Regulatory Delay definition

Regulatory Delay means any problems or delays in obtaining governmental or regulatory authorizations, orders, certificates, licenses, permits and approvals required or desirable in connection with the construction of Alberta Clipper.

Regulatory Delay means a delay or failure by a Regulator to provide an authorisation, consent, response, approval, notification or agreement required by the Contractor in connection with a Regulatory Process, where:

Regulatory Delay means an action by the FDA which (i) prevents QuatRx from commencing the second Phase III clinical trial of ospemifene, and (iii) lasts beyond the twelve (12) month anniversary of QuatRx' receipt of such final report.

Examples of Regulatory Delay in a sentence

• New Disclosures, Governmental Intervention, and Regulatory Delay M&T filed the Joint Proxy with the SEC, which was declared effective on February 22, 2013, mailed it to all shareholders five days later, and scheduled a vote on the proposal for April.

• The parties reached an understanding regarding the consequences of the Regulatory Delay, in the absence of the issuance of a Notice of Termination, including the payment of compensation (pursuant to the provisions of Section .

• If commencement of construction of Alberta Clipper Canada is delayed beyond August, 2008 (or any replacement date selected by EPI for the commencement of construction), or if the actual In-Service Date is delayed to a date that is later than the Targeted Date set forth above, in either case, as a result of any Unavoidable Event or Regulatory Delay, then, the Targeted Date shall be deferred by one day for each day of such delay.

• During the Regulatory Delay, the parties signed Letters of Understanding and concurred to extend the Regulatory Delay until July 20th, 2005 (agreeing not to require a determination by the Disputes 1 The preamble to the second amendment to the Concession Agreement, dated 10.1.2006, was not incorporated hereto.

• R.R. Braeutigam, The Effect of Uncertainty in Regulatory Delay on the Rate of Innovation, 43 L.

More Definitions of Regulatory Delay

Regulatory Delay has the meaning set forth in Section 2.3(a).

Regulatory Delay means a delay in the approval of the Transaction by a Government Authority where Purchaser has filed an application or notice with a Government Authority within ten (10) Business Days of the date hereof and responded to any questions or concerns raised by such Government Authorities within a reasonable period of time following receipt of such questions or concerns; provided, however, that a Regulatory Delay shall not be deemed to be occurring solely as a result of Purchaser’s failure to obtain the financing necessary to consummate the Transaction.

Regulatory Delay means any problems or delays in obtaining governmental or regulatory authorizations, orders, certificates, licenses, permits and approvals required or desirable in connection with the construction of the Line 4 Extension.

Regulatory Delay means a delay in the issuance of any Governmental Approval or of any interconnecting utility approval that is not attributable to acts by or omissions of the Contractor and impacts activities in the Project Schedule that makes it impossible or impracticable for the Project to achieve Substantial Completion on or before the Guaranteed Substantial Completion Date.

Regulatory Delay means a delay in the completion of a clinical stage Diligence Milestone that results from the FDA either (a) putting a clinical hold on one or more classes of Licensed Products that Licensee or a Sublicensee is developing pursuant to this Agreement, (b) requiring additional data related to the Licensed Product that Licensee or a Sublicensee is developing pursuant to this Agreement based on FDA guidelines or regulations and such guidelines or regulations were only implemented after initiation of a human clinical trial for such Licensed Product or (c) determining that there is a potential safety risk associated with such Licensed Product; provided, however, that with respect to (a)-(c) (i) such delay is not primarily due to Licensee’s actions or inactions that were counter to the guidance provided to Licensee or otherwise published by the FDA, and (ii) such delay is not primarily due to Licensee’s failure to provide data to the FDA in a form, amount and quality commonly used in the pharmaceutical industry or to undertake preclinical and clinical development in a form and of a quality that would be commonly used in the pharmaceutical industry.

Regulatory Delay means a delay in any milestone date or other date on or before which a specific event mentioned herein or in any Annex hereto must occur which delay is caused by any action, request, requirement or failure to act of a Regulatory Agency in a country of a Major Market.

Regulatory Delay has the meaning set forth in Section 5.23.