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Agreement on the Conduct of a Clinical Study Pursuant to the

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Agreement on the Conduct of a Clinical Study Pursuant to the Powered By Docstoc
					 Agreement on the Conduct of a Clinical Study Pursuant to the Austrian
                        Pharmaceutical Act

                                      entered into by and between

                         1. [Sponsor's name and registered office/address]

                                 (hereinafter referred to as "Sponsor")

                                                     and

        2. Medizinische Universität Wien, [name of the relevant organisational unit],
                         Spitalgasse 23, A-1090 Vienna, Austria

                              hereinafter referred to as "MedUni Wien"

     represented by the head of the organisational unit [name of the head of the relevant
   organisational unit] pursuant to Section 27 (1) (3) of the Austrian University Act 2002,




                                                  as well as

    3. [Name of the Investigator], Medizinische Universität Wien, name of the relevant
                                     organisational unit,
                    Währinger Gürtel 18-20, A-1090 Vienna, Austria,

                               hereinafter referred to as "Investigator" -

                                           Project Number: [ ]




Please note that this draft agreement is a standard sample agreement. It is not advisable to use this sample
agreement without legal review, since the conclusion of any agreement may be based on case-by-case
particularities which, under certain circumstances, may require particular provisions taking into account these
particularities. Certain provisions of this sample agreement therefore may have to be modified according to the
specific circumstances of the particular case and/or the ideas of the parties and the individual requirements of
the specific research project.
PLEASE CONSULT WITH THE LEGAL DEPARTMENT OF MEDIZINISCHE UNIVERSITÄT WIEN
PRIOR TO CONCLUDING AN AGREEMENT.



                                                                        Draft Clinical Trial “AMG” / MedUni Wien V1
                                                               -2-



Contents

1.     Definitions.................................................................................................................. 3
2.     Subject-matter of the Agreement ............................................................................. 6
3.     Sponsor's special duties ............................................................................................ 7
4.     Duties of the MedUni Wien and the Investigator...................................................... 8
5.     Use of data ................................................................................................................. 9
6.     Compensation ............................................................................................................ 9
7.     Other expenses......................................................................................................... 10
8.     Payment ................................................................................................................... 10
9.     Study Results and Service Inventions ...................................................................... 11
10.    Publications ............................................................................................................. 14
11.    Non-disclosure of Confidential Information.......................................................... 16
12.    Liability.................................................................................................................... 17
13.    Acceptance of other research contracts ................................................................. 17
14.    Sub-contracts........................................................................................................... 17
15.    Advertising restrictions........................................................................................... 17
16.    Term......................................................................................................................... 17
17.    Termination ............................................................................................................. 18
18.    Governing law/place of jurisdiction ....................................................................... 18
19.    Final provisions ....................................................................................................... 19




Exhibits

Annex 1                  Protocol
Annex 2                  Payment Schedule




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                                               -3-



1.           Definitions

             In this Agreement, defined terms (including defined abbreviations) are indicated in
             italics.

             AMG                            "AMG" (“Arzneimittelgesetz”) means the Austrian
                                            Pharmaceutical Act, Federal Law Gazette I, no.
                                            185/1983, as amended from time to time

             Applicable Regulations         "Applicable      Regulations"     means:       the
                                            Pharmaceutical Act and all other (Austrian as well
                                            as Community) laws, regulations and directives
                                            that are applicable to the conduct of clinical
                                            studies as well as the ICH-GCP Guidelines, the
                                            Declaration of Helsinki and requirements, if any,
                                            adopted by the Ethics Committee

                                            The Parties declare to be aware of the Applicable
                                            Regulations

             Federal Office                 "Federal Office" means the Austrian Federal
                                            Office for Safety in Health Care (Bundesamt für
                                            Sicherheit im Gesundheitswesen)

             Service Inventor's             "Service Inventor's Compensation" means any
             Compensation                   compensation payable to the inventor under relevant
                                            laws based on and/or as a result of rights to Service
                                            Inventions being claimed, including but not limited
                                            to compensations pursuant to Sections 8 et seq of the
                                            Patent Act. For the avoidance of doubt, the Parties
                                            note that even compensations for any amendment of
                                            the invention payable pursuant to Section 10 of the
                                            Patent Act are Service Inventor's Compensations

             Service Invention              "Service Invention" means any invention made by
                                            the Principal Investigator or by members of the
                                            Investigation Team of the MedUni Wien in the
                                            course and on the subject of the Clinical Study
                                            (service invention pursuant to Section 106 (2) of the
                                            Austrian University Act 2002 in conjunction with
                                            Section 7 (3) of the Austrian Patent Act). This does
                                            not apply to free inventions

             DSG                            "DSG" (“Datenschutzgesetz”) means the Austrian
                                            Data Protection Act 2000, Federal Law Gazette I,
                                            no. 165/1999, as amended from time to time

