LICENSE AND COLLABORATION AGREEMENT* by and between SILENCE THERAPEUTICS PLC and MALLINCKRODT PHARMA IP TRADING DAC Dated as of July 18, 2019
EXHIBIT 10.5
Certain information in this document, marked by [***], has been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K under the Securities Act of 1933, as amended, because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.
LICENSE AND COLLABORATION AGREEMENT*
by and between
and
MALLINCKRODT PHARMA IP TRADING DAC
Dated as of July 18, 0000
XXXXXX (XX) XXX, XXXXXXXX, 00 XXX XXXXX XXXXXX, XXXXXX XX0X 0XX, XX
T: x00 (0) 00 0000 0000 F: x00 (0) 00 0000 0000 XXX.XXXXXX.XXX
* Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K and will be furnished on a supplemental basis to the Securities and Exchange Commission upon request.
THIS LICENSE AND COLLABORATION AGREEMENT is made and entered into effective as of July 18, 2019 (the “Effective Date”) by and between
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(1) |
SILENCE THERAPEUTICS PLC, a public limited company organized under the laws of England and Wales (“Silence”), and |
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(2) |
MALLINCKRODT PHARMA IP TRADING DAC, a designated activity company formed under the laws of Ireland (“Mallinckrodt”); and |
Silence and Mallinckrodt are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
BACKGROUND
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(A) |
Silence owns certain intellectual property rights with respect to the research and development of RNAi Products. |
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(B) |
Mallinckrodt wishes to obtain, and Silence wishes to grant to Mallinckrodt, a license under Silence’s rights in such technology and related intellectual property rights to develop and commercialize Licensed Products in respect of the C3 Target, all on the terms and conditions set forth below. |
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(C) |
Mallinckrodt also wishes to obtain, and Silence wishes to grant to Mallinckrodt, an option to obtain a license under Silence’s rights in such technology and related intellectual property rights to develop and commercialize Licensed Products in respect of additional (non-C3) Complement Targets. |
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(D) |
The Parties wish to discover and develop additional intellectual property related to the Products pursuant to the Work Plans and will perform the activities set forth in such Work Plans. |
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NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
As used in this Agreement and the Schedules to this Agreement the following capitalized terms, whether used in the singular or plural, shall have the meanings set out below:
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1.1 |
“Acceptance Notice” has the meaning set forth in Section 5.3.2. |
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1.6 |
“Agreement” means this agreement and all schedules, appendices and other addenda attached hereto as any of the foregoing may be amended in accordance with the provisions of this Agreement. |
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1.7 |
“Alliance Manager” has the meaning set forth in Section 2.9. |
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1.10 |
“Auditor” has the meaning set forth in Section 9.6. |
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1.11 |
“Bankruptcy Code” has the meaning set forth in Section 14.6. |
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1.12 |
“Business Day” means a day other than a Saturday or Sunday on which banking institutions in London, England are open for business. |
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1.15 |
“C3 Work Plan” has the meaning set forth in Section 5.2.2. |
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1.16 |
“Centralized Approval Procedure” means the procedure through which a MAA filed with the EMA results in a single marketing authorization valid throughout the European Union. |
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1.18 |
“Claims” has the meaning set forth in Section 13.1. |
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product versus any competitive offerings; the relative difficulties associated with achieving insurance and other payor coverage for the product; the relative difficulties associated with achieving formulary acceptance for the product; the resources available to Mallinckrodt to market and sell the product to the relevant target audience; and the pricing and reimbursement dynamics associated with the product. |
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1.23 |
“Competing Product” means with respect to a particular Licensed Product any pharmaceutical product that [***]. |
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1.25 |
“Complement Target” means any one of the human gene complement targets as further described in Schedule 1.25 including the Restricted Targets. |
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1.26 |
“Complement Work Plan” has the meaning set forth in Section 5.2.3. |
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and (c) Joint Research IP shall be deemed to be the Confidential Information of both Parties and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto. |
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1.29 |
“Cost Overrun Threshold” has the meaning set forth in Section 5.4.2. |
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1.32 |
“Development Costs Report” has the meaning set forth in Section 5.4.2. |
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1.33 |
“Dispute” has the meaning set forth in Section 15.6. |
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1.36 |
“Effective Date” means the effective date of this Agreement as set forth in the preamble hereto. |
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1.37 |
“EMA” means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
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1.40 |
“Exclusivity Covenant” means the covenant under Section 4.8.1 and, if applicable, Section 4.8.2. |
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1.42 |
“FDA” means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
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1.44 |
“Field” means the diagnosis, prevention, control, and/or treatment of any and all therapeutic conditions in humans. |
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1.53 |
“Indemnitee” has the meaning set forth in Section 13.3. |
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1.54 |
“Indemnitor” has the meaning set forth in Section 13.3. |
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1.56 |
“Indirect Taxes” has the meaning set forth in Section 9.3.2. |
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1.60 |
“Intellectual Property” has the meaning set forth in Section 14.6. |
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1.64 |
“Joint Steering Committee” or “JSC” has the meaning set forth in Section 2.1. |
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1.66 |
“Licensed Mallinckrodt Research IP” has the meaning set forth in Section 4.2.2. |
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1.67 |
“Licensed Mallinckrodt Research Know-How” has the meaning set forth in Section 4.2.2. |
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1.68 |
“Licensed Mallinckrodt Research Patents” has the meaning set forth in Section 4.2.2. |
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1.72 |
“Losses” has the meaning set forth in Section 13.1. |
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1.74 |
“Mallinckrodt Background IP” means the Mallinckrodt Background Patents and Mallinckrodt Background Know-How. |
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1.77 |
“Mallinckrodt Indemnitees” has the meaning set forth in Section 13.2. |
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1.78 |
“Mallinckrodt Research IP” means the Mallinckrodt Research Patents and Mallinckrodt Research Know-How. |
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1.80 |
“Mallinckrodt Research Patents” means any and all Patents Controlled by Mallinckrodt after the Effective Date that Cover any Mallinckrodt Research Know-How. |
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1.82 |
“Mono Product” has the meaning set forth in the definition of “Net Sales” in Section 1.84. |
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(b) |
discounts, price reductions, chargebacks or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees; |
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(c) |
taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced; |
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(d) |
amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions; |
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(g) |
freight, insurance, import/export, and other transportation charges included in the total amount invoiced; and |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre- clinical, clinical, regulatory, or governmental purposes. Net Sales shall include the amount of fair market value of all other consideration received by Mallinckrodt, its Affiliates, or Sublicensees in respect of the Licensed Product, whether such consideration is in cash, payment in kind, exchange, or other form. Net Sales shall not include sales between or among Mallinckrodt, its Affiliates, or Sublicensees.
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of Mallinckrodt, its Affiliates, or Sublicensees, which must be in accordance with Accounting Standards and consistent with the audited net sales reported externally by Mallinckrodt in its SEC filings.
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 9.2.
In the event a Licensed Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows:
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which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction and “B” is Mallinckrodt’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies in such country or other jurisdiction, for products that contain as their sole active ingredients the Other Active Ingredients in such Combination Product. |
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(iv) |
If Mallinckrodt, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and the Other Active Ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative fair market value of such Mono Product and such Other Active Ingredient or ingredients. If the Parties cannot agree on such relative value, the Dispute shall be resolved pursuant to Section 15.6. |
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1.85 |
“Neutral Expert” has the meaning set forth in Section 15.6.5. |
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1.86 |
“Option” has the meaning set forth in Section 3.1. |
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1.87 |
“Option Exercise Payment” has the meaning set forth in Section 3.2. |
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1.89 |
“Optioned Complement Target” means a Complement Target for which Mallinckrodt has exercised its Option pursuant to Section 3.1 and, if applicable, paid the Option Exercise Payment pursuant to Section 3.2. |
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1.91 |
“Patent Challenge” has the meaning set forth in Section 14.4. |
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1.94 |
“Phase 1 Clinical Program” means the Phase 1 Trial or Phase 1 Trials contemplated for Research Stage 3 for the applicable Licensed Product, as specified in the applicable Work Plan. |
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1.100 |
“PMDA” means Japan’s Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function. |
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1.101 |
“Product Specific Claims” has the meaning set forth in Section 1.102. |
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1.102 |
“Product Specific Patent” means: (i) the Silence Background Patents listed on Schedule 1.102, (ii) with respect to Silence Background Patents or Silence Research Patents that are filed or otherwise become Controlled by Silence after the Effective Date, such Patents that: (a) specifically claim [***] and/or [***] and which do not claim subject matter which is [***], (b) specifically claim [***] and/or [***] where [***] specific to [***] and/or [***] (which shall not include any patent that is [***], (c) specifically claim [***] and, in each case, for which [***], and (iii) [***], unless, with respect to a particular [***] and/or [***]. Product Specific Patents will also include patents and pending patent applications that are divisionals or are otherwise direct continuations of any Product Specific Patent. Claims within the scope of item (ii), subparts (a), (b) and (c) are “Product Specific Claims.” |
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1.103 |
“Publishing Party” has the meaning set forth in Section 11.5.3. |
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1.110 |
“Research Budget” has the meaning set forth in Section 5.2.1. |
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1.112 |
“Research Stage” means Research Stage 1, Research Stage 2, and/or Research Stage 3, as the context dictates. |
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1.113 |
Research Stage 1” means the portion of the applicable Work Plan pertaining to [***] with respect to the applicable Licensed Product and specified in such plan as Research Stage 1. |
