Provision Language
5. Assistance with Product Development and Regulatory Approvals
[…]
Clinical Research Activities
5.9 The MPPF shall (a) promptly forward to ViiV any notice of Clinical Research Activity received pursuant to Clause 4.8 of the Sublicence, (b) provide ViiV with regular updates of any meetings with the Licensee regarding any Clinical Research Activity and (c) ensure that Licensees complies with ViiV’s reasonable requests in relation to the design and conduct of such Clinical Research Activities.
6. Reporting
Annual reporting
6.1 As soon as practicable and in any event by no later than 15 November in each Calendar Year of the Term and provided that the MPPF receives the relevant information from the appropriate Third Parties, the MPPF shall provide to ViiV a written forecast (in a form that is satisfactory to ViiV) of the amount of Licensed Product it expects the Sublicensee(s) to sell in the following Calendar Year, broken down in respect of each country in the Territory and each Licensed Product.
6.2 By no later than 28 February in each Calendar Year of the Term, the MPPF shall deliver a written report (in a form that is satisfactory to ViiV) setting out, (i) on a country-by-country, Sublicensee-by-Sublicensee and Licensed Product-by-Licensed Product basis the total amount of Licensed Product sold by each Sublicensee in each country in the Territory in the previous Calendar Year; (ii) on a country-by-country and Licensed Product-by-Licensed Product basis the total amount of Licensed Product which was forecast to be sold in that Calendar Year pursuant to the relevant forecast in Clause 6.1; and (iii) the difference between the amounts in (i) and (ii) above.
Quarterly reporting
6.3 Within twenty (20) Business Days after the end of each Agreement Quarter, the MPPF shall deliver written report(s) to ViiV consolidating the contents of all reports provided to the MPPF by each Sublicensee under Clause 8 of the Sublicence and setting out:
(A) on a country-by-country, Sublicensee-by-Sublicensee and Licensed Product-by-Licensed Product basis:
(i) all Development Activities and Regulatory Approval activities and estimated timelines for Stringent Regulatory Authority submissions and national regulatory submissions;
(ii) the total amount of Licensed Products sold and/or supplied for the immediately preceding Agreement Quarter;
(iii) the total aggregate amount of Licensed Products sold and/or supplied in that Calendar Year up to and including the immediately preceding Agreement Quarter; and
(iv) the calculations for any royalty due to ViiV in respect of each Sublicence for the immediately preceding Agreement Quarter; and
(B) on a country-by-country and Licensed Product-by-Licensed Product basis, the estimated total number of persons on a Licensed Product in the Calendar Year up to and including the immediately preceding Agreement Quarter; and
(C) for each sale or supply of Licenced Product made pursuant to an Approved Royalty Country Procurement, the outcome of MPPF’s verification under Clause 8.1(B), summarising the steps taken by the MPPF in reaching such outcome.
Such report(s) shall further include a written certification by an officer of the MPPF confirming that the MPPF has reviewed the contents of all reports provided to the MPPF by each Sublicensee in the preparation of this report and that, in the MPPF’s reasonable opinion: (i) each Sublicensee’s sales comply with the terms of the Sublicence and (ii) each Sublicensee’s royalty calculations for the relevant period are correct.
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.
6.5 By no later than five (5) Business Days following receipt by the MPPF of a clinical trial report under Clause 13.2.5 of a Sublicence, the MPPF shall forward such report to ViiV.
7. Approval Requests
[…]
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
(B) inform the Sublicensee whether it approves the Affiliate as an Approved Affiliate or the Local Distributor as an Approved Local Distributor (providing its grounds for refusal in the event it does not approve the request).
