|ARRAY BIOPHARMA INC filed this Form 10-K on 08/11/2017|
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(c) such Party sells or transfers to any Third Party, in one or more related transactions, properties or assets representing all or substantially all of such Party’s assets to which this Agreement relates.
For the purpose of this definition of Change in Control: (i) “person” and “group” have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term “group” includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the aforesaid Act; (ii) a “beneficial owner” shall be determined in accordance with Rule 13d-3 under the aforesaid Act; (iii) the terms “beneficially owned” and “beneficially own” shall have meanings correlative to that of “beneficial owner”; and (iv)“Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity or any government, any agency or political subdivisions thereof.
Such “person” or “group” in Section 1.11(a), such surviving Person in Section 1.11(b) or such Third Party in Section 1.11(c) shall be referred to herein as “Acquirer”.
1.7 “Clinical Studies” means any human clinical study of a Product, including without limitation Post-Approval Marketing Clinical Studies.
1.8 “Combination Product” means any pharmaceutical preparations, in any dosage strengths, formulations and methods of administration, that combine Binimetinib or Encorafenib and one or more other active ingredients (other than Binimetinib or Encorafenib) in fixed dose combination, whether co-formulated or co-packaged.
1.9 “Commercialization” means all processes and activities conducted to establish and maintain sales for the Products, including offering for sale, distribution, detailing, selling (including launch), promoting, importing, exporting, market access activities, all marketing activities undertaken prior to and after the launch of the Products (including education and advertising activities), branding, developing promotional materials, advertising, organizing speakers programs and post-marketing safety surveillance and reporting. “Commercialize” and “Commercializing” shall have the correlative meanings.
1.10 “Companion Diagnostic” means an in vitro diagnostic medical device as defined in the European directive 98/79/EC; for the avoidance of doubt the term Companion Diagnostic includes companion diagnostics for a pharmaceutical product as defined in FDA’s “Draft Guidance for Industry and Food and Drug Administration Staff – In Vitro Companion Diagnostic Devices”.
1.11 “Control” (including any variations such as “Controlled” and “Controlling”), in the context of intellectual property rights, data and/or other information, means that such Party or its Affiliate owns, is licensed or otherwise possesses rights to such intellectual property, data and/or information,