Supply and Quality Documentation Sample Clauses

Supply and Quality Documentation. BMS shall supply the BMS Study Drug to the Recipient in accordance with such supply and quality addenda or agreement(s) as the Parties may agree (the “Supply and Quality Documentation”). The Parties shall finalize and execute the Supply and Quality Documentation within [ ]* of the Effective Date, but in no event later than the date on which the first shipment of the BMS Study Drug is supplied for use in the Combined Therapy Clinical Trial. The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of BMS Study Drug in support of the Combined Therapy Clinical Trial. It shall include the responsibility for quality elements as well as exchanged GMP documents and certifications required to release the BMS Study Drug for the Combined Therapy Clinical Trial. In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of BMS Study Drug supplied to the Recipient or its designee for use in the Combined Therapy Clinical Trial.
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Supply and Quality Documentation. BMS shall supply the BMS Study Drug to the Recipient in accordance with such supply and quality addenda or agreement(s) as the Parties may agree (the “Supply and Quality Documentation”). The Supply and Quality Documentation will, among other things, (i) specify the vial sizes of BMS Study Drug to be supplied by BMS to the Recipient, (ii) confirm that the BMS Study Drug shall be supplied in commercially labeled vials, (iii) address the acceptable expiration dates of such supplied BMS Study Drug to align with the needs of the Combined Therapy Clinical Trial; and (iv) memorialize the Parties’ agreement regarding appropriate BSE/TSE statements.. The Parties shall finalize and execute the Supply and Quality Documentation within [**] of the Effective Date, but in no event later than the date on which the first shipment of the BMS Study Drug is supplied for use in the Combined Therapy Clinical Trial. The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of BMS Study Drug in support of the Combined Therapy Clinical Trial. It shall include the responsibility for quality elements as well as exchanged GMP documents and certifications required to release the BMS Study Drug for the Combined Therapy Clinical Trial. In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of BMS Study Drug supplied to the Recipient or its designee for use in the Combined Therapy Clinical Trial.
Supply and Quality Documentation. The Other Party shall supply its Compound to the Sponsoring Party in accordance with such supply and quality addenda or agreement(s) as the Parties may agree (the “Supply and Quality Documentation”). The Parties shall finalize and execute the Supply and Quality Documentation in no event later than the date on which the first shipment of the Other Party’s Compound is supplied for use in the Combined Therapy Study. The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of each Party’s Compound in support of the Combined Therapy Study. It shall include the responsibility for quality elements as well as exchanged GMP documents and certifications required to release the Other Party’s Compound for the Combined Therapy Study. In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of the Other Party’s Compound supplied.
Supply and Quality Documentation. BeiGene shall supply the BeiGene Product to Immix in accordance with the supply and quality addenda or agreement(s) as the Parties may agree (the “Supply and Quality Documentation”). The Parties shall finalize and execute the Supply and Quality Documentation within forty-five (45) calendar days of the Effective Date, but in no event later than the date on which the first shipment of the BeiGene Product is supplied for use in the Combination Study. The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of BeiGene Product in support of the Combination Study. It shall include the responsibility for quality elements as well as exchanged cGMP documents and certifications required to release the BeiGene Product for the Combination Study. In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of BeiGene Product supplied to Immix or its designee for use in the Combination Study.
Supply and Quality Documentation. BMS shall supply the BMS Study Drug to the Recipient in accordance with such supply and quality addenda or agreement(s) as the Parties may agree (the “Supply and Quality Documentation”). The Parties shall finalize and execute the Supply and Quality Documentation within [***] days of the Effective Date, but in no event later than the date on which the first shipment of the BMS Study Drug is supplied for use in the Combined Therapy Study. The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of BMS Study Drug in support of the Combined Therapy Study. It shall include the responsibility for quality elements as well as exchanged GMP documents and certifications required to release the BMS Study Drug for the Combined Therapy Study. In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of BMS Study Drug supplied to the Recipient or its designee for use in the Combined Therapy Study.

Related to Supply and Quality Documentation

  • SMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Participates in an annual performance development review. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with Government, WA Health, South Metropolitan Health Service and Departmental / Program specific policies and procedures. 4.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • NMHS Governance, Safety and Quality Requirements 2.1 Participates in the maintenance of a safe work environment. 2.2 Participates in an annual performance development review. 2.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 2.4 Completes mandatory training (including safety and quality training) as relevant to role. 2.5 Performs duties in accordance with Government, WA Health, North Metropolitan Health Service and Departmental / Program specific policies and procedures. 2.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Actively participates in the Peak Performance program. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with the EMHS Vision and Values, WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act and Government, WA Health, EMHS and Departmental / Program specific policies and procedures.

