Amendment to Agreement. 1. The contracting parties hereby agree to amend the Agreement to adjust the Study budget in connection with the update of the Study protocol (Protocol version11): a) The current Appendix 1: Financial Terms of the Agreement is deleted in its entirety and replaced with the new Appendix 1 – Revised by Amendment No. 1 attached to this Amendment. III.
Amendment to Agreement. Due to the significant increase in the number of prematurely terminated patients with regard to the pandemic situation, the Parties hereby agreed on these amendments to the Agreement:
Amendment to Agreement. 1. The Parties hereby agreed to amend the Agreement as follows: a) The current wording of Section 2.10, Art. 2 of the Agreement is deleted and its new wording is inserted: “Contract Partners shall inform the trial subjects involved in the Study that they may not participate in any other study during the course of this Study and during any suspension period specified in the Protocol without the prior written approval of Bayer.” b) The first paragraph of Section 2.17, Art. 2 of the Agreement is deleted and its new wording is inserted: “Contract Partners are aware that Bayer or a third party on behalf of Bayer is monitoring the conduct of the Study closely and is visiting the Center on a regular basis. Contract Partners agree to appropriately support such monitoring activities, including without limitation by providing such monitor with access to the facilities and data as required, and cooperate with Bayer or the relevant third party in this regard. The commitment of Contract Partners under the previous sentence includes (but is not limited to) the obligation to allow verification of the correctness and completeness of data entered into CRF against source documentation in its original form (i.e. not its copies, even if verified), irrespective of whether this documentation is kept in paper and / or electronic form, to the extent of the informed consent granted by the trial subject. Principal Investigator shall be available for personal discussion, if requested by Xxxxx.” c) From Section 4.4, Art. 4 of the Agreement, its second sentence is deleted and a new one inserted: “All remunerations and costs according to this Agreement and Appendix No. 2 of this Agreement will be paid to Center in the following manner: Retrospectively for the past and not yet invoiced period always by April 30 and September 30 of each calendar year of the Study, Principal Investigator together with the monitoring person delegated by Xxxxx will mutually agree in writing or by email on the overview of number, sort and corresponding value of particular activities performed by Principal Investigator and/or other Study Team Members, that shall be paid by Bayer pursuant to this Agreement (i.e. Invoice proposal), sent by monitoring person delegated by Xxxxx.”
Amendment to Agreement. 1. The Parties hereby agreed to amend the Agreement to update the study budget in compliance with Protocol Amendment 1 (Integrated Clinical Study Protocol, version 2.0 dated 29 September 2020). 2. Appendix 1 is deleted in its entirety and replaced with the new Appendix 1 – Revised by Amendment No. 2 attached to this Amendment No. 2. III. Final
Amendment to Agreement. 1. The Parties hereby agreed to amend the Agreement due to change of Study protocol and informed consent for patients as follows: a) The current table in Section 4 of the Appendix 1 of the Agreement is deleted and new one inserted: III. Final
Amendment to Agreement. 1. The Parties hereby agreed to amend the Agreement as follows:
Amendment to Agreement. 1. In connection with the change of identification of the payment agent and an update of the Study budget due to its Protocol Amendment, the Parties hereby agreed on the following amendments to the Agreement: a) the current wording of the first subparagraph in Sec. 4.3 in Article 4 of the Agreement is deleted in its entirety and replaced by the following new wording: “The Contracting Partners acknowledge and agree that Sponsor processes payments of any remuneration and reimbursement which shall be paid to the Center under this Article hereof and Appendix 1 through its administrative payment agent IQVIA Clinical Trial Payments (hereinafter referred to as the “Payment Agent”), unless explicitly agreed otherwise.” b) The current wording of the eighth, nineth and tenth subparagraph in Sec. 4.3 in Article 4 of the Agreement is deleted in its entirety and replaced by the following new wording: Invoices shall be issued in English language in the name of payer: BAYER s.r.o.
Amendment to Agreement. 1. The Parties hereby agreed to amend the Agreement as follows: a) The current wording of the first paragraph of Preamble of the Agreement is amended so that the existing title of the Protocol is replaced by the following: “A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids” b) From Section 3, Art. II of the Agreement, its penultimate and last sentences, as stated below, are deleted: “The involvement of any such Study Team Physicians in the Study requires his/her prior signature of a declaration as outlined in the template attached as Appendix No. 2. Such signed declarations shall be forwarded by Contract Parties to Bayer.” c) From Section 5, Art. II of the Agreement, its penultimate and last sentences, as stated below, are deleted: “The involvement of any Study Team Member in the Study requires his/her prior signature of a declaration as outlined in the template attached as Appendix No. 2. Such signed declarations shall be forwarded by Contract Parties to Bayer.” d) The second paragraph of Section 8, Art. II of the Agreement is deleted and its new wording is inserted: “Recruitment of the trial subjects is expected to begin on x and to be completed until x. Expected recruitment rate is x subjects/3 months.” e) The current wording of Section 11, Art. II of the Agreement is deleted and its new wording is inserted: “Contract partners shall inform the trial subjects involved in the Study that they may not participate in any other study during the course of this Study and during any suspension period specified in the Protocol without the prior written approval of Bayer.” f) The first paragraph of Section 19, Art. II of the Agreement is deleted and its new wording is inserted: “Contract partners are aware that Bayer or a third party on behalf of Bayer is monitoring the conduct of the Study closely and is visiting Center on a regular basis. Contract parners