Common use of Interaction with Competent Authorities Clause in Contracts

Interaction with Competent Authorities. After the HSR Date, each Party shall provide to the other Party a copy of any material correspondence or materials that it receives from a Competent Authority regarding any Licensed Product. If such correspondence is not received in English, a summary in English of all material matters addressed thereby will be provided. Such correspondence or summary shall be provided within *** business days of receipt thereof by the relevant Party. Following Governmental Approval, BDSI shall be provided reasonable advance written notice of all material meetings, conferences, or calls with Competent Authorities in the Territory concerning any Licensed Product, and BDSI shall be permitted to have one representative attend all such meetings, conferences, or calls. With respect to any Licensed Product following Governmental Approval thereof, Meda shall provide BDSI with copies of any materials relating to any material regulatory matter and, when reasonably practicable, shall provide copies of any documents to be presented to any Competent Authority in respect of such matters prior to their presentation thereto, and, in either case, if such primary materials are not in English, a summary in English of all material matters addressed thereby, so that the Development Committee, if practicable, shall have an opportunity to review and approve CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***” thereof in advance. The materials provided to BDSI under this Article VI with respect to material interactions with any Competent Authority will be forwarded to BDSI within ***. Further, Meda agrees to take such reasonable actions, provide such documentation, and allow such access as necessary to enable BDSI to comply with Section 3.2 and Sections 4.1.1, 4.2, 4.3, 4.4, 4.5.2 and 4.6 of the CDC Agreement and Arius to comply with Article VI of the Arius Two Agreement.

Interaction with Competent Authorities. After the HSR Effective Date, each Party shall provide to the other Party a copy of any material correspondence or materials that it receives from a Competent Authority regarding any the Licensed Product, in respect of Meda, in the Territory and, in respect of BDSI, in the United States. If such correspondence is not received in English, a summary in English of all material matters addressed thereby will be providedthereby. Such correspondence or summary shall be provided within *** business days of receipt thereof by the relevant Party. Following Governmental Approval, BDSI shall be provided reasonable advance written notice of all material meetings, conferences, or calls with Competent Authorities in the Territory concerning any the Licensed Product, and BDSI shall be permitted to have one representative attend all such meetings, conferences, or calls. With respect ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “***”. to any the Licensed Product following Governmental Approval thereofProduct, Meda shall provide BDSI with copies of any materials relating to any material regulatory matter and, when reasonably practicable, shall provide copies of any documents to be presented to any Competent Authority in respect of such matters prior to their presentation thereto, and, in either case, if such primary materials are not in English, a summary in English of all material matters addressed thereby, so that the Development CommitteeESC, if practicable, shall have an opportunity to review and approve CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***” thereof in advance. The materials provided to BDSI under this Article VI with respect to material interactions with any Competent Authority will be forwarded to BDSI within ***. Further, Meda agrees to take such reasonable actions, provide such documentation, and allow such access as necessary to enable BDSI to comply with Section 3.2 and Sections 4.1.1, 4.2, 4.3, 4.4, 4.5.2 and 4.6 of the CDC Agreement and Arius to comply with Article VI of the Arius Two Agreement.

Interaction with Competent Authorities. After This Section 6.03 shall only be effective until such time as, and shall cease to apply once, the HSR Date, each Pharmacovigilance Agreement is executed by the Parties. Each Party shall provide to the other Party a copy of any material correspondence or materials that it receives from a Competent Authority in the Territory regarding any Licensed Product. If such correspondence is not received in English, a summary in English of all material matters addressed thereby will be provided. Such correspondence or summary shall be provided within *** business days of receipt thereof by the relevant Party. Prior to Marketing Authorization Transfer, Purdue shall be provided reasonable advance written notice of all material meetings, conferences, or calls with Competent Authorities in the Territory concerning any Licensed Product. Following Governmental ApprovalMarketing Authorization Transfer, BDSI shall be provided reasonable advance written notice of all material meetings, conferences, or calls with Competent Authorities in the Territory concerning any Licensed Product, Product and BDSI shall be permitted to have one regulatory representative attend all such meetings, conferences, or callscalls that could reasonably be anticipated to materially concern issues that are related or relevant to BEMA generally or any BEMA-based Products other than Licensed Products. With respect to any Licensed Product following Governmental Approval thereofProduct, Meda Purdue shall provide BDSI with copies of any materials relating to any material regulatory matter in the Territory and, when reasonably practicable, shall provide copies of any documents to be presented to any Competent Authority in respect of such matters prior to their presentation thereto, and, in either case, if such primary materials are not in English, a summary in English of all material matters addressed thereby, so that the Development CommitteeBDSI, if practicable, shall have an opportunity to review and approve CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***” thereof in advance. The materials provided to BDSI under this Article VI with respect to material interactions with any Competent Authority will be forwarded to BDSI within ***. Further, Meda agrees to take such reasonable actions, provide such documentation, and allow such access as necessary to enable BDSI to comply with Section 3.2 and Sections 4.1.1, 4.2, 4.3, 4.4, 4.5.2 and 4.6 of the CDC Agreement and Arius to comply with Article VI of the Arius Two Agreementconsidered Purdue’s Confidential Information.

Interaction with Competent Authorities. After This Section 6.03 shall only be effective until such time as, and shall cease to apply once, the HSR Date, each Pharmacovigilance Agreement is executed by the Parties. Each Party shall provide to the other Party a copy of any material correspondence or materials that it receives from a Competent Authority in the Territory regarding any Licensed Product. If such correspondence is not received in English, a summary in English of all material matters addressed thereby will be provided. Such correspondence or summary shall be provided within *** business days of receipt thereof by the relevant Party. Following Governmental ApprovalPrior to Marketing Authorization Transfer, BDSI Purdue shall be provided reasonable advance written notice of all material meetings, conferences, or calls with Competent Authorities in the Territory concerning any Licensed Product. Following Marketing Authorization Transfer, BDSI shall be provided reasonable Confidential Treatment Requested by BioDelivery Sciences International, Inc. Confidential treatment requested with respect to certain portions hereof denoted with “***” advance written notice of all material meetings, conferences, or calls with Competent Authorities in the Territory concerning any Licensed Product and BDSI shall be permitted to have one regulatory representative attend all such meetings, conferences, or callscalls that could reasonably be anticipated to materially concern issues that are related or relevant to BEMA generally or any BEMA-based Products other than Licensed Products. With respect to any Licensed Product following Governmental Approval thereofProduct, Meda Purdue shall provide BDSI with copies of any materials relating to any material regulatory matter in the Territory and, when reasonably practicable, shall provide copies of any documents to be presented to any Competent Authority in respect of such matters prior to their presentation thereto, and, in either case, if such primary materials are not in English, a summary in English of all material matters addressed thereby, so that the Development CommitteeBDSI, if practicable, shall have an opportunity to review and approve CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***” thereof in advance. The materials provided to BDSI under this Article VI with respect to material interactions with any Competent Authority will be forwarded to BDSI within ***. Further, Meda agrees to take such reasonable actions, provide such documentation, and allow such access as necessary to enable BDSI to comply with Section 3.2 and Sections 4.1.1, 4.2, 4.3, 4.4, 4.5.2 and 4.6 of the CDC Agreement and Arius to comply with Article VI of the Arius Two Agreementconsidered Purdue’s Confidential Information.