnaire” field of the application form

If an Educational Partner is involved, an Eligibility Questionnaire must also be completed and signed by this party and uploaded within the “Educational Partner Questionnaire” field of the application form

p. 11

Required Document (see Forms link on company websites)

Eligibility Questionnaire (Con’t) Electronic signature is accepted Assures OMJSA that accredited provider/educational

sponsor meets the standards set forth by J&J and abides by acceptable standards (e.g., ACCME, ANCC, ACPE, FDA, and OIG)

To be completed by the accredited provider and educational partner and included as part of the submission packet.

If accreditation status is Probationary Status, this will result in rejection of the grant application.

Note: After January 1, 2010, use of the CE Provider Questionnaire and Certification of Separation templates will result in the rejection of the request. – NEW in 2010!

p. 12

Required Document - LOR

Signed Letter of Request (LOR) on Accredited Provider’s /Requesting Organization’s Letterhead (electronic signatures acceptable)

LOR Should Include:

• CME/CE Activity – LOR on Accredited Provider’s letterhead

• Name or topic of program/event

• Date of program/event

• Accredited Providers must be Schools of Medicine, Pharmacy, or Nursing, Hospitals, Medical Societies, Professional

• Accreditation information (if CME activity)

• Program agenda and/or topics New in 2009

• Societies, or government agencies

• Criteria for selecting faculty

p. 13

Required Document – LOR (Con’t)

• Funding amount

• Organization’s 9-digit Federal Tax ID number

• Name and address to which the check should be made payable, and mailed if your request is approved.

New in 2009:

• Payee must be the accredited provider

• It is preferred that Accredited Providers receive funds from OMJSA. There may be exceptions to Educational Planners receiving funds from OMJSA but these exceptions are handled on a case by case basis.

• Exceptions must be addressed in the Accredited Provider’s LOR. New in 2010:

• Non-CME/CE Activity – LOR on requestor’s organization’s letterhead. Discussion of Johnson & Johnson products must be within approved product labeling and fairly balanced.

• Statement of how disclosure of financial support will be made to program participants (see the Guidelines section for specific language)

p. 14

Request For Grant Applications – RFGAs (NEW in 2009)(see Forms link on company websites)

OMJSA may occasionally issue notifications of funding availability in the form of RFGAs

RFGAs may be broadly disseminated to potential applicants and/or posted on the OMJSA Medical Education website

RFGAs do not replace the spontaneous process of grant submissions (OMJSA has an open submission process)

Questions regarding the RFGA process or regarding specific RFGAs may be directed to OMJSA-RFGA@its.jnj.com

Organizations may opt-out of receiving RFGAs by following the link embedded in each RFGA, or by sending an email to OMJSA-RFGA@its.jnj.com

Note: RFGA responses in review may have a status of composing as a function of our process

p. 15

Totality Status / Customer Status Definitions

Status Applicant Definition

- Composing In Process (Processing)

- Withdrawn (RFGAs) Declined

- Review In Review

- Request for More Information Applicant must submit more information

- Declined Not approved/denied

- Contracting Awaiting signed Educational Grant Agreement

- Approved Approved

- Procurement Initiated Payment being executed or

Pending Reconciliation

- Closed Payment mailed and copy of signed EGA was e-mailed to applicant

Grant Status Definitions

p. 16

Grant Submission Process

1 MINIMUM OF 10 WEEKS PRIOR TO PROGRAM

Organization submits complete grant request package on-line through the appropriate operating company website. A notification will be sent to the primary email address on file upon receipt of the application. OMJSA reserves the right to deny requests not submitted in this timeframe.

No faxed or mailed requests will be accepted.

2 CHECK GRANT STATUS ON-LINE

Grant status is available on-line. To access the status, you will need to provide the grant identification number and the email address of the primary contact on file with the grant application.

3 AFTER REVIEW AND APPROVAL

EGA e-mailed to the organization for signature. A written agreement must be executed between OMJSA and the institution prior to the date of program and disbursement of funds. The agreement must be signed and returned within 15 days.

