Protocol <Number/Name>                                                                 CONFIDENTIAL


THIS AGREEMENT dated on <Day Month Year>, is made By and Between

<Company’s Name>, incorporated under the laws of <Country>, represented by <Name>,
<Designation>, <Address> (The “<Company or Supplier or Company’s Name>”)


<Principal Investigator’s Name>, Department of <Dept Name>, National University Hospital,
Singapore 119074 (The “Principal Investigator”),


National University Hospital, 5 Lower Kent Ridge Road, Singapore 119074 (The "Institution")


    <Company’s Name>, has decided to support the following clinical trial in Singapore: <“Title of
     Trial’>. Protocol <Number>. (the ‘Trial’). The nature of the Trial is further elaborated upon in this

    The Institution has the expertise and a necessary resource relating to clinical trial design, conduct,
     evaluation and analysis and has agreed to conduct the Trial at the Institution under the supervision
     of its employee the Principal Investigator, under the terms and conditions of this Agreement.

<Company’s Name>                                           Clinical Trial Agreement (Investigator-Initiated Trial)   1
Protocol <Number/Name>                                                                  CONFIDENTIAL



1.1    Definitions

       The following definitions apply in this Agreement.

       "Budget Sheet" means the abbreviated budget sheet set out as Annexure B.

       "Business Day" means a day that is not a Sunday or public holiday, but can be a Saturday, in

       "Commencement Date" means <Date>.

       "Confidential Information" means information provided by either party to the other party in
       connection with this Agreement or the Trial Protocol and includes, without limitation:

       (a)     Information relating to the conduct of the Trial;

       (b)     Information and personal data relating to the persons who apply to be Subjects of the

       (c)     The information relating to the know-how, methodology, trade secrets, processes,
               sequences, structure and organisation of the Trial;

       (d)     Information relating to the Trial Protocol and Trial Materials; and

       (e)     The results of Institution’s performance of the Trial, except as permitted to be disclosed
               under clause 14 of this Agreement.

       "Consent Form" means the consent form to be completed by each Subject or the Subject’s
       legal guardian and any other person or authority as required by law and that has been
       approved by the Ethics Committee.

       "CRA" means a clinical research associate who is a representative nominated by the Company
       to monitor the conduct of the Trial.

       "Eligible Subject" means a person who meets all the eligibility criteria for enrolment into the
       Trial as indicated in the Trial Protocol.

       "Ethics Committee" means the properly constituted Ethics Committee for the Institution that is
       responsible for approving the Trial Protocol. In this case, it is the Institutional Review Board
       (IRB) / National Healthcare Group Domain Specific Review Boards (NHG DSRB).

       "Force Majeure Event" means any occurrence or omission as a direct result of which the party
       relying on it is prevented from or delayed in performing any of its obligations (other than a
       payment obligation) under this Agreement and that is beyond the reasonable control of the
       party, including without limitation forces of nature, industrial action and action or inaction by a
       government agency.

       "Indemnity” means the indemnity for clinical trials set out in Article 6.

       "Intellectual Property Rights" means all intellectual property rights throughout the world
       including, without limitation, copyright (both present and future), trade mark, design, patent,
       semi-conductor or circuit layout rights.

<Company’s Name>                                            Clinical Trial Agreement (Investigator-Initiated Trial)   2
Protocol <Number/Name>                                                               CONFIDENTIAL

       "Obvious Corrections Document" means the Company’s internal document which identifies
       corrections allowable by the CRA or data entry staff to case report forms and data classification
       forms on behalf of the Company.

       "Plain Language Statement" means the document that has been approved by the Company
       and the Ethics Committee and that explains the procedures and risks of the Trial.

       "Serious Adverse Drug Experience" includes a serious adverse event as defined under the
       Medicines (Clinical Trials) Regulations.

       "SGGCP" means Singapore Guideline for Good Clinical Practice adapted from the ICH
       Harmonised Tripartite Guideline E6: Note for Guidance on Good Clinical Practice

       "Subject" means a person who is enrolled in the Trial as either an Eligible Subject or an
       Ineligible Subject. "Ineligible Subject" means a person who does not meet the inclusion
       criteria, in accordance with the Trial Protocol, at the time of screening.

       "Termination Date" means <Date> or if terminated earlier in accordance with the terms and
       conditions of this Agreement, then that earlier date.

       "Trial Materials" means medication, the Trial Protocol, case report forms, study aids, and any
       other material that is used in, or arises out of, the conduct of the Trial.

       "Trial Protocol" means the protocol for the Trial written up by the Principal Investigator,
       attached as Annexure A, [as may be amended by the Principal Investigator from time to time].

1.2    Rules for interpreting this Agreement

       Headings are for convenience only, and do not affect interpretation. The following rules also
       apply in interpreting this Agreement, except where the context makes it clear that a rule is not
       intended to apply.

       (a)     a reference to the law includes all applicable statutes, regulations, proclamations,
               ordinances, by-laws and guidelines, a reference to any statute, regulation,
               proclamation, ordinance, by-law or guideline includes all statutes, regulations,
               proclamations, ordinances, by-laws or guidelines varying, consolidating or replacing
               them and a reference to a statute includes all regulations, proclamations, ordinances,
               by-laws or guidelines issued under that statute;
       (b)     words importing the singular include the plural and vice versa and reference to one
               gender includes all genders;
       (c)     a reference to a document, Agreement or agreement including this Agreement includes
               a reference to that document or agreement as amended, supplemented, varied or
               replaced from time to time;
       (d)     where a word or phrase is given particular meaning, other parts of the speech or
               grammatical forms of that word or phrase have corresponding meanings;
       (e)     a recital or annexure forms part of this Agreement; and
       (f)     a reference to an individual or person includes a corporation, partnership, joint venture,
               association, authority, state or government and vice versa.

1.3    Business Days

       If the day on or by which a person must do something under this Agreement is not a Business

<Company’s Name>                                         Clinical Trial Agreement (Investigator-Initiated Trial)   3
Protocol <Number/Name>                                                                CONFIDENTIAL

       (a)     if the act involves a payment that is due on demand, the person must do it on or by the
               next Business Day; and
       (b)     in any other case, the person must do it on or by the previous Business Day.


