Commercial Manufacture Sample Clauses

Commercial Manufacture. The Parties agree that the Product will be manufactured by such Person, and at such location, that maximizes the commercial success of the Product in the marketplace for any market in the Territory. Nothing herein precludes either IPC or ELITE from bidding to become such manufacturer for any market, provided only that the issue of selection of a manufacturing entity should not delay the entry of the Product into that market.
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Commercial Manufacture. (a) Except as provided in Section 3.5(c), Inhale shall have a first option to negotiate a commercial supply agreement for the manufacture and supply of a Powder Formulation of Designated Products. Any such agreement shall provide that Alliance shall supply bulk Active Substance to Inhale for commercial manufacture at no cost, and pay to Inhale a purchase price for such Powder Formulation equal to *********************** together with other reasonable terms and conditions customary in the industry for the supply of similar products. Any such agreement shall also provide that Inhale shall deliver to Alliance bulk Powder Formulation in containers mutually agreeable to both parties. For each Designated Product, Alliance shall notify Inhale when Alliance determines in good faith that it has sufficient information to define the manufacturing process and is able to provide reasonable data regarding anticipated volume requirements for the Designated Product. If Inhale reasonably and in good faith agrees that the information provided by Alliance is sufficient to commence negotiation of a commercial supply agreement for a Powder Formulation of a Designated Product, Inhale shall so notify Alliance and within thirty (30) days thereafter Inhale shall notify Alliance whether Inhale desires to negotiate the terms of an agreement pursuant to which Inhale shall manufacture and supply a Powder Formulation of such Designated Product. (b) If the parties do not enter into a commercial supply agreement for the Powder Formulation of a particular Designated Product within ********************** after Inhale notifies Alliance of its interest in negotiating such an agreement, or if Inhale does not notify Alliance of its interest in manufacturing a Powder Formulation of a Designated Product within the thirty (30) day period provided in subsection (a), then Alliance may manufacture a Powder Formulation of the Active Substance itself or enter into a manufacturing agreement therefor with a Third Party that is not a Competitor of Inhale, in which case Inhale shall provide to Alliance technical assistance as described in Section 3.5(c). (c) If Alliance acquires the right to develop a Designated Product pursuant to Section 3.2(c), Alliance may request that Inhale provide reasonable advice regarding whether Alliance's proposed formulation for the relevant Designated Product is compatible with Inhale's proprietary technology for manufacturing a Powder Formulation of such Designated Product,...
Sample 1
Commercial Manufacture. 5.6.1 Unless otherwise determined by the terms and conditions of this License Agreement, following the Effective Date, Company shall have the sole responsibility, to manufacture the Licensed Compound and Licensed Product, itself or through one or more Affiliates, Sublicensees or CMOs selected by Company, and shall have the sole decision-making authority in all matters relating to the manufacturing of Licensed Compound and Licensed Product in the Field in the Territory. [*] Certain information in this document has been omitted as the information is not material and would be competitively harmful if publicly disclosed. 5.6.2 Promptly after the Effective Date, Merus shall deliver (or shall cause its CMO to deliver) to Company [*] such quantities of the Licensed Compound and Licensed Product in the possession of Merus existing as of the Effective Date, the description and quantities of which are set forth in Schedule 5.6.2 (the “Existing Inventory”); provided that Company [*] or (iii) has less than [*] of remaining [*] at the time of delivery, provided that, for clarity and notwithstanding the foregoing, any quantities actually used by Company after the Effective Date shall be purchased irrespective of (i) or (ii). For any Existing Inventory that is delivered by Merus to Company pursuant to this Section 5.6.2, Company shall pay for the Existing Inventory at a supply price of [*] of the Manufacturing Costs incurred by Merus in connection with the supply of such Existing Inventory. In addition, Company shall be responsible for all Out-of-Pocket Costs of shipping (including, but not limited to handling, insurance and transit) with respect to such Existing Inventory from the facilities of Merus or its CMO, as applicable. Merus shall provide an invoice to Company for Existing Inventory purchased and used after the Effective Date, and Company shall pay the invoiced amount within [*]. The Parties acknowledge and agree that the Existing Inventory was manufactured by Merus’ CMO pursuant to Merus’ existing agreements with such CMO, and Company shall comply with the applicable terms of such agreements in connection with the transfer, storage and use of such Existing Inventory. For clarity, in no event shall Merus be required to supply any Licensed Compound or Licensed Product to Company, other than the Existing Inventory pursuant to this Section 5.6.2, unless the Parties agree otherwise in writing. 5.6.3 Merus agrees to cooperate with Company in facilitating the transfer...
