CLINICAL TRIAL AGREEMENT - National … · Web viewObtain prior written approval from the Ethics Committee/ IRB / NHG DSRB for any proposed advertisements to be used for the purpose

Protocol <Number/Name> CONFIDENTIAL

CLINICAL TRIAL AGREEMENT (INVESTIGATOR-INITIATED TRIAL)

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>”)

AND

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

AND

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

RECITALS

<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 Agreement.

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


OPERATIVE PROVISIONS

1. INTERPRETATION

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 Singapore.

"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 Trial;

(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.



"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 (CPMP/ICH/135/95).

"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 Day:



(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.

2. CONDITION PRECEDENT AND TERM

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. OBLIGATIONS OF THE INSTITUTION AND THE PRINCIPAL INVESTIGATOR

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.



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



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 misconduct.

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 following,:

(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 documents:

(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 Agreement.



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 Trial.

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 Hospital5 Lower Kent Ridge RoadSingapore 119074



6. INDEMNITIES

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 expense.

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.

7. LIMITATION OF LIABILITY

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.

8. INSURANCE

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.



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.

9. CONFIDENTIAL INFORMATION

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 (3rd) 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 Agreement;

(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 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. WARRANTIES

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.



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 existing.

11. EVENTS OF DEFAULT

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. TERMINATION

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 enrolment of subjects for the Clinical Trial may be suspended if any of the following events



occurs:

(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; andd. no law, regulation or guideline would be violated by continuation of the

treatment.

(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 termination.

13. INTELLECTUAL PROPERTY

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.



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 information.

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. RELATIONSHIP BETWEEN THE PARTIES

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. FORCE MAJEURE

15.1 Notice and suspension of obligations



(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 event.

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. PUBLICATION

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 disclosed.



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 rd) 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.

17. DISPUTE RESOLUTION PROCESS

(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



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 jurisdiction.

(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.

18. COSTS AND STAMP DUTY

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 Agreement.



19. GOVERNING LAW AND JURISDICTION

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 Agreement.

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.

21. SEVERABILITY

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.

22. ASSIGNMENT

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 rd) party, without the prior written consent of the other party, which consent shall not be unreasonably withheld;



(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.

23. ENTIRE 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>Address:Telephone: +65 Facsimile: +65

If to the Principal InvestigatorAttention: <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 InstitutionAttention: NUHS Research OfficeAddress: National University Hospital, 5 Lower Kent Ridge Road, Singapore 119074Telephone: +65 6772 3716Facsimile: +65 6778 5743

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;



(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 mail),

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 be.

25. VARIATION

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. NO THIRD (3RD) PARTY BENEFICIARIES

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 rd) party beneficiary under or by reason of this Agreement.

27. PROJECT DIRECTION

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.

28. USE OF NAMES



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 rd) parties of the fact that this Agreement is in effect.

29. NO OBLIGATION REGARDING REFERRAL

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.

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EXECUTED as an Agreement:

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

Signature of party

Date

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

Signature of party

Date

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

Signature of party

Date

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

Signature of party

Date

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

Signature of party

Date



ANNEXURE A: Trial Protocol


ANNEXURE B: Budget

Protocol Title:

Company’s Name:

Contract Research Organization:

Principal Investigator:

Trial duration:

Number of subjects:

(Example of Budget)Description of Service Unit charge Charges

per subject QuantityTotal

A.

B.

C.

Grand total SGD

Documents

CLINICAL TRIAL AGREEMENT - National … · Web viewObtain prior written approval from the Ethics Committee/ IRB / NHG DSRB for any proposed advertisements to be used for the purpose