       The Institution and the Principal Investigator agree to participate in the Trial in accordance with
       the Trial Protocol. The Institution agrees that the Trial can be undertaken on its premises,
       utilising such facilities, personnel and equipment as may reasonably be required for the Trial.

       The Trial will commence on the Commencement Date and continue until the Termination Date
       subject to the terms and conditions of this Agreement.


3.1    Pre-Trial Obligations

       The Principal Investigator must:
       (a)     Obtain all necessary approvals from the Ethics Committee / Institutional Review Board
               (IRB) / National Healthcare Group Domain Specific Review Boards (NHG DSRB) and
               the relevant departmental head of the Institution and any other authority that is
               responsible for the administration of the Institution;
       (b)     Ensure the Institution has laboratory facilities that will be maintained for the duration of
               the Trial and suitably qualified staff who are available for the conduct of the Trial;

       (c)     Ensure all the Institution's employees, contractors and agents who are involved in the
               Trial fully understand and give full effect to the Trial Protocol and the obligations of both
               the Institution and the Principal Investigator;

       (d)     Obtain prior written approval from the Ethics Committee/ IRB / NHG DSRB for any
               proposed advertisements to be used for the purpose of Subject recruitment in the Trial
               and provide the Subjects for the Trial;

       (e)     Resolve any revenue issues in respect of the Trial and keep the Institution informed of
               such issues and the progress of resolution of such issues;

       (f)     Ensure each Subject, or the Subject's legal guardian and any other person or authority
               as required by law is given a Plain Language Statement before the Subject participates
               in the Trial and before the Subject or Subject's legal guardian signs the Consent Form;

       (g)     Obtain from each Subject enrolled in the Trial or the Subject's legal guardian a signed
               and dated Consent Form; and

       (h)     Inform the Subjects or the Subject’s legal guardian and any other person or authority as
               required by law that the Trial is being conducted subject to the Guidelines for
               Compensation for Injury in accordance with national and local regulations.

<Company’s Name>                                          Clinical Trial Agreement (Investigator-Initiated Trial)   4
Protocol <Number/Name>                                                                 CONFIDENTIAL

3.2    Conduct of the Trial

       Each of the Institution and Principal Investigator must:
       (a)     Conduct the Trial in accordance with the terms of this Agreement and:
               (i)       All applicable laws and regulations in Singapore, including the Medicines Act,
                         the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore
                         Guideline for Good Clinical Practice (SGGCP) 1998,
               (ii)      The International Conference on Harmonization Guideline for Good Clinical
                         Practice (ICH-GCP),
               (iii)     The principles of the Declaration of Helsinki,
               (iv)      Health Sciences Authority of Singapore, Ethics Committee/ IRB / NHG DSRB
                         and any other applicable national laws and regulations governing the conduct
                         of clinical studies,
               (v)       The Protocol applicable for conducting the Study, depending on which of the
                         stated options ensures the greatest protection for the patient.
       (b)     Ensure that all Trial Materials are handled correctly and stored securely by the Principal
               Investigator and the Institution's employees for the duration of the Trial and any period
               thereafter as required by law or this Agreement, whichever is later;
       (c)     Ensure that the target number of XX Eligible Subjects are recruited for the Trial and
               that data from all Eligible Subjects are available on or before the Termination Date;
       (d)     Maintain accurate data collection and up-to-date records of all Trial Materials and Trial
               related correspondences by the Principal Investigator, the Institution's employees, the
               Company and any other person involved in the Trial, during the Trial;
       (e)     Submit written reports, in accordance with all laws, regulations and guidelines including
               the Ethics Committee standards, to the Company and the Ethics Committee on the
               status of the Trial being conducted at the Institution on request;
       (f)     Adverse Events - The Principal Investigator will notify the Company of all adverse
               events experienced by the Study subjects which may be reasonably regarded in any
               way related to the Study within reasonable time and take all appropriate and
               reasonable measures, in consultation with the Company, to protect the subjects at risk
               following the occurrences of any unanticipated complications or adverse events. If the
               adverse effect is alarming, it shall be reported within twenty-four (24) hours of the
               Principal Investigator becoming aware of any such event and in accordance with
               applicable local laws and regulations, by telephone or facsimile. The Principal
               Investigator shall cooperate with the Company in the investigation of any unanticipated
               complications or adverse events and notify Ethics Committee/ IRB / NHG DSRB as
               required. The Company shall, so far as is lawful, have full responsibility for the
               reporting of any adverse event that is likely to affect the safety or well-being of the
               subject which has arisen during the clinical trial or which has come to his or her
               knowledge from reports of similar clinical trials conducted elsewhere from time to time,
               in accordance with the Medicines (Clinical Trials) Regulations or such other applicable
               laws or regulations.
       (g)     Data Protection - Data collected in the Study may include personal data and sensitive
               personal data which is subject to specific legislation relating to the processing, storage,
               transfer and use of such data. The Principal Investigator and the Institution will comply
               with all relevant laws relating to the protection and use of personal data and data
               privacy in its conduct and reporting of the Study. The Principal Investigator and the
               Institution shall take all technical and organizational measures to prevent unauthorized
               or unlawful processing, accidental loss, destruction of, damage to, or disclosure of such
               data. The Company will take appropriate measures to protect the confidentiality and
               security of all personal data that it receives from the Principal Investigator and the
               Institution in connection with the Study. Personal data relating to the Principal
               Investigator and the Institution shall be processed and used for the purposes of

<Company’s Name>                                           Clinical Trial Agreement (Investigator-Initiated Trial)   5
Protocol <Number/Name>                                                                 CONFIDENTIAL

               administration of this Agreement and in connection with the Study and will be held on
               one (1) or more databases for the purposes of determining the Principal Investigator's
               and/or the Institution’s involvement in future research and in order to comply with any
               regulatory requirements. Such data may be disclosed or transferred to other members
               of the Company group of companies, to representatives and contractors working on
               behalf of the Company group and to regulatory authorities across the world, with the
               prior written consent of the Principal Investigator and the Institution. The Principal
               Investigator shall ensure that all necessary consents are in place to comply with the
               provisions of this clause.
       (h)     Storage of Study Records - The Principal Investigator and the Institution will retain
               Study Records, under storage conditions conducive to their stability and protection, as
               required by the local regulations in particular, the Medicines (Clinical Trials)
               Regulations or such other applicable laws or regulations at the Study Site.
       (i)     Safety Information – If findings from a research study indicate that current and past
               subjects are at increased risk of a problem that was not anticipated at the time of study
               design, both current and past subjects should be notified. The Sponsor is responsible
               for notifying the PI who will then communicate these findings to the subjects.
       (j)     Report Findings To Institution - Sponsor should report to Institution / IRB / DSRB if
               they detect any findings during monitoring / audits that could affect the safety of clinical
               trial subjects/participants or their willingness to continue participation, influence the
               conduct of the trial, or alter the IRB / DSRB’s approval to continue the trial. Such
               findings may include serious or continuing non-compliance, or evidence of scientific