             Ethics Committee               "Ethics Committee" means the relevant competent



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                                                    -4-



                                                Ethics Committee within the meaning of Section 2a
                                                (6) of the AMG (Section 41 of the AMG, Section 30
                                                of the University Act 2002, Section 8c of the
                                                Hospitals Act)

             Hospitals Act                      Austrian Federal Act on Hospitals and
                                                Convalescence Homes, Federal Law Gazette I no.
                                                1/1957, as amended from time to time

             Clinical Study                     "Clinical Study" means the research work
                                                contracted under this Agreement to be carried out
                                                by the MedUni Wien and the Investigator pursuant
                                                to this Agreement, including but not limited to the
                                                Protocol. This is a clinical study within the
                                                meaning of Section 2a (1) of the AMG

             Monitor                            "Monitor" means the person who is to be assigned
                                                by the Sponsor to monitor the Clinical Study and
                                                who is responsible for the report on the progress of
                                                the Clinical Study and for verifying the data
                                                (monitor within the meaning of Section 2a (8) of
                                                the AMG)

             Multicentre Clinical Study         Multicentre clinical study within the meaning of
                                                Section 2a (2) of the AMG

             Patent Act                         Austrian Patent Act, Federal Law Gazette I, no.
                                                259/1970, as amended from time to time

             Protocol                           "Protocol" means the study protocol pursuant to
                                                Section 2a (13) of the AMG, as set forth in Exhibit
                                                1

             Investigational Product            "Investigational Product" means the research
                                                product      [name     of      the   Investigational
                                                Pharmaceutical], which is the subject matter of the
                                                Clinical Study (investigational pharmaceutical in
                                                terms of Section 2a (14) of the AMG)

             Investigation Team                 "Investigation Team" means the individuals involved
                                                in the Clinical Study. 1



1
    Please note that the MedUni Wien generally has no right to claim inventions made by members of the
    University, who are not subject to an employment, service or training relationship in terms of Section 106
    of the University Act 2002 with the University or with the Federal Government. If such individuals should
    be among the members of the Investigational Team, this Agreement must be appropriately modified with




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             Study Results                     "Study Results" means all work results (including
                                               prepared reports, data and documentation) and
                                               other findings, excluding Service Inventions and
                                               free inventions, which are generated in the course
                                               of the Clinical Study during the performing of this
                                               Agreement and relate to the tasks of the Clinical
                                               Study, including but not limited to the Protocol

             Subjects                          "Subjects" means the individuals participating in
                                               the Clinical Study either as a Recipient of the
                                               Investigational Product or as a member of a
                                               control group

             Trial Centre                      "Trial Centre" means the location at which the
                                               MedUni Wien and/or the Investigator carry out the
                                               Clinical Study

             Publication(s)                    "Publication(s)" means publications (including the
                                               process of making available and/or publishing,
                                               including the forwarding to an editor and/or
                                               publishing company), which – in any manner
                                               whatsoever – may make available or include Study
                                               Results. This includes publications of any kind,
                                               including abstracts, posters, oral or written
                                               contributions at congresses or clinical seminars or
                                               any other oral or written material. For the
                                               avoidance of doubt, the Parties note that this list is
                                               not exhaustive

             Serious Adverse Event             Serious Adverse Event within the meaning of
                                               Section 2a (20) of the AMG

             Sponsor                           The "Sponsor" is [name of the Sponsor] who has
                                               contracted the Clinical Study to be carried out by
                                               the MedUni Wien, and assumes responsibility for
                                               the planning, initiation, support and financing of
                                               the Clinical Study (Sponsor within the meaning of
                                               Section 2a (16) of the AMG)

             University Act 2002               Austrian University Act 2002, Federal Law
                                               Gazette I, no. 120/2002, as amended from time to
                                               time



   regard to the assignment of rights to inventions or a separate assignment agreement with those individuals
   would be required.




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             Adverse Event                  Adverse Event within the meaning of Section 2a
                                            (18) of the AMG

             Parties                        "Parties" collectively means the parties to this
                                            Agreement; i.e. the Sponsor, the MedUni Wien and
                                            the Investigator

             Confidential Information       "Confidential Information" means any knowledge
                                            and know-how contributed to this Clinical Study as
                                            well as other confidential information, including
                                            but not limited to trade and business secrets, which
                                            one Party obtained from the respective other
                                            Party(ies)

2.           Subject matter of the Agreement

2.1          Objective of the Agreement

             The Sponsor instructs the MedUni Wien to carry out the Clinical Study according
             to the Protocol included in Exhibit 1. The objective of the Clinical Study is to
             investigate [description of the subject of investigation in compliance with Section
             2a (1) (1) through (3) of the AMG].

