Common use of Regulatory Materials and Studies Clause in Contracts

Regulatory Materials and Studies. To the best of Affymax's knowledge, all Regulatory Materials Controlled by Affymax in existence as of the Effective Date and to which Takeda has rights of use or reference hereunder (collectively, "Affymax Regulatory Materials"), including the Regulatory Materials described in Section 4.1(a), have been prepared, maintained and retained in accordance with applicable Laws. All preclinical and clinical studies conducted with respect to Hematide and the Product in connection with the preparation of the Affymax Regulatory Materials, including such studies from which the data described in Section 4.1(a) are derived, have been conducted substantially in accordance with applicable Laws by persons with appropriate education, knowledge and experience. Affymax has not been debarred and is not subject to debarment, in each case pursuant to Section 306 of the FD&C Act or any similar law or regulation in any jurisdiction outside the United States.

Regulatory Materials and Studies. To the best of Affymax's knowledge, all Regulatory Materials Controlled by Affymax in existence as of the Effective Date and to which Takeda Collaborator has rights of use or reference hereunder (collectively, "Affymax Regulatory Materials"), including the Regulatory Materials described in Section 4.1(a4.2(b), as of the Effective Date have been prepared, maintained and retained in accordance with applicable Laws. All preclinical and clinical studies conducted with respect to Hematide and the Product Products in connection with the preparation of the Affymax Regulatory Materials, including such studies from which the data described in Section 4.1(a) and Section 4.1(b) are derived, as of the Effective Date have been conducted substantially in accordance with applicable Laws by persons with appropriate education, knowledge and experience. Affymax has not been debarred and is not subject to debarment, in each case pursuant to Section 306 of the FD&C Act or any similar law or regulation in any jurisdiction outside the United States.

Regulatory Materials and Studies. To the best of Affymax's ’s knowledge, all Regulatory Materials Controlled by Affymax in existence as of the Effective Date and to which Takeda has rights of use or reference hereunder (collectively, "“Affymax Regulatory Materials"”), including the Regulatory Materials described in Section 4.1(a), have been prepared, maintained and retained in accordance with applicable Laws. All preclinical and clinical studies conducted with respect to Hematide and the Product in connection with the preparation of the Affymax Regulatory Materials, including such studies from which the data described in Section 4.1(a) are derived, have been conducted substantially in accordance with applicable Laws by persons with appropriate education, knowledge and experience. Affymax has not been debarred and is not subject to debarment, in each case pursuant to Section 306 of the FD&C Act or any similar law or regulation in any jurisdiction outside the United States.