Reporting and Review. (i) The JPT or JDC shall develop and implement procedures for drafting and review of material Regulatory Materials for Products in the Territory, which shall provide sufficient time (at least one week) for each Party to provide substantive comments prior to the filing of such Regulatory Materials (with material regulatory filings, or regulatory filings that materially change existing regulatory filings, subject to prior approval by the JPT or, when formed, the JDC or the JSC pursuant to Section 2.2(c)(ix) or Section 2.3(b)(xv), as applicable).
Appears in 5 contracts
Samples: Development and Commercialization Agreement (Fibrogen Inc), License, Development and Commercialization Agreement, Development and Commercialization Agreement (Fibrogen Inc)
