Key Product Event means any serious adverse event that (i) is determined by an independent safety review committee overseeing the safety of the relevant clinical study to be directly related to the Key Product and to have (a) resulted in death, (b) been life threatening, (c) required inpatient hospitalization or a significant prolongation of existing hospitalization, (d) resulted in persistent or significant disability or incapacity, (e) resulted in a congenital anomaly or birth defect, or (f) required significant intervention to prevent permanent impairment or damage; and (ii) (x) results in the FDA, Health Canada or the Therapeutic Goods Administration (Australia) placing a clinical hold on the development program of the Key Product or (y) is likely to result in a significant delay to the development timeline of the Key Product as of the date of this Agreement;

Key Product Event means any event with respect to […***…] that: (a) […***…]; and (b) […***…].

Key Product Event means any event with respect to the 309 Antibody Program or Existing Antibodies, that: (a) is determined by an independent safety review committee overseeing the safety of the relevant clinical trial to be directly related to the 309 Antibody or any other Existing Antibody in such program and (i) to have resulted in death, (ii) been life-threatening, (iii) required inpatient hospitalization or a significant prolongation of existing hospitalization, (iv) resulted in persistent or significant disability or incapacity, (v) resulted in a congenital anomaly or birth defect or (vi) required significant intervention to prevent permanent impairment or damage; and (b) results in any Applicable Regulatory Authority (as defined in the Stock Purchase Agreement) placing a clinical hold on such program.

Examples of Key Product Event in a sentence

Galapagos shall have delivered a certificate signed on its behalf by its Chief Executive Officer certifying whether or not a Key Product Event shall have occurred as of immediately prior to the Effective Date.
Goffman Lisa LaukitisFour Times SquareNew York, New York 10036-6522 Telephone: (212) 735-3000Fax: (212) 735-2000-and-Elizabeth M.
If (a) a Key Product Event occurs for the Autotaxin Program or ADAMTS-5 Program after the Execution Date, […***…].
Since the date of this Agreement, there has not occurred any Key Product Event.
The Company shall give prompt notice to Parent of any change, fact or condition that has had or would reasonably be expected to have a Company Material Adverse Effect or Key Product Event, or would reasonably be expected to make the satisfaction of any of the Tender Offer Conditions impossible or unlikely.

More Definitions of Key Product Event

Key Product Event means any Serious Adverse Event (an “SAE”) that (i) is determined by an independent safety review committee overseeing the safety of the relevant clinical study to be directly related to the Key Product (not predominantly related to any compound with which the Key Product is co-administered) and to have (a) resulted in death, (b) been life-threatening, (c) required inpatient hospitalization or a significant prolongation of existing hospitalization, (d) resulted in persistent or significant disability or incapacity, (e) resulted in a congenital anomaly or birth defect, or (f) required significant intervention to prevent permanent impairment or damage; and (ii) (x) results in the FDA’s placing a clinical hold on the development program of the Key Product or (y) is likely to result in a significant delay to the development timeline of the Key Product as of the date of this Agreement. As used in this Agreement, “Key Product” means the Company’s uracil nucleotide analog polymerase inhibitor referred to as PSI-7977.

Key Product Event means any event with respect to the Collaboration Program or any Collaboration Product, that: (a) is determined by an independent safety review committee overseeing the safety of the relevant clinical trial to be directly related to the Collaboration Product, and (i) to have resulted in death, (ii) been life-threatening, (iii) required inpatient hospitalization or a significant prolongation of existing hospitalization, (iv) resulted in persistent or significant disability or incapacity, (v) resulted in a congenital anomaly or birth defect or (vi) required significant intervention to prevent permanent impairment or damage; and (b) results in a clinical hold being imposed on such program by the FDA or any comparable state, foreign or other Regulatory Authority to which the Collaboration Program or Collaboration Products are subject.

Key Product Event means any serious adverse event that (a) is determined by the safety review committee overseeing the safety of the Phase 1 clinical trial to be directly related to intravitreally administered APL-2 (and not predominantly related to any compound with which APL-2 is co-administered) and to have: (i) resulted in death; (ii) been life-threatening; (iii) required inpatient hospitalization or prolongation of existing hospitalization; (iv) resulted in persistent or significant disability or incapacity; (v) resulted in a congenital anomaly or birth defect; or (vi) required significant intervention to prevent permanent impairment or damage; and (b) results in the FDA’s placing a clinical hold on the Phase 1 clinical trial. A “Key Product Event” shall also mean (x) accumulation of aggregates in the eye, or (y) the recommendation by the safety review committee that the administration of APL-2 to participants in the Phase I clinical trial be halted.

Key Product Event shall also mean (x) accumulation of aggregates in the eye, or (y) the recommendation by the safety review committee that the administration of APL-2 to participants in the Phase I clinical trial be halted.

Key Product Event means any Serious Adverse Event (an “SAE”) that […***…].

Key Product Event means any event with respect to VIR-2482: (a) is determined by an independent safety review committee overseeing the safety of the relevant clinical trial to be directly related to VIR-2482, in such program and (i) to have resulted in death, (ii) been life-threatening, (iii) required inpatient hospitalization or a significant prolongation of existing hospitalization, (iv) resulted in persistent or significant disability or incapacity, (v) resulted in a congenital anomaly or birth defect or (vi) required significant intervention to prevent permanent impairment or damage; and (b) results in any Applicable Regulatory Authority (as defined in the Stock Purchase Agreement) placing a clinical hold on such program; and