BIOTECHNOLOGY & PHARMACEUTICAL LICENSING AGREEMENT

Submitted by

Pooja Vikram and Sanjuktha A Yermal

15040141030, 15040141065

2015-20 Batch

Submitted to

Prof. Abhishek Sarma

Alliance School of Law

Alliance University, Bangalore

Date of Submission: 03.09.2019

 Abstract

Pfizer is one of the biggest pharmaceutical companies in UK whose main purpose is

grounded to fund programs that provide public benefit, advance medical care and
improve patient outcomes. The company believes that all people deserve to live
healthy lives and this drives out the desire to provide access to medicines that are safe,
effective and affordable.

Celgene is one of the biggest pharmaceutical companies in France working with the
vision of developing innovative medicines to change the lives of patients. Their
ambition is to build a world class biopharmaceutical laboratory dedicated to the
research, development and commercialization of innovative therapeutics in diseases
for which medical needs are important.

The main objective of this Agreement is to provide license to Celgene Company to

manufacture and sell the product “Oxecta”.
 BIOTECHNOLOGY & PHARMACEUTICAL LICENSING AGREEMENT

This Biotechnology and Pharmaceutical Licensing Agreement (“Agreement”) is entered

into on 17th September 2019(“effective date”) by and between:

(1) Pfizer Ltd., a Pharmaceutical company incorporated under the laws of United
Kingdom, with its registered office at Walton Oaks, Dorking Road, Tadworth KT20
7NS, United Kingdom.(“Pfizer”)

(2) Celgene, a Pharmaceutical company incorporated under the laws of France having its
principal place of business at La Defense, 2 Avenue Gambetta, 92066 Courbevoie,
France.(“Celgene”)

For the purpose of this Agreement, Pfizer and Celgene are hereinafter individually
referred to as “Party” and collectively referred to as “Parties”.

WHEREAS;

A. Pfizer is engaged in the business of discovering, developing and producing drugs and
vaccines, commercialization of biopharmaceutical products and facilitating access to
intellectual property on these medicines; and
B. Celegene is engaged in the business of specializing in the research, development and
commercialization of innovative therapeutics for diseases for which medical needs are
important.
C. The parties have entered into an Agreement whereby Pfizer has agreed to license
Oxecta (“Patented Drug”) to Celgene.

NOW, THEREFORE, in consideration of the promises and mutual obligations hereiafter

described, the receipt and sufficiency of which is hereby acknowledged, the Parties
hereby covenant and agree as follows:
1. GENERAL SCOPE
1.1 This Agreement specifies the terms and conditions under which Pfizer shall
license the Patented Drug to Celgene. In the event of a conflict or inconsistency
between the provisions of this Agreement and any amendment or addendum to
the same, the provisions of this Agreement will prevail and control in determining
the rights and liabilities of the Parties.
1.2 The Parties understand and acknowledge that this Agreement shall not prohibit
Pfizer from licensing the patented drug to any third party.
1.3 Pfizer shall license the patented drug subject to and in compliance with the terms
and conditions of this Agreement and all the applicable laws and regulatory
guidelines. Pfizer reserves the right to propose changes within this Agreement.
Such changes shall be discussed between the Parties in good faith and
incorporated into the Agreement as an amendment.

2. DEFINITIONS AND INTERPRETATION

2.1 Definitions
For the purposes of this Agreement, the following definitions shall apply:
“Affiliate” means, with respect to a particular Party, a person, a corporation, firm or
other entity that controls, is controlled by or is under the common control with
such Party. For the purposes of this definition, “control” means the actual power,
either directly or indirectly to direct or cause the direction of the management and
policies of such entity, whether by the ownership of more than fifty
percent(50%)of the voting stock of such entity, or by contractual arrangement or
otherwise;
“Business day” means a day other than Saturday, Sunday or any day on which
commercial banks located in United Kingdom are authorized or obligated by law
to close;
“Commercialization” or “Commercialize” means activities directed at obtaining
pricing and reimbursement approvals, marketing, promoting, distributing,
importing or selling a licensed product;
“Confidential Information” means and includes all technical and non-technical
information relating to the Product, technology, processes, tradesecrets, all
intellectual property related information, inventions, improvements, modifications
or discoveries, whether patentable or not, patent and patent applications,
 copyrights, tradesecrets technical/process/scientific information, study, drug,
research, experimental work, clinical development plans, protocols, data, know-
how, techniques, formulae, drug delivery regiments, materials, processes,
apparatus, equipment ,quality assurance and quality control development,
toxicology, pharmacology, test development methods and stability testing;
“Licensed Patent Rights” means:
(a) The patents and patent applications of Pfizer in the territory related to licensed
product;
(b) Any continuation, continuation in part, divisional and continued prosecution
applications of any patent applications included in paragraph (a);
(c) Any patents issuing from any patent applications included in the paragraphs
(a) and (b),

