Common use of Manufacturing Clause in Contracts

Manufacturing. 3.11.1 Subject to section 3.11.4, NovaDel shall manufacture and supply Licensee with Licensed Product on commercially reasonable terms for clinical development of the Licensed Product pursuant to a manufacturing agreement (the "Manufacturing Agreement") to be entered into following execution of this Agreement. 3.11.2 Subject to section 3.11.4, following receipt of Regulatory Approval, NovaDel shall manufacture and supply Licensee with Licensed Product on commercially reasonable terms pursuant to the Manufacturing Agreement. 3.11.3 NovaDel agrees that, at all times during the performance of the Development Activities, it will act in accordance with GMP and all applicable laws, rules and regulations. 3.11.4 The manufacturing agreement will provide among other things that in the event that Licensee enters into a Sublicense for a Licensed Product and such Sublicensee desires to obtain rights to manufacture such Licensed Product, then NovaDel will not unreasonably withhold its consent to transfer the manufacturing rights to such Sublicensee, provided that measures are incorporated into the sublicensing agreement to continue to safeguard the confidentiality of NovaDel Know-how and technology with respect to the Licensed Product as set forth in section 3.11.5 3.11.5 It is the intent of the Parties that NovaDel be the exclusive manufacturer of the Licensed Product pursuant to the terms of the Manufacturing Agreement; provided, however, that in the event that NovaDel is unable or unwilling to provide clinical or commercial supply of Licensed Product within a reasonable period of time upon commercially reasonable terms, then Licensee shall be entitled to seek alternate manufacturing source. In such event, Licensee shall use commercially reasonable efforts to ensure that any such alternate manufacturing source agree (a) to maintain in strictest confidence all information relating to the manufacture of the Licensed Product and the Licensed Technology, (b) not to file any intellectual property protection relating to inventions that may arise from the manufacture of the Licensed Product and Licensed Technology, and (c) that any intellectual property that does arise out of the manufacture of the Licensed Product and Licensed Technology belong to NovaDel.

Manufacturing. 3.11.1 3.5.1 Subject to section 3.11.4the other provisions of this Section 3.5.1, NovaDel PAR shall be solely responsible for the manufacture and supply Licensee with of the Licensed Product on commercially reasonable terms Product, both for clinical development of the Licensed Product pursuant to a manufacturing agreement (the "Manufacturing Agreement") to be entered into following execution of this Agreement. 3.11.2 Subject to section 3.11.4, and following receipt of Regulatory ApprovalApproval of the Licensed Product; provided that PAR may contract with a Third Party to perform such manufacturing services. PAR shall share all data and other information relating to the manufacturing process and shall consult with NovaDel with respect thereto. Without limiting the generality of the foregoing, NovaDel shall manufacture and supply Licensee have the opportunity to review, prior to execution, all agreements with Licensed Product on commercially reasonable terms pursuant Third Parties relating to the Manufacturing Agreementmanufacture of the Licensed Product; provided, however, that PAR shall have the ultimate decision making authority in the event of any dispute between NovaDel and PAR relating to the terms of any such manufacturing agreement (or the choice of such Third Party manufacturer). NovaDel and its Extraterritorial Licensees (as defined in the NovaDel-Hana License) retain the right to purchase product from said Third Party, if applicable, at the same costs as PAR with the exception of an increase of cost due to a modification to the packaging/labeling by NovaDel or any Extraterritorial Licensee. 3.11.3 NovaDel 3.5.2 PAR agrees that, at all times during the performance of the Development Activitiesdevelopment activities, it it, or its designee, will act in accordance with GMP and all applicable laws, rules and regulationsApplicable Laws. 3.11.4 The manufacturing agreement will provide among other things that in 3.5.3 To the event that Licensee enters into extent PAR contracts with a Sublicense for a Licensed Product and such Sublicensee desires to obtain rights Third Party to manufacture such the Licensed Product, then NovaDel will not unreasonably withhold its consent such Third Party shall agree in writing to transfer be bound by the manufacturing rights obligations of confidentiality and non-use at least equivalent in scope to such Sublicensee, provided that measures are incorporated into the sublicensing agreement to continue to safeguard the confidentiality of NovaDel Know-how and technology with respect to the Licensed Product as those set forth in section 3.11.5Article 9 of this Agreement. 