Exhibit 10.10

 

***Certain portions of this exhibit have been omitted based on a request for
confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended. The omitted portions have been filed separately with the
Securities and Exchange Commission.

 

SERVICES AGREEMENT

 

Services Agreement (the “Agreement”) dated as of September 13, 2016 (the
“Execution Date”) is by and among ADAPTIMMUNE LIMITED (“Adaptimmune”), a limited
company registered in England and Wales having its principal office at 101 Park
Drive, Milton Business Park, Abingdon, Oxfordshire OX14 4RY, United Kingdom,
ADAPTIMMUNE LLC, a Delaware limited liability company, having its principal
office address at Two Commerce Square, Suite 1700, 2001 Market Street,
Philadelphia, PA 19103, USA (“Client”) and PCT, LLC, A CALADRIUS COMPANY, a
Delaware limited liability company having its principal office at 4 Pearl Court,
Suite C, Allendale, New Jersey 07401 (“PCT”). Each of Adaptimmune, Client and
PCT are referred to herein a “Party” and are collectively referred to as the
“Parties”.  This Agreement incorporates by reference the terms and conditions
set forth in Attachment A (“Attachment A”) attached hereto and made a part
hereof.  Capitalized terms not otherwise defined herein will have the meaning
set forth in Attachment A.  In consideration of the premises and mutual
covenants herein contained, the Parties hereby agree as follows:

 

DESCRIPTION – BACKGROUND

 

(1)      Client and Adaptimmune are engaged in the business of the development
of pharmaceutical products. Client wishes to manufacture certain pharmaceutical
products and, in connection therewith, to retain PCT to perform the services
described in this Agreement (the “Services”) through the provision by PCT of
certain personnel and dedicated facilities.  Adaptimmune owns or controls
certain intellectual property rights in relation to those pharmaceutical
products.

 

(2)      Client, Adaptimmune and PCT previously executed certain agreements
prior to the Execution Date for the manufacture and supply of cell therapy
products as more particularly described in such agreements (as amended,
collectively “Prior Agreements”).

 

(3)      This Agreement provides for PCT to (a) expand its current manufacturing
capacity at PCT’s Allendale, New Jersey Facility (the “Allendale Facility”) in
order for PCT to manufacture Client’s products as the Parties mutually agree to
manufacture pursuant to this Agreement (individually and collectively referred
to a “Product”) in support of Client’s anticipated clinical trials in both the
United States and Europe and (b) transition from a shared capacity manufacturing
model to a dedicated clean room and personnel model.

 

EFFECTIVE DATE OF SERVICES

 

Notwithstanding the Execution Date, this Agreement is effective as of October 1,
2016 (the “Effective Date”) and commencing on the Effective Date PCT will
provide Client with the services described in this Agreement (the “Services”) in
lieu of services set forth in the Prior Agreements. From and after the Effective
Date, this Agreement supersedes and replaces the Prior Agreements and as of the
Effective Date the Prior Agreements are terminated and no longer in force and
effect except for those obligations that survive termination of the Prior
Agreements as provided therein, such as payment obligations.  Close out
activities set forth in the Prior

 

 

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Agreements will not be performed unless the Parties otherwise mutually agree in
writing and Client will pay PCT for close out activities for any Product as
provided herein.  Storage of Product as described in the Prior Agreements will
be governed by this Agreement rather than the provisions, if any, set forth in
the Prior Agreements.

 

SCOPE OF WORK

 

(1)      Definitions.  The definitions set forth below shall apply to any
capitalised terms or expressions used in this Agreement:

 

(A)  “*** Audit Hours” has the meaning in Section 13(a) of Attachment A.

 

(B)   “Additional Audit Hours” has the meaning in Section 13(a) of Attachment A.

 

(C)   “Additional Runs” has the meaning set forth in Paragraph
2(E)(iii)(d) below.

 

(D)  “Additional Services” has the meaning in Section 17(m)(ii) of Attachment A.

 

(E)    “Affiliate” has the meaning in Section 17(d) of Attachment A.

 

(F)     “Allendale Facility” shall have the meaning given above.

 

(G)  “Alliance Manager” has the meaning in Section 2(d) of Attachment A.

 

(H)  “Applicable Laws” has the meaning in Section 2(a) of Attachment A.

 

(I)  “Assumptions” has the meaning in Section 7(a) of Attachment A.

 

(J)  “Attachment A” shall have the meaning given above.

 

(K)  “Attachment B” has the meaning set forth in Paragraph 2(D)(i) below.

 

(L)    “Attachment C” has the meaning in Section 9(d)(ii) of Attachment A.

 

(M)      “Audit” has the meaning in Section 13(a) of Attachment A.

 

(N)  “Audit Hours” has the meaning in Section 13(a) of Attachment A.

 

(O)  Automatic Room 6 Termination Date” has the meaning, as applicable, set
forth in Paragraph 2(D)(ii) or Paragraph 2(D)(iii) below.

 

(P)     “Business Day” means any day at the Allendale Facility other than a
Saturday, Sunday, the Friday after Thanksgiving or state and federal holidays.

 

(Q)  “Business Hours” are (1) 8:30 a.m. – 5:00 p.m. on any Business Day.

 

(R)   “CER” means a controlled environment room.

 

(S)     “***” has the meaning in Section 9(d)(ii) of Attachment A.

 

(T)     “Claims” has the meaning in Section 10(a) of Attachment A.

 

(U)  “CLBS” has the meaning in Section 17(i) of Attachment A.

 

(V)  “Client/Adaptimmune’s Agents” has the meaning in Section 10(a) of
Attachment A.

 

(W)     “Client Background Intellectual Property” has the meaning in
Section 6(b) of Attachment A.

 

(X)  “***” has the meaning in Section 9(d)(ii) of Attachment A.

 

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(Y)  “Client Mitigation Plan Request” has the meaning set forth in Paragraph
2(D)(xi) below.

 

(Z)    “Client’s Point of Contact” means *** or any other individual designated,
in writing, from Client to PCT as the individual at the Client that PCT is to
coordinate the Services hereunder.

 

(AA)  “COLA” has the meaning in Section 4(g) of Attachment A.

 

(BB)    “Confidential Information” has the meaning in Section 5(a) of Attachment
A.

 

(CC)    “Construction” has the meaning set forth in Paragraph 2(D)(i) below.

 

(DD)  “Consultations” has the meaning in Section 13(c) of Attachment A.

 

(EE)      “Defective Product” has the meaning in Section 3(b) of Attachment A.

