Shionogi – GARDP, Cefiderocol License Agreement

Liability | Indemnification & liability

Summary of Approaches

What occurrences could result in a liability claim against which one party will indemnify the other?
- GARDP must indemnify Shionogi for liability arising from (a) the activities that either GARDP or GARDP sublicensees conduct pursuant to the Agreement, Collaboration Agreement or any sublicense agreement; (b) breaches of the Agreement or Collaboration Agreement; (c) negligence or misconduct; (d) breaches of any sublicense agreement; and (e) GARDP or GARDP sublicensee use of Shionogi background or foreground IP.
- Shionogi must indemnify GARDP for liabilities arising from either (a) material breaches of written warranties in sections 7.2 and 7.3, which concern Shionogi’s intellectual property and other matters; or (b) gross negligence or willful misconduct in connection with performing the Agreement.
- Sublicences must include indemnification provisions that hold Shionogi harmless on the same terms as the Agreement.
- Sublicense provisions: The sublicensee must indemnify Shionogi for liability arising from (a) its activities under the sublicense agreement; (b) material breach sublicense agreement; (c) negligence or misconduct; (d) use of the licensed rights including claims related to product liability, infringement of third party IP and/or failure to comply with applicable laws.
Are there any circumstances under which one party will not indemnify the other?
- Indemnification is not required when the liability arises from the indemnitee’s own breaches of the Agreement’s representations and warranties, gross negligence or willful misconduct.
- Shionogi is not required to indemnify GARDP or GARDP sublicensees when Shionogi exercises its right to suspend or terminate the performance of the Agreement or sublicenses to avoid liability for violating sanctions, export control or similar laws.
- Shionogi is not required to indemnify GARDP or GARDP sublicensees for any consequences arising from modifications made to Shionogi’s manufacturing processes.
- Shionogi is not required to indemnify GARDP or GARDP sublicensees for third-party infringement claims absent Shionogi’s breach of its IP ownership and noninfringement representations
- The Agreement may limit indemnification when the party seeking indemnification fails to mitigate its losses.
What is the process for managing liability claims?
- Each party must promptly notify the other when it learns of a third party claim for which indemnification may be sought. If the party seeking indemnification (Indemnified Party) fails to do so, it becomes ineligible for indemnification if the other party (Indemnifying Party) is actually prejudiced.
- The Indemnifying Party has the right to exclusive control over defending the third-party claim and must consent to any settlement, admission, or “material prejudice” to the defense. The Indemnified Party’s consent is required for settlement or entry of judgment.
- The Indemnified Party must reasonably cooperate at the Indemnifying Party’s expense.
- The Indemnified Party may participate and have separate counsel. The Indemnified Party bears its own participation expenses, except in certain circumstances.
- Sublicense provisions: The sublicense provisions follow those in the head license.
Is there any limitation or monetary cap on each party’s liabilities under the agreement?
- The Agreement disclaims special, incidental, punitive or indirect damages arising from breaches of, and activities conducted in connection with, the Agreement.
- The exceptions to the limit on liability are (a) breaches of the Agreement’s confidentiality provisions, (b) gross negligence, fraud or willful misconduct; and (c) indemnification claims.
- The amount of Shionogi’s liability is limited to the greater of either (a) the total cost recoupment fees it has received or (b) the insurance proceeds paid to Shionogi in connection with the claim.

Annotations

This License and Technology Transfer Agreement is between Shionogi, a public pharmaceutical company located in Japan, and the Global Antibiotic Research and Development Partnership (“GARDP”), a Swiss nonprofit antibiotic R&D organization. The Agreement governs a non-exclusive license of Shionogi technology relating to the antibiotic drug cefiderocol and technology transfer necessary for third party sublicensees to develop and commercialize the drug in a list of high-, middle-, and low-income countries (“Territory”). The Agreement is effective as of June 15, 2022.

The Agreement includes provisions for the sublicense agreements between GARDP and third parties in Schedule F. We have included these provisions under the relevant MAPGuide issues as part of our analysis of the agreement.

The Agreement is part of a broader collaboration between the Clinton Health Access Initiative (“CHAI”), Shionogi and GARDP, which is governed by a separate agreement (“Collaboration Agreement”). The Collaboration Agreement addresses operational aspects of the collaboration, including a “Market Access Plan”, which plans and tracks the specific activities required of Shionogi and GARDP. The collaboration aims to achieve both affordable and sustainable access to medication and good antimicrobial stewardship.