3.11.5 It is 3.5.4 PAR shall not object to permitting any Third Party manufacturer from selling NovaDel and its Extraterritorial Licensees Licensed Product under Section 3.5.1 in the intent identical packaging and labeling as PAR purchases such Licensed Product for sale in the United States, subject to the requirement by NovaDel and Sublicensees to have such Licensed Product uniquely identified by a separate batch record identification or other indicia sufficient to distinguish sales by NovaDel, or its Extraterritorial Licensees, from those of PAR. 3.5.5 PAR shall use Commercially Reasonable Efforts to obtain any required licenses, permissions needed and documentation (e.g., Certificate of Pharmaceutical Product) in order for NovaDel and its Extraterritorial Licensees to buy and export Licensed Product from the Parties United States. NovaDel shall reimburse all reasonable expenses incurred by PAR for obtaining such licenses or permissions within thirty (30) days of an Extraterritorial Licensee’s receipt of an invoice from PAR itemizing such expenses 3.5.6 NovaDel warrants, covenants and agrees that any license agreement that NovaDel be the exclusive manufacturer of the enters into with an Extraterritorial Licensee regarding Licensed Product pursuant that are subject to this Agreement shall contain an indemnity clause requiring the terms Extraterritorial Licensee to indemnify PAR and its Affiliates against any and all claims, proceedings, demands, liability and expenses of any kind, including legal expenses and attorneys’ fees (collectively, “Claims”), arising out of or in connection with the Manufacturing Agreementmanufacture, sale, use, consumption, advertisement or other disposition of Licensed Product by the Extraterritorial Licensee, its Affiliates or any end user, or arising from any violation of law, negligence, willful or reckless misconduct, or from any breach of any material obligation of such Extraterritorial Licensee under its agreement with NovaDel, other than Claims resulting from the gross negligence or willful misconduct of PAR; provided, however, that in no event shall the event that NovaDel is unable or unwilling to provide clinical or commercial supply of Licensed Product within a reasonable period of time upon commercially reasonable terms, then Licensee shall be entitled to seek alternate manufacturing source. In such event, Licensee shall use commercially reasonable efforts to ensure that any such alternate manufacturing source agree (a) to maintain in strictest confidence all information relating to the manufacture scope of the Licensed Product and indemnification to PAR be any less than the Licensed Technology, (b) not to file any intellectual property protection relating to inventions that may arise from the manufacture scope of the Licensed Product and Licensed Technology, and (c) that any intellectual property that does arise out of the manufacture of the Licensed Product and Licensed Technology belong Extraterritorial Licensee’s indemnification obligations to NovaDel.

Manufacturing. 3.11.1 3.5.1 Subject to section 3.11.4the other provisions of this Section 3.5.1, NovaDel PAR shall be solely responsible for the manufacture and supply Licensee with of the Licensed Product on commercially reasonable terms Product, both for clinical development of the Licensed Product pursuant to a manufacturing agreement (the "Manufacturing Agreement") to be entered into following execution of this Agreement. 3.11.2 Subject to section 3.11.4, and following receipt of Regulatory ApprovalApproval of the Licensed Product; provided that PAR may contract with a Third Party to perform such manufacturing services. PAR shall share all data and other information relating to the manufacturing process and shall consult with NovaDel with respect thereto. Without limiting the generality of the foregoing, NovaDel shall manufacture and supply Licensee have the opportunity to review, prior to execution, all agreements with Licensed Product on commercially reasonable terms pursuant Third Parties relating to the Manufacturing Agreementmanufacture of the Licensed Product; provided, however, that PAR shall have the ultimate decision making authority in the event of any dispute between NovaDel and PAR relating to the terms of any such manufacturing agreement (or the choice of such Third Party manufacturer). NovaDel and its Extraterritorial Licensees (as defined in the NovaDel-Hana License) retain the right to purchase product from said Third Party, if applicable, at the same costs as PAR with the exception of an increase of cost due to a modification to the packaging/labeling by NovaDel or any Extraterritorial Licensee. 