Provision Language
Definitions
“Charitable Purpose” has the meaning set forth in the Grant Agreement.
“Developed Countries” means the countries (each a “Developed Country”) that are not listed in Appendix A.
“Developing Countries” means the countries (each a “Developing Country”) listed on Appendix A as Developing Countries.
“IPDP”means Integrated Product Development Plan dated as of May 29, 2015 and referenced in the Grant Agreement or as otherwise updated and mutually agreed by the parties.
“Total Product Manufacturing Capacity” means the total Doses the Company manufactures on an annual basis for any RSV product, either directly or through its CMO or Affiliates. The Company will forecast its manufacturing capacity on a rolling quarterly basis, which forecast will be subsequently trued–up quarterly based on the Total Product Manufacturing Capacity.
1. Charitable Purpose and Use of Funds
The Foundation’s primary purpose in making the Grant to Company is to further significantly the accomplishment of the Foundation’s charitable purposes, including its support of the research and development of drugs, vaccines and diagnostics to address diseases that have a disproportionate impact on people within developing countries. More specifically, the purpose of the Grant is to support development (including the Phase 3 Clinical Trial) of an affordably–priced RSV vaccine for use in maternal immunization to provide RSV protection to infants in Developing Countries and other low income countries including as reflected herein and in Company’s proposal submitted to the Foundation together with other documentation provided to or made available to the Foundation prior to or after submission of the grant proposal and documents related to the Project (as defined in the Grant Agreement).
Company understands and acknowledges that a primary organizational objective of the Foundation is to support development of an affordably–priced RSV vaccine for use in maternal immunization to provide RSV protection to infants in Developing Countries and as otherwise agreed in this GACA further defines the specific Global Access commitments of Company.
3. Global Access Commitments
In furtherance of the Charitable Purpose, Company agrees to the following “Global Access Commitments”:
(a) Prompt and Broad Dissemination of Knowledge and Information. Consistent with the Publication provisions of the Grant Agreement, Company will use reasonable and diligent steps to:
(i) publish (in a customary and reasonable manner as Company sees fit) information related to the Phase 3 Clinical Trial under the Project, which shall include:
(A) prospective registration of clinical trials on a WHO compliant clinical trial registry (e.g.,www.who.int/ictrp), with final clinical trial results publicized within 12 months from the completion date of the trial in accordance with WHO reporting guidelines/recommendations;
(B) publication of status of each clinical trial conducted under the Project on clintrials.gov within the earlier of 12 months of completion of each such clinical trial or the date imposed or specified by applicable law; and
(C) publication of final results of each clinical trial under the Project in one or more applicable peer reviewed open access journals within 12months from the last subject last visit time point of any such clinical trial, consistent with the provisions in the Grant Agreement.In the event of an inability to obtain peer reviewed publication, Company agrees to publish in manner that the Foundation determines in its reasonable discretion satisfies the requirement that such research be published in a form that is “available to the interested public” as described in Treasury Regulation 1.501(c)(3)- 1(d)(5)(iii)(c)(2) (the “Publication Requirement”).
(ii) provide to the Foundation (or as applicable in section 3(a)ii)(C), to a technology transfer recipient) with access to information as follows:
(A) in connection with any stage–gate review under the Grant or related to the Project, access to de–identified data and information regarding the Project including anticipated Product approval timelines;
(B) upon the Foundation’s reasonable request (no more frequently than quarterly), access to de–identified data and information regarding the Project including anticipated Product approval timelines; and
(C) provide the information and documentation as contemplated in the Technology Transfer provisions set forth in Section 6(d).
