Common use of Regulatory Materials Clause in Contracts

Regulatory Materials. Promptly following the Inventory Sell Down Period: (i) Hospira shall promptly assign and transfer to Pfenex all Regulatory Materials for Product that are held or controlled by or under authority of Hospira or its Affiliates, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under the Regulatory Materials to Pfenex and Pfenex shall assume all obligations, including pharmacovigilance obligations, under all Applicable Laws with regard to such Regulatory Materials. (ii) Hospira shall cause each of its Affiliates to transfer any such Regulatory Materials to Pfenex if this Agreement terminates or expires. (iii) If Applicable Law prevents or delays the transfer of ownership or possession of Regulatory Material to Pfenex, Hospira shall grant, and does hereby grant, to Pfenex an exclusive (except as to Hospira to the extent necessary to comply with all Applicable Laws) and irrevocable right of access and reference to such Regulatory Material for Product, and shall cooperate fully to make the benefits of such Regulatory Materials available to Pfenex or its designee(s). (iv) Hospira shall provide to Pfenex copies of all such Regulatory Materials. (v) Pfenex shall be free to use and disclose such Regulatory Materials and other items in connection with the exercise of its rights and licenses under this Section 10.4(b). [***] 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.

Regulatory Materials. Promptly following the Inventory Sell Down Period: Licensee shall, as instructed by Licensor, either (i) Hospira shall if applicable and if permitted by Applicable Laws, promptly transfer and assign and transfer to Pfenex Licensor or its designee all Regulatory Materials for Product Materials, including each Regulatory Approval that are held or controlled is owned by or under authority of Hospira Licensee or its Affiliates, and shall take such actions and execute such other instruments, assignments and documents as may be necessary Affiliate with respect to effect the terminated Product(s). If the transfer and assignment of rights Regulatory Materials is not possible under Applicable Laws, the parties will consider in good faith a strategy which allows the Regulatory Materials to Pfenex and Pfenex shall assume all obligations, including pharmacovigilance obligations, under all be so assigned on transferred while complying with Applicable Laws at the request of Licensor or (ii) terminate or withdraw each Regulatory Approval that is Controlled by Licensee or its Affiliate with regard respect to the terminated Product(s), in either case in accordance with Applicable Laws. Prior to the effective date of termination and thereafter, Licensee shall take all action necessary to, and shall use Commercially Reasonable Efforts to, transfer, terminate or withdraw (as the case may be) all Regulatory Approvals with respect to the terminated Product(s) owned by Licensee on or promptly after the effective date of termination. Licensee may retain copies of all Regulatory Materials to the extent required by Applicable Laws or for so long as may be required for Licensee to perform any of its surviving obligations under this Agreement. All Regulatory Materials transferred and assigned to Licensor under this Article shall be the Confidential Information of Licensor and, to the extent Licensee retains Regulatory Materials in accordance with the preceding sentence, Licensee shall be subject to and shall comply with Article 12 with respect to such Regulatory Materials. (ii) Hospira shall cause each of its Affiliates to transfer any such Regulatory Materials to Pfenex if this Agreement terminates or expires. (iii) If Applicable Law prevents or delays the transfer of ownership or possession of Regulatory Material to Pfenex, Hospira shall grant, and does hereby grant, to Pfenex an exclusive (except as to Hospira to the extent necessary to comply with all Applicable Laws) and irrevocable right of access and reference to such Regulatory Material for Product, and shall cooperate fully to make the benefits of such Regulatory Materials available to Pfenex or its designee(s). (iv) Hospira shall provide to Pfenex copies of all such Regulatory Materials. (v) Pfenex shall be free to use and disclose such Regulatory Materials and other items in connection with the exercise of its rights and licenses under this Section 10.4(b). [***] 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.