             The MedUni Wien will endeavor to its best knowledge and belief to recruit the
             number of Subjects required under the Protocol. However, the actual number of
             recruited Subjects depends on the patient admission rate at the Vienna General
             Hospital (“AKH”) of the Vienna Hospital Association.

2.2          Framework conditions

2.2.1        The MedUni Wien will diligently and dutifully organize and properly carry out this
             Clinical Study by the Investigator in accordance with this Agreement, including
             but not limited to the Protocol, and in compliance with relevant Applicable
             Regulations from [Commencement Date] through [End Date]. The MedUni Wien
             and the Investigator are not authorized to represent the Sponsor in any legal
             transaction.

2.2.2        The MedUni Wien shall carry out the Clinical Study according to the technical and
             scientific state of the art. Within the scope of performing this Agreement and/or
             carrying out the Clinical Study, rather than owing any success, the MedUni Wien is
             merely required to carry out the Clinical Study pursuant to this Section 2.2.1.

2.2.3        The Investigator confirms that he is appropriately qualified to carry out the
             Clinical Study and, in particular, meets the requirements set forth in Section 35 of
             the AMG.




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                                                 -7-



3.           Sponsor's special duties

3.1          The Sponsor is required to observe all requirements imposed upon it pursuant to
             the Applicable Regulations and shall fulfill all obligations, including but not
             limited to those set forth in the following provisions of this Section 3., which it is
             required to observe pursuant to the Applicable Regulations.

3.2          The Sponsor shall prepare detailed procedural regulations within the meaning of
             Section 2a (17) of the AMG (Section 31 of the AMG).

3.3          The Sponsor shall notify the Investigator in writing of all present non-clinical and
             clinical data and results. This notification duty shall also apply to any relevant
             information that becomes available in the course of the Clinical Study (Section 32
             (1) (4) of the AMG).

3.4          The Sponsor shall obtain the Federal Agency's approval prior to the
             commencement of the Clinical Study (Section 32 (1) (5) in conjunction with
             Section 40 (1) of the AMG).

3.5          Upon the filing of the application with the Federal Agency at the latest, the
             Sponsor shall involve the Ethics Committee (Section 32 (1) (5) in conjunction with
             Section 40 (1) of the AMG). If the Clinical Study is a Multi-centre Clinical Study,
             the Sponsor shall also observe Section 41b of the AMG.

3.6          The Sponsor shall notify the Federal Agency and the Ethics Committee of the end
             of this Clinical Study within 90 (ninety) days. If the Clinical Study is prematurely
             terminated, the Federal Agency and the Ethics Committee shall be notified within
             15 (fifteen) days pursuant to Section 32 (1) (5) of the AMG, (Section 32 (1) (5) of
             the AMG).

3.7          The Sponsor shall provide the Investigational Product as well as the control
             product used during the Clinical Study free of charge. The Investigational Product
             as well as the control product shall be sufficiently characterized and labeled and
             shall meet the requirements of Section 32 (1) (7) of the AMG.

3.8          The Sponsor shall procure that neither the Subjects nor the Austrian social
             insurance institutions incur any costs from the provision of the Investigational
             Product under Section 3.7 hereof. However, if the conditions set forth in Section
             32 (3) (1) through (4) of the AMG are met, the Sponsor shall be exempt from this
             obligation.

3.9          The Sponsor shall provide a Monitor qualified in terms of Section 33 of the AMG.
             The Sponsor shall procure that the Monitor fulfils his obligations pursuant to
             Section 34 of the AMG and shall hold harmless and indemnify the MedUni Wien
             and/or the Investigator in this respect.

3.10         The Sponsor shall document in detail any Adverse Events and Serious Adverse
             Events notified to the Monitor by the Investigator pursuant to Section 4.5 hereof



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             and, if necessary, to submit these records to the authorities set forth in Section
             § 41d (4) of the AMG. The Adverse Events or Serious Adverse Events shall be
             immediately evaluated in cooperation with the Investigator, and appropriate
             measures pursuant to Section 37a (4) of the AMG shall be taken subsequently.

3.11         The Sponsor shall in due time fulfill all obligations pursuant to Section 41e of the
             AMG to record and report any presumable unexpected material side effects in
             terms of Section 2a (19) through (21) of the AMG.

3.12         The Sponsor shall ensure that a summary final report in terms of Section 2a (4) of
             the AMG is completed (Section 32 (10) of the AMG).

3.13         The Sponsor shall effect a personal injury insurance policy, meeting all
             requirements under Section 32 (1) (11) and Section 32 (2) of the AMG, and shall
             provide documentary evidence thereof to the MedUni Wien and the Investigator
             prior to the commencement of the Clinical Study.

3.14         The Sponsor shall further effect sufficient liability and legal expenses insurance
             policies for the Investigator (Section 32 (1) (12) of the AMG) and shall provide
             documentary evidence thereof to the MedUni Wien and the Investigator prior to
             the commencement of the Clinical Study as well.

