CPD Phase II Bylaws; approved on November 3, 2016
National Science Foundation Industry/University Cooperative Research Center (“I/UCRC”) for Pharmaceutical Development (CPD)
If there are any inconsistencies between the Bylaws and the Membership Agreement, the terms and conditions outlined in the Membership Agreement take precedence over the Bylaws.
The Center for Pharmaceutical Development (“CPD”) has three sites, at the Georgia Institute of Technology (lead) in Atlanta, GA, at the University of Kentucky in Lexington, KY, and at the University of Delaware in Newark, DE (the “Universities”).
1. Primary goals of CPD
(a) Establish the nation’s premier multidisciplinary research center in pharmaceutical development as a basis for long-term partnership and collaboration amongst industry, academia, and government;
(b) Directly support research needs of industry and government partners in a cost-effective manner with pooled, leveraged resources, and maximized synergy;
(c) Enhance the educational experience for a diverse set of top-quality graduate and undergraduate students as well as postdoctoral researchers; and
(d) Advance knowledge and technologies in this field and ensure commercial relevance of the research with rapid and effective technology transfer.
2. Operational vision for CPD as a multi-institutional center
The CPD is comprised of the University sites that are loosely coupled logistically but operate together as a single, multi-institutional research center. Each University site must have a healthy, research program in conjunction with their center Members to give them value. Within each site, each research project will be structured to attain the critical mass of personnel and other resources necessary to ensure success. The CPD keeps member entities (“Members”) informed on a regular basis through semi-annual meetings, interim reports, and/or site visits at the University or Member site.
3. Role of the Center Director
To lead, organize, and manage activities between sites and between the Center, National Science Foundation (“NSF”), and Members, and serve as the contact point on issues that span the entire Center. The Center Director also serves as Site Director for the lead institution and as faculty member on one or more projects there.
4. Role of each Site Director
To lead, organize, and manage activities within the site, with the sites’ sponsor Members, with NSF concerning matters of that site, and to serve as the contact point on issues that span that entire site. Each Site Director also serves as a Co-Director of the overall Center and possibly as faculty member on one or more projects at their site.
5. Role of each participating faculty member
To lead, organize, and manage activities within their project and serve as the contact point on issues specific to that project at their home site.
6. Role of the NSF Evaluator
To gather data by observation and survey of Industrial Advisory Board (“IAB”) members and faculty so as to provide objective feedback on Center processes and outcomes and thereby assist in refining Center operations and help ensure that the needs of all Members are met. The NSF Evaluator is appointed by the NSF.
7. Meaning and characteristics of a Full Membership
A Full Membership is one in which the annual fee (currently $50,000 US dollars) has been contributed by the Member in cash. The annual fee might be prorated. Each Full Membership has associated with it the full rights and privileges of the Center, including but not limited to standard intellectual property (“IP”) rights as defined by I/UCRC in the CPD standard membership agreement and voting rights in the IAB on Center policies and projects. Members only can seek rights to IP that was substantially developed during the time period of active membership in the Center. Each Membership is associated with one of the Universities of the Center in each respective Membership agreement. Membership provides voting rights in terms of project selection and resource allocation. A Member may hold up to two voting memberships at each University. A Full Member is permitted to use all Center research results for its internal research and development purposes. A Full Member may also use Center research results for commercial purposes, except if such results that rise to the level of an invention are patented and a Member does not seek a non-exclusive royalty-free license.
8. Other types of memberships
Entities that are eligible for Small Business Innovation Research (‘SBIR’)/Small Business Technology Transfer (‘STTR’) funding can elect to become Half-members. A Half-Membership (currently $25,000 US dollars/year) carries the same IP rights as a Full Membership but carries only 50% of weight of voting rights of Full Members.
9. Role of the Industrial Advisory Board (IAB)
The IAB serves as the advisory committee of the Center and reviews and decides all research activities funded totally or in part by membership fees and approves Center bylaws. The IAB is comprised of one official liaison from each Full or Half Member. The IAB Chair and Vice-Chair are elected by the Members of the IAB at the IAB Spring meeting for renewable one-year terms. The IAB Chair heads the IAB meetings and keeps contact with the Center Director and the Site Directors on policy matters. On policy decisions, Members hold voting seats on the IAB (with one vote for each Full Membership and one-half vote for each Half-Membership). A quorum for IAB vote is two-thirds of the voting IAB Members or their proxies. Members can vote on projects even if they cannot attend the IAB meeting, until up to one week after the IAB meeting, either in writing to the IAB Chair after reviewing electronic project proposals, or by assigning a proxy prior to the meeting. In general, a simple majority outcome to a vote will carry an action, except for Bylaws changes, which require a two-thirds majority. Proposals for new projects as well as progress reports of current or continuing projects have to be disseminated by the Center Director two weeks ahead of any IAB meeting.
