Common use of Other Transparency/Disclosure Initiatives Clause in Contracts

Other Transparency/Disclosure Initiatives. GSK represents that it posts on its company website the following information with respect to both grants and charitable contributions in the United States: GSK shall continue to post (and provide updates to) the above-described information about grants and charitable contributions throughout the term of this CIA. GSK shall notify the OIG in writing at least 60 days prior to any change in the substance of its policies regarding the funding of grants and charitable contributions or posting of the above-referenced information relating to such funding. GSK shall require all Consultants to comply fully with all applicable disclosure obligations relating to their relationship with GSK that may be externally imposed on the Consultants based on their affiliation with formulary or P&T committees or committees associated with the development of treatment protocols or standards. GSK shall maintain this requirement throughout the term of this CIA. GSK represents that within 120 days after the Effective Date, GSK shall, if necessary, amend its policies relating to Consultants to explicitly state that GSK requires all Consultants to fully comply with all applicable disclosure obligations relating to their relationship with GSK that may be externally imposed on the Consultants based on their affiliation with formulary, P&T committees, or committees associated with the development of treatment protocols or standards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. In addition, for any GlaxoSmithKline LLC Corporate Integrity Agreement amendment to its contracts with Consultants and in any new contracts with Consultants entered into after 150 days following the Effective Date, GSK shall include an explicit requirement that the Consultants fully comply with all applicable disclosure requirements, as referenced above in this paragraph. GSK shall continue these disclosure requirements throughout the term of this CIA. To the extent not already accomplished, within 120 days after the Effective Date, GSK shall post or make available information on its company website about FDA postmarketing commitments (PMCs). The GSK website or links included therein shall provide access to general information about the PMC process, descriptions of ongoing GSK studies, and information about the nature and status of the post-marketing commitments. GSK shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.

Other Transparency/Disclosure Initiatives. GSK AstraZeneca represents that on a bi-annual basis, it posts on its company website the following information with respect to both medical education grants and charitable contributions in contributions: 1) the United Statesrecipient organization’s name: GSK 2) a brief description of the program for which the grant or charitable contribution was requested; and 3) the amount of the grant or charitable contribution. AstraZeneca shall continue to post (and provide updates to) the above-described information about grants medical education and charitable contributions contribution grants throughout the term of this CIA. GSK AstraZeneca shall notify the OIG in writing at least 60 days prior to any change in the substance of its policies regarding the funding of medical education grants and charitable contributions or posting of the above-referenced information relating to such funding. GSK shall require AstraZeneca represents that it requires all Consultants to fully comply fully with all applicable disclosure obligations relating to their relationship with GSK AstraZeneca that may be externally imposed on the Consultants based on their affiliation with formulary or P&T committees or committees associated with the development of treatment protocols or standards. GSK AstraZeneca shall maintain continue this requirement throughout the term of this CIA. GSK represents that within Within 120 days after the Effective Date, GSK shall, if necessary, AstraZeneca shall amend its policies relating to Consultants to explicitly state that GSK requires all AstraZeneca’s requirement about full disclosure by Consultants to fully comply with all applicable disclosure obligations relating to their relationship with GSK that may be externally imposed on the Consultants based on their affiliation with formulary, P&T committees, or committees associated consistent with the development requirements of treatment protocols or standards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. In addition, for any GlaxoSmithKline LLC Corporate Integrity Agreement amendment to its contracts with Consultants and in any new contracts with Consultants entered into after 150 120 days following the Effective