3.15         Pursuant to Section 32 (1) (14) of the AMG, the Sponsor shall establish a contact
             point for the Subjects.

3.16         If the Sponsor intends to have the Trial Centre inspected by the Monitor, it shall
             notify the MedUni Wien of the intended inspection 5 (five) working days in
             advance.

4.           Duties of the MedUni Wien and the Investigator

4.1          The Investigator is required to observe all requirements ensuing from the
             Applicable Regulations and shall meet all obligations resting upon him under the
             Applicable Regulations, in particular those set forth in the following provisions of
             this Section 4.

4.2          The Investigator shall comprehensively instruct and inform the Subjects orally as
             well as in writing on the nature, significance, scope and risks of the Clinical Study
             (Section 38 (1) of the AMG). In any case, the contents of these instructions shall
             meet the requirements under Section 39 (1), (3) and (4) of the AMG.

4.3          After instructing and informing the Subjects pursuant to Section 4.2 hereof, the
             Investigator shall obtain the Subjects' written consent required for carrying out the
             Clinical Study. The Investigator shall procure that the consent to be obtained by
             him meets the requirements of Section 39 (2) of the AMG.

4.4          If a Subject is an individual belonging to one of the groups of persons particularly
             protected under Sections 42, 43 or 43a of the AMG, the Investigator shall obtain



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             the consent for carrying out the Clinical Study from the individuals stated in these
             regulations, and shall procure that the provisions set forth in these regulations are
             complied with in general.

4.5          Pursuant to Section 41d (1) and (2) of the AMG, the Investigator shall report to the
             Sponsor any Serious Adverse Events and Adverse Events and, in the event of
             Section 41d (3) of the AMG, shall transmit to the Sponsor any additional
             information required by the Sponsor.

4.6          The Investigator shall carry out the Clinical Study in compliance with the
             Protocol.

5.           Use of data

5.1          In using data in the course of the Clinical Study, the Parties shall observe the Data
             Protection Act 2 and/or the Privacy Directive 95/46/EC of the European Council
             dated 24 October 1995 as well as the supplementary regulations of the AMG.

5.2          In particular, pursuant to Section 46 (1) of the AMG, the Parties shall also take
             suitable measures for the diligent and confidential handling of all data generated in
             the context of this Clinical Study. Moreover, the Sponsor shall be responsible for
             the Monitor assigned by the Sponsor handling such data correctly in terms of data
             protection laws.

5.3          The Sponsor shall retain the Protocol, the records, the agreements made by and
             between the MedUni Wien, the Investigator and the Sponsor as well as all other
             documents generated in the context of the Clinical Study for a period of 15
             (fifteen) years after the Clinical Study has been completed or prematurely
             discontinued (Section 46 (2) of the AMG).

5.4          Pursuant to Section 46 (3) of the AMG, the Investigator shall preserve the records
             relating to the encrypted allocation to the specific treatment groups for a period of
             15 (fifteen) years after the Clinical Study has been completed or prematurely
             discontinued.

6.           Compensation

6.1          The MedUni Wien shall receive from the Sponsor a compensation payment
             pursuant to the payment schedule set forth in Exhibit 2 for the carrying out of the
             Clinical Study.




2
      See http://www.dsk.gv.at.




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                                                      - 10 -



6.2          The Parties agree on a compensation payment in accordance with the payment
             schedule 3 set forth in Exhibit 2 for the assignment of rights pursuant to Section 9
             hereof.

7.           Other expenses

7.1          Should the Subjects experience an Adverse Event or a Serious Adverse Event due
             to the administration of the Investigational Product or the Control Product, the
             Sponsor shall bear all costs necessary or expedient from a medical point of view
             for the treatment of the affected Subjects.

7.2          The Sponsor shall pay a contribution to the costs pursuant to Section 32 (1) (15) of
             the AMG.

7.3          The Sponsor shall further pay the fees and/or cost reimbursements prescribed by
             the owner of the Vienna General Hospital (“AKH”) with reference to the Clinical
             Study (“AKH-fee”).

7.4          This shall not affect the provisions of Sections 9.4 and 9.5 4 hereof.

8.           Payment

             All payments to be made by the Sponsor to the MedUni Wien under this
             Agreement shall be made by bank transfer to the following account within 30 days
             following invoicing by MedUni Wien, stating the project number:

                                      Account number: 40410070700
                                      Sort code: 20111 (Erste Bank)
                                     IBAN: AT3620111404100707/00,
                                            BIC: GIBAATWW




3
      Please note that an appropriate compensation should be agreed for the assignment of rights. If rights are
      assigned free of charge and/or without an appropriate (customary) compensation, this may, in the worst
      case, constitute state aid that was inadmissibly provided to the Sponsor by the MedUni Wien. The European
      Commission assumes that a customary compensation shall be paid for intellectual property rights. More
      details on this issue are available in the Community Framework for State Aid for Research, Development
      and Innovation.
      PLEASE CONSULT THE LEGAL DEPARTMENT OF THE MEDUNI WIEN IN THIS CONTEXT.
4
      Please note that this reference must be appropriately modified if alternative 2 of Section 9. hereof is used
      (Section 9.6.49.6); if Alternatives 3 or 4 are used, this reference shall be deleted.




