Manufacturing Shortfall Clause Samples
The Manufacturing Shortfall clause defines the procedures and consequences when a manufacturer is unable to produce or deliver the agreed quantity of goods within a specified timeframe. Typically, this clause outlines the notification requirements, possible remedies such as sourcing from alternative suppliers, and any penalties or adjustments to obligations that may result from the shortfall. Its core function is to allocate risk and provide a clear framework for addressing supply disruptions, thereby ensuring both parties understand their rights and responsibilities if production targets are not met.
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Manufacturing Shortfall. Regeneron shall provide prompt written notice to ZLAB if it reasonably determines that it will not, despite using Commercially Reasonable Efforts, be able to supply the Product in accordance with the Development Supply Agreement or Commercial Supply Agreement. Upon such notification, the matter will be referred to the JPSC to determine what, if any (and identify and establish, as quickly as possible, if applicable) alternative Third Party supply source of the Product should be utilized. For clarity, any such alternative Third Party supply source would be […***…]. In the event of an actual supply shortfall, Regeneron shall allocate available Product supply in descending order of priority as follows: (a) first to meet […***…] (provided that if available Product supply is insufficient to meet […***…], Product supply shall be allocated […***…]); (b) then for […***…]; (c) then for […***…] and (d) then for […***…].
Manufacturing Shortfall. Each Party shall be required to provide prompt written notice to the other Party if it reasonably determines that it will not be able to supply the agreed upon demand forecast for the VEGF Products. Upon such notification, the matter shall be referred to the Supply Chain Sub-Committee (or the JSC) to determine what, if any alternative supply source of VEGF Product (an “Alternative Supplier”) should be identified and established. The goal of the Parties in identifying an Alternative Supplier will be first to use the internal capacity of Aventis and/or its Affiliates and/or Regeneron to fill the supply shortfall, such that the manufacturing Party shall be considered the Alternative Supplier for purposes of this Section 8.5. In the event the Supply Chain Sub-Committee (or JSC) agrees to establish an Alternative Supplier, each Party shall transfer or license (on a royalty free basis) Know-How and Patent Rights necessary to transfer production to such Alternative Supplier in a timely manner and provide reasonable assistance to the Alternative Supplier to effect such transfer. Any increase in COGS and any other reasonable and direct costs directly associated with the transfer of production responsibilities to Alternative Suppliers shall be borne exclusively by the Party responsible for the shortfall. For purposes of the preceding sentence, a Party shall not be deemed responsible for such shortfall to the extent such shortfall arises from a material increase in Commercial Supply Requirements from that in the agreed upon demand forecast that could not reasonably be anticipated and supplied through the exercise of Commercially Reasonable Efforts.
Manufacturing Shortfall. Each Party is required to provide prompt written notice to the other Party if it reasonably determines that it will not, despite its using Commercially Reasonable Efforts, be able to supply the agreed upon demand forecast for the Licensed Products set forth in the Manufacturing Plan. Upon such notification, the matter will be referred to the JMC and JSC to determine what, if any (and identify and establish, as quickly as possible, if applicable) alternative supply source of Licensed Product (including the other Party) should be utilized.
Manufacturing Shortfall. Manufacturing Shortfall and Failure to Supply. In the event that SIIPL anticipates, or in the event SIIPL’s actual Manufacturing capacity will, or does not meet Forecasted Quantities resulting in a shortfall (“Manufacturing Shortfall”), SIIPL shall immediately notify VALNEVA in writing of any such anticipated or actual Manufacturing Shortfall. If an anticipated or actual Manufacturing Shortfall is expected to last more than [***], the Parties shall promptly upon receipt of notice meet to discuss SIIPL's efforts to remedy the Manufacturing Shortfall and ways to maintain its Manufacturing capacity. Furthermore, upon VALNEVA’s request, SIIPL shall provide VALNEVA with all materials, documents and other information relevant to confirm SIIPL's efforts and their respective status.
Manufacturing Shortfall. Each Party is required to provide prompt written notice to the other Party if it reasonably determines that it will not be able to supply the agreed upon demand forecast for the Licensed Products set forth in the Manufacturing Plan. Upon such notification, the matter will be referred to the JSC to determine what, if any (and identify and establish, as quickly as possible, if applicable) alternative supply source of Licensed Product should be utilized. In case of Finished Product or Formulated Bulk Product shortages, available supplies will be allocated as between the Parties on a pro rata basis based on their forecasted requirements for Licensed Product in the Field in the Territory and the Excluded Territory over the relevant period; provided that priority shall be given to meeting supply requirements for countries in which Licensed Products are in the launch phase and that, if the shortage is due solely to a breach by Regeneron, Company’s (and, if applicable, Regeneron’s) reasonable requirements under the Plans will be filled first in advance of filling requirements for the Excluded Territory.