Validation and Qualification Batches Sample Clauses

Validation and Qualification Batches. Once scale-up of the ------------------------------------ Manufacturing Process is completed at the Genentech Facility, Genentech shall perform all required process validation and shall perform Qualification Runs and manufacture Qualification Batches at commercial scale as set forth in the Tech Transfer Agreement in order to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the regulatory documents described in Section 3.4 hereof. Genentech shall provide the Product ----------- and Bulk Drug resulting from such Qualification Runs and Qualification Batches to Immunex, [*], in accordance with the delivery terms set forth in Section 4.4 hereof. -----------
Sample 1
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Validation and Qualification Batches. Once scale-up of the Manufacturing Process is completed at the Lonza Facility, and Genentech has reviewed and approved the deliverables specified in Section 4.4.1 above, Lonza shall use Commercially Reasonable Best Efforts to perform all required process validation described in Section 12.3 and shall perform Qualification Runs sufficient to produce, at commercial scale, [*] as set forth in the Tech Transfer Agreement in order to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the regulatory documents described in Section 4.6 hereof. Lonza shall provide the Product and Bulk Drug resulting from such Qualification Runs and Qualification Batches to Genentech, at no other costs than the cost specified in Section 6.4.2 (except as otherwise agreed by the Parties pursuant to Section 4.9 hereof) in accordance with the delivery terms set forth in Section 5.5 hereof; provided, Genentech shall have [*] Genentech may make whatever further use of such Qualification Batches, including, without limitation, any Product therefrom, as it shall determine appropriate.
Sample 1

Related to Validation and Qualification Batches

  • Formation and Qualification (a) Each Borrower is duly incorporated and in good standing under the laws of the state listed on Schedule 5.2(a) and is qualified to do business and is in good standing in the states listed on Schedule 5.2(a) which constitute all states in which qualification and good standing are necessary for such Borrower to conduct its business and own its property and where the failure to so qualify could reasonably be expected to have a Material Adverse Effect on such Borrower. Each Borrower has delivered to Agent true and complete copies of its certificate of incorporation and by-laws and will promptly notify Agent of any amendment or changes thereto.

  • Incorporation and Qualification The Company has been duly organized and is validly existing as a Corporation and in good standing under the laws of the State of Colorado with the requisite corporate power and authority to own and use its properties and assets and to carry on its business as currently conducted.

  • Diversification and Qualification 6.1. The Fund will invest its assets in such a manner as to ensure that the Contracts will be treated as annuity or life insurance contracts, whichever is appropriate, under the Code and the regulations issued thereunder (or any successor provisions). Without limiting the scope of the foregoing, each Designated Portfolio has complied and will continue to comply with Section 817(h) of the Code and Treasury Regulation Section 1.817-5, and any Treasury interpretations thereof, relating to the diversification requirements for variable annuity, endowment, or life insurance contracts, and any amendments or other modifications or successor provisions to such Section or Regulations. In the event of a breach of this Article VI by the Fund, it will take all reasonable steps (a) to notify the Company of such breach and (b) to adequately diversify the Fund so as to achieve compliance within the grace period afforded by Regulation 1.817-5.

  • Organization and Qualification The Company and each of the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company nor any Subsidiary is in violation nor default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational or charter documents. Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not have or reasonably be expected to result in: (i) a material adverse effect on the legality, validity or enforceability of any Transaction Document, (ii) a material adverse effect on the results of operations, assets, business, prospects or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under any Transaction Document (any of (i), (ii) or (iii), a “Material Adverse Effect”) and no Proceeding has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.

  • Registration and Qualification If and whenever the Company is required to effect the registration of any Registrable Securities under the Securities Act as provided in this Article II, the Company shall as promptly as practicable:

  • Organization and Qualifications Customer and each of its Subsidiaries (i) is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, (ii) has the power and authority to own its properties and assets and to transact the businesses in which it presently is engaged and (iii) is duly qualified and is authorized to do business and is in good standing in each jurisdiction where it presently is engaged in business and is required to be so qualified.

  • Due Organization and Qualification Borrower and each Subsidiary is a corporation duly existing and in good standing under the laws of its state of incorporation and qualified and licensed to do business in, and is in good standing in, any state in which the conduct of its business or its ownership of property requires that it be so qualified.

  • Existence and Qualification Purchaser is a corporation organized, validly existing, and in good standing under the Laws of the state of Delaware.

  • Corporate Organization and Qualification Buyer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. Buyer has the requisite corporate power and authority to own or lease all of its properties and assets and to carry on its business as it is now being conducted.

  • Enumeration and Qualification The officers of the Trust shall be a President, a Chief Compliance Officer, a Treasurer, a Secretary and such other officers, including Vice Presidents, if any, as the Trustees from time to time may in their discretion elect. The Trust also may have such agents as the Trustees from time to time may in their discretion appoint. Any officer may be, but need not be, a Trustee or shareholder. The same person may hold any two or more offices.

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