In each case including any renewals, extensions, patents of addition, supplementary

protection certificates, revivals, re-examinations, and reissues thereof;

“Licensed Products” means the patented pharmaceutical drug “Oxecta”, an

immediate release tablet formulation of the opioid analgesic oxycodone HCl.
Oxecta is specifically indicated for the management of acute and chronic
moderate to severe pain where the use of an opioid analgesic is appropriate;

“Person” means any individual, firm, corporation, partnership, Limited Liability

Company, trust, business trust, joint venture, governmental authority, associations
or other entities or other form of business organisations;

“Third Party” means any person other than Pfizer, Celgene and their respective
affiliates.

2.2 Interpretation
In this license Agreement:
(a) Clause headings are for convenience only and are not intended to affect the
interpretation of this license Agreement;
(b) Where any word or phrase has a defined meaning or any other form of that
word or phrase has a corresponding meaning;
(c) Words in the singular include the plural and vice-versa;
 (d) Any reference to “includes” or “including” are to be construed as indicative
and non-exhaustive lists;
(e) Unless otherwise specified or prevented by applicable laws, reference to
“writing” includes faxes, email, letters, digital signature or certificates or any
other legible form of writing;
(f) If a period of time is specified to the contrary, in the event of any
inconsistency between any clause, any attachment or other document
incorporated by reference, the clauses override the attachments, and the
attachments override any other incorporated documents incorporated by
reference, to the extent of any inconsistency.

3. LICENSE GRANT
3.1 Licensed patent rights
(a) Upon the terms and subject to the conditions set out in this Agreement, Pfizer
hereby grants to the licensee and the licensee hereby accepts, a non-exclusive,
non sub licensable, royalty bearing (under the conditions of clauses 3.3 and
4), non- transferable license under the licensed patent rights, the licensed
product anywhere in the world exclusively for ultimate use in the territory.
(b) Pfizer hereby agrees to grant to the Licensee, the right to manufacture and sell
the Licensed Product in the territory.
(c) The licensee will not have any rights to practice the license granted under this
clause 3.1 or otherwise exploit the licensed patent rights for any other
purpose.
3.2 Term of License Grant
The license granted to the licensee in clause 3.1 with respect to the licensed patent
rights will expire upon the expiration of the last to expire of the licensed patent
rights that are granted and in force, unless where terminated earlier in accordance
with clause 12.
3.3 No implied License
No license or other right is or will be created or granted under this Agreement by
implication, estoppels or otherwise. All licenses and rights are or will be granted
only as expressly provided in this Agreement.
 3.4 Retained Rights
(a) All rights not expressly granted under this Agreement are reserved by Pfizer
and may be used by Pfizer for any purpose.
(b) Without limiting the foregoing Pfizer retains any and all rights under the
licensed patent rights.
(c) Pfizer also expressly reserves and retains the right to make or have made and
use the licensed product for any internal research purpose.

