Audits of BeiGene Distributors Sample Clauses

Audits of BeiGene Distributors. Amgen may, from time to time, upon reasonable notice (at least [*]) and at a reasonable frequency ([*]), perform audits of selected sites and downstream distributors to ensure compliance with the Applicable Law, including, but not limited to, Proper Conduct Practices, Anti-Corruption Laws and the Quality and Compliance Standards, including NMPA Good Supply Practice (GSP). If Third Party logistic services are used for storage and distribution of Products, BeiGene shall establish a policy and process to manage such services, including, but not limited to, a quality agreement and operation procedures. Within a reasonable time prior to the expected First Commercial Sale in the Collaboration Territory, Amgen will perform an audit of BeiGene on its management of product distribution in compliance with the Quality and Compliance Standards, including NMPA Good Supply Practice (GSP). Remediation of any discrepancies identified in such initial audit shall be closed prior to Amgen’s supply of Product. BeiGene shall promptly notify Amgen of any significant discrepancies or concerns related to BeiGene’s, an Affiliate’s or any Third Party’s (including sub-distributors, wholesalers and pharmacies) ability to perform any of its obligations related to the Distribution of Products in the Collaboration Territory or to comply with the Quality and Compliance Standards or, if applicable, the Proper Conduct Practices. In the event that Amgen, following good faith consultation with BeiGene regarding any Affiliate or Third Party, raises reasonable concerns over the ability of such Affiliate or Third Party (including sub-distributors, wholesalers and pharmacies) conducting Distribution of Products in the Collaboration Territory to comply with the Quality and Compliance Standards or, if applicable, the Proper Conduct Practices, BeiGene shall not engage (or, if BeiGene has already engaged such Affiliate or Third Party, BeiGene shall promptly agree on corrective action with Amgen), such Affiliate or Third Party for Distribution of Products in the Collaboration Territory. Any dispute regarding the immediately preceding sentence shall be elevated to the JSC for final determination. Amgen shall have the right to audit BeiGene with respect to such Distribution activities, upon reasonable notice (at least [*]) and at a reasonable frequency (no more than once per year absent reasonable evidence of a concern), and BeiGene shall ensure that Amgen has the right to audit any such Affiliates or ...
AutoNDA by SimpleDocs

Related to Audits of BeiGene Distributors

  • Distributors The Manager shall make or cause to be made such arrangements as are expedient for the distribution of Units, having regard to the requirements of Applicable Laws and applicable stock exchange rules and regulations respecting such distribution of Units in the jurisdiction or jurisdictions in which they are to be distributed. It is understood and agreed that: (i) the Manager or the Investment Manager may distribute Units itself in the offering jurisdictions in which it is registered, or is exempt from such registration, under applicable Securities Legislation; and (ii) the Manager will retain the services of the Underwriters pursuant to the Underwriting Agreement to assist it in the distribution of the Units in the offering jurisdictions.

  • Notification and Distribution of Materials The Company shall notify the Holders in writing of the effectiveness of the Resale Shelf Registration Statement as soon as practicable, and in any event within one (1) Business Day after the Resale Shelf Registration Statement becomes effective, and shall furnish to them, without charge, such number of copies of the Resale Shelf Registration Statement (including any amendments, supplements and exhibits), the Prospectus contained therein (including each preliminary prospectus and all related amendments and supplements) and any documents incorporated by reference in the Resale Shelf Registration Statement or such other documents as the Holders may reasonably request in order to facilitate the sale of the Registrable Securities in the manner described in the Resale Shelf Registration Statement.

  • Royalties on Net Sales Novo will pay to Neose royalties as a percentage of annual Net Sales of each New Product during the Term at the applicable rates set forth in this Section 4.1 and in accordance with this Section 4:

  • Preparation for Each Auction; Maintenance of Registry of Existing Holders (a) As of the date hereof, the Fund shall provide the Auction Agent with a list of the Broker-Dealers previously approved by the Auction Agent and shall cause to be delivered to the Auction Agent for execution by the Auction Agent a Broker-Dealer Agreement signed by each such Broker-Dealer. The Auction Agent shall keep such list current and accurate based upon information provided to it by Broker-Dealers and shall indicate thereon, or on a separate list, the identity of each Existing Holder, if any, whose most recent Order was submitted by a Broker-Dealer on such list and resulted in such Existing Holder continuing to hold or purchase AMPS. Not later than five Business Days prior to any Auction Date for which any change in such list of Broker-Dealers is to be effective, the Fund shall notify the Auction Agent in writing of such change and, if any such change is the addition of a Broker-Dealer to such list, the Fund shall cause to be delivered to the Auction Agent for execution by the Auction Agent a Broker-Dealer Agreement signed by such Broker-Dealer. The Auction Agent shall have entered into a Broker-Dealer Agreement with each Broker-Dealer prior to the participation of any such Broker-Dealer in any Auction.

