Obligation to Submit MA; Conditions to Submission Sample Clauses

Obligation to Submit MA; Conditions to Submission. Subject to Subsection 4.1.10 below with respect to Japan, promptly after the conclusion of the Phase III Trial and the completion of the tasks necessary for MA submission under the Initial or the then current Development Plan, as the case may be, TILLOTTS has the right and the obligation, at its expense, to prepare and file MAs, based on CPP´s prepared eCTD (or equivalent as is acceptable to TILLOTTS), and to obtain MA Approval in regard to the Licensed Formulation and the Primary Indication in the countries of the Licensed Territory. TILLOTTS must exercise Commercially Reasonable Diligence in prosecuting and obtaining MA Approvals based on its MA submission, file all necessary reports, and timely and fully respond to any requests by Regulatory Authorities in connection with those submissions and their review. TILLOTTS must exhaust all administrative remedies reasonably available (it being understood that litigation or other adversarial proceedings are not reasonably available remedies) in instances of adverse action by the EMA. TILLOTTS may elect not to submit an MA for the Licensed Formulation in the Licensed Territory if the JSC opines that the results of the Phase III Trial do not suggest that MA Approval is reasonably possible. Subject to Subsection 4.1.10 below with respect to Japan, either party may request that the filing of the MA in the Licensed Territory be deferred if: (i) the party requesting deferral demonstrates to the other party’s reasonable satisfaction that because of changes in regulatory requirements since the date of the conclusion of the Phase III Trial, the prospects for obtaining MA Approval or favorable pricing decisions from the applicable Regulatory Authorities would substantially improve by a deferral in the date of that submission; or (ii) the party requesting deferral demonstrates to the other party’s reasonable satisfaction that it is necessary to conduct additional studies to obtain MA Approval of the Licensed Formulation in the Licensed Territory, in which event the parties must promptly commence good faith discussions to inform each other regarding the need and purposes of those studies and to develop and agree upon a protocol to govern them and the parties’ respective obligations for paying for them, it being understood that neither party is obligated to agree upon the protocol or to pay for or contribution to the cost of those additional studies. Notwithstanding TILLOTTS’ election not to submit an MA based on the JSC’s ...
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Related to Obligation to Submit MA; Conditions to Submission

  • Conditions to Each Party’s Obligation to Effect the Merger The respective obligations of each party hereto to effect the Merger shall be subject to the satisfaction (or waiver, if permissible under applicable Law) on or prior to the Closing Date of the following conditions:

  • Conditions to Each Party’s Obligation to Effect the Closing The respective obligation of each party to effect the Closing shall be subject to the satisfaction at or prior to the Closing Date of each of the following conditions:

  • Conditions to Each Party’s Obligation to Effect the Exchange The obligation of each party to effect the Exchange and otherwise consummate the transactions contemplated by this Agreement is subject to the satisfaction, at or prior to the Closing, of each of the following conditions:

  • Conditions to Each Party’s Obligation to Effect the Mergers The respective obligation of each party to effect the Mergers is subject to the satisfaction or waiver on or prior to the Closing Date of the following conditions:

  • Conditions to Each Party’s Obligation to Effect the Transactions The obligation of each Party to effect the Closing is subject to the satisfaction or waiver (by such Party) at or prior to the Closing of the following conditions:

  • Conditions to Each Party’s Obligations to Effect the Merger The respective obligations of each party hereto to effect the Merger are subject to the satisfaction at or prior to the Effective Time of the following conditions:

  • Amendment to Subsection 9(m). Subsection 9(m)(i)(x) of the Credit Agreement is hereby amended by deleting such subsection in its entirety and substituting in lieu thereof the following:

  • Conditions to Each Party’s Obligation to Close The obligations of the Parties to consummate the transactions contemplated by this Agreement shall be subject to the satisfaction, at or prior to the Closing, of each of the following conditions:

  • Inability of Lender to Submit Forms If any Lender determines, as a result of any change in applicable law, regulation or treaty, or in any official application or interpretation thereof, that it is unable to submit to the Borrower or the Administrative Agent any form or certificate that such Lender is obligated to submit pursuant to subsection (b) of this Section 13.1 or that such Lender is required to withdraw or cancel any such form or certificate previously submitted or any such form or certificate otherwise becomes ineffective or inaccurate, such Lender shall promptly notify the Borrower and Administrative Agent of such fact and the Lender shall to that extent not be obligated to provide any such form or certificate and will be entitled to withdraw or cancel any affected form or certificate, as applicable.

  • Relation to Subordination Provisions Interest Drawings under the Liquidity Facilities and withdrawals from the Cash Collateral Accounts, in each case, in respect of interest on the Certificates of any Class, will be distributed to the Trustee for such Class of Certificates, notwithstanding Sections 2.01(b) and 3.02.

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