100. Sponsor, and the other organization mentioned above in this clause 99, shall have the right to store, transfer and use the Samples only in accordance with the applicable Law, the Protocol and ICF (as approved by the Ethics Committee). Principal Investigator shall promptly notify Sponsor of any withdrawal of or changes in the informed consent of a Clinical Trial Subject, which may affect the use of such Clinical Trial Subject’s Samples under this Agreement. In such event, Sponsor shall destroy or return the affected Samples if necessary.
101. Upon termination or expiration of the Clinical Trial, and at least at any time the Samples are no longer needed to be retained by Sponsor for any pending registration purpose related to the Study Drug in relation to the Protocol or as defined in the ICF, or as required per any Applicable Law or regulation the remainder of the Samples in Sponsor’s or any of its designee’s possession will be returned to the Site Parties, retained by the Sponsor in accordance with clause 18.2 or destroyed by the Sponsor, as described in the Protocol and/or the ICF.
102. For the avoidance of any doubt, the control (in Dutch: zeggenschap) of the Samples remains at all times at the Clinical Trial Subjects they are derived from, with the Institution and/or Sponsor acting as custodian of the Samples, as described in the Protocol.
103. MISCELLANEOUS
104. Sponsor and CRO shall have the right to assign this Agreement to an Affiliate or another CRO upon prior written notification to Institution. Institution shall have the right to assign this Agreement to an Affiliate upon prior written approval from Sponsor or CRO, which approval shall not be withheld unreasonably. Any approval by a Party of an assignment, transfer or encumbrance by the other Party shall not release the assigning
Party of any of its obligations under this Agreement due up until such assignment. Subject to the foregoing, this Agreement shall bind and inure to the benefit of the respective Parties and their successors and assignees.
105. Institution or the Principal Investigator may not sub-contract the performance of all or any of their obligations under this Agreement without the prior written consent of the Sponsor and/or CRO, such consent not to be unreasonably withheld or delayed. Any Party who so sub-contracts shall be responsible for the acts and omissions of its sub-contractors as though they were its own.
106. Nothing shall be construed as creating a joint venture, partnership or contract of employment between the Parties.
107. Any agreement to amend, vary or modify the terms of the Agreement in any manner shall be valid only if effected in writing and signed by duly authorized representatives of each of the Parties hereto.
108. Should there be any inconsistency between the Protocol and the terms of this Agreement, or any other document incorporated therein, the Protocol shall prevail in case such inconsistency concerns clinical matters and the Agreement shall prevail the inconsistency concerns non-clinical matters. For the avoidance of doubt, Termination and Publication provisions of this Agreement shall always prevail above the Protocol.
109. Unless otherwise agreed, formal notices to the respective Parties required by this Agreement shall be given, made or served if in writing and delivered personally or sent by registered mail or by facsimile with receipts confirmed to the contact details as set out in Annex 7. Other communication between the Parties may also be effected by other means such as e-mail with acknowledgement of receipt, which fulfils the conditions of written form. Change of the contact details has to be notified to the other Party or Parties, but shall not require amendment of this Agreement.
110. The clauses 1 (Definitions); 3.8; 18 (Liabilities, Indemnification and Insurance); 34 (Quality Assurance and Control); 46 (Use of Investigational Product); 8 (Confidentiality and Data Protection); 54 (Intellectual Property); 60 (Publicity); 65 (Publication); 78 and 80-83 (Termination); 87 and 88 (Financial Provisions); 91 (Misconduct and Debarment);
94 (Disclosure of Financial Interest); 96 (Force Majeure); 97 (Governing Law and Dispute Resolution); 98 (Human Samples) and this clause 110 (Surviving Clauses) or other clauses (including but not limited to those in Annexes) contemplating performance after termination, shall survive termination or expiry of this Agreement. Notwithstanding the above, the provisions of clause 8.6 and 8.7 (Confidential Information) shall remain in force for a period of [five (5)] / [ ten (10)] years as from the date of termination or expiration of this Agreement.
