Common use of Product Recall Determination Clause in Contracts

Product Recall Determination. If at any time or from time to time, a Competent Authority requests Meda to conduct a Product Recall of any Licensed Product in the Territory or if a voluntary Product Recall of any Licensed Product in the Territory is contemplated by Meda, Meda shall immediately notify BDSI in writing, and except as otherwise set forth in this Article XII, Meda will, at its sole cost and expense, conduct such Product Recall in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the Licensed Products and the goodwill and reputation of the Parties, provided that: (a) Meda shall not carry out a voluntary Product Recall in the Territory with respect to such Licensed Product without the prior written approval of BDSI, such approval not to be unreasonably withheld (for the avoidance of doubt, any Product Recall that is reasonably deemed necessary in order to avoid serious personal injury shall not be considered as a voluntary Product Recall, provided that Meda shall provide BDSI the opportunity to advise and comment with respect to any such Product Recall prior to its execution); and (b) the Parties shall reasonably cooperate, at Meda’s expense, in the conduct of any Product Recall for such Licensed Product in the Territory. Notwithstanding the foregoing, Meda may, without BDSI’s prior consent, immediately effect any Product Recall (A) resulting from any death or life-threatening adverse event associated with any Licensed Product or (B) required to comply with any regulatory or legal requirements, guidelines, directives, orders, or injunctions with respect to any Licensed Product. In the event Meda does not undertake such a Product Recall in a reasonable period of time, BDSI shall be entitled to do so without Meda’s prior written consent.

Product Recall Determination. If at any time or from time to time, a Competent Authority requests Meda Collegium to conduct a Product Recall of any Licensed Product Developed or Commercialized by or for Collegium, any Affiliate thereof, or any Sublicensee in the Territory or if a voluntary Product Recall of any such Licensed Product in the Territory is contemplated by MedaCollegium, Meda any Affiliate thereof, or any Sublicensee, Collegium shall immediately notify BDSI in writing, and except as otherwise set forth in this Article XII, Meda Collegium will, at its sole cost and expense, conduct such Product Recall in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the such Licensed Products and the goodwill and reputation of the Parties, provided that: (a) Meda Collegium shall not not, and shall ensure that its Affiliates and Sublicensees do not, carry out a voluntary Product Recall in the Territory with respect to such Licensed Product without the prior written approval of BDSI, such approval not to be unreasonably withheld withheld, conditioned or delayed (for the avoidance of doubt, any Product Recall that is reasonably deemed necessary in order to avoid serious personal injury shall not be considered as a voluntary Product Recall, provided that Meda Collegium shall provide BDSI the opportunity to advise and comment with respect to any such Product Recall prior to its execution); and (b) the Parties shall reasonably cooperate, at MedaCollegium’s expense, in the conduct of any Product Recall for such Licensed Product in the Territory. Notwithstanding the foregoing, Meda Collegium, any Affiliate thereof, or any Sublicensee may, without BDSI’s prior consent, immediately effect any Product Recall (Ai) resulting from any death or life-threatening adverse event Adverse Event *** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information. associated with any Licensed Product or (Bii) required to comply with any regulatory or legal requirements, guidelines, directives, orders, or injunctions Applicable Law with respect to any Licensed Product. In the event Meda Collegium notifies BDSI, or BDSI otherwise becomes aware, that Collegium, any Affiliate thereof, or any Sublicensee does not intend to undertake such a Product Recall of the type described in a reasonable period of timeclauses (i) or (ii) above, BDSI shall be entitled to do so upon notice to Collegium without MedaCollegium’s prior written consent.

Product Recall Determination. If at any time or from time to time, a Competent Authority requests Meda to conduct a Product Recall of any the Licensed Product in the Territory or if a voluntary Product Recall of any the Licensed Product in the Territory is contemplated by Meda, Meda shall immediately notify BDSI in writing, and except as otherwise set forth in this Article XII, Meda will, at its sole cost and expense, conduct such Product Recall in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the Licensed Products Product and the goodwill and reputation of the Parties, provided that: (a) Meda shall not carry out a voluntary Product Recall in the Territory with respect to such the Licensed Product without the prior written approval of BDSI, such approval not to be unreasonably withheld (for the avoidance of doubt, any Product Recall that is reasonably deemed necessary in order to avoid serious personal injury shall not be considered as a voluntary Product Recall, provided that Meda shall provide BDSI the opportunity to advise and comment with respect to any such Product Recall prior to its execution); and (b) the Parties shall reasonably cooperate, at Meda’s expense, in the conduct of any Product Recall for such the Licensed Product in the Territory. Notwithstanding the foregoing, Meda may, without BDSI’s prior consent, immediately effect any Product Recall (A) resulting from any death or life-threatening adverse event associated with any the Licensed Product or (B) required to comply with any regulatory or legal requirements, guidelines, directives, orders, or injunctions with respect to any the Licensed Product. In the event Meda does not undertake such a Product Recall in a reasonable period of time, BDSI shall be entitled to do so without Meda’s prior written consent.

Product Recall Determination. If at any time or from time to time, a Competent Authority requests Meda Collegium to conduct a Product Recall of any Licensed Product Developed or Commercialized by or for Collegium, any Affiliate thereof, or any Sublicensee in the Territory or if a voluntary Product Recall of any such Licensed Product in the Territory is contemplated by MedaCollegium, Meda any Affiliate thereof, or any Sublicensee, Collegium shall immediately notify BDSI in writing, and except as otherwise set forth in this Article XII, Meda Collegium will, at its sole cost and expense, conduct such Product Recall in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the such Licensed Products and the goodwill and reputation of the Parties, provided that: (a) Meda Collegium shall not not, and shall ensure that its Affiliates and Sublicensees do not, carry out a voluntary Product Recall in the Territory with respect to such Licensed Product without the prior written approval of BDSI, such approval not to be unreasonably withheld withheld, conditioned or delayed (for the avoidance of doubt, any Product Recall that is reasonably deemed necessary in order to avoid serious personal injury shall not be considered as a voluntary Product Recall, provided that Meda Collegium shall provide BDSI the opportunity to advise and comment with respect to any such Product Recall prior to its execution); and (b) the Parties shall reasonably cooperate, at MedaCollegium’s expense, in the conduct of any Product Recall for such Licensed Product in the Territory. Notwithstanding the foregoing, Meda Collegium, any Affiliate thereof, or any Sublicensee may, without BDSI’s prior consent, immediately effect any Product Recall (Ai) resulting from any death or life-threatening adverse event Adverse Event associated with any Licensed Product or (Bii) required to comply with any regulatory or legal requirements, guidelines, directives, orders, or injunctions Applicable Law with respect to any Licensed Product. In the event Meda Collegium notifies BDSI, or BDSI otherwise becomes aware, that Collegium, any Affiliate thereof, or any Sublicensee does not intend to undertake such a Product Recall of the type described in a reasonable period of timeclauses (i) or (ii) above, BDSI shall be entitled to do so upon notice to Collegium without MedaCollegium’s prior written consent.