Shionogi’s primary role in the Agreement is to license cefiderocol technology, provide an initial technology transfer and grant access to data already submitted to regulatory authorities. GARDP’s role is to manage a network of sublicensees to develop and commercialize cefiderocol. However, Shionogi has significant control over sublicensing. Some notable examples include: the right to refuse proposed sublicensees and proposed sublicense access plans, which set forth sublicensee commercialization plans. Shionogi also has the right to veto proposed development activities, including clinical trials, regulatory filings and trademarks. GARDP and GARDP sublicensees are jointly and severally liable for sublicensees for certain breaches of the Agreement or relevant sublicense agreement.

While Shionogi must refer enquiries from potential sublicensees to GARDP for joint evaluation, Shionogi ultimately may decide to directly license the technology for commercialization in the same territory.

Provision Language

2. LICENSE GRANTstrong>span>p>
2.9 OFAC Licensesb>p>
(b) […] in the event that performance of the License Agreement or any Sublicense Agreement by GARDP or its Sublicensee would (or might), in the reasonable opinion of Shionogi, breach, or expose Shionogi to potential liability under, any Sanctions or export control regime or any other similar laws of any jurisdiction (whether or not such Sanctions, controls, or laws were in existence at the date of this License Agreement, and whether or not there have been any other changes in circumstance from those that existed at the Effective Date of this License Agreement or execution date of any Sublicense Agreement), Shionogi shall be entitled to immediately request that GARDP or its Sublicensees (i) cease all shipments of Licensed Compound or Licensed Product into any country or territory that is the target of countrywide or territory–wide Sanctions, or (ii) if the Licensed Compound or Licensed Product is already in such country or territory but still within the custody and control of GARDP, its Sublicensees or its respective agents or representatives, to use its reasonable best efforts to remove such Licensed Compound or Licensed Product from the country or territory, or (iii) suspend the operation of such provisions of the License Agreement or relevant Sublicense Agreement(s) (including any supply provisions) which require or permit performance by either Party or the Sublicensee which, in the reasonable opinion of Shionogi, would result in a breach of, or expose Shionogi to potential liability under, any such Sanctions, controls, or laws, until, in the reasonable discretion of Shionogi, such time as all necessary approvals or licenses have been obtained to enable the License Agreement to continue in a lawful and compliant manner and without exposure to liability for Shionogi. Notwithstanding any provision of the License Agreement or the relevant Sublicense Agreement(s), Shionogi shall not be obliged to pay any compensation to GARDP or any Sublicensee or otherwise indemnify them in respect of any losses or costs which they may suffer or incur as a result of such suspension and/or termination.span>p>
7.REPRESENTATIONS AND WARRANTIESstrong>span>p>
[…]p>
7.3 Representations, warranties and covenants of GARDPb>p>
[…]p>
(vi) any modifications to the <a href=”#kt“>Manufacturing a> process or compound technology will be undertaken at the Sublicensees’ sole risk and in no event will Shionogi indemnify, hold harmless, or defend GARDP or any Sublicensees for any consequences of such modifications; span>p>
[…]p>
7.6 Limitation of liability b>p>
IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL, PUNITIVE OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THE LICENSE AGREEMENT OR THE ACTIVITIES CONDUCTED BY SUCH PARTY PURSUANT TO THE LICENSE AGREEMENT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES ARISING OUT OF ANY BREACH OF THE LICENSE AGREEMENT OR THE ACTIVITIES CONDUCTED BY SUCH PARTY PURSUANT TO THE LICENSE AGREEMENT. THE FOREGOING LIMITATIONS DO NOT APPLY TO CLAIMS BASED ON: (1) THE BREACH OF ITS CONFIDENTIALITY OBLIGATIONS, (2) A PARTY’S GROSS NEGLIGENCE, FRAUD, OR WILLFUL MISCONDUCT, OR (3) A PARTY’S INDEMNIFICATION OBLIGATION UNDER SECTION 11. span>p>
NOTWITHSTANDING THE FOREGOING, ANY AMOUNTS DUE TO GARDP FROM SHIONOGI AND/OR ITS AFFILIATES WITH RESPECT TO THE ACTIVITIES CONTEMPLATED BY THE LICENSE AGREEMENT, WHETHER BY MEANS OF INDEMNIFICATION OR OTHERWISE, SHALL BE LIMITED TO THE GREATER OF (A) THE AGGREGATE TOTAL AMOUNT OF COST RECOUPMENT FEES RECEIVED BY SHIONOGI PURSUANT TO THE LICENSE AGREEMENT, AND (B) THE INSURANCE PROCEEDS ACTUALLY RECOVERED BY SHIONOGI FROM ITS INSURERS FOR THE CORRESPONDING CLAIM(S). For the avoidance of doubt, the fact that no amount will be due to GARDP unless insurance proceeds are received by Shionogi may not be used as a justification not to pay the corresponding insurance proceeds to Shionogi that would otherwise be due by the insurer.span>p>
8. INVENTIONS, PATENT MAINTENANCE, INFRINGEMENTb>span>p>
8.6 Enforcement of Licensed Rightsb>p>
[…]p>