4. ROYALTIES
4.1 Royalties Collection
(a) As a consideration for the license granted to the licensee under this
Agreement, the Licensee will be required to pay to Pfizer, for the duration of
the royalty term, a royalty of 3% on the net sales of the licensed products in
the territory where licensed patent rights are granted and in force.
(b) Royalty payments will be payable to Pfizer by the Licensee on a product by
product basis starting on the date of first commercial sale of a Licensed
Product continuing until the expiration of the last to expire Licensed Patent
Rights that are granted and in force (“Royalty Term”). Royalties will be
payable quarterly, 30 days following the end of every calendar quarter and be
paid by way of bank transfer to Pfizer’s designated bank account to be
communicated to the Licensee.
5. COMMERCIALIZATION
(a) The Licensee will be responsible, at its own expense, for the conduct of all
activities relating to the commercialization of the Licensed Products in the
territory.
(b) The Licensee will use all reasonable efforts to provide an adequate supply of
the Licensed Products to meet the therapeutic needs in the territory and will
provide a strong supply network to support the distribution of the Licensed
Products in the territory.
6. PHARMACOVIGILANCE AND QUALITY MATTERS.
6.1 Pharmacovigilance
(a) If the Licensee becomes aware of any adverse reaction relating to the licensed
product in connection with this Agreement, the Licensee must inform Pfizer
 within 24 hours of its becoming aware and co-operate with Pfizer in fulfilling
Pfizer’s reporting responsibilities under applicable laws and regulations.
(b) The Licensee will maintain effective and reliable systems for receiving and
tabulating any reports of adverse reactions to the Licensed Product and to
report such information on a timely basis to the relevant authorities and to
Pfizer pursuant to the terms of this Agreement.
6.2 Quality
The Licensee will manufacture the licensed product in a manner consistent with:
(a) World Health Organizations(WHO) prequalification standards; or
(b) The standards of any Stringent Regulatory Authority, defined as Regulatory
Authorities, which are members, observers or associates of the International
Conference of Harmonisation of technical requirements for registration of
pharmaceuticals for human use, as may be updated from time to time.
7. REPRESENTATIONS AND WARRANTIES
7.1 General
Each Party hereby represents, covenants and warrants to the other that:
(a) it is duly organized and validly existing under the Applicable Law of the
jurisdiction of its incorporation, and has full corporate power and
authority to enter into this Agreement and to carry out the provisions
hereof;
(b) it is qualified to do business and is in good standing in each jurisdiction in
which it conducts business;
(c) it is duly authorized to execute and deliver this Agreement and to perform
its obligations hereunder, and the Person executing this Agreement on its
behalf has been duly authorized to do so by all requisite corporate action;
and
(d) this Agreement is legally binding upon it and enforceable in accordance
with its terms and the execution, delivery and performance of this
Agreement by it does not conflict with any Agreement, instrument or
understanding, oral or written, to which it is a party or by which it may be
bound, nor violate any material Applicable Law;
(e) the performance of this License Agreement by either Party does not create
a breach or default under any other Agreement to which it is a party;
 (f) It will during the Term perform regular internal due diligence to ensure
ongoing compliance with all applicable laws and the terms of this
Agreement.
7.2 Representations, warranties and covenants of the Licensee
The Licensee warrants and covenants to Pfizer that:
(a) It has the capability and intent to manufacture the presentations and strengths
of the Licensed Products for ensuring access to appropriate and needed the
opioid analgesic oxycodone HCl formulations made possible through this
License Agreement;
(b) it will have and maintain suitable mechanisms in order to comply with all
applicable laws (including the UK Bribery Act) , in particular, Licensee will
not, directly or indirectly, offer, promise or give any financial or other
advantage and or pay money or anything of value to government officials,
political parties, candidates and any other person for the purposes of corruptly
obtaining or retaining business; Licensee will certify to Pfizer in writing, at
the frequency requested by Pfizer (and at least once annually), compliance
with their obligations under this Agreement (including compliance with the
UK Bribery Act 2010);
(c) all of its activities related to the use of the Licensed Patent Rights and
Licensed Manufacturing Know-How and the Development and
Commercialization of the Licensed Products pursuant to this Agreement will
comply with all applicable legal and regulatory requirements;
(d) it will not engage in any activities that use the Licensed Patent Rights and/or
Licensed Manufactured Know-How in a manner that is outside the scope of
the license rights granted to it under this Agreement and that any
modifications to the manufacturing process will be undertaken at the
Licensees’ sole risk and in no event will Pfizer indemnify, hold harmless or
defend the Licensee for any such modifications; and
(e) the Licensee acknowledges and agrees that Pfizer will have no liability
whatsoever in relation to any infringement of the intellectual property rights
of any Third Party arising out of the Development, manufacture and
Commercialization of the Licensed Products by the Licensee, except and only
to the extent that the Licensed Product incorporates any Pfizer’s Licensed
Manufacturing Know-How relied on by Licensee in such Development,
 manufacture and Commercialization of the Licensed Products by the
Licensee.

7.3 “AS IS” license

(a) Notwithstanding any other provision of this Agreement, the Licensee acknowledges
and agrees that the Licensed Patent Rights and Licensed Manufacturing Know-How
are licensed to Licensee “as is”.

(b) Notwithstanding any other provision of this Agreement, Pfizer makes no

representation or warranty of non-infringement or any representation or warranty that
the Licensed Patent Rights or Licensed Manufacturing Know-How is suitable for any
purpose for which it may be used by the Licensee.

7.4 Limitation of liability

Notwithstanding anything in this Agreement or otherwise, in recognition of the

humanitarian nature of this Agreement and the lack of any royalty to Pfizer or other
payments to Pfizer under this Agreement, Pfizer will not have any liability to the
Licensee for any indirect, special, consequential, punitive, exemplary or incidental
damages related to this Agreement, whether under contract, negligence, strict liability
or other legal or equitable theory. In particular, and without limiting the foregoing,
Pfizer will have no liability in the event the licensed patent rights are invalid or
unenforceable, or in the event the exercise by Licensee of its rights under this
Agreement infringes the intellectual property rights of any third party.

