Common use of Alvogen Responsibilities Clause in Contracts

Alvogen Responsibilities. Alvogen (itself or, subject to Section 3.3, through its Affiliates or Third Parties) shall use Diligent Efforts to: (a) Procure and provide to Pfenex Reference Product from the E.U. and U.S. necessary to support Pfenex’s analytical testing activities to be conducted in accordance with the Development Plan, provided that Alvogen shall provide a [***] sourced from each of the E.U. and U.S. as provided in the Development Plan. The Parties shall share any expenses for such analytical testing activities (as outlined in the Development Plan, including the costs for the RLD and the Product that will be used for the analytical studies and the cost of the 3-way analytical studies) [***]; (b) Design and conduct a bioequivalence study as described in the Development Plan (the “E.U. BE Study”) and will be responsible for all costs of such E.U. BE Study; provided that (i) Pfenex shall [***] it incurs in accordance with the Development Plan for such conduct of the E.U. BE Study, [***] and (ii) any changes to the Development Plan are approved by Pfenex in writing in advance; (c) prepare, file with the EMA and defend the MAA for Product and obtain MAA Approval for Product and Regulatory Approval for each Major EU Country; (d) Upon receipt of each MAA Approval and Regulatory Approval for Product in the Territory, Alvogen shall notify Pfenex thereof; (e) be responsible for and conduct (itself or, subject to Section 3.3(c), through its Affiliates or Third Parties) (A) all Regulatory Commitment Activities and post-marketing surveillance studies and data collection and analysis with respect to Product in the Territory; (B) all pharmacovigilance activities with respect to Product in the Territory (subject to the PV Agreement); and (C) all medical investigations and evaluations and the reporting of Adverse Drug Responses related to Product in the Territory, in each case (clauses (A) – (C)) as required by EMA or the Regulatory Agency in the Territory or otherwise under Applicable Law; (f) have the exclusive right to control, and shall use Diligent Efforts to conduct, a comprehensive strategy of all medical affairs matters relating to Product in the Territory (the “Territory Medical Affairs Strategy”), including with respect to (i) the preparation of any publication based on data and other information relating to any trial or study with respect to Product in the Territory, or (ii) the planning and implementation of congress participations, medical education programs and key opinion leader or advisory board meetings with respect to Product in the Territory; [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. (g) use Diligent Efforts to take such other actions reasonably necessary to maintain the Regulatory Approvals throughout the Territory; and (h) at Pfenex’s request, (i) file and maintain with the applicable Regulatory Agency(ies) a backup MAA for the Product to support a Regulatory Approval for the Product throughout the Territory and obtain back up MAA Approvals thereon (a “Backup MAA Approval”) as provided in this Agreement and (ii) cause its Sublicensee to provide full support to obtain and maintain the Backup MAA Approval. For clarity, subject to consent of the Sublicensee given pursuant to Sublicensing Agreement, Alvogen may Commercialize Product under the Backup MAA Approval as necessary or appropriate to maintain the Backup MAA Approval. If Sublicensee does not consent to such sales, Alvogen shall obtain the Backup MAA Approval at least twelve (12) months prior to expiry of the Sublicensing Agreement or file the MAA corresponding to the Backup MAA Approval immediately after the occurrence of any event (including the receipt of or issuance of any termination or breach notice) that could result in termination of the Sublicensing Agreement, in each case in order to allow sale of Product immediately after expiry or termination of the Sublicensing Agreement. (i) Alvogen shall bear all costs and expenses in connection with Alvogen’s responsibilities under this Section 3.2 (the “Regulatory Commitment Costs”), including the costs and expenses incurred in connection with the Commitment Activities and the Territory Medical Affairs Strategy and regulatory costs.