 

(FF)  “Determination Date” has the meaning in Section 4(g) of Attachment A.

 

(GG)  “Disclosing Party” has the meaning in Section 5(a) of Attachment A.

 

(HH)  “Disputed Charges” has the meaning in Section 4(e) of Attachment A.

 

(II)  “Effective Date” shall have the meaning given above.

 

(JJ)  “EU Annex 1” means EudraLex, Volume 4, “EU Guidelines to Good
Manufacturing Practice, Medicinal Products for Human and Veterinary Use”, Annex
1, “Manufacture of Sterile Medicinal Products”.

 

(KK)  “Excess Audit Fees” has the meaning in Section 13(a) of Attachment A.

 

(LL)      “Execution Date” shall have the meaning given above.

 

(MM)    “Expense Prepayment” has the meaning in Section 8(a) of Attachment A.

 

(NN)        “Facility” has the meaning in Section 2(b) of Attachment A.

 

(OO)  “FDA” has the meaning in Section 4(c)(i) of Attachment A.

 

(PP)        “Fees” have the meaning set forth in Paragraph 6 below.

 

(QQ)  “Force Majeure” has the meaning in Section 15 of Attachment A.

 

(RR)    “GMP” has the meaning in Section 2(a) of Attachment A.

 

(SS)  “GMP Audit” has the meaning in Section 13(a) of Attachment A.

 

(TT)        “***” has the definition defined pursuant to the law of the State of
New York.

 

(UU)  “Improvements” has the meaning in Section 6(d) of Attachment A.

 

(VV)  “Indemnified Party” has the meaning in Section 10(d) of Attachment A.

 

(WW)  “Indemnifying Party” has the meaning in Section 10(d) of Attachment A.

 

(XX)  “Initial Room 1 Services” has the meaning set forth in Paragraph
2(D)(ii) below.

 

(YY)  “Initial Room 1 Turnover Inspection” has the meaning set forth in
Paragraph 2(D)(ii)(c) below.

 

(ZZ)      “Maintenance” has the meaning in Section 13(d) of Attachment A.

 

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(AAA)  “Maintenance Period” has the meaning in Section 13(d) of Attachment A.

 

(BBB)     “Manufacturing Process” means any and all processes and activities (or
any step in any process of activity) used by PCT to manufacture Product
(including the manufacturing, processing, packaging, labeling, quality control
testing, release and storage of Product) as evidenced in batch documentation
relating to such Product.

 

(CCC)     “Materials” has the meaning in Section 2(j) of Attachment A.

 

(DDD)  “MBR” means Client’s master batch record for a particular Product
Manufacturing Process as transferred to PCT and incorporated into PCT’s document
control or other applicable system.

 

(EEE)  “Mitigation Period” has the meaning set forth in Paragraph
2(D)(xii) below.

 

(FFF)     “Mitigation Plan” has the meaning set forth in Paragraph
2(D)(xi) below.

 

(GGG)  “Mitigation Plan Compliance Notice” has the meaning set forth in
Paragraph 2(D)(xii) below.

 

(HHH)  “New Information” has the meaning in Section 7(a) of Attachment A.

 

(III)  “New Intellectual Property” has the meaning in Section 6(c) of Attachment
A.

 

(JJJ)  “Parties” shall have the meaning given above.

 

(KKK)  “PCT Background Intellectual Property” has the meaning in Section 6(b) of
Attachment A.

 

(LLL)  “PCT’s Agents” has the meaning in Section 10(a) of Attachment A.

 

(MMM)  “PCT Team” means a team of PCT Team Members that will, from time to time,
be identified and established by PCT for the Services.

 

(NNN)  “PCT Team Member Fee” have the meaning set forth in Paragraph 6(C) below.

 

(OOO)  “PCT Team Members” means, collectively, identified existing PCT staff
personnel and PCT staff personnel that PCT hires for the Services provided
pursuant to this Agreement.  PCT Team Members are employees of PCT and not of
the Client.

 

(PPP)     “Point of Contact” has the meaning in Section 2(d) of Attachment A.

 

(QQQ)  “Prior Agreements” shall have the meaning given above.

 

(RRR)     “Product” shall have the meaning given above.

 

(SSS)     “Product Run” means a Product Manufacturing Process at full scale that
results in the production of Product and includes a first Product Run or a
replacement Product Run

 

(TTT)     “Program Amendment Order” has the meaning in Section 1 of Attachment
A.

 

(UUU)  “Prospective Cost Increase” has the meaning in Section 11(a) of
Attachment A.

 

(VVV)  “Prospective Illegality” has the meaning in Section 11(a) of Attachment
A.

 

(WWW)     “QP” has the meaning set forth in Paragraph 2(D)(x) below.

 

(XXX)  “QP Inspections” has the meaning set forth in Paragraph 2(D)(x) below.

 

 

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(YYY)  “QP Report” has the meaning set forth in Paragraph 2(D)(x) below.

 

(ZZZ)  “Quality Agreement” has the meaning in Section 2(c) of Attachment A.

 

(AAAA)  “Raw Materials” has the meaning set forth in Section 10(c) of Attachment
A.

 

(BBBB)  “Resolution Corrective Items” has the meaning set forth in Paragraph
2(D)(v) below.

 

(CCCC)  “Receiving Party” has the meaning in Section 5(a) of Attachment A.

 

(DDDD)  “Records” has the meaning in Section 2(i) of Attachment A.

 

(EEEE)    “Regulatory Agency” has the meaning in Section 2(a) of Attachment A.

 

(FFFF)  “Resolution Activities” has the meaning set forth in Paragraph
2(D)(i) below.

 

(GGGG)  “Room 1” means CER room 1 at the Allendale Facility.

 

(HHHH)  “Room 1 Availability Notice” has the meaning set forth in Paragraph
2(D)(iii) below.

 

(IIII)  “Room 1 Fee” has the meaning set forth in Paragraph 6(A) below.

 

(JJJJ)  “Room 1 Initial Services Availability Notice” has the meaning set forth
in Paragraph 2(D)(ii) below.  The Parties agree that the Room 1 Initial Services
Availability Notice was received by Client on August 15, 2016.

 

(KKKK)  “Room 1 Initial Services Start Date” has the meaning set forth in
Paragraph 2(D)(ii) below.

 

(LLLL)    “Room 1 Product Manufacturing Start Date” has the meaning set forth in
Paragraph 2(D)(iii) below.

 

(MMMM)      “Room 1 Start Date” has the meaning set forth in Paragraph
2(D)(i) below.

