Precedent Condition. The Parties hereby agree and undertake that the Agreement shall not enter into effect before both of following cumulative approvals have been granted (hereinafter: “the Approvals”): 4.1. The approval of the Trial Protocol by the Medical Center Helsinki Committee and the MOH, if such latter approval is required by the Guidelines; and 4.2. The approval of the Agreement in general, its budget and Appendix C in particular, by the MOH and the committee of engagement with commercial companies in accordance Section 9 of the Guidelines; and 4.3. The approval of the Trial Protocol, Investigator Brochure and related documents by the FDA
Appears in 3 contracts
Samples: Clinical Trial Agreement (Biocancell Therapeutics Inc.), Clinical Trial Agreement (Biocancell Therapeutics Inc.), Clinical Trial Agreement (Biocancell Therapeutics Inc.)
Precedent Condition. The Parties hereby agree and undertake that the Agreement shall not enter into effect before both of following cumulative approvals have been granted (hereinafter: “the Approvals”):
4.1. The approval of the Trial Protocol by the Medical Center Helsinki Committee and the MOH, if such latter approval is required by the Guidelines; and
4.2. The approval of the Agreement in general, its budget and Appendix C in particular, by the MOH and the committee of engagement with commercial companies in accordance Section 9 of the Guidelines; and
4.3. The approval of the Trial Protocol, Investigator Brochure and related documents by the FDA.
Appears in 1 contract
Samples: Clinical Trial Agreement (Biocancell Therapeutics Inc.)