Alvogen Responsibilities. (a) Alvogen shall use Diligent Efforts to conduct the development activities assigned to Alvogen for Product in the Territory set forth in the Development Plan and associated timelines and such activities shall be conducted in accordance with applicable cGxP and Applicable Law with the goal of supporting the preparation and filing of an NDA for the Product and obtaining NDA Approval for the Product. (b) After the Milestone Payment, Alvogen shall (unless otherwise provided in the Development Plan): (i) have the sole right and responsibility, and bear all costs, for all regulatory matters relating to the Product, and Alvogen shall own all Regulatory Materials and Regulatory Approvals for the Product in the Territory. NRx hereby assigns to Alvogen all of its right, title and interest in and to all Regulatory Materials and Regulatory Approvals for the Product in the Territory, and agrees to execute and deliver all documents and instruments reasonably requested by Alvoxxx xx effect, evidence or record the foregoing assignment. Alvogen shall (itself or, subject to Section ‎Section 3.3, through its Affiliates or Third Parties) shall use Diligent Efforts to: (a) Procure and provide to Pfenex Reference Product from the E.U. and U.S. necessary to support Pfenex’s analytical testing activities to be conducted in accordance with the Development Plan, provided that Alvogen shall provide a [***] sourced from each of the E.U. and U.S. as provided in the Development Plan. The Parties shall share any expenses for such analytical testing activities (as outlined in the Development Plan, including the costs for the RLD and the Product that will be used for the analytical studies and the cost of the 3-way analytical studies) [***]; (b) Design and conduct a bioequivalence study as described in the Development Plan (the “E.U. BE Study”) and will be responsible for all costs of such E.U. BE Study; provided that (i) Pfenex shall [***] it incurs in accordance with the Development Plan for such conduct of the E.U. BE Study, [***] and (ii) any changes to the Development Plan are approved by Pfenex in writing in advance; (c) prepare, file with the EMA FDA and defend the MAA NDA for Product and obtain MAA NDA Approval for Product with the Initial Label Indication. In connection with the filing and Regulatory Approval for each Major EU Country; (d) Upon receipt review of each MAA Approval and Regulatory Approval for Product in the Territorysuch NDA, Alvogen shall notify Pfenex thereof;apply for and use Diligent Efforts to obtain a waiver (or reduction) with respect to the PDUFA Fee, as provided in 21 U.S.C. 379h(d); provided, however, if despite such Diligent Efforts, the FDA notifies Alvogen that any PDUFA Fee is payable, then the Parties shall share the cost of such PDUFA Fee in accordance with their Pro-Rata Portion. Accordingly, NRx shall remit its share of the PDUFA Fee to Alvogen within ten (10) Business Days of receipt of an invoice therefor from Alvogen (eii) be responsible for and use Diligent Efforts to conduct (itself or, subject to Section ‎Section 3.3(c), through its Affiliates or Third Parties) (A) all Regulatory Commitment Activities and post-marketing surveillance studies and data collection and analysis with respect to Product for the Field in the Territory; (B) all pharmacovigilance activities with respect to Product in the Territory (subject to the PV Agreement); and (C) all medical investigations and evaluations and the reporting of Adverse Drug Responses related to Product in the Territory, in each case (clauses (A) – (C)) as required by EMA the FDA or the Regulatory Agency in the Territory or otherwise under Applicable LawLaw (collectively, the “Commitment Activities”); (fiii) have the exclusive right to control, and shall use Diligent Efforts to conduct, a comprehensive strategy of all medical affairs matters relating to Product in the Territory (the “Territory Medical Affairs Strategy”), including with respect to (i) the preparation of any publication based on data and other information relating to any trial or study with respect to Product in the Territory, or (ii) the planning and implementation of congress participations, medical education programs and key opinion leader or advisory board meetings with respect to Product in the Territory; [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.; (giv) upon NDA Approval of the Product in the US, use Diligent Efforts to commercialize the Product in the United States, and take such other actions reasonably necessary to maintain the Regulatory Approvals throughout the TerritoryNDA Approval for Product; and (hv) at Pfenex’s request, (i) file be responsible for and maintain use Diligent Efforts to conduct studies in accordance with the applicable Regulatory Agency(ies) a