3.3    Cooperation with the Company (Only applicable if Company will be monitoring trial)

       (a)     The Institution and Principal Investigator must allow any person nominated by the
               Company during regular business hours and with seven (7) Business Days notice in
               advance and any Singapore or International health or other authority access to the

               (i)       Subject records relating to the Trial (excluding patients’ medical records);

               (ii)      The Institution and facilities where the Trial is being conducted; and

               (iii)     Any Trial Materials.

       (b)     The Institution and Principal Investigator must allow the CRA to make the following
               changes to the case report forms, data classification forms and any other relevant

               (i)       Transfer of information to the correct module;

               (ii)      Translation of entries into English;

               (iii)     Improvements in legibility and spelling errors; and

               (iv)      Correct other obvious errors as outlined in the Obvious Corrections Document.

       (c)     Subject to clause 14, the Institution and the Principal Investigator must not, without the
               prior written approval of the Company, disclose any Confidential Information to any
               third person other than for the proper conduct of the Trial and in accordance with this

<Company’s Name>                                           Clinical Trial Agreement (Investigator-Initiated Trial)   6
Protocol <Number/Name>                                                                CONFIDENTIAL

4.     OBLIGATIONS OF the Company

4.1    Provision of Material

       The Company agrees to provide:

       (a)     All Trial Materials necessary for the conduct of the Trial;

       (b)     All relevant clinical pharmacology and toxicology information and advice to the Principal
               Investigator and the Institution which are required for the proper planning and conduct
               of the Trial throughout the Trial period. Such information will include any serious
               adverse drug experience, all relevant clinical, pharmacological and toxicology data; and

       (c)     Reasonable supervision, training and monitoring support during the conduct of the

4.2    Parties agree to adhere to all applicable laws and regulations pertaining to medical
       confidentiality of the subjects. The Principal Investigator shall not disclose to the Company the
       identity of the subjects or information from which the identity of the subject can be deduced
       without prior consent of the subject. The only exception shall be the source data verification,
       during which the monitors of the Company are not allowed to make copies of the patient case
       notes in any form whether electronic or otherwise.

5.     PAYMENT

5.1    Consideration

       In consideration of the Institution’s participation in the Trial and the Principal Investigator’s
       supervision of the Trial:

       (a)     The Company must pay the Institution, subject to the other provisions of clause 5, the
               eligibility payments set out in the Budget Sheet for each Eligible Subject who completes
               all visits as required under the Trial Protocol. If an Eligible Subject does not complete
               all visits or undergo all procedures for each visit as required under the Trial Protocol,
               then the Company will reduce the amounts payable correspondingly. The payments for
               the service rented shall be made as follows:

               (i)       A total amount of XXXXXXSGD (subject to modifications) as written in the
                         attached budget.

               (ii)      A minimum of XX% of this total amount as upfront payment,

               (iii)     Invoices have to be paid within 1 month of receipt.

       (b)     All other patient related costs earlier approved by the Company, if any, will be made to
               the Institution based on the Institution’s correctly rendered invoices.

       (c)     Cheques will be made payable to:           National University Hospital (S) Pte Ltd

               Address:                                   National University Hospital
                                                          5 Lower Kent Ridge Road
                                                          Singapore 119074

<Company’s Name>                                          Clinical Trial Agreement (Investigator-Initiated Trial)   7
Protocol <Number/Name>                                                                 CONFIDENTIAL


       The Company shall indemnify, defend and hold harmless the Institution, its servants and agents
       against all or any liability, claim, expenses [including court costs and fees of solicitors (on a full
       indemnity basis) and that of other professionals] or loss in respect of damage to any property or
       personal injury to or the death of any person due to the act, default, omission or negligence of
       The Company, its servants or agents arising out of or in the course of the performance of this
       Agreement PROVIDED THAT the Institution promptly notifies the Company in writing of any
       such claim AND the Company may not enter into any settlement, agreement, arrangement or
       compromise that would have a material adverse effect on the Institution. The Institution shall
       co-operate with the Company, at the Company’s expense, in defending or settling such claim(s)
       and the Institution may join in defence with counsel of its own choice at its own cost or

6.1    Indemnity to Cover Injuries of Subjects

       Company agrees to pay for the cost of reasonable and customary medical treatment of any
       illness or injury sustained by a Study subject as a result of the administration of the Study drug
       in accordance with the Protocol (except to the extent such costs are covered by the subject's
       insurance or other third party coverage); provided, however, that Company's obligations under
       this clause shall not apply to the extent that any such costs or such illness or injury is
       attributable to

       (i)     The failure of Institution, the Investigator, any Sub-investigator or any other Institution
               personnel involved in the Study to adhere to the terms of the Study protocol or any
               written instructions (including, without limitation, package inserts, where appropriate)
               relative to the use of any product(s) used in the performance of the Study, or comply
               with applicable FDA or other governmental requirements;

       (ii)    Any negligent or wrongful act or omission, or willful malfeasance, of Institution, the
               Investigator, any Sub-investigator or any other Institution personnel (including
               employees, agents or independent contractors) involved in the Study;

       (iii)   The Study subject's primary disease or any concurrent disease not caused by the
               administration of the Study drug in accordance with the Protocol; and/or

       (iv)    The Study subject's failure to comply with instructions contained in the Informed
               Consent executed by such subject or communicated to the subject by Study personnel.


       In carrying out their respective obligations under this Agreement, the Company and the
       Institution shall comply with all laws and regulations applicable thereto but save for wilful acts,
       default or gross negligence on their respective parts, neither party shall be liable to the other
       party for any indirect, incidental, special, punitive or consequential damages however caused,
       including any loss of profits or business interruption costs and under any theory of liability,
       including but not limited to contract, strict liability and negligence; whether or not the other party
       has been advised of the possibility of such damage.


