Tax Classification The Series shall elect to be treated as an association taxable as a corporation under Treasury Regulations Section 301.7701-3 with effect for each taxable period of its existence. The Series and each Member shall file all tax returns and shall otherwise take all tax and financial reporting positions in a manner consistent with such treatment. No election will be filed with the Internal Revenue Service (or the tax authorities of any State) to have the Series taxable other than as an association taxable as a corporation for income tax purposes.
Classification maintains the relevant Classification free of all requirements and recommendations of the relevant Classification Society; and
Stability Testing Patheon may be requested to conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client ail stability test data and results at Client’s request.
Traceability Distributor agrees to maintain access to records allowing Micrus the ability to determine all customers who were shipped specific product lots. Product Identification and traceability requirements are defined in ISO 9001 : 1994 (E) requirement 4.8 as : “...the supplier shall maintain documented procedures for identifying the product from production, delivery and installation.” Traceability in ISO 8402 Vocabulary is defined as : “ability to trace the distribution and location of the product after delivery”.
Quality Quality matters related to the Manufacture of the Compounds shall be governed by the terms of the Clinical Quality Agreement in addition to the relevant quality provisions of this Agreement.
Stability During the Term, Seller shall conduct the commercial stability program pursuant to Regulatory Requirements applicable as of the Effective Date at its own expense. Should additional stability studies be required, the Parties shall agree, in good faith, upon the protocol, and associated charges, based on the then current charge rates for the staff services, with invoicing for such additional services to occur when the lot is placed on stability.
Monitoring System In each case in which the Custodian has exercised delegated authority to place Assets with a Foreign Custodian, the Custodian shall establish a system, to re-assess or re-evaluate selected Foreign Custodians, at least annually in accordance with Rule 17f-5(c)(3).
Repair and classification Each Borrower shall keep the Ship owned by it in a good and safe condition and state of repair:
Components Patheon will purchase and test all Components (with the exception of Client-Supplied Components) at Patheon’s expense and as required by the Specifications.
Industry Classification Groups For purposes of this Agreement, the Borrower shall assign each Portfolio Investment to an Industry Classification Group. To the extent that any Portfolio Investment is not correlated with the risks of other Portfolio Investments in an Industry Classification Group, such Portfolio Investment may be assigned by the Borrower to an Industry Classification Group that is more closely correlated to such Portfolio Investment. In the absence of any correlation, the Borrower shall be permitted, upon prior notice to the Administrative Agent and each Lender, to create up to three additional industry classification groups for purposes of this Agreement.