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1.114 |
“Research Stage 2” means the portion of the applicable Work Plan pertaining to [***] with respect to the applicable Licensed Product and specified in such plan as Research Stage 2. |
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1.117 |
“Research Stage Data Package” means, with respect to a particular Licensed Product and a particular Research Stage, a report in the format set forth in Schedule 1.117 of all data generated by or on behalf of Silence in performing activities under the applicable Work Plan in respect of such Licensed Product during such Research Stage, including data generated regarding the physical, chemical, and pharmaceutical properties of such Licensed Product, and data generated pursuant to non-clinical studies and Clinical Studies in respect of such Licensed Product. For clarity, all Information included in a Research Stage Data Package shall be deemed to be Joint Research Know-How, Silence Background Know-How or Silence Research Know-How, as applicable. |
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1.118 |
“Restricted Targets” means the following Complement Targets: [***], each as further described in Schedule 1.25. |
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1.121 |
“Senior Officer” means, with respect to Silence, its Chief Executive Officer or his/her designee, and with respect to Mallinckrodt, its Chief Scientific Officer or his/her designee. |
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1.124 |
“Silence Background Patents” means any and all Patents Controlled by Silence or any of its Affiliates on the Effective Date or during the Term that Cover any Silence Background Know-How, including the patents and patent applications set forth on Schedule 1.124 and including all continuation, continuation-in-part, divisional, renewal, reexamination, reissue or foreign counterpart applications or other Patents that claim priority to any such Patents and all patents that issue therefrom and all reissues, reexaminations and term extensions thereof and all patents issued from any post-grant proceeding involving any of the foregoing. |
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1.125 |
“Silence Indemnitees” has the meaning set forth in Section 13.1. |
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1.131 |
“Subscription Agreement” means the Subscription Agreement by and between the Parties in the form of Schedule 1.131 attached hereto. |
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1.133 |
“Supplementary Rights Patents” has the meaning set forth in Section 10.2.4(b). |
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1.135 |
“Technology Transfer” means the portion of the applicable Work Plan pertaining to the technology transfer for the applicable Licensed Product and specified in such plan as Technology Transfer. |
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1.137 |
“Term” has the meaning set forth in Section 14.1. |
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1.139 |
“Third Party” means any Person other than Silence, Mallinckrodt, or an Affiliate of Silence or Mallinckrodt. |
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1.141 |
“Withholding Party” has the meaning set forth in Section 9.3. |
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1.144.1 |
all references to a particular clause or schedule shall be a reference to that clause or schedule in or to this Agreement as it may be amended from time to time pursuant to this Agreement; |
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1.144.2 |
the headings are inserted for convenience only and shall be ignored in construing this Agreement; |
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1.144.3 |
words importing the masculine gender shall include the feminine and vice versa and words in the singular include the plural and vice versa; |
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1.144.5 |
the words “include”, “included”, and “including” are to be construed without conveying any limitation to the generality of the preceding words; |
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1.144.6 |
reference to any statute or regulation includes any modification or re- enactment of that statute or regulation; |
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1.144.8 |
in the event of any inconsistency or conflict between this Agreement and any of the Schedules, this Agreement shall prevail. |
ARTICLE 2
COLLABORATION MANAGEMENT
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2.2.1 |
agree on the C3 Work Plan and, with respect to any Optioned Complement Target, the applicable Complement Work Plan; |
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2.2.2 |
review and discuss the overall status of each Work Plan and the conduct of research and Development activities under the Work Plans; |
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2.2.3 |
review and discuss the results of each activity under the Work Plans, whether completed or ongoing; |
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2.2.5 |
review and discuss the prosecution strategy for Silence Research Patents and Joint Research Patents, including [***] |
[***];
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2.6 |
Procedural Rules. The JSC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JSC shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Representation by proxy shall be allowed. The JSC shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one (1) representative appointed by each Party. Employees or consultants of either Party that are not representatives of the Parties on the JSC may attend meetings of the JSC; provided, that (a) unless the other Party agrees, no more than two (2) such persons may attend any particular meeting, (b) attendance of any non- employee must be pre-approved by the other Party, such approval not to be unreasonably withheld and (c) such attendees (i) shall not vote or otherwise participate in the decision- making process of the JSC and (ii) are bound by obligations of confidentiality and non- disclosure that are substantially similar to those set forth in ARTICLE 11. |
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2.7.2. |
Final Decision Making Authority. If the Senior Officers are not able to agree on the resolution of any such issue within thirty (30) days after such issue was first referred to them, then subject to the remainder of this Section 2.7.2, (a) [***] shall have the final say on [***] (including [***]), (b) [***] and the [***] and (c) [***] shall have final decision making authority with respect to [***] (including, for clarity, [***] Notwithstanding the foregoing subsections (a), (b) and (c): (u) [***] final decision making authority with respect to [***] shall not be deemed to, and cannot be used to, limit or eliminate, [***] rights under [***] below or that would result in [***] breach of its covenants under [***] and [***] final decision making authority with respect to [***] shall not be deemed to, and cannot be used to limit or eliminate [***] rights under [***] below or that would result in [***] breach of its covenants under [***], (v) with respect to [***] shall consider in good faith any comments or concerns from [***] regarding the [***] as a result of [***] (w) [***] shall not have the right to make changes to [***] that will or are likely to have a material adverse effect on the applicable [***]; provided that if or to the extent that [***] the terms of [***] shall govern the Parties’ rights and obligations in respect of any such [***], (x) with respect to any [***] for which [***], [***] shall have the right to make any decision that [***]; provided that if or to the extent that any such changes will result in [***] , the terms of [***] shall govern the Parties’ rights and obligations in respect of any such [***], (y) neither Party shall use its final decision-making authority to (i) require the other Party to violate any Applicable Law, clinical or non-clinical research ethical requirement (including the conduct of any animal study that would not [***] or any requirement necessary to comply with an informed consent form), or any agreement it may have with any Third Party, (ii) amend the terms and conditions of this Agreement, (iii) other than as specifically set out in [***], require the other Party to [***] unless the Parties have agreed as to [***], and (z) [***] shall not have the right to (i) require [***] in excess of [***] required for the [***] as set out in [***] or (ii) require [***] that is reasonably expected to result in [***] (i.e., for which neither Party has exercised its decision making authority under this Section 2.7.2). |
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2.7.2 |
Other Disputes. For clarity, disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith that are outside of the jurisdiction of the JSC shall be resolved pursuant to Section 15.6. |
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2.8 |
Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JSC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. The JSC does not have the power to amend, modify, or waive compliance with this Agreement, and this Agreement may only be amended or modified as provided in Section 15.8 and compliance with this Agreement may only be waived as provided in Section 15.10. |
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2.10 |
Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, the JSC. |
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3.1 |
Option Grant to Mallinckrodt. Silence hereby grants to Mallinckrodt, on a Complement Target-by-Complement Target basis, the exclusive right and option, exercisable at any time during the Option Term at Mallinckrodt’s sole discretion, to obtain and exercise the exclusive license under the Silence Background IP, the Silence Research IP, and Silence’s interest in the Joint Research IP as set forth in Section 4.1 with respect to the Exploitation of the corresponding Complement Licensed Products in the Field in the Territory (each, an “Option”). Mallinckrodt may exercise its Option in respect of a Complement Target by providing written notice to Silence of its election to exercise such Option at any time during the Option Term. Upon delivery of such written notice and, if applicable, payment of the applicable Option Exercise Payment, the license set forth in Section 4.1 with respect to the Exploitation of the Complement Licensed Products directed to such Complement Target in the Field in the Territory shall, and hereby does, automatically become effective. |
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3.2 |
Option Exercise Payment. In consideration of the upfront payment to Silence pursuant to Section 8.1, Mallinckrodt shall have the right to exercise its Option for up to two (2) Complement Targets for no additional payment. For the avoidance of doubt Mallinckrodt has been granted rights in relation to the C3 Target as of the Effective Date and so the C3 Target will not count towards the two (2) Complement Targets referred to in this Section 3.2. If Mallinckrodt exercises its Option with respect to more than two (2) Complement Targets, then with respect to each Option exercised by Mallinckrodt for an additional (in excess of two (2)) Complement Target, Mallinckrodt shall pay to Silence the non-refundable, non-creditable sum of [***] (the “Option Exercise Payment”) within [***] days after the exercise of such Option or, if later, upon the final determination of the Parties of the development and sales milestones payable in respect of Licensed Products directed to such Target, in accordance with Sections 8.4.3 and 8.5.3 below. |
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3.4 |
Exclusivity. During the Option Term: (a) Silence shall not (and shall ensure that its Affiliates do not) license, sublicense, transfer, assign or take any other action with respect to any Silence Background IP, Silence Research IP, or Silence’s interest in the Joint Research IP that would be inconsistent with or prevent Silence from granting the license under Section 4.1.2 in respect of any Complement Target and (b) neither Party shall (and shall ensure that its Affiliates do not), itself or with or through a Third Party, Exploit any [***] and/or [***]. |
ARTICLE 4
LICENSE GRANTS
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4.1 |
License Grants to Mallinckrodt. Subject to Sections 4.3 and 4.4, Silence, for itself and its Affiliates, hereby grants to Mallinckrodt: |
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4.1.1 |
an exclusive, royalty-bearing license, with the right to grant sublicenses as provided in Section 4.3, under the Silence Background IP, Silence Research IP, and Silence’s interest in the Joint Research IP to Exploit C3 Licensed Products in the Field in the Territory; and |
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4.1.2 |
upon Mallinckrodt exercising its Option in respect of a particular Complement Target and, if applicable, paying the Option Exercise Payment with respect thereto, an exclusive, royalty-bearing license, with the right to grant sublicenses as provided in Section 4.3, under the Silence Background IP, Silence Research IP, and Silence’s interest in the Joint Research IP to Exploit Complement Licensed Products directed to such Optioned Complement Target in the Field in the Territory. |
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4.2.2 |
