Transcript Document

University of Pittsburgh
Presentation to Department of Ophthalmology
Outside Engagements within the
Industry Relationship Policy
December 15, 2009 by
Theresa J. Colecchia, JD/Associate General Counsel
David T. Wehrle, CPA, CIA, CFE/Director, COI Office
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Outside Engagements with
Industry—What is Allowed?
•
•
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True consulting, where payment is reasonable and
related to the services provided, is permitted under
the Industry Relationship Policy (IRP).
Where consulting payments are made without
services being provided, or where payment rates
are out of proportion to the service provided, the
payments may be considered kick-backs.
Any consulting agreement, under University/UPMC
policies, requires the prior approval of the
department chair and/or dean.
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Consulting Contract Guidelines



A contract detailing the proposed services to be
provided must be in writing;
Faculty member should provide company with
“Guidelines for Contracting with Outside Industry”
(see IRP, FAQ # 7);
Consultant cannot engage in promotional or
marketing activities on behalf of the company;




How do you know if it is promotional?
Is it organized by the Marketing Dept or the R & D Dept.?
Who invites the attendees?
Who controls the content?
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Consulting Contract Guidelines
(cont’d)




University’s/UPMC’s name and address cannot appear
in the contract; consultant’s personal address must be
used instead;
Any non-compete clause in the contract cannot interfere
with faculty member’s duties at the University/UPMC;
Use of University/UPMC resources is not permitted;
Use of consulting Addendum helps ensure that contract
terms will comply with IRP.
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Acceptable/Not Acceptable
Consulting Activities

Not Acceptable
“Physician shall conduct and/or assist with any clinical
studies and trials on behalf of Argus LLC, including
reviewing data, and assist with the preparation of any
reports or articles regarding same.”
Faculty are not permitted to conduct research as
consultants. This work must be done, instead, through a
sponsored research agreement with the company.
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Acceptable/Not Acceptable
Consulting Activities (cont’d)


Not Acceptable
 “Develop strategies to implement approaches to
enhance surgical patient care processes involving
Optical Adventure, Inc.’s MicroIncision forceps.”
 “Train surgeons to use Optical Adventure, Inc.’s
glaucoma shunts at UPMC’s Eye & Ear Institute.”
Acceptable
 “Serve on Cleervu, Inc.’s scientific advisory board or
data safety monitoring board.”
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Consulting Contract Guidelines
(cont’d)

Compensation


There must be a direct correlation between
services provided and payment received.
Contract must include specific, legitimate tasks
and deliverables. …
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Consulting Contract Guidelines
(cont’d)



Payment must be commensurate with the task
performed;
Hourly payment of more than $500 is deemed
excessive;
Consultant cannot be pre-paid for services.
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Does agreement provide legitimate
tasks and deliverables?

Not Acceptable
“Lensfix will pay you a $4,000 per month retainer for
your availability to be on our advisory board as
needed. The board will meet as necessary.”

Acceptable
“Advise Lensfix’s scientists on our experimental
plans, protocols, and equipment purchases;
consultant should not be expected to develop entire
protocols.”
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Is the type of compensation
appropriate? Stock Options


Not Acceptable
“Consultant will receive 500 stock options upon
signing the consulting agreement with Hawkeye
Corporation, and quarterly thereafter.”
Acceptable
“500 stock options will be awarded for each hour
of service provided to Hawkeye Corporation by
the scientific advisory board member. Options will
be awarded only upon receipt of periodic invoices
detailing the dates, hours, and types of services
provided by the member.”
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Is the type of compensation
appropriate? Royalties

Not Acceptable
“Ocular Adventure, Inc. will provide Consultant with 1%
of royalties on net sales of products each annum.”
Receipt of royalties as compensation is always
prohibited.
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Consulting Contract
Guidelines Conveyance of IP

Not acceptable
“Consultant agrees to assign to Lensfix, Inc. all intellectual
property rights, including, without limitation, patents, trade
marks and copyrights, in the work performed hereunder.”