  • Client Representations and Warranties 10.1 You, the Client, represent and warrant that as at the date of these Account Terms and at all times during these Account Terms: if you are a legal entity other than a natural person, the Client is duly organised and validly existing (or, if a natural person, you are of legal age to make binding agreements and are not under a legal disability or incapacity which would make these Account Terms unenforceable or invalid) and you have full power and authority to enter into, and has taken all necessary steps to enable it lawfully to enter into, these Account Terms and the Transactions and obligations under it; the person executing (for the Client) the application for an agreement on these Account Terms has full power and authority to execute these Account Terms on behalf of the Client, and bind the entity (whether a natural person, company, partnership or otherwise); these Account Terms constitutes a legal, valid and binding obligation of the Client; if the Client is more than one person they will each be jointly (that is, together) and severally (that is, individually fully) liable under these Account Terms; if the Client is a corporation, you have been and remain duly formed under the laws of the place of its incorporation and has power and authority to deal in the Admiral Products offered by Admiral, and the person executing the Application Form on these Account Terms has full power and authority to execute (for the Client) the application for an agreement on these Account Terms; if the Client is one or more persons acting as a partnership in relation to these Account Terms, the Client and each other partner has power and authority to deal in Transactions and to be bound by these Account Terms, and the person executing the Application Form on these Account Terms has full power and authority to execute these Account Terms on behalf of all of the partners; if the Client is a Trustee, the trust deed specifically empowers and authorises dealings in the Admiral Products covered by these Account Terms, and such dealings are within the authorised ambit of the Trust’s investment strategy; if the Client is comprised of two or more persons (that is, holding a joint Account), that all such decisions made, and instructions issued, pursuant to these Account Terms, are made on a fully informed and agreed basis by all the parties to the joint Account; a Client may be comprised of two or more persons. If the client is comprised of more than one person then the Account will be deemed to be held by the persons as joint tenants despite any actual or constructive notice to Admiral of any partnership or other agreement between the persons. The joint holding will be only be deemed not to be held as joint tenants if Admiral expressly agrees that in writing that the persons consisting the client hold the Account as tenants in common in equal shares or by a court determination of that it is not held as joint tenants; if the Client is an investment manager or a responsible entity, the investment management agreement or fund constitution specifically empowers and authorises dealings in the Admiral Products, by the Client and on behalf of their underlying clients or investors; and such dealings are within the authorised ambit of each underlying client’s investment strategy; it will enter into Transactions pursuant to the applicable investment management agreement as investment manager or responsible entity and not otherwise; (iii) it will only deal in Admiral Products when the funds or other assets under its control are sufficient to meet the obligations which arise in connection with such dealing; and if your appointment as investment manager or responsible entity is terminated, it is authorised to arrange for Closing Out of all Transactions entered into on behalf of the Client prior to the date of such termination as soon as possible; is not an employee or the close relative of an employee of any exchange participant; you have read these Account Terms and any product disclosure statement issued by Admiral in relation to the Admiral Products and Transactions relevant to the Account (including the disclosures of significant risks); you have considered your objectives and financial situation and you have had a reasonable opportunity to obtain appropriate independent advice prior to entering into these Account Terms, and has formed the opinion that dealing in the Admiral Products is suitable for your needs and purposes; the Client is willing and able, financially and otherwise, to assume the risk of trading in high risk investments, Transactions using Margin and all other Transactions covered by these Account Terms; all information supplied to Admiral by the Client is, or at the time it is supplied will be, accurate in all material respects and the Client will not omit or withhold any information which would make such information inaccurate in any material respect; you will rely upon your own knowledge and judgment and will seek such advice (financial or otherwise) as may be prudent before placing an Order with Admiral and you assume full responsibility for any Order placed with Admiral; you fully understand the relevant provisions of: the prohibition of false or misleading markets and other market manipulation as described in Applicable Laws and section 1041A of the Corporations Act; the prohibition of xxxxxxx xxxxxxx as described in section 1043A of the Corporations Act; the prohibition of false trading and market rigging as described in sections 1041B and 1041C of the Corporations Act; the prohibition of misleading and deceptive conduct described in section 1041H of the Corporations Act; and Applicable Laws and, to the extent your investing in Admiral Products have Underlying Reference Instruments which are governed by the Corporations Act, the conditions upon which short selling is permitted on the ASX and the disclosure obligations are imposed on short sellers. You will notify Admiral if you are funding your account using superannuation as that may impact your classification as a retail or wholesale client. You acknowledge to us that you have received or downloaded, and read and understood the TMD document and you agree that you are within the class of consumers described in our TMD.

  • Performance of Obligations; Representations and Warranties The Company shall have performed in all material respects each of its agreements contained in this Agreement required to be performed on or prior to the Effective Time, each of the representations and warranties of the Company contained in this Agreement that is qualified by materiality shall be true and correct on and as of the Effective Time as if made on and as of such date (other than representations and warranties which address matters only as of a certain date which shall be true and correct as of such certain date) and each of the representations and warranties that is not so qualified shall be true and correct in all material respects on and as of the Effective Time as if made on and as of such date (other than representations and warranties which address matters only as of a certain date which shall be true and correct in all material respects as of such certain date), in each case except as contemplated or permitted by this Agreement, and Parent shall have received a certificate signed on behalf of the Company by its Chief Executive Officer and its Chief Financial Officer to such effect.

  • SHIPPING AND AIR TRANSPORT 1. Profits of an enterprise of a Contracting State from the operation of ships or aircraft in international traffic shall be taxable only in that State. 2. The provisions of paragraph 1 shall also apply to profits from the participation in a pool, a joint business or an international operating agency.

  • Accuracy of the Company’s Representations and Warranties Each of the representations and warranties of the Company in this Agreement and the other Transaction Documents that are qualified by materiality or by reference to any Material Adverse Effect shall be true and correct in all respects, and all other representations and warranties shall be true and correct in all material respects, as of the date when made and as of the Closing Date as though made at that time, except for representations and warranties that are expressly made as of a particular date, which shall be true and correct in all respects as of such date.

  • Existence and Qualification; Power; Compliance With Laws Borrower is a corporation duly formed, validly existing and in good standing under the Laws of the State of California. Borrower is duly qualified or registered to transact business and is in good standing in the State of California, and each other jurisdiction in which the conduct of its business or the ownership or leasing of its Properties makes such qualification or registration necessary, except where the failure so to qualify or register and to be in good standing could not reasonably be expected to have a Material Adverse Effect. Borrower has all requisite power and authority to conduct its business, to own and lease its Properties and to execute and deliver each Loan Document to which it is a Party and to perform its Obligations. The chief executive offices of Borrower are located in San Dimas, California. All outstanding capital stock of Borrower is duly authorized, validly issued, fully paid and non-assessable, and no holder thereof has any enforceable right of rescission under any applicable state or federal securities or other Laws. Borrower is in compliance with all Laws and other legal requirements applicable to its business, has obtained all authorizations, consents, approvals, orders, licenses and permits from, and has accomplished all filings, registrations and qualifications with, or obtained exemptions from any of the foregoing from, any Governmental Agency that are necessary for the transaction of its business, except where the failure so to comply with Laws and other legal requirements applicable to its business, obtain authorizations, etc., file, register, qualify or obtain exemptions could not reasonably be expected to have a Material Adverse Effect.

  • Accuracy of the Company’s Representations and Warranties; Performance by the Company The Company shall have delivered the certificate required to be delivered pursuant to Section 4(o) on or before the date on which delivery of such certificate is required pursuant to Section 4(o). The Company shall have performed, satisfied and complied with all covenants, agreements and conditions required by this Agreement to be performed, satisfied or complied with by the Company at or prior to such date, including, but not limited to, the covenants contained in Section 4(p), Section 4(q) and Section 4(r).

  • Client’s Representations and Warranties Client hereby represents and warrants to Adviser that: (i) Client has the requisite legal capacity and authority to execute, deliver and to perform its obligations under this Agreement; (ii) this Agreement has been duly authorized, executed and delivered by Client and is the legal, valid and binding agreement of Client, enforceable against Client in accordance with its terms; (iii) Client’s execution of this Agreement and the performance of its obligations hereunder do not conflict with or violate any provisions of the governing documents of Client or any obligations by which Client is bound, whether arising by contract, operation of law or otherwise; (iv) Client will deliver to Adviser evidence of Client’s authority in compliance with such governing documents upon Adviser’s request; and (v) the Client is the owner of all cash, Investments and other assets in the Account, and there are no restrictions on the pledge, hypothecation, transfer, sale or public distribution of such cash, securities or assets.

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