Meeting Attendance and Information. MERCK shall use reasonable efforts to provide ARCHEMIX with at least [***] days advance notice of any meeting with the FDA or other Regulatory Authority regarding a Drug Approval Application relating to, or Regulatory Approval for, any Development Candidate or Product, (i) prior to the acceptance of an IND with respect to each Development Candidate or Product and (ii) after acceptance of an IND with respect to each Development Candidate or Product if the subject matter of the meeting shall include any milestone event applicable to such Development Candidate or Product. Upon written request ARCHEMIX may send one person [***] to participate as an observer in such meeting [***]; provided, that, (A) MERCK approves such ARCHEMIX request for any such meetings occurring after acceptance of the IND and (B) to the extent MERCK’s approval is required, MERCK shall [***] any such request of ARCHEMIX. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. With regard to any meeting with the FDA or other Regulatory Authority regarding a Drug Approval Application relating to, or Regulatory Approval for, any Development Candidate or Product, to which ARCHEMIX did not send a representative as provided in this Section 4.8.3(c), MERCK will provide ARCHEMIX with a written summary of information communicated and received thereat.
Appears in 2 contracts
Samples: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Meeting Attendance and Information. MERCK shall use reasonable efforts to provide ARCHEMIX with at least [***] days advance notice of any meeting with the FDA or other Regulatory Authority regarding a Drug Approval Application relating to, or Regulatory Approval for, any Development Candidate or Product, (i) prior to the acceptance of an IND with respect to each Development Candidate or Product and (ii) after acceptance of an IND with respect to each Development Candidate or Product if the subject matter of the meeting shall include any milestone event applicable to such Development Candidate or Product. Upon written request ARCHEMIX may send one person [***] to participate as an observer in such meeting [***]; provided, that, (A) MERCK approves such ARCHEMIX request [***] to any Product that is not a Co-Developed Product for any such meetings occurring after acceptance of the IND and (B) to the extent MERCK’s approval is required, MERCK shall [***] any such request of ARCHEMIX. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. With regard to any meeting with the FDA or other Regulatory Authority regarding a Drug Approval Application relating to, or Regulatory Approval for, any Development Candidate or Product, to which ARCHEMIX did not send a representative as provided in this Section 4.8.3(c4.9.3(c), MERCK will provide ARCHEMIX with a written summary of information communicated and received thereat.
Appears in 2 contracts
Samples: Collaborative Research and License Agreement (Archemix Corp.), Collaborative Research and License Agreement (Nitromed Inc)