(b) Availability and Accessibility at Affordable Price to People in Developing Countries. Company will use reasonable and diligent steps to:
(i) conduct all clinical trials specified in the IPDP to meet the Minimum TPP and keep the Foundation promptly informed of any information impacting the Product’s ability to meet the Minimum TPP thereunder or that is otherwise deemed to impact the Project or timelines by three (3) months or more;
(ii) obtain and maintain the regulatory and Project expertise to support Company’s clinical, regulatory and development plans including with respect to Developing Country plans and WHO PQ;
(iii) conduct activities set forth in the IPDP; meet specified timelines and criteria included in the IPDP; and keep the Foundation promptly informed of any information impacting Company’s ability to meet such timelines or criteria by three (3) months or more;
(iv) consider utilizing WHO’s joint regulatory review mechanism for clinical trial approvals in Developing Countries provided always that all regulatory activity decisions will be Company’s sole responsibility;
(v) submit an applicable dossier to WHO for WHOPQ of the Product for Maternal Immunization in Developing Countries by [**];
(vi) develop Total Product Manufacturing Capacity to a minimum of [**] Doses of the Released Product by [**];
(vii) keep the Foundation promptly informed of the activities related to progress on the Project (including providing the Foundation with information reasonably requested by the Foundation related to the Product, trials and deliberations of review committees) and Company’s Global Access Commitments and consult with the Foundation in good faith in connection with Developing Country launch strategic decisions, including by holding meetings with the Foundation no less often than once every three (3) months;
(viii) consider in good faith requests for donation of Released Product for Maternal Immunization by global health entities for demonstration studies/trials or additional research studies/trials supporting regulatory approval and/or demand stimulation in Developing Countries, provided however that Company’s provision of Released Product for such purposes shall not be deemed a first sale hereunder;
(ix) promptly, upon WHOPQ or any applicable regulatory approval for distribution of Released Products in a Developing Country for Maternal Immunization, provide reasonable publicity of the availability of the Product for sale for Maternal Immunization in each applicable Developing Country including to Public Sector Purchasers (regardless of the location of such Public Sector Purchaser, provided the Released Product procured is intended for use in or distribution to the applicable Developing Country) and responding to tender offers applicable to the Released Product for Maternal Immunization, subject to the Price Commitment outlined in Section 3(c) below;
(x) promptly upon WHOPQ, seek local Developing Country registration, to the extent such Developing Country participates, for Released Product for Maternal Immunization through the WHO Collaborative Registration Procedure (CRP); and
(xi) provide the Product to applicable Public Sector Purchasers for Maternal Immunization in accordance with this GACA and any applicable laws and regulations.
(xii) pursue applicable regulatory approval of Released Product for Maternal Immunization in those countries listed on Appendix A as “Additional Countries” after WHOPQ, and, upon such approval, commit to make such Released Product available to Public Sector Purchasers in such countries at a price per dose to be negotiated in good faith by the parties.
c) Price Commitment
(i) Upon WHOPQ, and in compliance with applicable laws and regulations, Company will offer and provide to Public Sector Purchasers the Aggregate Minimum Supply at the Annual Minimum Supply (as set forth in section 3(d)) of the Released Product for Maternal Immunization in the Developing Countries at a maximum price as reflected in Table A:
TABLE A
“Price Commitment” is equal to the [**] Costs (as adjusted from time to time under this section 3(c)) plus [**] mark–up but provided always that such price does not exceed:
[**] per Dose (USD) herein after the “[**]”
(i) The Parties acknowledge and agree that (1) the [**] described in Table A above is based on principle assumptions about Novavax future manufacturing efficiencies at the time of WHOPQ as set forth on Appendix C attached hereto and incorporated by reference herein, and (2) to the extent that actual results differ from such Appendix C principal assumptions, then the Parties shall take such factors causing differing results into account and will thereafter adjust such [**] pursuant to Section 3(c)(ii).
