Data Generated by Affymax. (i) Within thirty (30) days after the Effective Date, Affymax shall provide Collaborator with copies of IND and CTA filings made for the Product in the U.S. and Europe prior to the Effective Date. With regard to all other preclinical and non-clinical data (including [*] above-mentioned IND and CTA filings, in the form then existing) generated as of the Effective Date and Controlled by Affymax, Affymax shall, if requested by Collaborator, provide Collaborator with copies thereof within a reasonable time after such request to the extent relevant to the Development of Product or Collaborator's seeking Regulatory Approval for the Product in the Licensed Territory. Thereafter, from time to time but in a timely manner compliant with the requirements of the Regulatory Authority in the Licensed Territory, Affymax shall provide Collaborator with copies of [*] preclinical and non-clinical data generated from [*] the Effective Date by Affymax and Controlled by Affymax. Collaborator 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)(i) in connection with the Development of the Product in the Licensed Territory, including the incorporation of such data or reports in any MAA. (ii) Within thirty (30) days after the Effective Date, Affymax shall provide Collaborator with copies of all clinical data resulting from [*] completed or ongoing (where available) as of the Effective Date and Controlled by Affymax. Thereafter, following completion of any additional [*] conducted by Affymax with or without [*], Affymax shall, in a timely manner compliant with the requirements of the Regulatory Authority in the Licensed Territory, provide Collaborator with copies of all resulting data, to the extent such data is Controlled by Affymax. Collaborator shall have the full right to use any and all such data and reports supplied by Affymax pursuant to this Section 4.1(a)(ii) in connection with the Development of the Product in the Licensed Territory, including the incorporation of such data or reports in any MAA. (iii) With respect to clinical data Controlled by Affymax and resulting from [*] completed or ongoing as of the Effective Date, Affymax shall provide Collaborator with copies of all resulting data upon request of Collaborator after completion of such trial. It is understood and agreed, however, that Collaborator shall have the right to use any and all such data and reports supplied by Affymax hereunder only to the extent that the Regulatory Authorities in the Licensed Territory require that such data and or reports be submitted to it to substantiate the clinical data generated by or on behalf of Collaborator in seeking Regulatory Approval for the Product in the Licensed Territory, either as part of the MAA or otherwise. In no event shall Collaborator have the right to utilize such [*] data in its MAA for the Product in the Licensed Territory in lieu of additional [*] data generated by or on behalf of Collaborator in the Licensed Territory, without the written consent of Affymax, which consent may be withheld in its sole discretion, and which consent if given, shall require [*] to Affymax for such use of such data. (iv) Collaborator acknowledges and understands that Affymax intends to license the Product to one or more Third Party licensees for development and commercialization in the Affymax Territory (each, a "Third Party Partner"). Pursuant to any agreements between Affymax and its Third Party Partner, Affymax and/or such Third Party Partners will generate, at the expense primarily of such Third Party Partner, additional non-clinical, preclinical and clinical data and reports (including in particular [*] and [*] with respect to the Product for use in seeking Regulatory Approval for the Product in the Affymax Territory (the "Third Party Data"). With respect to any Third Party Data Controlled by Affymax [*], Affymax shall provide Collaborator with copies of all such Third Party Data upon request of Collaborator unless (X) Affymax [*] and/or (Y) [*] Third Party Partner in connection therewith. For any Third Party Data to which (X) and/or (Y) applies, Collaborator shall have the rights set forth