Preamble

Defined Terms

A.   Purpose

B.   Research and Technology Development Committee

1.       Membership

2.   Responsibilities

C.   Scope

D.   Technology Reporting and Disclosure

1.       Reporting to OCR

2.       Disclosure Outside the Medical Center

E.   Technology Ownership

1.   Principles

2.   Process

F.   Protecting Intellectual Property Rights

G.   Marketing and Commercialization

H.   Distribution of Net Proceeds:

1. Net Proceeds

2. Equity

3. Medical Center Research Fund

4. Medical Center General Fund

5. Distribution Schedule

6. Multiple Inventors

7. No Active Research Program

8. Death or Departure from Medical Center

9. Unauthorized Payments to Inventors

10. Postponement of Distribution

11. Distribution Review

I.    General Equity Provisions:

1. Decision to Accept Equity

2. Receipt of Equity

3. Distribution of Equity

4. Monitoring

5. Clinical or Other Sponsored Research

6. Governing or Scientific Board Membership

J.    Conflicts of Interest Policies

K.   Consulting Agreements

L.   Other Arrangements

M.  Former Policies

Exhibit A – Participation Agreement

Preamble

The collaboration between the Beth Israel Deaconess Medical Center and its physicians and researchers is critical to the Medical Center’s successful fulfillment of its mission of providing a high level of excellence in clinical care, teaching and research.  Over the last several years, a variety of relationships with industry have brought new resources to the support of science that facilitate translation of knowledge from the laboratory to the bedside.  These relationships have great potential to benefit the public as well as research institutions, their faculty and staff, and their industrial partners.  The Trustees of the Beth Israel Deaconess Medical Center are strongly committed to the continued growth in these innovative and mutually beneficial relationships, while realizing their paramount responsibility to safeguard the principles of academic freedom and timely dissemination of information about important new scientific developments.

This policy is intended to serve as a guide for members of the Medical Center community in structuring their relationships with industry and other outside ventures in view of their academic responsibilities for teaching, research and patient care.  In addition, the policy encourages creativity and innovation of researchers, with incentives for productivity and opportunities to gain recognition for individual accomplishments.

In addition, this policy is also meant to encourage researchers to disclose discoveries in a timely manner in order to protect the intellectual property rights of the Medical Center, while providing for fair and equitable allocation of responsibilities and rewards among inventors, researchers, the Medical Center, and other collaborators which may have contributed in whole or in part to inventions, discoveries or technology.

Finally, the policy supports the goal of bringing to the public important new Medical Center discoveries which, through commercialization, address unmet medical needs and alleviate human suffering.

Defined Terms

Academic Council Subcommittee:  A subcommittee of the Medical Center’s Academic Council consisting of the Senior Vice President for Academic Affairs, the Chief of the Inventor’s Department, and three (3) other Medical Center members of the Academic Council selected by the Academic Council (pg.5)

Committee:  Research and Technology Development Committee (pg.2)

Covered Person:  A full or part-time professional staff, faculty, employee of, student, trainee, or person or entity otherwise engaged at the Medical Center, such as consultants or agents (pg. 2,3)

Equity: Stocks, options, warrants and/or other financial instruments convertible to equity in an entity which has rights to Technology (pg.8)

Equity Subcommittee: A subcommittee of the Research and Technology Development Committee designated by the chair of the Research and Technology Development Committee to address issues relating to equity ownership (pg.11)

General Fund: The Medical Center General Fund supports initiatives generally of the Medical Center (pg.8)

Invention:  Any invention, discovery, data, writing or other intellectual property, including trade-or servicemarks, works-for-hire, know-how, computer software and biological materials, whether or not patentable, copyrightable or otherwise entitled to legal protection (pg. 2)

Inventor: A full or part-time professional staff, faculty, employee of, student, trainee, or person or entity otherwise engaged at the Medical Center, such as consultants or agents who makes, conceives, reduces to practice, or generates an Invention (pg.3)

Medical Center:  Beth Israel Deaconess Medical Center, Inc. (pg. 1)

Net Proceeds:  The amount actually received by the Medical Center from the sale, license or other commercialization of Technology owned in whole or in part by the Medical Center, including but not limited to, royalties, fees, milestone payments, and Equity, less all costs and expenses reasonably attributable to obtaining intellectual property protection and commercialization of the Technology (pg. 7)

OCR:  Office of Corporate Research (pg. 3)

Policy:  Research and Technology Development Policy (pg. 1)

