Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Management of REO Property (a) Prior to the acquisition of title to any Mortgaged Property securing a defaulted Mortgage Loan, the Special Servicer shall review the operation of such Mortgaged Property and determine the nature of the income that would be derived from such property if it were acquired by the Trust. If the Special Servicer determines from such review that:
Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.
Supplier Selection If Customer selects a seat or galley supplier that is not on the Boeing recommended list, such seat or galley will become BFE and the provisions of Exhibit A, Buyer Furnished Equipment Provisions Document, of the AGTA will apply.
Formation; Composition Each Party will initially appoint [***] representatives to the JCC, with each representative having knowledge and expertise in the commercialization of products similar to the Regional Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JCC’s responsibilities. The JCC may change its size from time to time by mutual consent of its members, provided that the JCC will consist at all times of an equal number of representatives of each of Surface and Novartis. Each Party may replace its JCC representatives at any time upon written notice to the other Party. The JCC may invite non-members to participate in the discussions and meetings of the JCC, provided that such participants have no voting authority at the JCC and are bound under written obligation of confidentiality no less protective of the Parties’ Confidential Information than those set forth in this Agreement. The JCC will be co-chaired, with one chairperson designated by Surface and [***] designated by Novartis, whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achieved. Responsibility for running each meeting of the JCC will alternate between the chairpersons from meeting-to-meeting, with Novartis’s chairperson running the first meeting. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Contract in Force As of the Closing Date (or the applicable Subsequent Transfer Date in the case of Subsequent Contracts), no Contract has been satisfied or subordinated in whole or in part or rescinded, and the related Motorcycle securing any Contract has not been released from the lien of the Contract in whole or in part.
Specially Serviced Mortgage Loans To the extent and for so long as the Class B Certificates of a Series are outstanding and the Class B Holder owns at least 75% of the most subordinate outstanding class of the Class B Certificates of such Series (calculated by dividing the then outstanding Certificate Principal Balance of such Class B Certificates by the then outstanding Certificate Principal Balance of all certificates of the same class), Delinquent Mortgage Loans of the related Series may, at the option of the Class B Holder, be designated in writing by the Class B Holder as Specially Serviced Mortgage Loans and transferred to the Special Servicer for servicing. The Special Servicer shall service the Specially Serviced Mortgage Loans in accordance with the terms of the related Pooling and Servicing Agreement [and the Servicer Guide]. Following the designation of a Delinquent Mortgage Loan as a Specially Serviced Loan, the Company shall transfer servicing of such Delinquent Mortgage Loan to the Special Servicer substantially in the manner set forth herein and in Schedule II hereto. [The parties hereto agree that any fees resulting from the transfer of the servicing of a Delinquent Mortgage Loan from the Company or a subservicer to the Special Servicer (or any successor thereto) shall be the obligation of the Company.] As of the Effective Date (as defined below) of each Specially Serviced Mortgage Loan, the Special Servicer shall succeed to and undertake all rights, duties and obligations of the prior servicer (including, without limitation, the making of advances, any right to purchase such Specially Serviced Mortgage Loan at the purchase price set forth in the related Pooling and Servicing Agreement and the right to receive the servicing fee with respect to such Specially Serviced Mortgage Loan) pursuant to and in accordance with the terms of the related Pooling and Servicing Agreement [and the terms and conditions of the Servicer Guide]. With respect to each Specially Serviced Mortgage Loan, the effective date (the "Effective Date") shall be the first day of the month immediately following the month of designation of such Specially Serviced Mortgage Loan as such, provided that such written designation is received by the Company on or prior to the 15th calendar day of such month. Once a Delinquent Mortgage Loan becomes a Specially Serviced Mortgage Loan, such Delinquent Mortgage Loan shall remain a Specially Serviced Mortgage Loan, and shall continue to be serviced by the Special Servicer, until the earlier of the liquidation or other disposition of such Specially Serviced Mortgage Loan or the termination of this Agreement, regardless of delinquency status, whether the related Mortgaged Property becomes an REO Property or otherwise; provided, however, that if the Company exercises its right as Master Servicer to purchase all of the Mortgage Loans in a Trust Fund pursuant to an optional termination provision under the related Pooling and Servicing Agreement, the servicing of any related Specially Serviced Mortgage Loans with respect to which foreclosure proceedings have not been commenced shall be transferred promptly by the Special Servicer in accordance with written instructions from the Company. If the Class