Recent Updates
Recently added Catalysts
LEGN Positive Sentiment Score: 70/100

Certain information contained in this document, marked by brackets, has been omitted because it is both not material and would be competitively harmful if publicly disclosed. MASTER TECHNOLOGY TRANSFER, MANUFACTURING AND

Key Takeaway: Legend Biotech USA Inc. and Janssen Research & Development have entered into a Master Technology Transfer, Manufacturing, and Clinical Supply Services Agreement for a BCMA CAR-T product. The agreement involves collaboration with Novartis Pharmaceuticals and outlines responsibilities regarding data management, product supply, and operational execution. It emphasizes regulatory compliance, data protection, and the potential for continued partnerships in cell and gene therapy. This formal agreement marks a significant step in advancing their shared clinical goals in oncology.

Market Sentiment Analysis

POSITIVE FACTORS

  • Establishment of a formal agreement for technology transfer and services.
  • Collaboration between significant pharmaceutical companies (Janssen, Legend, and Novartis) indicates strong industry partnerships.
  • Focus on compliance and best practices for data protection and manufacturing standards.
  • Potential for development of innovative BCMA CAR-T product leading to advancements in oncology.

Full Press Release Details

[***] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and would be competitively harmful if publicly disclosed.
MASTER TECHNOLOGY TRANSFER, MANUFACTURING AND CLINICAL SUPPLY SERVICES AGREEMENT FOR BCMA CAR-T PRODUCT
This Master Technology Transfer, Manufacturing and Clinical Supply Services Agreement for BCMA CAR-T Product is effective as of the date of last signature hereto (the "Effective Date"),
by and among Janssen Research & Development, LLC, having a business address at 920 US Route 202, Raritan, NJ 08869 (hereinafter referred to as "Company"), Legend Biotech USA Inc., having a business address at 2101 Cottontail Lane, Somerset, NJ 08873 (hereinafter referred to individually as "Legend" and collectively with Company
as "Collaboration Partners") and Novartis Pharmaceuticals Corporation, having a business address at One Health Plaza, East Hanover, NJ 07936 (hereinafter referred to as "Provider"). Company, Legend and Provider may be hereinafter referred to collectively as the "Parties" and individually as a "Party". For
the avoidance of doubt, each reference herein to the Collaboration Partners shall refer to each of Legend and Company, and not either Party on behalf of both Legend and Company, unless the Agreement expressly provides otherwise.
WHEREAS, Company's Affiliates, Janssen Biotech, Inc. and Janssen Pharmaceutica NV, together with Legend and Legend Biotech Ireland Limited, are parties to a Collaboration and License Agreement effective December 21,
2017, as amended ("Collaboration and License Agreement"), related to an autologous BCMA CAR-T cell therapy product in the oncology field; and
WHEREAS, Provider has facilities and capabilities related to the development and manufacturing of cell and gene therapy products for use in clinical and/or non-clinical research and is interested in performing contract
manufacturing services for Collaboration Partners related to their BCMA CAR-T Product, and Collaboration Partners wish to engage Provider to perform such services. In furtherance of the foregoing, Company and Provider have entered into the Technology
Transfer Agreement and the Parties have entered into the Equipment Letter Agreement; and
WHEREAS, Collaboration Partners have assigned Company to be the lead contact for the management and operational execution of this Agreement with Provider.
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below, the Parties, intending to be legally bound, hereby agree as follows:
Provider will keep complete and accurate records in their original or validated format, the scope of which is defined in the applicable Quality Agreement [***]
(collectively, the "Records"). Records will be available at reasonable times for inspection, examination and copying by or on behalf of the Collaboration Partners upon [***]
Business Days' prior written notice; provided, however, that in the event of a regulatory inspection, audit or request from a Regulatory Authority, such Records will be available upon [***] Business Days' notice. Collaboration Partners and Provider will each retain and archive all of its respective original Records of the Manufacture of each Product under this Agreement in accordance with the timelines and
requirements set forth in the applicable Quality Agreement and all Applicable Law, but in no case for less than a period of [***] years following delivery of such Product. Upon Company's request, Provider will
promptly provide copies of such Records to the Collaboration Partners. Provider will not destroy any Records without prior written notification to Collaboration Partners and, if requested by Company, will provide such Records to Collaboration Partners
in lieu of such destruction. [***].
The term of this Agreement will begin on the Effective Date and end [***] years thereafter, unless sooner terminated in
accordance with the terms of this Agreement (the "Term"). This Agreement will remain in effect after any expiration of the Term for the sole purpose of and until the completion of all Work Orders hereunder and
the performance of all of Provider's duties with respect to all Services being conducted pursuant to Work Orders entered into or Purchase Orders issued during the Term.
During the Term and the term of each applicable Work Order, and notwithstanding Provider's compliance with the Johnson & Johnson Policy on Data Safeguards attached hereto as Exhibit H (Data
Safeguards) and the Cybersecurity Requirements attached hereto as Exhibit I (Cybersecurity Requirements), Provider has developed, implemented and maintains a business continuity plan (as updated from time to time) for the Facility (the "BCP"), [***]. With respect to Records, such BCP requires Provider to, and Provider shall, use all commercially reasonable and appropriate industry standard measures and