Research Fund: The Medical Center Research Fund supports only Medical Center-based research.  This is a separately held special fund.  Allocations of both the principal and interest from this fund may be made by the President of the Medical Center in consultation with the Vice President after reporting the proposed distribution to the Committee (pg. 8)

Technology: Any Invention that (1) either has potential commercial value or is patentable, copyrightable, or otherwise entitled to legal protection, and (2) is made, conceived, reduced to practice or generated by a Covered Person while engaged in activities (a) for which the Covered Person received financial support from or through the Medical Center; (b) during which the Covered Person made use of any facilities, materials, equipment, staff, information, ideas, data, computers or other resources of the Medical Center; or (c) which are related to the employment, research or other activities conducted at the Medical Center by the Covered Person (pg. 3)

Trustees:  Trustees of the Beth Israel Deaconess Medical Center (pg. 1)

Vice President:  Vice President, Science and Technology (pg. 2)

A.  PURPOSE

The mission of the Beth Israel Deaconess Medical Center (the "Medical Center") is to provide a high level of excellence in clinical care, teaching and research.  To further this mission, the Trustees of the Medical Center (the “Trustees”) who are responsible for the overall allocation of resources among these three objectives, have adopted this Research and Technology Development Policy (the “Policy”) to:

• benefit the public by facilitating commercial development and utilization of inventions, discoveries and other technology;

• encourage the creativity and innovation of current staff, as well as to encourage the recruitment and retention of talented and innovative staff;

• provide incentives to researchers to be productive and recognize individual accomplishment;

• foster scholarly pursuits and principles of academic freedom;

• encourage researchers to disclose discoveries in a timely manner in order to protect the intellectual property interests of the Medical Center;

• provide assistance in negotiating, preparing and implementing contracts with outside sponsors, collaborators and licensees.

• provide equitable allocation of responsibilities and financial rewards among inventors, researchers, the Medical Center and any other entity which may have

• developed, sponsored or financed in whole or in part such inventions, discoveries or technology; and

• provide financial support of the Medical Center’s mission of excellence in clinical care, teaching and research.

The Trustees retain the discretion to amend this Policy from time to time to fulfill these purposes.

B.  RESEARCH AND TECHNOLOGY DEVELOPMENT COMMITTEE

1.  Committee Membership.  The Trustees, in consultation with the President of the Medical Center and the Vice President, Science and Technology (the “Vice President”) will appoint members of the Research and Technology Development Committee (the “Committee”).  Membership may consist of the President of the Medical Center or designee; the Vice President; the Vice President, Information Systems; the Chief Medical Officer; a Chief of Service; two Senior Investigators active in research at the Medical Center; and at least five members of the Board of Trustees.  The Trustee members of the Committee shall have the right to vote on matters that come before the Committee.  All other members of the Committee shall be non-voting members.  All voting and non-voting members of the Committee shall serve at the pleasure of the Board of Trustees.

The Chairman of the Committee shall be designated annually by the Chairman of the Trustees.  The Vice President or designee, shall be responsible for scheduling all meetings of the Committee and keeping the minutes for such meetings.  The President and Chief Medical Officer of the Medical Center shall have the right to attend all meetings, and the Vice President shall be responsible for notifying them of all meetings.

2.      Responsibilities.  The Committee shall oversee and advise the Vice President on the interpretation and application of this policy, and may grant exceptions to the Policy in special cases.  From time to time the Committee may recommend to the Trustees amendments and/or additions to his Policy.

C.  SCOPE

      This Policy applies to any invention, discovery, data, writing and other intellectual property, including trade- or servicemarks, works-for-hire, know-how, computer software and biological materials, whether or not patentable, copyrightable or otherwise entitled to legal protection (collectively “Invention”) made, conceived, reduced to practice or generated by full or part-time professional staff, faculty, employee of, student, trainee, or person or entity otherwise engaged at the Medical Center, such as consultants or agents retained by the Medical Center (collectively “Covered Person”) any invention that (1) either has potential commercial value or is patentable, copyrightable, or otherwise entitled to legal protection, and (2) is made, conceived, reduced to practice or generated by a Covered Person while engaged in activities (a) for which the Covered Person received financial support from or through the Medical Center; (b) during which the Covered Person made use of any facilities, materials, equipment, staff, information, ideas, data, computers or other resources of the Medical Center; or (c) which are related to the employment, research or other activities conducted at the Medical Center by the Covered Person is referred to as “Technology”.  Steps taken toward commercialization, such as filing a patent application or seeking other protection of intellectual property, will be interpreted as demonstrating potential commercial value.