 

(NNNN)              “Room 1 Turnover Inspection” has the meaning set forth in
Paragraph 2(D)(v) below.

 

(OOOO)  “Room 6” means CER room 6 at the Allendale Facility.

 

(PPPP)  “Room 6 Fee” has the meaning set forth in Paragraph 6(B) below.

 

(QQQQ)  “Room 6 Termination Date” has the meaning set forth in Paragraph
2(E)(ii) below.

 

(RRRR)  “Run” means (i) a Product Run, (ii) one or more mutually scheduled
Training Activities and (iii) any other activity associated with a Product
Manufacturing Process mutually agreed to by the Parties to be provided by PCT
Team Members.

 

(SSSS)  “Services” shall have the meaning given above.

 

(TTTT)        “Services Period” shall mean the period from the Effective Date
until the Termination Date unless terminated earlier on the Room 6 Termination
Date.

 

(UUUU)  “Share of Responsibility” has the meaning in Section 3(b) of Attachment
A.

 

(VVVV)  “Stage” has the meaning in Section 1 of Attachment A.

 

 

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(WWWW)  “Start Date” means, as to each PCT Team Member, the date that PCT
notifies Client, as provided in Paragraph 2(C)(ii) below that a PCT staff member
has been assigned to the PCT Team and is to be treated as a PCT Team Member.

 

(XXXX)  “TCR” has the meaning in Section 6(f) of Attachment A.

 

(YYYY)  “TCRs” has the meaning in Section 6(d) of Attachment A.

 

(ZZZZ)    “Termination Date” has the meaning set forth in Paragraph
2(E)(ii) below.

 

(AAAAA)  “***” ***                                                           .

 

(BBBBB) “Training Activities” has the meaning set forth in Paragraph
2(C)(iv) below.

 

(CCCCC) “Training Plan” has the meaning set forth in Paragraph 2(C)(iv) below.

 

(DDDDD)  “Upfront Audit Fee” has the meaning in Section 13(a) of Attachment A.

 

(EEEEE)  “Written Notice” has the meaning in Section 9(b) of Attachment A.

 

(2)      Services.  Commencing as of the Effective Date, PCT will provide
Services as set forth below:

 

(A)  DEDICATED ROOM 6.  PCT will assign Room 6 on a dedicated and exclusive
basis to Client in order that, as provided in this Agreement, Client can request
and have PCT perform up to the maximum number of Runs at the times and manner
provided in Paragraph 2(B) below.  Commencing on the Effective Date, Room 6 will
be exclusive to Client and during the Services Period:

 

(i)  PCT will not perform any other services either on its own behalf or for the
benefit of any other client of PCT in Room 6.

 

(ii) PCT will (a) maintain in Room 6 such equipment, as is necessary for the
Services and (b), as applicable, maintain, validate, clean, monitor and provide
calibration services for Room 6 and the equipment within Room 6 in accordance
with current PCT standard operating procedures.

 

(B) DETERMINATION OF RUN CAPACITY.  During the Services Period, Client and PCT
will periodically determine and mutually agree on the maximum number of Product
Runs to be performed by PCT in particular periods (such as weekly or monthly, as
the Parties mutually determine) in, as applicable, each of Room 6 and Room 1. 
The determination of the number of Product Runs to be performed in particular
periods will reflect, among other items, the length of the applicable
Manufacturing Processes for the applicable Product, the different viral vectors
in the applicable Product, the number of individuals permitted within Room 6 and
Room 1 at any time pursuant to applicable standard operating procedures and the
number and availability of equipment therein (including biosafety cabinets)
which will affect the ability to perform unit operations within a Product
Manufacturing Process while another Product Manufacturing Process is being
performed.

 

(C)   PCT TEAM MEMBERS.

 

(i)          (a) As Client and PCT from time to time determine the maximum
number of Product Runs to be performed by PCT in particular periods in, as
applicable, Room 6 and Room 1, Client and PCT will then, from time to time,
mutually agree on the number, make-up and roles of PCT Team Members necessary
for providing the number of

 

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Product Runs agreed upon pursuant to Paragraph 2(B) above.  Once the number,
make-up and roles of the PCT Team Members are determined and mutually agreed,
PCT will identify and establish a PCT Team consisting of PCT Team Members to
perform the agreed upon maximum number of Product Runs.  Failure of the Parties
to mutually agree on the number, make-up and/or roles of PCT Team Members
necessary for providing the maximum number of Product Runs pursuant to Paragraph
2(B) above, as applicable for Room 6 and Room 1 may impact PCT’s ability to
provide such agreed upon Services in Room 6 or Room 1.

 

(b) PCT reserves the right to periodically alter the identity, make-up and/or
roles of the PCT Team Members, provided, however, that PCT will make such
changes only when PCT reasonably determines, in good faith that such change is
required.  PCT will provide Client with as much prior notice of such PCT
determined change as reasonably possible, provided, however, PCT is under no
obligation to explain and/or justify to Client the reason for such change.  In
connection with changes in the PCT Team, PCT will endeavor to minimize any
impact on the agreed schedule of Runs and other Services provided by PCT
pursuant to this Agreement. Any replacement of PCT Team Members shall remain
subject to the terms of this Agreement.

 

(ii)      On an on-going basis, PCT’s designated Point of Contact (as defined in
Section 2(d) of Attachment A) shall notify the designated Client Point of
Contact, in writing (with email being an acceptable writing), the identity and
responsibility of the various individuals that PCT assigns to the PCT Team.  The
date that PCT notifies Client that a PCT staff member has been assigned to the
PCT Team shall be such PCT Team Member’s Start Date in the PCT Team. PCT shall
only assign and hire persons to the PCT Team that PCT has a reasonable belief
will have sufficient experience and expertise to adequately perform such
person’s respective role on the PCT Team. If Client, within *** (***) Business
Days of receipt of PCT’s applicable notices identifying the particular PCT Team
Member(s) that are assigned to the PCT Team, notifies PCT’s Point of Contact, in
writing (with email being an acceptable writing) that a particular individual
***
                                                                                                                                                         . 
The Parties agree that, in accordance with the Prior Agreements, PCT has
previously identified PCT Team Members for the Services to be provided pursuant
to this Agreement and as of the Execution Date, PCT Team Members identified as
PCT Members pursuant to the Prior Agreements are PCT Team Members for Services
under this Agreement.

