Common use of Existing Data Clause in Contracts

Existing Data. Within thirty (30) days after the Effective Date, Affymax shall provide Takeda with copies of IND and CTA submissions made for the Product in the U.S. and EU prior to the Effective Date, unless previously provided. With regard to all other preclinical and non-clinical data relevant to an IND or CTA submission (including, as needed for Takeda regulatory submissions, copies of [*] the above-mentioned IND and CTA submissions, in the form then existing) generated as of the Effective Date and Controlled by Affymax, Affymax shall, if requested by Takeda, provide Takeda with copies thereof within a reasonable time after such request to the extent relevant to the Development of Product or Takeda's seeking Regulatory Approval for the Product in the Field in the Licensed Territory. Takeda shall have the full right, without any additional consideration, to use any and all such data and reports supplied by Affymax under this Section 4.1(a) in connection with the Development and/or Commercialization of the Product in the Licensed Territory, including the incorporation of such data or reports in any regulatory submissions, including MAA and NDA submissions.

Appears in 1 contract

Sources: Collaboration and License Agreement (Affymax Inc)

Existing Data. Within thirty (30) days after the Effective Date, Affymax shall provide Takeda with copies of IND and CTA submissions made for the Product in the U.S. and EU prior to the Effective Date, unless previously provided. With regard to all other preclinical and non-clinical data relevant to an IND or CTA submission (including, as needed for Takeda regulatory submissions, copies of [*[ * ] the above-mentioned IND and CTA submissions, in the form then existing) generated as of the Effective Date and Controlled by Affymax, Affymax shall, if requested by Takeda, provide Takeda with copies thereof within a reasonable time after such request to the extent relevant to the Development of Product or Takeda's ’s seeking Regulatory Approval for the Product in the Field in the Licensed Territory. Takeda shall have the full right, without any additional consideration, to use any and all such data and reports supplied by Affymax under this Section 4.1(a) in connection with the Development and/or Commercialization of the Product in the Licensed Territory, including the incorporation of such data or reports in any regulatory submissions, including MAA and NDA submissions.

Appears in 1 contract

Sources: Collaboration and License Agreement (Affymax Inc)

Existing Data. Within thirty (30) days [*] after the Effective Date, Affymax shall provide Takeda with copies of IND and CTA submissions made for the Product in the U.S. and EU prior to the Effective Date, unless previously provided. With regard to all other preclinical and non-clinical data relevant to an IND or CTA submission (including, as needed for Takeda regulatory submissions, copies of [*] the above-mentioned IND and CTA submissions, in the form then existing) generated as of the Effective Date and Controlled by Affymax, Affymax shall, if requested by Takeda, provide Takeda with copies thereof within a reasonable time after such request to the extent relevant to the Development of Product or Takeda's seeking Regulatory Approval for the Product in the Field in the Licensed Territory. Takeda shall have the full right, without any additional consideration, to use any and all such data and reports supplied by Affymax under this Section 4.1(a) in connection with the Development and/or Commercialization of the Product in the Licensed Territory, including the incorporation of such data or reports in any regulatory submissions, including MAA and NDA submissions.

Appears in 1 contract

Sources: Collaboration and License Agreement (Affymax Inc)