Manufacture and Supply; Territory. Subject to the provisions herein, Isoray shall, manufacture and supply Product through drop-shipments to end users designated by GT MED TECH. For clarity, Isoray may use Third Party subcontractors or vendors for certain aspects of the manufacturing process, such as sterilization. GT MED TECH shall purchase such Products from Isoray, all in quantities to be set forth on purchase orders submitted from time to time by GT MED TECH in accordance with the provisions of Section 3.3. In the event (a) Isoray is unwilling or unable to supply, in compliance with the terms set forth in this Agreement, quantities of Product ordered by GT MED TECH in accordance with Section 3.3 and (b) GT MED TECH is at such time in full compliance with this Agreement, then GT MED TECH shall be permitted to obtain from a Third-Party manufacturer (or manufacture itself) those quantities of Product that Isoray is unwilling or unable to supply. At all times during the Term, any and all of Isoray’s and GT MED TECH’s obligations under this Agreement shall be subject to and in accordance with the provisions, limitations and conditions imposed by FDA in respect of the Products. On an “as needed basis" as the Product is launched in countries outside the United States, the Parties shall negotiate in good faith an amendment to this Agreement to include such additional terms as the Parties shall deem necessary to ensure compliance with applicable laws in such countries. Notwithstanding this Section 3.1, if GT MED TECH elects to have the Product manufactured at a non-Isoray facility then GT MED TECH shall give Isoray six (6) months written notice that GT MED TECH intends to have the Product manufactured at another facility and shift its purchase to the Seeds, so that Isoray can have sufficient time to reallocate resources as needed of its staff and facility. The Seeds shall be sold at prices and pricing adjustments as provided in Article 5. GT MED TECH shall have sole responsibility for and pay, or cause to be paid, all costs related to ensure that the new manufacturing facility has a proper radioactive materials license allowing for the receipt of Isoray’s Seeds.
Manufacture and Supply; Territory. Subject to the provisions herein, Isoray shall, manufacture and supply Seeds to GT MED TECH or end users as designated by GT MED TECH. GT MED TECH shall purchase such Seeds from Isoray, all in quantities to be set forth on purchase orders submitted from time to time by GT MED TECH in accordance with the provisions of Section 3.3. In the event (a) Isoray is unwilling or unable to supply, in compliance with the terms set forth in this Agreement, quantities of Seeds ordered by GT MED TECH in accordance with Section 3.3 and (b) GT MED TECH is at such time in full compliance with this Agreement, then GT MED TECH shall be permitted to obtain from a Third-Party manufacturer (or manufacture itself) those quantities of Seeds that Isoray is unwilling or unable to supply. At all times during the Term, any and all of Isoray's and GT MED TECH's obligations under this Agreement shall be subject to and in accordance with the provisions, limitations and conditions imposed by FDA in respect of the Seeds. On an "as needed basis" as GT MED TECH’s products including Seeds are launched in countries outside the United States, the Parties shall negotiate in good faith an amendment to this Agreement to include such additional terms as the Parties shall deem necessary to ensure compliance with applicable laws in such countries.”
Manufacture and Supply; Territory. Subject to the provisions herein, and subject to receipt of the Regulatory Approval for the Product in the United States (i.e., the “510(k) Clearance,” as defined in the Development Agreement), IsoRay shall, manufacture and supply Product through drop-shipments to end users designated by GT MED TECH. For clarity, IsoRay may use Third Party subcontractors or vendors for certain aspects of the manufacturing process, such as sterilization. GT MED TECH shall purchase such Products from IsoRay, all in quantities to be set forth on purchase orders submitted from time to time by GT MED TECH in accordance with the provisions of Section 2.3. GT MED TECH shall obtain its supply of Product exclusively from IsoRay during the Term; provided, however, in the event (a) IsoRay is unwilling or unable to supply, in compliance with the terms set forth in this Agreement, quantities of Product ordered by GT MED TECH in accordance with Section 3.3 and (b) GT MED TECH is at such time in full compliance with this Agreement, then GT MED TECH shall be permitted to obtain from a Third Party manufacturer (or manufacture itself) those quantities of Product that IsoRay is unwilling or unable to supply. At all times during the Term, any and all of IsoRay’s and GT MED TECH’s obligations under this Agreement shall be subject to and in accordance with the provisions, limitations and conditions imposed by FDA in respect of the Products. On an “as needed basis" as the Product is launched in countries outside the United States, the Parties shall negotiate in good faith an amendment to this Agreement to include such additional terms as the Parties shall deem necessary to ensure compliance with applicable laws in such countries.