3.11.3 NovaDel 3.5.2 PAR agrees that, at all times during the performance of the Development Activitiesdevelopment activities, it it, or its designee, will act in accordance with GMP and all applicable laws, rules and regulationsApplicable Laws. ***Portion for which confidential treatment requested. 3.11.4 The manufacturing agreement will provide among other things that in 3.5.3 To the event that Licensee enters into extent PAR contracts with a Sublicense for a Licensed Product and such Sublicensee desires to obtain rights Third Party to manufacture such the Licensed Product, then NovaDel will not unreasonably withhold its consent such Third Party shall agree in writing to transfer be bound by the manufacturing rights obligations of confidentiality and non-use at least equivalent in scope to such Sublicensee, provided that measures are incorporated into the sublicensing agreement to continue to safeguard the confidentiality of NovaDel Know-how and technology with respect to the Licensed Product as those set forth in section 3.11.5Article 9 of this Agreement. 3.11.5 It is 3.5.4 PAR shall not object to permitting any Third Party manufacturer from selling NovaDel and its Extraterritorial Licensees Licensed Product under Section 3.5.1 in the intent identical packaging and labeling as PAR purchases such Licensed Product for sale in the United States, subject to the requirement by NovaDel and Sublicensees to have such Licensed Product uniquely identified by a separate batch record identification or other indicia sufficient to distinguish sales by NovaDel, or its Extraterritorial Licensees, from those of PAR. 3.5.5 PAR shall use Commercially Reasonable Efforts to obtain any required licenses, permissions needed and documentation (e.g., Certificate of Pharmaceutical Product) in order for NovaDel and its Extraterritorial Licensees to buy and export Licensed Product from the Parties United States. NovaDel shall reimburse all reasonable expenses incurred by PAR for obtaining such licenses or permissions within thirty (30) days of an Extraterritorial Licensee’s receipt of an invoice from PAR itemizing such expenses 3.5.6 NovaDel warrants, covenants and agrees that any license agreement that NovaDel be the exclusive manufacturer of the enters into with an Extraterritorial Licensee regarding Licensed Product pursuant that are subject to this Agreement shall contain an indemnity clause requiring the terms Extraterritorial Licensee to indemnify PAR and its Affiliates against any and all claims, proceedings, demands, liability and expenses of any kind, including legal expenses and attorneys’ fees (collectively, “Claims”), arising out of or in connection with the Manufacturing Agreementmanufacture, sale, use, consumption, advertisement or other disposition of Licensed Product by the Extraterritorial Licensee, its Affiliates or any end user, or arising from any violation of law, negligence, willful or reckless misconduct, or from any breach of any material obligation of such Extraterritorial Licensee under its agreement with NovaDel, other than Claims resulting from the gross negligence or willful misconduct of PAR; provided, however, that in no event shall the event that NovaDel is unable or unwilling to provide clinical or commercial supply of Licensed Product within a reasonable period of time upon commercially reasonable terms, then Licensee shall be entitled to seek alternate manufacturing source. In such event, Licensee shall use commercially reasonable efforts to ensure that any such alternate manufacturing source agree (a) to maintain in strictest confidence all information relating to the manufacture scope of the Licensed Product and indemnification to PAR be any less than the Licensed Technology, (b) not to file any intellectual property protection relating to inventions that may arise from the manufacture scope of the Licensed Product and Licensed Technology, and (c) that any intellectual property that does arise out of the manufacture of the Licensed Product and Licensed Technology belong Extraterritorial Licensee’s indemnification obligations to NovaDel.

