Novo Nordisk Diabetes and Obesity Biologics
Science Forum Awards
Terms and Conditions (“Terms”)
Types and scope of Novo Nordisk Awards
Novo Nordisk offers two types of research funding opportunities and collaborative models
under the Novo Nordisk Diabetes and Obesity Biologics Science Forum Awards: The Early
Exploration and Proof of Principle (PoP) Awards.
The Awards are reserved for nonclinical research only and support both young and
established scientists at selected US and Canadian academic and medical research
institutions (the “Institution”) exploring novel hypotheses in protein-based therapeutics
(biologics) for diabetes and obesity. The purpose of the Awards is to facilitate translation of
new ideas from early diabetes and obesity research into innovation by bringing new biologics
concepts to a non (pre) clinical Proof of Principle milestone.
Early Exploration Award
$250,000 for a two year period, plus Facility and Administrative Expenses
The Early Exploration Award supports nonclinical research for early-stage hypotheses that
do not yet have preliminary data but show considerable promise for advancing the treatment
of diabetes or obesity.
The Early Exploration Award provides research funding up to $125,000 per year for up to a
two year period. In addition to the possible $250,000 funding of direct expenses, the Award
will cover the Institution’s standard indirect costs (Facilities and Administrative) in accordance
with the Terms.
Proof of Principle (PoP) Award
$500,000 for a two year period, plus Facility and Administrative Expenses
The Proof of Principle (PoP) Award supports nonclinical research for the validation of early
stage innovations with sufficient supporting data to conclude on nonclinical PoP studies.
Priority will be given to research proposals which have the highest likelihood of achieving
PoP within a two year period. In general, PoP studies will require results from experiments in
established animal models, in vitro human systems or reduction to practise experiments for
protein and delivery technologies.
The Proof of Principle (PoP) Award provides research funding up to $250,000 per year for up
to a two year period. In addition to the possible $500,000 funding of direct expenses, the
Award will cover the Institution’s standard indirect costs (Facilities and Administrative) in
accordance with the Terms.
Novo Nordisk Direct R&D Support. For both the Early Exploration and the PoP Award,
Applicants have the option to have additional scientific support provided by Novo Nordisk.
Types of Novo Nordisk R&D support can include counseling by Novo Nordisk senior
scientists, custom synthesis and characterization of novel peptides and proteins, access to
Novo Nordisk marketed protein therapeutics and in-house R&D specialized lab equipment
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and animal models. The Recipient and/or Institution and Novo Nordisk will enter into a
separate research agreement covering the direct R&D support to be provided by Novo
Nordisk.
Award Criteria and Novo Nordisk Award Review Committee
Each summary pre-proposal and full research proposal will be reviewed by the Novo Nordisk
R&D Award Review Committee (the “Committee”). The Committee is comprised of senior
scientists and management of Novo Nordisk R&D. The decision of the Committee is final and
cannot be appealed.
The areas of research funded by the Awards are:
Non-clinical research related to new biologics and targets amenable to
biologics or novel effects of known biologics in the field of Type 1
Diabetes and Type 2 Diabetes, including microvascular and
macrovascular complications, and obesity.
Non-clinical research includes translational research (bed to bench), i.e. wet lab analyses on
samples procured from clinical studies. The term ‘biologics’ means peptide or protein
ligands (e.g. hormones), inhibitory or modulating antibodies, immunotherapies, small
interfering RNA (siRNA) or microRNA (miRNA), and cell based concepts (e.g. stem cells).
Such biologics either have to be novel or represent novel effects of a known entity. More
specifically, biologics in scope under the Awards are those with potential effects on glucose
lowering with diabetes co-morbidity benefits (e.g. cardiovascular and obesity), improving βcell function, increasing β-cell mass, microvascular complications such as nephropathy and
retinopathy, and immune intervention of Type 1 diabetes. Excluded from the definition are
novel targets easily manipulated by small molecule entities such as enzyme inhibitors and
intracellular targets with significant access barriers for larger molecules.