The MPPF shall keep an up to date written record of all Approved Affiliates and Approved Local Distributors, and make such record available to ViiV through the MPPF’s online trade dress portal or in any other manner agreed between the Parties
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:
(A) Reporting – procuring that all Sublicensees provide the reports referred to in Clauses 8 and 13 of the Sublicence in a timely manner and in accordance with the terms of those Clauses and any Reporting Guidance (where applicable). If, notwithstanding the MPPF’s efforts, a Sublicensee does not provide such reports:
(i) in the case of reports under Clause 8 of the Sublicence, within five (5) Business Days after the ten (10) Business Day period provided under the terms of the Sublicence; or
(ii) in the case of the report under Clause 13 of the Sublicence, (a) within five (5) Business Days after the required ten (10) Business Day period provided under Clause 13.2.4 of the Sublicence and (b) promptly in the case of clinical trial reports (provided under Clause 13.2.5 of the Sublicence) at the conclusion of the relevant clinical research),
the MPPF shall inform ViiV of the same and provide details of its efforts to date to procure such reports;
(B) Approved Royalty Country Public Procurement – verifying that every sale or supply of Licensed Product for use in the Public Market of a Royalty Country was made in accordance with an Approved Royalty Country Public Procurement and report the outcome of such verification to ViiV (summarising the steps taken by the MPPF in reaching such outcome) in the relevant quarterly report under Clause 6.3;
(C) Non-diversion – verifying that:
(i) all sales and/or supplies of Licensed Product by each Sublicensee were made in compliance with Clause 10 of the Sublicence; and
(ii) the volume of Licensed Product sold and/or supplied by Sublicensee(s) for use in any Permitted Market for any period of time is commensurate with the demand for Licenced Product(s) in such Permitted Market for such period of time, as reasonably estimated by the MPPF. If the volume of Licenced Product sold and/or supplied by Sublicensee(s) for use in a Permitted Market exceeds such demand, the MPPF shall take reasonable steps to determine whether any Sublicensee has breached the terms of its Sublicence;
(D) Royalty calculations – verifying the accuracy of any royalty calculation included in or accompanying each sales report provided by the Sublicensee pursuant to Clause 9 of the Sublicence. If an error is identified by the MPPF in respect of such a royalty calculation, the MPPF shall promptly take all steps necessary to ensure that such error is rectified and that the correct amount of royalties payable under the Sublicence is remitted to ViiV;
(E) Royalty payment – where applicable, ensuring the timely quarterly (i) delivery of invoices issued by ViiV in respect of royalties owed to ViiV pursuant to (and in accordance with) Clause 9 of the Sublicence to each Sublicensee and (ii) payment of such royalties (together with any interest due) to ViiV (or to such other person as ViiV has nominated). ViiV shall use reasonable endeavours to issue all invoices in a timely manner to ensure compliance by the MPPF with the timelines under Clause 9 of the Sublicence;
(F) Pharmacovigilance – monitor the activities and duties of each Sublicensee as regards pharmacovigilance obligations under Clause 13 of the Sublicence, and (b) otherwise procuring 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; and
(G) Audit rights – fully exercising the audit right set out in Clause 19 of the Sublicence at the MPPF’s own cost as soon as the MPPF has reasonable cause to believe an audit is necessary (including grounds for suspecting non-compliance with the Sublicence).
8.2 Management of breaches – If the MPPF becomes aware of any act or omission of a Sublicensee which may in the MPPF’s reasonable opinion constitutes a breach of the Sublicence, then the MPPF shall:
(A) share with ViiV as soon as reasonably practical details of the suspected breach and the MPPF’s proposed course of action; and
(B) keep ViiV up to date of the management of such breach including any mitigation plan agreed with the Sublicensee.
10. Records and Audit Rights
10.1 During the Term and for a period of three (3) years thereafter, the MPPF shall keep, complete, accurate and systematic records of all transactions under or in connection with this Agreement. The MPPF must maintain a system of internal accounting controls reasonably designed to ensure that it maintains no off-the-books accounts.
10.2 During the Term of this Agreement and for a period of three (3) years thereafter, ViiV shall have the right to, upon reasonable advance written notice to the MPPF, and during normal business hours at a mutually agreed upon time (such agreement not to be unreasonably withheld or delayed), and through the engagement of an independent, internationally recognized accounting firm (at ViiV’s expense and subject to confidentiality restrictions consistent with Clause 13), review and inspect records maintained by the MPPF in respect of its performance of this Agreement and the Sublicences and its compliance with Applicable Law for the sole purpose of determining the MPPF’s compliance with this Agreement, the Sublicences and Applicable Law. The scope of any such review may at ViiV’s discretion include the review of relevant internal procedures, training records, financial books and records and any other documents reasonably necessary to assess compliance by the MPPF with any of the terms of this Agreement or the Sublicence(s). The MPPF will cooperate fully with any audit and provide all reasonable assistance to ViiV and its representatives or contractors for completion of such audit. To the extent that any material deficiencies are identified as the result of such inspection, the MPPF shall take all reasonable corrective measures to remedy any such material deficiencies.
13. Confidentiality
[…]
13.8 For the avoidance of doubt, ViiV shall treat any information relating to a Sublicensee disclosed to it by the MPPF under Clauses 6 as Confidential Information provided that ViiV shall be entitled to disclose information about the quantities of Licensed Products sold or supplied by Sublicensees on an aggregate basis provided such disclosure does not reveal any Confidential Information of any Sublicensee.
Schedule 2 – Form of Sublicense
4. DEVELOPMENT, REGISTRATION AND COMMERCIALISATION
[…]
4.8 Clinical Research Activities. Prior to engaging in any Clinical Research Activity, the Licensee shall:
4.8.1 provide the Licensor with not less than one (1) month’s written notice of its intention to carry out such Clinical Research Activity;
4.8.2 meet with the Licensor at such times and with such frequency as is reasonably requested by them to discuss the proposed activity; and
4.8.3 comply with the Licensor’s reasonable requests in relation to the design and conduct of such Clinical Research Activity.
