Engineering Runs Sample Clauses

Engineering Runs. If called for in the Project Plan, Paragon shall perform Engineering Runs and manufacture Engineering Batches in accordance with the Project Plan. Paragon and Client may agree to include one or more Engineering Targets in the Project Plan for a Project. Paragon will provide the services to perform such Engineering Runs and produce such Engineering Batches in accordance with the Project Plan and Client shall make the payments pursuant to the Payment Schedule to purchase such services and manufacture as further set forth in Article 6. Paragon shall provide Client with any Engineering Batches requested by Client that results from any partial or completed Engineering Runs, except to the extent that Reference Material is to be retained for use in connection with manufacture of Product in one or more Production Runs. Except for the Engineering Targets, there will be no specifications for acceptance of Engineering Batches, but the parties may mutually agree on certain additional target quality attributes to aim for, if set forth in the applicable Project Plan. Mutually agreed Engineering Targets shall be the sole and exclusive basis for alleging any “failure” with respect to an Engineering Run. In the event (i) an Engineering Batch does not meet the Engineering Target(s), or (ii) Paragon proceeds with an Engineering Batch without stopping at any “go/no-go” decision point agreed to in the Project Plan or Master Batch Record and receiving written instructions from Client to proceed (which instructions can be provided by any writing, including email); then at Client’s written request Paragon will repeat the Engineering Run once at no additional charge to Client assuming Client previously paid all invoices and payments associated with the failed Engineering Run (if such invoices and payments had not been paid previously, they shall be due and paid pursuant to the Payment Schedule). Except as in the preceding sentence, Paragon shall have no obligation to repeat any Engineering Run unless Client and Paragon execute a Change Order for such additional Run and the appropriate additional costs. Except as provided in this Section 3.3, Client waives all other remedies at law or in equity in connection with asserted failures in any Engineering Runs. Paragon shall provide analytical testing of the batch as agreed by the parties in each Project Plan and will report the results to Client. Client shall have the right to make whatever further use of such Engineering Batches as it ...

Engineering Runs. Notwithstanding Section 4c) or any other provision of the Supply Agreement, the Parties acknowledge that Sponsor has cancelled the [***] and as such, Fujifilm shall no longer plan to perform such manufacture and Sponsor shall have no obligation to pay Fujifilm for such [***].

Engineering Runs. If called for in the Project Plan, Paragon shall perform Engineering Runs and manufacture Engineering Batches in accordance with the SOW/Project Plan. Paragon will provide the services to perform such Engineering Runs and produce such Engineering Batches in accordance with the SOW/Project Plan and Client shall make the payments pursuant to the Payment Schedule to purchase such services and manufacture as further set forth in Article 6. Paragon shall provide Client with any Engineering Batches requested by Client that results from any partial or completed Engineering Runs, except to the extent that Reference Material is to be retained for use in connection with manufacture of Product in one or more Manufacturing Runs. There will be no specifications for acceptance of Engineering Batches, but the Parties may mutually agree on certain target quality attributes to aim for, if set forth in the applicable SOW/Project Plan. Paragon shall provide analytical testing of the Engineering Batch as agreed by the Parties in each SOW/Project Plan and will report the results to Client. Client shall have the right to make whatever further use of such Engineering Batches as it shall determine, provided that such use does not violate any Applicable Laws. Paragon shall in no way be responsible for any claims, demands, losses, liabilities, expenses or damages, whatsoever, including but not limited to indirect or consequential damages, arising out of or in any way related to Client’s use of such Engineering Batches.

Engineering Runs. Supplier will perform a minimum of [*]Engineering Runs ([*]) prior to manufacturing any cGMP batches. The Engineering Runs will take place on the Equipment located in the Dedicated Suite under non-GMP conditions. Assuming that Batches are run at Full Scale for [*] and at least equivalent batch size for the [*] presentation, the price of the Engineering Run(s) will be billed to Company at a rate of $[*]/[*]. All testing, raw materials (excluding [*] and [*]) and Batch Record Documentation of the Engineering Runs will be covered in this pricing. The price of these [*] will count toward the Preliminary Monthly Fee and Monthly Fees, covered in Section 10.7.