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9.           Study Results and Service Inventions

9.1          Previously existing property rights

             Any know-how, copyrights, inventions and other registered or granted property
             rights of the Parties existing prior to the signing of this Agreement shall not be
             affected in their legal existence by this Agreement, without prejudice to the use of
             such rights for the carrying out of the Clinical Study. In particular, the relevant
             Party shall remain the sole proprietor of such previously existing property rights.
             As far as the Investigator and/or the MedUni Wien are dependent on the use of the
             Sponsor's previously existing property rights for carrying out this Clinical Study,
             the Sponsor hereby expressly grants the Investigator and the MedUni Wien a non-
             exclusive, non-transferable right to use these previously existing property rights
             for the term of this Clinical Study. 5

             [Alternative 1] 6,7

9.2          Rights to Study Results

9.2.1        The Study Results shall be the sole property of the Sponsor, and shall be
             immediately reported to the Sponsor in writing by the Investigator and/or the
             MedUni Wien.

9.2.2        Upon conclusion of this Agreement, the MedUni Wien and/or the Investigator shall
             assign to the Sponsor any existing rights to the Study Results in advance.
             Notwithstanding Section 10. hereof, these rights shall include any exclusive,
             transferable rights that are unlimited as to time, territory and content, for all types
             of use, to use copyrighted works, as well as the right to file utility models in [the
             Sponsor's] own name. Upon the Sponsor's request, the MedUni Wien and the
             Investigator shall support the Sponsor as far as possible in the carrying out of any
             filings; the Sponsor shall bear any cost incurred in this context by the MedUni
             Wien.

9.2.3        The MedUni Wien shall be entitled to the rights to any results generated in the
             course of this Clinical Study that do not concern the tasks of this Clinical Study.

9.2.4        The transfer of rights pursuant to Section 9.2.2. hereof is subject to the condition
             subsequent of the Sponsor fulfilling its payment obligations pursuant to Sections
             6. and 7. hereof.




5
      Please note: It is recommended to specify these rights in more detail in a particular case.
6
      Please note: Either Alternative 1 or Alternative 2 should be used only if the principal fully pays for the
      project and assumes the sponsorship.
7
      Please note: Please select one of the Alternatives 1 through 4 and delete the others.




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                                                      - 12 -



9.2.5        The MedUni Wien shall have the non-exclusive, non-transferable right to use the
             Trial Results for its research and teaching activities as well as for the care for and
             treatment of patients. This shall not affect Section 10. hereof.

9.3          Rights to Service Inventions

9.3.1        Subject to Section 9.3.5 hereof, the Sponsor shall have a right to the assignment of
             the rights to Service Inventions made in the course of carrying out this Clinical
             Study under this Agreement and that relate to the task of the Clinical Study. The
             rights to the Service Invention to be assigned include, but are not limited to, the
             right to file the corresponding patents in [the Sponsor's] own name worldwide.

9.3.2        The MedUni Wien shall immediately notify the Sponsor in writing of receipt of a
             report concerning an invention pursuant to Section 106 (3) of the University Act
             2002 and shall attach to such notification all documents and other information
             provided to the rector's office along with the report on the Service Invention
             pursuant to Section 106 (3) of the University Act 2002 necessary for the
             understanding of the Service Invention. The Sponsor shall confirm to the MedUni
             Wien in writing the date of receipt of such information.

9.3.3        The Sponsor shall notify the MedUni Wien in writing no later that within 6 (six)
             weeks 8 of receipt of the information under Section 9.3.2 hereof whether it requests
             the assignment of the rights to such Service Invention. In this case, the MedUni
             Wien shall immediately claim by written notice such Service Invention in full from
             the inventor, but in any case within the time limit prescribed by law. The MedUni
             Wien shall then immediately transfer to the Sponsor the rights to the respective
             Service Invention.

9.3.4        Upon the Sponsor's request, the MedUni Wien and the Investigator shall support
             the Sponsor as far as possible in filing patents. Any cost incurred in this context by
             the MedUni Wien and/or the Investigator shall be borne by the Sponsor.

9.3.5        If the Sponsor fails to issue a statement within the time limit set forth in
             Section 9.3.3 hereof, or if the Sponsor states that it does not desire a transfer of the
             rights to the Service Invention, the Sponsor's claim to the transfer of such rights
             shall expire. The MedUni Wien may then claim these rights at its discretion.

