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US Approval Payments Sample Clauses

US Approval Payments a. Within thirty (30) Calendar Days of Initial US Approval, BDSI will provide written notice thereof to Arcion and pay Arcion the US Approval Payment. b. Notwithstanding Section 1.42 or anything to the contrary, if the FDA, as a condition of Regulatory Approval in the United States or a matter to be disclosed on labeling, or in any communication to physicians, health care providers, or prescribers, for the Product in the United States, requires or recommends the performance of a capsaicin challenge, diagnostic, or test (or a particular outcome of any of the foregoing) as a precondition or precursor to the prescription or administration of a Product, the US Approval Milestone Payment shall be equal to $17,500,000 while the amount of the first (1st) and second (2nd) Sales Milestone Payments, respectively, listed in Section 3.11 shall each be increased by $8,000,000 (to $18,000,000 and $28,000,000, respectively) (such reduction of the US Approval Milestone Payment, the “Diagnostic Requirement Adjustment”). c. If (i) the Diagnostic Requirement Adjustment does not apply, (ii) the Initial US Approval Payment is reduced to an amount less than thirty-five million dollars ($35,000,000) as described in Section 1.42, and (iii) BDSI receives any US Post-Approval Licensing Revenue, then BDSI will pay Arcion an additional amount, due within ninety (90) Calendar Days of the First Commercial Sale of Product in the United States, equal to the lesser of (x) the difference between thirty-five million dollars ($35,000,000) and Initial US Approval Payment as calculated pursuant to Section 1.42 or (y) an amount equal to the result of the following equation: where A equals the amount of any US Post-Approval Licensing Revenue, if any. d. If the Remaining Approval Amount is greater than zero: (1) the US Base Rate shall be increased from *** to *** for BDSI’s and its Affiliates’ Net Sales of Product in the United States, (2) the US Sublicense Base Rate shall be increased from *** to ***, and (3) the Ex-US Milestone Rate shall be increased by an additional *** of Ex-US Approval Milestones (i.e. it shall be increased to *** or *** of Ex-US Approval Payments, depending on the applicable percentage payable thereon as set forth in Section 3.8), subject in each case to any other agreed-upon adjustments applicable to any of the foregoing under this Agreement, until the total, aggregate additional amounts due under this Agreement resulting from such increases under this Section 3.10.d. col...

Related to US Approval Payments

  • Authorization, Approval, etc No authorization, approval, or other action by, and no notice to or filing with, any governmental authority, regulatory body or any other Person is required either (a) for the pledge by the Pledgor of any Collateral pursuant to this Pledge Agreement or for the execution, delivery, and performance of this Pledge Agreement by the Pledgor, or (b) for the exercise by the Collateral Agent of the voting or other rights provided for in this Pledge Agreement, or, except with respect to any Pledged Shares, as may be required in connection with a disposition of such Pledged Shares by laws affecting the offering and sale of securities generally, the remedies in respect of the Collateral pursuant to this Pledge Agreement.

  • Consents, Approvals, Etc No consent, approval, authorization, filing with or order of any court or governmental agency or body is required in connection with the transactions contemplated herein or in the Trust Agreement, the Warrant Agreement, the Securities Subscription Agreement, the Private Placement Warrants Purchase Agreement, the Registration Rights Agreement, or the Insider Letter, except for the registration under the Act and the Exchange Act of the Securities, and such as may be required under the state securities or blue sky laws of any jurisdiction in connection with the purchase and distribution of the Securities by the Underwriters in the manner contemplated herein and in the Registration Statement, Statutory Prospectus and the Prospectus.

  • Consents, Licenses, Approvals, etc Lender shall have received copies of all consents, licenses and approvals, if any, required in connection with the execution, delivery and performance by Borrower, and the validity and enforceability, of the Loan Documents, and such consents, licenses and approvals shall be in full force and effect.

  • Board Approval; Vote Required (a) The BCAC Board, by resolutions duly adopted by majority vote of those voting at a meeting duly called and held and not subsequently rescinded or modified in any way, has duly (i) determined that this Agreement and the Transactions are fair to and in the best interests of BCAC and its stockholders, (ii) approved this Agreement and the Transactions (including the Merger) and declared their advisability, (iii) recommended that the stockholders of BCAC approve and adopt this Agreement and Transactions (including the Merger), and directed that this Agreement and the Transactions (including the Merger), be submitted for consideration by the stockholders of BCAC at the BCAC Stockholders’ Meeting. (b) The only vote of the holders of any class or series of capital stock of BCAC necessary to approve the Transactions is the affirmative vote of the holders of a majority of the outstanding shares of BCAC Common Stock (the “BCAC Stockholder Approval”). (c) The Merger Sub Board, by resolutions duly adopted by written consent and not subsequently rescinded or modified in any way, has duly (i) determined that this Agreement and the Merger are fair to and in the best interests of Merger Sub and its sole stockholder, (ii) approved and adopted this Agreement and the Transactions (including the Merger) and declared their advisability, (iii) recommended that the sole stockholder of Merger Sub approve and adopt this Agreement and approve the Transactions (including the Merger) and directed that this Agreement and the Transactions (including the Merger) be submitted for consideration by the sole stockholder of Merger Sub. (d) The only vote of the holders of any class or series of capital stock of Merger Sub is necessary to approve this Agreement, the Merger and the other Transactions is the affirmative vote of the sole stockholder of Merger Sub.

