PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED. CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. REDACTED MATERIAL IS MARKED...
Exhibit 4.14.2
PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
REDACTED MATERIAL IS MARKED WITH [***].
FIRST AMENDMENT TO COPACKER SUPPLY AGREEMENT DATED 23 DECEMBER 2014 BETWEEN
RECKITT BENCKISER HEALTHCARE (UK) LIMITED AND INDIVIOR UK LIMITED
This First Amendment to Copacker Supply Agreement (the "Amendment") is effective as of the date of last signature below (the "Amendment Effective Date") by and between
(1) Reckitt Benckiser Healthcare (UK) Limited ("Supplier") and
(2) lndivior UK Limited, formerly known as RB Pharmaceuticals Limited ("Buyer")
and collectively "the parties".
This Amendment amends the Copacker Supply Agreement dated 23 December 2014 between the parties (the "Agreement").
Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Agreement.
WHEREAS, the parties wish to amend the Agreement as set forth herein.
IT IS AGREED as follows:
1. Clause 1.1 – shall be amended by –
a. addition of the following definitions:
"Business" shall mean the manufacture and sale of Subutex and Suboxone Tablets and Temgesic;
"Buyer Ran TT" shall mean those activities required by the Buyer to perform its own technical transfer of technology to a Buyer's TT Recipient, ran by and at the cost of the Buyer, pursuant to clauses 2.4 and/or 14.1;
"Buyer's TT Recipient" shall mean the PRC Purchaser (or their designee), and/or the party to whom the Buyer transfers demand in accordance with under clause 14.1;
"Contractual Year" shall mean January 1st to December 31st inclusive;
"New Country" shall mean any country additional to those countries for which the Supplier has already manufactured Products for the Buyer set out in Schedule 4 as at the Commencement Date;
"PRC Purchaser" means the Third-Party purchaser of the Buyer's business to exploit Suboxone Products in the People's Republic of China (excluding Hong Kong, Taiwan and Macao);
"Products" means those products listed in Schedule Two for potential sale worldwide or as otherwise agreed by the parties in writing, together with such additional, improved, modified or replacement products as shall be agreed between the parties from time to time as are manufactured by the Supplier and for supply to the Buyer under this Agreement and wherever "Products" is referred to in this Agreement it shall refer to the relevant Products or all Products as the case may be, as listed in Schedule Two;
"Suboxone Products" means Suboxone Tablets 2 mg and Suboxone Tablets 8 mg.
b. the deletion of the definition "Existing Tooling" in its entirety and replaced with:
"Existing Tooling" means the punch and die tooling which are required for the anticipated supply of the Products and which, as at the date of this Agreement, is owned by the Supplier, as indicated in Schedule Seven.
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c. The revision of the definition of" Commencement Date" such that:
"Commencement Date" shall now refer to having the meaning set out in clause 2.6.
2. Clause 2.1 is deleted in its entirety and replaced with the following:
“2.1 This Agreement shall be effective from the Commencement Date and, subject to applicable laws and the provisions of clause 15 (Termination), shall have effect until ten (10) years following the Commencement Date. The parties agree that during the sixth (6th) year of this Agreement, they shall discuss renewal of this Agreement.”
3. Clause 2.2 is deleted in its entirety and replaced with the following:
“2.2 Notwithstanding anything to the contrary contained herein and only in the event that –
2.2.1 the Agreement enters the final four years the Agreement without the Supplier making any commitment of intent to renew this Agreement following discussion under 2.1; or
2.2.2 the Buyer has given the Supplier notice and terminates the Agreement pursuant to clauses 15.1 or 15.2; or
2.2.3 the Buyer has given the Supplier notice of an unjustified proposed price increase pursuant to discussion under 2.1, which unreasonable proposed price increase is calculated in contrary to clause 7.1 and/or Schedule One, which prevents a renewal of the Agreement;
and at the request of the Buyer any time during such notice period, the Supplier shall promptly and efficiently undertake and complete a Technical Transfer in accordance with clause 14 to the Buyer or a third party identified by the Buyer (the Buyer or the third party (or both) being the "Transferee") to enable the Transferee to establish and conduct cGMP manufacture of Products. For the sake of clarity, the parties agree that the provisions set out in clause 14 are subject to this clause 2.2. The Parties specifically agrees that the Supplier shall not be obliged to perform any Technical Transfer in the event that:
(i) the Buyer provides the Supplier notice to terminate or terminates this Agreement for whatever reason, other than set out in clauses 15.1 or 15.2; or
(ii) the Supplier provides the Buyer notice to in terms of clauses 2.4 or 14.1; or
(iii) the Supplier provides the Buyer notice to terminate or terminates this Agreement as a result of a breach, including as set out in clauses 15.1 or 15.2, by the Buyer or as a result of any negligent act or omission, or any wilful misconduct of the Buyer."