Termination License. If Mallinckrodt does not provide to Silence the Acceptance Notice with respect to a Target and this Agreement terminates with respect to such Target (and all Licensed Products directed to such Target) as set forth in Section 5.3.2, if Mallinckrodt terminates this Agreement pursuant to [***], or if Silence terminates this Agreement pursuant to [***], Mallinckrodt (for itself and its Affiliates) shall, and hereby does, grant to Silence (without any further action required on the part of Mallinckrodt) a non-exclusive, royalty-free and fully paid-up, irrevocable and perpetual license, with the right to grant sublicenses (on the same terms applicable Mallinckrodt’s right to grant sublicenses under its licenses, as set forth in Section 4.3), under any Mallinckrodt Research [***] the applicable Target (such Mallinckrodt Research IP the “Licensed Mallinckrodt Research IP” and, as applicable, the “Licensed Mallinckrodt Research Patents” and/or the “Licensed Mallinckrodt Research Know-How”) solely for purposes of further Development of [***] the applicable Target, including in connection with Development of products that [***]. If Silence wishes to Commercialize any such product, then upon Silence’s request, Mallinckrodt will grant Silence a license under the Licensed Mallinckrodt Research IP for such purpose subject to the following financial terms: (i) if [***] and [***], as applicable, the license would be non-exclusive and royalty free; (ii) if [***], as applicable, then (a) if any Licensed Mallinckrodt Research Patent or Joint Research Patent [***], the license shall be exclusive and Silence shall be required to pay a royalty of no more than [***] of the net sales of such |
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product; (b) if [***], but [***] the applicable Target, the license shall be exclusive and Silence shall be required to pay a royalty of no more than [***] of the net sales of such RNAi Product; (c) if [***], the license shall be exclusive and Silence shall be required to pay a royalty of no more than [***] of the net sales of such RNAi Product; (d) in the event that [***] (i.e., [***], then the maximum royalty payable by Silence on net sales of such product shall be [***]; and (e) if [***] with respect to such Target ]prior to completion of Research Stage 3] for such Target, the total net sales royalty payable to Mallinckrodt in respect of such Target, at the rate that satisfies the applicable criteria above, will be capped at [***]. |
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4.3 |
Sublicenses. Mallinckrodt shall have the right to grant sublicenses, through multiple tiers of sublicenses, under the licenses granted in Section 4.1 to Sublicensees; provided that any such sublicenses shall (a) be in writing, (b) be consistent with the terms and conditions of this Agreement, and (c) require the applicable Sublicensee to comply with all applicable terms of this Agreement. Mallinckrodt shall be responsible for the performance of any Sublicensee as if such Sublicensee was “Mallinckrodt” hereunder. Each sublicense granted by Mallinckrodt to any rights licensed or granted will terminate immediately upon the termination of the license from Silence to Mallinckrodt with respect to such rights; provided, however, that with respect to any such Sublicensee that has rights to Commercialize a Licensed Product, then, unless such Sublicensee caused a breach of this Agreement that resulted in its termination, effective upon termination of this Agreement, Silence will grant such Sublicensee such rights under the Silence Background IP, Silence Research IP, and Silence’s interest in the Joint Research IP consistent with the scope of the sublicense under such rights granted by Mallinckrodt to such Sublicensee to enable such Sublicensee to wind-down such activities in a commercially reasonable manner and, upon the written request of such Sublicensee, will consider in good faith assuming such Sublicensee’s agreement with Mallinckrodt or entering into a license agreement with such Sublicensee under terms and conditions that are substantially similar, in all material respects, to those of such Sublicensee’s agreement with Mallinckrodt, to the extent such terms are within the scope of the subject |
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matter of this Agreement and provided that Silence’s obligations under such agreement would not be greater than its obligations under this Agreement. |
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4.4 |
Retention of Rights. Notwithstanding the exclusive licenses granted to Mallinckrodt pursuant to Section 4.1, Silence hereby expressly reserves the right (a) under the Silence Background IP, Silence Research IP, and Silence’s interest in the Joint Research IP for internal research purposes outside the scope of Section 4.8 and to exercise its rights and perform its obligations under this Agreement, whether directly or through one or more Affiliates or subcontractors, including the right to perform those activities assigned to it under the Work Plans, and (b) to practice, and to grant licenses under, the Silence Background IP, Silence Research IP, and Silence’s interest in the Joint Research IP outside the scope of the licenses granted to Mallinckrodt in Section 4.1 and, during the Option Term, outside the scope of its covenants under Section 3.4. |
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4.8.1 |
C3 Target. Subject to Section 14.7.4, neither Party shall, itself or with or through a Third Party, Develop or Commercialize any [***] of the C3 Target and/or [***] of the C3 Target. |
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4.8.2 |
Complement Target. Subject to Section 14.7.4, following Mallinckrodt’s exercise of its Option and, if applicable, payment of the Option Exercise Payment with respect to a particular Complement Target, neither Party shall, itself or with or through a Third Party, Develop or Commercialize any [***] of the Optioned Complement Target and/or [***] of the Optioned Complement Target. |
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Party to perform activities under this Agreement or any Work Plan, either before or after the Change of Control Transaction. If the Change of Control Transaction is within the scope of item (c) of that definition or if, upon or following the closing of the Change of Control Transaction, acquired Party ceases to exist, then all of the Acquirer shall continue to be bound by and subject to the terms of this Agreement that are within the scope of the immediately preceding sentence. In addition, in the event of a Change of Control Transaction involving a Party, if, prior to, on, or after such Change of Control, the Acquirer of such Party has a program or otherwise is engaged (either directly or through an Affiliate, or in collaboration with a Third Party) in any activities that would be prohibited under Section 4.8 or 3.4(b) (“Prohibited Programs”), the Acquirer and the acquired Party will institute commercially reasonable technical and administrative safeguards to ensure that the conduct of each Work Plan will be separate from the conduct of the Prohibited Programs and that no Silence Background IP, Silence Research IP, Joint Research IP or Confidential Information of Mallinckrodt (if Silence is the acquired Party) or Mallinckrodt Background IP, Mallinckrodt Research IP, Joint Research IP or Confidential Information of Silence (if Mallinckrodt is the acquired Party) will be used in connection with the Prohibited Programs, including by creating “firewalls” between the personnel working on (or who have worked on) such Prohibited Programs and the personnel working on (or who have worked on) each Work Plan or otherwise having access to data or information from activities performed under this Agreement. Except as provided in this Section 4.9.3, nothing in Section 4.8 shall apply to or bind any Acquirer of a Party. |
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ARTICLE 5
DEVELOPMENT AND REGULATORY
|
5.2.1 |
General. The Work Plans shall set forth the timeline and details for all activities to be conducted pursuant to such plan, including Research Stage 1, Research Stage 2 and Research Stage 3 and Technology Transfer activities to be conducted pursuant to Section 7.2. The Work Plans shall also: (a) include a reasonably detailed budget of the Development Costs for the activities to be conducted pursuant to such plan (the “Research Budget”) on an activity-by- activity or study-by-study basis, as appropriate, (b) mutually agreed upon Advancement Criteria for each Work Plan and the consequences of satisfying or failing to satisfy such Advancement Criteria, and (c) the protocol for the applicable Phase 1 Trial. For clarity, the Parties acknowledge and agree that an initial Work Plan directed to Development of Licensed Products for a particular Target will include descriptions of activities to be conducted during Research Stage 1 and Research Stage 2 and a Research Budget for such activities, together with outlines of activities to be conducted during Research Stage 3 and the Technology Transfer and projected Research Budgets for such activities, with such descriptions, outlines, and budgets at a level of detail consistent with those descriptions, outlines, and budgets for the same Research Stage set forth in the C3 Work Plan agreed by the JSC (with such Work Plan to be based on the outline attached to this Agreement as Schedule 5.2.1). Upon achievement of appropriate Advancement Criteria, as set forth |
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in the applicable Work Plan, the Parties shall prepare and agree upon, via the JSC, updates to the Work Plan to provide more detailed descriptions of activities to be conducted during Research Stage 3 and the Technology Transfer. Unless the Parties otherwise agree, initial drafts of Work Plans directed to the foregoing shall be prepared by Silence. In addition, from time to time, the Parties may prepare updates and amendments, as appropriate, to a Work Plan (including any consequential changes to the Research Budget), for review of and approval by the JSC, subject to and in accordance with the applicable provisions of ARTICLE 2, including Section 2.7. If the terms of a Work Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. |
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such plan shall be a “Complement Work Plan”. Notwithstanding the foregoing, unless otherwise agreed in writing by Silence, Silence shall not be obligated to commence activities under a particular Complement Work Plan within [***] of having commenced work under the C3 Work Plan or another Complement Work Plan, but unless otherwise agreed in writing by Mallinckrodt, it must commence work under a particular Complement Work Plan [***] of Mallinckrodt’s exercise of its Option for the applicable Optioned Complement Target. |
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period, Silence, by written notice to Mallinckrodt, may request Mallinckrodt’s affirmative notice of its intention to proceed with or terminate Development of Licensed Products directed to such Target, and if Mallinckrodt fails to provide an Acceptance Notice or affirmative notice of its intention to terminate within [***] days after such notice from Silence, this Agreement shall automatically terminate with respect to such Target (and the corresponding Licensed Products) upon the expiration of such [***] day period. |
|
5.4.2 |
Research Stage 3. As further set forth in and subject to this Section 5.4.2, Mallinckrodt shall be responsible for Research Stage 3 Costs incurred by Silence in the performance of the Research Stage 3 portion of each Work Plan. Prior to the beginning of each calendar quarter during which a Research Stage 3 is in process, Mallinckrodt shall pay to Silence the amount budgeted (such budget to be based on the actual expenditure expected by Silence in such calendar quarter) in the applicable Research Budget for such calendar quarter. Silence shall notify the JSC if it anticipates that its actual Research Stage 3 Costs for any Research Stage 3 Development activity will exceed the amount budgeted in the applicable Research Budget for such activity by more than [***] of the amount so budgeted for such activity (the “Cost Overrun Threshold”). Any such notice must be provided at least [***] days prior to the date upon which such activity is to be performed and shall include a description of the likely consequences of any material delay in the |
