AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties. 14.2 Any amendment to the Protocol pursuant to clause 4.8 (“Protocol Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2 14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Amendment. 14.2.2 Where the Sponsor or CRO originates a change request, the Trust shall provide the Sponsor or CRO, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Amendment will have upon the costs of carrying out the Clinical Trial and the other terms of this Agreement. 14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all Parties. 14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above. 14.2 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other negotiations, representations and undertakings whether written or oral of prior date between the Parties relating to the Clinical Trial which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 7 contracts
Samples: Tripartite Clinical Trial Agreement, Tripartite Clinical Trial Agreement, Tripartite Clinical Trial Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol pursuant to clause 4.8 4.7 (“Protocol Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust shall provide the Sponsor or CROSponsor, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Amendment will have upon the costs of carrying out the Clinical Trial and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all both Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Trial, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 5 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol pursuant to clause 4.8 (“Protocol Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust Board shall provide the Sponsor or CRO, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Amendment will have upon the costs of carrying out the Clinical Trial and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other negotiations, representations and undertakings whether written or oral of prior date between the Parties relating to the Clinical Trial which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 4 contracts
Samples: Tripartite Clinical Trial Agreement, Tripartite Clinical Trial Agreement, Tripartite Clinical Trial Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol Clinical Investigation Plan pursuant to clause 4.8 4.9 (“Protocol Clinical Investigation Plan Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Clinical Investigation Plan Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust Board shall provide the Sponsor or CROSponsor, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Clinical Investigation Plan Amendment will have upon the costs of carrying out the Clinical Trial Investigation and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all both Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Investigation, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 4 contracts
Samples: Clinical Investigation Agreement, Clinical Investigation Agreement, Clinical Investigation Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol pursuant to clause 4.8 4.7 (“Protocol Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust [Practice][Practice and Investigator][Investigator][delete as appropriate] shall provide the Sponsor or CROSponsor, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Amendment will have upon the costs of carrying out the Clinical Trial and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all both Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Trial, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 4 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol Clinical Investigation Plan pursuant to clause 4.8 4.10 (“Protocol Clinical Investigation Plan Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Clinical Investigation Plan Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust shall provide the Sponsor or CRO, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Clinical Investigation Plan Amendment will have upon the costs of carrying out the Clinical Trial Investigation and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Investigation, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 3 contracts
Samples: Tripartite Clinical Investigation Agreement, Tripartite Clinical Investigation Agreement, Tripartite Clinical Investigation Agreement
AGREEMENT AND MODIFICATION.
14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol pursuant to clause 4.8 4.7 (“Protocol Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust Board shall provide the Sponsor or CROSponsor, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Amendment will have upon the costs of carrying out the Clinical Trial and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all both Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Trial, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 2 contracts
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol Clinical Investigation Plan pursuant to clause 4.8 4.10 (“Protocol Clinical Investigation Plan Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Clinical Investigation Plan Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust Board shall provide the Sponsor or CRO, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Clinical Investigation Plan Amendment will have upon the costs of carrying out the Clinical Trial Investigation and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Investigation, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 2 contracts
Samples: Tripartite Clinical Investigation Agreement, Tripartite Clinical Investigation Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol Clinical Investigation Plan pursuant to clause 4.8 4.9 (“Protocol Clinical Investigation Plan Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Clinical Investigation Plan Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust shall provide the Sponsor or CROSponsor, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Clinical Investigation Plan Amendment will have upon the costs of carrying out the Clinical Trial Investigation and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all both Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Investigation, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 2 contracts
Samples: Clinical Investigation Agreement, Clinical Investigation Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol Clinical Investigation Plan pursuant to clause 4.8 4.9 (“Protocol Clinical Investigation Plan Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Clinical Investigation Plan Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust shall provide the Sponsor or CROSponsor, within thirty five (35) days of receiving the change request, details of the impact impact, which the proposed Protocol Clinical Investigation Plan Amendment will have upon the costs of carrying out the Clinical Trial Investigation and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all both Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Investigation, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 1 contract
Samples: Clinical Investigation Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol pursuant to clause 4.8 4.7 (“Protocol Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust Board shall provide the Sponsor or CROSponsor, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Amendment will have upon the costs of carrying out the Clinical Trial and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all both Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Trial, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 1 contract
Samples: Clinical Trial Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol Clinical Investigation Plan pursuant to clause 4.8 4.9 (“Protocol Clinical Investigation Plan Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Clinical Investigation Plan Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust NHS Body shall provide the Sponsor or CROSponsor, within thirty five (35) days of receiving the change request, details of the impact impact, which the proposed Protocol Clinical Investigation Plan Amendment will have upon the costs of carrying out the Clinical Trial Investigation and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all both Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Investigation, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 1 contract
Samples: Clinical Investigation Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol pursuant to clause 4.8 4.7 (“Protocol Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement Agreement, a “change request” is a request to change the obligations of the Parties arising from a Protocol Amendment.
14.2.2 Where the Sponsor or CRO / Affiliate originates a change request, the Trust shall provide the Sponsor or CRO/ Affiliate, within thirty five -five (35) days of receiving the change request, details of the impact which the proposed Protocol Amendment will have upon the costs of carrying out the Clinical Trial and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements [Sponsor’s Protocol Reference Number], [Name of Site Principa1l Investigator] NHS-ABPI-BIA model Clinical Trial Agreement 2011 -– England – (DRAFT revision 2015 v0.4) of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all both Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral oral, of prior date between the Parties relating to the Clinical Trial Trial, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 1 contract
Samples: Clinical Trial Agreement
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol Clinical Investigation Plan pursuant to clause 4.8 4.10 (“Protocol Clinical Investigation Plan Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Clinical Investigation Plan Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust NHS Body shall provide the Sponsor or CRO, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Clinical Investigation Plan Amendment will have upon the costs of carrying out the Clinical Trial Investigation and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Investigation, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 1 contract
AGREEMENT AND MODIFICATION. 14.1 Any change in the terms of this Agreement shall be valid only if the change is made in writing, agreed and signed by the Parties.
14.2 Any amendment to the Protocol pursuant to clause 4.8 4.7 (“Protocol Amendment”) shall be managed by means of the change control procedure set out in this clause 14.2clause
14.2.1 For the purposes of this Agreement a “change request” is a request to change the obligations of the Parties arising from a Protocol Amendment.
14.2.2 Where the Sponsor or CRO originates a change request, the Trust Investigator shall provide the Sponsor or CROSponsor, within thirty five (35) days of receiving the change request, details of the impact which the proposed Protocol Amendment will have upon the costs of carrying out the Clinical Trial and the other terms of this Agreement.
14.2.3 A change request shall become a “change order” when the requirements of the change control procedure have been satisfied and any necessary change to this Agreement is signed by the authorised representatives of all both Parties.
14.2.4 An amended financial schedule shall be signed and appended to this Agreement according to clause 10.2 above.
14.2 14.3 This Agreement including its Appendices contains the entire understanding between the Parties and supersedes all other agreements, negotiations, representations and undertakings undertakings, whether written or oral of prior date between the Parties relating to the Clinical Trial Trial, which is the subject of this Agreement. Nothing in this Agreement will, however, operate to limit or exclude any liability for fraud.
Appears in 1 contract
Samples: Clinical Trial Agreement