Common use of Deferred registration Clause in Contracts

Deferred registration. If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in clause 4.2 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, registration of the Clinical Investigation may be deferred as follows: 4.3.1 Regulated Clinical Investigation The Sponsor may defer registration until 30 days after the date that the Investigational Medical Device is CE Marked for the intended purpose being investigated. In the event that the Sponsor decides not to CE ▇▇▇▇ the Investigational Medical Device for the intended purpose being investigated, the Sponsor may defer registration for up to 24 months after the Completion Date. The Clinical Investigation shall also be registered within 21 days of a decision to close the Clinical Investigation on safety grounds. In any event, the Sponsor shall register the Clinical Investigation within 36 months of the date scheduled for resolution of all CRF queries set out in Appendix 2.

Appears in 1 contract

Sources: Clinical Investigation Agreement

Deferred registration. If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in clause 4.2 4.3 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, registration of the Clinical Investigation may be deferred as follows: 4.3.1 4.4.1 Regulated Clinical Investigation The Sponsor may defer registration until 30 thirty (30) days after the date that the Investigational Medical Device is CE Marked for the intended purpose being investigated. In the event that the Sponsor decides not to CE ▇▇▇▇ the Investigational Medical Device for the intended purpose being investigated, the Sponsor may defer registration for up to 24 twenty four (24) months after the Completion Date. The Clinical Investigation shall also be registered within 21 twenty one (21) days of a decision to close the Clinical Investigation on safety grounds. In any event, the Sponsor shall register the Clinical Investigation within 36 thirty six (36) months of the date scheduled for resolution of all CRF queries set out in Appendix 2.

Appears in 1 contract

Sources: Tripartite Clinical Investigation Agreement

Deferred registration. If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in clause 4.2 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, registration of the Clinical Investigation may be deferred as follows: 4.3.1 Regulated Clinical Investigation The Sponsor may defer registration until 30 thirty (30) days after the date that the Investigational Medical Device is CE Marked for the intended purpose being investigated. In the event that the Sponsor decides not to CE ▇▇▇▇ the Investigational Medical Device for the intended purpose being investigated, the Sponsor may defer registration for up to 24 twenty four (24) months after the Completion Date. The Clinical Investigation shall also be registered within 21 twenty one (21) days of a decision to close the Clinical Investigation on safety grounds. In any event, the Sponsor shall register the Clinical Investigation within 36 thirty six (36) months of the date scheduled for resolution of all CRF queries set out in Appendix 2.

Appears in 1 contract

Sources: Clinical Investigation Agreement