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performance of such activity. Silence shall not proceed with such Development activity unless and until such Development activity has been approved by Mallinckrodt; in the absence of such approval and so long as Silence’s notice of such excess Research Stage 3 Costs complied with this Section 5.4.2 and so long as such excess Research Stage 3 Costs did not result from Silence’s breach of other activities it was required to perform under such Work Plan, Silence’s failure to carry out activities that are the subject of such notice shall not be deemed to be a breach of its obligations under such Work Plan or this Agreement. Silence shall provide Mallinckrodt (a) a non-binding, estimate within [***] days after the end of each calendar quarter, and (b) a report within [***] days after the end of each calendar quarter, in reasonable detail and format, of all Research Stage 3 Costs incurred by it and its Affiliates during such calendar quarter (the “Development Costs Report”). Within [***] Business Days following the receipt of a Development Costs Report, and without limiting Mallinckrodt’s rights under Section 9.5 below, Mallinckrodt shall have the right to request reasonable additional information related to Silence’s Research Stage 3 Costs during such calendar quarter and Silence’s payment to Third Parties for out-of- pocket costs included therein in order to confirm such Development Costs and such payments to third parties. If the Development Costs for such calendar quarter were in excess of the amounts paid to Silence by Mallinckrodt under this Section 5.4.2 for such calendar quarter and were below the Cost Overrun Threshold or approved by Mallinckrodt, then Silence shall invoice Mallinckrodt for the difference and Mallinckrodt shall pay such invoice within [***] days after receipt thereof. For the avoidance of doubt, Mallinckrodt shall have no obligation to pay any Development Costs that exceed the Cost-Overrun Threshold unless such excess costs were approved by Mallinckrodt, and Development Costs for purposes of this Section 5.4.2 shall not include costs for any work performed by or on behalf of Mallinckrodt pursuant to Section 5.4.3. If the Development Costs for such calendar quarter were less than the amounts paid to Silence by Mallinckrodt |
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under this Section 5.4.2 for such calendar quarter, then any such excess shall be credited towards future amounts to be paid by Mallinckrodt under this Section 5.4.2 or, at Mallinckrodt’s option as evidenced by written notice provided to Silence within [***] days of its receipt of the Development Costs Report and to the extent a payment by Mallinckrodt is not reasonably expected to be owed to Silence within the following [***] period, refunded to Mallinckrodt, any such refund to be paid within [***] days of Silence’s receipt of Mallinckrodt’s invoice therefor. |
|
5.4.3 |
Mallinckrodt Assumption of Work and Offsets. Mallinckrodt, in its discretion, may from time to time propose to the JSC that it will undertake any one or more tasks that were specified in a Work Plan to be the responsibility of Silence. In such event, the JSC (with neither Party having the final decision making authority) shall agree in writing on the scope of work to be performed by Mallinckrodt and the corresponding Research Budget. If such scope and Research Budget is so agreed by the Parties (through the JSC), Mallinckrodt shall offset the costs and expenses incurred by Mallinckrodt or its Affiliates in the performance of such tasks, but only to the extent such costs and expenses (a) were not otherwise costs and expenses for which Mallinckrodt was already responsible pursuant to such Work Plan and (b) do not exceed such Research Budget by more than [***] in the aggregate, against the next milestone payment(s) owed by Mallinckrodt to Silence pursuant to Section 8.3 or 8.4. For clarity, if Mallinckrodt assumes primary responsibility for Research Stage 3, then Mallinckrodt shall (x) not be entitled to offset any costs or expenses incurred in the performance of Research Stage 3 and (y) prepare the Research Stage Data Package for Research Stage 3 in respect of the applicable Target and deliver such Research Stage Data Package to Silence, and Mallinckrodt’s delivery of an Acceptance Notice in respect of such Target shall be due within [***] days of Mallinckrodt’s delivery of such Research Stage Data Package to Silence, and the terms of Section 5.3.2 shall otherwise apply. |
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5.5.2 |
Following Acceptance Notice. Following Mallinckrodt’s delivery of an Acceptance Notice in respect of a Target until receipt of Regulatory Approval of the first Licensed Product directed to such Target in the United States, Japan, and at least one country that is a Major European Market, Mallinckrodt shall update Silence on a semi-annual basis regarding its Development activities with respect to Licensed Products directed to such Target at a level of detail reasonably required by Silence to determine Mallinckrodt’s compliance with its obligations under Section 5.6 of this Agreement. Following the discontinuation of the JSC pursuant to Section 2.3, Mallinckrodt shall provide further relevant information as Silence may reasonably request following the delivery of any such update. |
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Agreement, taking into account the scope of work initially planned under such Work Plan, and (ii) to achieve the objectives of the Work Plan. Each Party shall use its Commercially Reasonable Efforts to adhere to any timeframes set forth in a Work Plan. Silence shall not be obliged to undertake any work in respect of Research Stage 1 or Research Stage 2 if the cost of such work would exceed more than [***] of the Research Budget applicable to such Research Stage and if and to the extent such excess costs [***] in respect of such Research Stage; provided, that Silence must notify Mallinckrodt if it anticipates that any such work will exceed such amount promptly and, in any event at least [***] days prior to the date upon which such activity is to be performed. |
|
5.6.2 |
Following Acceptance Notice. Following Mallinckrodt’s delivery of an Acceptance Notice with respect to a Target as set forth in Section 5.3.2, Mallinckrodt, directly or via its Affiliates or Sublicensees, shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for at least one Licensed Product directed to such Target for at least one Indication that is [***] in each of [***]. For clarity, Silence acknowledges and agrees that, as appropriate to the extent consistent with Commercially Reasonable Efforts, Mallinckrodt may conduct certain Clinical Studies of a Licensed Product in [***] prior to launching equivalent Clinical Studies of such Licensed Product in [***] so as to rely on data generated in the performance of such Clinical Studies in [***] in the design and execution of such Clinical Studies in [***]. For further clarity, Mallinckrodt acknowledges and agrees that, as appropriate to the extent consistent with such Commercially Reasonable Efforts, such Development shall include [***]. |
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5.7 |
Subcontracting. Each Party shall have the right to subcontract its obligations under this Agreement to subcontractors and Affiliates, subject to any limitations, restrictions or other qualifications that are set forth in an applicable Work Plan; provided, that such subcontractors and Affiliates agree in writing to be subject to the applicable terms and conditions of this Agreement, including the confidentiality provisions of ARTICLE 11, and provided that the subcontracting Party directly owns all Intellectual Property that may arise as required by ARTICLE 10. |
|
5.8.2 |
Inspection. Each Party shall have the right to reasonably inspect the other Party’s records, and shall provide copies of all requested records, to the extent reasonably required for the exercise or performance of the requesting Party’s rights under this Agreement; provided, however, that the requesting Party shall maintain such records and the Information of the other Party as Confidential Information of the other Party in accordance with ARTICLE 11 hereof and shall not use such records or Information except to the extent otherwise permitted by this Agreement. |
|
5.8.3 |
Other Record Keeping and Audit Rights. For clarity, Sections 9.4 and 9.5 set out the recording keeping responsibilities and audit rights of the Parties in |
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respect of the Research Stage 3 Costs. |
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ARTICLE 6
COMMERCIALIZATION
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6.3 |
Reporting. Mallinckrodt shall update Silence on an annual basis regarding its significant Commercialization activities with respect to the Licensed Products in the Territory. Each such update shall summarize Mallinckrodt’s, its Affiliates’, and Sublicensees’ significant Commercialization activities in the Territory with respect to Licensed Products directed to each Target for which Mallinckrodt has provided Silence an Acceptance Notice at a level of detail reasonably required by Silence to determine Mallinckrodt’s compliance with its obligations under Section 6.2 of this Agreement. |
ARTICLE 7
MANUFACTURING & SUPPLY
|
7.1 |
Silence Obligations. Silence, through one or more Third Party contract manufacturers, shall be responsible for all manufacturing activities necessary to perform any activities contemplated by a Work Plan, at, subject to Section 5.4.2, its own expense. |
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manufacturing activities, or undertake any activity not specified in the relevant Work Plan (ii) and, on a Complement Target-by-Complement Target basis, Silence’s obligation shall be limited to no more than [***] of effort to be taken within [***] months of the delivery of the Acceptance Notice in respect of such Complement Target. At Mallinckrodt’s request, Silence shall introduce Mallinckrodt to Silence’s contract manufacturer and shall facilitate the discussions so that Mallinckrodt may enter into a direct contractual relationship with such contract manufacturer for the procurement of such Licensed Product on terms substantially equivalent to those agreed with Silence. |
|
7.2.2 |
Technology Transfer Costs. As further set forth in and subject to this Section 7.2.2, Mallinckrodt shall be responsible for Technology Transfer Costs incurred by Silence in the performance of the Technology Transfer portion of each Work Plan. Prior to the beginning of the calendar month during which the Technology Transfer 3 will commence, Mallinckrodt shall pay to Silence the applicable Research Budget for such Technology Transfer. Silence shall notify the JSC if it anticipates that its actual Technology Transfer Costs will exceed the amount budgeted in the applicable Research Budget for such activity by more than the Cost Overrun Threshold. Any such notice must be provided at least [***] days prior to the date upon which such activity is to be performed and shall include a description of the likely consequences of any material delay in the performance of such activity. Silence shall not proceed with such Technology Transfer activity unless and until such Technology Transfer activity has been approved by Mallinckrodt; in the absence of such approval and so long as Silence’s notice of such excess Technology Transfer Costs complied with this Section 7.2.2 and so long as such excess Technology Transfer Costs [***] Technology Transfer activities [***] under such Work Plan], Silence’s failure to carry out activities that are the subject of such notice shall not be deemed to be a breach of its obligations under such Work Plan or this Agreement. Within [***] days after the |
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completion of the Technology Transfer, Silence shall provide to Mallinckrodt a report, in reasonable detail and format, of all Technology Transfer Costs incurred by it and its Affiliates during such calendar quarter. Within [***] Business Days following the receipt of such report, and without limiting Mallinckrodt’s rights under Section 9.5 below, Mallinckrodt shall have the right to request reasonable additional information to confirm such Technology Transfer Costs. If the Technology Transfer Costs were in excess of the amounts paid to Silence by Mallinckrodt under this Section 7.2.2 and were below the Cost Overrun Threshold or approved by Mallinckrodt, then Silence shall invoice Mallinckrodt for the difference and Mallinckrodt shall pay such invoice within [***] days after receipt thereof. For the avoidance of doubt, Mallinckrodt shall have no obligation to pay any Technology Transfer Costs that exceed the Cost-Overrun Threshold unless such excess costs were approved by Mallinckrodt in accordance with this Section 7.2.2. If the Technology Transfer Costs were less than the amounts paid to Silence by Mallinckrodt under this Section 7.2.2 for such calendar quarter, then any such excess shall be refunded to Mallinckrodt, any such refund to be paid within [***] days of Silence’s receipt of Mallinckrodt’s invoice therefor. |
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8.1 |
Upfront Payment. Within [***] days after the Effective Date, Mallinckrodt shall pay to Silence the non-refundable, non-creditable sum of Twenty Million Dollars ($20,000,000). |
|
8.2 |
Equity. In partial consideration of the rights and licenses granted herein, the Parties will enter into the Subscription Agreement. |
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8.3.2 |
Notice and Payment. Silence shall notify Mallinckrodt in writing within [***] days after the first achievement of any milestone event set forth in this Section 8.3 by or on behalf of Silence, together with documentation that validates such achievement. Mallinckrodt shall pay to Silence the applicable milestone payment within [***] days (i) after the delivery of such notice and such documentation, or, (ii) if requested by Mallinckrodt within [***] days after its receipt of such notice, after receipt of any additional documentation reasonably requested by Mallinckrodt. |
|
8.3.3 |
Once Per Target. Each milestone payment in this Section 8.3 shall be payable only upon the achievement of such milestone by the first Licensed Product directed to a particular Target to achieve such milestone event and no amounts shall be due for subsequent or repeated achievements of such milestone by another Licensed Product directed to the same Target. |