       The Company shall: (a) at its sole cost and expense, procure and maintain products liability
       insurance, including coverage for the Study or equivalent self-insurance, which provides
       contractual liability coverage for the Company's indemnification under this clause; and (b) upon
       the Institution’s request, provide the Institution with written evidence of such insurance.

<Company’s Name>                                           Clinical Trial Agreement (Investigator-Initiated Trial)   8
Protocol <Number/Name>                                                                 CONFIDENTIAL

       During the performance of the Study under this Agreement, the Institution and the Principal
       Investigator each agrees to maintain professional liability insurance in levels sufficient to cover
       the liabilities of the Principal Investigator and/or sub-investigators arising from the activities as
       set forth in this Agreement.


       Both parties agree to treat as confidential all information received from the other party which
       the latter has indicated in writing or labelled to be “Confidential”, “Proprietary Information” or
       with any other comparable legend to similar effect, at the time of disclosure [or if disclosed
       orally, confirmed in writing by the disclosing party as such within thirty (30) days after its
       disclosure], including but without any limitation whatsoever:

       (i)     all commercial, marketing and business information, strategic and development plans,
               intentions, any matter concerning the institution, its affairs, business, operations,
               shareholders, directors, officers, business associates, clients or any other person or
               entity having dealings with the institution;

       (ii)    information relating to the financial condition of the institution, its accounts, audited or
               otherwise, notes, memoranda, documents and/or records in any form whatsoever,
               whether electronic or otherwise; and

       (iii)   scientific, technical, intellectual or other information in any form whatsoever, whether
               electronic or otherwise, relating to methods, processes, formulae, compositions,
               systems, techniques, product information, inventions, know-how, trade secrets, design
               rights, machines, computer programs, software, development codes and research
               projects; business plans, co-developer/collaborator identities, data, business records of
               every nature, customer lists and client database, pricing data, project records, market
               reports, sources of supply, employee lists, business manuals, policies and procedures,
               information relating to technologies or theory and all other information which may be
               disclosed by the institution, whether stored electronically or otherwise; and all copies,
               reproductions and extracts thereof, in any format or manner of storage, whether in
               whole or in part, together with any other property of the institution made or acquired by
               the other party or coming into their possession or control in any manner whatsoever.

       The Company shall ensure that none of the patients of the Institution can be identified in any
       reports, submissions and publications of the Company. Patients’ medical records shall be
       deemed to be Confidential Information of the Institution within the meaning of this clause.

7.1    Disclosure of Confidential Information

       Both parties shall use all reasonable steps to ensure that any information marked as
       confidential or proprietary to the Institution and/or the Company shall not be disclosed, whether
       directly or indirectly, to third (3 ) parties without the prior written consent of the other party,
       which consent shall not be unreasonably withheld, except: -

       (i)     For the purpose contemplated, pursuant to and in accordance with the terms of this
       (ii)    With the consent of the other party and then only to the extent specified in such
               consent; and
       (iii)   To the extent as may be required by law or in accordance with the order of a court of
               competent jurisdiction, regulation, effective government policy or by any regulatory
               authority arising out of this Agreement or relating to or in connection with the other
               party, provided that the party so required must give the other party prompt written
               notice and make a reasonable effort to obtain a protective order.

       The restrictions on disclosure of Confidential Information described above do not extend to

<Company’s Name>                                           Clinical Trial Agreement (Investigator-Initiated Trial)   9
Protocol <Number/Name>                                                               CONFIDENTIAL

       information which:

       (a)     Is, or becomes public knowledge by reason other than a breach of this Agreement;

       (b)     Is, or becomes public knowledge as required by law;

       (c)     Is, or becomes public knowledge, through no fault of the Institution, the Principal
               Investigator or the Institution's employees;

       (d)     Was in the possession of the Institution (as evidenced by written records) prior to being
               disclosed by the Company; and

       (e)     Was developed by the Institution independently (as evidenced by written records) of
               any Confidential Information of the Company.

       Each party must promptly inform the other party about any unauthorised disclosure of such
       other party’s Confidential Information.

       Subject to the foregoing, each party’s confidentiality obligations under this clause shall survive
       the expiry or termination of this Agreement.

9.2    Employees and Agents

       Each party hereby agrees that it shall take all reasonably necessary steps to limit access to
       Confidential Information of the other party to those principals, directors, officers, agents,
       employees, bankers, financial advisors, consultants and legal or other advisors, whose duties
       require them to possess such information or who are directly concerned with the purposes
       contemplated by this Agreement and are made aware of its confidential status, to the extent
       reasonably required for the performance of this Agreement, and ensure that they do not
       disclose or make public or authorize any disclosure or publication of any Confidential
       Information in violation of this Agreement.


10.1   Warranties by the Institution and the Principal Investigator

       (a)     The Institution and Principal Investigator each warrants that the Trial will be conducted
               in accordance with the Trial Protocol, the SGGCP, conditions imposed by the Ethics
               Committee, the terms and conditions set out in this Agreement, as well as all laws and
               guidelines (including those governing the protection and privacy of personal data).

       (b)     The Institution and the Principal Investigator each warrant that all necessary approvals
               and licences from the relevant governmental or other authorities will be obtained prior
               to the commencement of the Trial.

       (c)     The Principal Investigator warrants that all necessary approvals from the Ethics
               Committee and relevant department head of the Institution will be obtained prior to the
               commencement of the Trial.

       (d)     The Institution makes no warranties, express or implied, concerning the results of the
               study, merchantability or fitness for a particular purpose of such results. The Institution
               shall not be liable for any direct, consequential or other damages suffered by the
               Company or others as a result of the study.

<Company’s Name>                                         Clinical Trial Agreement (Investigator-Initiated Trial)   10
Protocol <Number/Name>                                                                CONFIDENTIAL

10.2   Warranties by Company
       Company warrants that the supplied drug(s) are of satisfactory quality and fit for purpose as
       outlined in the Protocol belonging to this Study and in accordance with the description.