4. Clause 2.3 is deleted in its entirety and replaced with the following:
“2.3 Upon termination or expiry of this Agreement for whatever reason (apart from the circumstances outlined in clauses 2.2), the Supplier shall at the Buyer's cost and the request promptly and efficiently enable the Buyer access to all technical information needed to undertake and complete its own technical transfer to a Transferee to enable that Transferee to establish and conduct cGMP manufacture of the Products. The Supplier acknowledges that in the circumstances described in 2.2 the Supplier's obligations to perform a Technical Transfer shall include allowing the Buyer access to all technical information as described in this clause 2.3.”
5. The following clauses are inserted as clause 2.4 and 2.5:
“2.4 The parties agree that in the event that the Buyer has given the Supplier 6 (six) months' prior written notice that the Buyer requires a Buyer Ran TT for the purposes of assisting a PRC Purchaser (as a Buyer's TT Recipient), the Supplier shall at the request, cost and reasonable instructions of the Buyer reasonably and actively assist the Buyer to undertake and complete the Buyer Ran TT. For the sake of clarity, the parties agree that the Supplier shall not be responsible for the cost or to lead such Buyer Ran TT, which shall be the sole responsibility of the Buyer with appropriate active support from the Supplier as set out in clause 2.5.
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2.5 In this regard the parties agree that for a Buyer Ran TT:
2.5.1 access to the Supplier's Manufacturing Site as part of any technical transfer shall not be granted to a Buyer's TT Recipient without prior written consent from the Supplier; such consent not to be unreasonably withheld;
2.5.2 the Supplier gives no warranties or guarantees of success in transferring the technology under a Buyer Ran TT; and
2.5.3 notwithstanding 2.5.1, the Supplier shall use all commercially reasonable endeavours (at cost and reasonable instructions of the Buyer) to actively facilitate such transfer which shall include without limitation:
(i) providing reasonable access to the necessary data/technical information;
(ii) reasonable participation in creation of the technical transfer plan;
(iii) reasonable assistance in participation in 3-way communication with the Buyer and the Buyer's TT Recipient;
(iv) reasonable assistance in resolving problems identified with item(s) transferred to the Buyer's TT Recipient but not meeting expected requirements despite Buyer action and support (including without limitation equipment set-up and validations, and in-process controls and process validation);
(v) where reasonably required, travel and in-plant visit/support at as the designated plant of the Buyer's TT Recipient; and
(vi) providing reasonable support in such activity consistent with that described in clause 14.4, as modified to reflect such activity is Buyer lead and at the Buyer's cost."
6. The following is inserted as clause 2.6:
“2.6 The parties agree that this Agreement shall commence on 1st January 2019 (the "Commencement Date").”
7. The first sentence of clause 5.6 is deleted in its entirety and replaced with the following:
"The Supplier represents and warrants that it shall have the capacity to fill the Buyer's requirements for the amount of Products set forth in any Order so long as such amount is limited to [***] ([***]) consumer units per annum ("Annual Volume") and does not exceed [***]% of the forecast demand set forth in the immediately preceding Product Forecast. The Supplier agrees that it has the capacity to provide the Annual Volume to a maximum of [***] ([***]) consumer units per annum ("Maximum Volume")."
8. Clause 6.6 is deleted in its entirety and replaced with the following:
“6.6 The Buyer may agree in its sole discretion to provide the Supplier with sufficient funds to cover the Supplier's purchase of the punch and die tooling (as described in Schedule seven) required to support the capacity requirement for the anticipated supply of the Products, such tooling to be used for the production of the Products (being such tooling specified in Schedule Seven and hereinafter referred to as "Tooling"). The purchase of the Tooling, the Purchase Process and the commercial terms ("Purchase Terms") in respect thereof are set out in Schedule Seven."
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9. Clause 6.7 is deleted in its entirety and replaced with the following:
“6.7 The Supplier acknowledges and agrees that all designs, drawings, samples, prototypes and Intellectual Property Rights related thereto, with respect to the Products are the exclusive property of the Buyer."