|
8.3.4 |
Non-Creditable. After a milestone payment due under this Section 8.3 or under Section 8.4 below has been paid, it shall not be creditable against any amounts that may be subsequently owed by Mallinckrodt to Silence; for clarity, however, milestone payments due under this Section 8.3 or under Section 8.4 below may be offset in accordance with Section 5.4.3 above. |
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Milestone Event |
Milestone Payment [***] |
Milestone Payment [***] |
Milestone Payment [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
8.4.2 |
Notice and Payment. Mallinckrodt shall notify Silence in writing within [***] days after the first achievement of any milestone event set forth in this Section 8.4 by or on behalf of Mallinckrodt or its Affiliates or Sublicensees. Mallinckrodt shall pay to Silence the applicable milestone payment within [***] days after the delivery of such notice. For clarity, each milestone payment set forth in the table above shall be paid only once upon first achievement of the corresponding milestone event by the C3 Licensed |
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Product, regardless of the number of times such event is achieved, and the maximum aggregate amount payable to Silence pursuant to this Section 8.4 in respect of the C3 Licensed Product is One Hundred Million Dollars ($100,000,000). |
|
8.4.3 |
Complement Licensed Product Milestones. In connection with Mallinckrodt’s exercise of its Option with respect to any Complement Target other than the C3 Target, the Parties shall identify the milestone payments that will be due for the achievement of the milestone events set forth in the table in this Section 8.4 based upon the applicable [***] for the Complement Licensed Product directed to such Complement Target and according to the parameters set forth in Schedule 8.4.3. If the Parties fail to reach agreement on such milestone payments within [***] days after the date of Mallinckrodt’s exercise of such Option (or such longer period of time as may be mutually agreed by the Parties), then the matter shall be submitted to and finally decided by a Neutral Expert as set forth in Section 15.6.5. Mallinckrodt, by written notice delivered to Silence within [***] days after the Parties’ receipt of the decision of the Neutral Expert, may relinquish its Option with respect to such Complement Target. If Mallinckrodt fails to provide such notice, it shall be deemed to have agreed to the decision of the Neutral Expert regarding such milestone payments and it shall be obligated to pay the Option Exercise Payment within [***] days after the Parties’ receipt of the decision of the Neutral Expert. |
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8.5.1 |
Initial Three Complement Target Licensed Product Sales Milestone Payments. In partial consideration of the rights granted by Silence to Mallinckrodt hereunder and subject to the terms and conditions set forth in this Agreement, Mallinckrodt shall pay to Silence the following non- refundable, non-creditable milestone payments upon the first achievement of the corresponding milestone event in respect of Licensed Product in respect of each of C3 and the first two (2) Complement Targets for no additional payment is payable pursuant to Section 3.2 (a “Relevant Target”) (whether by or on behalf of Mallinckrodt or its Affiliates or Sublicensees: |
Annual Net Sales of all Licensed Products directed to the C3 Target in the Territory |
Sales Milestone Payments |
Equal or exceed [***] |
[***] |
Equal or exceed [***] |
[***] |
Equal or exceed [***] |
[***] |
Equal or exceed [***] |
[***] |
Total |
$562,500,000 |
|
8.5.2 |
Notice and Payment. Mallinckrodt shall notify Silence in writing of the first achievement of any milestone event set forth in this Section 8.5 by or on behalf of Mallinckrodt or its Affiliates or Sublicensees in its report provided pursuant to Section 9.1 and payment of such milestone shall be due on the date the first such statement that reflects achievement of such sales milestone payment is due. For clarity, each milestone payment set forth in the table above shall be paid only once with respect to a Relevant Target, upon first achievement of the corresponding milestone event by all Licensed Products directed to the Relevant Target, regardless of the number of times such event is achieved. |
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8.5.3 |
Complement Licensed Product Sales Milestones. In connection with Mallinckrodt’s exercise of its Option with respect to any Complement Target in respect of which it has to make a payment pursuant to Section 3.2, the Parties shall identify the milestone payments that will be due for the achievement of the milestone events set forth in the table in this Section 8.5, which shall be similar to those set forth in such table. If the Parties fail to reach agreement on such milestone payments within [***] days of the date of Mallinckrodt’s exercise of such Option (or such longer period of time as may be mutually agreed by the Parties), then the matter shall be submitted to and finally decided by a Neutral Expert as set forth in this Section 15.6.5, who shall establish such milestone payments, which shall be similar to those set forth in the table in this Section 8.5. Mallinckrodt, by written notice delivered to Silence within [***] days of the Parties’ receipt of the decision of the Neutral Expert, may relinquish its Option with respect to such Complement Target. If Mallinckrodt fails to provide such notice, it shall be deemed to have agreed to the decision of the Neutral Expert regarding such milestone payments and it shall be obligated to pay the Option Exercise Payment within [***] days of the Parties’ receipt of the decision of the Neutral Expert. |
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8.6.1 |
Royalty Rate. As further consideration for the rights granted to Mallinckrodt under this Agreement, subject to the other terms of this Section 8.6, during the Royalty Term, Mallinckrodt shall make quarterly non-refundable, non- creditable royalty payments to Silence on the annual Net Sales of each Licensed Product sold in the Territory at the applicable rate set forth below: |
Annual Net Sales in the Territory of a Particular Licensed Product |
Royalty Rate |
For that portion of Annual Net Sales less than [***] |
[***] |
For that portion of Annual Net Sales equal to or greater than [***] but less than [***] |
[***] |
For that portion of Annual Net Sales equal to or greater than [***] but less than [***] |
[***] |
For that portion of Annual Net Sales equal to or greater than [***] |
[***] |
|
8.6.2 |
Royalty Term. Royalties shall be paid on a Licensed Product-by-Licensed Product and country-by-country basis in the Territory from [***]. |
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|
(a) |
In the event that it is necessary for Mallinckrodt, in order to Exploit a Licensed Product, to obtain a license under any Patents owned by a Third Party that has claims that Cover [***] such Licensed Product or the Licensed Product, Mallinckrodt shall be entitled to deduct [***] of the amount of [***] accrued and payable by Mallinckrodt to such Third Party from the royalties paid to Silence in any given Quarter (determined in accordance with the Accounting Standards) pursuant to Section 8.6, provided always that nothing in this Section 8.6.3 shall operate to reduce the amount of royalties otherwise payable to Silence to less than [***] of the royalties provided for in Section 8.6.1. |
|
(b) |
On a Licensed Product-by-Licensed Product basis, if the Royalty Term does not end on the date upon which there is no Valid Claim [***] that Covers such Licensed Product in the country of sale or the country of manufacture, then with respect to sales of such Licensed Product occurring from and after such date in such country, the royalty rate used to calculate royalties due on Net Sales of such Licensed Product in such country for the remainder of the Royalty Term for such Licensed Product in such country (subject to further reduction in accordance with Section 8.6.3(c) below, but subject to Section 8.6.4 below), shall be reduced by [***] from the applicable royalty rate (i.e., [***] as applicable). |
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|
(c) |
If, during the Royalty Term with respect to a Licensed Product and a particular country, one or more Generic Products of such Licensed Product are sold in such country, then (i) during each Quarter in which there is an Initial Loss of Market Share with respect to such Licensed Product in such country, then the royalty rates used to calculate royalties due on Net Sales of such Licensed Product in such country for such Quarter shall be reduced by [***] from the applicable royalty rate (i.e., [***], as applicable) and (ii) during each Quarter in which there is a Loss of Market Share with respect to such Licensed Product in such country, then the royalty rates used to calculate royalties due on Net Sales of such Licensed Product in such country for such Quarter shall be reduced by [***] from the applicable royalty rate (i.e., [***], as applicable) it being understood that the deduction under part (ii) of this Section 8.6.3(c) is in substitution for, not in addition to, part (i) of this Section 8.6.3(c). |
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of such Year, Mallinckrodt shall report to Licensor the difference between the royalties actually paid in respect of Net Sales in such Year and the royalties that should have been paid in such Year taking into consideration the Competing Product Reduction and Licensor shall remit such difference to Mallinckrodt promptly after its receipt of such report. For the avoidance of doubt, the Competing Product Reduction, if any, shall be in addition to any reduction in the royalty rate pursuant to Section 8.6.3(b) or 8.6.3(c) above, but subject to Section 8.6.4 below. |
|
8.6.4 |
Cumulative Reductions Floor. Notwithstanding Section 8.6.3, in no event will the reductions set forth in Sections 8.6.3(a), 8.6.3(b), 8.6.3(c), and 8.6.3(d) above operate, individually or in combination, to reduce the amount of royalties due to Silence with respect to Net Sales of a Licensed Product in a country in any given Quarter during the Royalty Term for such Licensed Product in such country by more than [***] of the amount of royalties that otherwise would have been due and payable to Silence in such Quarter for such Licensed Product in such country at the rate set out in the table in Section 8.6.1. |
ARTICLE 9
PAYMENT; RECORDS; AUDITS
|
9.1 |
Royalty Payments and Reports. Mallinckrodt shall calculate all amounts payable to Silence pursuant to Section 8.6 at the end of each Quarter, which amounts shall be converted to Dollars, in accordance with Section 9.2. Mallinckrodt shall pay to Silence the royalty amounts due with respect to a given Quarter on or before [***] following the end of the Quarter in which the Net Sales on which such royalty amounts are due are deemed to have occurred. Each payment of royalties due to Silence shall be accompanied by a statement of (a) the amount of gross sales and Net Sales of each Licensed Product in each country in the Territory during the applicable Quarter |
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(including such amounts expressed in local currency and as converted to Dollars), (b) the deductions applied in the calculation of Net Sales from gross sales, (c) the applicable royalty rate(s) under this Agreement (including any reduction(s) to such royalty rate(s) under Section 8.6.3), and (d) a calculation of the amount of royalty payment due on such Net Sales for such Quarter. |
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refundable, creditable or otherwise recoverable, each Party will provide the other such assistance as is reasonably required to obtain a refund of the withheld taxes, obtain a credit with respect to such taxes paid, or otherwise recover such taxes. In the event that a government authority retroactively determines that a payment made by a Party to the other pursuant to this Agreement should have been subject to withholding (or to additional withholding) taxes, and such Party (the “Withholding Party”) remits such withholding taxes to the government authority, the Withholding Party shall have the right (a) to offset such amount, including any interest and penalties that may be imposed thereon (except to the extent any such interest or penalties result from the negligence of the Withholding Party), against future payment obligations of the Withholding Party under this Agreement, (b) to invoice the other Party for such amount (which shall be payable by the other Party within [***] days of its receipt of such invoice), or (c) to pursue reimbursement by any other available remedy. |
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[***] days after receipt. |
|
9.3.3 |