 

(iii)  The make-up of the PCT Team may include (without limitation)
(a) manufacturing specialists, (b) quality assurance/documentation specialists,
(c) environmental monitoring specialists, (d) quality control analysts,
(e) project managers, (f) operations supervisors, (g) quality supervisors,
(h) materials managers and (i) as the Parties determine any other individuals.

 

(iv)  PCT will provide training to each PCT Team Member pursuant to a training
plan agreed to by the Parties (the “Training Plan”). Such training will be
provided as soon as reasonably possible after the relevant PCT Team Member’s
Start Date. The Training Plan will outline the requirements/activities regarding
applicable manufacturing, quality control and quality assurance training and
include skillset

 

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development and training not directly connected to the performance of a specific
manufacturing process, observations of the manufacturing, analytical, quality or
other ancillary procedures as required for the specific role as the Parties may
determine and GMP training runs utilizing the GMP resources (clean room,
analytical laboratories, existing trained staff) (collectively, “Training
Activities”).  Each PCT Team Member (including those PCT Team Members as of the
Execution Date that have not completed training) may require approximately ***
(***) months of Training Activities in order to be capable of performing Product
Runs and Client understands that such training is contingent on the availably of
training resources, trainers and clean room facility with respect to the ongoing
agreed upon schedule for Runs.  Client agrees that this training requirement may
have an effect on PCT’s ability to provide Product Runs at the maximum capacity
for Room 6 and/or Room 1 pursuant in Paragraph 2(B) above but both Client and
PCT agree that they shall work together to minimize any impact on PCT’s ability
to schedule and perform Runs.  Training shall occur at the Allendale Facility
and such other locations as the Parties mutually agree.

 

(v)      Client will have first priority (but not exclusive use) to PCT Team
Members for Runs by PCT Team Members.  In the event of any simultaneous conflict
affecting a PCT Team Member’s availability to perform Services for the Client
and PCT’s need for such PCT Team Member for other services, Client’s need for
the Services requiring such PCT Team Member will supersede any PCT need for such
PCT Team Member.

 

(vi)  During the Services Period, PCT may cancel a scheduled Run or a particular
scheduled Run, if there are insufficient, trained PCT Team Members at the time
of the commencement of the scheduled Run or anytime during such Run due to
(a) the fact that a necessary PCT Team Member required for the Services or Runs
is on personal time off, on a prescheduled vacation, ill, injured, fails to
arrive at the Allendale Facility without notification to PCT or is no longer
employed by PCT or (b) Force Majeure, and PCT reasonably determines that as a
result of any such occurrence the then existing/remaining PCT Team Member
complement cannot support the particular Run. PCT shall reasonably mitigate any
delay associated with such cancellation and will work with Client to minimize
any disruption.

 

(D)  DEDICATED CER ROOM 1.

 

(i)          Through the period ending ***          PCT will undertake
activities determined by PCT (collectively, the “Resolution Activities”),
including construction (“Construction”), if necessary, at the Allendale Facility
(including in Room 1) as PCT reasonably determines will enable PCT no later than
***            (the “Room 1 Start Date”) ***
                                                                                                                                                                                  
(each as set forth in Attachment B (“Attachment B”) attached hereto and made a
part hereof.

 

(ii)      (a)       Upon PCT’s satisfaction of those Resolution Activities, in
PCT’s reasonable determination, that will enable Client for the remainder of the
Services Period to perform Runs in Room 1 identical in scope to those that are
capable of being provided in Room 6 as of the Effective Date for use within the
United States (the

 

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“Initial Room 1 Services”), PCT may deliver to Client a written notice (the
“Room 1 Initial Services Availability Notice”) together with any remaining data
and/or reports (to the extent not previously provided to Client) supporting
PCT’s statements, stating that Room 1 (a) and the critical manufacturing
equipment therein have been qualified according to existing PCT records (IQ/OQ)
as well as any previously Room 6 agreed upon process-specific qualifications
within the context of Client’s Product Manufacturing Process and (2) satisfies
the environmental requirements outlined in EU Annex 1 and, therefore, PCT is
able to perform Product Runs in Room 1 for use within the United States using
Client’s MBR for Product.

 

(b)      Upon Client’s receipt of the Room 1 Initial Services Availability
Notice, PCT will have determined that Room 1 is assigned to Client for Initial
Room 1 Services on an exclusive basis as of the first day of the month following
Client’s receipt of the Room 1 Initial Services Availability Notice or the first
day of the month if such date of receipt is the first day of a month (the “Room
1 Initial Services Start Date”) and, except to the extent necessary to complete
any ongoing Runs within Room 6, as of day immediately preceding the Room 1
Initial Services Start Date (the “Automatic Room 6 Termination Date”) Services
will cease to be performed or provided by PCT in Room 6.  For purposes of
clarity, until the Room 1 Product Manufacturing Start Date has occurred, PCT has
no obligation to provide Runs in Room 1 for use in the European Union.

 

(c)       Should Client believe it necessary to ensure conformance of Room 1
with United States regulatory requirements, Client may carry out an inspection
of Room 1 (the “Initial Room 1 Turnover Inspection”) within the ***     day
period following Client’s receipt of the Room 1 Initial Services Availability
Notice together with any remaining data and/or reports supporting PCT’s
statement as to its ability to perform Product Runs in Room 1 for use within the
United States using Client’s MBR for Product.  PCT will use reasonable efforts
to facilitate such Initial Room 1 Turnover Inspection. Client has ***    days
following Client’s receipt of the Room 1 Initial Services Availability Notice
together and other items referred to in the opening sentence of this Paragraph
2(D)(ii)(c), to notify PCT’s Point of Contact, in writing, of Client’s
reasonable, good faith objection to PCT’s determination Room 1’s suitability for
Runs.

 

(d)     Provided the written notice referred to in Paragraph 2(D)(ii)(c) above
is based on Client’s Initial Room 1 Inspection and/or any of the other items
referred to in the opening sentence of Paragraph 2(D)(ii)(c) and such written
notice contains the corrective action(s) to be taken by PCT to address and
correct such objections, until all such objections have been addressed to the
reasonable satisfaction of both Parties both the Room 1 Initial Services Start
Date and the Automatic Room 6 Termination Date will be delayed and once such
objections have been addressed the Parties will determine the date that the Room
1 Initial Services Start Date and the Automatic Room 6 Termination Date shall
occur.  The Room 1 Initial Services Start Date shall be the first day of a month
and the Automatic Room 6 Termination Date shall be the date immediately
preceding the Room 1 Initial Services Start Date.