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
8.1.2 all Licensed Products sold or otherwise supplied, setting out:
(d) the smallest unit, pack size, gross sales and Net Sales Value in US Dollars on a Licensed Product-by-Licensed Product, month-by-month, country-by-country and purchaser-by-purchaser basis;
(e) any royalty calculations regarding royalties due under Clause 9 for such sales and/or supplies; and
(f) where any Licensed Product was sold and/or supplied pursuant to an Approved Royalty Country Public Procurement, all relevant Public Market procurement documentation relating to such sale/supply.
8.2 For avoidance of doubt, the Licensor agree that information contained in any reports under this Clause 8 shall be treated as Confidential Information.
9. ROYALTIES
[…]
9.4 Licensee shall provide its calculation of the royalty fee payable pursuant to this Clause 9 (if any) for each Agreement Quarter in the relevant written report under Clause 8.1.2.
9.5 If upon examination of a royalty fee calculation provided by the Licensee, the Licensor (or its nominee) disagrees with such calculation, it shall promptly notify the Licensee of the same. The Parties shall endeavour to resolve any disagreement as quickly as possible, and in any event at the next scheduled Quarterly Meeting. If the Parties cannot reach consensus, the matter shall be resolved in accordance with Clause 34.
[…]
9.8 If an examination pursuant to Clause 19 reveals an underpayment by the Licensee, the Licensee shall promptly, and in any event on or before the thirtieth (30th) calendar day following the date of an invoice issued by ViiV for such shortfall, pay to ViiV (or ViiV’s nominee) the amount of such shortfall (including any interest payable pursuant to Clause 9.7) together with all costs incurred by ViiV and/or the Licensor in carrying out the examination. 9.9 Without prejudice to Clause 9.8, if at any point the Licensee becomes aware of it having made an underpayment, it shall promptly, and in any event within ten (10) days of it becoming so aware notify Licensor of the same, providing its calculations in accordance with Clause 9.4. The Licensee shall promptly, and in any event on or before the thirtieth (30th) calendar day following the date of an invoice issued by ViiV for such shortfall pay to ViiV (or ViiV’s nominee) the amount of such shortfall (including any interest payable pursuant to Clause 9.7).
9.9 Without prejudice to Clause 9.8, if at any point the Licensee becomes aware of it having made an underpayment, it shall promptly, and in any event within ten (10) days of it becoming so aware notify Licensor of the same, providing its calculations in accordance with Clause 9.4. The Licensee shall promptly, and in any event on or before the thirtieth (30th) calendar day following the date of an invoice issued by ViiV for such shortfall pay to ViiV (or ViiV’s nominee) the amount of such shortfall (including any interest payable pursuant to Clause 9.7).
10. NON-DIVERSION
[…]
10.3 Breach. Without prejudice to the Licensor’s rights under Clause 21, if at any time the Licensee becomes aware that it, or a Third Party to which it has sold or supplied Licensed Product, has sold or supplied Licensed Product in breach of the terms of this Clause 10, the Licensee shall:
10.3.1 immediately notify the Licensor in writing, providing details of such breach; and
10.3.2 provide to the Licensor, within thirty (30) days of such notification, details of a mitigation plan to prevent any repeated sale or supply in breach of this Agreement.
13. PHARMACOVIGILANCE
[…]
13.2 Without prejudice to Clause 13.1:
[…]
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.
14. IMPROVEMENTS AND PATENT PROSECUTION, ENFORCEMENT AND DEFENCE
14.1 Improvements. If at any time during the Term of this Agreement the Licensee (or any of its employees, agents, or other persons acting under its authority) makes, develops, conceives, acquires, reduces to practice, becomes entitled to or secures control over any Improvement it shall communicate such Improvement to the Licensor and ViiV in full together with all available information concerning the mode of working and using the same. The Licensor and ViiV shall treat this information as Confidential Information.
[…]
19. RECORDS AND AUDIT RIGHTS
19.1 Records. During the Term and for a period of five (5) years following the expiry and termination of this Agreement, Licensee shall keep complete, accurate and systematic records of all transactions under or in connection with this Agreement, including the batch number and identity of the purchaser for every Licensed Compound and Licensed Product sold and/or supplied under this Agreement.
19.2 Audit rights. During the Term and for a period of three (3) years thereafter, Licensor shall have the right (and the Licensee shall procure such right), during normal business hours and through a certified public accountant or like person appointed by Licensor, to audit Licensee (including the Licensee’s records under Clause 19.1) for compliance with all provisions of this Agreement. Such audit shall be at the expense of the Licensor save where such audit reveals a breach of this Agreement by the Licensee, in which case the Licensee shall pay for all costs incurred by Licensor in carrying out the audit. The right to audit under this Clause 19.2 shall not take place more often than twice in any Calendar Year.