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of the FTC to appoint a trustee after a failure to comply as a means to assure that assets are returned as required.150 Another included an express provision for the appointment of an interim trustee to ensure that the development of a particular product is maintained in the future.151 Perhaps most detailed, one consent order provided for the appointment of an interim monitor to ensure that information is adequately communicated to the FDA, that the company acquiring the divested product line gets assistance with a pending abbreviated new drug application (“ANDA”), and that transitional services are provided so the third party can eventually manufacture the product independently.152 These last two monitor duties relate to supply arrangements, which are further discussed below.
C. Prior Approval of Certain Activity
The prior approval provisions were tied to the acquisition of property or assets in the future. One iteration required the prior approval of the FTC before the acquisition of any stock in a company that manufactures or is an exclusive distributor for another manufacturer of a specific product.153 A second required prior approval from the FTC before acquisition of any manufacturing, production, or distribution capabilities for a specific product.154 A third prohibited the acquisition of certain listed assets without the prior approval of the FTC.155
There were several consent orders requiring the relinquishment of assets, including provisions requiring the relinquishment of marketing rights to another firm156 and the relinquishment of “all options to regain control over” a certain product.157 Termination requirements took many forms, such as the termination of an existing development and manufacturing agreement with a third party and transfer of manufacturing rights back to a third party,158 termination of a co-marketing agreement with a third party,159 termination of
150. See generally, Novartis AG, supra note 106, at 29-32. 151. See Pfizer Inc., supra note 143112, at 55. 152. See Akorn Inc., supra note 130, at 2-37. 153. See IVAX Corp., supra note 102, at 362 (specifying that prior approval is needed for ten years following the date the order becomes final). 154. See Dow Chemical Co., et al., supra note 92, at 742 (specifying that prior approval is needed for ten years following the date the order becomes final). 155. See Schering-Plough Co., supra note 116, 115 at 23-24 (specifying that prior approval is needed for ten years following the date the order becomes final). 156. See generally Watson Pharm., supra note 125, at 2-44. 157. See Glaxo Wellcome PLC, et al., supra note 96, at 56. 158. See generally Watson Pharm. Inc., et al. supra note 125. 159. See Baxter Int’l Inc., et al., supra note 88, at 49.