Triggering Clinical Trial definition

Triggering Clinical Trial means, for an Assembly Molecule:

Triggering Clinical Trial means for each Galapagos Program either: (A) the first Phase 2 Clinical Trial that reaches its Completion Date for a Galapagos Product in such Galapagos Program for a particular indication and that satisfies each of the following criteria: (1) […***…]; (2) […***…]; and (3) […***…]; or (B) the first Phase 3 Clinical Trial that reaches its Completion Date for a Galapagos Product in such Galapagos Program, if such Phase 3 Clinical Trial reaches its Completion Date prior to any Phase 2 Clinical Trial for such Galapagos Product in such Galapagos Program that satisfies the criteria in clause (A) above.

Triggering Clinical Trial means, for an Optioned Molecule in an Optioned GLP Initial New Target Program for an Initial New Target, the Clinical Trial(s) for such Optioned Molecule that are consistent with the TCT Criteria for the applicable Initial New Target as set forth in Section 8.3(b)(vii)(A). [***].”

Examples of Triggering Clinical Trial in a sentence

• If such dispute is regarding whether a Clinical Trial constitutes a Triggering Clinical Trial or whether or when a Qualifying Data Package has been delivered, in each case, for any Galapagos Program, then either Party may refer such dispute to the Parties’ Subject Matter Experts for Development after the […***…] Business Day after a Party requests a meeting of the JSC to make such a determination.

• Without limitation to the foregoing, with respect to each Galapagos Program, the JSC shall determine whether a Clinical Trial constitutes a Triggering Clinical Trial and whether and when a Qualifying Data Package has been delivered, in each case, for such Galapagos Program as further described in Sections 2.3(c) and 2.3(d).

• With respect to each Optioned Program for which the Triggering Clinical Trial is a Phase 3 Clinical Trial, if such Triggering Clinical Trial has reached its Completion Date, then Gilead shall pay to Galapagos an amount equal to the sum of (i) […***…] percent […***…] of the costs and expenses Gilead would have borne had such Triggering Clinical Trial been included in an R&D Plan and Budget and (ii) […***…].

• For clarity, a Triggering Clinical Trial with respect to an Arcus Combination shall be deemed a Triggering Clinical Trial for the Arcus Program with respect to the applicable Arcus Molecule included in such Arcus Combination.

• Once a Clinical Trial is approved by the JDC as a Triggering Clinical Trial, then, no later than [***] days after the applicable Completion Date for such Clinical Trial, Assembly shall deliver to Gilead a written notice including instructions and credentials with which Gilead may access a Data Room containing the data and information required to be included in a Qualifying Data Package with respect to the Assembly Program that includes such Triggering Clinical Trial.

More Definitions of Triggering Clinical Trial

Triggering Clinical Trial means for each Galapagos Program either:

Triggering Clinical Trial means, for an Arcus Molecule: (A) With respect to an Arcus Program other than an Acquired Arcus Program that constitutes an Arcus Program upon acquisition, except as otherwise specified in clause (B) below, the Clinical Trial(s) sponsored by Arcus and approved by the JSC as the Triggering Clinical Trial for such Arcus Molecule, which Clinical Trial shall be consistent with the TCT Criteria. The “TCT Criteria” are as set forth in Schedule 8.3(b)(vii); (B) With respect to the following Arcus Molecules: [***] (C) With respect to an Acquired Arcus Program that constitutes an Arcus Program upon acquisition, and except as otherwise specified in clause (D) below, the Clinical Trial(s) approved by the JSC as the Triggering Clinical Trial for such Arcus Molecule (whether pursuant to Section 3.3(c)(i)or 3.3(c)(iii)), which Clinical Trial shall be consistent with the TCT Criteria; and (D) With respect to an Acquired Arcus Program that constitutes an Arcus Program upon acquisition and that includes, at the time of acquisition, a [***] Clinical Trial that has reached its Completion Date or an Approved Acquired Product, a Triggering Clinical Trial will be deemed to have occurred as of the closing of the applicable acquisition. provided that with respect to each of clause (A), (B) and (C) above, if the existing Triggering Clinical Trial is halted, then the JSC shall designate a substitute Triggering Clinical Trial for such Arcus Molecule, and; provided, further, that, [***].

Triggering Clinical Trial means, for an Assembly Molecule: (A) (1) With respect to an Assembly Program (other than the [***]), the [***] Clinical Trial sponsored by Assembly and approved by the JDC [***]; or (2) with respect to the [***], the [***] Clinical Trial sponsored by Assembly and approved by the JDC [***] (each of (1) and (2), a “First Triggering Clinical Trial”), in each case, which Clinical Trial is consistent with the TCT Criteria set forth in the applicable Development Plan; and (B) the [***] Clinical Trial sponsored by Assembly and approved by the JDC [***] (a “Second Triggering Clinical Trial”), in each case, which Clinical Trial is consistent with the TCT Criteria set forth in the applicable Development Plan.