Specified Company Products definition

Specified Company Products shall have the meaning set forth in Section 1.6(a)(vii).

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Specified Company Products means (i) the Company’s products described on Annex II to Exhibit A of the Merger Agreement, including any derivatives or enhancements thereof; and (ii) Parent’s 2x1 100 Ghs WSS product if (and only if) (and only with respect to sales occurring after): (a) the labor hours required to manufacture such product become less than or equal to the number of labor hours currently required to manufacture the Company’s 2x1 product, as reasonably determined by Parent; and (b) such product is of a quality equal to or better than the Company’s current 2x1 product, as reasonably determined by Parent.

Specified Company Products means the Company’s sirolimus protein-bound particles for injectable suspension (albumin-bound) (“nab-sirolimus”), currently marketed for sale to consumers by Seller and the Company under the brand name FYARRO® as approved by the FDA under New Drug Application 213312, and any pharmaceutical products comprising nab-sirolimus, alone or in combination with one or more additional active pharmaceutical ingredients, in each case to the extent such additional active pharmaceutical ingredients are owned or controlled by Seller or the Company in such combination (whether packaged together or in the same therapeutic formulation or otherwise).

Examples of Specified Company Products in a sentence

• Each Seller hereby acknowledges and agrees that effective upon the occurrence of the Closing, the Company (as a subsidiary of Buyer) will have the sole and exclusive ownership of the Intellectual Property underlying the Specified Company Products and the unconditional right to manufacture the Specified Company Products but only in the manner manufactured by the Company as of the Effective Date.

• For the avoidance of doubt, each Seller acknowledges and agrees that the utilization of the Company’s manufacturing plant, in and of itself, by Buyer and its Affiliates after the Closing to manufacture the Specified Company Products, but only to the extent manufactured as of the Effective Date, shall not be deemed to infringe upon any of the Intellectual Property of any Seller.

• To the Knowledge of the Company and Seller, neither the Company Intellectual Property in whole or in part nor any of the Specified Company Products infringe, misappropriate, dilute or violate any intellectual property rights owned or controlled by any other Person.

• Except as set forth in Section 3.19(b) of the Seller Disclosure Letter, each of the Specified Company Products are (i) produced or manufactured in compliance in all material respects with applicable Law and (ii) not adulterated or misbranded within the meaning of any applicable Law.

• Section 3.19(e) of the Seller Disclosure Letter contains a complete and accurate list of all clinical trials sponsored or conducted by Seller or the Company that have been conducted or are currently being conducted with respect to the Specified Company Products.

• With respect to the Business and Specified Company Products, there is no act, omission, event, or circumstance that would reasonably be expected to constitute or result in (x) any Legal Proceeding; (y) a material violation; or (z) a failure to comply relating to compliance with any Healthcare Law, by the Company or Seller, or any of their respective officers, directors, managers, employees, or to the Company’s Knowledge, Affiliates, agents or contractors of the Company or Seller.

More Definitions of Specified Company Products

Specified Company Products means the following Company Products: E-wire guide Wire (GUIAS METALICOS JOTEC) IV 80152120001 10/1/2022 E-vita open plus Stent Graft System / E-vita thoracic 3G Stent Graft System (PROTESE VASCULAR E-VITA JOTEC) IV 80152120002 10/1/2022 E-njoy Peripheral Stent (FAMÍLIA DE STENTS PERIFÉRICOS JOTEC) IV 80152120003 11/12/2017 FlowLine Bipore ePTFE Vascular Graft (FAMÍLIA DE ENXERTOS VASCULARES EPTFE JOTEC) IV 80152120005 12/10/2022 Textile Vascular Grafts FlowNit Bioseal / FlowWeave Bioseal (FAMÍLIA DE ENXERTOS VASCULARES INORGÂNICOS JOTEC) IV 80152120011 12/8/2018 E-vita abdominal XT Stent Graft System (PRÓTESE VASCULAR ABDOMINAL E-VITA JOTEC) IV 80152120016 9/28/2019 E-asy plus Introducer Sheath (INTRODUTOR EASY) II 80152120017 10/26/2019 E-xpand Stent Graft Balloon Catheter (CATETER BALÃO E-XPAND JOTEC) IV 80152120019 2/25/2020 E-xl Aortic Stent (ENDOPRÓTESE AÓRTICA E-XL) IV 80152120021 5/31/2020 E-liac Stent Graft System (E®-LIAC SISTEMA STENT GRAFT ) III 80152120025 5/4/2020 E-ventus BX Peripheral Stent Graft System (Stent Periférico Recoberto E-ventus BX ) III 80152120026 6/6/2021 E-tegra Stent Graft System (Sistema de Endoprótese E-Tegra) III 80152120027 9/5/2021 

Specified Company Products means any products or assets of the Company or any of its Subsidiaries (including the ANDAs therefor) that as of the date hereof are not approved by the FDA under Subpart C of Part 314 of Title 21 of the Code of Federal Regulations (as evidenced by receipt by the Company or a Subsidiary thereof of a written approval letter from the FDA approving the immediate marketing and sale of such product) and (2) not, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole.