(p)“Finished Device” shall have that same meaning set forth in 21CFR§820.3.
(q)“Governmental Authority” means any country, including any political subdivision thereof, court instrumentality, or agency thereof, and any other federal, state, or public authority, domestic or foreign, exercising governmental powers and having jurisdiction, and all statutes, laws, ordinances, regulations, orders, decrees, permits, writs, process and rules issued thereby which may be applicable to the Parties’ performance under this Agreement.
(r)“Improvements” has the meaning given to such term in Section 5.2
(s)“Intellectual Property Right” means any and all intellectual property rights and industrial property rights and all other proprietary rights, including patents, patent rights, copyrights, trademarks, and trade secrets and all registrations and applications for all of the foregoing in any jurisdiction.
(t)“Long Lead-Time Components” shall refer to those Components with procurement lead times greater than [***] ([***]) [***].
(u)“MOQ” shall refer to that Minimum Order Quantity of Components that certain suppliers may require generally or at certain price points.
(v)“MRO” shall refer to Maintenance, Repair and Operations supplies and consumables that are necessary for normal equipment maintenance, repair and manufacturing operations but not typically included in the Specifications.
(w)“NCNR” shall refer to Component purchases that are non-cancellable and/or non-returnable, whether designated as such at purchase or that become NCNR after purchase (including “broken” packages, open reels, or passage of time).
(x)“Manufacturer of Record” shall have that meaning set forth for “Manufacturer” in 21CFR§820.3.
(y)“Medical Component” shall have that meaning set forth for “Component” in 21CFR§820.3 .
(z)“Nonconforming Product” shall refer to a Product that does not conform to the Product warranty provided in Section 12.3 below.
(aa) “Obsolete Components” shall mean the individual Authorized Purchase Component inventory for which there is no demand based upon Hyperfine’s Orders and/or Forecast (whether as a result of an ECO or any other reason whatsoever), even though Hyperfine considers the Products that incorporate such Components as “active” Products because such Products remain on Hyperfine’s Product list or price list made available to Hyperfine’s end users.
MANUFACTURE AND SUPPLY AGREEMENT
HYPERFINE RESEARCH, INC. AND BENCHMARK ELECTRONICS INC.
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