10.3   Warranties by All Parties

       The parties each represents and warrants that the following facts and circumstances are and at
       all times shall be true and correct : -

       (i)     that it has the requisite corporate power and authority to enter into this Agreement and
               that this Agreement does not conflict with any other agreement or obligation by which
               the respective party is bound;

       (ii)    that there is no material suit, action, arbitration, legal, administrative or other
               proceeding or governmental investigation pending or to its best knowledge or belief,
               threatened against it or affecting its ability to perform its obligations under this
               Agreement; and

       (iii)   that the signatories for and on behalf of that party are authorized and fully empowered
               to execute this Agreement on that party’s behalf.

10.4   Continuing Warranties

       The warranties in clauses 8.1 and 8.2 shall be deemed to be continuing and repeated
       throughout the term of this Agreement with reference to the facts and circumstances then


       Any one or more of the following events is a default ("Default"):
       (a)     if either party breaches any of its obligations under this Agreement and fails to remedy
               the breach within 30 days written notice being given by the other party requiring that
               breach to be remedied;
       (b)     if a party commits an act of bankruptcy; and

       (c)     if either party, being a company, shall pass a resolution to go into liquidation, or the
               courts shall make an order that the company be compulsorily wound up (otherwise than
               for the purpose of reconstruction or amalgamation) or the company is subject to the
               supervision of the court, either involuntarily or otherwise, or the company enters into an
               arrangement with or compounds or convenes a meeting of its creditors or has a
               receiver, manager, judicial manager or an administrator appointed on behalf of a
               creditor over all or a substantial part of its properties or assets or ceases or threatens to
               cease for any reason whatsoever to carry on its business or is unable to pay its debts
               as defined in the Companies Act (Cap. 50) or takes or suffers any similar action in
               consequence of debt, the other party shall be entitled to terminate this Agreement
               forthwith by written notice.


12.1   Parties' Right to Terminate
       Either party may immediately terminate this Agreement by thirty (30) days’ notice in writing to
       the other party if a Default by that other party occurs.

       Either party may terminate this Agreement by thirty (30) days’ written notice and further

<Company’s Name>                                          Clinical Trial Agreement (Investigator-Initiated Trial)   11
Protocol <Number/Name>                                                                CONFIDENTIAL

       enrolment of subjects for the Clinical Trial may be suspended if any of the following events
       (a)     Inability to recruit an adequate number of Eligible Subjects within the prescribed period
               as advised at the time of commencement;
       (b)     Serious Adverse Drug Experiences with the conduct of the Trial which necessitate the
               discontinuance of the Trial;
       (c)     Unsatisfactory progress of the Trial;
       (d)     Lack of commercial viability with respect to the conduct of the Trial;
       (e)     Such termination / suspension is necessary to protect the best interests of the Eligible
               Subjects participating in the Trial;
       (f)     If either party engages in conduct prejudicial to the interests of the other parties; or
       (g)     If either party wishes to terminate this Agreement without cause.

12.2   Consequences of Termination

       (a)     In the event either party terminates this agreement pursuant to this paragraph, drug
               treatment for individual subjects or groups of subjects may be continued. Continuation
               of the drug or device will be based upon an evaluation by the attending physician and
               the medical expert appointed by the Company taking into consideration the well being
               of the trial subject(s).

               Continuation of treatment will only apply provided that:
                  a. the tried drug or device is not freely available on the market at the moment; or
                  b. when the tried drug or device will be available on the market but the delay of
                      the independently acquisition of that drug or device will have an negative
                      impact on the Trial Subjects health or well being; and
                  c. the Company has sufficient supply of the drug or device available; and
                  d. no law, regulation or guideline would be violated by continuation of the

       (b)     In the event of termination by the Company or Institution, the Institution will be
               reimbursed for all non-cancellable costs and commitments incurred in performance of
               the Study through the effective date of termination.
       (c)     If termination is required due to a decision from Ethics Committee / IRB / DSRB, then
               the Institution will be reimbursed for costs incurred to the date of notification of the
               decision to terminate, reasonable costs of bringing this Study to termination and for
               non-cancelable commitments outstanding at that date.
       (d)     Any termination of this Agreement by either party howsoever caused shall not affect
               any rights or remedies of either party which have accrued prior to the date of


13.1   Data Ownership
       Principal Investigator shall retain ownership of all completed case report forms and data
       generated as a result of the study. However, the Company shall have the right to maintain a
       copy of all study data for its own research purposes and to use study results for publication.

<Company’s Name>                                          Clinical Trial Agreement (Investigator-Initiated Trial)   12
Protocol <Number/Name>                                                                CONFIDENTIAL

13.2   It is recognized and understood that the existing inventions and technologies of Company or
       the Institution are their separate property respectively and are not affected by this Agreement
       (including but not limited to the Confidential Information). The Institution shall not have any
       claims to or rights in such existing inventions and technologies of Company, and Company
       shall not have any claims to or rights in such existing inventions and technologies of the
       Institution. Title to any inventions or discoveries arising from the Institution's proper conduct of
       the Study and conceived and reduced to practice solely by the Institution, and not arising from
       Company’s Confidential Information or related to the Study Drug, shall be owned by the
       Institution and Principal Investigator, as the case may be, but shall be promptly disclosed in
       writing to Company. The Institution will grant Company a fully paid-up, royalty-free, worldwide,
       nonexclusive license, to make, use, sell and import for sale the new invention, and offer
       Company the first opportunity to enter into a royalty-bearing exclusive license for the
       Institution's rights in such invention or discovery. Such license shall be worldwide to the
       maximum extent permitted by the established policy of the Institution with a reasonable royalty,
       and will provide Company with an exclusive right to make, have made, use, and sell such
       invention or discovery conceived by employees arising from the Study.

13.3   Save as aforesaid, all information, Know-how and Intellectual Property disclosed in connection
       with this Agreement shall remain the property of the party introducing and/or disclosing the
       same to the other for the purposes of this Agreement. It is agreed by the parties that use of
       such information, Know-how and Intellectual Property shall not be construed as a grant of any
       right or license except as set forth in a separate duly executed license agreement. For the
       purposes of this Agreement:-

       (i)     “Intellectual Property” shall mean all Confidential Information, Know-how, patents,
               copyright, design rights, rights relating to computer software, and any other industrial or
               intellectual property rights; and

       (ii)    “Know-how” shall mean any experience, methods, techniques, processes, discoveries,
               inventions, innovations, unpatentable processes, technical information, specifications,
               recipes, formulae, designs, plans, documentation, drawings, data and other technical

       Save as aforesaid, all rights in any Intellectual Property and/or Know-how created in the course
       of or resulting from this Agreement solely by any party, their employees, staff, servants or
       agents, without any input or contribution from the other party or without use of such Intellectual
       Property or Know-how disclosed or introduced to this Agreement, shall be the sole and
       exclusive property of that party and its disposition shall be at that party’s sole discretion.