10. Clause 6.8 is deleted in its entirety and replaced with the following:
“6.8 The Buyer acknowledges and agrees that the Supplier is the sole and exclusive owner of the Tooling and the Existing Tooling and that legal ownership, title and interest in Tooling and the Existing Tooling (including but not limited to all designs, drawings, samples, prototypes and Intellectual Property Rights related thereto) shall at all times remain with Supplier. To the extent that the Supplier is not already the owner of the Tooling or the Existing Tooling, the Buyer agrees that it shall take all such actions as the Supplier may reasonably request (including without limitation, the execution and delivery to the Supplier of documents of title and other instruments) confirming the Suppliers exclusive right, title and interest therein."
11. Clause 6.11 is deleted in its entirety and replaced with the following:
“6.11 [Reserved.]”
12. The following Clause is inserted as Clause 6.12:
“6.12 The Supplier, at its expense, shall maintain Existing Tooling in good working order and repair for at least Five (5) Contract Years from the date the Existing Tooling was or is commissioned, the date of commissioning of the Existing Tooling shall be set out in Schedule 7 ("Existing Tooling Commissioned Date"). The Supplier shall use reasonable endeavours to ensure that the Existing Tooling shall have a working life of at least Five (5) Contract Years from Existing Tooling Commissioned Date. The repair, maintenance or replacement of any such Existing Tooling that fails to achieve such capacity before Five (5) Contract Years from the Existing Tooling Commissioned Date shall be at Supplier's sole cost and expense. Thereafter, the Supplier shall continue to provide routine maintenance or repairs on Existing Tooling after the Five (5) Contract Years from the Existing Tooling Commissioned Date, at the sole cost and expense of the Buyer, and if any such Existing Tooling fails after Five (5) Contract Years from the Existing Tooling Commissioned Date and the Supplier is unable to return Existing Tooling to service through the application of routine maintenance, any further costs of repair or replacement of such Existing Tooling shall be at Buyer's sole cost and expense."
13. Clause 7.1 is deleted and replaced by the following one:
“7.1 The price for the Products shall be those set out in Schedule One and shall be fixed for the period up to and including 31 December 2019. The parties agree that the Price shall be subject to review thereafter each year, and each such review shall commence following the Supplier's provision to the Buyer of the Supplier's proposed pricing for the forthcoming year by 31 July of the then current year. The first such review shall take place following the Supplier's first proposal for the year 2020 (to be made by 31 July 2019). The parties agree that the proposed pricing and review each year (and any corresponding adjustment) will reflect the principles set out in Schedule One."
14. There shall be added to clause 9 the following:
“9.8 The parties specifically agree that for any New Country, the Supplier will comply with all requirements of this clause 9 (including in particular and without limitation, clause 9.1.1) save that for any products manufactured for or distributed to a New Country, the Supplier specifically does not warrant that manufacture will comply with any applicable laws local to such New Country to the extent such applicable laws demand additional requirements or standards than those required for production of products for the European market, and shall not be liable for the products in any New Country save for failure to meet the Specification.”
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15. Clause 11.2 is hereby deleted in its entirety and replaced with the following:
“11.2 On the terms and subject to the conditions of this clause 11, the Supplier shall defend, indemnify and hold harmless the Buyer, its Affiliates, and their respective officers, directors, employees and agents (collectively, "Buyer lndemnitees"), from and against any and all Losses relating to any Proceeding to the extent arising out of or resulting from
(i) any negligent act or omission, or any wilful misconduct, of the Supplier, its Affiliates, its contract manufacturers or Raw Material suppliers (other than Buyer), or any of their respective officers, directors, employees or agents in connection with the performance of this Agreement; or
(ii) any breach by the Supplier or its Affiliates of any of its representations, warranties, or obligations contained in this Agreement;
in each case (i) and (ii), except for those Losses which Buyer has an obligation to indemnify a Supplier lndemnitee pursuant to clause 11.1, as to which Losses each party shall indemnify the other to the extent of their respective liability for such Losses."
16. The following text is added to the end of clause 11.3:
"The parties acknowledge that the Supplier does not have specific third-party insurance against loss arising out of a Cyber-Attack (being any malicious third party action which undermines the functions of the Supplier's information systems and/or the networks that deliver such information, including, without limitation, the unauthorised use of, or attempts to gain unauthorised access to, systems and/or to data, modification of a system's firmware, software or hardware without the Supplier's consent, and/or any actual or attempted malicious disruption or denial of service). Whilst the Buyer does not demand third party insurance against such risks, the parties acknowledge the absence of such insurance shall not be construed as an implied limitation of the Supplier's liability hereunder. Save to the extent that a Cyber Attack results from a failure by the Supplier to comply with its IT security or other obligations under this Agreement, the parties acknowledge and agree that the nature of Cyber Attacks is such that they cannot be completely prevented and as such will be deemed to constitute a "Force Majeure Event" for the purposes of this Agreement and the provisions of clause 18 shall apply."