Regulatory Materials. Promptly following the Inventory Sell Down Period: (i) Hospira Alvogen shall, and shall cause its Affiliates and Sublicensee(s) to covenant (and Pfenex shall be a third party beneficiary thereof), to promptly assign and transfer to Pfenex all Regulatory Materials and Regulatory Approval(s) for Product in the Territory that are held or controlled by or under authority of Hospira Alvogen, its Affiliates or its AffiliatesSublicensee(s), and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under the such Regulatory Materials and Regulatory Approval(s) to Pfenex and Pfenex shall assume all obligations, including pharmacovigilance obligations, under all Applicable Laws with regard to such Regulatory Materials.Materials and Regulatory Approval(s); (ii) Hospira Alvogen shall cause each of its Affiliates and Sublicensees to covenant (and Pfenex shall be a third party beneficiary thereof) to transfer any all such Regulatory Materials and Regulatory Approval(s) to Pfenex if this Agreement terminates or expires.Pfenex; (iii) If Applicable Law prevents or delays the transfer of ownership or possession of Regulatory Material Materials of Regulatory Approval for Product to Pfenex, Hospira Alvogen shall [***]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. grant, and does hereby grant, and shall cause any Affiliate or Sublicensee to covenant (and Pfenex shall be a third party beneficiary thereof) to grant, to Pfenex an exclusive (except as to Hospira Alvogen to the extent necessary to comply with all Applicable Laws) and irrevocable right of access and reference to such Regulatory Material for ProductMaterials and Regulatory Approval(s), and shall cooperate fully to make the benefits of such Regulatory Materials and Regulatory Approval(s) available to Pfenex or its designee(s).; and (iv) Hospira Alvogen shall provide to Pfenex copies of all such Regulatory Materials. (v) Pfenex shall be free to use and disclose such Regulatory Materials and other items in connection with the exercise of its rights and licenses under this Section 10.4(bRegulatory Approval(s). [***] 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.

Regulatory Materials. Promptly following the Inventory Sell Down Period: (i) Hospira Alvogen shall, and shall cause its Affiliates and Sublicensee(s) to covenant (and Pfenex shall be a third party beneficiary thereof), to promptly assign and transfer to Pfenex all Regulatory Materials and Regulatory Approval(s) for Product in the Territory that are held or controlled by or under authority of Hospira Alvogen, its Affiliates or its AffiliatesSublicensee(s), and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under the such Regulatory Materials and Regulatory Approval(s) to Pfenex and Pfenex shall assume all obligations, including pharmacovigilance obligations, under all Applicable Laws with regard to such Regulatory Materials.Materials and Regulatory Approval(s); (ii) Hospira Alvogen shall cause each of its Affiliates and Sublicensees to covenant (and Pfenex shall be a third party beneficiary thereof) to transfer any all such Regulatory Materials and Regulatory Approval(s) to Pfenex if this Agreement terminates or expires.Pfenex; (iii) If Applicable Law prevents or delays the transfer of ownership or possession of Regulatory Material Materials of Regulatory Approval for Product to Pfenex, Hospira Alvogen shall grant, and does hereby grant, and shall cause any Affiliate or Sublicensee to covenant (and Pfenex [***]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. shall be a third party beneficiary thereof) to grant, to Pfenex an exclusive (except as to Hospira Alvogen to the extent necessary to comply with all Applicable Laws) and irrevocable right of access and reference to such Regulatory Material for ProductMaterials and Regulatory Approval(s), and shall cooperate fully to make the benefits of such Regulatory Materials and Regulatory Approval(s) available to Pfenex or its designee(s).; and (iv) Hospira Alvogen shall provide to Pfenex copies of all such Regulatory Materials. (v) Pfenex shall be free to use and disclose such Regulatory Materials and other items in connection with the exercise of its rights and licenses under this Section 10.4(bRegulatory Approval(s). [***] 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.

Regulatory Materials. Promptly following the Inventory Sell Down Period: (i) Hospira NT Pharma shall promptly assign and transfer to Pfenex all Regulatory Materials for Product in the Territory that are held or controlled by or under authority of Hospira NT Pharma or its Affiliates, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under the such Regulatory Materials to Pfenex and Pfenex shall assume all obligations, including pharmacovigilance obligations, under all Applicable Laws with regard to such Regulatory Materials. (ii) Hospira NT Pharma shall cause each of its Affiliates to transfer any such Regulatory Materials to Pfenex if this Agreement terminates or expiresPfenex. (iii) If Applicable Law prevents or delays the transfer of ownership or possession of Regulatory Material Materials to Pfenex, Hospira NT Pharma shall grant, and does hereby grant, to Pfenex an exclusive (except as to Hospira NT Pharma to the extent necessary to comply with all Applicable Laws) and irrevocable right of access and reference to such Regulatory Material for ProductMaterials, and shall cooperate fully to make the benefits of such Regulatory Materials available to Pfenex or its designee(s). (iv) Hospira NT Pharma shall provide to Pfenex copies of all such Regulatory MaterialsMaterials that are held or controlled by NT Pharma. (v) Except for the parts constituting Confidential Information of NT Pharma, Pfenex shall be free to use and disclose such Regulatory Materials and other items in connection with the exercise of its rights and licenses under this Section 10.4(b). [***] 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.