Common use of Collegium Development Clause in Contracts

Collegium Development. Collegium shall use Commercially Reasonable Efforts to comply with and, upon Supplement Approval, maintain all Governmental Approvals in the Territory, including but not limited to the Current Product NDA, and, subject to the remainder of this Section 2.02, Develop Licensed Products in the Territory. BDSI will have the right to review and comment, and have such comments reasonably considered by Collegium, reasonably in advance with regard to all Development-, manufacturing-, and formulation-related activities (including Phase IV Studies) proposed to be conducted by or on behalf of Collegium in regards to any Licensed Product. In addition, Collegium shall not, without BDSI’s consent, Develop, Commercialize, or otherwise undertake any dosage-, manufacturing-, or formulation-related changes to the Current Product or any other Licensed Product that would, as reasonably determined by BDSI in good faith, have a material likelihood of adversely affecting BDSI’s, its Affiliates’, or its or their licensees’ or sublicensees’ development or commercialization of (a) BEMA Fentanyl Products or Competing Products outside the U.S., (b) any other BEMA-based Products outside the U.S., or (c) any BEMA-based Products, other than BEMA Fentanyl Products or Competing Products, in the U.S., provided that, notwithstanding the foregoing, BDSI’s prior written consent shall not be required under this Section 2.02 for those activities specifically described on Exhibit C; and, provided, further, that if BDSI does not notify Collegium in writing of its determination of a material likelihood of adverse effect as described above in respect of any dosage-, manufacturing-, or formulation-related changes to the Current Product or any other Licensed Product proposed by Collegium in accordance with this Section 2.02 within *** days after BDSI’s receipt of such proposal, then BDSI will be deemed to have waived its consent right with regards to the specific changes described in Collegium’s proposal and Collegium will be free to engage in those activities without the need to seek further consent from BDSI hereunder.

Collegium Development. Collegium shall use Commercially Reasonable Efforts to comply with and, upon Supplement Approval, maintain all Governmental Approvals in the Territory, including but not limited to the *** 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. Current Product NDA, and, subject to the remainder of this Section 2.02, Develop Licensed Products in the Territory. BDSI will have the right to review and comment, and have such comments reasonably considered by Collegium, reasonably in advance with regard to all Development-, manufacturing-, and formulation-related activities (including Phase IV Studies) proposed to be conducted by or on behalf of Collegium in regards to any Licensed Product. In addition, Collegium shall not, without BDSI’s consent, Develop, Commercialize, or otherwise undertake any dosage-, manufacturing-, or formulation-related changes to the Current Product or any other Licensed Product that would, as reasonably determined by BDSI in good faith, have a material likelihood of adversely affecting BDSI’s, its Affiliates’, or its or their licensees’ or sublicensees’ development or commercialization of (a) BEMA Fentanyl Products or Competing Products outside the U.S., (b) any other BEMA-based Products outside the U.S., or (c) any BEMA-based Products, other than BEMA Fentanyl Products or Competing Products, in the U.S., provided that, notwithstanding the foregoing, BDSI’s prior written consent shall not be required under this Section 2.02 for those activities specifically described on Exhibit C; and, provided, further, that if BDSI does not notify Collegium in writing of its determination of a material likelihood of adverse effect as described above in respect of any dosage-, manufacturing-, or formulation-related changes to the Current Product or any other Licensed Product proposed by Collegium in accordance with this Section 2.02 within *** days after BDSI’s receipt of such proposal, then BDSI will be deemed to have waived its consent right with regards to the specific changes described in Collegium’s proposal and Collegium will be free to engage in those activities without the need to seek further consent from BDSI hereunder.