      In keeping with principles of academic tradition, the Medical Center claims no ownership interest in scholarly publications, such as textbooks, that do not embody or disclose any Technology and were not prepared with significant use of Medical Center resources.

      Each Covered Person shall sign a Participation Agreement in which the Covered Person agrees to comply with this Policy.  A copy of a Participation Agreement is attached as Appendix A.

D.  TECHNOLOGY REPORTING AND DISCLOSURE

1.  Disclosure of Technology to OCR.  Each Covered Person who makes, conceives, reduces to practice or generates Technology (the “Inventor”) should promptly submit a completed Technology Disclosure Form to the Medical Center’s Office of Corporate Research (“OCR”) when Technology is identified.  Technology Disclosure Forms are available from the OCR.  If the Covered Person is a consultant engaged by an employee or staff member of the Medical Center, then the employee or the staff member is responsible for ensuring that the Technology Disclosure Form is completed and submitted.  The description of the Technology in the disclosure form should provide enough detail to determine the most appropriate steps, if any, to protect and commercialize the Technology.

  2.  Disclosure Outside the Medical Center.  If Technology is disclosed outside the Medical Center, such as in a publication or oral presentation, by use, or by public sale, before appropriate steps are taken to protect the intellectual property rights in the Technology, such as filing a patent application, then those rights may be lost.  Therefore, prior to any proposed publication of Technology or other disclosure of the Technology outside the Medical Center, the Inventor should contact the OCR to coordinate the disclosure with steps the Medical Center may take to protect rights in the Technology.  If Technology is to be disclosed to a third-party for commercial evaluation or other Medical Center purposes, in most cases an appropriate, signed Confidential Disclosure Agreement should be obtained from the recipient of the information.  For Technology Disclosure Forms, Confidential Disclosure Agreements, and information about the appropriate use of each, contact the OCR.

E.  TECHNOLOGY OWNERSHIP

1.  Principles:

a.     All Technology is owned by the Medical Center.  When an entity other than the Medical Center has also sponsored, financed, or otherwise participated in the Invention, the Vice President will negotiate with the other entity to determine the percentage of the Technology owned by the Medical Center.  The Vice President may consult with the Committee and the Inventor.

b.      The ownership of Technology made in whole or in part in connection with activities conducted under a grant from or other agreement with the U.S. Government is subject to the retained rights of the U.S. Government.

c.     The ownership of Technology made in whole or in part in connection with activities conducted pursuant to any industrially sponsored or otherwise sponsored research agreement between the Medical Center and the sponsor will be in accordance with this Policy.

2.  Process:

a.   The Vice President will make the initial determination of ownership. Decisions of the Vice President about whether an Invention is within the definition of Technology and other issues of ownership, may be appealed by an Inventor in writing within one (1) month to the Senior Vice President for Academic Affairs who will convene a subcommittee of the Medical Center’s Academic Council consisting of the Senior Vice President for Academic Affairs, the Chief Medical Officer, the Chief(s) of the Inventor or Inventors’ Department(s), and as many other Medical Center members of the Academic Council selected by the Academic Council needed to total at least five members (the ”Academic Council Subcommittee”), whose decision will be final.

b.     Subject to obligations to third-parties (such as sponsor or the Government), the Medical Center may release, in whole or in part, any Technology and its related patent, copyright or other legal protection, to the Inventor.  The terms of the release may include appropriate compensation to the Medical Center for its out-of-pocket expenses associated with the Technology.  The Medical Center may also elect to retain the right to use any released Technology for Medical Center research.

i.    If the Medical Center has not taken reasonable steps to obtain legal protection of Technology within one (1) month after the filing of a completed Technology Disclosure Form or the Effective Date of this Policy, whichever is later to occur, then the Inventor may submit a written request to the Vice President, for the release of the Technology to the Inventor(s).  Within one (1) month of receiving the request, the Vice President will inform the Inventor of whether or not the request is approved, and the reasons for the decision.  If the request is approved, then the Medical Center will provide appropriate documentation releasing the Technology to the Inventor(s).

ii.    If the Medical Center has not taken reasonable steps to commercialize the Technology within six (6) months after filing for the protection of the Technology by OCR or the Effective Date of this Policy, whichever is later to occur, then the Inventor may submit a written request to the Vice President for the release of the Technology to the Inventor(s).  Within three (3) months of receiving the request, the Vice President will review the Inventor’s request in consultation with the Committee and inform the Inventor of whether or not the request is approved, and the reasons for the decision.  If the request is approved, then the Medical Center will provide appropriate documentation releasing the Technology to the Inventor(s).

