Engineering Runs. PDL shall have the right to request that GMN manufacture at the Facility engineering runs of Product (“Engineering Runs”). The Engineering Runs shall only be used for internal purposes. All requests for Engineering Runs shall be subject to acceptance by GMN pursuant to Section 3.1.4 and 3.2. GMN shall consider all such requests in good faith and shall use Commercially Reasonable Efforts to accommodate all such requests.
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. [***] = CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED EXHIBIT C
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. 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.