Date, GSK AstraZeneca shall include an explicit requirement that the Consultants fully comply with all applicable disclosure requirementsrequirements and disclose their relationship with AstraZeneca as required pursuant to their affiliation with any HCI, medical committee, or other medical or scientific organization. Corporate Integrity Agreement AstraZeneca AstraZeneca represents that it expects all Authors of biomedical manuscripts to fully comply with the International Committee of Medical Journal Editors (ICMJE) criteria regarding authorship and disclosure of their relationship with AstraZeneca and to disclose any potential conflicts of interest, including any financial or personal relationships that might be perceived to bias their work. Within 120 days after the Effective Date, AstraZeneca shall amend its policies relating to Authors to explicitly state AstraZeneca’s requirement about full disclosure by Authors consistent with the requirements of any HCI, medical committee or other medical or scientific organization with which the Authors are affiliated. In addition, for any amendments to its contracts with Authors and in any new contracts with Authors entered into after 120 days following the Effective Date, AstraZeneca shall include an explicit requirement that Authors disclose in their manuscripts, journal submissions, and elsewhere as appropriate or required, any potential conflicts of interest, including their financial or personal relationship with AstraZeneca, the names of any individuals who have provided editorial support for any manuscript or other publication, and all funding sources for the study or publication. AstraZeneca represents that it registers all clinical studies involving individuals on the National Institutes of Health (NIH) sponsored website (xxx.xxxxxxxxxxxxxx.xxx). AstraZeneca represents that it discloses a summary of results of all studies in patients or volunteers for marketed and investigative products on the above-referenced above in this paragraphNIH website and on a company website (xxx.xxxxxxxxxxxxxxxxxxxxxxxxx.xxx). GSK AstraZeneca shall continue these disclosure requirements to post clinical study information as described above on the NIH website and the company’s website throughout the term of this CIA. To In addition, if there is a change in Federal health care program requirements, FDA requirements, or other applicable requirements relating to the extent not already accomplishedreporting of clinical study information, within 120 days after the Effective Date, GSK AstraZeneca shall post or make available fully comply with such requirements. AstraZeneca represents that it posts information on its company website about FDA postmarketing commitments (PMCs). The GSK AstraZeneca website or links included therein shall provide (xxxx://xxx.xxxxxxxxxxx- xx.xxx/xxxxxxxx-xxx-xxxxxxxxxxx/) provides access to general information about the PMC process, including study descriptions of ongoing GSK studies, and information about the nature and status of the FDA post-marketing commitments. GSK AstraZeneca shall continue to post or make available the above-above- described information about PMCs on its website or links included therein throughout the term of this CIA.

Other Transparency/Disclosure Initiatives. GSK represents To the extent not already accomplished, within 120 days after the Effective Date of the CIA, J&J shall ensure that it posts on its company website the J&J Pharmaceutical Affiliates shall post the following information with respect to both on their respective websites and the J&J website (through a link or other appropriate means) annual reports about grants and charitable contributions in to U.S.- based HCPs and HCIs: (1) the United States: GSK ultimate recipients organization’s name, to the extent known by J&J Pharmaceutical Affiliates; (2) a brief description of the program for which the grant or charitable contribution was requested; and (3) the amount of the grant or charitable contribution. The J&J Pharmaceutical Affiliates shall continue to post (and provide updates to) the above-described information about grants and charitable contributions throughout the term of this CIA. GSK The J&J Pharmaceutical Affiliates shall notify the OIG in writing at least 60 days prior to any change in the substance of its their policies regarding the funding of grants and charitable contributions or posting of the above-referenced information relating to such funding. GSK To the extent not already accomplished, within 120 days after the Effective Date, J&J shall ensure that all J&J Pharmaceutical Affiliates require all Consultants to comply fully with all applicable disclosure obligations relating to their relationship with GSK the J&J Pharmaceutical Affiliates