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. (b) The Borrower may at any time terminate, or from time to time reduce, the Revolving Commitments; provided that (i) each partial reduction of the Revolving Commitments shall be in an amount that is an integral multiple of $1,000,000 and not less than $5,000,000 and (ii) the Borrower shall not terminate or reduce the Revolving Commitments if, after giving effect to any concurrent prepayment of the Loans in accordance with Section 2.08, the sum of the Aggregate Total Exposure would exceed the total Commitments. (c) The Borrower shall notify the Administrative Agent of any election to terminate or reduce the Revolving Commitments under paragraph (b) of this Section at least three Business Days prior to the effective date of such termination or reduction, specifying such election and the effective date thereof. Promptly following receipt of any notice, the Administrative Agent shall advise the Lenders of the contents thereof. Each notice delivered by the Borrower pursuant to this Section shall be irrevocable; provided that a notice of termination of the Revolving Commitments delivered by the Borrower may state that such notice is conditioned upon the effectiveness of other credit facilities or another transaction, in which case such notice may be revoked by the Borrower (by notice to the Administrative Agent on or prior to the specified effective date) if such condition is not satisfied. Any termination or reduction of the Revolving Commitments shall be permanent. Each reduction of the Revolving Commitments shall be applied to the Lenders in accordance with their respective Applicable Percentages. (d) If, after giving effect to any reduction of the Revolving Commitments, the Letter of Credit Sublimit exceeds the amount of the Revolving Commitments, such Letter of Credit Sublimit shall be automatically reduced by the amount of such excess.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • COMMITMENT OF THE THREE PARTIES By signing7 this document, the staff member, the sending institution and the receiving institution/enterprise confirm that they approve the proposed mobility agreement. The sending higher education institution supports the staff mobility as part of its modernisation and internationalisation strategy and will recognise it as a component in any evaluation or assessment of the staff member. The staff member will share his/her experience, in particular its impact on his/her professional development and on the sending higher education institution, as a source of inspiration to others. The staff member and the beneficiary institution commit to the requirements set out in the grant agreement signed between them. The staff member and the receiving institution/enterprise will communicate to the sending institution any problems or changes regarding the proposed mobility programme or mobility period. The staff member Name: Signature: Date: The sending institution Name of the responsible person: Signature: Date: The receiving institution/enterprise Name of the responsible person: Signature: Date: 1 Adaptations of this template: In case the mobility combines teaching and training activities, the mobility agreement for teaching template should be used and adjusted to fit both activity types. In the case of mobility between Programme and Partner Countries, this agreement must be always signed by the staff member, the Programme Country HEI as beneficiary and the Partner Country HEI as sending or receiving organisation. In case of mobility from Partner Country HEIs to Programme Country enterprises the last box should be duplicated to include the signature of the Programme Country HEI (the beneficiary) and the receiving organisation (four signatures in total).

  • 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.

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

  • Audits, Inspections, Visits and Other Duties FIIOC and FSC shall make available during regular business hours all records and other data created and maintained pursuant to this Contract for reasonable audit and inspection by the Trust, any agent or person designated by the Trust, or any regulatory agency having authority over the Trust. Upon reasonable notice by the Trust, FIIOC and FSC shall make available during regular business hours its facilities and premises employed in connection with its performance of this Contract for reasonable visits by the Trust, any agent or person designated by the Trust, or any regulatory agency having authority over the Trust. FSC shall also inform any agent or person designated by the Trust of the existence and results of any audit, inspection or visit by any regulatory agency having authority over the Trust. FSC shall help facilitate periodic reviews by the Fund’s independent auditors (e.g., SOC 1 reports). FSC shall also maintain a continuing awareness of significant emerging regulatory and legislative developments that may affect the Fund and adopt additional procedures for compliance with regulations if necessary. FSC shall consult with independent accountants, legal counsel, officers of the Fund, and the Fund Treasurer’s Office in establishing such policies.

  • 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: (a) any opportunity to acquire, explore and develop any mining property, interest or right presently owned by it or offered to it outside of the Property at any time; and (b) the erection of any mining plant, mill, smelter or refinery, whether or not such mining plant, mill, smelter or refinery treats ores or concentrates from the Property.

  • 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. (b) The General Partner shall be reimbursed on a monthly basis, or such other basis as the General Partner may determine in its sole and absolute discretion, for all Administrative Expenses incurred by the General Partner.

  • Debarment, Suspension, and Other Responsibility Matters 3.1 The Contractor certifies to the best of its knowledge and belief, that it and its subcontractors: A. Are not presently debarred, suspended, proposed for disbarment, declared ineligible, or voluntarily excluded from covered transactions by any federal department or agency; B. Have not, within a three-year period preceding this Agreement, been convicted of or had a civil judgment rendered against them for commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public transaction; violation of federal or State antitrust statutes or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, or receiving stolen property; C. Are not presently indicted for or otherwise criminally or civilly charged by a governmental entity with commission of any of the offenses enumerated in the preceding paragraph; and D. Have not, within a three-year period preceding this Agreement, had one or more public transactions terminated for cause or default. 3.2 Contractor shall report immediately to County, in writing, any incidents of alleged fraud and/or abuse by either Contractor or Contractor’s subcontractor. Contractor shall maintain any records, documents, or other evidence of fraud and abuse until otherwise notified by County.

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