Horizon Territory definition
Examples of Horizon Territory in a sentence
For changes to the Product Specifications or Manufacturing Process proposed by Horizon (including any change that is required solely by a Regulatory Authority in the Horizon Territory), Horizon promptly shall reimburse AstraZeneca for all reasonable internal and external costs incurred by AstraZeneca or any Pass-Through Affiliate (including any and all costs AstraZeneca or any Pass-Through Affiliate must pay to a Pass-Through Supply Vendor) in connection with the implementation of any such change.
During the Term, subject to the terms and conditions of this Agreement, AstraZeneca will Manufacture or have Manufactured and supply or have supplied to Horizon such quantities of Supplied Products, including samples, as requested by Horizon for use by Horizon and its Sublicensees in connection with activities with respect to Supplied Products in the Horizon Territory, including Exploitation activities in the Horizon Territory.
In the event that any Supplied Product is Recalled in the Horizon Territory, Horizon shall be responsible for all costs and expenses related to such Recall and shall reimburse AstraZeneca or its applicable Pass-Through Affiliate for any out-of-pocket expenses incurred in connection with any such Recall, including any amounts payable to any Pass-Through Supply Vendors with respect thereto.
Neither AstraZeneca nor any Affiliate or Third Party engaged by it, in any capacity, in connection with the Manufacture of the Product has received in the past [...***...] years or is currently subject to a Warning Letter (as defined in the Act) with respect to any facility manufacturing Product for Exploitation in the Horizon Territory.
AstraZeneca shall cause its Affiliates and its and their respective licensees, sublicensees and distributors to notify AstraZeneca of any receipt of any orders for the Product or any Other Product in the Horizon Territory.
Horizon (a) shall, and shall cause its Affiliates and its and their respective Sublicensees and distributors to, distribute, market, promote, offer for sale and sell the Product and the Other Products only in the Horizon Territory, and (b) shall not, and shall not permit its Affiliates and its and their respective Sublicensees or distributors to, distribute, market, promote, offer for sale or sell the Product or any Other Product directly or indirectly to any Person for use in the AstraZeneca Territory.
AstraZeneca has made available to Horizon copies of material field alerts, dear doctor letters, complaints and notices of alleged defect or adverse reaction with respect to the Product in the Horizon Territory that have been received in writing by AstraZeneca and its Affiliates.
There are no Patent Rights in the Horizon Territory claiming any AstraZeneca Inventions (as defined in the Pozen Original Agreement) under the Pozen Original Agreement.
If AstraZeneca or any of its Affiliates receives or becomes aware of the receipt by a licensee, sublicensee or distributor of any orders for the Product or any Other Product in the Horizon Territory, such Person shall refer such orders to Horizon.
Neither AstraZeneca nor any Affiliate of AstraZeneca has received any written notice that any Person is suspected of infringing or misappropriating such intellectual property rights in the Horizon Territory.