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Amt.
Agreement on the Use of Results
Achieved in the Research and Development Project
Parties:
University Hospital Hradec Kralové
Registered office: Sokolské 581, 500 05 Hradec Kralové — Novy Hradec Kralové
ID: 00179906
Tax ID: CZOOl79906
Represented by: MUDr. Ales Herman, Ph.D., Director
(hereinafter referred to as the Project Promoter or FN HK)
and
Bioinova, a. 3.
Registered office: Vider'lska 1083, 142 00 Praha 4 — Krc
ID: 28452682
Tax ID: CZ28452682
Represented by: —
(hereinafter referred to as Bioinova)
and
Institute of Experimental Medicine of the Czech Academy of Sciences
Registered office: Videfiska 1083, 142 00 Praha 4 — Krc
ID: 68378041
Tax ID: CZ 68378041
Representedbyz—
(hereinafter referred to as IEM)
and
University of Oslo
Registered office: Problemveien 7, 0315 Oslo, Norway
ID: 971035854
Represented by:
(hereinafter referred to as UiO)
(hereinafter collectively referred to as the Parties)
made the following agreement on the day, month and year given below in accordance with
Section 16 of Act No. 130/2002 Sb., on support for research, experimental development and
innovation from public funds, and on amendments to certain related acts (the Act on Support
for Research, Experimental Development and Innovation):
1.
Basic information about the project
1. This agreement governs the use of research results generated within the joint project
entitled Advanced Drug Development for Alzheimer’s Disease, identification number
T001000078 (hereinafter referred to as the Project).
2. The Project implementation period: 1 January 2021 4 30 April 2024
3. The Project promoter: FN HK
4. Other recipients of the project: Bioinova a.s., Institute of Experimental Medicine of the
C.A.S., University of Oslo
5. The Project data is subject to the data confidentiality code “C” (the subject matter ofthe Project
is a trade secret).
6. The Project was implemented on the basis of a partnership agreement made by the Parties on
22 December 2020.
II.
Project results
1. Expected objectives of the Project: The Project aims to develop compounds for the
treatment of Alzheimer’s disease (AD). During the development process, the Project
will include personalized medicine approaches so that new compounds are tested in
a disease-in-a-dish (hereinafter referred to as DiD) model derived from patient samples.
2. Definition of the achieved results of the Project and their comparison with the Project
objectives: The Project achieved the main results as planned although there were
justified deviations during the Project. The development of the DiD model was
discontinued during the Project due to the loss of competitive advantage.
3. The list of all Project results (main results, beyond the plan results and other results)
subject to protection under Act No. 121/2000 Sb., on copyright, on rights related to
copyright and on amendments to certain acts (the Copyright Act) is attached as Annex
1 to this Agreement.
4. The list of project results subject to protection under Act No. 527/1990 Sb. on
inventions, industrial designs and improvement proposals:
Name of result Type of Patent Date of Date of award Ownership
result number submission 21 March 2024
N-methyl-D-aspartate Patent 310008 6 May 2023 shares
receptor antagonists FN HK — 66%
and their uses IEM — 34%
5. The Project Promoter declares that the Project result referred to in paragraph 4 of this
Article is not also a result of another project or research project.
111.
Regulation of ownership and exploitation rights to the Project results
The solution of the Project is not a public procurement and, therefore, the regulation of
the rights to the results and their exploitation is not covered by Section 16(1) and (2) of
Act No. 130/2002 Sb.
Within the meaning of Section 16(3) of Act No. 130/2002 Sb., all rights to the results
of the Project belong to the Parties.
The results of the Project under Article II (3) of this Agreement, including the final
report, are subject to protection under Act No. 121/2000 Sb. and, within the meaning of
Section 58 of the cited Act, they may be considered as employee works, the ownership
rights to which are exercised by the Parties in accordance with the affiliation of the
publication listed in the Table shown in Article 11(3) of this Agreement.
According to Article 11(4) of this Agreement, the Project resulted in an invention
protected by a Czech patent. FN HK and IBM made the Agreement on the Regulation
of Rights to Research and Development Results on 5 June 2023 in which they have
settled contractually all claims made by the originators of the rights in accordance with
the applicable legislation, which has allowed them to act as exclusive owners of the
intellectual property rights. The agreement of 5 June 2023 regulates all rights and
obligations in this respect.
IV.
Way of use of the Project results
The Parties are entitled to use the results of the Project for research, publication and
educational activities without restriction.
The Parties declare their intention to use the results of the research in their activities
within five years from the end of the Project.
-3-
If one of the Parties exploits commercially or will exploit commercially the result of
the Project achieved within the Project, the other Parties will be entitled to reasonable
compensation. The method of calculation of the compensation and the method of
payment will be specified in an amendment to this Agreement made at least 1 month
before the product is placed on the market.
The Parties will inform each other of the interest of third parties in using the results of
the Project. The sale of the Project result or the granting of a licence to a third party is
possible after approval of all co-owners, and the distribution of the proceeds from the
sale or licence will be made according to the co-ownership shares of the Parties. In such
a case, the Parties are obliged to regulate their mutual rights and obligations by a special
agreement made at least 30 days before the sale or licensing of the Project result to a
third party.
If one of the co-owners of the Project result assigns its co-ownership interest to a third
party, he will ensure by appropriate measures or contracts that his contractual
obligations under this Agreement are transferred to the new holder of the property
rights. The Party is obliged to inform the other Parties of this intention in writing at
least 30 days before the assignment of the obligations under this Agreement.
The Parties will provide each other with copies of the technical documentation
necessary for the exploitation of the results, in particular for the creation of copies of
the results.
V.
