Provision Language
Definitions
“Import Waiver” means, in respect of a country in the Territory where, at the time of the intended sale or supply, the Licensed Product does not have Regulatory Approval, all export and import licences, authorisations, permits, consents or approvals necessary to supply, sell and/or offer for sale that Licensed Product in that country.
“Relevant Regulatory Authority” means (i) in relation to a particular country in the Territory, any applicable federal, national, regional, state, provincial, or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Licensed Product in that country, or (ii) WHO pre-qualification programme where such approval has been deemed adequate by the authority referred to in (i).
5. Assistance with Product Development and Regulatory Approvals
Data Package
5.1 In the event the MPPF receives (pursuant to Clause 5 of a Sublicence) a written request for ViiV to provide a data package to expedite development and filing for Regulatory Approval in the Territory, the MPPF shall promptly forward such request to ViiV. Upon receipt of the request, ViiV shall consider the request and, if ViiV in its sole discretion considers it feasible to do so, ViiV shall assemble and make available to each Sublicensee a single discrete data package, which (i) content shall be determined by ViiV in its sole discretion, and (ii) provision shall be conditional on such Sublicensee entering into a separate non-disclosure agreement with ViiV regarding the data package.
ViiV Products
5.2 ViiV commits to sell to each Sublicensee, at a discounted price to be determined by ViiV at its sole discretion, and subject to terms to be agreed between ViiV and such Sublicensee, up to 1000 tablets of oral cabotegravir (30mg tablets) and up to 1000 vials of extended-release injectable suspension of cabotegravir (600mg/3mL vials), solely for use in (a) in vitro research related to the Sublicensee’s Licenced Product development and (b) bioequivalence studies required to obtain Regulatory Approval. In the event the MPPF receives (pursuant to Clause 5 of a Sublicence) a written request for ViiV to sell ViiV Product to a Licensee, the MPPF shall promptly forward such request to ViiV. The MPP shall ensure that as part of any request, a Sublicensee provides details of its (a) development plan and associated milestones and (b) bioequivalence study plans. ViiV shall work directly with the relevant Sublicensee to agree the terms of such sale.
Exclusivity waivers
5.3 Subject to compliance by a Sublicensee with the terms of the Sublicence, ViiV shall provide such Sublicensee:
(A) with new chemical entity exclusivity or other regulatory exclusivity waivers to the extent required by the applicable regulatory authorities to enable such Sublicensee to apply for Regulatory Approval; and
(B) such consents which it has the legal capacity to give as are necessary to enable such Sublicensee to perform its obligations under Clauses 4.2 and 4.3 of the Sublicence.
5.4 If a request for a Selective Waiver Letter is made to the MPPF by a Sublicensee in accordance with Clause 6 of the Sublicence:
(A) the MPPF shall notify ViiV and provide ViiV with the information required by ViiV to prepare the requested Selective Waiver Letter; and
(B) provided that the Sublicensee has complied with all the requirements of Clause 6 of the Sublicence (including in relation to the inclusion of a Paragraph III Certification), ViiV will complete the Selective Waiver Letter (including by printing such Selective Waiver Letter onto its official letterhead and arranging for the Selective Waiver Letter to be signed by a suitably authorised employee of ViiV or its Affiliate) and submit the Selective Waiver Letter to the FDA within thirty (30) days of receiving all the information required to prepare the requested Selective Waiver Letter, from the MPPF.
5.5 ViiV shall retain sole discretion as to the form and content of the Selective Waiver Letter, provided that the form and content of such Selective Waiver Letter is consistent with the terms of Clause 6 of the Sublicence.
5.6 ViiV shall remain entitled at any time to revoke a Selective Waiver Letter and/or any consent or waiver contained therein if the relevant Licensee fails to comply with any of the terms of the Sublicence (including any of the requirements of Clause 6 of the Sublicence) and/or if the relevant Sublicensee submits a Paragraph IV Certification in relation to any Relevant ANDA or Relevant NDA.
5.7 ViiV shall provide a copy of each Selective Waiver Letter as submitted by it to the FDA to the MPPF within ten (10) Business Days of its submission to the FDA.
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6. Reporting
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Pharmacovigilance reporting
6.4 By no later than twenty (20) Business Days after the end of the Agreement Quarters ending 30 June and 31 December, the MPPF shall deliver a written report to ViiV (in a form to be provided by ViiV) consolidating the contents of every pharmacovigilance report provided to the MPPF by each Sublicensee under Clause 13.2.4 of the Sublicence.
