SUBJECT MATTER OF THIS AGREEMENT. CONDITION PRECEDENT The subject matter of this Agreement is (i) the sale and transfer of all Shares held by the Sellers and the investment funds and separate accounts managed by the Sellers to the Purchaser as well as (ii) the settlement of all Legal Proceedings, to the extent the Sellers are a party to the Legal Proceedings; (iii) the agreement by the Sellers not to make future investments in the Company; and (iv) a general release relating to their investment in the Company.
SUBJECT MATTER OF THIS AGREEMENT. Biogen pověřuje Zdravotnické zařízení a Zkoušejícího prováděním Klinického hodnocení s výše uvedeným názvem jako součásti Studie v souladu s ustanoveními uvedenými v protokolu Studie (ve znění příležitostně změněném a písemně potvrzeném společností Biogen) (dále jen „Protokol“) a dále v této smlouvě; (a) Biogen entrusts the Institution and the Investigator to conduct the Trial as part of the Study with the above title in accordance with the provisions as stipulated in the Study protocol governing the Trial (as may be amended from time to time and confirmed in writing by Biogen) (the Protocol) and in this Agreement below.
SUBJECT MATTER OF THIS AGREEMENT. 1. The Parties are bound by an Agreement, the performance of which shall involve processing of Personal Data.
2. The Data Processor agrees to process Personal Data on the basis of the Data Processing Agreement and in compliance with GDPR.
3. In case of any inconsistencies between member state laws regarding data protection and GDPR following May 25, 2018, provisions of the GDPR shall prevail. Until May 25, 2018 member state regulations regarding data protection shall remain in force.
4. Terms used in the Data Processing Agreement, which have not been individually defined in its provisions shall be considered as defined within GDPR.
SUBJECT MATTER OF THIS AGREEMENT. 3.1 The subject matter of this Agreement is:
3.1.1 transfer for consideration of the ownership title to the Railway Carriages from the Seller to the Buyer, namely in the way and under the terms and conditions stipulated herein;
3.1.2 lease back of the Leased Carriages to the Lessee by the Lessor, namely in the way and under the terms and conditions stipulated herein; and
3.1.3 regulation of the rights and obligations of the Parties related to the Transfer and the Lease; and
3.1.4 regulation of other rights and obligations of the Parties, namely in the way and under the terms and conditions stipulated herein.
SUBJECT MATTER OF THIS AGREEMENT. 2.1. The Bank shall make available to the Borrower a credit facility with a limit of 2,085,000,000.00 (two billion and eighty-five million 00/100) US dollars (hereinafter referred to as the “Credit”) for financing the Borrower’s costs in accordance with the Project Budget until the commissioning of the Facilities; and the Borrower shall repay the Credit, pay interests to the Bank thereon (hereinafter referred to as “Interest”) and fulfill other obligations under this Agreement in accordance with its terms and conditions.
SUBJECT MATTER OF THIS AGREEMENT. Biogen pověřuje Zdravotnické zařízení a Zkoušejícího prováděním Klinického hodnocení s výše uvedeným názvem jako součásti Studie v souladu s ustanoveními uvedenými v protokolu Studie (ve znění aktualizovaném dle potřeby a písemně potvrzeném společností Biogen) (dále jen „Protokol“) a dále v této smlouvě.
SUBJECT MATTER OF THIS AGREEMENT. 1) The Contracting parties entered into this Agreement in order to establish their rights and obligations arising from their collaboration in search and identification of startup companies with specific profiles based on criteria required by Partner and making initial contact with such startup companies via e-mail or other communication tools using specific call to action messages (hereinafter “Startup scouting”). Based on this Agreement the WP shall provide its services comprising of Startup scouting using the Leadspicker for the benefit of Partner regarding Partner’s project called ESA BIC Prague February 2021 (hereinafter as the “Project”).
2) The specific criteria and timeline of Startup scouting regarding the Project shall be agreed on the initial meeting of the Contracting parties (hereinafter as the “kick-off meeting”) based on requirements of Partner. Partner hereby undertakes to take part in the kick-off meeting and to provide WP with all information and materials required by WP in order to execute Startup scouting within three days after the kick-off meeting unless agreed otherwise. Partner is especially obligated to provide WP with a blacklist, i.e. the list of startup companies that shall not be contacted within Startup scouting regarding the Project. In case the Partner fails to provide the blacklist to WP within three days after the kick-off meeting, WP is entitled to contact all relevant startup companies without any restrictions.