that may be externally imposed on the Consultants based on their affiliation with formulary or P&T committees or committees associated with the development of treatment protocols or standards. GSK J&J and J&J Pharmaceutical Affiliates shall maintain this requirement these requirements throughout the term of this CIA. GSK represents that within Within 120 days after the Effective Date, GSK the J&J Pharmaceutical Affiliates shall, if necessary, amend its their policies relating to Consultants to explicitly state that GSK requires the J&J Pharmaceutical Affiliates require all Consultants to fully comply with all applicable disclosure obligations relating to their relationship with GSK the companies that may be externally imposed on the Consultants based on their affiliation with formulary, P&T committees, or committees associated with the development of treatment protocols or standards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. In addition, for any GlaxoSmithKline LLC Corporate Integrity Agreement amendment to its contracts with Consultants and in any new contracts with Consultants entered into after 150 120 days following the Effective Date, GSK the J&J Pharmaceutical Affiliates shall include an explicit requirement that the Consultants fully comply with all applicable disclosure requirements, as referenced above in this paragraph. GSK J&J and/or J&J Pharmaceutical Affiliates shall continue these disclosure requirements throughout the term of this CIA. To the extent not already accomplished, within 120 days after the Effective Date, GSK J&J shall post ensure that the J&J Pharmaceutical Affiliates require all Authors of biomedical manuscripts to fully comply with the International Committee of Medical Journal Editors (ICMJE) criteria regarding authorship and disclosure of their relationship with the applicable J&J Pharmaceutical Affiliate and to disclose any potential conflicts of interest, including any financial or personal relationships that might be perceived to bias their work. Within 120 days after the Effective Date, the applicable J&J Pharmaceutical Affiliates, if necessary, shall amend their policies relating to Authors to explicitly state the companies’ requirement about full disclosure by Authors consistent with the requirements of any HCI, medical committee or other medical or scientific organization with which the Authors are affiliated. In addition, for any amendments to its contracts with Authors and in any new contracts with Authors entered into after 120 days following the Effective Date, the applicable J&J Pharmaceutical Affiliate shall include an explicit requirement that Authors disclose in their manuscripts, journal submissions, and elsewhere as appropriate or required, any potential conflicts of interest, including their financial or personal relationship with the applicable J&J Pharmaceutical Affiliate, the names of any individuals who have provided editorial support for any manuscript or other publication, and all funding sources for the study or publication. To the extent not already accomplished, within 120 days after the Effective Date, J&J shall ensure that the J&J Pharmaceutical Affiliates have registered all clinical studies and report results of such clinical studies on the National Institutes of Health (NIH) sponsored website (xxx.xxxxxxxxxxxxxx.xxx) in compliance with all current federal requirements. The applicable J&J Pharmaceutical Affiliate shall continue to comply with Federal health care program requirements, or other applicable requirements relating to the registration and results reporting of clinical studies throughout the term of this CIA. In addition, if there is a change in Federal health care program requirements, FDA requirements, NIH requirements or other applicable requirements relating to registration and results reporting of clinical study information, J&J and/or the applicable J&J Pharmaceutical Affiliate shall fully comply with such requirements. To the extent not already accomplished, within 120 days after the Effective Date, J&J shall ensure that the J&J Pharmaceutical Affiliates link, post, or make available information on its company their website(s) and on the J&J website (through a link or other appropriate means) about FDA postmarketing commitments (PMCs). The GSK website or links included therein applicable website(s) shall provide access to general information about the PMC process, descriptions of ongoing GSK studies, and information about the nature and status of the post-post- marketing commitments. GSK The J&J Pharmaceutical Affiliates shall continue to post or make available the above-described information about PMCs on its their websites and the J&J website or links included therein throughout the term of this CIA.