Go to company website (Read Guidelines section)

Submit/View Request Check Grant Status

Funding in any calendar year does not guarantee funding in subsequent years.

p. 17

Key Information To Consider

Review the “Therapeutic Areas of Interest” page to ensure funding is available before completing an application

Review the OMJSA Guidelines for areas of interest and download necessary forms (templates provided)

View Quick Reference Guide and FAQs for assistanceComplete and save attachments before submitting an

application (60 minutes timeout)Ensure that the Eligibility Questionnaire is signed by the

Accredited Provider and Educational Partner (if applicable) for CME/CE applications

p. 18

Key Information To Consider (Con’t)

The Requestor Information and Primary Contact information must both be from the Accredited Provider

Payee will be the Accredited Provider.Print and save confirmation page. You will need this

information to check the on-line status of your grant.A grant identification number and primary contact email

address is required to check the submission statusGrant identification number will facilitate all communications

about your application

p. 19

Key Information To Consider (Con’t)

When OMJSA requests more information Needs Assessment - new information should be bolded

and underlined Submit additional information within 5-10 business days,

unless otherwise specified Indicate Grant Identification # in Subject line of e-mail Failure to respond after the above timeline will prompt

system to deny request and a new submission will be required

For university/teaching institution sponsored activities, payments can only be directed to the institution or medical education department, not to a Department

p. 20

Document Submission Consideration

System is compatible with the following document types only: Word (.doc) Excel (.xls) PowerPoint (.ppt) PDF (.pdf)

Zip (.zip) files are not acceptedMaximum file size is 20 megabytesCombine files to condense the number of attachments (e.g., use

tabs within Excel for multiple budget templates)Name files appropriately (e.g., LOR, Agenda)A maximum of 6 documents can only be attached.

p. 21

Disclosure Statement - Required

The recommended language regarding disclosure of financial support is:

“Supported by an educational grant from (insert companyname), Division of Ortho-McNeil-Janssen Pharmaceuticals,

Inc., administered by Ortho-McNeil Janssen ScientificAffairs, LLC”.

Company logos will be provided upon request.

p. 22

Budget Adjustment

Applicants may be offered less financial support than requestedApplicants are required to adjust line items within budget

template to conform to approved grant amountRevised budget template is to be re-submitted within 10

business daysRequest for the signed EGA is contingent upon the receipt of

the adjusted budget

Note: If approved grant amount is same as requested, no action is needed

p. 23

Reconciliation of Paid Grants (Effective as of 4Q08)

Applicants are required to reconcile post activity using the approved budget template that was submitted with the application (refer to information in the “Requested Funding from OMJSA” column)

Provide activity materials:Grants >$25,000 (Completion of Verification of Education Activity

form - New in 2010, Summary of Activity Evaluations, and Activity Outcomes Measurement, if applicable)

Grants <$25,000 (Completion of Verification of Education Activity form - New in 2010, Final Agenda, and Summary of Activity Evaluations)

Financial audits will be conducted based upon selection by OMJSA

p. 24

Reconciliation of Paid Grants (Con’t)(Effective as of 4Q08)

Unused/excess funds must be returned within six months following the completion of all activities supported by this grant

Accounting Purposes – J&J Tax ID #22-2203696Program Monitoring – OMJSA reserves the right to monitor

supported activities to ensure appropriate standards are met

Note: Failure to comply with this reconciliation and return of unused/excess funds requirement, may risk approval of future requests.

p. 25

Public Posting: Transparency Process

Release Date: October, 2008Based on Johnson & Johnson’s policies, actual payments

made to grant recipients will be posted for public transparency on our operating division websites on a quarterly basis.

Information reported will include: Name and location of the payee Name and location of the accredited provider, if different The dollar amount paid Title of activity Program start date

p. 26

Contact Information

Contact Information Requests for funding should be submitted to

www.OMJSAMedEd.jnj.com - NEW in 2010!

Contacts for Further Information General Questions for grant submissions:

» Contact OMJSA @ 1-866-447-2687 or forward an e-mail to EdGrants@ompus.jnj.com

Technical Assistance:» If you are experiencing problems with the web page, please email

the System Administrator at Totalitysitemgr@ompus.jnj.com