backup MAA for the Product to support a Regulatory Approval for the Product throughout the Territory and obtain back up MAA Approvals thereon (a “Backup MAA Approval”) as provided in this Agreement and (ii) cause its Sublicensee to provide full support to obtain and maintain the Backup MAA Approval. For clarity, subject to consent of the Sublicensee given pursuant to Sublicensing Agreement, Alvogen may Commercialize Product under the Backup MAA Approval as necessary or appropriate to maintain the Backup MAA Approval. If Sublicensee does not consent to such sales, Alvogen shall obtain the Backup MAA Approval at least twelve (12) months prior to expiry of the Sublicensing Agreement or file the MAA corresponding to the Backup MAA Approval immediately after the occurrence of any event (including the receipt of or issuance of any termination or breach notice) that could result in termination of the Sublicensing Agreement, in each case in order to allow sale of Product immediately after expiry or termination of the Sublicensing AgreementDevelopment Plan. (ic) Unless otherwise provided in the Development Plan, Alvogen shall bear all costs and expenses in connection with Alvogen’s responsibilities under this Section 3.2 (the “Regulatory Commitment Costs”)‎Section 3.2, including the costs and expenses incurred in connection with the Commitment Activities and the Territory Medical Affairs Strategy Strategy, provided that NRx shall, at Alvogen’s request, advise Alvogen on the management of any study for use of the Product to treat bipolar depression in patients with SSIB, such advice to be provided at NRx’s cost and expense. (d) NRx will provide all required documents in its possession or control, as reasonably specified by Alvogen, at NRx’s cost and expense, for Alvogen to compile and file the NDA with the FDA for the Product. Alvogen may reasonably request that NRx provide any necessary support in connection with the filing and defense of any Regulatory Materials, including with respect to the NDA, for the Product in the Territory, including (i) providing any NRx Technology, materials or other documentation within NRx’s Control necessary for Alvogen to prepare and defend any Regulatory Materials for the Product, or that may otherwise be required by any Regulatory Agency within the Territory, and (ii) making available competent personnel to attend regulatory costsmeetings or join such meetings by teleconference. (e) Within and up to 24 months after NDA Approval of the Product in the US, Alvogen will exercise Diligent Efforts to advance the development, sub-licensing and/or Commercialization of the Product in the Field in the Territory outside of the United States; provided that any failure by Alxxxxx xo exercise Diligent Efforts pursuant to this ‎Section 3.2(e) shall not be considered a breach of this Agreement for any purpose hereunder. Should Alvogen not Commercialize the Product in the Field in any given country in the Territory within that 24 month period, upon the written request of NRx specifying such country and Alvogen’s written response agreeing to relinquish the Product License for such country (or if no response is delivered to NRx within thirty (30) days from Alvogen’s receipt of such written request by NRx), the Product License shall immediately be terminated in that country and all rights to the development and Commercialization of the Product in such country shall revert to NRx; provided that Alxxxxx xay reply within thirty (30) days from receipt of NRx’s request that it does not relinquish the Product License in such country solely in the case that Alvogen is continuing to exercise Diligent Efforts to develop and commercialize the Product in such country, and in such case, the Product License shall not terminate; provided, further, that NRx may dispute whether Alvogen is exercising Diligent Efforts in such country pursuant to ‎Section 12.4 and ‎Section 12.5. If the Product License is terminated for a country (the “Terminated License”), then NRx shall pay to Alvogen (i) tiered royalties in the amount of the applicable royalty rates set forth in the table below of the trailing four (4) quarter Net Sales (defined mutatis mutandis for NRx and its Affiliates) resulting from the sale of Product by or on behalf of NRx or its Affiliates in the Field in such country as follows: Up to $[*] [*] % $[*] and up to $[*] [*] % $[*] and up to $[*] [*] % $[*] and above [*] % provided that, the royalties payable by NRx pursuant to this ‎Section 3.2 for such Product in such country will be reduced by [*] percent ([*]%) [*] ([*]) years after the date that such Product License is terminated in such country; or (ii) [*]% of any and all consideration received by NRx or its Affiliates from licensing any of the rights granted under such Terminated License.