in Section 4.1(b)(ii). It is understood and agreed, however, that Collaborator shall have the right to use any and all such Third Party Data and reports supplied by Affymax under this Section 4.1(a)(iv) only to the extent that the Regulatory Authorities in the Licensed Territory require that such data be submitted to it to substantiate the non-clinical, preclinical or clinical data generated by or on behalf of Collaborator in seeking Regulatory Approval for the Product in the Licensed Territory, either as part of the MAA or otherwise. In no event shall Collaborator have the right to utilize such Third Party Data provided pursuant to this Section 4.1(a)(iv) in its MAA for the Product in the Licensed Territory in lieu of additional non-clinical, pre-clinical or clinical data generated by or on behalf of Collaborator in the Licensed Territory, without the written consent of Affymax, which consent may be withheld in its sole discretion, and which consent if given, shall require [*] for such use of such data. For clarity, this Section 4.1 (a)(iv) shall not apply to any audited data that Affymax may provide to Collaborator pursuant to Section 4.1(b)(i). (v) With respect to any data generated pursuant to any [*] that is commenced [*] by Affymax other than [*], to the extent such data is Controlled by Affymax, Affymax shall provide Collaborator with copies of all data arising from such trial upon request of Collaborator, provided that the Parties have first agreed upon a mutually acceptable [*] for such use of such data; provided that information regarding adverse events and serious adverse events shall be provided promptly as set forth in Section 4.8. (vi) For clarity, the foregoing shall not be deemed to limit the Parties' obligations with respect to information to be provided pursuant to Section 4.8. Additionally, except as expressly provided in subsections (iii) and (iv), Collaborator shall not be obligated [*] for the information, data and reports to be provided pursuant to this Section 4.1(a).
Appears in 1 contract
Data Generated by Affymax. (i) Within thirty (30) days after the Effective Date, Affymax shall provide Collaborator with copies of IND and CTA filings made for the Product in the U.S. and Europe prior to the Effective Date. With regard to all other preclinical and non-clinical data (including [*] [ * ]above-mentioned IND and CTA filings, in the form then existing) generated as of the Effective Date and Controlled by Affymax, Affymax shall, if requested by Collaborator, provide Collaborator with copies thereof within a reasonable time after such request to the extent relevant to the Development of Product or Collaborator's ’s seeking Regulatory Approval for the Product in the Licensed Territory. Thereafter, from time to time but in a timely manner compliant with the requirements of the Regulatory Authority in the Licensed Territory, Affymax shall provide Collaborator with copies of [*[ * ] preclinical and non-clinical data generated from [*[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. [ * ] the Effective Date by Affymax and Controlled by Affymax. Collaborator 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)(i) in connection with the Development of the Product in the Licensed Territory, including the incorporation of such data or reports in any MAA.
(ii) Within thirty (30) days after the Effective Date, Affymax shall provide Collaborator with copies of all clinical data resulting from [*[ * ] completed or ongoing (where available) as of the Effective Date and Controlled by Affymax. Thereafter, following completion of any additional [*[ * ]] conducted by Affymax with or without [*[ * ], Affymax shall, in a timely manner compliant with the requirements of the Regulatory Authority in the Licensed Territory, provide Collaborator with copies of all resulting data, to the extent such data is Controlled by Affymax. Collaborator shall have the full right to use any and all such data and reports supplied by Affymax pursuant to this Section 4.1(a)(ii) in connection with the Development of the Product in the Licensed Territory, including the incorporation of such data or reports in any MAA.