processes to ensure that all data collected and stored by Provider in the course of providing the Services is safeguarded against loss, damage and destruction arising from any cause, including, but not limited to, theft, fire, flood, earthquake,
lightening and electrical disruption. Such measures and processes shall include, but not be limited to []. With respect to the supply of Product, []. [***].
Prior to Provider processing any Personal Information under this Agreement, the Parties shall finalize and document a policy regarding the protection of such Personal Information. Once finalized, the
Parties shall attach such policy to this Agreement as Exhibit F (Protection of Personal Data), and Provider shall comply with such policy.
Provider shall maintain in full force and effect valid and collectible insurance policies in connection with the Services, which policies shall be in compliance with Exhibit G (Insurance
Requirements) attached to this Agreement.
If reasonably requested by Company (such requests to be limited to once per calendar year), Provider shall provide Collaboration Partners, with a financial reconciliation of funds paid by Company for
Services performed by Provider.
Provider, or where applicable, its Subcontracted Parties, shall at all times be and remain the sole employer of persons assigned to the performance of the Services hereunder and shall assume any and
all obligations, responsibilities and risks related to such employment and the possible termination thereof. No Party shall have any responsibility for the hiring, firing or compensation of any other Party's employees or for any employee benefits.
Neither this Agreement nor any Work Order implies an exclusive undertaking on the part of Collaboration Partners or Provider. [***], nothing contained herein
shall be interpreted as an obligation of the Collaboration Partners to commit to a certain volume, value or frequency of services to be assigned to Provider, and the Collaboration Partners may contract with other provider(s) for the procurement of
comparable services. Without limiting the foregoing, Provider agrees that the Collaboration Partners have the right to benchmark, formally or informally, any services offered by Provider or any terms of this Agreement or Work Order and to competitively
bid any projects it may have.
No Party may assign any of its rights or obligations under this Agreement, any Work Order or the Quality Agreement without the prior written consent of, [***].
Notwithstanding the foregoing, this Agreement, any Work Order, or any Quality Agreement (if applicable) may be assigned, in whole or in part, [***]. Any attempted assignment by a Party in violation of this
Section shall be null and void ab initio. This Agreement shall bind and inure to the benefit of the Parties hereto and their respective successors and permitted assigns.
Provider is a certified member of the Customs-Trade Partnership Against Terrorism ("C-TPAT") program of the U.S. Bureau of Customs and Border Protection. As
such, Provider has reviewed its supply chain security procedures and these procedures and their implementation are, and shall remain during the Term, in accordance with the importer security criteria set forth by C-TPAT.
Provider and its officers have read and understand the Johnson & Johnson Policy for Wood Pallets ("Pallet Policy") in effect as of the Effective Date and set
out in Exhibit K (Johnson & Johnson Policy for Wood Pallets), as updated from time to time by Company (to the extent that such update is generally applicable to Company's service providers), and Provider agrees that it shall comply with the
Pallet Policy. Provider shall certify compliance with such Pallet Policy at least annually. Such certification shall be sent to Company pursuant to the notice provisions set forth herein. Company has the right to reject any Products or materials
that fail to comply with this Pallet Policy.
If any Party is affected by any event beyond its reasonable control, including fires, floods, earthquakes, hurricanes, embargoes, war, acts of war (whether war is declared or not), terrorist acts,
civil commotion, strikes, lockouts, or other labor disturbances, or acts of God (a "Force Majeure Event"), such Party shall not be liable in connection with this Agreement, any Work Order or any Quality Agreement
to the extent affected by such Force Majeure Event; provided that such affected Party (the "Force Majeure Party") gives written notice as soon as reasonably practicable, to the other Parties of the Force Majeure
Event and that Force Majeure Party exercises commercially reasonable efforts to eliminate the effects of the Force Majeure Event on the Services, this Agreement, a Work Order or the Quality Agreement as soon as and to the extent practicable. If any
Force Majeure Event affecting Provider continues for a period longer than [***], then Company may terminate this Agreement and/or the applicable Work Order upon written notice to Provider. This Section does not
limit or alter a Party's right to terminate this Agreement, or any Work Order as set forth in Section 11 (Termination) or Section 14.4 (Notice). A performance failure of a Subcontracted Party of Provider will not be a Force Majeure
Event for Provider unless the Subcontracted Party's performance failure was caused by a Force Majeure Event.
No employee or representative of a Party shall have any authority to bind or obligate any other Party to this Agreement, each Quality Agreement or any Work Order for any sum or in any manner
whatsoever, or to create or impose any contractual or other liability on any other Party without said other Party's written approval. For all purposes, and notwithstanding any other provision of this Agreement, any Work Order or any Quality Agreement
to the contrary, each Party's legal relationship with one another under this Agreement, each Work Order and each Quality Agreement (as applicable) shall be that of independent contractor.
In the event that a court of competent jurisdiction holds any provision of the Agreement, any Work Order or any Quality Agreement to be invalid, such holding shall have no effect on the remaining
provisions of the Agreement, the applicable Work Order and/or the applicable Quality Agreement and they shall continue in full force and effect.