Alvogen Responsibilities. Alvogen (itself or, subject to Section 3.3, through its Affiliates or Third Parties) shall use Diligent Efforts to: (a) Procure and provide to Pfenex Reference Product from the E.U. and U.S. necessary to support Pfenex’s any analytical testing activities to be conducted in accordance with the development plan and associated timelines, which shall be agreed to by the Parties within thirty (30) days after the Effective Date (as may be updated by the Executive Steering Committee, the “Development Plan”). Alvogen may contract Pfenex to perform such analytical testing activities, provided provided, however, that Alvogen shall provide a [***] sourced from each of the E.U. bear any and U.S. as provided in the Development Plan. The Parties shall share any all expenses for such analytical testing activities (as outlined in the Development Plan, including the costs for the RLD and the Product that will be used for the any analytical studies and the cost of the any 3-way analytical studies) [***]including its own FTE and other internal costs; (b) Design and conduct a bioequivalence study as described in the Development Plan (the “E.U. BE Study”) and will be responsible for all costs of such E.U. BE Study; provided that (i) Pfenex shall [***] it incurs in accordance with the Development Plan for such conduct of the E.U. BE Study, [***] and (ii) any changes to the Development Plan are approved by Pfenex in writing in advance; (c) prepare, file with the EMA applicable Regulatory Agencies and defend the MAA for Product (including conduct of all pre-approval and post-approval regulatory inspections) and obtain MAA Approval for Product and Regulatory Approval for each Major EU Countryrelevant countries in the Territory; (dc) Upon receipt of each MAA Approval and Regulatory Approval for Product in the Territory, Alvogen shall notify Pfenex thereof;; [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. (ed) be responsible for and conduct (itself or, subject to Section 3.3(c), through its Affiliates or Third Parties) (A) all Regulatory Commitment Activities and post-marketing surveillance studies and data collection and analysis with respect to Product in the Territory; (B) all pharmacovigilance activities with respect to Product in the Territory (subject to the PV Agreement); and (C) all medical investigations and evaluations and the reporting of Adverse Drug Responses related to Product in the Territory, in each case (clauses (A) – (C)) as required by EMA or the applicable Regulatory Agency in the Territory or otherwise under Applicable Law; (fe) have the exclusive right to control, and shall use Diligent Efforts to conduct, a comprehensive strategy of all medical affairs matters relating to Product in the Territory (the “Territory Medical Affairs Strategy”), including with respect to (i) the preparation of any publication based on data and other information relating to any trial or study with respect to Product in the Territory, or (ii) the planning and implementation of congress participations, medical education programs and key opinion leader or advisory board meetings with respect to Product in the Territory; [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.and (gf) use Diligent Efforts to take such other actions reasonably necessary to maintain the Regulatory Approvals throughout the Territory; and (h) at Pfenex’s request, (i) file and maintain with the applicable Regulatory Agency(ies) a backup MAA for the Product to support a Regulatory Approval for the Product throughout the Territory and obtain back up MAA Approvals thereon (a “Backup MAA Approval”) as provided in this Agreement and (ii) cause its Sublicensee to provide full support to obtain and maintain the Backup MAA Approval. For clarity, subject to consent of the Sublicensee given pursuant to Sublicensing Agreement, Alvogen may Commercialize Product under the Backup MAA Approval as necessary or appropriate to maintain the Backup MAA Approval. If Sublicensee does not consent to such sales, Alvogen shall obtain the Backup MAA Approval at least twelve (12) months prior to expiry of the Sublicensing Agreement or file the MAA corresponding to the Backup MAA Approval immediately after the occurrence of any event (including the receipt of or issuance of any termination or breach notice) that could result in termination of the Sublicensing Agreement, in each case in order to allow sale of Product immediately after expiry or termination of the Sublicensing Agreement. (ig) Alvogen shall bear all costs and expenses in connection with Alvogen’s responsibilities under this Section 3.2 (the “Regulatory Commitment Costs”), including the costs and expenses incurred in connection with the Regulatory Commitment Activities and the Territory Medical Affairs Strategy and Strategy, regulatory costs, and any other costs and expenses associated with inspections by Regulatory Agencies of the Product supply chain.