7. Approval Requests
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7.2 Affiliates and Local Distributors – under Clauses 3.2 and 3.3 of the Sublicence, any request by a Sublicensee for an Approved Affiliate or an Approved Local Distributor (respectively). The MPPF shall, on the basis of the documentation provided by the Sublicensee:
(A) assess:
(i) in the case of a request for approval of an Affiliate, whether the proposed entity is an Affiliate of the Sublicensee; and
(ii) in the case of requests for approval of a Local Distributor, whether for the Licensed Product to be lawfully sold or otherwise supplied in such country the Regulatory Approval must be held in the name of a legal entity registered in the relevant country of the Territory and if so, whether the proposed Local Distributor fulfils the MPPF’s reasonable due diligence requirements; and
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8. Sublicence Compliance
8.1 Monitoring – The MPPF shall, using all reasonable care, diligence and skill, actively monitor each Sublicensee’s compliance with the terms of its Sublicence, including:
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(F) Pharmacovigilance – monitor the activities and duties of each Sublicensee as regards pharmacovigilance obligations under Clause 13 of the Sublicence, and (b) otherwise procuring compliance by each Sublicensee with such Clause 13 of the Sublicence. ViiV will communicate to MPP any significant safety issue that may (i) impact the benefit/risk ratio of the Product, (ii) require urgent communication by Licensees to health care professionals regarding Licensed Product or (iii) require the restriction of the use of the Product in a certain population. The MPPF shall promptly forward any such communications to each Licensee;
Schedule 2 – Form of Sublicense
3. GRANT OF LICENCE
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3.3 Local Distributors. The Licensor acknowledges that in some countries of the Territory, for Licensed Product to be lawfully sold or otherwise supplied, Regulatory Approval must to be held in the name of a local entity registered in such country (“Local Distributor”). Where Licenced Product can only be lawfully sold or otherwise supplied in a country of the Territory by a Local Distributor, and an Approved Affiliate of the Licensee cannot act as such Local Distributor pursuant to Clause 3.2, the Licensee may submit a written request to the Licensor to use a Third Party that is not an Affiliate as a Local Distributor in such country. Such request shall be supported by appropriate documentation on (a) the need to use a Local Distributor and (b) due diligence on the Third Party. The Licensor, acting reasonably, shall consider the request and respond within thirty (30) days of receipt of all appropriate supporting documents from the Licensee, with an approval or a written statement of why the request is not been approved. Any Third Party approved in writing by the Licensor pursuant to this Clause 3.3 shall be referred to in this Agreement as an “Approved Local Distributor”. The Licensee shall have the right, pursuant to the licence granted to it under Clause 3.1, to grant a sublicence to such Approved Local Distributor, solely to the extent necessary for such Approved Local Distributor to obtain Regulatory Approval and/or sell or otherwise supply the Licensed Product in the relevant country of the Territory.
4. DEVELOPMENT, REGISTRATION AND COMMERCIALISATION
4.1 Control and responsibility. As of the Effective Date and subject always to ViiV’s retained interests to the Patent Rights (and those of its licensees), the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture and commercialisation (as applicable) of all Licensed Compound and all Licensed Product.
4.2 Compliance. The Licensee shall:
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4.2.2 obtain from the relevant authorities in the Territory and maintain in force, as appropriate, all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Licensed Compound and Licensed Product (including but not limited to Import Waivers where applicable) which are necessary to enable the Licensed Compound and/or Licensed Product to be sold or otherwise supplied in the Territory in accordance with this Agreement.
4.3 Timelines for Regulatory Approval. The Licensee shall file, for Regulatory Approval (for both an oral Licensed Product and an extended-release Licensed Product) before at least one Relevant Regulatory Authority as soon as possible and in any event not later than 60 months from the Effective Date, in each case using the fastest approval route possible. Licensee shall also, upon Licensor’s reasonable request, file for regulatory approval before the Relevant Regulatory Authority for any subsequent Licensed Product within a reasonable time.
4.4 Regulatory exclusivity. The Licensee agrees, where applicable and to the extent that it is able, to not seek, and to waive, regulatory exclusivity in the Territory in relation to any data relating to Licensed Product.
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4.7 Supplies prior to Regulatory Approval. Notwithstanding the Effective Date of this Agreement, the Licensee undertakes not to sell or otherwise supply a Licensed Product in a country of the Territory prior to
4.7.1 Regulatory Approval in that country, unless the sale or supply is made pursuant to an Import Waiver; and
4.7.2 WHO prequalification or Stringent Regulatory Authority approval, or through any provisional authorizations available through WHO or a Stringent Regulatory Authority.