Manufacturing. 3.11.1 Subject Provided that MedPharm is able to section 3.11.4offer competitive pricing and quality as third-party manufacturers, NovaDel MedPharm shall manufacture and supply Licensee have the first right to enter into a manufacturing agreement with Virpax with respect to any Licensed Product on commercially reasonable terms for clinical development to be negotiated in good faith as set forth below. For a period of sixty (60) days from the execution of a Definitive License Agreement with respect to a Licensed Product pursuant to (the “Manufacturing Negotiation Period”), Virpax and MedPharm shall negotiate the terms of a manufacturing agreement (the "Manufacturing Agreement") to be entered into following execution of this Agreement. 3.11.2 Subject to section 3.11.4, following receipt of Regulatory Approval, NovaDel shall manufacture and supply Licensee with Licensed Product on commercially reasonable terms pursuant to the Manufacturing Agreement. 3.11.3 NovaDel agrees that, at all times during the performance of the Development Activities, it will act in accordance with GMP and all applicable laws, rules and regulations. 3.11.4 The manufacturing agreement will provide among other things that in the event that Licensee enters into a Sublicense for a Licensed Product and such Sublicensee desires to obtain rights to manufacture such Licensed Product, then NovaDel will not unreasonably withhold its consent to transfer the manufacturing rights to such Sublicensee, provided that measures are incorporated into the sublicensing agreement to continue to safeguard the confidentiality of NovaDel Know-how and technology with respect to the subject Licensed Product as set forth in section 3.11.5 3.11.5 It is the intent of the Parties that NovaDel be the exclusive manufacturer of the Licensed Product pursuant to the terms of the Manufacturing Agreement; provided, however, that in Product. In the event that NovaDel is MedPharm and Virpax are unable or unwilling to provide clinical or commercial supply of Licensed Product reach agreement on manufacturing terms within the Manufacturing Negotiation Period, Virpax shall have the option to enter into a manufacturing agreement with any third-party manufacturer it chooses on terms no less favorable to Virpax, in Virpax’s reasonable period of time upon commercially reasonable termsopinion, then Licensee than the final terms offered to Virpax from MedPharm during the Manufacturing Negotiation Period. For clarity, Virpax shall be entitled have the option to seek alternate manufacturing sourcesolicit bids from third-party manufacturers at any time, including during the Manufacturing Negotiation Period. In such eventthe event that Virpax reaches an agreement with a third-party manufacturer with respect to a Licensed Product, Licensee MedPharm shall use commercially reasonable efforts to ensure that any such alternate manufacturing source agree (a) to maintain in strictest confidence all information relating effect a technology transfer to the manufacture third-party manufacturer. The technology transfer shall include the provision of the Licensed Product staff as reasonably requested by Virpax and the Licensed Technology, (b) not grant of any licenses to file any intellectual property protection relating Controlled by MedPharm that are reasonably necessary or useful for the manufacturing and supply of Licensed Products. MedPharm shall be eligible to inventions that may arise from the manufacture be compensated for any of the Licensed Product and Licensed Technology, and (c) that any intellectual property that does arise out its staff assigned to provide in factory support at its then standard daily rates. Any provision of the manufacture of the Licensed Product and Licensed Technology belong documentation to NovaDela third-party manufacturer shall be done at no cost to Virpax.