  • Consents; Approvals No consents, filings (other than Federal and state securities filings relating to the issuance of the Shares pursuant to applicable exemptions from registration, which the Company hereby undertakes to make in a timely fashion), authorizations or other actions of any governmental authority are required to be obtained or made by the Company for the Company’s execution, delivery and performance of this Agreement which have not already been obtained or made or will be made in a timely manner following the Closing.

  • Required Consents No consent shall be required for any assignment except to the extent required by subsection (b)(i)(B) of this Section and, in addition: (A) the consent of the Borrower (such consent not to be unreasonably withheld or delayed) shall be required unless (x) an Event of Default has occurred and is continuing at the time of such assignment, or (y) such assignment is to a Lender, an Affiliate of a Lender or an Approved Fund; provided that the Borrower shall be deemed to have consented to any such assignment unless it shall object thereto by written notice to the Administrative Agent within ten Business Days after having received notice thereof; (B) the consent of the Administrative Agent (such consent not to be unreasonably withheld or delayed) shall be required for assignments if such assignment is to a Person that is not a Lender with a Commitment, an Affiliate of such Lender or an Approved Fund; and (C) the consent of each LC Issuing Bank and Swingline Lender shall be required for any assignment.

  • Government Approval, Regulation, etc No authorization or approval or other action by, and no notice to or filing with, any governmental authority or regulatory body or other Person is required for the due execution, delivery or performance by the Borrower of this Amendment.

  • Authorization; Approvals The issuance of the Policy and the execution, delivery and performance of this Agreement and the Insurance Agreement have been duly authorized by all necessary corporate proceedings. No further approvals or filings of any kind, including, without limitation, any further approvals of or further filings with any governmental agency or other governmental authority, or any approval of the Insurer’s board of directors or stockholders, are necessary for the Policy, this Agreement and the Insurance Agreement to constitute the legal, valid and binding obligations of the Insurer.

  • Non-Contravention; Approvals and Consents (i) Except as set forth in Schedule 3.02(d)(i) hereto, the execution and delivery of this Agreement by the Parent and the Merger-Sub does not, and the performance by the Parent and the Merger-Sub of their obligations hereunder and the consummation of the transactions contemplated hereby will not, conflict with, result in a violation or breach of, constitute (with or without notice or lapse of time or both) a default under, result in, or give to any person any right of payment or reimbursement, termination, cancellation, modification or acceleration of, or result in the creation or imposition of any Lien on any of the respective assets or properties of the Parent or the Merger-Sub under any of the terms, conditions or provisions of (x) the Certificate of Incorporation or By-Laws of the Parent or the Merger-Sub, (y) any Laws or Orders of any Governmental or Regulatory Authority applicable to the Parent or the Merger-Sub or any of their respective assets or properties, or (z) any Contracts to which either the Parent or the Merger-Sub is a party or by which either the Parent or the Merger-Sub or any of their respective assets or properties are bound, excluding from the foregoing clauses (y) and (z) conflicts, violations, breaches, defaults, terminations, modifications, accelerations, and creations and impositions of Liens, which individually or in the aggregate, could not be reasonably expected to have a Material Adverse Effect on the Parent or the Merger-Sub or on their ability to consummate the transactions contemplated by this Agreement. (ii) Except (x) for the filing of the Certificate of Merger and other appropriate merger documents required by the DGCL with the Secretary of State of Delaware and appropriate documents with the relevant authorities of other states in which the Constituent Entities are qualified to do business, and (y) as disclosed in Schedule 3.02(d)(ii) hereto, no consent, approval, or action of, filing with or notice to any Governmental or Regulatory Authority or other public or private third party is necessary or required under any of the terms, conditions or provisions of any Law or Order of any Governmental or Regulatory Authority or any Contract to which the Parent or the Merger- Sub is a party or by which the Parent or the Merger-Sub or any of their respective assets or properties is bound for the execution and delivery of this Agreement by the Parent and the Merger-Sub, the performance by the Parent and the Merger-Sub of their respective obligations hereunder or the consummation of the transactions contemplated hereby, except for such consents, approvals or actions of, filing with or notices to any Governmental or Regulatory Authority or other public or private third party the failure of which to make or obtain could not reasonably be expected to have a Material Adverse Effect on the Parent, the Merger-Sub or the Surviving Corporation or on the Parent's and the Merger-Sub's ability to consummate the transactions contemplated by this Agreement.

  • Government Approvals All authorizations, consents, orders or approvals of, or declarations or filings with, or expiration of waiting periods imposed by, any governmental authority necessary for the consummation of the transactions contemplated by this Agreement shall have been filed, occurred or been obtained.