Application Review and Agreement Process Sample Clauses

Application Review and Agreement Process. 1.1.1. Applications for product conformity assessment regarding to the Regulation (EU) 2017/745 concerning Medical Devices shall be filed in writing along with an application form. Verbal applications shall not be accepted. The company must fill in and sign the application forms completely. The documents required in the application form, the QMS documentation and the Technical Documentation must be delivered to SZUTEST Konformitätsbewertungsstelle GmbH along with this form. The company declares that the information it has provided is correct and complete and agrees that any discrepancy may lead to variations in the terms and conditions of the agreement or termination of the agreement by signing the application form. 1.1.2. SZUTEST Konformitätsbewertungsstelle GmbH shall initiate the application review process upon receiving the application documents. It may demand the company to provide additional documents other than those specified in the application form during this process. SZUTEST Konformitätsbewertungsstelle GmbH may consult to the Federal Institute for Drugs and Medical Devices listed in the ▇▇▇▇▇://▇▇▇.▇▇▇▇▇.▇▇ web site based on their scope of coverage in Germany or competent authorities of other Member States during the process of application assessment. During the application the company shall inform SZUTEST Konformitätsbewertungsstelle GmbH for the missing parts of the Technical Documentation together with a plan and declaration for completeness. SZUTEST Konformitätsbewertungsstelle GmbH shall take this into consideration. If the application review identifies missing parts for the Technical Documentation, the company shall submit these documents not later than the imposed deadline by SZUTEST Konformitätsbewertungsstelle GmbH. If the required documentation will not be received within maximum 15 days after the imposed date, SZUTEST Konformitätsbewertungsstelle GmbH may cancel the application. 1.1.3. SZUTEST Konformitätsbewertungsstelle GmbH may contact the previous Notified Body or Certification Body of the company or demand the company to provide the reports and documents issued by that notified body or certification body for transfer applications. 1.1.4. The application assessment may result positively or negatively. In case it is negative, the company shall be duly informed. 1.1.5. In case the application assessment results positively, an agreement shall be signed with the company. 1.1.6. Upon the signature of the agreement, the company must pe...
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Application Review and Agreement Process. 1.1.1. Applications for product conformity and ISO 13485 assessment concerning Medical Devices shall be filed in writing along with an application form. Verbal applications shall not be accepted. The company shall fill in and sign the application forms completely. The documents required in the application form shall be delivered to SZUTEST along with this form. The company declares that the information it has provided is correct and complete and agrees that any discrepancy may lead to variations in the terms and conditions of the agreement or termination of the agreement by signing the application form. 1.1.2. SZUTEST shall initiate the application assessment process upon receiving the application documents. It may demand the company to provide additional documents other than those specified in the application form during this process. SZUTEST may consult to the Competent Authority during the process of application assessment. 1.1.3. SZUTEST may contact the previous Notified Body or Certification Body of the company or demand the company to provide the reports and documents issued by that notified body or certification body for transfer applications. 1.1.4. The application assessment may result positively or negatively. In case it is negative, the company shall be duly informed. 1.1.5. In case the application assessment results positively, an agreement shall be signed with the company. 1.1.6. Upon the signature of the agreement, the company shall perform the financial obligations provided in the agreement and deliver all the documentation including specifically the Technical File, Design dossier and quality management system documentation to SZUTEST within maximum 10 business days. 1.1.7. As for transfer applications, SZUTEST may demand the company and the previous notified body to execute a transfer agreement with no financial value. 1.1.8. SZUTEST may contact the previous notified body or certification body of the company for transfer applications and reject the application of the company according to the information given. If it is not possible to receive information from the previous notified body or certification body, SZUTEST may evaluate the application as a new application or else reject it. 1.1.9. After the agreement is executed, the documentation delivered by the company shall be reviewed and missing documents, if any, shall be determined and notified to the company. The company shall deliver the missing documents within maximum 10 business days....
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Related to Application Review and Agreement Process

  • Agreement Review If, pursuant to section 25.10 (Review of Agreement) of the Bilateral Agreement, the Bilateral Agreement is reviewed after three or five years, or both, of the effective date of the Bilateral Agreement, and any changes to the Bilateral Agreement are required as a result, the Parties agree to amend the Agreement as necessary and in a manner that is consistent with such changes.

