Commercial Batches definition

Commercial Batches means any Batches of Product Manufactured after completion of the Process Validation Campaign.

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Commercial Batches. A Batch of bulk Product units, which are manufactured together in one process under the Supply Agreement for Commercialisation purposes;

Commercial Batches means a Batch or Batches ordered in accordance with Section 5.2, in contrast to Pre-Launch Batch(es) ordered as part of the SOW.

Examples of Commercial Batches in a sentence

In the event that the MSA is terminated for any reason prior to production of Commercial Batches, this Agreement shall also terminate as of the date of termination of the MSA.
In the event a Rejected Product is due to DPT’s willful malfeasance, breach of its warranties provided for herein or any other material breach of this Agreement and such conduct renders the Product unmarketable, or in the event more than two (2) Commercial Batches are rejected in any calendar year, DPT shall bear one hundred percent (100%) of the manufacturing fees, costs of materials supplied by DPT and costs of destruction.
In addition, for invoices issued with respect to Section 6.4.2(c), such invoices shall also reference a complete list of the Successful Commercial Batches produced, shipped and accepted by Genentech during such calendar year.
The following invoicing and payment terms apply: Commercial Batches Date Product available for pickup as notified by BAXTER (Shipment date documents under Section 9.3) Invoice Date + *** days Regulatory Services *** Receipt of Invoice Termination Termination date Invoice date + *** days Payments shall be made by wire transfer to a bank account specified by BAXTER.
IMMUCELL agrees that, for the Term of this Agreement, LONZA shall exclusively manufacture 100% of IMMUCELL’s Commercial Batches of Product (“Exclusivity Obligation”).
Such amount shall be the Purchase Price for such Commercial Batches.
It is understood and agreed, that no such payment shall be due for any Successful Commercial Batches in excess of such [*] Successful Commercial Batches, including without limitation any additional Batches purchased during the Term, including any extension thereof.
In conjunction with the report Lonza is to send to Genentech under Section 6.4.4 of the Agreement in each calendar year (as described in Section 3 of this 2nd Amendment above), Lonza shall also provide a report of the Successful Commercial Batches for such calendar year which are subject to reimbursement by Lonza to Genentech.
If the FDA does not approve SBL as a manufacturer for Batches of Commercial Product (other than the Regulatory Approvals, which will be obtained or maintained by Client) due to [***], Client shall not be responsible for any Reserved Capacity that was dedicated to Manufacturing Commercial Batches.

More Definitions of Commercial Batches

Commercial Batches means cGMP Batches which are not Process Validation Batches.

Commercial Batches means a Drug Substance or Drug Product that is Manufactured by SBL and which is intended for commercial sale and use by humans and for importation or exportation into countries or regions designated in each PSA and, for Drug Substance, is those manufactured after SBL obtains the Regulatory Approval certifying that the Manufacturing Process and the Facility meet the appropriate requirements and comply with cGMP.

Commercial Batches means any Batches of BDS Manufactured as part of the Contract Manufacture. [***] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.