Other Transparency/Disclosure Initiatives. GSK represents that it posts By January 1, 2011, Forest shall post on its company website the following information with respect to both medical education grants and charitable contributions in other industry support: 1) the United Statesrecipient organization’s name: GSK 2) a brief description of the program for which the grant or contribution was requested; and 3) the amount of the grant or contribution. After the initial posting, Forest shall continue to post (and provide updates to) the above-described information about grants and charitable contributions contribution on a quarterly basis throughout the term of this CIA. GSK Forest shall notify the OIG in writing at least 60 days prior to any change in the substance of its policies regarding the funding of grants and charitable contributions or posting of the above-referenced information relating to such funding. GSK shall require Forest represents that it requires all Consultants to fully comply fully with all applicable disclosure obligations relating to their relationship with GSK Forest that may be externally imposed on the Consultants based on their affiliation with formulary or P&T committees or committees associated with the development of treatment protocols or standards. GSK Forest shall maintain continue this requirement throughout the term of this CIA. GSK represents that within Within 120 days after the Effective Date, GSK shall, if necessary, Forest shall amend its policies relating to Consultants to explicitly state that GSK requires all Forest’ requirement about full disclosure by Consultants to fully comply with all applicable disclosure obligations relating to their relationship with GSK that may be externally imposed on the Consultants based on their affiliation with formulary, P&T committees, or committees associated consistent with the development requirements of treatment protocols or standards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. In addition, for any GlaxoSmithKline LLC Corporate Integrity Agreement amendment to its contracts with Consultants and in any new contracts with Consultants entered into after 150 120 days following the Effective Date, GSK Forest shall include an explicit requirement that the Consultants fully comply with all applicable disclosure requirementsrequirements and disclose their relationship with Forest as required pursuant to their affiliation with any HCI, medical committee, or other medical or scientific organization. Corporate Integrity Agreement Forest Laboratories, Inc. Xxxxxx represents that it expects all Authors of biomedical manuscripts to fully comply with the International Committee of Medical Journal Editors (ICMJE) criteria regarding authorship and disclosure of their relationship with Xxxxxx and to disclose any potential conflicts of interest, including any financial or personal relationships that might be perceived to bias their work. Within 120 days after the Effective Date, Forest shall amend its policies relating to Authors to explicitly state Forest’ requirement about full disclosure by Authors consistent with the requirements of any HCI, medical committee or other medical or scientific organization with which the Authors are affiliated. In addition, for any amendments to its contracts with Authors and in any new contracts with Authors entered into after 120 days following the Effective Date, Forest shall include an explicit requirement that Authors disclose in their manuscripts, journal submissions, and elsewhere as referenced above in this paragraphappropriate or required, any potential conflicts of interest, including their financial or personal relationship with Xxxxxx, the names of any individuals who have provided editorial support for any manuscript or other publication, and all funding sources for the study or publication. GSK Forest represents that it registers and reports the results of all Forest-sponsored clinical studies as required by applicable regulations on the National Institutes of Health (NIH) sponsored website (xxx.xxxxxxxxxxxxxx.xxx). Forest shall continue these disclosure requirements to comply with applicable regulations relating to the posting of clinical study information throughout the term of this CIA. To In addition, if there is a change in Federal health care program requirements, FDA requirements, or other applicable requirements relating to the extent not already accomplishedreporting of clinical study information, within 120 days after the Effective Date, GSK Forest shall fully comply with such requirements. Forest shall post or make available information on its company website about FDA postmarketing commitments (PMCs). The GSK Forest website or links included therein shall will provide access to general information about the PMC process, including study descriptions of ongoing GSK studies, and information about the nature and status of the post-marketing commitmentsFDA PMCs. GSK Forest shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.

Other Transparency/Disclosure Initiatives. GSK represents that it posts By January 1, 2011, Forest shall post on its company website the following information with respect to both medical education grants and charitable contributions in other industry support: 1) the United States: GSK recipient organization’s name; 2) a brief description of the program for which the grant or contribution was requested; and 3) the amount of the grant or contribution. After the initial posting, Forest shall continue to post (and provide updates to) the above-described information about grants and charitable contributions contribution on a quarterly basis throughout the term of this CIA. GSK Forest shall notify the OIG in writing at least 60 days prior to any change in the substance of its policies regarding the funding of grants and charitable contributions or posting of the above-referenced information relating to such funding. GSK shall require Forest represents that it requires all Consultants to fully comply fully with all applicable disclosure obligations relating to their relationship with GSK Forest that may be externally imposed on the Consultants based on their affiliation with formulary or P&T committees or committees associated with the development of treatment protocols or standards. GSK Forest shall maintain continue this requirement throughout the term of this CIA. GSK represents that within Within 120 days after the Effective Date, GSK shall, if necessary, Forest shall amend its policies relating to Consultants to explicitly state that GSK requires all Forest’ requirement