14.1   The Company, the Institution and the Principal Investigator enter into this Agreement as
       independent contractors and nothing in this Agreement creates a relationship of employer and
       employee, principal and agent, joint venture or partnership between the Company on the one
       hand and the Institution and the Principal Investigator on the other hand. No party shall have
       any authority to act for or assume any obligation or responsibility of any kind, express or
       implied, on behalf of the other party or bind or commit the other party for any purpose in any
       way whatsoever.


15.1   Notice and suspension of obligations

<Company’s Name>                                          Clinical Trial Agreement (Investigator-Initiated Trial)   13
Protocol <Number/Name>                                                                CONFIDENTIAL

       (a)     Neither party shall be liable for any loss, damage or penalty resulting from delays or
               failures in the performance of their obligations under this Agreement if the delay or
               failure results from events beyond the reasonable control of either party.

       (b)     For the purposes of this Agreement, such events shall include but are not limited to,
               acts of God, wars, hostility, invasions, acts of foreign enemies, rebellions, revolutions,
               riots, civil wars, disturbances, requisitioning or other acts of civil or military authority,
               laws, regulations, acts or orders of any governmental authority, body, agency or official,
               fires, inclement weather, rain or floods (however caused), industrial action, strikes,
               lock-outs or other labour disputes, epidemics, outbreaks, embargoes or other
               catastrophes affecting the availability of materials or labour necessary for the
               performance of this Agreement.

       (c)     For the avoidance of doubt, the failure to obtain the approval or the withdrawal of
               approval from the relevant government authorities or other governing bodies shall not
               be considered a force majeure event and the provisions of this clause shall not apply to
               such an event.

       (d)     The parties hereto agree to notify the other party promptly of any such circumstances
               delaying its performance and to resume performance as soon thereafter as is
               reasonably practicable.

       (e)     In any of the events mentioned in paragraph 2 of this clause, the parties shall for the
               duration of such event, be relieved of any obligation under this Agreement as is
               affected by the event except that the provisions of this Agreement shall remain in force
               with regard to all other obligations under this Agreement which are not affected by the

15.2   Termination

       If any force majeure event shall continue for a period exceeding one hundred and twenty (120)
       days, then either party may at any time thereafter, upon giving notice to the other, elect to
       terminate this Agreement.


16.1   Publication by the Company

       Any formal presentation or publication of data by the Company will be considered as a joint
       publication by the Principal Investigator(s) and appropriate Company personnel. Authorship will
       be determined by mutual agreement.

16.2   Publication by the Institution / the Principal Investigator

       The Company recognizes the Institution’s and the Principal Investigator's right of utilizing data
       derived from the Study for teaching purposes, communication at congresses and scientific
       publications. As such, the Company has no objection to publication by the Principal Investigator
       of any information collected or generated by the Principal Investigator, whether or not the
       results are favourable to the Company’s drug(s). However, to ensure the accuracy and
       scientific value of the information, while preserving the independence and accountability of the
       Institution, the Principal Investigator and/or the sub-investigators and to maintain the
       confidentiality of the information, only clear, checked and validated data will be used. To this
       effect, it is essential that the Principal Investigator provides the Company an opportunity to
       review any proposed publication or other type of disclosure before it is submitted or otherwise

<Company’s Name>                                          Clinical Trial Agreement (Investigator-Initiated Trial)   14
Protocol <Number/Name>                                                                CONFIDENTIAL

       The Principal Investigator agrees that the recommendations of the Company concerning
       abstracts, manuscripts or any other intended disclosure shall be taken into consideration in the
       preparation of final scientific documents for publication or presentation. For this purpose, the
       Company shall be provided with the draft of any publication or release or the full text of any
       other intended disclosure (poster presentation, invited speaker or guest lecturer presentation
       etc) and will have at least sixty (60) days to review and comment on such draft before they are
       submitted for publication or otherwise disclosed, and if necessary, to delay publication in order
       to protect the confidentiality or proprietary nature of any information contained therein. If
       Confidential Information is to be disclosed, proposed publications or presentations will be
       delayed until the appropriate patent applications and/or legal documents of a similar nature
       have been filed.

       Subject to the foregoing, the Principal Investigator understands that he may publish any
       research findings, scientific work, news release or other public communication about the Study
       or with respect to the Study drug(s) or its development and the results of the Study in a manner
       which fairly sets out his conclusions if such publication is approved by the publication
       committee and subject to the Company’s prior review of the manuscript or other materials
       prepared for the publication.

       The Company shall not use the name of the Institution, the Principal Investigator and/or sub-
       investigators either expressly or by implication in any advertising or promotional materials or
       publications, news or publicity release, without the express written approval of the Institution.
       However, nothing set out in this clause shall be construed as prohibiting the Company from
       reporting to a governmental agency or from exercising its rights under third (3 ) paragraph
       above. In addition, notwithstanding the aforesaid, the Company reserves the right to identify the
       Principal Investigator and the Institution in association with a listing of the Protocol in publicly
       available listings of on-going clinical trials, or other subject recruit services or mechanisms.

       The Institution shall not use and shall cause the Principal Investigator not to use the name(s) of
       the Company and/or of its employees in advertising or promotional materials or publications
       without the prior written consent of the Company.

       This clause does not give the Company any editorial rights over the contents of a publication or
       disclosure, other than to restrict the disclosure of the Company's Confidential Information.

16.3   Use of Publications

       No party may use publications of the other parties in any other publication except with the prior
       written consent of such other party and subject to any conditions attaching to that consent.


       (a) In the event of any dispute or difference arising out of or in connection with or in relation to
           this Agreement, including any question regarding the existence, validity, termination,
           application or interpretation of this Agreement or any of its provisions, or any claim,
           disagreement or dispute arising out of or relating to this Agreement or the breach of any of
           its provisions, both parties shall use their best endeavours to settle the dispute informally
           by agreement between the parties. Both parties shall always act in good faith and co-
           operate with each other to resolve any disputes.