(iii) With respect to clinical data Controlled by Affymax and resulting from [*[ * ] completed or ongoing as of the Effective Date, Affymax shall provide Collaborator with copies of all resulting data upon request of Collaborator after completion of such trial. It is understood and agreed, however, that Collaborator shall have the right to use any and all such data and reports supplied by Affymax hereunder only to the extent that the Regulatory Authorities in the Licensed Territory require that such data and or reports be submitted to it to substantiate the clinical data generated by or on behalf of Collaborator in seeking Regulatory Approval for the Product in the Licensed Territory, either as part of the MAA or otherwise. In no event shall Collaborator have the right to utilize such [*[ * ] data in its MAA for the Product in the Licensed Territory in lieu of additional [*[ * ] data generated by or on behalf of Collaborator in the Licensed Territory, without the written consent of Affymax, which consent may be withheld in its sole discretion, and which consent if given, shall require [*[ * ] to Affymax for such use of such data. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(iv) Collaborator acknowledges and understands that Affymax intends to license the Product to one or more Third Party licensees for development and commercialization in the Affymax Territory (each, a "“Third Party Partner"”). Pursuant to any agreements between Affymax and its Third Party Partner, Affymax and/or such Third Party Partners will generate, at the expense primarily of such Third Party Partner, additional non-clinical, preclinical and clinical data and reports (including in particular [*[ * ] and [*[ * ] with respect to the Product for use in seeking Regulatory Approval for the Product in the Affymax Territory (the "“Third Party Data"”). With respect to any Third Party Data Controlled by Affymax [*[ * ], Affymax shall provide Collaborator with copies of all such Third Party Data upon request of Collaborator unless (X) Affymax [*[ * ] and/or (Y) [*[ * ] Third Party Partner in connection therewith. For any Third Party Data to which (X) and/or (Y) applies, Collaborator shall have the rights set forth in Section 4.1(b)(ii). It is understood and agreed, however, that Collaborator shall have the right to use any and all such Third Party Data and reports supplied by Affymax under this Section 4.1(a)(iv) only to the extent that the Regulatory Authorities in the Licensed Territory require that such data be submitted to it to substantiate the non-clinical, preclinical or clinical data generated by or on behalf of Collaborator in seeking Regulatory Approval for the Product in the Licensed Territory, either as part of the MAA or otherwise. In no event shall Collaborator have the right to utilize such Third Party Data provided pursuant to this Section 4.1(a)(iv) in its MAA for the Product in the Licensed Territory in lieu of additional non-clinical, pre-clinical or clinical data generated by or on behalf of Collaborator in the Licensed Territory, without the written consent of Affymax, which consent may be withheld in its sole discretion, and which consent if given, shall require [*[ * ] for such use of such data. For clarity, this Section 4.1 (a)(iv4.1(a)(iv) shall not apply to any audited data that Affymax may provide to Collaborator pursuant to Section 4.1(b)(i).
(v) With respect to any data generated pursuant to any [*[ * ] that is commenced [*[ * ] by Affymax other than [*[ * ], to the extent such data is Controlled by Affymax, Affymax shall provide Collaborator with copies of all data arising from such trial upon request of Collaborator, provided that the Parties have first agreed upon a mutually acceptable [*[ * ] for [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. such use of such data; provided that information regarding adverse events and serious adverse events shall be provided promptly as set forth in Section 4.8.
(vi) For clarity, the foregoing shall not be deemed to limit the Parties' ’ obligations with respect to information to be provided pursuant to Section 4.8. Additionally, except as expressly provided in subsections (iii) and (iv), Collaborator shall not be obligated [*[ * ] for the information, data and reports to be provided pursuant to this Section 4.1(a).
Appears in 1 contract
Data Generated by Affymax. (i) Within thirty (30) days [*] after the Effective Date, Affymax shall provide Collaborator with copies of IND and CTA filings made for the Product in the U.S. and Europe prior to the Effective Date. With regard to all other preclinical and non-clinical data (including [*] above-mentioned IND and CTA filings, in the form then existing) generated as of the Effective Date and Controlled by Affymax, Affymax shall, if requested by Collaborator, provide Collaborator with copies thereof within a reasonable time after such request to the extent relevant to the Development of Product or Collaborator's seeking Regulatory Approval for the Product in the Licensed Territory. Thereafter, from time to time but in a timely manner compliant with the requirements of the Regulatory Authority in the Licensed Territory, Affymax shall provide Collaborator with copies of [*] preclinical and non-clinical data generated from [*] the Effective Date by Affymax and Controlled by Affymax. Collaborator 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)(i) in connection with the Development of the Product in the Licensed Territory, including the incorporation of such data or reports in any MAA.