(d) If the making, import, use, offer for sale, or sale of the Licensed Compound or the Licensed Product by or on behalf of GARDP or a Sublicensee infringe on the intellectual property rights of a Third Party in the Territory, GARDP or as applicable the Sublicensee will be solely responsible for such infringement, and Shionogi will not have any obligation to defend or indemnify GARDP or a Sublicensee with respect to any such claim, subject to <a href=”https://ghiaa.org/provision_document/shionogi–gardp–cefiderocol–license–agreement–16/” target=”_blank” rel=”noopener“>Section 7.2a>span>.span>p>
11. INDEMNITYb>span>p>
11.1 GARDP indemnity b>p>
GARDP will indemnify, defend and hold harmless Shionogi and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns, and representatives (span>Shionogi Indemniteeb>em>), from and against any and all claims, threatened claims, damages, losses, suits, proceedings, liabilities, costs (including reasonable legal expenses, costs of litigation and reasonable attorney’s fees) or judgments, whether for money or equitable relief, of any kind from a Third Party (including Sublicensees) (span>Losses and Claimsb>em>) arising out of or in connection with: span>p>
(a) any activities conducted by GARDP, its Affiliates, or Sublicensees pursuant to this License Agreement, the Collaboration Agreement or a Sublicense Agreement; span>p>
(b) any breach by GARDP of any of the provisions of this License Agreement or the Collaboration Agreement; span>p>
(c) any negligence or willful misconduct by or on behalf of GARDP; span>p>
(d) any breach of a Sublicense Agreement by GARDP or its Sublicensee; span>p>
(e) GARDP’s (or its Affiliates and its Sublicensee’s) use and practice of the Licensed Rights and <a href=”#kt“>Licensed Manufacturing Know-How a>, including claims and threatened claims based on: span>p>
(i) any product liability, bodily injury, risk of bodily injury, death, or property damage; span>p>
(ii) infringement or misappropriation of Third–Party patents, copyrights, trademarks, or other intellectual property rights; or span>p>
(iii) the failure to comply with applicable laws related to the matters referred to in the foregoing with respect to the Licensed Compound and/or any Licensed Product. span>p>
except in any such case for Losses and Claims to the extent arising out of or in connection with (i) a material breach by Shionogi or its Affiliates of any of its representations and warranties set forth in <a href=”https://ghiaa.org/provision_document/shionogi–gardp–cefiderocol–license–agreement–16/” target=”_blank” rel=”noopener“>Section 7.1 and 7.2a>span> of this License Agreement, or (ii) any gross negligence or willful misconduct by Shionogi or its Affiliates or agents in connection with their performance of or activities conducted under this License Agreement. span>p>
In addition to the foregoing, as a condition to the grant of each Sublicense Agreement, GARDP shall obtain a direct indemnification undertaking by each Sublicensee to Shionogi and its Affiliates requiring its Sublicensees to indemnify, defend and hold harmless Shionogi Indemnitees under the same terms as stated in this Section 11.1.span>p>
11.2 Shionogi indemnity b>p>
Shionogi will indemnify, defend and hold harmless GARDP and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns, and representatives (span>GARDP Indemniteeb>em>), from Losses and Claims to the extent arising out of or in connection with: span>p>
(a) A material breach by Shionogi or its Affiliates of any of its representations and warranties set forth in Section 7.1 and 7.2 of this License Agreement; or span>p>
(b) any gross negligence or willful misconduct by or on behalf of Shionogi or its Affiliates in connection with their performance of or activities conducted under this License Agreement, span>p>
except in any such case for Losses and Claims to the extent arising out of or in connection with (i) a material breach by GARDP or its Affiliates of any of its representations and warranties set forth in Section 7.1 and 7.3 of this License Agreement, or (ii) any gross negligence or willful misconduct of GARDP or its Affiliates or agents or any Sublicensee in connection with their performance of or activities conducted under this License Agreement or any Sublicense Agreement.span>p>
11.3 Indemnification Procedure b>p>
Each Party will promptly notify the other Party when it becomes aware of a Third Party claim (a span>Claimb>em>) for which indemnification may be sought hereunder. To be eligible to be indemnified for a Claim, a Person seeking indemnification (the span>Indemnified Partyb>em>) shall (i) provide the Party required to indemnify such Person (the span>Indemnifying Partyb>em>) with prompt written notice of the Claim giving rise to the indemnification obligation under this Section 11, provided that, the failure to provide such prompt notice shall not relieve the Indemnifying Party of any of its obligations under this Section 11 except to the extent the Indemnifying Party is actually prejudiced thereby; (ii) provide the Indemnifying Party with the exclusive ability to defend (with the reasonable cooperation of the Indemnified Party) against the Claim; and (iii) not settle, admit or materially prejudice