Common use of Regulatory Meetings Clause in Contracts

Regulatory Meetings. The Regulatory Lead Party shall provide the other Party with notice of all meetings, conferences, and discussions (including FDA advisory committee meetings and any other meeting of experts convened by the FDA concerning any topic relevant to a Product, as well as Product labeling and post-Regulatory Approval Product labeling discussions with the FDA) scheduled with the FDA concerning any pending Drug Approval Application or any material regulatory matters relating to a Product within [****]* after the Regulatory Lead Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDL’s and BMS’ respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDA. The Regulatory Lead Party shall also include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Product. * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions.

Regulatory Meetings. The Lead Regulatory Lead Party shall provide the other Party with notice of all meetings, conferences, and discussions (including FDA Regulatory Authority advisory committee meetings and any other meeting of experts convened by the FDA Regulatory Authority concerning any topic relevant to a Collaboration Product, as well as Collaboration Product labeling and post-Regulatory Approval Collaboration Product labeling discussions with the FDAany Regulatory Authority) scheduled with by the FDA Regulatory Authority concerning any pending Drug Approval Application or any material regulatory matters relating to a Collaboration Product [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. within [****][ * ] after the Lead Regulatory Lead Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDLFacet’s and BMS’ Trubion’s respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDARegulatory Authority. The Lead Regulatory Lead Party shall also reasonably attempt to include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA Regulatory Authority concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Collaboration Product. * Certain information , and will promptly copy such other Party on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portionsa contact report.

Regulatory Meetings. The Lead Regulatory Lead Party shall provide the other Party with notice of all meetings, conferences, and discussions (including FDA Regulatory Authority advisory committee meetings and any other meeting of experts convened by the FDA Regulatory Authority concerning any topic relevant to a Collaboration Product, as well as Collaboration Product labeling and post-Regulatory Approval Collaboration Product labeling discussions with the FDAany Regulatory Authority) scheduled with by the FDA Regulatory Authority concerning any pending Drug Approval Application or any material regulatory matters relating to a Collaboration Product within [****]* ] after the Lead Regulatory Lead Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDLFacet’s and BMS’ Trubion’s respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDARegulatory Authority. The Lead Regulatory Lead Party shall also reasonably attempt to include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA Regulatory Authority concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Collaboration Product. * Certain information , and will promptly copy such other Party on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portionsa contact report.

Regulatory Meetings. The Regulatory Lead Each Party (Alder with respect to the FDA and BMS with respect to the EMEA) shall provide the other Party with prior notice of with respect to all meetings, conferences, conferences and discussions (including FDA advisory committee meetings and any other meeting of experts convened by the FDA or EMEA concerning any topic relevant to a Co-Developed Product, as well as Product product labeling and post-Regulatory Approval Product product labeling discussions with the FDAdiscussions) scheduled with the FDA concerning any pending Drug Approval Application or any material regulatory matters relating to a Product EMEA for the Co-Developed Product. Such notice shall be provided within [****]* two (2) Business Days after the Regulatory Lead such Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the such other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The Such other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDLAlder’s and BMS’ respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDAFDA and EMEA. The Regulatory Lead To the extent practicable, each Party (Alder with respect to the FDA and BMS with respect to the EMEA) shall also include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA or EMEA concerning any pending IND, Drug Approval Application MAA or any material regulatory matters relating to a the Co-Developed Product. * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Regulatory Meetings. The Regulatory Lead Party holding the IND for a Co-Developed Product shall provide the other Party with notice of all meetings, conferences, and discussions (including FDA advisory committee meetings and any other meeting of experts convened by the FDA concerning any topic relevant to a ProductCo-Developed Products, as well as Product labeling and post-Regulatory Approval Product labeling discussions with the FDA) scheduled with the FDA concerning any pending Drug Approval Application or any material regulatory matters relating to a Product Co-Developed Products within [****]* ] after the Regulatory Lead such Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the such other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The Such other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDLEXEL’s and BMS’ respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDA. The Regulatory Lead To the extent practicable, the Party holding the IND for a Co-Developed Product shall also include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Product. * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portionsCo-Developed Products.

Regulatory Meetings. The Regulatory Lead Party holding the IND for a Co-Developed Product shall provide the other Party with notice of all meetings, conferences, and discussions (including FDA advisory committee meetings and any other meeting of experts convened by the FDA concerning any topic relevant to a ProductCo-Developed Products, as well as Product labeling and post-Regulatory Approval Product labeling discussions with the FDA) scheduled with the FDA concerning any pending Drug Approval Application or any material regulatory matters relating to a Product Co-Developed Products within [****][ * ] after the Regulatory Lead such Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the such other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The Such other Party shall be entitled to be present at, and to participate in, all such [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. meetings, conferences or discussions. PDL’s Exelixis’ and BMS’ respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDA. The Regulatory Lead To the extent practicable, the Party holding the IND for a Co-Developed Product shall also include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Product. * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portionsCo-Developed Products.

Regulatory Meetings. The Lead Regulatory Lead Party shall provide the other Party with notice of all meetings, conferences, and discussions (including FDA Regulatory Authority advisory committee meetings and any other meeting of experts convened by the FDA Regulatory Authority concerning any topic relevant to a Collaboration Product, as well as Collaboration Product labeling and post-Regulatory Approval Collaboration Product labeling discussions with the FDAany Regulatory Authority) scheduled with by the FDA Regulatory Authority concerning any pending Drug Approval Application or any material regulatory matters relating to a Collaboration Product within [****][ * ] after the Lead Regulatory Lead Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDLFacet’s and BMS’ Trubion’s respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDARegulatory Authority. The Lead Regulatory Lead Party shall also reasonably attempt to include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA Regulatory Authority concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Collaboration Product. * Certain information , and will promptly copy such other Party on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portionsa contact report.

Regulatory Meetings. The Regulatory Lead Each Party (Alder with respect to the FDA and BMS with respect to the EMEA) shall provide the other Party with prior notice of with respect to all meetings, conferences, conferences and discussions (including FDA advisory committee meetings and any other meeting of experts convened by the FDA or EMEA concerning any topic relevant to a Co-Developed Product, as well as Product product labeling and post-Regulatory Approval Product product labeling discussions with the FDAdiscussions) scheduled with the FDA concerning any pending Drug Approval Application or any material regulatory matters relating to a Product EMEA for the Co-Developed Product. Such notice shall be provided within [****]* two (2) Business Days after the Regulatory Lead such Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the such other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The Such other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDLAlder’s and BMS’ respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDAFDA and EMEA. The Regulatory Lead To the extent practicable, each Party (Alder with respect to the FDA and BMS [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. with respect to the EMEA) shall also include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA or EMEA concerning any pending IND, Drug Approval Application MAA or any material regulatory matters relating to a the Co-Developed Product. * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions.