Common use of Supply of Material Clause in Contracts

Supply of Material. OPKO will, * transfer to TESARO in accordance with the Technology Transfer Plan all quantities of API and Licensed Product in OPKO’s possession or control. To the extent such API or Licensed Product is identified as GMP-grade materials in the Technology Transfer Plan, OPKO represents that (i) since OPKO’s acquisition of such materials, OPKO has handled and stored such materials in accordance with current Good Manufacturing Practices as defined in the U.S. (“GMP”), and (ii) nothing has come to OPKO’s attention which leads it to believe that any such material has not been manufactured and stored in accordance with GMP, that it would not conform in all material respects to the applicable specifications or would not be fit for use in clinical trials pursuant to FDA guidelines and requirements. OPKO will provide copies of batch records and certificates of compliance in its possession with respect to such material. In addition, OPKO will, at the request of TESARO, require Merck & Co., Inc. to deliver the Hold Back API, as defined in the Asset Purchase Agreement, to TESARO or its designee, and to supply addition quantities of API to the extent consistent with Merck & Co., Inc.’s obligation under Section 7.11(b) of the Asset Purchase Agreement on terms to be approved by TESARO.

Supply of Material. OPKO will, **** transfer to TESARO in accordance with the Technology Transfer Plan all quantities of API and Licensed Product in OPKO’s possession or control. To the extent such API or Licensed Product is identified as GMP-grade materials in the Technology Transfer Plan, OPKO represents that (i) since OPKO’s acquisition of such materials, OPKO has handled and stored such materials in accordance with current Good Manufacturing Practices as defined in the U.S. (“GMP”), and (ii) nothing has come to OPKO’s attention which leads it to believe that any such material has not been manufactured and stored in accordance with GMP, that it would not conform in all material respects to the applicable specifications or would not be fit for use in clinical trials pursuant to FDA guidelines and requirements. OPKO will provide copies of batch records and certificates of compliance in its possession with respect to such material. In addition, OPKO will, at the request of TESARO, require Merck & Co., Inc. to deliver the Hold Back API, as defined in the Asset Purchase Agreement, to TESARO or its designee, and to supply addition quantities of API to the extent consistent with Merck & Co., Inc.’s obligation under Section 7.11(b) of the Asset Purchase Agreement on terms to be approved by TESARO.