Taxes Resulting from a Party’s Action. Notwithstanding the foregoing in this Section 9.3, if a Party takes any action of its own discretion (not required by the terms of this Agreement or a Regulatory Authority), including any assignment, sublicense, change of place of incorporation, change in the source of payment (which shall, as of the Effective Date be Ireland in the case of Mallinckrodt and the UK in the case of Silence) or failure to comply with Applicable Laws or filing or record retention requirements, which results in an additional or increased withholding obligation with respect to payments to be made pursuant to this Agreement (“Withholding Tax Action”), then such Party shall bear the amount of such withholding to the extent associated with such Withholding Tax Action. For clarity, if Mallinckrodt undertakes a Withholding Tax Action, then the sum payable by Mallinckrodt (in respect of which such withholding is required to be made) shall be increased to the extent necessary to ensure that Silence receives a sum equal to the sum which it would have received had no such Withholding Tax Action occurred. For the avoidance of doubt, a change in Applicable Laws that results in a new or increased withholding or deduction obligation, absent either Party taking a Withholding Tax Action, shall not affect the withholding and deduction obligations provided in Section 9.3.1. |
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9.5 |
Audit. At either Party’s request, the other Party shall, and shall cause its Affiliates to, permit one of the [***] largest (by turnover) independent public accounting firms in the country of the audited Party, the specific firm to be designated by the auditing Party, at reasonable times during normal business hours and upon reasonable notice, to audit the books and records maintained pursuant to Section 9.4 to ensure the accuracy of all reports and payments made hereunder. Such examinations may not (a) be conducted for any Quarter more than [***] Years after the end of such Year to which such books and records pertain, (b) be conducted more than once in any [***] month period (unless a previous audit during such [***] month period revealed an underpayment with respect to such period), or (c) be repeated for any Quarter, unless as a component of an examination applicable to a Year that includes such Quarter. The accounting firm shall report to the Parties with reasons whether the reports are correct or not, and the specific details concerning any discrepancies. No other information shall be shared with the auditing Party. Except as provided below, the cost of this audit shall be borne by the auditing Party, unless: (i) if the period in dispute is at least a [***] period, the audit reveals a variance of more than [***] from the reported amounts, or (ii) if the period in dispute is less than [***], the audit reveals a variance that, if [***], would be equivalent to a variance of more than [***] from the reported amounts, in which case the audited Party shall bear the cost of the audit. Unless disputed pursuant to Section 9.6 below, if such audit concludes that (x) additional amounts were owed by the audited Party, the |
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audited Party shall pay the additional amounts within [***] days, or (y) excess payments were made by the audited Party and the audited Party agrees to pay the costs of such audit, the auditing Party shall reimburse such excess payments, in either case ((x) or (y)), within [***] days after the date on which such audit is completed by the auditing Party. |
|
9.6 |
Audit Dispute. In the event of a dispute with respect to any audit under Section 9.5, Silence and Mallinckrodt shall work in good faith to promptly resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***] days, the dispute shall be submitted for resolution to an independent Third Party accounting firm jointly selected by the Parties or to such other Person as the Parties shall mutually agree (the “Auditor”). The decision of the Auditor shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Auditor shall determine. Not later than [***] days after such decision and in accordance with such decision, the audited Party shall pay the additional amounts, or the auditing Party shall reimburse the excess payments, as applicable. |
|
9.7 |
Confidentiality. The receiving Party shall treat all information subject to review under this ARTICLE 9 in accordance with the confidentiality provisions of ARTICLE 11 and the Parties shall cause the Auditor to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement. |
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ARTICLE 10
INTELLECTUAL PROPERTY
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10.1.4 |
Joint Ownership. As between the Parties, the Parties shall each own an equal, undivided interest in any and to all Joint Research IP. At least once per calendar quarter (which the Parties expect would be at each JSC meeting unless the JSC has been disbanded) each Party shall disclose to the other Party in writing the development, making, conception, or reduction to practice of any Joint Research IP. Subject to the exclusive licenses granted by Silence to Mallinckrodt to Joint Research IP under Section 4.1, each Party shall have the right to Exploit (including by way of granting licenses or otherwise) the Joint Research IP without a duty of seeking consent or accounting to the other Party. |
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10.1.5 |
Assignment Obligation. Each Party shall cause all Persons who perform Development activities for such Party under this Agreement to be under an obligation to assign (or, if such Party is unable to cause such Person to agree to such assignment obligation despite such Party’s using commercially reasonable efforts to negotiate such assignment obligation, provide a license under, sufficient to enable such Party to Control) their rights in any Information and inventions resulting therefrom to such Party to the extent that the foregoing would be within the scope of: (i) in respect of Silence, Silence Research IP or, to the extent relating to a Licensed Product, the C3 Target or an Optioned Complement Target or otherwise to the license grants under Section 4.1, Silence Background IP, (ii) in respect of Mallinckrodt, within the scope of the Mallinckrodt Research IP licensed to Silence pursuant to Section 4.2 and (iii) in respect of both Parties, Joint Research IP. For clarity, (a) Silence shall be solely responsible for any remuneration that may be due any Silence inventors under any applicable inventor remuneration laws as a result of activities performed under a Work Plan, other than to the extent such amounts are included in Research Stage 3 Costs and otherwise payable by Mallinckrodt under the terms of this Agreement and (b) Mallinckrodt shall be solely responsible for any remuneration that may be due any Mallinckrodt inventors under any applicable inventor remuneration laws as a result of activities performed under a Work Plan. |
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10.2.1 |
Silence Patents. Silence shall prepare, file, prosecute, and maintain the Silence Background Patents and the Silence Research Patents worldwide, at Silence’s sole cost and expense, subject to and in accordance with the provisions of this Section 10.2 and, except as provided in this Section 10.2, shall be solely responsible for such matters and shall use commercially reasonable efforts to perform such activities. |
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obligation, to prepare, file, prosecute, and maintain the Mallinckrodt Background Patents and the Mallinckrodt Research Patents worldwide, at Mallinckrodt’s sole cost and expense. |
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10.2.3 |
Joint Patents. Silence shall have the first right, but not the obligation, to prepare, file, prosecute, and maintain the Joint Research Patents worldwide, at Silence’s sole cost and expense. |
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payment due to provide Silence sufficient time to assume responsibility before any lapse or abandonment occurs and Mallinckrodt shall execute such powers of attorney and other documents necessary to enable Silence to assume such responsibilities. |
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(d) |
If Mallinckrodt exercises it right to assume prosecution of any Product Specific Patent pursuant to Section 10.2.4(c) above, then Mallinckrodt shall keep Silence reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance of all Silence Research Patents for which Mallinckrodt has the responsibility to prosecute and maintain, and shall provide Silence with a copy of material communications to and from the patent authorities regarding such Product Specific Patents, including drafts of any material filings or responses to be made to such patent |
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(e) |
Additionally, if or to the extent any Product Specific Patent, Joint Research Patent or Supplementary Rights Patent for which Mallinckrodt has the responsibility to prosecute and maintain [***], Mallinckrodt shall: (i) as instructed by Silence, [***] and (ii) not [***] absent Silence’s prior written consent. |
|
(f) |
For the purpose of this 10.2: (i) “prosecution” shall include any patent interference, opposition, pre-issuance Third Party submission, ex parte re-examination, post-grant review, inter partes review or other similar proceeding, appeals or petitions to any Board of Appeals in a patent office, appeals to any court for any patent office decisions, reissue proceedings, and applications for patent term extensions and the like, regardless whether said “prosecution” occurs in any jurisdiction within the Territory or outside the Territory and (ii) a Party shall not be deemed to have made a determination to abandon a pending patent application if, following such abandonment, a patent application that includes the disclosure of such pending patent application will be pending in such jurisdiction. |
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10.3.2 |
Silence Patents. Except as set out in Section 10.3.4 and 10.3.6, Silence shall have the sole and exclusive right, but not the obligation, to enforce and defend worldwide under its control, at its own expense, the Silence Background Patents and Silence Research Patents. |
|
10.3.4 |
Product Specific Patents. During the Term, Mallinckrodt shall have the first right, but not the obligation, to enforce and defend worldwide under its control, and at its own expense, the Product Specific Patents. If Mallinckrodt does not take commercially reasonable steps to enforce or defend any such infringement with respect to Product Specific Patents (a) within [***] days following the first notice provided to it pursuant to Section 10.3.1, or (b) if earlier, [***] Business Days before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, then Silence may prosecute such infringement with respect to such Product Specific Patents at its own expense. |
|
10.3.5 |
Joint Research Patents. During the Term, Silence shall have the first right, but not the obligation, to enforce and defend worldwide under its control, and at its own expense, the Joint Research Patent that are not Product Specific Patents. If Silence does not take commercially reasonable steps to enforce or defend any such infringement with respect to Joint Research Patents (a) within [***] days following the first notice provided to it pursuant to Section 10.3.1, or (b) if earlier, [***] Business Days before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, then Mallinckrodt may prosecute such infringement with respect to such Joint Research Patent(s) at its own expense. |
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10.3.6 |
Supplementary Rights Patents. During the Term, Silence shall have the first right, but not the obligation, to enforce and defend worldwide under its control, and at its own expense, the Supplementary Rights Patents. If (i) Silence does not take commercially reasonable steps to enforce or defend any such infringement with respect to any [***] of a Supplementary Rights Patent (a) within [***] days following the first notice provided to it pursuant to Section 10.3.1, or (b) if earlier, [***] Business Days before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, and (ii) [***] and/or [***], then Mallinckrodt may prosecute such infringement of such [***] that [***] (i.e., [***] and/or [***] of such Supplementary Rights Patent at its own expense. By way of example only, if [***], but [***], then [***] subject to this Section 10.3.6 shall [***] that [***]. |
|
10.3.7 |
Cooperation. The Parties agree to cooperate fully in any Infringement action pursuant to this Section 10.3. Where a Party brings such an action, the other Party shall, where necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action. Unless otherwise set forth herein, the Party entitled to bring any Infringement litigation in accordance with this Section 10.3 shall have the right to settle such claim; provided that no Party shall have the right to settle any Infringement litigation under this Section 10.3 in a manner that (a) [***], (b) [***], or (c) [***], in each case (a) – (c) without the express written consent of such other Party, such consent not to be unreasonably withheld, conditioned, or delayed. The Party commencing the litigation shall provide the other Party with copies of all pleadings and other documents filed with the court and shall consider reasonable input from the other Party during the course of the proceedings. |
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10.3.8 |
Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of such litigation described in this Section 10.3 (whether by way of settlement or otherwise) shall be first allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses). Any remainder after such reimbursement is made shall be retained by the Party that has exercised its right to bring the enforcement action; provided that to the extent that any award or settlement (whether by judgment or otherwise) is paid to Mallinckrodt [***], such amounts, net of amounts allocated to reimburse the Parties as provided above, shall be treated as Net Sales of the relevant Licensed Product in the Quarter in which such award or settlement is received. |