Manufacturing. 3.11.1 Except as the Parties otherwise agree pursuant to the terms of an applicable sublicense: 3.10.1 Subject to section 3.11.4the other provisions of this Section 3.10.1, Licensee shall be solely responsible for the manufacture of the Licensed Product, both for clinical development and following receipt of Regulatory Approval of the Licensed Product; provided that Licensee may contract with a Third Party to perform such manufacturing services. Licensee shall share all data and other information relating to the manufacturing process and shall consult with NovaDel with respect thereto. Without limiting the generality of the foregoing, NovaDel shall have the opportunity to review, prior to execution, all agreements with Third Parties relating to the manufacture of the Licensed Product. Any disputes between NovaDel and supply Licensee with Licensed Product on commercially reasonable terms for clinical development relating to the manufacture of the Licensed Product pursuant shall be resolved in the manner set forth in Section 3.3.3 hereof. NovaDel and its Extraterritorial Licensees retain the right to purchase product from said Third Party, if applicable, at the same costs as Licensee with the exception of an increase of cost due to a manufacturing agreement (modification to the "Manufacturing Agreement") to be entered into following execution of this Agreementpackaging/labeling by NovaDel or any Extraterritorial Licensee. 3.11.2 Subject to section 3.11.4, following receipt of Regulatory Approval, NovaDel shall manufacture and supply 3.10.2 Licensee with Licensed Product on commercially reasonable terms pursuant to the Manufacturing Agreement. 3.11.3 NovaDel agrees that, at all times during the performance of the Development Activities, it it, or its designee, will act in accordance with GMP and all applicable laws, rules and regulationsApplicable Laws. 3.11.4 The manufacturing agreement will provide among other things that in 3.10.3 To the event that extent Licensee enters into contracts with a Sublicense for a Licensed Product and such Sublicensee desires to obtain rights Third Party to manufacture such the Licensed Product, then NovaDel will not unreasonably withhold its consent such Third Party shall agree in writing to transfer be bound by the manufacturing rights obligations of confidentiality and non-use at least equivalent in scope to such Sublicensee, provided that measures are incorporated into the sublicensing agreement to continue to safeguard the confidentiality of NovaDel Know-how and technology with respect to the Licensed Product as those set forth in section 3.11.5Article 15 of this Agreement. 3.11.5 It is 3.10.4 NovaDel and its Extraterritorial Licensees may purchase Licensed Product under Section 3.10.1 in the intent identical packaging and labeling as Licensee purchases such Licensed Product for sale in the United States, subject to the requirement by NovaDel and Sublicensees to have such Licensed Product uniquely identified by a separate batch record identification or other indicia sufficient to distinguish sales by NovaDel, or its Extraterritorial Licensees, from those of Licensee. 3.10.5 Licensee shall use Commercially Reasonable Efforts to obtain any required licenses, permissions needed and documentation (e.g., Certificate of Pharmaceutical Product) in order for NovaDel and its Extraterritorial Licensees to buy and export Licensed Product from the Parties United States. NovaDel shall reimburse all reasonable expenses incurred by Licensee for obtaining such licenses or permissions within thirty (30) days of an Extraterritorial Licensee’s receipt of an invoice from Licensee itemizing such expenses. 3.10.6 NovaDel warrants, covenants and agrees that any license agreement that NovaDel be the exclusive manufacturer of the enters into with an Extraterritorial Licensee regarding Licensed Product pursuant that are subject to this Agreement shall contain an indemnity clause requiring the terms Extraterritorial Licensee to indemnify Licensee and its Affiliates against any and all claims, proceedings, demands, liability and expenses of any kind, including legal expenses and attorneys’ fees (collectively, “Claims”), arising out of or in connection with the Manufacturing Agreementmanufacture, sale, use, consumption, advertisement or other disposition of Licensed Product by the Extraterritorial Licensee, its Affiliates or any end user, or arising from any violation of law, negligence, willful or reckless misconduct, or from any breach of any material obligation of such Extraterritorial Licensee under its agreement with NovaDel, other than Claims resulting from the gross negligence or willful misconduct of Licensee; provided, however, that in no event shall the event that NovaDel is unable or unwilling to provide clinical or commercial supply of Licensed Product within a reasonable period of time upon commercially reasonable terms, then Licensee shall be entitled to seek alternate manufacturing source. In such event, Licensee shall use commercially reasonable efforts to ensure that any such alternate manufacturing source agree (a) to maintain in strictest confidence all information relating to the manufacture scope of the Licensed Product and indemnification to Licensee be any less than the Licensed Technology, (b) not to file any intellectual property protection relating to inventions that may arise from the manufacture scope of the Licensed Product and Licensed Technology, and (c) that any intellectual property that does arise out of the manufacture of the Licensed Product and Licensed Technology belong Extraterritorial Licensee’s indemnification obligations to NovaDel.