10. IAB recommendations on funding priorities
Proposed new projects are reviewed annually by the IAB. Each proposed project, both continued or new, has a designated annual cost associated with it. IAB members vote for projects associated with their site of membership. Each Member ranks in priority order up to five projects the Member is interested in funding (5 = highest priority). All projects, with their respective annual costs, are ranked according to the number of votes. They are considered prioritized for funding if the total funding level available to the site covers the requested funding level, starting with the top-ranked project. A maximum threshold of annual project cost may be designated. A Member’s top ranked project should always be prioritized for funding.
11. Formal schedule for participation
Center IAB meetings will be scheduled semiannually at rotating University sites, tentatively scheduled to occur in October and May of each year. The business of the IAB is conducted at these meetings. On-going and completed research is reviewed semiannually and continued, unless lack of success or progress warrants immediate termination. Annually, new research projects are proposed and selected for recommended funding. Projects are typically funded to operate for periods that closely match the calendar year or the semester calendar at each University site. Outside of the normal meetings of the IAB at the workshops, the IAB Chair and the Center Director may at his or her discretion call for decisions by other means (e.g. via email or telecon).
12. How research projects support graduate theses for participating students
Although projects are defined, undertaken, and completed on a yearly basis, it is anticipated that a majority of projects in CPD will contain sufficient breadth and depth so as to merit continuation for a second and perhaps third year with the addition of expanded tasks and deliverables. In this manner, a doctoral student serving on a project may leverage key scholarly research components of the project for his/her doctoral dissertation. The same is true for thesisoption MS students should the work span beyond the first year.
13. Attendance at the semiannual meetings
Attendance at the closed IAB meetings will normally be limited to the following: IAB members and their technical representatives; the NSF evaluator; NSF program managers and staff; and guests invited by the IAB members. Guests (but not representatives of paying Member entities) at the semi-annual meetings must sign a non-disclosure agreement and cannot participate in closed meetings, such as the IAB meeting.
14. Employing proprietary information from Members
Given the nature of an I/UCRC and research consortium, and the requirement that all research results from all research projects at all sites of CPD be equally shared with all Full Members in CPD, the faculty, students, and staff conducting the research will not be able to accept and employ proprietary information in the conduct of projects except with the approval of the IAB and the Center Director. For projects that rely upon proprietary information or unique requirements, a separate research contract or grant may be the appropriate vehicle (see Section 15).
15. Related research contracts and grants
As needs for proprietary research or unique applications may develop, a separate contract or grant may be negotiated between a Member and one or more of the University sites in CPD. Such contracts and grants are handled outside the Center membership agreement.
16. Equipment for research acquired at each site
Equipment donations from vendors are highly encouraged and will be supported by visibility with CPD on the web site and in various other materials, such as promotional brochures.
17. Publication review policy
Each University site is free to use the results of its research in CPD for its own educational, research, and publication purposes. Research that results in new IP is protected by a publication review policy. In accordance with the agreement, through their IAB representative, each Member shall have the opportunity to review a substantively complete draft of any public disclosure containing results of Center-funded research for thirty (30) days prior to the official submission of that disclosure, and shall have the right to request for cause (i.e. pursuit of patent disclosure) a delay in publication submission not to exceed ninety (90) days from date of distribution to the IAB.
18. Publication review procedure
The formal procedure as defined by NSF is as follows: (a) distribution of copy of Center-funded disclosure for review by IAB prior to submission for publication; (b) IAB Member must request publication delay within thirty (30) days or manuscript is approved; (c) to delay publication for up to ninety (90) days, IAB Member must ask that a patent disclosure be pursued; (d) University must file a patent disclosure and pursue patent or license; (e) all Center members will be asked to support patent filing cost; (f) only IAB Members who agree to supporting filing cost will retain a non-exclusive, royalty-free license; (g) IAB Members who do not agree to support filing costs will not retain a non-exclusive, royalty-free license. Publication for the purposes of this Section is not confined to articles in journals but also includes presentations and publication of a filed patent application by the University (see next Section).