|
10.4.1 |
Right to Defend. If the manufacture, sale, or use of a Licensed Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging patent infringement by Mallinckrodt (or its Affiliates or Sublicensees), Mallinckrodt shall have the first right, but not the obligation, to defend and control the defense of any such claim, suit, or proceeding at its own expense, using counsel of its own choice; provided, however, that the provisions of Section 10.3 shall govern the right of Mallinckrodt to assert a counterclaim of infringement of any Silence Background Patent or Silence Research Patent. Silence shall have the right, but not the obligation, to participate in (and to control should Mallinckrodt elect not to) the defense of any such claim, suit, or proceeding at its own expense, using counsel of its own choice. |
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10.5.4 |
Cooperation. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in this Section 10.5, including by being joined as a party plaintiff in such action or proceeding, providing access to relevant documents and other evidence, and making its employees available at reasonable business hours. In connection with any such defense or claim or counterclaim related to Section 10.5.3, the controlling Party shall keep the other Party reasonably informed of any steps taken, and shall provide copies of all documents filed, in connection with such defense, claim, or counterclaim. In connection with the activities set forth in this Section 10.5, each Party shall consult with the other as to the strategy for the defense of the Product Specific Patents and Joint Research Patents. |
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ARTICLE 11
CONFIDENTIALITY AND NON-DISCLOSURE
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11.1 |
Confidentiality Obligations. At all times during the Term and for a period of [***] years following termination or expiration hereof in its entirety, each Party shall, and each of the foregoing shall cause its Affiliates and its and their respective officers, directors, employees, consultants, contractors, and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Section 11.1 with respect to any Confidential Information shall not include any information that: |
|
11.1.1 |
has been published by a Third Party or otherwise is or hereafter becomes part of the public domain through no fault on the part of the receiving Party; |
|
11.1.4 |
has been independently developed by or for the receiving Party without reference to or use of the disclosing Party’s Confidential Information, as evidenced by contemporaneous written record. |
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Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
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11.2 |
Permitted Disclosures. Each Party may disclose Confidential Information of the other Party to the extent such disclosure is reasonably necessary in the following instances: |
(b) prosecuting or defending litigation as contemplated by this Agreement, or
(c) obtaining or maintaining Regulatory Approval of the Products;
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11.2.5 |
Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 11.2.1, 11.2.2 or 11.2.4, it will, except where impermissible, give reasonable advance notice to the other Party of such disclosure and comply with all reasonable requests of the disclosing Party with respect to maintaining confidence in such Confidential Information and in any event shall use the same diligent efforts to secure confidential treatment of such Confidential Information as such Party would use to protect its own Confidential Information, but in no event less than reasonable efforts. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential Information. Any information disclosed pursuant to this Section 11.2 shall remain Confidential Information and subject to the restrictions set forth in this Agreement, including the foregoing provisions of this ARTICLE 11. |
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11.3 |
Use of Name. Except as expressly provided in this Agreement, neither Party shall use the name, logo, or trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of such other Party in each instance, which approval shall not be unreasonably withheld, conditioned, or delayed. The restrictions imposed by this Section 11.3 shall not prohibit either Party from making any disclosure identifying the other Party that, in the opinion of the disclosing Party’s counsel, is required by Applicable Law; provided, that such Party shall submit the proposed disclosure identifying the other Party in writing to such other Party as far in advance as reasonably practicable (and in no event less than [***] Business Days prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment on such disclosure. |
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11.5.3 |
Review Process. Before any paper is submitted for publication or an oral presentation is made for which review or approval rights are provided under Section 11.5, the publishing or presenting Party (the “Publishing Party”) shall deliver a then-current copy of the paper or materials for oral presentation to the non-publishing Party at least [***] Business Days prior to submitting the paper to a publisher or making the presentation where written approval is required and at least [***] Business Days prior to submitting the paper to a publisher or making the presentation where approval is not required. The non-publishing Party shall review any such paper and give its comments to such Publishing Party within [***] Business Days after the delivery of such paper to such other Party. The Publishing Party shall comply with the other Party’s request to delete references to the other Party’s Confidential |
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Information in any such paper and will withhold publication of any such paper or any presentation of same for an additional [***] Business Days in order to permit the Parties to obtain Patent protection if such other Party deems it necessary. |
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REPRESENTATIONS AND WARRANTIES
|
12.1 |
Mutual Warranties. Each Party hereby represents and warrants, as of the Effective Date, as follows: |
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12.2 |
Additional Warranties by Silence. Silence hereby represents and warrants, as of the Effective Date, as follows: |
|
12.2.1 |
all Silence IP is owned by Silence and is not held under license from any other person or entity; |
|
12.2.4 |
it has not granted to any Third Party any right under the Silence Background IP or Silence Research IP that would conflict with the rights granted to Mallinckrodt hereunder; |
|
12.2.5 |
except as set forth in Schedule 12.2, it is not the subject of any Patent proceeding in respect of any Silence Background Patent, and it is not aware of any pending or threatened action, suit, proceeding, or claim by a Third Party challenging Silence’s ownership rights in, or the validity or scope of, such Silence Background Patents and, to Silence’s knowledge, all issued and granted Silence Background Patents are valid and enforceable; |
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12.2.6 |
Silence has prosecuted all Silence Background Patents in good faith and in accordance with Applicable Law; |
|
12.3 |
Mutual Covenants. Each Party hereby covenants and agrees, in connection with the performance of its activities under this Agreement: |
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INDEMNITY
|
13.1.1 |
the Exploitation of any Licensed Product by or on behalf of Mallinckrodt or any of its Affiliates, Sublicensees, subcontractors, agents, or consultants; or |
|
13.1.2 |
the breach by Mallinckrodt of any warranty, representation, covenant, or agreement made by Mallinckrodt in this Agreement; except in each case for those Losses for which Silence, in whole or in part, has an obligation to indemnify Mallinckrodt pursuant to Section 13.2. |
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13.2.1 |
the failure by Silence to perform any Development or other activities assigned to Silence in a Work Plan in accordance with the terms of this Agreement; or |
|
13.2.2 |
the breach by Silence of any warranty, representation, covenant, or agreement made by Silence in this Agreement; except in each case for those Losses for which Mallinckrodt, in whole or in part, has an obligation to indemnify Silence pursuant to Section 13.1. |
|
13.3 |
Indemnification Procedure. A Party that intends to claim indemnification under this ARTICLE 13 (the “Indemnitee”) shall promptly notify the indemnifying Party (the “Indemnitor”) in writing of any Claim in respect of which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have sole control of the defense or settlement of such Claim. The Indemnitee may participate at its expense in the Indemnitor’s defense of and settlement negotiations for any Claim with counsel of the Indemnitee’s own choice. The indemnity arrangement in this ARTICLE 13 shall not apply to amounts paid in settlement of any action with respect to a Claim if such settlement is effected without the consent of the Indemnitor, which consent shall not be unreasonably withheld, conditioned, or delayed. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any action with respect to a Claim shall only relieve the Indemnitor of its indemnification obligations under this ARTICLE 13 if and to the extent the Indemnitor is actually prejudiced thereby. The Indemnitee shall cooperate fully with the Indemnitor and its legal representatives in the investigation of any action with respect to a Claim covered by this indemnification. |
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13.4 |
Special, Indirect, and Other Losses. EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 13, NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE FOR ANY LOSS OF PROFITS OR BUSINESS INTERRUPTION OR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES, INCLUDING, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY, OR OTHERWISE IN CONNECTION WITH OR ARISING IN ANY WAY OUT OF THE TERMS OF THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THE USE OF THE LICENSED COMPOUND OR LICENSED PRODUCT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. The foregoing limitation of liability shall not operate to limit or exclude either Party’s liability for (a) death or personal injury, (b) fraud, (c) willful misconduct, or (d) any other liability which, pursuant to Applicable Law, cannot be limited or excluded. |
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14.1 |
Term. This Agreement shall commence on the Effective Date and, unless earlier terminated as provided herein, shall remain in effect, on a Licensed Product-by-Licensed Product and country-by-country basis, until the expiration of the Royalty Term for such Licensed Product in such country. Upon the expiration of the Royalty Term for a particular Licensed Product in a particular country, the licenses granted to Mallinckrodt under Section 4.1 for such Licensed Product in such country shall remain exclusive and become fully-paid, royalty-free, and perpetual. |
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14.2.2 |
No Acceptance Notice. This Agreement shall terminate with respect to a Target as set forth in Section 5.3.2. |
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14.4 |
Termination by Silence for Patent Challenge. Silence shall have the right to terminate this Agreement in full upon written notice to Mallinckrodt in the event that Mallinckrodt or any of its Affiliates or Sublicensees directly asserts in its own respective name, or directs a Third Party to assert, a Patent Challenge; provided that with respect to any such Patent Challenge by any Sublicensee, Silence will not have the right to terminate this Agreement under this Section 14.4 if, within [***] days of Silence’s notice to Mallinckrodt under this Xxxxxxx 00.0, Xxxxxxxxxxxx (x) causes such Patent Challenge to be terminated or dismissed or (b) terminates the sublicense granted to such Sublicensee. For purposes of this Section, “Patent Challenge” means any challenge in a legal or administrative proceeding to the patentability, validity, ownership or enforceability of any of the Silence Background Patents, Silence Research Patents, or Joint Research Patents (or any claim thereof), including by: (x) filing or pursuing a declaratory judgment action in which any of the Silence Background Patents, Silence Research Patents, or Joint Research Patents is alleged to be invalid or unenforceable; (y) citing prior art against any of the Silence Background Patents, Silence Research Patents, or Joint Research Patents (other than art required to be cited by Applicable Law, including under a duty of candor to a patent office), filing a request for or pursuing a re-examination of any of the Silence Background Patents, Silence Research Patents, or Joint Research Patents (other than with Silence’s written agreement), or becoming a party to or pursuing an interference; or (z) filing or pursuing any opposition, cancellation, nullity, or other like proceedings against any of the Silence Background Patents, Silence Research Patents, or Joint Research Patents; but excluding any challenge raised as a defense against a claim, action, or proceeding asserted by Silence or its Affiliates against Mallinckrodt or its Affiliates or Sublicensees and excluding any activities conducted by Mallinckrodt in the prosecution of Product Specific Patents and, if applicable, other Silence Research Patents or Joint Research Patents, so long as such prosecution is conducted in good faith and in accordance with the applicable provisions of this Agreement. |
