Manufacturing Process Transfer. Paratek shall have the right, on an annual basis during the Term, to conduct an audit of Almac’s Manufacturing process with respect to the Products in order to identify any updates to the technology used in, or any other improvements to, such Manufacturing process. During the Term, upon Paratek’s reasonable request, Almac shall transfer to Paratek all Almac Technology, Paratek Improvements and Joint Technology in Almac’s possession and not previously transferred to Paratek, for the purpose of enabling Paratek to exercise the license set forth in Section 11.2.2.
Manufacturing Process Transfer. (i) At Jazz’s request after achievement of the Manufacturing Process Transfer Criteria with respect to the applicable HemOnc Product, Pfenex shall transfer, at its expense, Pfenex’s manufacturing process for such HemOnc Product to Jazz, its Affiliate, or a Third Party manufacturer, in Jazz’s sole discretion (with respect to such HemOnc Product, the “Manufacturing Process Transfer”). For clarity, Pfenex shall not be required to perform more than a maximum of two (2) Manufacturing Process Transfers (i.e., one for each HemOnc Product). If the Manufacturing Process Transfer is to a Third Party manufacturer for commercial supply of the applicable Product, then the Parties shall negotiate in good faith to agree on the Third Party manufacturer, but if the Parties are unable to agree, Jazz may select the Third Party manufacturer; provided that Pfenex may reasonably object to any proposed Third Party manufacturer on the basis of reasonable concerns regarding the protection of Pfenex’s Confidential Information or intellectual property rights based on the Third Party manufacturer’s history of patent infringement or misappropriation or specific geographic concerns. Notwithstanding anything to the contrary in this Agreement, if Jazz requests that Pfenex perform the Manufacturing Process Transfer with respect to the applicable HemOnc Product prior to achievement of the Manufacturing Process Transfer Criteria for such HemOnc Product, then, provided that the Parties agree in writing (such agreement not to be unreasonably withheld) with respect to alternative criteria for such Manufacturing Process Transfer following discussion of any risk factors reasonably identified by Pfenex in response to such request, Pfenex shall perform such Manufacturing Process Transfer, at its expense, pursuant to such alternative criteria. Notwithstanding the foregoing, Pfenex shall perform a Manufacturing Process Transfer for an applicable Product at Jazz’s request (A) not later than the applicable time set forth in the Development Plan and/or (B) if after good faith discussions with Pfenex with an opportunity for Pfenex to take corrective action, Jazz reasonably determines that Pfenex will be unable achieve the Manufacturing Process Transfer Criteria by the applicable time set forth in the Development Plan.
Manufacturing Process Transfer. Promptly following the Effective Date and in any event no later than [***] thereafter, Combioxin shall, [***], promptly disclose to Eagle or its designee, such Licensed Know-How as is reasonably necessary or useful for the Manufacture of Licensed Products, including the manufacturing portions of any existing Regulatory Filings, in each case to the extent not previously provided to Eagle in accordance with the manufacturing technology transfer plan set forth on Exhibit 2.4.
Manufacturing Process Transfer. Eisai shall, when and as reasonably requested by the Licensee in writing, transfer, at the Licensee’s sole expense, to the Licensee or its permitted designee (which designee may be an Affiliate, Sublicensee or a permitted Third Party manufacturer) the Know-how related to the then-current process for the Manufacture of the Licensed Compound and the Existing Licensed Product (the “Manufacturing Process”) and, subject to Section 3.1.8, Regulatory Documentation. In addition, Eisai shall, as reasonably requested by the Licensee and subject to this Section 3.5.2, provide such support, at the Licensee’s sole expense, as may be necessary or reasonably useful to the Licensee or its designee to use and practice the Manufacturing Process (the “Manufacturing Transfer Services”). The Licensee shall reimburse Eisai for the FTE Costs incurred and the direct out-of-pocket costs recorded as an expense, in accordance with GAAP, by or on behalf of Eisai or any of its Affiliates related to the transfer of the Manufacturing Process or provision of Manufacturing Transfer Services within [***] ([***]) days after receipt of an invoice with respect thereto. Save as otherwise agreed by the Parties, the JMC shall be responsible for discussing, planning and coordinating any technical transfer services pursuant to this Section 3.5.2.
Manufacturing Process Transfer. Pursuant to Section 13.6(e) of the License Agreement, Takeda shall transfer the current manufacturing process for ITI-214 to ITI or its designee (as instructed by ITI in writing), commencing upon the Termination Date, and shall complete such transfer within [***] ([***]) months of the Termination Date; provided, however, that the failure to timely complete such transfer due to matters outside Takeda’s reasonable control shall not be deemed a breach of this Termination Agreement by Takeda. Takeda shall be required to provide, at its own cost and expense, no more than [***] ([***]) [***] (exclusive of any travel time) in support of the transfer of the manufacturing process to ITI or its designee, as applicable. In the event ITI requests Takeda provide manufacture transfer support in excess of [***] ([***]) [***], Takeda and ITI shall enter into good faith negotiations on a consulting agreement, pursuant to which Takeda would provide such continued support and ITI would reimburse Takeda for its FTE costs at the rate of $[***] (USD) per hour, along with reasonable travel and lodging expenses. Notwithstanding Section 13.6(e) of the License Agreement, the Parties agree that Takeda need not supply additional quantities of Products to ITI, and that the Returned Product (as defined below) is sufficient for ITI’s requirements, such that Takeda shall not be required to supply additional quantities to ITI. For clarity, Takeda’s obligation to support the transfer of manufacturing process, as described herein, shall survive the Transition Completion Date.
Manufacturing Process Transfer. (i) At Jazz’s request after achievement of the Manufacturing Process Transfer Criteria with respect to the applicable HemOnc Product, Pfenex shall transfer, at its expense, Pfenex’s manufacturing process for such HemOnc Product to Jazz, its Affiliate, or a Third Party manufacturer, in Jazz’s sole discretion (with respect to such HemOnc Product, the “Manufacturing Process Transfer”). For clarity, Pfenex shall not be required to perform more