19. Patenting procedure resulting from request by University site
Commonly, patenting of results that rise to the level of an invention is not pursued as a result of Member requests before approving a publication but as a result of disclosures filed to the Universities by faculty members. Upon the request by the faculty member, the IAB votes whether to require the University to file a patent application. The Members in favor of such an application agree to equally share patent filing and upkeep costs for the duration of the patent. In return, they receive a non-exclusive, permanent, royalty-free, sub-licensable only to Members’ Affiliates, license if the patent application is granted. For purposes of the foregoing, “Affiliate” shall mean any entity (i) in which fifty percent (50%) or more of the voting equity interests are now or hereafter owned or controlled, directly or indirectly, by a Member, (ii) which now or hereafter owns or controls, directly or indirectly, fifty percent (50%) or more of the voting equity interests of a Member, or (iii) in which fifty percent (50%) or more of the voting equity interests are now or hereafter owned or controlled, directly or indirectly, by an entity identified in the preceding clause (i) or (ii). Members can sub-license to toll manufacturers or service providers, provided that i) the Member names the sub-licensee to the patent holder (usually one of the CPD sites), ii) the sub-license is limited in time and scope to the contract with the Member, and provided iii) no intellectual property is generated that is assigned to the sub-licensee. As standard, such a patent application will cover the following countries: United States of America, Canada, Japan, Germany, the United Kingdom, France, the Netherlands, and Switzerland. Additional countries are to be voted on by the IAB. Expenses for filing and upkeep in additional countries will be shared among those members seeking protection in those countries. The University will pursue the most cost-effective route of patenting (PCT route or national applications). The Members not in favor of patenting do not receive a non-exclusive, royalty-free license and thus do not have access to commercial use of the invention.
20. Sharing of non research-related information among member companies
CPD member entities are not to engage in discussions at CPD-sponsored meetings on individual entity information on pricing, costs, output, production and transportation rates, and market procedures such as company bids, marketing or promotional plans, and customer or supplier contract terms.
21. Use of Member and University trademarks and logos
Except as required by law, expressly including but not limited to requests received under state Open Records Acts and the federal Freedom of Information Act, Universities will not disclose the terms of any membership agreement, or any separate research contract without a Member’s prior written consent. Universities and Members, recognize the value of the Members’ and Universities’ trademarks, service marks or logos, and shall not use or reproduce these in any publicity, advertising or announcement without the other party’s prior written consent. However, as is normal practice in membership collaborations, the Members’ name itself (but not its logo), can be used and included without separate consent by the Universities solely to describe its current Center membership in the Center in all usual and customary Center publications, presentations and correspondence including, but not limited to, scientific presentations, brochures, letterhead, articles of general interest announcing Center research and accomplishment, reports to federal and state agencies, listing of current members and background material, for recruitment of potential new members, but in no event shall this use of a Member’s name be permitted in any press release without prior written approval of such press release by the Member. Universities shall ensure that the use of Member’s name in the aforesaid manner and media will not be used in a way that indicates the Member’s approval of the content, only its active membership in the Center. As is afforded to all Members, Members may insert a disclaimer in any publication or presentation whose content they disagree with or cannot endorse, and for that purpose the Member shall be provided prior notice of each such publication or presentation (see also Sections 17. And 18.).
22. Debarment, Anti-bribery and Corruption, Exclusions Lists
All parties agree to obey to current FDA laws and regulations. (i) The Universities will not employ or otherwise use in any capacity the services of any person or entity debarred under Section 21 USC 335a in performing any CPD activities. The CPD sites shall notify Members in writing if any such debarment occurs or comes to its attention. (ii) The Universities shall not offer, make or promise any payment, either directly or indirectly, of money or other assets in connection with this Center (hereinafter collectively referred to as “Payment”) to any government or political party officials, officials of international public organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (hereinafter collectively referred to as “Officials”) where such Payment would constitute violation of any law. In addition regardless of legality, the Universities shall make no Payment either directly or indirectly to Officials if such Payment is for the purpose of improperly influencing decisions or actions with respect to the subject matter of the CPD. The Universities shall keep complete and accurate books, records, invoices and any other documents relating to payments and expenses in connection with the Center and reflect in reasonable detail the character and amount of transactions and expenditures. (iii) The Universities shall screen themselves, and their officers and directors against the Exclusions Lists and inform IAB Members in writing immediately if any such Violation occurs or comes to its attention. “Violation” shall mean that either a University, or any of its officers or directors has been: (a) convicted of any of the felonies identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (https://oig.hhs.gov/exclusions/index.asp); and/or (b) identified in the OIG List of Excluded Individuals/Entities (LEIE) database (https://oig.hhs.gov/exclusions/exclusions_list.asp) or the U.S. General Services Administration's list of Parties Excluded from Federal Programs (https://www.sam.gov/portal/public/SAM/) (each of (a) and (b), singly and collectively, the “Exclusion Lists”.