(ii) Notwithstanding Table A, within three (3) months prior to the estimated date for WHOPQ, and unless otherwise agreed by the Parties, at every third anniversary thereafter, coinciding with UNICEF tenders, the Parties shall, in good faith, discuss applicable adjustments to the Price Commitment (whether upwards or downwards) to proportionately, fairly, and reasonably reflect the factors set forth in Appendix C, including the impact on such factors caused by external or internal circumstances, including inflation, currency fluctuations, efficiencies of scale, product demand and yield improvements. In preparation for considering any such price adjustment, in the event that there are changes in [**] Costs that, in the aggregate exceed [**] since the last calculation, then Company shall provide to the Foundation an update to its [**] Costs consistent with Appendix C and the Foundation’s COGS Principles and Assessment Methodology Handbook, at least sixty (60) days in advance of such third anniversary and the Parties shall meet in good faith to discuss such changes within sixty (60) days after Company provides the Foundation with such update. In the event of any conflict between Appendix C of this GACA and the Foundation’s COGS Principles and Assessment Methodology Handbook, Appendix C of this GACA shall control. Upon agreement of the Parties to any price adjustment (which shall be reflected in a signed writing by the parties), the applicable price adjustments shall become effective within three (3) months after such written agreement or in time for the coinciding UNICEF tender, whichever is earlier. In the event that the Parties are unable to agree on a revised Price Commitment, an independent third–party, with specific expertise in assessing costs, [**]. and with experience with vaccines, reasonably acceptable to both Parties, shall be appointed to provide analysis of such potential adjustment upon the request of either Party and the cost of such analysis shall be shared equally by the Parties. That analysis will be shared with Company and the Foundation who will work together to resolve any adjustments to the Price Commitment. If there is no resolution within forty–five (45) days, the matter will be referred to Company’s President/CEO and the Foundation’s President of Global Health (or the equivalent in the event of any reorganization following which such position no longer exists). If these individuals are unable to resolve the matter of the revised Price Commitment based on this analysis within a further forty–five (45) days, then the price will be adjusted upwards in event that the third party analysis points to an upward adjustment or downwards if the third party analysis points to a downward adjustment, in each case, capped as follows: if the parties are unable to agree with respect to the first adjustment of the [**], then the adjustment shall be [**], as the case may be (based on the direction of the third party analysis) and if the parties are unable to agree as to any subsequent adjustments to the [**], then the adjustment shall be [**] as the case may be (based on the direction of the third party analysis).
(iii) Upon the written request of the Foundation and not more than once in each calendar year, Company will permit an independent third party accounting firm, with specific expertise in assessing costs [**] and with experience with vaccines selected by the Foundation and reasonably acceptable to Company, at Foundation’s expense, to have access during normal business hours to such of the records of Company as may be reasonably necessary for any year ending not more than three (3) years prior to the date of such request for the sole purpose of verifying the basis and accuracy of [**] Cost consistent with Appendix C and the Foundation’s COGS Principles and Assessment Methodology Handbook, for determining [**] Cost. Such third party accounting firm shall provide any such report to both the Foundation and Company and if such third party accounting firm identifies a discrepancy in [**] Cost made during such period, appropriate adjustments will be determined within ninety (90) days of the date such accounting firm’s written report is delivered to both Parties.
(iv) Multi Dose Vial Options: Notwithstanding the foregoing, if the Parties agree that to the extent the Company switches to a multi–dose presentation of the Product that meets WHOPQ requirements and satisfies the Company’s Global Access Commitments, the Price Commitment shall be appropriately reviewed and may be adjusted by mutual written agreement of the Parties, consistent with the process described in Scction 3(c)(i) above.
(v) Notwithstanding section 3(c)i) above, in the event that Company sells Released Product for Maternal Immunization to a Public Sector Purchaser in any country (whether a Developing Country or a Developed County) at a lower than the Price Commitment in subsection 3(ci) above, Company will promptly offer such Released Product for sale at such lower price to any Developing Countries in which the sale, use or marketing of Released Product is authorized by WHOPQ or applicable country registrations. Company will promptly notify the Foundation of any price decrease of the Released Product for Maternal Immunization.
(d) Volume Commitment
(i) In order to provide the greatest health benefit of the Product, Company desires to address worldwide necd for the Product including demand for its use in Maternal Immunization from Developed and Developing Countries. The Parties recognize that introduction and demand for the Product occurs over a period of time and that Company may not be fully able to address such demand in the period proximate to introduction and approval. Notwithstanding the foregoing, the Parties acknowledge that Company’s current and planned Total Product Manufacturing Capacity may not be sufficient to meet worldwide demand. Accordingly, the Parties desire to define the allocation of Product that Company intends to reserve to fulfill orders for use in Maternal Immunization in Developing Countries.
(ii) Upon applicable regulatory approval(s), the Company shall make the Released Product, available and accessible to Public Sector Purchasers for Maternal Immunization on the terms set forth in this GACA.
(iii) Company shall ensure Aggregate Minimum Supply is met subject to the Annual Minimum Supply as defined in Table B below in the context of Timing of First Sales set forth in Table B (“Annual Minimum Supply“). Company shall ensure that this Annual Minimum Supply is available each year starting at the date of the first sale of Released Product to a Public Sector Purchaser for a Developing Country and ending upon termination of this GACA, including any Extended Term as described in Section 3(d(v). Company shall use reasonable and diligent efforts to manufacture, fill finish, package, label, store and ship the Released Product in accordance with (a) all tender, purchase and sale agreements with any Public Sector Purchaser(s) up to the Aggregate Minimum Supply, (b) all applicable safety, legal, ethical, and regulatory requirements, and (c) the terms of this GACA. Shipping terms will be FCA Incoterms 2010, unless agreed in writing otherwise.
