Common use of Milestone Payment Clause in Contracts

Milestone Payment. Filing of first IND for the Candidate Compound directed against a designated target expressed by an Accepted Cell Line $ [*] Initiation of first Phase II clinical study for the Candidate Compound $ [*] Initiation of first Phase III clinical study for the Candidate Compound $ [*] Approval of a Product containing the Candidate Compound by Food and Drug Administration as drug $ [*] As used in this Exhibit B, the phrase “Initiation of first Phase III clinical study” shall be deemed to include, if a party conducts a Phase II/III study on a Candidate Compound, the point during such Phase II/III clinical trial when the party conducting the trial has the regulatory approval to proceed with such trial as a pivotal trial. BMS shall promptly notify Athersys of the first occurrence of any milestone with respect to each Candidate Compound. Milestone payments shall be made only once with respect to any given Candidate Compound, regardless of the number of indications sought (or approvals obtained) with respect to such Candidate Compound, whether alone or in combination with other compounds or products, and regardless of any new dosage strengths, preparations or forms of administration for such Candidate Compound. If BMS develops as a back-up Candidate Compound that inhibits or otherwise modulates the activity of a particular molecular target of a Candidate Compound on which BMS is already making milestone payments, then BMS may conduct clinical development on such back-up or follow-on Candidate Compounds and shall not be obligated to make any milestone payments with respect to any such back-up or follow-on Candidate Compound, except as otherwise provided below. In the event that a particular Candidate Compound is dropped from active clinical development work or marketing for safety or efficacy reasons and is specifically replaced with a different Candidate Compound targeting the same molecular target as such dropped Candidate Compound, such new Candidate Compound shall be deemed a “Replacement Compound.” BMS shall not be obligated to make milestone payments that were earlier made with respect to a dropped Candidate Compound and replaced by a Replacement Compound, but, subject to the preceding paragraph, BMS shall pay all milestone payments for milestone events achieved by such Replacement Compound that had not been achieved by such dropped Candidate Compound.

Milestone Payment. Filing of first IND for the Candidate Compound directed against a designated target expressed by an Accepted Cell Line $ $[*] Initiation of first Phase II clinical study for the Candidate Compound $ $[*] Initiation of first Phase III clinical study for the Candidate Compound $ $[*] Approval of a Product containing the Candidate Compound by Food and Drug Administration as drug $ $[*] As used in this Exhibit B, the phrase “Initiation of first Phase III clinical study” shall be deemed to include, if a party conducts a Phase II/III study on a Candidate Compound, the point during such Phase II/III clinical trial when the party conducting the trial has the regulatory approval to proceed with such trial as a pivotal trial. BMS shall promptly notify Athersys of the first occurrence of any milestone with respect to each Candidate Compound. Milestone payments shall be made only once with respect to any given Candidate Compound, regardless of the number of indications sought (or approvals obtained) with respect to such Candidate Compound, whether alone or in combination with other compounds or products, and regardless of any new dosage strengths, preparations or forms of administration for such Candidate Compound. If BMS develops as a back-up Candidate Compound that inhibits or otherwise modulates the activity of a particular molecular target of a Candidate Compound on which BMS is already making milestone payments, then BMS may conduct clinical development on such back-up or follow-on Candidate Compounds and shall not be obligated to make any milestone payments with respect to any such back-up or follow-on Candidate Compound, except as otherwise provided below. In the event that a particular Candidate Compound is dropped from active clinical development work or marketing for safety or efficacy reasons and is specifically replaced with a different Candidate Compound targeting the same molecular target as such dropped Candidate Compound, such new Candidate Compound shall be deemed a “Replacement Compound.” BMS shall not be obligated to make milestone payments that were earlier made with respect to a dropped Candidate Compound and replaced by a Replacement Compound, but, subject to the preceding paragraph, BMS shall pay all milestone payments for milestone events achieved by such Replacement Compound that had not been achieved by such dropped Candidate Compound.