PDL-241 Product. In the event of BMS’ exercise of the BMS Option, and prior to the completion of PDL’s transfer under Section 6.2 of the Manufacturing technology for PDL-241, PDL shall Manufacture, or arrange with Third Parties for the Manufacture of PDL-241 Product for the purpose of transitional supply of PDL-241 Product for any ongoing Phase I Clinical Trials with respect to PDL-241 Product and any pre-clinical PDL-241 Product Development activities set forth in an Approved Plan. As part of such Phase I Clinical Trial supply, and prior to the technology transfer to BMS described in Section 6.2, PDL shall be responsible for testing the supplies of PDL-241 Product and PDL will enable BMS’ manufacturing and quality units to review manufacturing records and test results performed and to release supplies of PDL-241 Product. Upon such technology transfer (which shall include the transfer of all test methods), BMS shall be responsible for all testing and releasing of supplies of PDL-241 Product. PDL shall continue and complete stability studies with respect to the materials manufactured prior to technology transfer to BMS. From and after the exercise by BMS of the BMS Option, PDL shall not enter into any agreements with Third Parties for the Manufacture of PDL-241 Product without the prior written consent of BMS. The costs and expenses incurred by PDL in carrying out such Manufacturing (or the costs associated with any such agreements with Third Parties) shall be treated as Development Costs. For clarity, if BMS does not exercise the BMS Option, PDL shall have the right to Manufacture, or retain Third Parties to Manufacture, PDL-241 Product, without BMS’ consent and consistent with PDL’s rights as provided in Section 3.8. After the completion of PDL’s transfer of the applicable Manufacturing technology under Section 6.2(a), BMS shall be responsible for Manufacturing, or arranging with Third Parties for the Manufacture of, PDL-241 Product, in bulk and finished form, for use in Development and for commercial sale.