Manufacturing. 3.11.1 Subject 4.6.1 With respect to section 3.11.4each Licensed Compound, NovaDel prior to the initiation of Phase I Clinical Trial to be conducted under the Development Plan, Ambrx shall provide Pre-Clinical Candidate for each such Licensed Compound, having completed the Scientific Development of the PCC as agreed by the unanimous decision of the Joint Steering Committee without invoking casting vote of its chairperson under Section 3.4.2. Sino shall be responsible for and shall perform all cGMP manufacturing activities and Pre-Clinical Development (including cGMP scale-up) related to manufacturing the Licensed Compounds and Licensed Products in a manner in order to achieve a Successful Dual IND Filing, and the Parties shall co-operate and provide assistance to each other in support of seeking Successful Dual IND Filing. Sino (by itself or through its Affiliate or a Third Party contract manufacturer appointed by Sino) (“Third Party Manufacturer”) shall manufacture all Licensed Compounds and supply Licensee Licensed Products in accordance with Licensed Product on commercially reasonable terms cGMP applicable to the United States and the equivalent standard or Current Good Manufacturing Practice in the PRC in order to support a Successful Dual IND Filing. Sino’s Affiliate or the Third Party Manufacturer shall perform the technology transfer of the manufacturing process for clinical development each of the Licensed Product pursuant to a manufacturing agreement (the "Manufacturing Agreement") to be entered into following execution of this Agreement. 3.11.2 Subject to section 3.11.4, following receipt of Regulatory Approval, NovaDel shall manufacture and supply Licensee with Licensed Product on commercially reasonable terms pursuant to the Manufacturing Agreement. 3.11.3 NovaDel agrees that, at all times during the performance of the Development Activities, it will act Products in accordance with GMP the Development Plan [***], provided that any activities in addition to the activities described in the Development Plan would be [***]. Ambrx shall provide technical support (including upon mutual agreement on-site assistance) relating to the Ambrx Cell Materials, and all applicable laws, rules Licensed Compounds with respect to manufacturing Licensed Compound and regulationsLicensed Products to Sino or its Affiliate or the Third Party Manufacturer [***]. 3.11.4 The 4.6.2 Upon request by Sino during the Research Term and for the period prior to the First Commercial Sale of a Licensed Product, for purposes of establishing manufacturing agreement will provide among other things that capability for each Licensed Compound and/or Licensed Product, Ambrx shall enable a technology transfer to Sino or its Affiliate or the Third Party Manufacturer the manufacturing process required to manufacture the Licensed Compounds and/or the Licensed Products in the event Sino Territory. Such enablement shall include a written description of the technology, together a copy of all relevant documents (including, without limitation, production manuals and experiment protocols), as well as on-site technical assistance at the facility designated by Sino, provided that Licensee enters into [***]. 4.6.3 Sino shall be responsible for manufacturing the Licensed Compound and Licensed Products for the Phase I Clinical Trials conducted by Sino under this Agreement in support of Regulatory Approval in the Sino Territory through a Sublicense Third Party Manufacturer. The Third Party Manufacturer costs, all fees and costs arising from engagement of the Third Party Manufacturer or manufacturing activities in the Sino Territory shall be borne by the Parties in accordance with Sections 4.2.3 and 4.2.4. Sino shall provide Ambrx with sufficient clinical supply to [***]. For the purpose of advancing Development and Commercialization of the Licensed Compounds and/or the Licensed Products in their respective territories, Sino and Ambrx agree to share all Regulatory Data and Regulatory Filings within sixty (60) days after the relevant submission to or obtaining of the grant of Regulatory Approval from the Regulatory Authority in their respective territories. Upon expiry of the Research Term, the Parties shall negotiate in good faith terms for a supply agreement under which Sino would fulfill Ambrx’s clinical and commercial needs for each Licensed Product and such Sublicensee desires to obtain rights to manufacture such Licensed Product, then NovaDel will not unreasonably withhold its consent to transfer the manufacturing rights to such Sublicensee, provided that measures are incorporated into the sublicensing agreement to continue to safeguard the confidentiality of NovaDel Know-how and technology with respect to the Licensed Product as set forth in section 3.11.5 3.11.5 It is the intent of the Parties that NovaDel be the exclusive manufacturer of the Licensed Product pursuant to the terms of the Manufacturing Agreement; provided, however, that in the event that NovaDel is unable or unwilling to provide clinical or commercial supply of Licensed Product within a reasonable period of time upon commercially reasonable terms, then Licensee shall be entitled to seek alternate manufacturing source. In such event, Licensee shall use commercially reasonable efforts to ensure that any such alternate manufacturing source agree (a) to maintain in strictest confidence all information relating to the manufacture of the Licensed Product and the Licensed Technology, (b) not to file any intellectual property protection relating to inventions that may arise from the manufacture of the Licensed Product and Licensed Technology, and (c) that any intellectual property that does arise out of the manufacture of the Licensed Product and Licensed Technology belong to NovaDelfurther Clinical Trials.