 

(e)       Further, no later than ***             days following Client’s receipt
of the Room 1 Initial Services Availability Notice together with any remaining
data and/or reports

 

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supporting PCT’s statement as to its ability to perform Product Runs in Room 1
for use within the United States using Client’s MBR for Product, Client may
elect to delay the Automatic Room 6 Termination Date and continue to use both
Room 6 and Room 1 for a period ending on the earlier to occur of (1) the last
day of a month selected by Client and (2) the day immediately preceding the Room
1 Product Manufacturing Start Date, in which event Runs may, at Client’s
election, be performed in Room 6 and in Room 1.

 

(iii)  Upon PCT’s satisfaction of ALL Resolution Activities PCT will deliver to
Client a written notice (the “Room 1 Availability Notice”) stating that (a) Room
1 and the critical manufacturing equipment therein have been qualified according
to existing PCT records (IQ/OQ) as well as any previously Room 6 agreed upon
process-specific qualifications within the context of Client’s Product
Manufacturing Process, (b) Room 1 satisfies the environmental requirements
outlined in EU Annex 1 and (c) PCT has ***                                  
and, therefore, as of the first day of the month following Client’s receipt of
the Room 1 Availability Notice or the first day of the month if such date of
receipt is the first day of a month (the “Room 1 Product Manufacturing Start
Date”), PCT is able to perform Product Runs in Room 1 for Client’s use within
the United States and European Union, using Client’s MBR for Product.

 

(iv)  To the extent the Room 1 Initial Services Start Date has not occurred
(1) as of the Room 1 Product Manufacturing Start Date, Room 1 is available to
Client for Services on an exclusive basis, (2) as of day immediately preceding
the Room 1 Product Manufacturing Start Date (also referred to as the “Automatic
Room 6 Termination Date”) Services will cease to be performed or provided by PCT
in Room 6 (except to the extent necessary to complete any ongoing Run
Manufacturing Process within Room 6), (3) after the Automatic Room 6 Termination
Date, Room 6 will no longer be assigned to and dedicated in any manner to Client
and (4) as of the Room 1 Product Manufacturing Start Date, PCT is able to
perform Product Runs in Room 1 for Client’s use within the European Union using
Client’s MBR for Product and for the remainder of the Services Period all
Services (except for any remaining Services that are to be completed in Room 6
as provided above) will be performed in Room 1 only.

 

(v)      Client has ***              days following Client’s receipt of the Room
1 Availability Notice together with any remaining data and/or reports supporting
PCT’s statement as to its ability to perform Product Runs in Room 1 for Client’s
use within the United States and European Union using Client’s MBR for Product,
to deliver to PCT a Client Mitigation Plan Request addressing Resolution
Corrective Items in order to prevent the increase of the Room 1 Fee as provided
in the definition of the Room 1 Fee.  To the extent PCT receives a Client
Mitigation Plan Request in the manner provided in this Paragraph 2(D)(v) that
includes a list of objections preventing a QP from releasing Product for use in
the European Union and such objectionable items include, in QP’s reasonable,
good faith determination that (a) identified Resolution Activities have not been
corrected or (b) based on the data and/or reports associated with PCT’s
qualification of Room 1 and/or any critical equipment therein and the results
associated with PCT’s complying with the environmental requirements of EU

 

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Annex 1 in Room 1 (collectively, the “Resolution Corrective Items”), provided
further that the Client Mitigation Plan Request contains the corrective
action(s) to be taken by PCT to address and correct such Resolution Corrective
Items, the Room 1 Fee ***            as provided in the definition of Room 1 Fee
until the first day of the month following PCT’s satisfaction of the Resolution
Corrective Items as set forth in the Mitigation Plan.  To the extent the Client
Mitigation Plan Request also contains items in addition to the Resolution
Corrective Items that are to be addressed by Mitigation Plan, such additional
items will not affect or prevent the increase in the Room 1 Fee upon completion
of the Resolution Corrective Items as set forth in the Mitigation Plan.  Client
within the ***           day period referred to in the opening sentence of this
Paragraph 2(D)(v) to carry out an inspection of Room 1 (the “Room 1 Turnover
Inspection”) and assess whether all Resolution Activities have been corrected. 
PCT will use reasonable efforts to facilitate such Room 1 Turnover Inspection.

 

(vi)        If the Room 1 Availability Notice is not provided by the Room 1
Start Date, PCT will immediately notify Client of such notice failure and
promptly schedule discussions with Client identifying the reasons for PCT’s
inability to provide the Room 1 Availability Notice as well as Resolution
Activities impacting Room 1 that remain incomplete.  PCT will provide Client
with PCT’s then current, good faith estimate regarding the timeframe required to
address and complete the identified, remaining Resolution Activities and PCT
will as quickly and diligently as commercially reasonable complete the remaining
Resolution Activities.  PCT will have a period ending on the last day of the
month following the expiration of the ***    month period following the
scheduled discussions with Client identifying the reasons for PCT’s inability to
provide the Room 1 Availability Notice as well as Resolution Activities
impacting Room 1 that remain incomplete to satisfy all such remaining Resolution
Activities and provide the Room 1 Availability Notice within such additional
period.

 

(vii)          If PCT does not provide the Room 1 Availability Notice by the end
of the additional period referred to in Paragraph 2(D)(vi) above, Client may, at
any time thereafter, terminate its need for Room 1 on the last day of a month
following PCT’s designated Point of Contact’s receipt of written notice (without
regard to the limiting language set forth in cause (b) of the definition of
Termination Date) of the termination of such Services and, on the first day of
the month following such last day, Client will have no obligations to use or pay
for Room 1 and all terms and provisions herein applicable to Room 1 will no
longer be in effect as to the Client.  The Parties expressly agree that any
election by Client affecting Room 1 pursuant to this Paragraph 2(D)(vii) has no
impact of Client’s use of and obligations relating to Room 6 but only if PCT has
not previously provided Client with the Room 1 Initial Services Availability
Notice in which event Client’s ability to use Room 6 will terminate as provided
regarding the Initial Room 1 Services (unless Client has elected to delay the
Automatic Room 6 Termination Date in accordance with Paragraph
2(D)(ii)(e) above).

 

(viii)                  If PCT has provided Client with the Room 1 Initial
Services Availability Notice, Client’s ability to terminate its need for Room 1
pursuant to Paragraph 2(D)(vii)

 

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above ceases if prior to PCT’s receipt of Client’s notice terminating Client’s
need for Room 1 PCT provides the Room 1 Availability Notice.