3) Criteria and timeline of Startup scouting determined at the kick-off meeting shall be recorded within a set-up document confirmed by both Contracting parties. Any changes of the set-up document after the kick-off meeting are possible only upon consent of both Contracting parties.
4) The deadline of Startup scouting shall be determined upon agreement of both Contracting parties and recorded in the set-up document (hereinafter as the “Deadline”). In case Partner is in delay with provision of any information or materials required by WP the Deadline shall be extended by the period of Partner’s delay.
SUBJECT MATTER OF THIS AGREEMENT. Biogen Idec pověřuje Zdravotnické zařízení, Zkoušejícího a Spolu-zkoušejícího prováděním Klinického hodnocení s výše uvedeným názvem jako součásti Studie v souladu s ustanoveními uvedenými v protokolu Studie (ve znění příležitostně změněném a písemně potvrzeném společností Biogen Idec) (dále jen „Protokol“) a dále v této smlouvě; (a) Biogen Idec entrusts the Institution, the Investigator and the Sub-investigator to conduct the Trial as part of the Study with the above title in accordance with the provisions as stipulated in the Study protocol governing the Trial (as may be amended from time to time and confirmed in writing by Biogen Idec) (the Protocol) and in this Agreement below.
SUBJECT MATTER OF THIS AGREEMENT. This RA Agreement shall clarify the responsibilities of XXXX and KANGZHE during the execution of the Consolidation Agreement with respect to Regulatory Affairs. The term “Regulatory Affairs“ or “RA” in general refers to all activities that aim to ensure that the development, manufacturing, marketing, sales, distribution and advertising of the Products and all related activities of the Parties comply with applicable regulations and laws if not otherwise provided for in this RA Agreement. Regulatory Affairs with respect to Products particularly refer to all aspects linked with Marketing Authorizations, Clinical Studies, manufacturing of the Products, Product Information and Labelling, medical and scientific information and advertising. In particular, this RA Agreement complements the Consolidation Agreement by specifically governing the cooperation between the Parties on following regulatory aspects of their distribution relationship: obtaining, maintenance, renewals and variations of Marketing Authorizations (including action timelines, document format etc.); the compliance with the regulation on Product Information (PI) and Labelling of Products; the compliance with the regulation on Clinical Studies. This RA Agreement also governs the cooperation between the Parties with respect to the interactions and communication with Regulatory Authorities regarding the Products, their regulatory status or their distribution in the Territory. This RA Agreement does not govern the regulatory aspects related to the development, manufacturing and pharmacovigilance as far as covered by other Exhibits to the Consolidation Agreement. Furthermore, this RA Agreement does not govern aspects of medical and science information, reimbursement, marketing and advertising which are not specifically related to MAA, MA, PI, Labelling of Products, interactions and communication with Regulatory Authorities or surveillance of Regulatory Authorities. With regard to Clinical Studies of 2016 Products the provisions of the Consolidation Agreement and its Exhibits referring to Clinical Studies of 2016 Products and 2016 Product IMPs shall take precedence over the provisions of this RA Agreement.
SUBJECT MATTER OF THIS AGREEMENT. 2.1 This Agreement constitutes the written agreement between XXXX and KANGZHE in accordance with Art. 12 of the Directive 2003/94/EC and § 9 (1) of the German “Ordinance on the Manufacturing of Medicinal Products and Active Pharmaceutical Ingredients” (“AMWHV”). This Agreement sets forth the roles and delineates the pharmaceutical responsibilities of the Parties in relation to the Manufacturing of 2016 Product IMPs and their use in the Clinical Studies of 2016 Products.
2.2 Under this Agreement, XXXX shall manufacture or have manufactured for KANGZHE the 2016 Product IMPs as Finished Products in accordance with the specifications of the 2016 Product IMPs as accepted by the competent authorities and the AMWHV and current GMP. Except for the responsibilities set forth in this Agreement, any rights and obligations in relation to the 2016 Product IMPs shall be determined in accordance with the Consolidation Agreement and its Exhibits (e.g., Safety Reporting Agreement, Regulatory Affairs Agreement), if applicable.