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SEC Filings

8-K
OREXIGEN THERAPEUTICS, INC. filed this Form 8-K on 07/31/2018
Entire Document
 


Patheon” means Patheon Inc. and any successor thereto.

Product Liability Claim” means any claim alleging (a) bodily injury or property damage arising out of any Contrave, Mysimba, naltrexone, bupropion or naltrexone hydrochloride/bupropion hydrochloride sold by Seller prior to the Closing or (b) personal or advertising injury but solely to the extent such personal or advertising injury arises out of clinical trials sponsored by Seller prior to the Closing and solely to the extent a clinical trial participant incurs such personal or advertising injury, in each case arising out of an accident, including continuous or repeated exposure to the same general harmful conditions; provided that Product Liability Claims shall not include claims relating to any of the following: (i) asbestos, (ii) bodily injury or property damage for which Seller is obligated to pay damages by reason of the assumption of such liability by contract, (iii) with respect to the Contrave Holdback Bottles, acts or omissions prohibited by applicable Law, including without limitation, the use of any materials prohibited by applicable Law, (iv) actual or alleged breach of contract by Seller, (v) criminal, dishonest, fraudulent or malicious conduct or acts of intentional wrongdoing by Seller, whether actual or alleged, (vi) bodily injury to any employee or any family member thereof, (vii) failure by Seller to prevent unauthorized access to information or systems, (viii) with respect to the Contrave Holdback Bottles, failure to comply with current Good Manufacturing Practices as promulgated by the FDA, including but not limited to, the presence of fungi or bacteria in a building or structure, (ix) actual or alleged breach by Seller of Intellectual Property rights, (x) exposure to lead or lead-containing products, (xi) medical services, (xii) misuse of confidential information, (xiii) bodily injury or property damage caused by nuclear material, (xiv) pollutants, (xv) exposure to silica or silica-containing products, and (xvi) the Contrave Holdback Bottles, in each case to the extent arising from or based on any act, omission or circumstance occurring, arising or existing prior to the Closing Date.

Purchaser Indemnified Parties” has the meaning set forth in Section 8.2(a).

Recall” means that certain potential recollection of the Contrave Impacted Bottles which may be initiated by the Seller (prior to the Closing) or the Purchaser (after the Closing), in consultation with FDA, based on the matter described in the Field Alert Report submitted to the FDA by the Seller on July 16, 2018.

Release Condition” has the meaning set forth in Section 2.13.

Secured Notes” means the secured notes issued by the Debtor under the Indenture.

Third Party Claim” has the meaning set forth in Section 8.3.

 

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