Manufacturing. 3.11.1 Subject to section 3.11.4Section 3.11.5, NovaDel NovaDel, or its designee, shall manufacture and supply Licensee with Licensed Product on commercially reasonable terms for clinical development of the Licensed Product pursuant to a manufacturing agreement (the "Manufacturing Agreement") to be entered into following execution of this Agreement. 3.11.2 Subject to section 3.11.4Section 3.11.5, following receipt of Regulatory Approval, NovaDel NovaDel, or its designee, shall manufacture and supply Licensee with Licensed Product on commercially reasonable terms pursuant to the Manufacturing Agreement. 3.11.3 NovaDel agrees that, at all times during the performance of the Development Activities, it it, or its designee, will act in accordance with GMP and all applicable laws, rules and regulations. 3.11.4 The manufacturing agreement will provide stipulate among other things that (i) Licensee will purchase Licensed Product from NovaDel at actual Cost of Goods Sold (COGS) for commercial supply will not exceed actual manufactured costs as defined by Generally Acceptable Accounting Principles (GAAP) in each calendar year plus 10% or Licensee will acquire Licensed Product from NovaDel designated third party manufacturer directly and (ii) in the event that Licensee enters into a Sublicense for a Licensed Product and such Sublicensee desires to obtain rights to manufacture such Licensed Product, then NovaDel will not unreasonably withhold its consent to transfer the manufacturing rights to such Sublicensee, provided that measures are incorporated into the sublicensing agreement to continue to safeguard the confidentiality of NovaDel Know-how and technology with respect to the Licensed Product as set forth in section Section 3.11.5 3.11.5 It is the intent of the Parties that NovaDel NovaDel, or its designee, be the exclusive manufacturer of the Licensed Product pursuant to the terms of the Manufacturing Agreement; provided, however, that in the event that NovaDel NovaDel, or its designee, is unable or unwilling to provide clinical or commercial supply of Licensed Product within a reasonable period of time of 90 days from receipt of purchase order preceded by a twelve (12) month rolling forecast upon commercially reasonable terms, then Licensee shall be entitled to seek alternate manufacturing source. In such event, Licensee shall use commercially reasonable efforts to ensure that any such alternate manufacturing source agree (a) to maintain in strictest confidence all information relating to the manufacture of the Licensed Product and the Licensed Technology, (b) not to file any intellectual property protection relating to inventions that may arise from the manufacture of the Licensed Product and Licensed Technology, and (c) that any intellectual property that does arise out of the manufacture of the Licensed Product and Licensed Technology belong to NovaDel. In such event, Novadel agrees to transfer all NovaDel Know-How to enable the manufacturer to meet Licensee's requirements for a stable and consistent commercial supply of the Licensed Product.

