Common use of Delay of Initial Regulatory Filing Clause in Contracts

Delay of Initial Regulatory Filing. In the event that Registration of the Initial Regulatory Filing is denied or is materially delayed by the FDA, then the PDC shall (a) immediately meet to discuss in good faith a reassessment of the relevant Clinical Development Plan to address the FDA's objections and questions, (b) immediately give the JEC notice of such developments, (c) from time to time as additional such developments arise, promptly give the JEC notice of such additional developments, and (d) keep the JEC reasonably informed of the PDC's deliberations regarding all such developments. As used in this Section 4.8, a material delay is a delay arising from a requirement set forth by the FDA that the Company conduct additional clinical studies not conducted in connection with the submission of the Initial Regulatory Filing. In the event of a material delay, the PDC shall apply its sound scientific, commercial and regulatory judgment with all deliberate speed to determine whether or not it is in the best interest of both of ERS and the Company to go forward with the conduct of any additional clinical studies required by the FDA. Upon reaching such determination, the PDC shall make a formal recommendation of its conclusions to the JEC and shall await direction from the JEC regarding what, if any, further action is to be taken with respect to such matters. Upon receiving the approval of the JEC to undertake the additional clinical studies required by the FDA, the PDC shall be authorized to, and is hereby directed to, redirect (without increasing) the existing overall Clinical Budget as necessary to undertake such studies and to cause such studies to be undertaken.

Delay of Initial Regulatory Filing. In the event that Registration of the Initial Regulatory Filing is denied or is materially delayed by the FDA, or if the FDA imposes additional material requirements at any time, then the PDC shall (a) immediately meet to discuss in good faith a reassessment of the relevant Clinical Development Plan to address the FDA's ’s objections and questions, (b) immediately give the JEC notice of such developments, (c) from time to time as additional such developments arise, promptly give the JEC notice of such additional developments, and (d) keep the JEC reasonably informed of the PDC's ’s deliberations regarding all such developments. As used in this Section 4.84.7, a material delay is a delay arising from a requirement set forth by the FDA that the Company DURECT conduct additional studies (clinical studies and non-clinical) not conducted in connection with the submission of the Initial Regulatory Filing. In the event of a material delay, the PDC shall apply its sound scientific, commercial and regulatory judgment with all deliberate speed to determine whether or not it is in the best interest of both of ERS Endo and the Company DURECT to go forward with the conduct of any additional clinical studies required by the FDA. Upon reaching such determination, the PDC shall make a formal recommendation of its conclusions to the JEC and shall await direction from the JEC regarding what, if any, further action is to be taken with respect to such matters. Upon receiving the approval of the JEC to undertake the additional clinical studies required by the FDA, the PDC shall be authorized toauthorized, and is hereby directed todirected, redirect (without increasing) to amend the existing overall Clinical Development Budget as necessary to undertake such studies and to cause such studies to be undertaken. ***Material has been omitted pursuant to a request for confidential treatment and such material has been filed separately with the SEC.

Delay of Initial Regulatory Filing. In the event that Registration of the Initial Regulatory Filing is denied or is materially delayed by the FDA, or if the FDA imposes additional material requirements at any time, then the PDC shall (a) immediately meet to discuss in good faith a reassessment of the relevant Clinical Development Plan to address the FDA's objections and questions, (b) immediately give the JEC notice of such developments, (c) from time to time as additional such developments arise, promptly give the JEC notice of such additional developments, and (d) keep the JEC reasonably informed of the PDC's deliberations regarding all such developments. As used in this Section 4.84.7, a material delay is a delay arising from a requirement set forth by the FDA that the Company DURECT conduct additional studies (clinical studies and non-clinical) not conducted in connection with the submission of the Initial Regulatory Filing. In the event of a material delay, the PDC shall apply its sound scientific, commercial and regulatory judgment with all deliberate speed to determine whether or not it is in the best interest of both of ERS Endo and the Company DURECT to go forward with the conduct of any additional clinical studies required by the FDA. Upon reaching such determination, the PDC shall make a formal recommendation of its conclusions to the JEC and shall await direction from the JEC regarding what, if any, further action is to be taken with respect to such matters. Upon receiving the approval of the JEC to undertake the additional clinical studies required by the FDA, the PDC shall be authorized toauthorized, and is hereby directed todirected, redirect (without increasing) to amend the existing overall Clinical Development Budget as necessary to undertake such studies and to cause such studies to be undertaken.