  • Marketing Rights Neither the Company nor any of its Subsidiaries have granted rights to license, market, or sell its products or services to any other Person and is not bound by any agreement that affects the Company’s (or any Subsidiary’s) exclusive right to develop, distribute, market or sell its products or services.

  • Third Party Vendors Nothing herein shall impose any duty upon DST in connection with or make DST liable for the actions or omissions to act of the following types of unaffiliated third parties: (a) courier and mail services including but not limited to Airborne Services, Federal Express, UPS and the U.S. Mails, (b) telecommunications companies including but not limited to AT&T, Sprint, MCI and other delivery, telecommunications and other such companies not under the party’s reasonable control, and (c) third parties not under the party’s reasonable control or subcontract relationship providing services to the financial industry generally, such as, by way of example and not limitation, the National Securities Clearing Corporation (processing and settlement services), Fund custodian banks (custody and fund accounting services) and administrators (blue sky and Fund administration services), and national database providers such as Choice Point, Acxiom, TransUnion or Lexis/Nexis and any replacements thereof or similar entities, provided, if DST selected such company, DST shall have exercised due care in selecting the same. Such third party vendors shall not be deemed, and are not, subcontractors for purposes of this Agreement.

  • Indemnification for Marketing Materials In addition to the foregoing indemnification, the Fund and the Investment Adviser also, jointly and severally, agree to indemnify and hold harmless each Underwriter, affiliates, directors, officers, employees and agents of each Underwriter, and each person, if any, who controls any Underwriter within the meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act, against any and all loss, liability, claim, damage and expense described in the indemnity contained in Section 6(a), as limited by the proviso set forth therein, with respect to any sales material.

  • Vendors (a) Section 4.28(a) of the Company Disclosure Letter sets forth, as of the date of this Agreement, the top ten (10) vendors based on the aggregate Dollar value of the Company’s and its Subsidiaries’ transaction volume with such counterparty during the trailing twelve months for the period ending December 31, 2020 (the “Top Vendors”).

  • BACKGROUND OF AGREEMENT 1.1 LICENSOR represents that it has certain intellectual property pertaining to services and technologies in the field of teleradiology, in respect to which it is prepared to grant a nonexclusive license to LICENSEE.

  • Sublicensees Licensee shall have the full right (but not the obligation) to sublicense those rights granted to it under Section 2.1 to a Third Party (a “Sublicensee”); provided, however, that, prior to the payment of the first milestone pursuant to Section 7.2, Licensee may not grant any such sublicense to any contract research organization conducting Clinical Trials of Products or any Third Parties conducting contract Manufacturing activities without Licensee’s prior written notice (at least twenty (20) Business Days in advance) to Lilly, which shall include a description of the rights to be granted and the purpose therefor, the identity of the Third Party and the countries involved, and Lilly’s prior written consent, but such consent shall only be required (i) until such time as Licensee is the holder of record for the Regulatory Materials related to Taladegib and (ii) to the extent such organization is not performing services for Licensee as of the Effective Date; and provided further, that Licensee shall remain responsible for the performance by any of its Sublicensees. With respect to any Sublicensee granted a sublicense to any Commercialization rights hereunder, Licensee shall ensure that each of its Sublicensees accepts in writing all applicable terms and conditions of this Agreement, including the non-compete, reporting, audit, inspection and confidentiality provisions hereunder. Each Sublicensee shall also be prohibited from further sublicensing. For the avoidance of doubt, (a) Licensee will remain directly responsible for all amounts owed to Lilly under this Agreement, and (b) each Sublicensee is subject to the negative and restrictive covenants set forth in Sections 2.3.1 and 2.5, respectively. Licensee hereby expressly waives any requirement that Lilly exhaust any right, power or remedy, or proceed against a subcontractor, for any obligation or performance hereunder prior to proceeding directly against Licensee.

Time is Money Join Law Insider Premium to draft better contracts faster.