Alvogen Responsibilities. Alvogen (itself or, subject to Section 3.3, through its Affiliates or Third Parties) shall use Diligent Efforts to: (a) Procure and provide to Pfenex Reference Product from the E.U. and U.S. necessary to support Pfenex’s any analytical testing activities to be conducted in accordance with the development plan and associated timelines, which shall be agreed to by the Parties within thirty (30) days after the Effective Date (as may be updated by the Executive Steering Committee, the “Development Plan”). Alvogen may contract Pfenex to perform such analytical testing activities, provided provided, however, that Alvogen shall provide a [***] sourced from each of the E.U. bear any and U.S. as provided in the Development Plan. The Parties shall share any all expenses for such analytical testing activities (as outlined in the Development Plan, including the costs for the RLD and the Product that will be used for the any analytical studies and the cost of the any 3-way analytical studies) [***]including its own FTE and other internal costs; (b) Design and conduct a bioequivalence study study, subject to requirements in the Territory, as described in the Development Plan (the “E.U. MENA BE Study”) and will be responsible for all costs of such E.U. MENA BE Study; provided that (i) Pfenex shall [***] it incurs in accordance with the Development Plan for such conduct of the E.U. BE Study, [***] and (ii) any changes to the Development Plan are approved by Pfenex in writing in advance; (c) prepare, file with the EMA applicable Regulatory Agencies and defend the MAA for Product and obtain MAA Approval for Product and Regulatory Approval for each Major EU Countrycountry in the Territory; (d) Upon receipt of each MAA Approval and Regulatory Approval for Product in the Territory, Alvogen shall notify Pfenex thereof;; [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. (e) be responsible for and conduct (itself or, subject to Section 3.3(c), through its Affiliates or Third Parties) (A) all Regulatory Commitment Activities and post-marketing surveillance studies and data collection and analysis with respect to Product in the Territory; (B) all pharmacovigilance activities with respect to Product in the Territory (subject to the PV Agreement); and (C) all medical investigations and evaluations and the reporting of Adverse Drug Responses related to Product in the Territory, in each case (clauses (A) – (C)) as required by EMA or the applicable Regulatory Agency in the Territory or otherwise under Applicable Law; (f) have the exclusive right to control, and shall use Diligent Efforts to conduct, a comprehensive strategy of all medical affairs matters relating to Product in the Territory (the “Territory Medical Affairs Strategy”), including with respect to (i) the preparation of any publication based on data and other information relating to any trial or study with respect to Product in the Territory, or (ii) the planning and implementation of congress participations, medical education programs and key opinion leader or advisory board meetings with respect to Product in the Territory; [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.and (g) use Diligent Efforts to take such other actions reasonably necessary to maintain the Regulatory Approvals throughout the Territory; and. (h) at Pfenex’s request, (i) file and maintain with the applicable Regulatory Agency(ies) a backup MAA for the Product to support a Regulatory Approval for the Product throughout the Territory and obtain back up MAA Approvals thereon (a “Backup MAA Approval”) as provided in this Agreement and (ii) cause its Sublicensee to provide full support to obtain and maintain the Backup MAA Approval. For clarity, subject to consent of the Sublicensee given pursuant to Sublicensing Agreement, Alvogen may Commercialize Product under the Backup MAA Approval as necessary or appropriate to maintain the Backup MAA Approval. If Sublicensee does not consent to such sales, Alvogen shall obtain the Backup MAA Approval at least twelve (12) months prior to expiry of the Sublicensing Agreement or file the MAA corresponding to the Backup MAA Approval immediately after the occurrence of any event (including the receipt of or issuance of any termination or breach notice) that could result in termination of the Sublicensing Agreement, in each case in order to allow sale of Product immediately after expiry or termination of the Sublicensing Agreement. (i) Alvogen shall bear all costs and expenses in connection with Alvogen’s responsibilities under this Section 3.2 (the “Regulatory Commitment Costs”), including the costs and expenses incurred in connection with the Regulatory Commitment Activities and the Territory Medical Affairs Strategy and Strategy, regulatory costs, and any other costs and expenses associated with inspections by Regulatory Agencies of the Product supply chain.