(iv) Obligation to Bid on Public Sector Purchaser Tenders. Subject at all times to the Aggregate Minimum Supply and Annual Minimum Supply, the Volume Commitment requires the Company to use reasonable and diligent efforts to bid on applicable Public Sector Purchaser tenders in accordance with the Price Commitment for any Public Sector Purchaser purchase order with an effective date that falls within the Term or Extended Term.
(v) Volume Commitment Rollover. During the Term of this GACA, in the event that during a calendar year the full amount of the Annual Minimum Supply is not committed for purchase by applicable Public Sector Purchasers (“Undemanded Capacity“), Company shall have the right to allocate such Undemanded Capacity as it sees fit and the same amount of Undemanded Capacity shall be rolled over into one or more extended years, depending on the amount of such Undemanded Capacity, which shall thereby extend the Term of this GACA (“Extended Term“). During the Extended Term, the terms and conditions of this GACA shall apply, until the Aggregate Minimum Supply is met. For the avoidance of doubt and notwithstanding any other provision of this GACA, this volume commitment rollover provides for an Extended Term that ensures that Company provides the Aggregate Minimum Supply over the Term or Extended Term. Notwithstanding the foregoing, Company may, but will not be obligated to, provide more than the Annual Minimum Supply to Public Sector Purchasers within any given calendar year during the Term or Extended Term. The Parties agree that in any event, the Extended Term shall not exceed five (5) additional years at which time the Volume Commitment will be deemed fulfilled.
(vi) Expanded Capacity. In the event the Foundation desires additional expanded capacity beyond the Aggregate Minimum Supply, the Foundation may at its full discretion request a proposal from Company detailing whether and how Company would meet such increased capacity and Company will respond promptly and in good faith with such a proposal; provided, however, that nothing in this paragraph is or will be deemed a promise of future funding and any such proposal is subject to all internal reviews, processes and approvals by the Foundation and any applicable laws and regulations, and any such proposal or future funding must be reflected in a definitive written agreement between the Parties. Nothing in this GACA is a promise or obligation for either Party to enter into any future agreement.
(e) Representations, Warranties, Covenants of Company: Company hereby represents, warrants and covenants to the Foundation:
(i) Project Diligence and Necessary Skill. Company will use reasonable and diligent efforts to meet the Project obligations, develop the Product, and meet its obligations under the Grant Agreement and this GACA, and Company has, and will maintain, the necessary expertise, personnel, facilities and equipment to meet the Project obligations, develop the Product, and meet its obligations under the Grant Agreement and this GACA;
(ii) Compliance with Applicable Laws & Regulations. Company will comply with all applicable laws, regulations, and rules and will not infringe, misappropriate, or violate the intellectual property rights of any third party and is in compliance in all material respects with all applicable laws, regulations, and rules (including all laws and regulations related to clinical trials, human health and safety, the protection of the environment, research, development and manufacture of vaccines intended for human use) regarding the use, design, research, development, production, manufacture, licensure, offer–for–sale, sale, distribution, import and export of the Product as contemplated by the Project, and no action has been filed or commenced against Company alleging any such failure. Company is in material compliance with all applicable cGMPs, Good Clinical Practices, Good Laboratory Practices and has (or will obtain prior to any applicable activity) all applicable licenses, approvals and permits related to the foregoing. Company is not aware of facts that (with or without notice or lapse of time, or both) could reasonably be expected to result in Company being in violation in any material respect of any law materially applicable to the use, design, research, development, production, manufacture, licensure, offer–for–sale, sale, distribution, import and export of any Product as contemplated by the Project. Company has in place and shall continue to maintain during the Term or Extended Term, a compliance program reasonably designed to identify, prevent, and address any material compliance issues.
(iii) Licenses and Permits. Company currently holds (or will hold prior to any applicable activities related to the Product): all necessary foreign, federal, state, local and other governmental licenses, approvals and permits necessary too use, design, develop, produce, manufacture, offer–for–sale, sell, distribute, import and export the Product for use as contemplated hereunder by the Project and this GACA.