Confidentiality of information
The Project, the way of its solution and its results do not constitute classified
information within the meaning of Act No. 412/2005 Sb., on the protection of classified
information and security eligibility, as amended.
The Parties have agreed that the information, documentation and results of work
submitted and produced in connection with the Project implementation may be
considered confidential. Information on the Project results which is supplied
compulsorily to the Information System of Research, Development and Innovations, the
Register of Information on Results or other similar registers will be transmitted in a form
and level of detail which respects the protection of confidential information.
. The protection of confidential information does not apply to information already
published in the form of the Project publication results.
VI.
Sanctions
In the event of a breach of any of the obligations under this Agreement by either Party,
any of the remaining Parties will call the other Party to remedy the breach and will allow
areasonable time for doing so. At the same time, the remaining Parties must be
informed of this step in writing. After the lapse of time for remedy, either Party is
entitled to withdraw from the Agreement in writing. Notification of such withdrawal
must be delivered to all the remaining Parties. Withdrawal results in the cancellation of
the Agreement.
2. The Party in breach of this Agreement will indemnify the remaining Parties for the
damage caused.
3. The Parties have agreed on a contractual penalty of CZK 50,000 (fifty thousand Czech
crowns) in addition to the compensation for damages for the following situations:
- A Party commercialises the results of a project without having made an effective
compensation agreement;
- A Party blocks the Project results licensing to third parties without cause.
VII.
Final provisions
1. This Agreement enters into force and effect on the date of its publication in the Register
of Contracts pursuant to Act No.340/2015 Sb., on special conditions for the
effectiveness of certain contracts, publication of such contracts, and on the register of
contracts (the Act on the Register of Contracts) and is made for an indefinite period of
time. The publication of this Agreement in the Register of Contracts will be ensured by
FN HK.
2. This Agreement may be amended in writing only.
3. The Parties declare that they have read this Agreement before signing it, that it has been
made after due consideration, freely and seriously, definitely and comprehensibly, not
under duress under manifestly unfavourable conditions, that they agree unconditionally
with its contents and in proof thereof they affix the signatures of their authorised
representatives.
4. This Agreement is drawn up in four copies, one of which will be given to each Party.
This Agreement may also be signed by certified electronic signatures of authorised
representatives of the Parties; in such case, it will be executed in a single original.
University Hospital Hradec Kralové, Project Promoter
2 6, 05. 20215 Fakultm nemocnice Hradec kraiové
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r. Ales Herman, Ph.D.
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Director, FN HK 500 05 Hradec Kralové — Novy Hradec Krélové
University of Oslo, Project Partner 1 IC 00179906, tel. 4905833380
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University of Oslo
Institute of Experimental Medicine of the Czech Academy of Sciences, v.v.i., Project
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Bioinova, a.s., Project Partner 3
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Annex 1 fl doi: : Published |
Annex1- List of outputs - TARIMAD project
M j Interim report “.1.-
Output No 1' First auth * Author CZE 3 Author NC": Nézev Clanku
Structure—activity relationships of https://doi.or
dually-acting acetylcholinesterase g/10.1016/j.e
inhibitors derived from tacrine on N- jmech.2021.
_\ GOrecki L. Soukup 0., Hora’ None methyl-D—Aspartate receptors 113434 31.03.2021 1
Scaffold fragmentation and https://doi.or
substructure hopping reveal potential, g/10.1016/j.c
robustness, and limits of computer— sbj.2021.05.
N Namasivaya None Pahnke J. aided pattern analysis (C@PA) 018 10.05.2021 2
https://doi.or
Development of deep learning models g/10.1016/j.j
for microglia analyses in brain tissue neumeth.20
3 Mohle L. None Pahnke J. using DeePathologyTM STUDIO 21.109371 27.09.2021 3
Physicochemistry shapes bioactivity
landscape of pan-ABC transporter https://doi.or
modulators: Anchor point for g/10.1016/j.ij
innovative Alzheimer's disease biomac.2022
4 Namasivaya Soukup O. Pahnke J. therapeutics .07.062 13.07.2022 2
https://doi.or
A curated binary pattern multitarget g/10.1038/s4
dataset of focused AT P-binding 1597-022-
5 Stefan Sven None Pahnke J. cassette transporter inhibitors 01506-z 26.07.2022 3
A Novel Huntington’s Disease doi.org/10.33
Assessment Platform to Support ..
Future Drug Discovery and figg‘égsnza
6 Wu None Pahnke J. Development 25.11.2022 3
lndole Derivatives as New Structural https://doi.or
Class of Potent and Antiprol‘rferative g/10.1021/ac
Inhibitors of Monocarboxylate s.jmedchem.
7 Purl S. None Pahnke J. Transporter1 (MCT1; SLC16A1) 2c01612 30.12.2022 3
Physiological expression of mutated
TAU impaired astrocyte activity and doi.org/10.11
exacerbates B-amyloid pathology in 86/512974-
8 Farfara D. None Pahnke J. 5xFAD mice 023-02823—9 26.07.2023 3
Apolar Extracts of St. John’s Wort
Alleviate the Effects of doi.org/ 10.33
B-Amyloid Toxicity in Early Alzheimer's 90/ijm52502
9 Menuawy E. None Pahnke J. l'.“ 1301 21.01.2024 3
Phenoxytacrine derivatives: Lowtoxicity https://doi.or
neuroprotectants exerting affinity to g/10.1016/j.e
ifenprodil-binding site and jmech.2024.
10 Misiachna A Soukup O. Pahnke J. cholinesterase inhibition 116130 07.01.2024 3
Emerging Role of ABC Transporters in
Glia Cells in Health and doi.org/10.33
Diseases of the Central Nervous 90/cells1309
11 Villa M. None Pahnke J. System 0740 24.04.2024 4