about full disclosure by Consultants to fully comply with all applicable disclosure obligations relating to their relationship with GSK that may be externally imposed on the Consultants based on their affiliation with formulary, P&T committees, or committees associated consistent with the development requirements of treatment protocols or standards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. In addition, for any GlaxoSmithKline LLC Corporate Integrity Agreement amendment to its contracts with Consultants and in any new contracts with Consultants entered into after 150 120 days following the Effective Date, GSK Forest shall include an explicit requirement that the Consultants fully comply with all applicable disclosure requirementsrequirements and disclose their relationship with Forest as required pursuant to their affiliation with any HCI, medical committee, or other medical or scientific organization. Forest represents that it expects all Authors of biomedical manuscripts to fully comply with the International Committee of Medical Journal Editors (ICMJE) criteria regarding authorship and disclosure of their relationship with Forest and to disclose any potential conflicts of interest, including any financial or personal relationships that might be perceived to bias their work. Within 120 days after the Effective Date, Forest shall amend its policies relating to Authors to explicitly state Forest’ requirement about full disclosure by Authors consistent with the requirements of any HCI, medical committee or other medical or scientific organization with which the Authors are affiliated. In addition, for any amendments to its contracts with Authors and in any new contracts with Authors entered into after 120 days following the Effective Date, Forest shall include an explicit requirement that Authors disclose in their manuscripts, journal submissions, and elsewhere as referenced above in this paragraphappropriate or required, any potential conflicts of interest, including their financial or personal relationship with Forest, the names of any individuals who have provided editorial support for any manuscript or other publication, and all funding sources for the study or publication. GSK Forest represents that it registers and reports the results of all Forest-sponsored clinical studies as required by applicable regulations on the National Institutes of Health (NIH) sponsored website (xxx.xxxxxxxxxxxxxx.xxx). Forest shall continue these disclosure requirements to comply with applicable regulations relating to the posting of clinical study information throughout the term of this CIA. To In addition, if there is a change in Federal health care program requirements, FDA requirements, or other applicable requirements relating to the extent not already accomplishedreporting of clinical study information, within 120 days after the Effective Date, GSK Forest shall fully comply with such requirements. Forest shall post or make available information on its company website about FDA postmarketing commitments (PMCs). The GSK Forest website or links included therein shall will provide access to general information about the PMC process, including study descriptions of ongoing GSK studies, and information about the nature and status of the post-marketing commitmentsFDA PMCs. GSK Forest shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.

Other Transparency/Disclosure Initiatives. GSK 1. Independent Medical Education Activity Grants and Health Care Related Charitable Contributions. Shire represents that that, on a quarterly basis, it posts on its company website the following information with respect to both all Independent Medical Education Activity grants and health care related charitable contributions in contributions. The information posted on the United Statescompany website includes: GSK (i) the name of the recipient; (ii) the program name; and (iii) the amount of the grant or donation. Shire shall continue to post (and provide updates to) the above-described information about Independent Medical Education Activity grants and health care related charitable contributions throughout the term of this CIA. GSK Shire shall notify the OIG in writing at least 60 days prior to any change in the substance of its policies regarding the funding of Independent Medical Education Activity grants and health care related charitable contributions or posting of the above-referenced information relating to such funding. GSK Shire North American Group, Inc. Corporate Integrity Agreement 2. Consultant Disclosure Obligations. Shire shall require all Consultants to fully comply fully with all applicable disclosure obligations relating to their relationship with GSK Shire that may be externally imposed on the Consultants based on their affiliation with formulary or P&T Pharmacy & Therapeutics (P&T) committees or committees associated with the development of treatment protocols or standardsstandards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. GSK shall maintain this requirement throughout the term of this CIA. GSK represents that within Within 120 days after the Effective Date, GSK shallto the extent not already accomplished, if necessary, Shire shall amend its policies relating to Consultants to explicitly state that GSK Shire requires all Consultants to fully comply with all applicable disclosure obligations relating to their relationship with GSK Shire that may be externally imposed on the Consultants based on their affiliation with formulary, P&T committees, or committees associated with the development of treatment protocols or standards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. In addition, for any GlaxoSmithKline LLC Corporate Integrity Agreement amendment to its contracts with Consultants and in any new contracts with Consultants entered into after 150 120 days following the Effective Date, GSK Shire shall include an explicit requirement that the Consultants fully comply with all applicable disclosure requirements, as referenced above in this paragraph. GSK Shire shall continue these disclosure requirements throughout the term of this CIA. To the extent not already accomplished, within 120 days after the Effective Date, GSK shall post or make available information on its company website about FDA postmarketing commitments (PMCs). The GSK website or links included therein shall provide access to general information about the PMC process, descriptions of ongoing GSK studies, and information about the nature and status of the post-marketing commitments. GSK shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.