(iv) Records Compliance. Company will maintain, in accordance with and for the period required under cGMPs and applicable laws, complete and adequate records pertaining to the methods, and the facilities, manufacture, procedures, testing and the like, related to the Products.
(v) No Conflict. Company will not enter into any agreement or arrangement with any third party which will prevent it from performing or impair its ability to perform its obligations hereunder.
(vi) IP Due Diligence. Company currently has (or will have prior to any commercialization of the Product), conducted reasonable due diligence with respect to the Product, including intellectual property and freedom to operate analyses related to such Product.
(vii) IP Rights. Company currently has (or will have prior to commercialization of the Product) rights to any and all intellectual property (including rights in any patents, data, confidential information, know–how or other proprietary right) required to commercialize (make, have made, sell, offer– for–sale, distribute, import, export and use as contemplated by the Project) the Product.
(viii) Product Modification. In the event of any injunction or prohibition against Company’s manufacture, licensure, import, export, sale, offer–for–sale, distribution, or use of the Product by reason of infringement of a patent, proprietary, or intellectual property right, or if in Company’s opinion the Product is likely to become the subject of a claim of infringement of a patent, proprietary, or intellectual property right Company will, at its option and at its expense, either: (a) procure (such as by licensing or otherwise) the right to continue to make, have made, import, export, sell, offer–for–sale, distribute, and use such Product, or (b) replace or modify such Product so it becomes non–infringing, but is reasonably equivalent or superior in terms of efficacy, quality and safety. Notwithstanding the previous, Company’s inability to further develop, manufacture, sell or license the Product because it cannot reasonably procure rights or modify the Product as prescribed hereunder, which limitation has been reasonably veritied by the Foundation, shall not be deemed a Charitability Default provided the Foundation reasonably agrees that such procurement or modification is not reasonable.
(ix) No Disputes. The Product, including its commercialization, manufacture, sale, offer–for–sale, distribution, import, export and use as contemplated by the Project, is not the subject of any current third party intellectual property claims and is not currently subject to any disputes with a third party. Company agrees to notity the Foundation of any such claims or disputes which arise during the Term or Extended Term.
(x) Disqualification and Debarment. Company, its employees or contractors or agents are not and will not be, at the time of performance of any activity contemplated hereunder, (a) disqualified or debarred by any applicable governmental authority for any purpose pursuant to applicable law or regulation or threatened with any such disqualification or debarment or (b) charged or convicted for conduct relating to the development or approval of, or otherwise relating to the regulation of, any product under any applicable law or regulation, which activity with respect to (a) or (b) could adversely impact the Project or Product or obligations under this GACA.
(xi) Warranty. The Product is or will be manufactured by Company (and/or its CMOs or Affiliates) in conformity with its regulatory label and package insert and all applicable laws and regulations.
(xii) Company is Sponsor. Company is and shall be responsible for all aspects and stages of the Project and Product, including Product research, development, clinical trials, and commercialization (including any applicable legal, regulatory, and governmental requirements and/or registrations), including acting as the sponsor of any clinical trials or research studies related thereto. In no event shall the Company make any representation or statement that the Foundation is a sponsor of any trial, study, Product registration, or marketing authorization or the like. Except as may be required by law, Company shall not include the Foundation on any document relating to the foregoing or in any communication with any governmental or regulatory body without the express prior written consent of the Foundation. Any input, consultation, or communication to Company by the Foundation shall not diminish the foregoing.
5. Obligations in the Event of Acquisition of Product or Company by Another
In the event Company, Company assets necessary to perform Company’s obligations hereunder are licensed to, transferred to, sold to or otherwise acquired by a third party, including as a result of a Change in Control (any such license, transfer, sale or acquisition, including a Change in Control, is referred to herein as a “Transfer”), Company will ensure all such obligations are assumed by the licensee, purchaser, transferee, acquirer or successor in a written agreement reasonably acceptable to the Foundation. Company will not grant to a third party any rights or enter into any arrangements that would prohibit, prevent or otherwise restrict Company or any purchaser, transferee, acquirer, or successor of Company assets or Company from fulfilling its obligations hereunder. For clarity, notwithstanding anything to the contrary herein, the Foundation’s rights hereunder which exist on the date of the Transfer shall not be terminated by such Transfer. A breach of this provision will constitute a Charitability Default.