 

(ix)  PCT ***         will complete the Resolution Activities, including any
validations and qualifications as determined by PCT.  PCT will be responsible,
at its cost and expense for validation, cleaning as necessary as a result of any
Construction.

 

(x)      Any time after Client’s receipt of the Room 1 Availability Notice, in
addition to Room 1 Turnover Inspection, Client may schedule and conduct, at
Client’s cost and expense, one or more inspections (“QP Inspections”), including
for cause QP Inspections, of the Allendale Facility (and Room 1) by a qualified
person (“QP”) selected by and paid for by Client. QP Inspections are for the
purpose of ascertaining whether Product to be manufactured in Room 1 after the
Room 1 Product Manufacturing Start Date can be released for Client’s clinical
trial in the European Union. Subject at all times to the Allendale Facility’s
standard operating procedures and requirements of confidentiality as the same
relate to PCT’s business and PCT’s other clients, during any QP Inspection PCT
will provide such additional information and access to the Allendale Facility as
the QP reasonably determines is necessary for the QP to determine the Allendale
Facility’s adherence to European Union GMP requirements and ability to provide
Product from Room 1 suitable for release for clinical trials in the European
Union.  QP Inspections shall be scheduled at time(s) mutually acceptable to the
Parties during Business Hours on at least ***    days prior written notice from
Client to PCT’s designated Point of Contact.  Client agrees to provide PCT with
a copy(ies) of the QP’s written Inspection report (“QP Report”).

 

(xi)  On Client’s written request (the “Client Mitigation Plan Request”)
delivered to PCT’ designated Point of Contract and based on the QP Report(s), if
such QP Report(s) do(es) not indicate that Product manufactured at the Allendale
Facility can be released for use in Client’s European clinical trial without
further action, PCT will in good faith develop a plan (a “Mitigation Plan”) that
PCT determines is reasonably necessary to address such action items and the
mitigation thereof and timeline for mitigation thereof.  The Client Mitigation
Plan Request must provide specific reasons for Client’s determination that
Product cannot be released for use in the European Union and corrective actions
necessary to satisfy Client’s objections.  The Client Mitigation Request must
also indicate which the objections arises out of PCT’s failure to correct a
Resolution Activity or if such objection is a result of the QP determining that
PCT needs to take additional actions not included in the Resolution Activities.

 

(xii)          Such Mitigation Plan shall be prepared on a timely basis, as soon
as reasonably possible after the provision of the Client Mitigation Plan Request
and in any event within ***     days of PCT’s receipt of Client Mitigation Plan
Request. After Client’s written approval of the Mitigation Plan (which written
approval will not be unreasonably withheld, delayed or conditioned), PCT will
expeditiously undertake such Mitigation Plan ***               .  If within the
period ending on the last day of the month following ***            days of
PCT’s receipt of the Client Mitigation Plan Request (the “Mitigation Period”)
either (1) the Parties cannot reasonably agree, in good faith, that additional
action items need to be taken by PCT in order that Product manufactured can be
released for use in Client’s European clinical trial(s) or (2) a Mitigation Plan
is not agreed to by the Parties using commercially reasonable good

 

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faith efforts to negotiate an acceptable Mitigation Plan, Client may terminate
its need for Room 1 on the last day of a month following PCT’s designated Point
of Contact’s receipt of written notice (without regard to the limiting language
set forth in cause (b) of the definition of Termination Date) of termination of
Services within Room 1 and, on the first day of the month following such last
day, Client will have no obligations to use or pay for Room 1 and all terms and
provisions herein applicable to Room 1 will no longer be in effect as to the
Client.  Client’s ability to terminate its need for Room 1 pursuant to this
Paragraph 2(D)(xi) ceases if prior to delivering such notice terminating
Client’s need for Room 1 PCT provides the agreed Mitigation Plan.

 

(xiii)      If a Mitigation Plan is agreed to by the Parties and PCT fails to
comply with the terms of the Mitigation Plan as evidenced by PCT’s failure (as
provided in such Mitigation Plan) to provide a mitigation plan compliance notice
to Client that PCT has successfully completed the actions required under the
Mitigation Plan (the “Mitigation Plan Compliance Notice”), PCT will immediately
notify Client of such notice failure and promptly schedule discussions with
Client identifying the reasons for PCT’s inability to provide the Mitigation
Plan Compliance Notice as well as the unsatisfied activities impacting Room 1
that remain incomplete in the Mitigation Plan.  PCT will provide Client with
PCT’s then current, good faith estimate regarding the timeframe required to
address and complete the identified, remaining Mitigation Plan activities and
PCT will as quickly and diligently as commercially reasonable complete the
Mitigation Plan activities.  PCT will have a period ending on the last day of
the month following the expiration of the ***     month period following the
scheduled discussions with Client identifying the reasons for PCT’s inability to
provide the Mitigation Plan Compliance Notice to satisfy all remaining
Mitigation Plan activities and provide the Mitigation Plan Compliance Notice
within such additional period.

 

(xiv)      If PCT has not provided the Mitigation Plan Compliance Notice by the
end of the additional period referred to above, Client may, at any time
thereafter, terminate its need for Room 1 on the last day of a month following
PCT’s designated Point of Contact’s receipt of written notice (without regard to
the limiting language set forth in cause (b) of the definition of Termination
Date) of the termination of such Services and, on the first day of the month
following such last day, Client will have no obligations to use or pay for Room
1 and all terms and provisions herein applicable to Room 1 will no longer be in
effect as to the Client.  Client’s ability to terminate its need for Room 1
pursuant to this Paragraph 2(D)(xiv) ceases if prior to PCT’s receipt of
Client’s notice terminating Client’s need for Room 1 PCT provides the Mitigation
Plan Compliance Notice.

 

(xv)          Commencing on the earlier to occur of the Room 1 Initial Services
Start Date and Room 1 Product Manufacturing Start Date PCT will (a) assign Room
1 on a dedicated and exclusive basis to Client in order that, as provided in
this Agreement Client can request and have PCT perform up to the number of Runs
in Room 1 at the times and manner provided in Paragraph 2(B) above and (b) not
perform any other services either on its own behalf or for the benefit of any
other client of PCT in Room 1.

 

(xvi)      As of the earlier of the Room 1 Initial Services Start Date and Room
1 Product Manufacturing Start Date and during the remainder of the Services
Period, PCT will

 

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(a) maintain in Room 1 such equipment as is necessary for the Services and (b),
as applicable, maintain, validate, clean, monitor and provide calibration
services of Room 1 and the equipment within Room 1 in accordance with current
PCT standard operating procedures.