9.3.6        A transfer of rights under Section 9.3.3 shall be subject to the condition
             subsequent of the Sponsor fulfilling its payment obligations pursuant to Sections
             6. and 7. hereof.

9.3.7        Sections 9.2.4 and 9.2.5 shall apply by analogy.




8
      Please note that this time limit may not exceed two months (in light of the MedUni Wien's right to claim the
      service invention, which shall be exercised within three months).




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9.4          Service Inventor's Compensation

9.4.1        In case of Service Inventions subject to the provisions of Section 9.3 hereof, the
             Service Inventor's Compensations shall be fully borne by the Sponsor. The
             Sponsor shall hold harmless and indemnify the MedUni Wien in this respect.

9.4.2        Section 8. hereof shall apply by analogy.

9.5          Other costs

9.5.1        The Sponsor shall bear all costs incurred in connection with the filing,
             maintenance, defense and enforcement of rights the Sponsor is entitled to pursuant
             to this Section 9.

             [Alternative 2] 9,

9.6          Rights to Trial Results and Service Inventions

9.6.1        The Sponsor shall be the sole proprietor of all Trial Results and Service
             Inventions. The Sponsor shall be entitled to all material rights to the Trial Results
             and Service Inventions. These rights include, but are not limited to the right to file
             relevant patents and/or utility models in [the Sponsor's] own name worldwide.

9.6.2        The MedUni Wien has a right to the assignment of a non-exclusive, transferable
             right that is unlimited as to time and territory to use the Trial Results and Service
             Inventions.

9.6.3        MedUni Wien's rights pursuant to Section 10. hereof shall remain unaffected.

9.6.4        The provisions of Sections 9.6.1 through 9.6.3 hereof shall apply subject to the
             condition that Service Inventor's Compensations shall be borne in full by the
             Sponsor and that the Sponsor fulfils its payment obligations pursuant to Sections
             6. and 7. hereof. The Sponsor shall hold harmless and indemnify the MedUni Wien
             in this respect.

             [Alternative 3] 10,

9.7          Rights to Trial Results and Service Inventions

9.7.1        The MedUni Wien shall be the sole proprietor of all Trial Results and Service
             Inventions. The MedUni Wien shall be entitled to all substantive rights to the Trial
             Results and Service Inventions. These rights shall in particular include the right to


9
      Note: Please select one of the Alternatives 1 through 4 and delete the others. Alternatives 1 or 2 should be
      selected only if the principal pays for the study in full and assumes the sponsorship.
10
      Note: Please select only one of the Alternatives 1 through 4 and delete the others. Alternatives 3 or 4 should
      be selected only if the principal does not pay for the study in full and/or does not assume the sponsorship.




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                                                        - 14 -



             file relevant patents and/or utility models in [the MedUni Wien's] own name
             worldwide.

9.7.2        The Sponsor has a right to the assignment of a non-exclusive, non-transferable
             right that is unlimited as to time and territory to use the Trial Results and Service
             Inventions.

9.7.3        This shall not affect the MedUni Wien's rights pursuant to Section 10. hereof.

             [Alternative 4] 11,

9.8          Rights to Trial Results and Service Inventions

9.8.1        The MedUni Wien shall be the sole proprietor of all Trial Results and Service
             Inventions. The MedUni Wien shall be entitled to all substantive rights to the Trial
             Results and Service Inventions. These rights shall in particular include the right to
             file relevant patents and/or utility models in [the MedUni Wien's] own name
             worldwide.

9.8.2        This shall not affect the MedUni Wien's rights pursuant to Section 10. hereof.

10.          Publications

10.1         The Sponsor undertakes to publicly register the Clinical Study in an internationally
             established data base. Pursuant to the Declaration of Helsinki and the Uniform
             Requirements for Manuscripts Submitted to Biomedical Journals – which are also
             agreed to apply, as amended from time to time, to the conduct of this study – the
             Parties agree to publish the results of the study in any case.

             [Alternative for mono-centre trial] 12

10.2         Subject to the following provisions of this Section 10., the MedUni Wien and the
             Investigator are unrestrictedly entitled to publish the results of the Study.

10.3         The MedUni Wien and the Investigator acknowledge the Sponsor's interest in the
             protection of its rights pursuant to Section 9. and non-disclosure of any
             Confidential Information pursuant to Section 11. hereof. The MedUni Wien and/or
             the Investigator thus shall transmit to the Sponsor for review any intended
             Publications no later than 60 (sixty) days in advance. The Sponsor shall confirm to



11
      Note: One of the Alternatives 1 through 4 must be selected and the others deleted. Alternatives 3 or 4
      should be selected only if the principal does not pay in full and/or does not assume the sponsorship. If
      Alternative 3 or 4 is selected, the reference in Section 7.2. hereof to the principal's claim for protection of
      its rights pursuant to Section 6 hereof shall be deleted since, in this case, the MEDUNI WIEN is entitled to
      all rights anyway.
12
      Note: Please delete the non-applicable alternatives as appropriate




10761401V3                                                                    Draft Clinical Trial / MEDUNI WIEN dated
                                                      - 15 -



             the MedUni Wien and the Investigator in writing the date of receipt of the intended
             Publication.

