Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.
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.
Adverse Developments Promptly after the Lessee acquires knowledge thereof, written notice of:
Infringement Proceedings Each Party agrees to promptly notify the other Party of any unauthorized use of the other Party's Marks of which it has actual knowledge. Each Party will have the sole right and discretion to bring proceedings alleging infringement of its Marks or unfair competition related thereto; provided, however, that each Party agrees to provide the other Party with its reasonable cooperation and assistance with respect to any such infringement proceedings.
Patent Prosecution 7.1 UFRF shall diligently prosecute and maintain the Licensed Patents using counsel of its choice. UFRF shall provide Licensee with copies of all patent applications amendments, and other filings with the United States Patent and Trademark Office and foreign patent offices. UFRF will also provide Licensee with copies of office actions and other communications received by UFRF from the United States Patent and Trademark Office and foreign patent offices relating to Licensed Patents. Licensee agrees to keep such information confidential.
Commercialization Diligence Novartis shall dedicate commercially reasonable efforts, during each [**] month period, necessary to commercialize a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries. If Novartis commercializes a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries, Novartis will be deemed to satisfy all diligence obligations with respect to such Profile.
Arbitration Process Any arbitration will be conducted pursuant to the applicable rules (the “Arbitration Rules”) of the American Arbitration Association, as modified herein, to the extent such modifications are not prohibited by the Arbitration Rules. The arbitration will be conducted in Indianapolis, Indiana. The parties will select a single arbitrator, but in the event that the parties are unable to agree, the arbitrator will be appointed pursuant to the Arbitration Rules. The arbitrator will be a practicing attorney with significant expertise in litigating and/or presiding over cases involving the substantive legal areas involved in the dispute. The parties to the arbitration will not request, and the arbitrator will not order, that any discovery be taken or provided, including depositions, interrogatories or document requests, except to the extent the amount in controversy exceeds $50,000. The arbitration will be concluded within three months of the date the arbitrator is appointed. The arbitrator’s findings, reasoning, decision, and award will be stated in writing and based upon applicable law. Judgment on the arbitration award may be entered in any court having jurisdiction. In the event that the arbitration results in an award which imposes an injunction or contains a monetary award in excess of $100,000, the award will be reviewable on appeal initiated by filing notice of appeal with the AAA office within 30 days of the award, governed by the AAA Optional Appellate Arbitration Rules and conducted by a panel of three new arbitrators, ruling by majority, under the procedure for appointment from the national roster of arbitrators. Unless the applicable Arbitration Rules require otherwise, arbitration fees and costs will be shared equally by the claimant(s) and respondent(s), respectively, in any arbitration proceeding. Should the AAA be unavailable, unable or unwilling to accept and administer the arbitration of any claim under these arbitration provisions as written, the parties will agree on a substitute arbitration organization, such as JAMS, that will enforce the arbitration provisions as written. Because this Agreement memorializes a transaction in interstate commerce, the Federal Arbitration Act governs the interpretation and enforcement of these arbitration provisions. More information about arbitration, including the Arbitration Rules, is available at xxx.xxx.xxx or by calling 0-000-000-0000.
Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).
Reverse Engineering The Customer must not reverse assemble or reverse compile or directly or indirectly allow or cause a third party to reverse assemble or reverse compile the whole or any part of the software or any products supplied as a part of the Licensed System.