5. REFERENCE PRODUCT AND DATA PACKAGE
In the event that the Licensee:
(a) wishes to procure ViiV Product directly from ViiV for use in bioequivalence studies required to obtain Regulatory Approval; and/or
(b) would like ViiV to consider providing the Licensee with a data package to expedite filing for Regulatory Approval,
Licensee shall submit a written request for the same (which shall, for any request to procure ViiV Product, include the details of the Licensee’s (a) development plan and associated milestones and (b) bioequivalence study plans) to the Licensor. Upon receipt of such request, the Licensor shall forward the request to ViiV for consideration under Clauses 5.1 and 5.2 of the Head Licence (as applicable), and keep Licensee informed of progress and outcome of the request.
6. SELECTIVE WAIVER LETTER
6.1 The Parties acknowledge that, in order for the Licensee to be able to supply a Licensed Product to applicable countries in the Territory under PEPFAR, it may be necessary for the Licensee to obtain tentative approval for that Licensed Product from the FDA under section 505(b)(2) or 505(j) of the U.S. Food, Drugs and Cosmetics Act (the “Act”). In the event that the Licensee wishes to obtain tentative approval from the FDA for a Licensed Product in circumstances where:
6.1.1 the purpose of obtaining such tentative approval from the FDA is solely to enable the Licensee to supply that Licensed Product to countries in the Territory under PEPFAR;
6.1.2 the FDA’s tentative approval is sought in respect of a Relevant ANDA or Relevant NDA (as applicable);
6.1.3 the NCE Exclusivity Period has not expired; and
6.1.4 the Licensee has complied with, and continues to comply with this Agreement, including the requirements of this Clause 6,
the Licensee shall submit a written request to do so to the Licensor. The Licensor shall, following receipt of such written request, request pursuant to Clause 5 of the Head Licence that ViiV submits to the FDA a Selective Waiver Letter in respect of the Licensee’s Relevant ANDA or Relevant NDA (as applicable). The Licensee shall provide to the Licensor such information in respect of its Relevant ANDA or Relevant NDA as the Licensor or ViiV may reasonably require in connection with the preparation of such a Selective Waiver Letter and/or in order to assess the Licensee’s compliance with the requirements of this Clause 6.
6.2 The Licensee acknowledges Clauses 5.3 to 5.6 of the Head Licence.
6.3 The Licensor shall, on request, provide the Licensee with a copy of any Selective Waiver Letter in respect of the Licensee’s Relevant ANDA or Relevant NDA following receipt by the Licensor of the same.
6.4 The Licensee undertakes, in respect of any Relevant ANDA or Relevant NDA for which a Selective Waiver Letter is requested, to:
6.4.1 identify the VOCABRIA NDA or the APRETUDE NDA (as applicable) as the “listed drug” (as that term is used and defined in section 505 of the Act and related regulations) in such Relevant ANDA or Relevant NDA; and
6.4.2 include with Relevant ANDA or Relevant NDA (as applicable) a Paragraph III Certification in respect of each Listed Patent; and
6.4.3 maintain that Paragraph III Certification until the expiration of the period described in sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) of the Act, as extended by any applicable paediatric exclusivity describe in section 505A(c)(1)(A)(i)(I) of the Act; and
6.4.4 submit any Relevant ANDA or Relevant NDA (as applicable) within 90 days of the date of the Selective Waiver Letter.
6.5 Nothing in this Agreement or any Selective Waiver Letter issued pursuant to this Clause 6 shall:
6.5.1 be read, interpreted or otherwise considered to be a waiver of any other rights which extend to ViiV under section 505 of the Act, including (without limitation) the right to receive notice of any Paragraph IV Certification, to bring suit within forty-five (45) days of receiving such a notice and, to prevent the approval of an application during the applicable periods set forth in sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) of the Act, as extended by any applicable paediatric exclusivity described in section 505A(c)(1)(A)(i)(I) of the Act (the Licensee acknowledges that nothing in this Agreement or any Selective Waiver Letter shall relieve the Licensee of any obligations in respect of a Paragraph IV Certification that may be imposed by the Act); or
6.5.2 authorise the Licensee to obtain final approval for a Relevant ANDA or Relevant NDA prior the expiration of the NCE Exclusivity Period and any other applicable periods set forth in sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) of the Act, as extended by any applicable paediatric exclusivity described in section 505A(c)(1)(A)(i)(I) of the Act; or
6.5.3 authorise the Licensee to do (or permit any Third Party to do) anything that infringes a Patent Right or Listed Patent.