Acceptable
“Any assignment of intellectual property rights shall be subject
to the superior rights of the University of Pittsburgh and UPMC,
if any, under their respective Patent and Copyright policies, and
only after they have waived such rights.”
Note: the University does not assert rights in the copyright
to “scholarly works.”
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Speaking Contract Guidelines

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A contract detailing the proposed services to be provided
must be in writing (e.g., an e-mail invitation is not
sufficient);
The Speaker’s Agreement Addendum helps ensure that
contract terms will comply with provisions of the
IRP;
Compensation for speaking is limited to a modest
honorarium not to exceed $2,500 per event, and
reimbursement of reasonable travel expenses;
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Speaking Guidelines (cont’d)
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
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Presentation must be designed to promote evidencebased clinical care and/or to advance scientific research;
Marketing activities and promotional speaking are not
permitted;
Speakers must make clear that views expressed are
their own, not those of the University/UPMC;
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Speaking Guidelines (cont’d)

Speaker must control content of presentation, and
content cannot be subject to company’s approval;

Content must reflect a balanced assessment of current
science and treatment options, and cannot focus on a
single company’s product.
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Speaking Contract Language

Acceptable
“Advisor will speak at a half-day meeting of Rod &
Cone, Inc., to discuss the latest research surrounding
the treatment of retinal disease for an honorarium of
$1,200 and agrees that this payment is at fair market
value.”
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Speaking Contract Language
(cont’d)

Not acceptable
“You will receive $5,000 for attending a dinner
meeting at Buena Vista Resort where new Lensfix
products will be unveiled.”

Not acceptable
“Physician shall serve as a Lensfix advisor for
ongoing physician education activities; shall conduct
presentations, lectures, and meetings at medical
conferences in coordination with Lensfix; and shall
conduct training of any employees, sales
representatives, or distributors of Lensfix products.”
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Speaking Contract Language
(cont’d)

Not acceptable
“Physician shall provide presentation materials to
Tonometronics Corp. at least five days prior to
their intended use in order to provide the
company sufficient time to review and approve
the materials. Presentation must comply with
FDA requirements, and speaker agrees not to
discuss off-label use of drugs.”
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Speaking Contract Language
(cont’d)

Not acceptable
“If the Speaker intends to use any materials (e.g., scripts,
notes, handouts, slides, etc.) in connection with the
presentation that will refer, directly or indirectly, by
illustration, text or otherwise, to Lensfix-manufactured or
like products, the materials must be consistent with
labeling or other literature provided by Lensfix, Inc.”
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Speaking Contract Language
(cont’d)

Not acceptable
“The Company may provide you with formal or informal
training for speaking on Rod & Cone’s behalf. Upon
request, the Company will provide you with technical
assistance in preparing or making available slides,
videos or other audiovisual materials. The Company may
from time to time also provide you with suggestions or
input on the Company approved presentations.”
Speaking Contract Language
(cont’d)

Not acceptable
“Formal ‘Surgeon Profile’ interview for Optometrics
Sales Newsletter focused on experience using
MicroIncision System. This interview will focus on
both your clinical and surgical experience with the
product….This interview will also include photos
and commentary on intra-operative experience
including commentary of use in your surgical
practice along with commentary on other
MicroIncisin methods.”
Contacts
Barbara Barnes, MD
412-647-8212; [email protected]
Pamela Grimm, JD
412-647-4915; [email protected]
Theresa J. Colecchia, JD
412-624-6281; [email protected]
David T. Wehrle, CPA, CIA, CFE
412-383-1774; [email protected]
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For more information…
On the University’s COI Web site:
COI/Industry Relationship Policy pages:
http://www.coi.pitt.edu/IndustryRelationships/index.htm
Also:
Archives of Ophthalmology, September 2009:
A Perspective on Commercial Relationships Between
Ophthalmology and Industry
http://archopht.ama-assn.org/cgi/content/full/127/9/1194
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