the defense of the Claim, without the Indemnifying Party’s prior written consent. The Indemnified Party shall reasonably cooperate with the Indemnifying Party, at the Indemnifying Party’s expense, in the defense of any Claim. Notwithstanding the foregoing, the Indemnified Party shall have the right to participate in and have its own counsel participate in any action or proceeding for which the Indemnified Party seeks to be indemnified by the Indemnifying Party. Such participation shall be at the Indemnified Party’s expense, unless (i) the Indemnifying Party and the Indemnified Party shall have mutually agreed to the retention of such counsel or (ii) the named parties to any such proceeding (including any impleaded parties) include both the Indemnifying Party and the Indemnified Party and representation of both Parties by the same counsel would be inappropriate due to actual or potential differing interests between them. The Indemnifying Party’s obligations under Section 11, as the case may be, shall not apply to the extent of the Indemnified Party’s failure to take reasonable action to mitigate any Losses. The Indemnifying Party shall not settle or compromise, or consent to the entry of any judgment with respect to, any Claim, without the prior written consent of the Indemnified Party, which will not be unreasonably withheld or delayed.span>p>
Schedule F: Provisions for Sublicense Agreementb>span>p>
10. Indemnification by Sublicensee of Licensorstrong>p>
Sublicensee hereby agrees to defend, hold harmless and indemnify Licensor and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns, and representatives (Licensor Indemniteesstrong>em>), from and against any and all claims, threatened claims, damages, losses, suits, proceedings, liabilities, costs (including reasonable legal expenses, costs of litigation and reasonable attorney’s fees) or judgments, whether for money or equitable relief, of any kind from a Third Party (Losses and Claimsstrong>em>) arising out of or in connection with:p>
(a) any activities conducted by Sublicensee or its Affiliates pursuant to this Sublicense Agreement;p>
(b) any material breach by Sublicensee of any of the provisions of this Sublicense Agreement;p>
(c) any negligence or willful misconduct by or on behalf of Sublicensee;p>
(d) Sublicensee’s use and practice of the Licensed Rights and Licensed Manufacturing Know-How , including claims and threatened claims based on:p>
(i) any product liability, bodily injury, risk of bodily injury, death, or property damage;p>
(ii) infringement or misappropriation of Third–Party patents, copyrights, trademarks, or other intellectual property rights; orp>
(iii) the failure to comply with applicable laws related to the matters referred to in the foregoing with respect to the Licensed Compound and/or any Licensed Product.p>
11. Indemnification Proceduresstrong> 
Each Party will promptly notify the other Party when it becomes aware of a Third Party claim for which indemnification may be sought hereunder (a Claimstrong>em>). To be eligible to be indemnified for a Claim, a Person seeking indemnification (the “Indemnified Partystrong>em>”) shall (i) provide the Party required to indemnify such Person (the “Indemnifying Partystrong>em>”) with prompt written notice of the Claim giving rise to the indemnification obligation under this Section [X], provided that, the failure to provide such prompt notice shall not relieve the Indemnifying Party of any of its obligations under this Section [X] except to the extent the Indemnifying Party is actually prejudiced thereby; (ii) provide the Indemnifying Party with the exclusive ability to defend (with the reasonable cooperation of the Indemnified Party) against the Claim; and (iii) not settle, admit or materially prejudice the Claim, without the Indemnifying Party’s prior written consent. The Indemnified Party shall reasonably cooperate with the Indemnifying Party, at the Indemnifying Party’s expense, in the defense of any Claim. Notwithstanding the foregoing, the Indemnified Party shall have the right to participate in and have its own counsel participate in any action or proceeding for which the Indemnified Party seeks to be indemnified by the Indemnifying Party. Such participation shall be at the Indemnified Party’s expense, unless (i) the Indemnifying Party and the Indemnified Party shall have mutually agreed to the retention of such counsel or (ii) the named parties to any such proceeding (including any impleaded parties) include both the Indemnifying Party and the Indemnified Party and representation of both Parties by the same counsel would be inappropriate due to actual or potential differing interests between them. The Indemnifying Party’s obligations under Section [X], as the case may be, shall not apply to the extent of the Indemnified Party’s failure to take reasonable action to mitigate any Losses. The Indemnifying Party shall not settle or compromise, or consent to the entry of any judgment with respect to, any Claim, without the prior written consent of the Indemnified Party, which will not be unreasonably withheld or delayedp>

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