Alvogen Responsibilities. Alvogen (itself or, subject to Section 3.3, through its Affiliates or Third Parties) shall use Diligent Efforts to: (a) Procure and provide to Pfenex Reference Product from Upon receipt of the E.U. and U.S. necessary to support Pfenex’s analytical testing activities to be conducted in accordance Transfer Notice, Alvogen shall file a notice with the Development Plan, provided that Alvogen shall provide a [***] sourced from each FDA (and copying Pfenex) under 21 C.F.R. 314.72 accepting transfer of the E.U. NDA Approval and U.S. as provided specifying the date that the change in ownership is effective (the Development Plan. The Parties shall share any expenses for such analytical testing activities (as outlined in the Development Plan, including the costs for the RLD and the Product that will be used for the analytical studies and the cost of the 3-way analytical studies) [***];“Transfer Effective Date”). (b) Design and conduct a bioequivalence study as described in As of the Development Plan (the “E.U. BE Study”) and will be responsible for all costs of such E.U. BE Study; provided that Transfer Effective Date, Alvogen shall: (i) Pfenex shall [***] it incurs in accordance with the Development Plan for such conduct of the E.U. BE Study, [***] and (ii) any changes to the Development Plan are approved by Pfenex in writing in advance; (c) prepare, file with the EMA and defend the MAA for Product and obtain MAA Approval for Product and Regulatory Approval for each Major EU Country; (d) Upon receipt of each MAA Approval and Regulatory Approval for Product in the Territory, Alvogen shall notify Pfenex thereof; (e) be responsible for and conduct (itself or, subject to Section 3.3(c), through its Affiliates or Third Parties) (A) all Regulatory Commitment Activities and post-post- [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. marketing surveillance studies and data collection and analysis with respect to Product in the Territory; (B) all pharmacovigilance activities with respect to Product in the Territory (subject to the PV Agreement); and (C) all medical investigations and evaluations and the reporting of Adverse Drug Responses related to Product in the Territory, in each case (clauses (A) – (C)) as required by EMA the FDA or the Regulatory Agency in the Territory or otherwise under Applicable LawLaw (collectively, the “Commitment Activities”); (fii) have the exclusive right to control, and shall use Diligent Efforts to conduct, a comprehensive strategy of all medical affairs matters relating to Product in the Territory (the “Territory Medical Affairs Strategy”), including with respect to (i) the preparation of any publication based on data and other information relating to any trial or study with respect to Product in the Territory, or (ii) the planning and implementation of congress participations, medical education programs and key opinion leader or advisory board meetings with respect to Product in the Territory; [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.and (giii) use Diligent Efforts to take such other actions reasonably necessary to maintain the Regulatory Approvals throughout the Territory; and (h) at Pfenex’s request, (i) file and maintain with the applicable Regulatory Agency(ies) a backup MAA for the Product to support a Regulatory NDA Approval for the Product throughout the Territory and obtain back up MAA Approvals thereon (a “Backup MAA Approval”) as provided in this Agreement and (ii) cause its Sublicensee to provide full support to obtain and maintain the Backup MAA Approval. For clarity, subject to consent of the Sublicensee given pursuant to Sublicensing Agreement, Alvogen may Commercialize Product under the Backup MAA Approval as necessary or appropriate to maintain the Backup MAA Approval. If Sublicensee does not consent to such sales, Alvogen shall obtain the Backup MAA Approval at least twelve (12) months prior to expiry of the Sublicensing Agreement or file the MAA corresponding to the Backup MAA Approval immediately after the occurrence of any event (including the receipt of or issuance of any termination or breach notice) that could result in termination of the Sublicensing Agreement, in each case in order to allow sale of Product immediately after expiry or termination of the Sublicensing AgreementProduct. (ic) Alvogen shall bear all costs and expenses in connection with Alvogen’s responsibilities under this Section 3.2 (the “Regulatory Commitment Costs”), including the costs and expenses incurred in connection with the Commitment Activities and the Territory Medical Affairs Strategy Strategy; provided that Pfenex may, at its sole discretion, elect to reimburse Alvogen for any portion of such Regulatory Commitment Costs, and regulatory costsany such reimbursed amounts shall not be counted toward the amounts described in Section 10.2(b)(v).