  • Project Review All plans, specifications, work write-ups, projected cost estimates, punch lists or other means of outlining work on a particular project will be submitted in writing to HCD for review and approval prior to bidding. HCD Construction and Rehabilitation Inspectors will review these items for compliance with new construction and/or rehabilitation standards and materials use.

  • Document Review (a) During the Evaluation Period, Purchaser and the Licensee Parties shall have the right to review and inspect, at Purchaser’s sole cost and expense, all of the following which, to Seller’s Knowledge, are in Seller’s possession or control (collectively, the “Documents”): all existing environmental reports and studies of the Real Property, real estate tax bills, together with assessments (special or otherwise), ad valorem and personal property tax bills, covering the period of Seller’s ownership of the Property; Seller’s most current lease schedule in the form attached hereto as Exhibit F (the “Lease Schedule”); current operating statements; historical financial reports; the Leases, lease files, Service Contracts, and Licenses and Permits. Such inspections shall occur at a location selected by Seller, which may be at the office of Seller, Seller’s counsel, Seller’s property manager, at the Real Property, in an electronic “war room” or any of the above. Purchaser shall not have the right to review or inspect materials not directly related to the leasing, maintenance and/or management of the Property, including, without limitation, Seller’s internal e-mails and memoranda, financial projections, budgets, appraisals, proposals for work not actually undertaken, income tax records and similar proprietary, elective or confidential information, and engineering reports and studies. (b) Purchaser acknowledges that any and all of the Documents may be proprietary and confidential in nature and have been provided to Purchaser solely to assist Purchaser in determining the desirability of purchasing the Property. Subject only to the provisions of Article XII, Purchaser agrees not to disclose the contents of the Documents or any of the provisions, terms or conditions contained therein to any party outside of Purchaser’s organization other than its attorneys, partners, accountants, agents, consultants, lenders or investors (collectively, for purposes of this Section 5.2(b), the “Permitted Outside Parties”). Purchaser further agrees that within its organization, or as to the Permitted Outside Parties, the Documents will be disclosed and exhibited only to those persons within Purchaser’s organization or to those Permitted Outside Parties who are responsible for determining the desirability of Purchaser’s acquisition of the Property. Purchaser further acknowledges that the Documents and other information relating to the leasing arrangements between Seller and Tenants are proprietary and confidential in nature. Purchaser agrees not to divulge the contents of such Documents and other information except in strict accordance with the confidentiality standards set forth in this Section 5.2 and Article XII. In permitting Purchaser and the Permitted Outside Parties to review the Documents and other information to assist Purchaser, Seller has not waived any privilege or claim of confidentiality with respect thereto, and no third party benefits or relationships of any kind, either express or implied, have been offered, intended or created by Seller, and any such claims are expressly rejected by Seller and waived by Purchaser and the Permitted Outside Parties, for whom, by its execution of this Agreement, Purchaser is acting as an agent with regard to such waiver. (c) Purchaser acknowledges that some of the Documents may have been prepared by third parties and may have been prepared prior to Seller’s ownership of the Property. PURCHASER HEREBY ACKNOWLEDGES THAT, EXCEPT AS EXPRESSLY SET FORTH IN SECTION 8.1 BELOW, SELLER HAS NOT MADE AND DOES NOT MAKE ANY REPRESENTATION OR WARRANTY REGARDING THE TRUTH, ACCURACY OR COMPLETENESS OF THE DOCUMENTS OR THE SOURCES THEREOF. SELLER HAS NOT UNDERTAKEN ANY INDEPENDENT INVESTIGATION AS TO THE TRUTH, ACCURACY OR COMPLETENESS OF THE DOCUMENTS AND IS PROVIDING THE DOCUMENTS SOLELY AS AN ACCOMMODATION TO PURCHASER.