 

(xvii)        Commencing on the earlier of the Room 1 Initial Services Start
Date and Room 1 Product Manufacturing Start Date and thereafter through the
Termination Date for the Services to be provided in Room 1 as more particularly
described below PCT will identify and continue to identity PCT Team Members for
the Services as provided in Paragraph 2(B).

 

(xviii)                      Client acknowledges and agrees that the Parties’
ability to schedule and/or PCT’s ability to perform a Run in Room 6 may be
affected by Construction in connection with PCT’s obligation to perform
Resolution Activities in order to manufacture Product in Room 1 no later than
the Room 1 Start Date.  To the extent that Construction may have an impact on
Runs in Room 6, PCT and Client will mutually discuss and schedule and perform
Runs and/or schedule Construction around scheduled Runs in order to minimize the
impact of Resolution Activities on both Client and PCT.

 

(E)    SCHEDULING AND PERFORMANCE OF RUNS.

 

(i)          Through the Termination Date under GMP conditions, PCT will perform
the Services and be prepared to schedule up to the maximum number of Product
Runs determined pursuant to Paragraph 2(B) above, subject to PCT having
reasonably determined that designated PCT Team Members have satisfactorily
completed the Training Activities required for PCT to be able to provide such
agreed upon maximum number of Product Runs.  PCT has no obligation to provide
Runs in Room 6 or, prior to the Room 1 Product Manufacturing Start Date, in Room
1 for use in the European Union and to provide Services of any kind in Room 1 or
perform Runs in Room 1 prior to the earlier of the Room 1 Initial Services Start
Date or the Room 1 Product Manufacturing Start Date.

 

(ii)      Paragraph 2(E)(ii) Definitions.

 

“Room 6 Termination Date” means the earlier of (1) the date the Parties mutually
agree, in writing that the Runs scheduled and to be performed in Room 6 shall
end (which shall be the last day of a month), (2) the Automatic Room 6
Termination Date and (3) the last day of the month following PCT’s receipt of
not less than ***     days written notice from Client that Client’s desire to
schedule and have Runs performed in Room 6 will end.  As of the Room 6
Termination Date all Services in Room 6 shall cease.

 

“Termination Date” means the earlier of:

 

(a)       The date the Parties mutually agree, in writing that the scheduling
and performance of all Runs and Services (in both Room 6 (to the extent the Room
6 Termination Date has not occurred) and Room 1) ends (which shall be the last
day of a month).

 

(b)      The last day of the month following PCT’s designated Point of Contact’s
receipt of no less than ***               days written notice from Client that
Client will no

 

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longer require Services in Room 6 and Room 1 provided, however, if the Room 1
Product Manufacturing Start Date has occurred prior to PCT’s receipt of Client’s
written notice of termination of Services and notwithstanding Section 9(d) of
Attachment A to the contrary, the Termination Date shall not be effective prior
to the last day of the month following the ***               of the first day of
the month following the month in which the Room 1 Product Manufacturing Start
Date has occurred.

 

(c)       The date this Agreement terminates pursuant to Section 9 of Attachment
A, provided, however Client’s ability to terminate the Agreement pursuant to
Section 9(d)(i) of Attachment A is limited as provided in Paragraph (b) of the
definition of Termination Date.

 

(iii)  Scheduling and Performing Runs.

 

(a)       Subject to all other terms and provisions of this Agreement relating
to the pre-conditions for a Run (including PCT’s receipt of the applicable Raw
Materials on the mutually scheduled date for the Run), through the Termination
Date, the Parties shall mutually schedule date(s) for PCT’s commencement of
Runs.  Client agrees that to the extent during a particular period Client has
not requested that up to the maximum number of Product Runs determined pursuant
to Paragraph 2(B) above be scheduled, PCT has no obligation to provide extra
Runs in subsequent periods above the amount described in this Paragraph
2(E)(iii)(a).

 

(b)      The Parties will, in advance of each calendar month, discuss the dates
for the scheduling of Runs in the applicable calendar month up to the maximum
number of Runs as mutually determined pursuant to Paragraph 2(B) above.  All
Runs will start on a Business Day.

 

(c)       Once the Parties have scheduled the particular date that a Run is to
be commenced by PCT, if (x) Client cancels the mutually scheduled Run or (y) PCT
does not receive the necessary Client sourced materials and/or Raw Materials for
the scheduled Run by ***    on the date such Run is scheduled, then, unless the
Parties otherwise mutually agree, PCT shall be relieved of the obligation to
commence the Run on the mutually scheduled date.

 

(d)     If Client requests PCT to schedule additional Runs in excess of the
agreed upon maximum number of Product Runs determined pursuant to Paragraph
2(B), as applicable, for each of Room 6 and Room 1 (“Additional Runs”), to the
extent all other terms and provisions of this Agreement relating to the
pre-conditions for a Run are met, PCT will use commercially reasonable efforts
reflecting the then existing and trained PCT Team Member make-up and PCT Team
availability for, as applicable, Room 6 and Room 1 to accommodate Client’s
request for such Additional Run(s) in excess of the maximum number of Runs
determined pursuant to Paragraph 2(B) during a particular period.

 

(e)       In-process testing and final product testing of Product Runs by PCT,
Client or a third party service provider will be performed in accordance with
the methods previously qualified by PCT pursuant to the applicable Prior
Agreement or, in the case, of

 

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Product not covered by a Prior Agreement then as the Parties mutually agree to
in writing.

 

(f)        Product resulting from the Manufacturing Process for a Product Run
will be stored in quarantine at the Allendale Facility until release and after
release maintained at the Allendale Facility until shipment of such lot of
Product is requested by Client in accordance with a procedure mutually agreed
to, in writing, by PCT and Client.  Retain samples will be maintained by PCT for
the duration of the Agreement. Product will be shipped to clinical sites as
instructed by Client.

 

(g)      Manufacturing inventories, Run production schedules and shipments of
Product will be coordinated with Client through PCT’s Point of Contact, as
designated in writing by PCT to Client.

 

(h)      Through the Termination Date, PCT will maintain the utilities, systems
and equipment used in connection with the Services and provide environmental
monitoring, cleaning and Quality Control testing services as specified in the
Quality Agreement.

 

(i)          After the Room 6 Termination Date, Room 6 will no longer be
available to Client for Services and no longer dedicated to Client on an
exclusive basis.  The existence of the Room 6 Termination Date has no effect on
the definition of the Termination Date.

