Force Majeure has the meaning defined in Section 9(a).
Governmental Authority means any court, agency, department, authority, or other instrumentality of any multi-national, national, state, county, city, province, or other political subdivision.
IDE means investigational device exemption.
Immediately means, with respect to any obligation of a Party hereunder to act in a certain manner upon the occurrence of any event, as soon as possible upon becoming aware of such event and without delay, and in any case within one (1) Business Day.
Indemnitee has the meaning defined in Section 7.3(a).
Indemnitor has the meaning defined in Section 7.3(a).
Individual Purchase Order means any purchase order placed by Acutus with Biotronik for Products.
Initial Term has the meaning defined in Section 12.1(a).
Intellectual Property Rights means all and any intellectual property rights, including any copyrights, utility model rights, design rights, patent rights, trademark rights, topography rights, trade secret rights, know-how rights, rights in databases as well as any other proprietary rights, in all cases whether or not registered or registerable.
Lead Time means eight (8) calendar weeks. In case of FCA (Incoterms 2020), the Lead Time will be calculated from the date of the respective Individual Purchase Order receipt by Biotronik to the date the purchased Bio Products are ready to be picked up from the pick-up point designated by Biotronik, provided that if the last day of the Lead Time is not a Business Day, the Lead Time will end on the following Business Day.
License and Distribution Agreement means the agreement titled License and Distribution Agreement, entered into between the Parties and VascoMed GmbH, having an effective date of June 28, 2019
Manufacturer of Record shall mean the natural or legal person responsible for the design, manufacture, packaging and labelling of a medical device before it is placed on the market, regardless of whether these operations are carried out by that person or on his behalf by a Third Party.
Marketing Authorization Approval or MAA means, with respect to a product in any country or jurisdiction, any approval, registration, license, or authorization from a Regulatory Authority or other Governmental Authority in that country or jurisdiction that is necessary to offer for sale, market, and sell such product in such country or jurisdiction.
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