Manufacturing. 3.11.1 Except as the Parties otherwise agree pursuant to the terms of an applicable sublicense: 3.10.1 Subject to section 3.11.4the other provisions of this Section 3.10.1, Licensee shall be solely responsible for the manufacture of the Licensed Product, both for clinical development and following receipt of Regulatory Approval of the Licensed Product; provided that Licensee may contract with a Third Party to perform such manufacturing services. Licensee shall share all data and other information relating to the manufacturing process and shall consult with NovaDel with respect thereto. Without limiting the generality of the foregoing, NovaDel shall have the opportunity to review, prior to execution, all agreements with Third Parties relating to the manufacture of the Licensed Product. Any disputes between NovaDel and supply Licensee with Licensed Product on commercially reasonable terms for clinical development relating to the manufacture of the Licensed Product pursuant shall be resolved in the manner set forth in Section 3.3.3 hereof. NovaDel and its Extraterritorial Licensees retain the right to purchase product from said Third Party, if applicable, at the same costs as Licensee with the exception of an increase of cost due to a manufacturing agreement (modification to the "Manufacturing Agreement") to be entered into following execution of this Agreementpackaging/labeling by NovaDel or any Extraterritorial Licensee. 3.11.2 Subject to section 3.11.4, following receipt of Regulatory Approval, NovaDel shall manufacture and supply 3.10.2 Licensee with Licensed Product on commercially reasonable terms pursuant to the Manufacturing Agreement. 3.11.3 NovaDel agrees that, at all times during the performance of the Development Activities, it it, or its designee, will act in accordance with GMP and all applicable laws, rules and regulationsApplicable Laws. ***Portion for which confidential treatment requested. 3.11.4 The manufacturing agreement will provide among other things that in 3.10.3 To the event that extent Licensee enters into contracts with a Sublicense for a Licensed Product and such Sublicensee desires to obtain rights Third Party to manufacture such the Licensed Product, then NovaDel will not unreasonably withhold its consent such Third Party shall agree in writing to transfer be bound by the manufacturing rights obligations of confidentiality and non-use at least equivalent in scope to such Sublicensee, provided that measures are incorporated into the sublicensing agreement to continue to safeguard the confidentiality of NovaDel Know-how and technology with respect to the Licensed Product as those set forth in section 3.11.5Article 15 of this Agreement. 3.11.5 It is 3.10.4 NovaDel and its Extraterritorial Licensees may purchase Licensed Product under Section 3.10.1 in the intent identical packaging and labeling as Licensee purchases such Licensed Product for sale in the United States, subject to the requirement by NovaDel and Sublicensees to have such Licensed Product uniquely identified by a separate batch record identification or other indicia sufficient to distinguish sales by NovaDel, or its Extraterritorial Licensees, from those of Licensee. 3.10.5 Licensee shall use Commercially Reasonable Efforts to obtain any required licenses, permissions needed and documentation (e.g., Certificate of Pharmaceutical Product) in order for NovaDel and its Extraterritorial Licensees to buy and export Licensed Product from the Parties United States. NovaDel shall reimburse all reasonable expenses incurred by Licensee for obtaining such licenses or permissions within thirty (30) days of an Extraterritorial Licensee’s receipt of an invoice from Licensee itemizing such expenses. 3.10.6 NovaDel warrants, covenants and agrees that any license agreement that NovaDel be the exclusive manufacturer of the enters into with an Extraterritorial Licensee regarding Licensed Product pursuant that are subject to this Agreement shall contain an indemnity clause requiring the terms Extraterritorial Licensee to indemnify Licensee and its Affiliates against any and all claims, proceedings, demands, liability and expenses of any kind, including legal expenses and attorneys’ fees (collectively, “Claims”), arising out of or in connection with the Manufacturing Agreementmanufacture, sale, use, consumption, advertisement or other disposition of Licensed Product by the Extraterritorial Licensee, its Affiliates or any end user, or arising from any violation of law, negligence, willful or reckless misconduct, or from any breach of any material obligation of such Extraterritorial Licensee under its agreement with NovaDel, other than Claims resulting from the gross negligence or willful misconduct of Licensee; provided, however, that in no event shall the event that NovaDel is unable or unwilling to provide clinical or commercial supply of Licensed Product within a reasonable period of time upon commercially reasonable terms, then Licensee shall be entitled to seek alternate manufacturing source. In such event, Licensee shall use commercially reasonable efforts to ensure that any such alternate manufacturing source agree (a) to maintain in strictest confidence all information relating to the manufacture scope of the Licensed Product and indemnification to Licensee be any less than the Licensed Technology, (b) not to file any intellectual property protection relating to inventions that may arise from the manufacture scope of the Licensed Product and Licensed Technology, and (c) that any intellectual property that does arise out of the manufacture of the Licensed Product and Licensed Technology belong Extraterritorial Licensee’s indemnification obligations to NovaDel.