8. INFRINGEMENT

If any unauthorised person without the consent of Pfizer,

(a) where the invention is a product, makes, disposes of, offers to dispose of, uses or
imports the product or keeps it whether for disposal or otherwise;

(b) where the invention is a process, uses the process or he offers it for use in the United
Kingdom when he knows, or it is obvious to a reasonable person in the circumstances,
that its use there without the consent of the proprietor would be an infringement of the
patent;
(c) where the invention is a process, he disposes of, offers to dispose of, uses or imports
any product obtained directly by means of that process or keeps any such product
whether for disposal or otherwise,

Then the act of the unauthorised person constitutes infringement.

9. INVENTIONS AND PATENT MAINTENANCE

9.1 Inventions
(a) Pfizer (or its Affiliates) will own the entire right, title and interest in and to any and all
inventions conceived solely by its employees and agents after the Effective Date
relating to the Licensed Product, including any adaptation of any manufacturing
process or proprietary drug delivery or formulation technology of Pfizer or its
Affiliates for the production of the Licensed Product, and any patents covering such
invention( Pfizer’s Sole invention) ,subject to the license grant to the Licensee under
clause 2.
(b) The Licensee will own the entire right, title and interest in and to any and all
inventions conceived solely by its employees and agents after the Effective Date
relating to the Licensed Product in the Territory (but only to the extent separable from
Pfizer’s intellectual property) (Licensee’s Sole Inventions). The Licensee will notify
to Pfizer in writing of any such invention and Pfizer will automatically have a non-
exclusive, perpetual, worldwide, royalty-free license to use any such invention and
any related intellectual property, irrespective of expiration or termination of this
Agreement.

9.2 Patent maintenance and abandonment

Pfizer will be responsible (at its own expense and discretion) for, and will control, the
prosecution (including any interferences, reissue proceedings and re-examinations)
and maintenance of all Licensed Patent Rights in the Territory.

10. AUDIT AND REPORTS

10.1 Reports

The Licensee will send to Pfizer within 30 Business Days following the end of each
calendar quarter the number of units of Licensed Products sold in the territory.
Licensee agrees that information contained in quarterly and other such reports shall be
treated as Confidential Information.
 10.2 Audit

1) The Licensee grants to Pfizer the right, with reasonable notice, to:
a) Inspect and audit the performance of, and compliance with, this Agreement and
applicable laws; and
b) Inspect and audit all documents and other records relating to the performance of
this Agreement.

11. CONFIDENTIALITY

a) Confidential or proprietary information may include without limitation, technical,

clinical, manufacturing and commercial information, procedures, products,
formulations, policies and results(“Confidential Information”).The licensee agrees
not to disclose such confidential information to any person or entity without Pfizer’s
prior consent, and that the confidential information is and shall remain the sole and
exclusive property of Pfizer. Nevertheless such confidential information may be
disclosed to employees of the licensee and/or external consultants, sub contractors,
professional advisors who are engaged by the licensee, only on need to know basis,
with each of them bound by comparable obligations of confidentiality. However, the
licensee will in all events continue to be liable as a principle party for any breach of
the confidentiality obligation under this Agreement by its affiliates, directors,
employees, officers, consultants, agents, sub-contractors and professional advisors.
All obligations of confidentiality on the licensee hall survive for a period of fifteen
(15) years after the expiry or sooner termination of this Agreement.
b) The licensee agrees that any threatened or actual breach of any terms of this
Agreement including the confidential information obligation as per the paragraph (a)
above, by the licensee may cause irreparable loss to Pfizer and the said loss may not
be compensated by monetary compensation and, in addition to all other rights and
remedies that Pfizer may have under law and equity, Pfizer will have the right to seek
appropriate injunctive relief and/or, specific performance of the licensee’s obligations
from courts of competent jurisdiction.

12. INDEMNIFICATION

The licensee shall indemnify, keep indemnified, defend and hold harmless Pfizer, its
affiliates, their employees, directors and agents, from and against any and all losses,
 damages, liabilities, reasonable attorney fees, court cause, and expenses resulting or
arising from any third party claims, actions, proceedings, investigations or litigation
relating to or arising from or in connection with this Agreement.

13. TERM AND TERMINATION

13.1 Term

This Agreement will commence as of the Effective Date and, unless sooner terminated in
accordance with the terms of this Agreement or by mutual written consent, will expire
upon the expiration of the last-to-expire of the Licensed Patent Rights.