Other Transparency/Disclosure Initiatives. GSK Amgen represents that that, on a quarterly basis, it posts on its company website the following information with respect to both all independent medical education grants and charitable contributions in healthcare donations. The information posted on the United Statescompany website includes: GSK (i) the name of the recipient; (ii) the program name; and (iii) the amount of the grant or donation. Amgen shall continue to post (and provide updates to) the above-described information about grants and charitable contributions healthcare donations throughout the term of this CIA. GSK Amgen shall notify the OIG in writing at least 60 days prior to any change in the substance of its policies regarding the funding of grants and charitable contributions healthcare donations or posting of the above-above- referenced information relating to such funding. GSK Amgen shall require all Consultants to fully comply fully with all applicable disclosure obligations relating to their relationship with GSK Amgen that may be externally imposed on the Consultants based on their affiliation with formulary or P&T Pharmacy & Therapeutics (P&T) committees or committees associated with the development of treatment protocols or standardsstandards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. GSK shall maintain this requirement throughout the term of this CIA. GSK represents that within Within 120 days after the Effective Date, GSK Amgen shall, if necessary, amend its policies relating to Consultants to explicitly state that GSK Amgen requires all Consultants to fully comply with all applicable disclosure obligations relating to their relationship with GSK Amgen that may be externally imposed on the Consultants based on their affiliation with formulary, P&T committees, or committees associated with the development of treatment protocols or standards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. In addition, for any GlaxoSmithKline LLC Corporate Integrity Agreement amendment to its contracts with Consultants and in any new contracts with Consultants entered into after 150 120 days following the Effective Date, GSK Amgen shall include an explicit requirement that the Consultants fully comply with all applicable disclosure requirements, as referenced above in this paragraph. GSK Amgen shall continue these disclosure requirements throughout the term of this CIA. Corporate Integrity Agreement Amgen Inc. Amgen represents that it expects all Authors of biomedical manuscripts to fully comply with the International Committee of Medical Journal Editors (ICMJE) criteria regarding authorship and disclosure of their relationship with Amgen and to disclose any potential conflicts of interest, including any financial or personal relationships that might be perceived to bias their work. Within 120 days after the Effective Date, Amgen, if necessary, shall amend its Author confirmation letter to explicitly state Xxxxx’s requirement about full disclosure by Authors consistent with the requirements of any HCI, medical committee or other medical or scientific organization with which the Authors are affiliated. In addition, for any amendments to its engagement letters with Authors and in any new engagement letters with Authors entered into after 120 days following the Effective Date, Amgen shall include an explicit requirement that Authors disclose in their manuscripts, journal submissions, and elsewhere as appropriate or required, any potential conflicts of interest, including their financial or personal relationship with Amgen, the names of any individuals who have provided editorial support for any manuscript or other publication, and all funding sources for the study or publication. To the extent not already accomplished, within 120 days after the Effective Date, GSK Amgen shall post or make available information on its company website about FDA postmarketing post- marketing commitments (PMCs). The GSK Amgen website or links included therein shall provide access to general information about the PMC process, descriptions of ongoing GSK Amgen studies, and information about the nature and status of the FDA post-marketing commitments. GSK Amgen shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.