The failure of any Party to require performance by another Party of any of such other Party's obligations hereunder shall in no manner affect the right of the first Party to enforce the same at a later
time. No waiver by any Party hereto of any condition, or of the breach of any provision, term, representation or warranty contained in the Agreement shall be deemed to be or construed as a further or continuing waiver of any such condition or breach,
or of any other condition or of the breach of any other provision, term, representation, or warranty in this Agreement. The remedies provided in this Agreement are not exclusive and the Party suffering from a breach or default of this Agreement may
pursue all other remedies, both legal and equitable, alternatively or cumulatively.
Novartis Pharmaceuticals Corporation
With a copy to (which does not constitute notice):
Novartis Pharmaceutical Manufacturing GmbH
Janssen Research & Development, LLC
Attention: Head, Discovery, Product Development, and Supply
Office of General Counsel
1 Johnson & Johnson Plaza
New Brunswick, NJ 08933
Attention: General Counsel, Pharmaceuticals
Legend Biotech USA Inc.
2101 Cottontail Lane
Attention: Senior Vice President, Technical Operations
With a copy to (which does not constitute notice):
Legend Biotech USA Inc.
2101 Cottontail Lane
Attention: General Counsel
This Agreement, the Technology Transfer Agreement, the Equipment Letter Agreement, each Work Order and each Quality Agreement represents the entire and integrated agreement between the Parties with
respect to the subject matter herein and supersedes all prior negotiations, representations or agreements, either written or oral, regarding the performance of the Services. All services performed by Provider under the Technology Transfer Agreement
shall be considered performed under this Agreement. No additional or different terms or conditions, whether set forth in an invoice, or other document shall be effective to bind any Party. No amendment, change or modification of this Agreement will be
effective unless in writing and signed by the Parties. No amendment, change or modification of any Work Order or any Quality Agreement will be effective unless in writing and signed by the Parties thereto.
If there is any conflict, discrepancy, or inconsistency between the terms of this Agreement, the Technology Transfer Agreement, the Equipment Letter Agreement and any Quality Agreement, this Agreement
will govern. In the event of a conflict between this Agreement and any Work Order, this Agreement will govern unless this Agreement provides that the Work Order governs for that specific matter.
This Agreement contains headings only for convenience and the headings do not constitute or form a part of this Agreement and should not be used in the construction of this Agreement.
Except as provided under Section 17 (Indemnification), the representations, warranties, covenants and agreements set forth in this Agreement, each Work Order and each Quality Agreement are for
the sole benefit of the Parties hereto and their successors and permitted assigns, and they will not be construed as conferring any rights on any other persons.
The Parties shall not collude on commercial strategies, neither expressly nor tacitly, aimed at directly or indirectly influencing prices or allocating customers or geographic territories. The Parties
agree to adhere to all competition laws, as applicable, prohibiting any discussion, understanding or agreement, however informal, or the exchange of information on: product pricing; costs of production or distribution; projected or actual sales or
marketing strategies; projected or actual market shares; terms and conditions of purchases or sales; confidential research and development projects, budgets, spend, or priorities; bids or intentions to bid for particular products; or refusals to do
business with particular suppliers, vendors, customers or competitors, or the suggestion that such a refusal or boycott might be appropriate or desirable.
Company has a policy of maximizing opportunities for small, disadvantaged and women-owned businesses where appropriate when working with suppliers who offer further subcontracting opportunities. When
these conditions exist, Provider shall carry out this policy in good faith in connection with the award of permitted subcontracts to the fullest extent consistent with its efficient performance of this Agreement.
This Agreement may be executed in counterparts where execution in counterparts is valid and enforceable, and each such counterpart shall be an original and all such counterparts together shall
constitute the entire Agreement. Facsimile signatures and photocopied signatures transmitted by email shall be deemed to be originals for all purposes under this Agreement where facsimile and photocopied signatures are valid and enforceable. This
Agreement, each Work Order, each Quality Agreement and any amendment to this Agreement, a Work Order or a Quality Agreement may be signed electronically as long as (a) electronic signatures are valid and effective in the jurisdiction in which such
instrument is signed, and (b) electronic signatures are permitted by Company's policies as in effect from time to time and authenticated in accordance with such policies.
[Signature page follows]
IN WITNESS WHEREOF, each Party has caused this Agreement to be executed by its duly authorized representatives, on the date set forth below. The Parties agree to execute this Agreement by way of an electronic signature

Frequently Asked Questions

What is the effective date of the agreement?

The agreement becomes effective on the date of the last signature.

Who are the collaboration partners in this agreement?

The collaboration partners are Janssen, Legend Biotech, and Novartis.

How long does the agreement last?

The term lasts for a specified number of years, unless terminated earlier.

What type of services does the provider offer?

The provider offers contract manufacturing services for BCMA CAR-T products.

What happens to records after the agreement ends?

Records must be retained for a minimum number of years post-delivery.

Last updated: Apr 14, 2023