111. Each person signing this Agreement represents and warrants that he or she is duly authorized and has legal capacity to execute and deliver this Agreement. Each party represents and warrants to the other that the execution and delivery of the Agreement and the performance of such party's obligations hereunder have been duly authorized and that the Agreement is a valid and legal agreement binding on such party and enforceable in accordance with its terms.
Annexes
Annex 1: Protocol Annex 2: Timelines
Annex 3: Financial arrangements Annex 4: Pharmacy agreement Annex 5: Equipment
Annex 6: Bribery and Corruption Statement Annex 7: Contact details
Annex 8: Power of Attorney / Delegation of Authority to CRO
[The remainder of this page is intentionally left blank; for signatures, see next page]
Signed on behalf of the Sponsor / CRO
Signature: ………
Name: ………
Title: ………
Date: ………
Signed on behalf of the Institution
Signature: ………
Name: ………
Title: ………
Date: ………
[If Principal Investigator is NOT a contracting party, insert: The undersigned Principal Investigator hereby declares that he/she has read the above Agreement between the Parties and that he/she acknowledges the provisions of the Agreement relative to his/her role, responsibilities and duties concerning the Clinical Trial:]
Signed by the Principal Investigator
Signature: ………
Name: ………
Title: ………
Date: ………
ANNEX 1
PROTOCOL (by reference only)
ANNEX 2
TIMELINES
ANNEX 3
FINANCIAL ARRANGEMENTS
ANNEX 4
PHARMACY AGREEMENT
ANNEX 5
EQUIPMENT
ANNEX 6
BRIBERY AND CORRUPTION
A. The Site Parties must at all times act with integrity and honesty and comply with the highest ethical standards.
B. The Site Parties must not make, give, or offer any payment, gift or other benefit or advantage to any person for the purposes of:
i. securing any improper advantage; or
ii. inducing the recipient or another person to do or omit to do any act in violation of their duties or responsibilities (or for the purposes of rewarding such conduct).
C. This restriction applies at all times and in all contexts. For the avoidance of any doubt, it applies both to dealings with "public officials" and to dealings with employees and agents of commercial enterprises.
D. Nevertheless, particular care must be exercised with dealings with public officials. The Site Parties must not make, give or offer any payment, gift or other benefit or advantage for the purposes of influencing any act or decision of a public official (or inducing such official to use their influence with another person, entity or government instrumentality or to affect or influence any act or decision of such other person, entity or government instrumentality).
E. The term "Public Official" includes any person acting on behalf of any government
department, agency or instrumentality or any state-owned or controlled enterprise. By way of example, this includes health care professionals employed by a state- or local municipality-run hospital or clinic, and representatives of public international organizations.
F. The Site Parties must not make, give or offer any payment, gift or other benefit or advantage to any person whilst knowing or suspecting that all or a portion of such money, gift, benefit or advantage will be used, whether directly or indirectly, in breach of (B) or (C) above.
G. The Site Parties shall make and keep books, records, and accounts, which, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Site Parties, in accordance with Dutch law.
H. The Site Parties shall devise and maintain a system of internal accounting controls in accordance with Dutch law, sufficient to provide reasonable assurances that –
i. transactions are executed in accordance with management’s general or specific authorization;
ii. transactions are recorded as necessary
(I) to permit preparation of financial statements in conformity with generally accepted accounting principles or any other criteria applicable to such statements, and
(II) to maintain accountability for assets;
iii. access to assets is permitted only in accordance with management’s general or specific authorization; and
iv. the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences.
v.
ANNEX 7
CONTACT DETAILS
Recipients of Notice in accordance with clause 109 of this Agreement:
If to Sponsor / CRO For scientific matters:
Name:
Address:
Tel.:
Mail:
For legal matters:
Name:
Address:
Tel.:
Mail:
For financial matters:
Name:
Address:
Tel.:
Mail:
If to Institution / Principal Investigator For scientific matters:
Name:
Address:
Tel.:
Mail:
For legal matters:
Name:
Address:
Tel.:
Mail:
For financial matters:
Name:
Address:
Tel.:
Mail:
ANNEX 8
POWER OF ATTORNEY / DELEGATION OF AUTHORITY TO CRO