Other Transparency/Disclosure Initiatives. GSK represents that it posts Within 120 days after the Effective Date of this CIA, and thereafter on a bi-annual basis, Allergan shall post on its company website the following information with respect to both medical education grants and charitable contributions in to U.S.-based HCIs: 1) the United Statesrecipient organization’s name: GSK 2) a brief description of the program for which the grant or charitable contribution was requested; and 3) the amount of the grant or charitable contribution. Allergan shall continue to post (and provide updates to) the above-described information about medical education grants and charitable contributions to U.S.-based HCIs throughout the term of this CIA. GSK Allergan shall notify the OIG in writing at least 60 days prior to any change in the substance of its policies regarding the funding of medical education grants and charitable contributions to U.S.-based HCIs or posting of the above-referenced information relating to such funding. GSK shall require Allergan represents that it requires all U.S.-based Consultants to fully comply fully with all applicable disclosure obligations relating to their relationship with GSK Allergan that may be externally imposed on the Consultants based on their affiliation with formulary or P&T Pharmacy & Therapeutics committees or committees associated with the development of treatment protocols or standards. GSK Allergan shall maintain continue this requirement throughout the term of this CIA. GSK represents that within Within 120 days after the Effective Date, GSK shall, if necessary, Allergan shall amend its policies relating to Consultants to explicitly state that GSK requires all Allergan’s requirement about full disclosure by Consultants to fully comply with all applicable disclosure obligations relating to their relationship with GSK that may be externally imposed on the Consultants based on their affiliation with formulary, P&T committees, or committees associated consistent with the development requirements of treatment protocols or standards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. In addition, for any GlaxoSmithKline LLC Corporate Integrity Agreement amendment to its contracts with Consultants and in any new contracts with Consultants entered into after 150 120 days following the Effective Date, GSK Allergan shall include an explicit requirement that the Consultants fully comply with applicable disclosure requirements and disclose their relationship with Allergan as required pursuant to their affiliation with any HCI, medical committee, or other medical or scientific organization. Allergan represents that it expects all Authors of biomedical manuscripts to fully comply with the International Committee of Medical Journal Editors (ICMJE) criteria regarding authorship and disclosure of their relationship with Allergan and to disclose any potential conflicts of interest, including any financial or personal relationships that might be perceived to bias their work. Within 120 days after the Effective Date, Allergan shall amend its policies relating to Authors to explicitly state Allergan’s requirement about full disclosure by Authors consistent with the requirements of any HCI, medical committee or other medical or scientific organization with which the Authors are affiliated. In addition, for any amendments to its contracts with Authors and in any new contracts with Authors entered into after 120 days following the Effective Date, Allergan shall include an explicit requirement that Authors disclose in their manuscripts, journal submissions, and elsewhere as appropriate or required, any potential conflicts of interest, including their financial or personal relationship with Allergan, the names of any individuals who have provided editorial support for any manuscript or other publication, and all funding sources for the study or publication. Allergan represents that for all applicable disclosure clinical trials (as defined by 42 U.S.C. §282(j)) where Allergan is a sponsor, it registers and reports the results on the National Institutes of Health (NIH) sponsored website (xxx.xxxxxxxxxxxxxx.xxx) or requires that another responsible party (as defined by 42 U.S.C. § 282(j)) register and report the results on the NIH website. Allergan shall continue to comply with Federal health care program requirements, as referenced above in this paragraph. GSK shall continue these disclosure FDA requirements, or other applicable requirements relating to the reporting of clinical study information throughout the term of this CIA. To In addition, if there is a change in Federal health care program requirements, FDA requirements, or other applicable requirements relating to the extent not already accomplishedreporting of clinical study information, within 120 days after the Effective Date, GSK Allergan shall post or make available fully comply with such requirements. Allergan represents that it posts information on its company website about FDA postmarketing commitments (PMCs). The GSK Allergan website or links included therein shall provide (xxx.xxxxxxxx.xxx) provides access to general information about the PMC process, including study descriptions of ongoing GSK studies, and information about abut the nature and status of the post-marketing commitmentsFDA PMCs. GSK Allergan shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.