10.4         If the Sponsor fails to issue a statement pursuant to Section 10.5 hereof within 60
             (sixty) days of receipt of the intended Publication, the MedUni Wien and/or the
             Investigator shall be entitled to publish.

10.5         If the Sponsor notifies the MedUni Wien and/or the Investigator within 60 (sixty)
             days of receipt of the draft of the Manuscript that it will take the necessary
             measures to protect its rights pursuant to Section 9. hereof (e.g. filing patents), the
             MedUni Wien and/or the Investigator shall postpone the intended Publication
             until the Sponsor has taken the necessary measures to protect its rights. After the
             expiry of 120 (one hundred and twenty) days after receipt of the draft of the
             Manuscript by the Sponsor, however, the MedUni Wien and/or the Investigator
             shall in any case be entitled to publish.

10.6         The MedUni Wien and the Investigator shall take the necessary steps in order to
             warrant that all members of the Investigation Team comply with the provisions of
             this Section 10.

10.7         The Parties agree that the provisions of this Section 10. shall survive the end of
             this Clinical Study or its termination pursuant to Section 16. and/or Section 17.
             hereof.

             [For Multi-centre Trial] 13

10.8         On principle, the Sponsor supports Publications and the MedUni Wien and/or the
             Investigator may publish Study Results observing academic standards and subject
             to the following provisions of this Section 10.

10.9         The MedUni Wien and the Investigator acknowledge that the Clinical Study is part
             of a Multi-centre Clinical Study and that a joint Publication by all participating
             Investigators is envisaged ("Joint Publication"). The MedUni Wien and the
             Investigator thus will not publish the Study Results prior to such Joint Publication.

10.10        Notwithstanding Section 10.9 hereof, the MedUni Wien and the Investigator may
             publish the Study Results under the following conditions:

             (a)    the Multi-centre Clinical Study was prematurely discontinued and no Joint
                    Publication is planned; or

             (b)    no Joint Manuscript was submitted for publication within a period of 12
                    (twelve) months after the study database lock and no negotiations or




13
     Note: Please delete the non-applicable alternatives as appropriate.




10761401V3                                                                 Draft Clinical Trial / MEDUNI WIEN dated
                                                - 16 -



                   discussions regarding a proposed Joint Publication are being held at this
                   time by the publication committee; or

             (c)   a sub-study is being carried out by the MedUni Wien.

             If one of the above conditions is given, the MedUni Wien and/or the Investigator
             will transmit the intended Publication to the Sponsor 60 (sixty) days in advance
             for review and comment. The Sponsor shall confirm to the MedUni Wien and the
             Investigator in writing the date of receipt of the intended Publication. The Sponsor
             may request within this 60 (sixty) day time limit that the intended Publication be
             postponed for another 60 (sixty) days in order to protect its rights under Section 9.
             hereof.

10.11        However, when a period of 120 (one hundred and twenty) days after receipt of the
             intended Publication by the Sponsor has expired, the MedUni Wien and/or the
             Investigator shall be entitled to publish.

10.12        The MedUni Wien and the Investigator shall take the necessary steps in order to
             warrant that all members of the Investigation Team comply with the provisions of
             this Section 10.

11.          Non-disclosure of Confidential Information

11.1         Subject to the provisions of Section 10. hereof, the Parties are required not to
             disclose any Confidential Information.

11.2         The following information shall not constitute Confidential Information:

             (a)   information that was public domain when this Agreement was signed; or

             (b)   information that became public domain at a later point in time, but not due
                   to any violation of this non-disclosure obligation; or

             (c)   information that was demonstrably known to the recipient before this
                   Agreement was signed; or

             (d)   information that the recipient received from a third party that is or was
                   authorized to disclose such information at the time such information was
                   disclosed; or

             (e)   information the Parties agreed in writing not to treat as confidential.

11.3         This non-disclosure obligation with regard to Confidential Information shall not
             apply where the Parties or their group companies are subject to legally
             acknowledged disclosure obligations.

11.4         This non-disclosure obligation pursuant to this Section 11. shall survive the
             termination of this Agreement, provided the Confidential Information does not



10761401V3                                                        Draft Clinical Trial / MEDUNI WIEN dated
                                                - 17 -



             become evident and/or public domain, but for a maximum of than 5 (five) years
             after termination of this Agreement.

11.5         The MedUni Wien and the Investigator shall take the necessary steps in order to
             warrant that all members of the Investigation Team comply with the provisions of
             this Section 11.