6.6 The provisions of this Clause 6 apply solely in respect of a Relevant ANDA or Relevant NDA submitted by the Licensee for the purposes specified in Clause 6.1 and, for the avoidance of doubt and without limitation, the provisions of this Clause 6 do not apply in respect of:
6.6.1 any Abbreviated New Drug Application or New Drug Application submitted to the FDA:
(a) that is not, in respect of the Licensed Product concerned, a First U.S. Application; and/or
(b) in connection with which the Licensee submits a Paragraph IV Certification; or
6.6.2 any application for a marketing authorisation or equivalent licence in respect of any product (including any Licensed Product) in any country other than the U.S.
8. REPORTING OBLIGATIONS
8.1 Within ten (10) Business Days following the end of each Agreement Quarter, the Licensee shall provide the Licensor written reports for such Agreement Quarter (prepared in accordance with any Reporting Guidance) on:
8.1.1 Development Activities and regulatory activities. Such report shall set out:
(a) a summary of all Development Activities, including a list of Licensed Product(s) in the Licensee’s development pipeline and status of development of such Licensed Product(s), summary of work completed and in progress, current schedule of anticipated events and milestones, all bioequivalence data generated by or on behalf of Licensee related to Licensed Product;
(b) Regulatory Approval filing plan for each Licensed Product(s); and
(c) list of the countries in which applications for Regulatory Approval have been planned, filed and/or Regulatory Approvals have been obtained for such Licensed Product(s) as well as anticipated market introduction dates; and
13. PHARMACOVIGILANCE
13.1 The responsibilities of the Parties for reporting of Human Safety Information related to the Licensed Product to Relevant Regulatory Authorities shall be performed in accordance with local laws and regulations. The responsibilities of the Parties for safety related or Licensed Product related inquiries shall be performed in accordance with local laws and regulations.
13.2 Without prejudice to Clause 13.1:
13.2.1 the Licensee undertakes that it will maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures, training programmes and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement;
13.2.2 the Licensee undertakes that it will ensure that it will comply with all Applicable Law regarding the Product including those laws and regulations relating to risk management, drug safety and pharmacovigilance. This includes but is not limited to collating Human Safety Information, expedited and periodic reporting to relevant Regulatory Authorities, literature review, performing safety evaluation and signal detection on all available Human Safety Information;
13.2.3 the Licensee will hold and maintain a safety database regarding Product, which shall contain all Human Safety Information (for marketed Product) and all Serious Adverse Events (SAEs) and Pregnancy Reports (for investigational Product) of which the Licensee becomes aware either directly or from another source;
13.2.4 the Licensee shall provide the Licensor a report containing information regarding Human Safety Information which are associated with the Product and which have been received by the Licensee, from any source, including spontaneous, solicited, and clinical trial sources. Such report shall (i) be provided every six (6) months, within ten (10) Business Days after the end of the Agreement Quarters ending 30 June and 31 December, and shall (ii) cover the two Agreement Quarters immediately preceeding the due date of such report, or as otherwise requested by the Licensor;
13.2.5 on conclusion of any clinical research relating to the Licensed Products, the Licensee shall submit to Licensor copies of the clinical trial reports generated by or on behalf of the Licensee relating to such clinical research promptly after such reports are generated;
13.2.6 the Licensee shall notify the Licensor and ViiV forthwith of the receipt of an enquiry from a Relevant Regulatory Authority relating to the Product that concerns any safety issue. If the Licensee becomes aware of action that may or will be or has been taken by a regulatory authority for a safety reason connected with the Product, it shall immediately and in any event no later than twenty-four (24) hours after receiving such notice from a regulatory authority notify the Licensor and ViiV in writing (including, but not limited to email communications) with available details regarding the same; and
13.2.7 notwithstanding Clause 27, notices to be provided pursuant to Clause 13.2.6 shall, in addition, also be sent to:
oxa63163@viivhealthcare.com
For the attention of VP, Safety & Pharmacovigilance, ViiV Healthcare
13.3 Notwithstanding and without prejudice to the Licensor’s rights under Clause 19, the Licensor shall have the right to monitor compliance with this Clause 13. The Licensee shall, when contacted by the Licensor regarding such monitoring, promptly provide any requested relevant information, and will promptly take corrective actions in relation to any identified non-compliance with this Clause 13.