17. Clauses 14.1, 14.1.1 and 14.1.2 are deleted in their entirety and replaced with the following:
"14.1 Parties agree that the Buyer's obligations to [***] the Supplier as set out under this Agreement shall be modified such that during the final four years of this Agreement, the Buyer shall upon written notice to the Supplier be [***] over the remaining term of this Agreement [***]. The parties agree that under this clause 14.1, in order to enable the Buyer to identify and utilise an [***], the Supplier shall at the request, cost and reasonable instructions of the Buyer reasonably assist the Buyer to undertake and complete its own Buyer Ran TT to a Buyer's TT Recipient. The parties agree that such Buyer Ran TT will be supported by the Supplier in accordance with clause 2.5."
18. Clause 15.4 is deleted in its entirety and replaced with the following:
“15.4 [Reserved.]”
19. There shall be added to clause 15 the following:
“15.5 This Agreement may be terminated by the Buyer at any time;
15.5.1 subject to clause 16.2, by giving not less than twelve (12) months written notice in the event of loss of main Market License (e.g. France or Canada);
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15.5.2 by giving not less than twenty four (24) months written notice if the Buyer's annual demand from the Supplier falls below [***] packs or if there are commercial pressures making it no longer economically viable for the Buyer to maintain the Business. In either case, should the Supplier find a replacement Business during that 24 month notice period, the Buyer shall be relieved from its financial responsibility for the remainder of the notice period."
20. There shall be added to clause 16 the following:
16.2 Notwithstanding anything to the contrary contained in this Agreement and without prejudice to Supplier's other rights or remedies whether hereunder, at law or in equity, if the Agreement is terminated pursuant to clause 15.5.1 as a result of or attributed to the Buyer's negligent or wilful act(s) or omission(s), or any wilful misconduct, then the Buyer shall (i} give the Supplier not less than twenty four (24) months written notice (in lieu of twelve (12) months) and, (ii) pay all the Supplier's fixed cost for same notice period (twenty four (24) months), payable on/before the end of each the remaining Contractual Year. Should the Supplier find a replacement Business during that 24 months' notice period, the Buyer shall be relieved from its financial responsibility for the remainder of the notice period.
16.3 Buyer acknowledges and agrees that the provisions set out in clause 16.2 does not constitute a penalty.”
21. Clause 16.1.3 is deleted in its entirety and replaced with the following:
“16.1.3 Subject to clause 2.2, the Supplier shall at the request of the Buyer promptly and efficiently undertake and complete a Technical Transfer to the Transferee to enable the Transferee to establish and conduct cGMP manufacture of the Products."
22. Clause 16.1.5 is deleted in its entirety and replaced with the following:
“16.1.5 [Reserved.]”
23. Clauses 17.1 and 17.2 are deleted in their entirety and replaced as follows:
“17.1 Save as provided in clause 17.2 neither the benefit nor the obligations of this Agreement or of any provision of it may be assigned or transferred by either party without the prior written consent of the other, such consent not to be unreasonably withheld.
17.2 The benefit subject to the obligations of this Agreement shall be assignable by the Buyer to any Affiliate of the Buyer or to the purchaser of all or a substantial part of the Business of the Buyer (or any other Affiliate of the Buyer) (otherwise than to a competitor of the Supplier where clause 17.1 above shall continue to operate), and in the event of such assignment, the Buyer shall with effect from such assignment be released from its obligations hereunder and all references in this Agreement to the Buyer shall be deemed to include its assigns.”
23. The following Clause is inserted as Clause 18.3:
“18.3 [***]."
24. Clause 21.1 is deleted in its entirety and replaced with the following:
“21.1 The Supplier shall comply with Supplier Code of Business Conduct and Anti-Bribery Policy (the "Policies") referred to in Schedule Eight hereto, and shall otherwise comply with all applicable national and legal requirements, customs, and accepted international standards pertaining to employment and manufacturing."