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(a) |
Upon any termination of this Agreement with respect to a Target, all rights and licenses granted with respect to such Target and all Licensed Products directed to such Target under Sections 4.1 and 4.2.1 shall terminate and be of no further force or effect. |
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(b) |
If this Agreement terminates with respect to a Target pursuant to Section 14.2.1 or 14.2.2 or by Silence pursuant to Section 14.3, 14.4 or 14.5, Mallinckrodt hereby grants to Silence licenses on the terms set out in Section 4.2.2 in respect of the Target which is the subject of such termination, and such licences shall survive any expiration or termination of this Agreement. |
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(x) |
Other Clinical Studies. If any Clinical Studies that were Initiated by or on behalf of Mallinckrodt prior to the termination of this Agreement (whether terminated in its entirety or with respect to a Target) are on-going as of the effective date of such termination, Mallinckrodt shall cooperate with Silence to wind-down such Clinical Study(ies) in an orderly fashion; provided, however, that [***] to transition the sponsorship of any such ongoing Clinical Study(ies) to Silence. Mallinckrodt shall not commence any Clinical Study at any time after it has given or received a notice of termination pursuant to this ARTICLE 14. |
|
(c) |
Cooperation. Mallinckrodt shall provide reasonable cooperation to Silence and its designee(s) to facilitate, and the Parties shall use reasonable efforts to effect, a reasonable, orderly, and prompt transition of the Development activities relating to any terminated Target and corresponding terminated Licensed Products to Silence and/or its designee(s) following delivery of notice of termination so that Silence is able to assume responsibility for same as of the effective date of termination. Where the same cannot be fully achieved prior to the effective date of termination, Mallinckrodt shall continue to provide such reasonable cooperation to Silence and its designee(s) for a period of no more [***] after the effective date of termination for the purpose of facilitating such transition and providing access to Silence any Mallinckrodt Research Know-How that is the subject of the license granted to Silence pursuant to Section 4.2.2 that is not already in Silence’s possession, to the extent reasonably necessary for Silence to exercise such license rights. For clarity, the foregoing shall not require Mallinckrodt to create any new Know-How. |
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14.7.4 |
Exclusivity. Upon any termination of this Agreement with respect to a Target, each Party’s obligations under Section 4.8 with respect to such Target shall terminate. |
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14.7.5 |
Patent Prosecution. Upon any termination of this Agreement with respect to a Target, Mallinckrodt’s rights in respect of the prosecution and enforcement of any Silence Background Patents and Silence Research Patents, including any Product Specific Patents, shall terminate. If Mallinckrodt has assumed the prosecution of any Product Specific Patent pursuant to Section 10.2.1, Mallinckrodt shall ensure that the prosecution of such Product Specific Patent(s) is transferred to Silence in a prompt and orderly fashion such that no deadline is missed in respect of such prosecution and/or enforcement and that the scope of such Patents is not limited or restricted as a consequence of such transfer. Unless and to the extent the Parties otherwise agree, |
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Mallinckrodt and Silence will continue to cooperate regarding prosecution and maintenance of any Joint Research Patents, in accordance with Section 10.2.3. |
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14.7.6 |
Confidential Information. Upon any termination of this Agreement with respect to a Target, each Party shall destroy, return or cause to be returned to the other Party all Confidential Information of the other Party relating to such Target as provided in Section 11.6. Upon any termination of this Agreement in its entirety, each Party shall destroy, return or cause to be returned to the other Party all Confidential Information of the other Party as provided in Section 11.6. |
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14.9 |
Accrued Rights; Surviving Obligations. Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. Without limiting the foregoing, the following Sections shall survive any such termination or expiration: [ARTICLE 1, Section 4.2.2 (to the extent specified in such Section), Section 5.8, Section 9.4, Section 9.5, Section 9.6, Section 9.7, Section 10.1, ARTICLE 11, ARTICLE 12 (to the extent applicable to continuing obligations under ARTICLE 13), ARTICLE 13, and Sections 14.7, 14.8, 14.9, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 15.10, 15.11, 15.12, 15.13 and 15.14]. |
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MISCELLANEOUS
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15.3.1 |
in connection with a Change of Control Transaction, subject to and as further set out in Section 4.9; or |
The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties, and the name of a Party appearing herein will be deemed to include the name of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Section 15.3. Any assignment not in accordance with this Section 15.3 shall be null and void.
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15.5 |
Governing Law. This Agreement or the performance, breach, or termination hereof shall be interpreted, governed by, and construed in accordance with the laws of [***], excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction; provided, that all questions concerning (a) inventorship of Patents under this Agreement shall be determined in accordance with Section 10.1.1 and (b) the construction or effect of Patents shall be determined in accordance with the laws of the country or other jurisdiction in which the particular Patent has been filed or granted, as the case may be. The parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods. |
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15.6 |
Dispute Resolution. Except for disputes resolved by the procedures set forth in Sections 2.7.2 and 9.6, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a “Dispute”), it shall be resolved pursuant to this Section 15.6. |
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15.6.1 |
General. Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within [***] days (or such other period of time as mutually agreed by the Senior Officers) after such issue was first referred to them, then, except as otherwise set forth in Section 15.6.2 and Section 15.6.5, if a Party wishes to pursue further resolution of such Dispute, such Dispute shall be subject to exclusive jurisdiction of the courts of [***] or, if the Parties mutually agree, the Parties may initiate arbitration proceedings pursuant to the procedures set forth in Section 15.6.3 for purposes of having the matter finally settled. EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION BETWEEN THE PARTIES, DIRECTLY OR |
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INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH THIS AGREEMENT OR ANY TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY, OR ANY DISPUTES RELATED HERETO OR THERETO. EACH PARTY HERETO (A) CERTIFIES THAT NO AGENT, REPRESENTATIVE OR ATTORNEY OF THE OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS SET FORTH IN THIS SECTION 15.6.1. |
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15.6.2 |
Intellectual Property Disputes. In the event that a Dispute arises with respect the validity, scope, enforceability, inventorship or ownership of any Patent, trademark or other intellectual property rights, and such Dispute cannot be resolved in accordance with Section 15.6.1, unless otherwise agreed by the Parties in writing, such Dispute shall not be submitted to arbitration in accordance with Section 15.6.3 and instead, either Party may initiate litigation in a court of competent jurisdiction, in accordance with Section 15.5, in any country or other jurisdiction in which such intellectual property rights apply. |
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15.6.4 |
Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 15.6 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction, or other interim equitable relief concerning a Dispute prior to or following the initiation of arbitration procedures set forth in Section 15.6.3, if necessary to protect the interests of such Party. This Section shall be specifically enforceable. |
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15.6.5 |
Baseball Determination. Any Dispute for which determination pursuant to this Section 15.6.5 is specifically provided for in this Agreement shall be finally decided by expedited expert determination in accordance with the following procedures: |
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(c) |
Within [***] Business Days after the appointment of the Neutral Expert, each Party shall submit to the other Party and the Neutral Expert a written summary regarding its position with respect to the Dispute. Contemporaneously with the submission of its written summary regarding its position, each Party shall provide the other Party and the Neutral Expert with copies of all documents it relied upon in its written summary; provided that each Party may redact any portion of such documents which are covered by an applicable privilege or do not relate to the subject matter of this Agreement. Within [***] Business Days after receipt of the other Party’s written summary regarding its position, each Party may submit an opposition statement. Neither Party will be allowed to conduct any discovery. Neither Party may have any communications (either written or oral) with the Neutral Expert other than for the sole purpose of engaging the Neutral Expert or as expressly permitted in this Section 15.6.5; provided, that oral presentations and follow-up written submissions may be made to the Neutral Expert at such Neutral Expert’s request. Evaluating each Party’s written submissions, the Neutral Expert shall, within [***] Business Days after receipt of the written opposition statements, evaluate each Party’s written submissions and select which of either Mallinckrodt’s submission or Silence’s submission most closely reflects the intent of the Parties with respect to the relevant subject matter (i.e. [***]) and determine the manner in which the expenses and fees of the Neutral Expert shall be allocated. Such decision shall be final, binding and not appealable. |
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15.7 |
Notices. Any notice or other communication required under this Agreement shall be in writing, shall refer specifically to this Agreement, and shall be deemed given only if (a) delivered by hand or (b) sent by internationally recognized overnight delivery service addressed to the Parties at their respective addresses specified below or to such other address as a Party may specify in accordance with this Section 15.7. Such notice shall be deemed to have been given as of the date delivered by hand or on the second business day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 15.7 is not intended to govern the day-to-day business ommunications necessary between the Parties in performing their obligations under the terms of this Agreement. |
If to Mallinckrodt, to:
Mallinckrodt Pharma IP Trading DAC c/o Mallinckrodt LLC
000 XxXxxxxxx Xxxx.
Xxxxxxxxx, XX 00000
Telephone: (000) 000-0000
Fax: (000) 000-0000
Attention: Xxxxx Xxxxxxxx, Associate General Counsel – Business Development
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Xxxxxxxxx Xxxxxx
Xxxxx Xxxx Xxxxxxxx Xxxxxxx LLP 000 X. Xxxxxxxx, Xxxxx 0000
Xx. Xxxxx, XX 00000 Telephone: (000) 000-0000
Fax: (000 000-0000
If to Silence, to:
Silence Therapeutics Plc 00 Xxxxxxxxxxx Xxxx Xxxxxx X00 0XX Xxxxxx Xxxxxxx
Attention:JohnStrafford, VP, Head of Business Development
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15.11 |
No Benefit to Third Parties. Except as provided in ARTICLE 13, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons. |
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{SIGNATURE PAGE FOLLOWS}
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THIS LICENSE AND COLLABORATION AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date.
MALLINCKRODT PHARMA IP |
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By: |
/s/ Xxxxxxxx X. Xxxxxx |
Name: |
Xxxxxxxx X. Xxxxxx |
Title: |
Director and Company Secretary |
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SILENCE THERAPEUTICS PLC |
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By: |
/s/ Xxxxx Xxxx Xxxxxxx |
Name: |
Xxxxx Xxxx Solomon |
Title: |
CEO |
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