The Committee will review the Applications based upon the scientific and innovative merit of
the Application and according to following criteria:
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Focus on development of a protein (biologics) therapeutic and/or cell based therapy
Strength of scientific rationale and medical need
Novelty/differentiation
Likelihood of achieving milestones including path to non-clinical proof of principle
Availability of requested and internal Novo Nordisk resources
Alignment with Novo Nordisk early research project portfolio
Application Submission
Each Application must be entirely Applicant’s own work and to the Institution’s best
knowledge, the research proposed does not infringe upon or violate any laws or any rights of
third parties, including, but not limited to, such violations as infringement or copyright, patent,
trade secret or other proprietary or property right, or other right of any individual or entity.
The summary pre-proposal shall not contain any confidential information and the Applicant is
responsible for ensuring that all confidential information is removed prior to submission. Novo
Nordisk will not be responsible for the confidentiality of any information submitted in the preproposal summary. Prior to presenting or submitting further information relating to the
research proposal, Novo Nordisk and the Institution will enter into a separate confidentiality
agreement governing the confidentiality and use of such information.
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Use of Award Funds
The Award funds may be used as detailed below. Expenses must be allowable, allocable
and reasonable and comply with Institution policies and applicable law and regulations.
Direct Expenses
Direct expenses are costs that can be specifically identified as part of the research project.
Examples of allowable direct costs are Principal Investigator (PI) time allocation and
technical support staff hired for the specific research project (e.g., post docs), lab supplies,
equipment, travel expenses, publication expenses and contract services (e.g., animal
facilities). Budget allocation for PI time is not expected to exceed 10% of PI’s full time work at
Institution. Salary of a technical associate shall follow the U.S. National Institutes of Health
(NIH) salary guidelines. Up to $2,000 per year of the Award amount may be allocated for
travel expenses to project related scientific meetings. Up to 10% of the Award amount may
be used for purchase of relevant laboratory equipment. Equipment purchased with Award
funds is for the use of the funded research and may need to be returned to Novo Nordisk
after the Award term.
Direct expenses may not include: rent for office or lab space, computer hardware or
telephone service support, custodial or administrative support, tuition, relocation costs,
memberships and subscriptions.
Indirect Expenses
In addition to permitted direct expenses, the Award covers the Institution’s indirect costs
(also known as Facility and Administrative) needed to conduct the research. Such indirect
cost will be covered according to the Institution’s standard rate. Examples of indirect costs
include such items as laboratory space and utilities, hazardous waste disposal, campus
security and fire protection, radiation safety, occupational safety, disaster preparedness,
liability insurance and administrative services.
For example, if Applicant proposes direct expenses of the proposed research of $250,000,
and the Institution’s Facility and Administrative rate is 50%, then the total Award proposal
would be $375,000, and such amount would be fully funded by the Award.
Payment of Award Funding
Funding for the Award is paid to the Institution, but the individual applying for a winning
Award is referred to as the Recipient of the Award. The Institution is responsible for
administering the funds in accordance with its procedures and policies, and the stated Terms.
The Institution is responsible for taxes relative to the Award.
For a two year Award term: forty percent (40%) of the Award amount is provided upon
commencement of the Award term; forty percent (40%) of the Award amount is provided
after receipt by Novo Nordisk of the First Year Progress Report; and twenty percent (20%) of
the Award amount is provided after receipt by Novo Nordisk of the Final Report.
For a one year Award term: eighty percent (80%) of the Award amount is provided upon
commencement of the Award term; and twenty percent (20%) of the Award is provided after
receipt of the Final Report.
After one year of research, the Recipient may propose alterations in the approved Award
budget and Novo Nordisk will consider such alterations on a case by case basis.
Unexpended funds from the first year of the Award term may be carried over to the second
year of the Award term provided that the justification for such carryover is submitted to, and
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approved by, Novo Nordisk. Any Award funds that are not expended in accordance with the
approved budget at the end of the Award term must be returned to Novo Nordisk. Any
extension of the Award term to complete the research must be requested by the Recipient
and will be considered by Novo Nordisk on a case by case basis.