25. Schedule Eight attached to this Amendment supersedes and replaces Schedule Eight of the Agreement.
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26. Clause 22.5 is deleted in its entirety and replaced with the following:
“22.5 All notice, consents, and approvals required or permitted to be given hereunder shall be in writing and shall be delivered (i) personally; (ii) by registered or certified mail, postage prepaid; or (iii) by reliable and nationally recognized overnight delivery service with parcel tracking enabled, addressed to the receiving party as follows (or to such other address as a party may designate in writing):
| TO SUPPLIER: | Reckitt Benckiser Healthcare (UK) limited | ||||
| [***] | |||||
Attn: SVP Manufacturing | |||||
| With copy to: | Reckitt Benckiser Health limited | ||||
| [***] | |||||
Attn: Legal Department | |||||
| TO BUYER: | lndivior UK Ltd. | ||||
| [***] | |||||
Attn: Company Secretary | |||||
| With copy to: | lndivior UK ltd. | ||||
| [***] | |||||
Attn: Chief Legal Officer | |||||
Any such notice, consent, or approval shall be deemed given, in the case of personal delivery, on the date of delivery; in the case of mailing, on the fifth calendar day following its deposit in the mail; and in the case of overnight delivery service, on the next business day following its deposit with the delivery service."
27. Schedule One section 4(b)(i) is deleted and replaced by the following:
“(i) if the Actual Volume is less than the Budget Order Volume (other than as a result of (A) Supplier's own fault or technical issues which leads to a breach of this Agreement or (B) a Force Majeure Event experienced by Supplier), invoice the Buyer for an amount equal to the following: (Budget Order Volume less Actual Volume), multiplied by the Indirect Manufacturing Cost Product Allocation, which invoice shall be paid by the Buyer within sixty (60) days of receipt thereof;]”
28. Schedule once section 1(3) is deleted and replaced by the following:
“[***]% margin on Manufacturing Costs, as agreed between the parties in accordance with clause 7.1 for the first (1) year after the Commencement Date. Such margin shall increase to [***] per cent ([***]%) for the remainder of the agreement, provided that in each individual contractual year, the Supplier meets an OTIF of >95% in at least nine (9) months of that year.
In the eventuality that the Supplier fails to meet the above requirement (except where failure to meet the OTIF target is entirely the fault of lndivior) in a specific contractual year, then the [***]% margin applies for that specific year, and the Supplier shall reimburse the buyer for any margin overpayment by March 1st of the subsequent contractual year.”
29. Schedule 4 attached to this Amendment supersedes and replaces the existing Schedule 4 to the Agreement.
30. Schedule 7 attached to this Amendment supersedes and replaces the existing Schedule 7 to the Agreement.
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31.Except as modified by this Amendment, the Agreement shall remain in full force and effect. If there is a conflict between the terms of this Amendment and the terms of this Agreement, the terms of this Amendment shall govern.
The parties have caused their duly authorized representatives to execute this Amendment as of the Effective Date.
RECKITT BENCKISER HEALTHCARE (UK) LTD | INDIVIOR UK LTD | |||||||||||||||||||||||||||||||
| By: | /s/Xxxxxxxxx Xxxxxxxx | By: | /s/Xxxxx Xxxxx | |||||||||||||||||||||||||||||
| Name: | Xxxxxxxxx Xxxxxxxx | Name: | Xxxxx Xxxxx | |||||||||||||||||||||||||||||
| Title: | SVP Manufacturing Health | Title: | Chief Manufacturing and Supply Officer | |||||||||||||||||||||||||||||
| Date: | March 29, 2019 | Date: | March 12, 2019 | |||||||||||||||||||||||||||||
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SCHEDULE FOUR
THE SPECIFICATION
Temgesic Injection 0.3mg/ml
[***]
Temgesic Sublingual Tablets 0.2mg
[***]
Temgesic Sublingual Tablets 0.4mg
[***]
Subutex Tablets 0.4mg
[***]
Subutex Tablets 2mg
[***]
Subutex Tablets 8mg
[***]
Suboxone Tablets 2mg
[***]
Suboxone Tablets 8mg
[***]
Suboxone Tablets 12mg
[***]
Suboxone Tablets 16mg
[***]
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SCHEDULE SEVEN
TOOLING AND EXISTING TOOLING
1.Tooling
2.Existing Tooling
[***]
3.Purchasing process (applicable to Tooling)
The Supplier shall obtain a quotation for Tooling which is to be agreed by Xxxxx. The cost of such Tooling shall be agreed upfront by Xxxxx. The Buyer shall pay the full sum for such Tooling upfront.
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SCHEDULE EIGHT
SUPPLIER’S CODE OF CONDUCT AND ANTI-BRIBERY POLICY
Supplier’s Code of Conduct and Anti-Bribery Policy attached.
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