(ii) Within thirty (30) days [*] after the Effective Date, Affymax shall provide Collaborator with copies of all clinical data resulting from [*] completed or ongoing (where available) as of the Effective Date and Controlled by Affymax. Thereafter, following completion of any additional [*] conducted by Affymax with or without [*], Affymax shall, in a timely manner compliant with the requirements of the Regulatory Authority in the Licensed Territory, provide Collaborator with copies of all resulting data, to the extent such data is Controlled by Affymax. Collaborator shall have the full right to use any and all such data and reports supplied by Affymax pursuant to this Section 4.1(a)(ii) in connection with the Development of the Product in the Licensed Territory, including the incorporation of such data or reports in any MAA.
(iii) With respect to clinical data Controlled by Affymax and resulting from [*] completed or ongoing as of the Effective Date, Affymax shall provide Collaborator with copies of all resulting data upon request of Collaborator after completion of such trial. It is understood and agreed, however, that Collaborator shall have the right to use any and all such data and reports supplied by Affymax hereunder only to the extent that the Regulatory Authorities in the Licensed Territory require that such data and or reports be submitted to it to substantiate the clinical data generated by or on behalf of Collaborator in seeking Regulatory Approval for the Product in the Licensed Territory, either as part of the MAA or otherwise. In no event shall Collaborator have the right to utilize such [*] data in its MAA for the Product in the Licensed Territory in lieu of additional [*] data generated by or on behalf of Collaborator in the Licensed Territory, without the written consent of Affymax, which consent may be withheld in its sole discretion, and which consent if given, shall require [*] to Affymax for such use of such data.
(iv) Collaborator acknowledges and understands that Affymax intends to license the Product to one or more Third Party licensees for development and commercialization in the Affymax Territory (each, a "Third Party Partner"). Pursuant to any agreements between Affymax and its Third Party Partner, Affymax and/or such Third Party Partners will generate, at the expense primarily of such Third Party Partner, additional non-clinical, preclinical and clinical data and reports (including in particular [*] and [*] with respect to the Product for use in seeking Regulatory Approval for the Product in the Affymax Territory (the "Third Party Data"). With respect to any Third Party Data Controlled by Affymax [*], Affymax shall provide Collaborator with copies of all such Third Party Data upon request of Collaborator unless (X) Affymax [*] and/or (Y) [*] Third Party Partner in connection therewith. For any Third Party Data to which (X) and/or (Y) applies, Collaborator shall have the rights set forth in Section 4.1(b)(ii). It is understood and agreed, however, that Collaborator shall have the right to use any and all such Third Party Data and reports supplied by Affymax under this Section 4.1(a)(iv) only to the extent that the Regulatory Authorities in the Licensed Territory require that such data be submitted to it to substantiate the non-clinical, preclinical or clinical data generated by or on behalf of Collaborator in seeking Regulatory Approval for the Product in the Licensed Territory, either as part of the MAA or otherwise. In no event shall Collaborator have the right to utilize such Third Party Data provided pursuant to this Section 4.1(a)(iv) in its MAA for the Product in the Licensed Territory in lieu of additional non-clinical, pre-clinical or clinical data generated by or on behalf of Collaborator in the Licensed Territory, without the written consent of Affymax, which consent may be withheld in its sole discretion, and which consent if given, shall require [*] for such use of such data. For clarity, this Section 4.1 (a)(iv) shall not apply to any audited data that Affymax may provide to Collaborator pursuant to Section 4.1(b)(i).
(v) With respect to any data generated pursuant to any [*] that is commenced [*] by Affymax other than [*], to the extent such data is Controlled by Affymax, Affymax shall provide Collaborator with copies of all data arising from such trial upon request of Collaborator, provided that the Parties have first agreed upon a mutually acceptable [*] for such use of such data; provided that information regarding adverse events and serious adverse events shall be provided promptly as set forth in Section 4.8.
(vi) For clarity, the foregoing shall not be deemed to limit the Parties' obligations with respect to information to be provided pursuant to Section 4.8. Additionally, except as expressly provided in subsections (iii) and (iv), Collaborator shall not be obligated [*] for the information, data and reports to be provided pursuant to this Section 4.1(a).
Appears in 1 contract