Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.
Failure to Supply If IPC is unable (or anticipates an inability) to manufacture or deliver all or a portion of a Product to Tris as required by a confirmed or accepted Purchase Order pursuant to Section 3.3 of this Agreement, IPC shall promptly notify Tris in writing of the period for which such inability (or anticipated inability) to so manufacture or deliver is expected (an “Anticipated Inability to Deliver”). For avoidance of doubt, so long as IPC uses Commercially Reasonable Efforts and the anticipated inability is a force majeure event, IPC shall not be in breach of the Purchase Order(s) affected nor this Agreement, however, regardless of whether or not IPC has breached a Purchase Order or this Agreement it shall still be liable for Cover and the other obligations set forth in this Section 3.10. In the event IPC is unable to meet Tris’s Purchase Orders or IPC issues a notice of an Anticipated Inability to Deliver, IPC’s obligation to supply shall continue but Tris’ obligation to purchase the Product that IPC is unable to timely supply in accordance with Section 3.3 above shall be suspended and Tris, without relieving IPC of its obligations under Section 3.3, may mitigate its damages by purchasing from another Person the quantity of substitute product that it requires beyond what IPC is able to deliver. Tris shall use Commercially Reasonable Efforts to obtain such substitute product at a reasonable price and communicate same to IPC in writing. Tris shall be entitled to deduct the difference in cost paid by Tris for such substitute product over the cost of the Product (“Cover”), if any, from any amounts otherwise payable to IPC hereunder, and, to the extent not so offset, IPC shall reimburse Tris for such Cover , within thirty (30) days of receipt of invoice from Tris. IPC will not be entitled to any share of positive Net Profits for sale of substitute product not sourced by Tris from IPC hereunder (provided IPC shall continue to fund its share of negative Net Profits), except to the extent IPC has fully reimbursed Tris for the Cover expense with respect to such product. If at any time thereafter during the Term, IPC is able to timely deliver Product in satisfaction of Tris’ Purchase Orders, IPC shall so notify Tris in writing and, subject to Tris’ contractual commitments to third parties, Tris shall undertake commercially reasonable efforts to limit such contractual commitment in order not to exceed IPC’s volume and period it is unable to supply, Tris will resume purchasing the Product from IPC. If IPC’s inability to timely deliver to Tris the quantity of the Product described in this Section 3.3 continues for a period beyond three (3) months, Tris may terminate this Agreement upon thirty (30) days’ notice in writing to IPC. IPC shall reimburse Tris for any failure to supply and late supply penalties and/or damages charged to Tris for late supply or non-supply caused by IPC’s failure to timely supply Product pursuant to Purchase Orders delivered to IPC in accordance with this Agreement. For clarity and audit purposes, such failure to supply penalties shall be supported by appropriate invoices detailing the failure to supply penalties issued by the affected customers and wholesallers of Tris. IPC shall reimburse Tris for such penalties and damages, within ten (10) days of receipt of invoice for same from Tris, provided that if such invoice is not timely paid, Tris may at its option offset such amounts owed against other amounts payable by Tris to IPC.
Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.
Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.
Manufacture (a) Manufacturer shall only manufacture the specific number of Products as requested by Company and at no time shall manufacture excess goods or overruns. Manufacturer shall not sell any Products bearing the Trademarks to any third parties without the express written consent of Company.
Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].
Product Supply 5.2.1 HEMISPHERX undertakes and agrees to supply to IMPATIENTS on an exclusive basis, IMPATIENTS’ requirements of Product ordered in accordance with the terms of this Agreement, for distribution and sale in the Territory, limited to EAP use of Product in accordance with Early Access Approvals.
Development License A non-transferable (except as provided in Section 17.1 (Assignment)), sublicensable (subject to Section 11.2.5 (Voyager Sublicense Rights)), worldwide, non-exclusive, royalty-free license under the Genzyme Technology, Genzyme Collaboration Technology and Genzyme’s interest in the Joint Collaboration Technology to (a) Develop the Split Territory Licensed Products and conduct such Split Territory Licensed Program inside and outside the Voyager Territory for Commercialization of such Split Territory Agreement Products in the Field in the Voyager Territory, and (b) Manufacture the Split Territory Licensed Products inside or outside of the Voyager Territory for the purposes of such Development, in each case (a) and (b) as and to the extent set forth in any Global Development Plan or Voyager Territory Development Plan.
API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.
Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.