13.2 Termination

a) Any of the Parties will have the right to terminate this Agreement, at its sole
discretion, upon delivery of written notice to the other Parties, upon the occurrence of
any of the following:
(i) one of the other Parties becomes bankrupt, insolvent or cannot pay its debts when
due;
(ii) a material breach of this Agreement by another Party that is not cured within ninety
(90) days after written notice of such breach is given.
b) Pfizer may terminate this Agreement in its entirety upon thirty (30) calendar days’
prior written notice to Pfizer. Pfizer’s obligations in the event of such terminations
shall be limited to compensate the licensee up to the effective date of termination that
is accepted by Pfizer.

14. EEFECT OF EXPIRATION OR SOONER TERMINATION

14.1 Expiration or sooner termination of this Agreement shall not affect the rights and
obligations of the Parties accrued prior to the Effective date of expiration or
termination. The terms, provisions, obligations, warranties, representation and
covenants contained in this Agreement that by their nature and context are intended to
survive shall so survive expiration or termination of the Agreement.

14.2Within fifteen (15) calendar days of expiration or sooner termination of this

Agreement, licensee shall return and hand over to Pfizer all confidential information,
deliverables, all materials, samples received from Pfizer, all records, documents and
reports generated in connection with this Agreement.
15. DISPUTE RESOLUTION

Any dispute in respect of this Agreement may be referred to Arbitration by either party.
Such Arbitration may be conducted by a single arbitrator appointed by the mutual
consent of the parties and shall be conducted in accordance with the rules of
Arbitration of the International Chamber of Commerce (ICC).The decision of the
arbitrator shall befinal and binding and conclusive on the parties and the judgement
thereon may be entered into any court having jurisdiction over the parties and the
subject matter thereof.

16. MISCELLANEOUS

16.1 Severability

If any one or more of the provisions of this Agreement is held to be invalid or

unenforceable, the provision will be considered severed from this Agreement and will
not serve to invalidate any remaining provisions of this Agreement. The Parties will
make a good faith effort to replace any invalid or unenforceable provision with a valid
and enforceable one such that the objectives contemplated by the Parties when
entering this Agreement may be realized.

16.2 Notices

a) Any notice required or permitted to be given under this Agreement will be in writing
and will be delivered by hand or overnight courier with tracking capabilities or mailed
postage prepaid by first class, registered or certified mail addressed as set forth below
unless changed by notice so given:

(i) If to Pfizer:

Pfizer Ltd

Walton Oaks,

Dorking Road,

Tadworth KT20 7NS,

United Kingdom
Copy to: Head-Legal

Pfizer Ltd

(ii) If to Celgene:

Celgene

La Defense,

2 Avenue Gambetta,

92066 Courbevoie,

France

16.3 Force Majeure

If either party is delayed in performing an obligation under this Agreement by strike,

lockout, or other labour troubles of a third party; by restrictive governmental or
judicial order or by riots, insurrection, war, inclement weather, or Acts of God;
performance is excused for the period of such delay. The part affected by such Force
Majeure event shall promptly notify the other in writing of the delaying event. If such
delay continues for more than ninety (90) calendar days, the party not claiming Force
Majeure may terminate this Agreement.

16.4 Choice of law

This Agreement will be governed, and will be construed in accordance with the laws of
England without regard to its conflicts of law provisions.

16.5 Waiver and modifications

The failure of any Party to insist on the performance of any obligation under this
Agreement will not be deemed to be a waiver of such obligation. Waiver of any
breach of any provision of this Agreement will not be deemed to be a waiver of any
other breach of such provision or any other provision on such occasion or any
succeeding occasion. No waiver, modification, release or amendment of any
obligation under or provision of this Agreement will be valid or effective unless in
writing and signed by all Parties.
 16.6 Headings

Headings and captions are for convenience only and are not to be used in the
interpretation of this Agreement.

16.7 Entire Agreement

This Agreement constitutes the entire Agreement between the Parties as to the subject
matter of this Agreement, and supersedes and merges all prior negotiations,
representations, Agreements and understandings regarding the same.

16.8 Counterparts

This Agreement may be executed in counterparts with the same effect as if both Parties
had signed the same document. All such counterparts will be deemed an original, will
be construed together and will constitute one and the same instrument.

16.9 Assignment

Pfizer may assign any of its rights or obligations under this Agreement to any of its
affiliates in which event Pfizer will notify the licensee of such assignment. The
licensee shall not assign any of its rights or obligations under this Agreement to any
third party without the written consent of Pfizer.

IN WITNESS WHEREOF the Parties have caused this Agreement to be executed by

their respective duly authorized officers.

For an on behalf of

Pfizer Ltd:

Signature:__________

Name: __________

Title: __________

For an on behalf of

Celgene

Signature :___________
Name: ___________

Title:____________