12.          Liability

12.1         The MedUni Wien's liability and warranty obligations apply exclusively to the
             manner of carrying out this Clinical Study set forth in Sections 2.2.1 and 2.2.2
             hereof; however, these obligations do not include actual achievement of the
             desired Study Result.

12.2         The MedUni Wien shall only be liable in case of intent and gross negligence, and
             exclusively for losses suffered in connection with this Clinical Study as a result of
             non-compliance with the manner of carrying out this Clinical Study as set forth in
             Sections 2.2.1 and 2.2.2 hereof. The Sponsor shall be fully liable for any other
             losses suffered. The Sponsor shall hold harmless and indemnify the MedUni Wien
             and the Investigator for any claims of third parties and for any losses suffered as a
             result of carrying out the clinical study subject-matter of this Agreement.

12.3         The MedUni Wien does not warrant that the Study Results and Service Inventions
             will be capable of being exploited / commercialized.

13.          Acceptance of other research contracts

             It is at the MedUni Wien's complete and unlimited discretion to accept other
             research contracts from third parties at any time.

14.          Sub-contracts

             The MedUni Wien may rely in full or in part on sub-contractors to perform this
             Agreement without requiring the Sponsor's consent.

15.          Advertising restrictions

             The Sponsor may not state the MedUni Wien's or the Investigator's name in
             Publications or in advertising material of any kind (ads, advertisement spots, other
             oral or written presentations etc.) without the MedUni Wien's or the Investigator's
             consent. The same shall apply to using other signs (including the logo) of the
             MedUni Wien or the Investigator.

16.          Term

16.1         This Agreement enters into force upon signing by the Parties and ends upon
             complete delivery of the mutual services by the Parties.



10761401V3                                                        Draft Clinical Trial / MEDUNI WIEN dated
                                                     - 18 -



16.2         However, this shall not affect Sections 5.3, 5.4, 10.7, 11.4 and 15. hereof.
             Moreover, the Parties' rights and obligations as set forth herein shall survive the
             termination of this Agreement, provided that the validity of such rights and/or
             obligations, according to their spirit and purpose, is not limited to the term of this
             Agreement.

17.          Termination

17.1         Premature termination

             The MedUni Wien and the Sponsor may terminate this Agreement by giving 2
             (two) months' notice.

17.2         Termination for good cause

17.2.1       The MedUni Wien and the Sponsor may terminate this Agreement at any time for
             good cause without giving notice.

17.2.2       Good cause shall include, but not be limited to

             (a) the violation of the provisions of this Agreement by a Party and the failure
             of such Party to discontinue and/or revoke such violation within 10 (ten) days
             after a written request has been issued by the MedUni Wien or the Sponsor;

             (b) the continuation of this Clinical Study not being justifiable from a medical
             point of view.

17.2.3       Notice of termination for good cause shall be given in writing within 3 (three)
             weeks after the existence of the cause has become known.

17.3         In case of termination pursuant to Section 17.1 or 17.2 hereof, the compensation
             payable to MedUni Wien pursuant to Section 6. hereof shall be paid in
             correspondence with the services provided, until such termination becomes
             effective. 14 Should the continuation of the treatment of the Subjects be necessary
             from a medical point of view and therefore the MedUni Wien and/or the
             Investigator provide further services after such termination has become effective,
             the Sponsor shall also pay an appropriate compensation for such services,.

18.          Governing law/place of jurisdiction

18.1         This Agreement shall be governed by and construed in accordance with Austrian
             law, without giving effect to its conflict of law rules.



14
      Please note: It is recommendable here to specify in the payment schedule the compensation for the specific
      services to be provided and/or the specific steps of procedure and, as the case may be, include in this
      section a reference to the payment schedule.




10761401V3                                                                 Draft Clinical Trial / MEDUNI WIEN dated
                                                - 19 -



18.2         The Parties agree that any dispute arising from this Agreement shall be referred to
             the court having local jurisdiction for the first district of Vienna and subject-matter
             jurisdiction hereunder.

19.          Final provisions

19.1.1       If any term hereof is or becomes invalid, this shall not affect the validity of the
             remaining terms hereof. The invalid term shall be retroactively replaced by a valid
             and enforceable term that closest reflects the Parties' legal and economic intent or
             their intent had they considered that aspect when concluding this Agreement.

19.1.2       No side agreements have been reached. Any amendment of or modification to this
             Agreement requires the written form. The same shall apply to any waiver of the
             written form requirement.




             Date, signature MedUni Wien:




             Date, signature Investigator:




             Date, signature Sponsor:




10761401V3                                                         Draft Clinical Trial / MEDUNI WIEN dated
                 - 20 -



               Annex 1

             Trial Schedule




10761401V3                    Draft Clinical Trial / MEDUNI WIEN dated
                  - 21 -



                Annex 2

             Payment Schedule




10761401V3                      Draft Clinical Trial / MEDUNI WIEN dated

				
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