Other Transparency/Disclosure Initiatives. GSK represents that it posts To the extent not already accomplished, within 120 days after the Effective Date, BIPI will post on its company website the following information with respect to both grants and charitable contributions in to U.S.-based HCPs and HCIs: 1) the United States: GSK ultimate recipient organization’s name, to the extent known by XXXX; 2) a brief description of the program for which the grant or charitable contribution was requested; and 3) the amount of the grant or charitable contribution. BIPI shall continue to post (and provide updates to) the above-described information about grants and charitable contributions throughout the term of this CIA. GSK BIPI shall notify the OIG in writing at least 60 days prior to any change in the substance of its policies regarding the funding of grants and charitable contributions or posting of the above-referenced information relating to such funding. GSK shall To the extent not already accomplished, within 120 days after the Effective Date, BIPI will require all Consultants to fully comply fully with all applicable disclosure obligations relating to their relationship with GSK BIPI that may be externally imposed on the Consultants based on their affiliation with formulary or P&T committees or committees associated with the development of treatment protocols or standards. GSK BIPI shall maintain continue this requirement throughout the term of this CIA. GSK BIPI represents that within 120 days after the Effective Date, GSK BIPI shall, if necessary, amend its policies relating to Consultants to explicitly state that GSK BIPI requires all Consultants to fully comply with all applicable disclosure obligations relating to their relationship with GSK BIPI that may be externally imposed on the Consultants based on their affiliation with formulary, P&T committees, or committees associated with the development of treatment protocols or standards or that are required by any HCI, medical committee, or other medical or scientific organization with which the Consultants are affiliated. In addition, for any GlaxoSmithKline LLC Corporate Integrity Agreement amendment to its contracts with Consultants and in any new contracts with Consultants entered into after 150 days following the Effective Date, GSK BIPI shall include an explicit requirement that the Consultants fully comply with all applicable disclosure requirements, as referenced above in this paragraph. GSK BIPI shall continue these disclosure requirements throughout the term of this CIA. To the extent not already accomplished, within 120 days after the Effective Date, GSK BIPI will require all Authors of biomedical manuscripts to fully comply with the International Committee of Medical Journal Editors (ICMJE) criteria regarding authorship and disclosure of their relationship with XXXX and to disclose any potential conflicts of interest, including any financial or personal relationships that might be perceived to bias their work. Within 120 days after the Effective Date, BIPI, if necessary, shall amend its policies relating to Authors to explicitly state BIPI’s requirement about full disclosure by Authors consistent with the requirements of any HCI, medical committee or other medical or scientific organization with which the Authors are affiliated. In addition, for any amendments to its contracts with Authors and in any new contracts with Authors entered into after 120 days following the Effective Date, BIPI shall include an explicit requirement that Authors disclose in their manuscripts, journal submissions, and elsewhere as appropriate or required, any potential conflicts of interest, including their financial or personal relationship with XXXX, the names of any individuals who have provided editorial support for any manuscript or other publication, and all funding sources for the study or publication. To the extent not already accomplished, within 120 days after the Effective Date, BIPI shall ensure that all clinical studies and report results of such clinical studies are registered on the National Institutes of Health (NIH) sponsored website (xxx.xxxxxxxxxxxxxx.xxx) in compliance with all current federal requirements. BIPI shall continue to comply with Federal health care program requirements, or other applicable requirements relating to the registration and results reporting of clinical studies throughout the term of this CIA. In addition, if there is a change in Federal health care program requirements, FDA requirements, NIH requirements, or other applicable requirements relating to registration and results reporting of clinical study information, BIPI shall fully comply with such requirements. To the extent not already accomplished, within 120 days after the Effective Date, BIPI shall post or make available information on its company website about FDA postmarketing commitments (PMCs). The GSK BIPI website or links included therein shall provide access to general information about the PMC process, descriptions of ongoing GSK BIPI studies, and information about the nature and status of the FDA post-marketing commitments. GSK BIPI shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.