The Institution must maintain a separate financial record for each Award. The Institution
agrees to maintain books and records documenting the expenditure of Award funds in
accordance with customary accounting procedures. Reports of expenditures must be
submitted annually to Novo Nordisk as part of the First Report and Final Report. A financial
report prepared by the investigator’s fiscal officer or Award administrator and signed by either
the fiscal officer or Award administrator and the Recipient must be submitted at the same
time as the First Year Progress Report and Final Report.
Upon reasonable prior written notice and mutually agreed upon times, Novo Nordisk may
audit all expenses related to the Award at any time during the term of the Award and for one
(1) year thereafter to ensure compliance with the Award Terms and applicable laws and
regulations, at Novo Nordisk’s cost.
Other Funding for Proposed Research
The Award may not be combined with another award or grant to fund the research proposed
to be conducted under the Award that would conflict with or negatively impact Novo Nordisk’s
rights under the Award. The research carried out under the Award may not be funded by
private sector companies or their foundations or non-profit organizations. Prior funding from
third parties related to earlier related research shall not conflict with the Terms. Applicants
will disclose all current sources of financial support directly related to the proposed research
as well as any other financial support from Novo Nordisk.
Reports and Publicity
A First Year Progress Report must be submitted to Novo Nordisk within thirty (30) days
following the end of the first year of the Award term, in such format as provided by Novo
Nordisk. Payment of the second year funding will be made promptly after receipt of the First
Year Progress Report. Novo Nordisk may terminate the Award if the First Year Progress
Report is not timely received, after giving Recipient thirty (30) days’ notice to cure. A Final
Report must be submitted to Novo Nordisk within 60 days following the end of the Award
term, in such format as provided by Novo Nordisk. The Recipient and/or Institution and Novo
Nordisk will enter into a separate confidentiality agreement relating to confidential information
contained in Reports submitted by the Recipient.
As part of the Award, at the request of Novo Nordisk, Recipient will present its research to
Novo Nordisk Diabetes R&D during or after the Award Term.
Publications
All publications and major presentations resulting from work done with the support of this
Award shall indicate that the scientist is/was a Novo Nordisk Award Recipient and that the
work was supported by a Novo Nordisk Award.
For the Early Exploration Award, copies of all publications resulting from Novo Nordisk
supported research must be promptly sent to Novo Nordisk after publication. For the Proof of
Principle (PoP) Award, proposed articles for publication resulting from Novo Nordisk
supported research must be provided to Novo Nordisk at least 45 days prior to submission
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for publication for Novo Nordisk review and such publication may not contain Novo Nordisk
confidential information.
Intellectual Property Rights
Patent applications on any inventions conceived and reduced to practice in the performance
of research supported by the Novo Nordisk Award (“Inventions”) shall be reported to Novo
Nordisk within 90 days after filing. Recipients are required to report such patent applications
for a period of one year after the expiration of the Novo Nordisk Award. Recipients are
required to indicate in their Progress Report and Final Report if any Inventions were made
during the Award term.
Novo Nordisk shall have an exclusive first right to negotiate with the Institution to exclusively
license any Inventions and other intellectual property rights (e.g., know-how) generated in the
conduct of the research supported by the Novo Nordisk Award on commercially reasonably
terms. The right of first negotiation shall continue during the Award term and for a (1) one
year period after the Award Term. Institution and Novo Nordisk shall negotiate in good faith
for a period not less than 90 days from the date of Novo Nordisk election to negotiate an
exclusive license, or other time period agreed between the Institution and Novo Nordisk
(“Negotiation Period”). If such agreement is not concluded in the Negotiation Period or
during any extension of the period requested by either party, Institution shall have no further
obligations to Novo Nordisk, with respect to the option.