B Holder (i) transfers such percentage interest in any Class B Certificates of a Series such that the Class B Holder owns less than 75% of the then outstanding Certificate Principal Balance of such class, or (ii) purchases such percentage interest in any Class B Certificates of a Series such that the Class B Holder owns 75% or more of the then outstanding Certificate Principal Balance of such class, the Class B Holder shall promptly notify the Company and the Special Servicer in writing of any such transfer or acquisition. Upon receipt of written notice from the Class B Holder, the Company or the Class B Holder shall revise Schedule I hereto to reflect any such transfer or acquisition and shall forward promptly a copy of such revised schedule to the Company or the Class B Holder, as applicable, and the Special Servicer. With respect to the purchase of at least 75% of the Class B Certificates of any Series by the Class B Holder after the date hereof, this Agreement shall be effective as of the date such written notice of acquisition is received by the Company. If and to the extent the Company is permitted to purchase Delinquent Mortgage Loans under the related Pooling and Servicing Agreement, the Class B Holder may direct the Company to purchase any Specially Serviced Mortgage Loan and to promptly resell such Mortgage Loan to the Class B Holder at the price and on the terms set forth in such Pooling and Servicing Agreement. In the event the Class B Holder directs the Company to purchase a Specially Serviced Mortgage Loan as permitted under this Section, the Company shall promptly take all action necessary under the terms of the related Pooling and Servicing Agreement in order to accomplish such purchase (i.e. provide notification to the Trustee and/or Custodian) and to resell such Specially Serviced Mortgage Loan to the Class B Holder. The Class B Holder, and not the Company, shall be required to remit the purchase price for such Specially Serviced Mortgage Loan to the related Trustee. The Company will inform the Trustee in writing of the purchase of such Specially Serviced Mortgage Loan by the Class B Holder and further shall promptly take all actions necessary or desirable to effect the conveyance of such Mortgage Loan and the related servicing rights to the Class B Holder or its designee, time being of the essence. Notwithstanding any provision herein to the contrary, the Special Servicer shall (i) in no event be obligated to effect any cure or remedy in connection with a deficiency in the documentation for any Specially Serviced Mortgage Loan to the extent such deficiency existed at the time such Mortgage Loan became a Specially Serviced Mortgage Loan or (ii) have any responsibility for any obligations, duties, or liabilities of the Company with respect to the servicing of a Specially Serviced Mortgage Loan that arose prior to the related Effective Date for such Specially Serviced Mortgage Loan, other than those which would customarily be assumed after the Effective Date.
Patient Records Upon termination of this Agreement, the New PC shall retain all patient dental records maintained by the New PC or the MSO in the name of the New PC. During the term of this Agreement, and thereafter, the New PC or its designee shall have reasonable access during normal business hours to the New PC's and the MSO's records, including, but not limited to, records of collections, expenses and disbursements as kept by the MSO in performing the MSO's obligations under this Agreement, and the New PC may copy any or all such records.
Clinical Supply Takeda will provide to Licensee[***] the amount of TAK-385 Licensed Compound or TAK-385 Licensed Products needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan (estimated by Licensee as of the Effective Date to be [***]), solely to the extent that Takeda can supply such TAK-385 [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Licensed Compound or TAK-385 Licensed Products (a) from its supply of TAK-385 Licensed Compound or TAK-385 Licensed Products in existence as of the Effective Date and which supply can be used for its intended purposes without further re-processing (the “Initial Clinical Supply”) and (b) after retaining the amount needed by Takeda for Clinical Trials in the Takeda Territory. Takeda will also provide to Licensee, at [***] any additional supplies of TAK-385 Licensed Compound or TAK-385 Licensed Products in excess of the Initial Clinical Supply needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan. Within [***] days after the Effective Date, the Parties will enter into a manufacturing and supply agreement (the “Takeda Clinical Manufacturing and Supply Agreement”), which will govern the terms and conditions of the Manufacturing and supply of the TAK-385 Licensed Compound and TAK-385 Licensed Products (including the Initial Clinical Supply) by Takeda to Licensee for Development purposes, including the exact quantities and the timelines for delivery. The Parties will negotiate the terms and conditions of such Takeda Clinical Manufacturing and Supply Agreement in good faith for a period of [***] days (as may be extended upon agreement of the Parties). As part of the negotiation related to the Takeda Clinical Manufacturing and Supply Agreement, the Parties shall discuss in good faith the ability of Takeda to supply to Licensee [***]. If the Parties have not entered into a definitive agreement within such negotiation period, then the final terms and conditions of such agreement will be resolved in accordance with Section 8.2 (Arbitration for Failure to Agree).
