Post-Approval Commitments and other Post Opt-In Development Activities Sample Clauses

Post-Approval Commitments and other Post Opt-In Development Activities. Biogen Idec, in consultation with Sobi, will design and conduct all post approval clinical study activities that are required by both the FDA and the EMA as conditions to the Regulatory Approvals granted by such agencies and, if one such Regulatory Approval precedes the other, any activities that are reasonably likely to be conditions to both such Regulatory Approvals (collectively, “US/EU Post-Approval Commitments”) in accordance with the applicable Joint Development Plan. Biogen Idec and Sobi will share [**]. Except as provided in the foregoing sentences and for Additional Agreed Activities, each Selling Party shall conduct, at its expense, all other clinical studies required as conditions to the Regulatory Approvals granted by Regulatory Authorities in its Territory; provided, that if, at the time of Sobi’s Opt-In for a Product, Biogen Idec is conducting such a clinical study for such Product in the EU, Biogen Idec shall continue to be the sponsor of, and have regulatory responsibility for, such clinical study. The JMDC will consider and make decisions in which a clinical study sponsored in one Party’s Territory would benefit by recruiting patients in the other Party’s Territory. Subject to proposing to the JSC or JMDC, as the case may be, that a study be an Additional Agreed Activity, each Party may conduct, at its own expense, Phase IV and other additional clinical studies in its Territory to support its post approval commercial efforts; however, the proposing Party shall not conduct clinical studies to which the other Party may reasonably object, following good-faith discussion of such clinical studies. The clinical studies described on Schedule 3.5 shall be deemed Additional Agreed Activities, which studies shall be set forth in the Joint Development Plan following Opt-In, and the Parties shall share the costs of such studies in accordance with the terms set forth in Section 4.4 and Schedule 3.5. The sponsor for each such study shall be as set forth on Schedule 3.5. If either Party desires to conduct a clinical study comprising Post Opt-In Development, it shall notify the JMDC and provide the JMDC the protocol, estimated costs and cost sharing ratio and such other information as the JMDC may request so that the other Party may determine whether such study shall be an Additional Agreed Activity and to determine whether it has any reasonable objection to the conduct of such study. If the other Party agrees to [**] of the costs for such study, it shall...
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Related to Post-Approval Commitments and other Post Opt-In Development Activities

  • Termination and Reduction of Revolving Commitments (a) Unless previously terminated, the Revolving Commitments shall terminate on the Maturity Date.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Incremental Revolving Commitments (a) The Borrower may on one or more occasions, by written notice to the Administrative Agent, request during the Revolving Commitment Period the establishment of Incremental Revolving Commitments, provided that the aggregate amount of all the Incremental Revolving Commitments to be established hereunder on any date shall not exceed the Incremental Amount as of such date. Each such notice shall specify (i) the date on which the Borrower proposes that the Incremental Revolving Commitments shall be effective, which shall be a date not less than 10 Business Days (or such shorter period as may be agreed to by the Administrative Agent) after the date on which such notice is delivered to the Administrative Agent, (ii) the amount of the Incremental Revolving Commitments being requested (which shall be an amount not less than $5,000,000) and (iii) the identity of each Person proposed to become an Incremental Revolving Lender in connection therewith (it being agreed that (x) any Lender approached to provide any Incremental Revolving Commitment may elect or decline, in its sole discretion, to provide such Incremental Revolving Commitment and (y) any Person that the Borrower proposes to become an Incremental Revolving Lender, if such Person is not then a Lender, must be an Eligible Assignee and, if such approval would then be required under Section 10.6(c) for an assignment to such Person of a Commitment or Loan, must be approved by the Administrative Agent, each Issuing Bank and the Swing Line Lender (such approval not to be unreasonably withheld or delayed)).

  • Commitment Terminations The Term A-2 Loan Commitments and Additional Term A-2 Commitments shall automatically terminate upon the making, conversion or continuance, as applicable, of the Term A-2 Loans and Additional Term A-2 Loans on the Amendment and Restatement Effective Date. The Borrowers shall have the right at any time and from time to time, upon three (3) Business Days’ prior written notice to the Administrative Agent (which notice may conditioned upon the effectiveness of other credit facilities, indentures or similar agreements or other transactions, in which case such notice may be revoked by the Borrowers (by notice to the Administrative Agent on or prior to the specified effective date) if such condition is not satisfied), to terminate the Revolving Credit Commitments in whole or in part, any partial termination to be (i) in an amount not less than $1.0 million or any greater amount that is an integral multiple of $0.1 million and (ii) allocated ratably among the Lenders in proportion to their respective Revolver Percentages; provided that the Revolving Credit Commitments may not be reduced to an amount less than the sum of the aggregate principal amount of Revolving Loans and of L/C Obligations then outstanding; provided further that all Revolving Credit Commitments shall terminate automatically on the Revolving Credit Termination Date. Any termination of the Revolving Credit Commitments below the L/C Sublimit then in effect shall reduce the L/C Sublimit by a like amount. The Administrative Agent shall give prompt notice to each Lender of any such termination (in whole or in part) of the Revolving Credit Commitments. Any termination of the Revolving Credit Commitments pursuant to this Section 2.10 may not be reinstated.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Independent Activities 14.1 Except as expressly provided herein, each party shall have the free and unrestricted right to independently engage in and receive the full benefit of any and all business endeavours of any sort whatsoever, whether or not competitive with the endeavours contemplated herein without consulting the other or inviting or allowing the other to participate therein. No party shall be under any fiduciary or other duty to the other which will prevent it from engaging in or enjoying the benefits of competing endeavours within the general scope of the endeavours contemplated herein. The legal doctrines of "corporate opportunity" sometimes applied to persons engaged in a joint venture or having fiduciary status shall not apply in the case of any party. In particular, without limiting the foregoing, no party shall have any obligation to any other party as to:

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

  • Reimbursement of General Partner (a) Except as provided in this Section 6.5 and elsewhere in this Agreement (including the provisions of Articles 5 and 6 regarding distributions, payments, and allocations to which it may be entitled), the General Partner shall not be compensated for its services as general partner of the Partnership.

  • Activities of the Local Manager The services of the Local Manager to the Fund are not to be deemed to be exclusive, the Local Manager and any person controlled by or under common control with the Local Manager (for purposes of this Article V referred to as “affiliates”) being free to render services to others. It is understood that Directors, officers, employees and shareholders of the Fund are or may become interested in the Local Manager and its affiliates, as directors, officers, employees and shareholders or otherwise and that directors, officers, employees and shareholders of the Local Manager and its affiliates are or may become similarly interested in the Fund, and that the Local Manager and directors, officers, employees, partners and shareholders of its affiliates may become interested in the Fund as shareholders or otherwise.

  • Revolving Commitments If for any reason the Total Revolving Outstandings at any time exceed the Aggregate Revolving Commitments then in effect, the Borrower shall immediately prepay Revolving Loans and/or Swing Line Loans and/or Cash Collateralize the L/C Obligations in an aggregate amount equal to such excess; provided, however, that the Borrower shall not be required to Cash Collateralize the L/C Obligations pursuant to this Section 2.05(b)(i) unless after the prepayment in full of the Revolving Loans and Swing Line Loans the Total Revolving Outstandings exceed the Aggregate Revolving Commitments then in effect.

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