       (b) Notwithstanding anything in this Agreement, if the dispute is not settled informally in
           accordance with paragraph 1 of this clause, no party shall proceed to litigation or any other
           form of dispute resolution unless the parties have made reasonable efforts to resolve the
           same through mediation, in accordance with the mediation rules of the Singapore
           Mediation Centre. A party who receives a notice for mediation from the other party shall

<Company’s Name>                                          Clinical Trial Agreement (Investigator-Initiated Trial)   15
Protocol <Number/Name>                                                                CONFIDENTIAL

           consent and participate in the mediation process in good faith in accordance with this
           clause. The parties undertake to abide by the terms of any settlement reached. Failure to
           comply with this clause shall be deemed to be a breach of this Agreement.

       (c) In the event that mediation is unsuccessful, the dispute shall be resolved either by
           reference to arbitration or by court proceedings as elected by either party, by way of a
           written notice to the other party, which shall state the specific dispute to be resolved and
           the nature of such dispute.

       (d) Any reference to arbitration in Singapore shall be a submission to arbitration within the
           meaning of the Arbitration Act (Cap. 10) for the time being in force in Singapore. Such
           arbitration shall be conducted in the English language in accordance with the Arbitration
           Rules of the Singapore International Arbitration Centre (“SIAC Rules”) for the time being in
           force, which rules are deemed to be incorporated by reference into this clause, except in so
           far as such Rules conflict with the express provisions of this clause, in which event the
           provisions of this clause will prevail.

       (e) The arbitral tribunal shall consist of one (1) arbitrator to be appointed by mutual agreement
           between the parties. Either party may propose to the other the name or names of one (1) or
           more persons, one (1) of whom would serve as the arbitrator. If no agreement is reached
           within thirty (30) days after receipt by one (1) party of such a proposal from the other, the
           arbitrator shall be appointed by the Appointing Authority.

       (f) The Appointing Authority shall be the Chairman of SIAC.

       (g) The arbitrator must not be a present or former employee or agent of, or consultant or
           counsel to, either party or any related corporation [as defined in Section 6 of the
           Companies Act (Cap 50)] of either party.

       (h) Any decision or award of an arbitral tribunal appointed pursuant to this clause will be final
           and binding on the parties and the execution thereof may be entered into any court having

       (i) Interest at the annual rate of six per cent (6%) per annum will be due and payable to the
           party in receipt of an arbitration award from such date as the arbitral tribunal may decide
           until the date of payment to such party.

       (j) The parties hereto undertake to keep the arbitration proceedings and all information,
           pleadings, documents, evidence and all matters relating thereto confidential.

       (k) The application of Part II of the International Arbitration Act (Cap. 143A) and the Model Law
           referred to therein, to this Agreement is hereby excluded.

       (l) For the avoidance of doubt, it is agreed that nothing in this clause shall prevent a party from
           seeking urgent equitable relief before any appropriate court and the commencement of any
           dispute resolution proceedings shall in no way affect the continual performance of the
           parties’ obligations under this Agreement.


       Each party must pay its own legal costs in relation to the preparation and execution of this
       Agreement. the Company agrees to pay the cost of stamp duty, if any, on or in respect of this

<Company’s Name>                                          Clinical Trial Agreement (Investigator-Initiated Trial)   16
Protocol <Number/Name>                                                                CONFIDENTIAL


19.1   Choice of Law

       This Agreement shall be deemed to be made in Singapore, subject to, governed by and
       construed in all respects in accordance with the laws of the Republic of Singapore for every
       intent and purpose.

19.2   Jurisdiction

       The parties hereby agree to submit irrevocably to the non-exclusive jurisdiction of the Courts of
       the Republic of Singapore to settle any and all disputes in connection with this Agreement.

20.    WAIVER

       No waiver of any breach of any covenant, condition, stipulation, obligation or provision
       contained or implied in this Agreement shall operate or be interpreted as a waiver of another
       breach of the same or of any covenant, condition, stipulation, obligation or provision in this

       Any time or other indulgence granted by the Institution under this Agreement shall be without
       prejudice to and shall not be taken as a waiver of any of the Institution’s rights under this
       Agreement nor shall it prejudice or in any way limit or affect any statutory rights or powers from
       time to time vested in or exercisable by the Institution.


       In the event that any term, condition or provision contained in this Agreement or the application
       of any such term, condition or provision shall be held by a court of competent jurisdiction to be
       wholly or partly illegal, invalid, unenforceable or a violation of any applicable law, statute or
       regulation of any jurisdiction, the same shall be deemed to be deleted from this Agreement and
       shall be of no force and effect; whereas the remaining terms, conditions or provisions of this
       Agreement shall remain in full force and effect as if such term, condition and provision had not
       originally been contained in this Agreement, unless the severed provisions render the
       continuing performance of this Agreement impossible, or materially change either party’s rights
       or obligations under this Agreement; in which event such party may give written notice of its
       intent to terminate this Agreement to the other party.

       Notwithstanding the aforesaid, in the event of such deletion, the parties hereto shall negotiate
       in good faith in order to agree to terms of mutually acceptable and satisfactory alternative
       provision(s) in place of the provision(s) so deleted.


       Subject to the other provisions of this Agreement, all the terms and conditions of this
       Agreement shall be binding upon and inure to the benefit of the parties and their respective
       permitted assigns and successors-in-title except that:-

           (i)     neither party shall transfer or assign all or any of its rights, obligations or benefits
                   hereunder in whole or in part to any third (3 ) party, without the prior written
                   consent of the other party, which consent shall not be unreasonably withheld;

<Company’s Name>                                          Clinical Trial Agreement (Investigator-Initiated Trial)   17
Protocol <Number/Name>                                                                    CONFIDENTIAL

             (ii)        any permitted assignee or transferee shall agree in writing to comply with all terms
                         and conditions of this Agreement; and
             (iii)       any assignment shall not exceed the existing scope of this Agreement.