Institution shall have the right, but not the obligation, to file patent applications on Inventions
solely owned by Institution. In the event that it is necessary in the opinion of Institution as
communicated to Novo Nordisk to file any patent applications to protect an Invention during
the Award Term, and at the request of Novo Nordisk, Institution will file such application
provided that Novo Nordisk will reimburse reasonable and documented patent costs incurred
by Institution during the Award Term.
In addition, if a portion of the Award includes substantial direct support from Novo Nordisk
R&D, ownership of any inventions arising from the research conducted with such direct
support will be according to inventorship as determined under US law. The Institution and
Novo Nordisk will enter into a separate agreement relating to such Novo Nordisk direct R&D
support, which agreement will include customary terms and conditions, including with respect
to the intellectual property rights relating to any invention conceived and reduced to practice
during the conduct of the research supported by the Novo Nordisk.
No patent or patent application relating to an Invention made with the support of the Award
will be abandoned without first notifying Novo Nordisk in writing at least 60 days prior to such
abandonment in order to allow Novo Nordisk the opportunity to license such patent and
continue its prosecution and/or maintenance at Novo Nordisk’s own expense.
Transferability, forfeiture, and termination
If the Recipient leaves the Institution or receives additional non-Novo Nordisk funding for the
research covered by the Award, Novo Nordisk must be promptly notified. Recipients may not
transfer an Award between institutions.
Novo Nordisk may terminate an Award or withhold Award payments, in whole or in part, at
the discretion of Novo Nordisk based on financial, ethical, administrative, or programmatic
non-compliance, including failure to timely file the First Year Progress Report and Final
Report, or if reasonable efforts to achieve the established research milestones for the project
during the Award term are not undertaken by Recipient. This determination will be made by
the Novo Nordisk Review Committee. If termination of the Award is warranted, the Recipient,
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and/or the Institution shall execute a written agreement regarding termination. In such case,
any Award funds will be promptly returned to Novo Nordisk and any unpaid balance of the
Award will be cancelled other than Award funds allocated for any non-cancellable obligations
incurred by Institution prior to termination in accordance with the budget. Institution
undertakes to use commercially reasonable efforts to mitigate such costs.
Conduct relating to the Award
Each Institution is expected to have and enforce its own policies and procedures for the
avoidance and reporting of conflicts of interests as well as scientific and financial misconduct
relating to the research supported by the Award funding. Agreeing to the Terms of the Novo
Nordisk Award effectively acknowledges that the Institution has such established policies and
procedures and agrees to abide by them in the carrying out of research and other activities
relating to the Award. Award Recipients are required to report any instances of conflict of
interest or scientific or financial misconduct to Novo Nordisk as soon as they are aware of the
misconduct. Should scientific or financial misconduct occur, the Institution must notify Novo
Nordisk of the nature of the violation, the corrective actions that will be taken in order to
correct the violation, and a timeline in which those corrective actions will be taken.
Miscellaneous
Award Recipient will comply with applicable Novo Nordisk policies in carrying out research,
such as the Animal Ethics, Stem Cell and Gene Technology policies and the U.S. National
Institutes of Health (NIH) Guidelines for the humane care and use of animals in research set
forth at www.novonordisk.com/science/Bioethics/default.asp or equivalent standards.
According to U.S. federal and Canadian law, institutions that use laboratory animals for
research or instructional purposes must establish an Institutional Animal Care and Use
Committee (IACUC) to oversee and evaluate all aspects of the institution's animal care and
use programs, facilities, and procedures.
The amount of an Award, including any Institution Facility and Administrative Expense, and
any Novo Nordisk direct R&D support will be reported to authorities as may be required
under applicable state or federal law.
An Award may not be tied, in any way, to past, present, or future prescribing, purchasing, or
recommending (including formulary recommendations) of any drug. Any evidence that
suggests that an Application or Award is tied, in any way, to past, present or future
prescribing or recommending of any drug will cause the Application to be rejected, and the
Application may not be resubmitted or cause an Award to be terminated.
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