F.  PROTECTING INTELLECTUAL PROPERTY RIGHTS

      The Vice President, or designee working with the Inventor, will decide whether to seek legal protection of Technology.  If the Medical Center seeks patent, copyright or other legal protection of Technology, in whole or in part, then the Inventor and the Medical Center will work together to protect the Technology.  The Medical Center will provide professional services at its expense.  The Inventor will provide technical information, documentation, and all other assistance deemed necessary by the Medical Center, including an assignment of the Inventor’s rights in the Technology to the Medical Center.  The OCR will retain Participation Agreements, invention disclosures, inventorship declarations, and assignments.  The Medical Center is not obligated to pay for professional services that are not authorized in advance by the Vice President.

G.  MARKETING AND COMMERCIALIZATION

      The Vice President and the Inventor, working together, will decide what measures are to be taken to commercialize the Technology, taking into account the principles of academic freedom while optimizing the utility of the Technology to the public and its commercial value to the Medical Center.  This may include, but are not limited to, agreements with third-parties for the development, patenting, promotion, marketing, licensing and manufacturing of Technology.  Transfers of any interest in Technology to third-parties are to be by license, rather than assignment, unless otherwise decided by the Vice President in consultation with the Committee.  The license should provide the Medical Center the right to reduce or terminate the license if the third-party does not make a diligent effort to make the Technology available to the public. If an Inventor is no longer employed or otherwise engaged at the Medical Center, then the Vice President may independently decide what measures are to be taken to commercialize the Technology.

Only approved agreements signed by an authorized representative of the Medical Center shall be valid and binding upon the Medical Center.  The Vice President or designee is authorized to negotiate agreements for the development or transfer of technology with commercial and non-commercial third-parties.  The President of the Medical Center is authorized to approve and sign License Agreements.  The Vice President, and in the case of agreements for clinical research the Vice President or designee, is authorized to approve and sign all other technology development and transfer agreements.

H.  DISTRIBUTION OF NET PROCEEDS

1      Net Proceeds.  The term “Net Proceeds” as used in this Policy shall mean the amount actually received by the Medical Center from the sale, license or other commercialization of Technology owned in whole or in part by the Medical Center, including, but not limited to, royalties, fees, milestone payments, and Equity (as defined below) less all costs and expenses reasonably attributable to obtaining intellectual property protection and commercialization of the Technology.  These costs and expenses may include, without limitation, attorneys’ fees, and out-of-pocket administrative and other costs and expenses of contract negotiations and administration, and any out-of-pocket cost or expense of patent or copyright prosecution, litigation, marketing, licensing and/or negotiation.  Research funding and contributions of equipment received by the Medical Center from the sale, licensing or other commercialization of any Technology, shall be the property solely of the Medical Center and shall not be included within Net Proceeds.

2.     Equity.  The term “Equity” as used in this Policy shall include stocks, options, warrants and/or other financial instruments convertible to equity in an entity that has rights to Technology.

3.       Medical Center Research Fund.  The Medical Center Research Fund is a separately designated fund that supports only Medical Center-based research.  Allocations of both the principal and interest from this fund may be made by the President of the Medical Center in consultation with the Chief Medical Officer and the Vice President after reporting the proposed distribution to the Committee.  This fund is hereinafter referred to as the “Research Fund”.

4.       Medical Center General Fund.   The Medical Center General Fund supports initiatives generally of the Medical Center.  This fund is hereinafter referred to as the “General Fund”

5.       Distribution Schedule.  The Medical Center may receive Net Proceeds for the license, sale or other transfer of Technology.  If the Inventor chooses not to receive any portion of the Net Proceeds received by the Medical Center pursuant to its agreement for the transfer of Technology, then the Inventor may, in a separate transaction relating to the transfer of that Technology, arrange to receive Equity from the company to which the Technology, is transferred.  The receipt of equity by the Inventor will demonstrate the Inventor’s choice not to receive any portion of the Net Proceeds received by the Medical Center for that Technology.  The Net Proceeds actually received by the Medical Center for its interest in Technology, excluding works-for-hire and trade- or service marks, shall be periodically distributed by the Medical Center as provided in the following schedule:

Distribution Schedule