Sample 1
Commercial Manufacture. (a) BMS shall have responsibility for supply of Licensed Products (including the IFN-Lambda contained therein) for commercial sale throughout the Territory. For avoidance of doubt, BMS shall be allowed to contract with Third Parties for the Manufacture of Licensed Products in its discretion. (b) If a Conversion has not occurred and BMS anticipates a shortfall in production of a Licensed Product, which shortfall is reasonably likely to result in the inability to meet the combined requirements of the parties for a Licensed Product in the USA and the ROW: (i) BMS shall promptly notify Zymo in writing as to the reason for the shortfall, and state (and give reasons for) its expectations as to the duration of the shortfall; (ii) BMS shall make Reasonable Commercial Efforts to avoid the shortfall and keep Zymo reasonably informed as to such Reasonable Commercial Efforts and their results; and (iii) the parties shall agree upon an equitable allocation of all available Licensed Product between the USA and the ROW on the basis of the Net Sales in the respective markets in prior years and forecasts of future Net Sales in the respective markets, and taking into consideration performance versus forecast following any previous allocations under this Section 6.2.
Sample 1
Commercial Manufacture. After Milestone 3, ADURO BIOTECH shall purchase and IDT shall Manufacture and Deliver to ADURO BIOTECH the Product for commercial supply to meet [ * ] of the worldwide requirements of ADURO BIOTECH and its Affiliates and its Licensees, for such Product until the end of [ * ] months after [ * ]. Notwithstanding the foregoing provision, in the event that [ * ], shall be [ * ] after the date of [ * ], then the [ * ] period shall commence to run independently, i.e. from the date [ * ]. The period of time calculated under the preceding sentences is referred to herein as the “Commercial Supply Period”. The Parties agree that all such commercial Product shall (i) be at [ * ] per dose (final product, labeled and in bulk packaging) agreed in good faith by the Parties but not exceeding [ * ] per dose, and (ii) be delivered in whole lot quantities not more than [ * ] days after the same is ordered by ADURO BIOTECH.
Sample 1
Commercial Manufacture. Following ANDA approval, Elite shall be responsible for manufacturing, storing and overseeing the labeling, packaging and shipping of the Product in a manner that complies with all applicable legal requirements, including , but not limited to the laws and regulations enforced by the FDA. Elite shall be paid a transfer price as agreed upon with the licensee and with ORIT.
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Commercial Manufacture 
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Related to Commercial Manufacture

  • 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. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Manufacturing Technology Transfer During the [*] Period, Xxxxxxx shall transfer to Forest or its designee (which designee may be an Affiliate or a Third Party manufacturer, and which Third Party manufacturer may be a backup manufacturer or a second manufacturer of Licensed Product) all Xxxxxxx Know-How constituting the then-current process for the Manufacture of the Licensed Compounds and Licensed Products (the “Manufacturing Process”) and necessary or reasonably useful to implement the Manufacturing Process at facilities designated by Forest. Xxxxxxx shall provide, and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), all reasonable assistance requested by Forest to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, including (a) to the extent not already provided pursuant to Section 2.6.1, making available all Manufacturing-related Xxxxxxx Know-How, Information and documentation and materials that are necessary or reasonably useful to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, and (b) assisting Forest (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities that are specific for the Manufacture of the Licensed Compounds and the Licensed Products at the applicable facilities. If requested by Forest, Xxxxxxx’x assistance shall include (x) assigning to Forest any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products to the extent permitted under such existing agreement (any such agreement that is assigned to Forest, a “Transferred Agreement”), (y) if (i) the terms of any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products prohibits Xxxxxxx from assigning it to Forest, or (ii) any existing agreement between Xxxxxxx or any of its Affiliates and any Third Party supplier that pertains to one or more Licensed Compounds or Licensed Products also relates to other compounds or products, in either case ((i) or (ii)), obtaining for Forest the benefit under such agreement with respect to the Licensed Compounds and the Licensed Products, and (z) otherwise facilitating Forest’s entering into agreements with applicable Third Party suppliers relating to the Licensed Compounds and Licensed Products.