       The parties expressly acknowledge that they have read this Agreement and understood its
       provisions. The parties agree that this Agreement and all Schedules annexed to the same
       constitute the entire agreement between them with respect to the subject matter of this
       Agreement and that it supersedes all prior or contemporaneous proposals, agreements,
       negotiations, representations, warranties, understandings, correspondence and all other
       communications (whether written or oral, express or implied) or arrangements entered into
       between the parties prior to this Agreement in respect of the matters dealt with in it. No
       promise, inducement, representation or agreement other than as expressly set forth in this
       Agreement has been made to or by the parties.

24.    NOTICES

24.1   Method of Giving Notices

       A notice, consent, approval or other communication (each a "Notice") under this agreement
       must be signed by or on behalf of the person giving it, addressed to the person to whom it is to
       be given.

24.2   Addresses for Notices

       Notices under this Agreement will be given by hand, pre-paid post or by facsimile for the
       attention of the persons designated below:

       If to the Company
       Attention:     <Name>, <Designation>
       Telephone:            +65
       Facsimile:            +65

       If to the Principal Investigator
       Attention:       <Name of Principal Investigator>
       Address:              Department of <Dept Name>, National University Hospital, 5 Lower Kent Ridge
                             Road, Singapore 119074.
       Telephone:            +65
       Facsimile:            +65

       If to Institution
       Attention:        Office of Biomedical Research
       Address:              National University Hospital, 5 Lower Kent Ridge Road, Main Building Level 6
                             (Administrative Office), Singapore 119074.
       Telephone:            +65 6772 5040
       Facsimile:            +65 6777 5509

24.3   Any Notice so served by hand, facsimile or post shall be deemed to have been duly given:

       (a)           in the case of delivery by hand, when delivered;
<Company’s Name>                                              Clinical Trial Agreement (Investigator-Initiated Trial)   18
Protocol <Number/Name>                                                                CONFIDENTIAL

       (b)     in the case of facsimile, at the time of transmission;

       (c)     in the case of post, on the second Business Day after the date of posting (if sent by
               local mail) and on the seventh Business Day after the date of posting (if sent by air

       provided that in each case where delivery by hand or by fax occurs after 6pm on a Business
       Day or on a day which is not a Business Day, service shall be deemed to occur at 9am on the
       next following Business Day.

       References to time in this clause are to local time in the country of the addressee.

24.4   A party may notify the other parties to this Agreement of a change to its name, relevant
       addressee, address or fax number for the purposes of this clause, provided that, such notice
       shall only be effective on:

       (a)     the date specified in the notice as the date on which the change is to take place; or

       (b)     if no date is specified or the date specified is less than five (5) Business Days after the
               date on which notice is given, the date following five (5) Business Days after notice of
               any change has been given.

24.5   In proving such service it shall be sufficient to prove that the envelope containing such notice
       was properly addressed and delivered either to the address shown thereon or into the custody
       of the postal authorities as a pre-paid recorded delivery, special delivery or registered post
       letter, or that the facsimile transmission was made after obtaining in person or by telephone
       appropriate evidence of the capacity of the addressee to receive the same, as the case may


       No amendment, modification of or addition to any provision of this Agreement shall be effective
       unless made in writing and signed by the duly authorized representatives of all parties.

26.                 RD

       Nothing contained in this Agreement is intended to confer upon any person (other than the
       parties hereto) any rights, benefits or remedies of any kind or character whatsoever or any right
       to enforce the terms of this Agreement under the Contracts (Rights of Third Parties) Act (Cap.
       53B), and no person shall be deemed to be a third (3 ) party beneficiary under or by reason of
       this Agreement.


       The project will be directed by <Name of Principal Investigator>. If the Principal Investigator is
       unable, for any reason, to perform his duties under this Agreement and the Institution and
       Company are unable to agree upon a replacement for the Principal Investigator within ninety
       (90) days from the time that the Principal Investigator ceases to perform as contemplated in this
       Agreement, any Party may terminate this Agreement by giving written notice to the other
       Parties with immediate effect.


<Company’s Name>                                          Clinical Trial Agreement (Investigator-Initiated Trial)   19
Protocol <Number/Name>                                                                 CONFIDENTIAL

       Neither of the parties shall use the name of the other party either expressly or by implication for
       any purpose whether in relation to any news, advertisement, promotional materials or other
       form of publicity without obtaining the prior written consent of the other party. However, nothing
       herein shall be construed as prohibiting the parties from reporting on this collaboration to a
       governmental agency, or of exercising their publication rights under Clause 14.
       Notwithstanding the generality of paragraph 1 of this clause, the parties may notify third (3 )
       parties of the fact that this Agreement is in effect.


       It is agreed and understood that the entering of this Agreement between the Company, the
       Institution and the Principal Investigator in no way, either overtly or covertly, directly or
       indirectly, requires that the Institution or the Principal Investigator to make any
       recommendations to the Principal Investigator’s patients with respect to the Company’s
       products. There shall be no adjustment to the rate of funding hereunder due to the presence of
       or absence of any recommendations of the Company’s products to the Principal Investigator’s
       patients by the Institution or the Principal Investigator.

                            (The rest of this page is intentionally left blank)

<Company’s Name>                                           Clinical Trial Agreement (Investigator-Initiated Trial)   20
Protocol <Number/Name>                                                      CONFIDENTIAL

EXECUTED as an Agreement:

SIGNED by <Name of Principal Investigator>
Principal Investigator, Department of <Dept
Name>, National University Hospital:
                                                  Signature of party


SIGNED by Mr Joe Sim, Chief Executive
Officer, for and on behalf of National
University Hospital:
                                                  Signature of party


SIGNED by A/Prof Manuel Salto-Tellez, Head
of Clinical Research Sciences, for and on
behalf of National University Hospital:
                                                  Signature of party


SIGNED by Dr Goh Khean Teik, Director of
Medical Affairs for and on behalf of National
University Hospital:
                                                  Signature of party


SIGNED by <Name>, <Designation>, for and
on behalf of the Company:
                                                  Signature of party


<Company’s Name>                                Clinical Trial Agreement (Investigator-Initiated Trial)   1
Protocol <Number/Name>       CONFIDENTIAL

ANNEXURE A: Trial Protocol
Protocol <Number/Name>                                            CONFIDENTIAL


Protocol Title:

Company’s Name:

Contract Research Organization:

Principal Investigator:

Trial duration:

Number of subjects:

(Example of Budget)
          Description of Service   Unit charge    Charges               Total
                                                 per subject Quantity




Grand total                                                      SGD

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