 

(j)          In connection with PCT’s receipt throughout the term of this
Agreement of materials and Raw Materials, the Parties agree that the Services
described herein, do not include the performance by PCT of any raw biological
material testing, Product intermediate testing, Product stability studies or
reagent testing beyond the existing Certificate of Analysis for such items. If
Client desires any such stability studies or testing, such additional stability
study(ies) or testing, if provided by PCT, will be at additional cost to Client
and any such services will be provided by PCT in accordance with a Program
Amendment Order or other writing executed by the Parties.

 

(iv)  Failure to cause PCT to perform a Product Run in any particular month may
affect PCT’s ability to perform subsequently requested Product Runs in, as
applicable, Room 6 or Room 1, in subsequent months as PCT may determine that
additional training and other activities are necessary in order for PCT to
continue to provide appropriate Product Runs in, as applicable, Room 6 or Room
1.

 

(v)      Product Testing.  All tests required in connection with a Run and not
performed in-house by PCT or directly by the Client, will be contracted out by
PCT, and PCT will manage the performance of such product testing, including
review of such results prior to communication to Client. Client may subcontract
out other vendors for release testing in which event Client will be solely
responsible for such testing.

 

(vi)  PCT shall use commercially reasonable efforts to provide adequate supply
chain and other support services in connection with the Services.

 

DELIVERABLES. (1) Product and (2) data related to the manufacture, testing,
release, shipping and storage of Product and the maintenance of the
corresponding equipment, materials and CER and other deliverables mutually
agreed between the Parties.

 

 

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DURATION OF SERVICES PERIOD.  The Services Period commences on the Effective
Date and ends on the Termination Date.

 

(3)      Storage of Product after Termination Date.

 

(A)  If Product and/or retain samples remain in storage/cryostorage after the
Termination Date, PCT and Client may agree, in writing, that such items are to
remain in storage/cryostorage at the Allendale Facility provided Client pays for
each sample and/or lot of Product at PCT’s then standard storage rates for
samples and Product and the Parties execute either a Program Amendment Order or
other writing addressing the continued storage/cryostorage of such items.

 

(B)   In the alternative, Client or Adaptimmune may instruct PCT, in writing and
at Client’s cost and expense, to deliver all samples and Product then at the
Allendale Facility to Client’s Point of Contact or other address as instructed
by Client or Adaptimmune.

 

(C)   If Client or Adaptimmune fails to provide written instructions regarding
the shipment of all samples and/or Product then in the Allendale Facility or
fail to agree with PCT regarding the continued storage/cryostorage of samples
and/or Product at the Allendale Facility after the Termination Date, Client and
Adaptimmune shall be deemed to have instructed PCT to store/cryostore all such
items after the Termination Date for a period of up to *** months and Client
will be invoiced and pay for each individual sample and Product in storage in
advance and Client will be invoiced and pay PCT an extraction fee and shipping
fee (together with all reimbursable costs and expenses), for any items requested
by Client or Adaptimmune to be extracted and shipped from storage.

 

(D)  In the event any samples or Product are likely to remain at PCT after such
*** month period, PCT may, at any time, contact Client (with notice to Client
being deemed notice to Adaptimmune) for written instructions regarding either
(i) continued storage of such samples and Product at the Allendale Facility
after such *** month period, (ii) return of the samples and Product to Client,
Adaptimmune or other acceptable site for the storage of such items promptly
after such *** month period or (iii) the destruction of all samples and Product
then at the Allendale Facility after such *** month period.

 

(E)    If Client or Adaptimmune do not provide written instructions regarding
such remaining samples and Product or ceases to pay PCT the costs associated
with storage/cryostorage of such samples and Product, PCT may, at Client’s cost
and expense and liability, destroy all remaining samples and Product at the
Allendale Facility in accordance with Applicable Law following PCT providing
Client (which notice shall also be deemed notice to Adaptimmune) with no less
than *** Business Days written notice of PCT’s intent to destroy all such items
then at the Allendale Facility.

 

(F)     If Client or Adaptimmune fail to respond to PCT’s written notice and/or
fails to make alternative arrangements with PCT prior to the end of such *** day
notice period regarding the disposition of the samples and Product, then PCT may
arrange for the destruction of all remaining samples and Product at the
Allendale Facility and Client will be invoiced for and pay for all costs and
expenses relating to storage/cryostorage through the date of destruction as well
as all costs and expenses incurred by PCT in connection with the destruction of
such items.

 

(4)      Close-Out Services.

 

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(A)  Following the Termination Date, PCT will cooperate with Client to collect
and transfer all data, documentation, Product (other than Product Client has
elected to maintain in cryostorage), materials, reagents, supplies and equipment
which Client has provided or paid for as required by Client and arrange to
deliver the same, at Client’s cost, to Client or a third party.  In addition, if
Client determines that as to any particular Product, that prior to the
Termination Date as to all such Product of a similar type that it desires any
additional close-out services other than those described in this Paragraph
4(A)the Parties will mutually agree the timing and costs for such additional
close-out services.

 

(B)   Alternatively following the Termination Date, should PCT agree to provide
additional services not covered by this Agreement, close-out services may be
deferred as the Parties mutually agree, in writing, until the completion of such
additional services.

 

ESTIMATED DURATION OF ANY CLOSE-OUT SERVICES.

 

Approximately *** months (depending on the number of Products that at any given
time are the subject of close-out services).  Close-Out Services will commence
on the first day of the month following the Termination Date.  Additional
Close-Out Services as provided in Paragraph 4(A) above shall commence on such
dates as the Parties mutually schedule.

 

(5)      General Provisions

 

(A)  If:

 

(i)          either Party reasonably determines that the PCT Team requires
additional training for successful performance of the Services and/or that the
agreed upon number of PCT Team members is inadequate for the performance of the
Services hereunder,

 

(ii)      either Party requests (A) additional training activities not
specifically addressed in this Agreement or (B) requests any other services
outside the Services expressly provided in this Agreement,

 

(iii)  either Party determines that a particular Product’s Manufacturing Process
is not of sufficient maturation and/or that additional process/product
development or manufacturing process and/or analytical method development
thereof is necessary or required, and/or that additional resources not
specifically set forth in this Agreement for the performance of Services and/or
requested additional services is or will be required for successful performance
of the activities described herein,

 

then any such determination will be communicated to the other Party and may
result in additional services to be provided by PCT which are outside the scope
of this Agreement and may require additional cost to the Client and potentially
affect the Services.

 

(B)   Such determination(s) will be handled in accordance with the terms
regarding Program Amendment Orders set forth in this Agreement or other writings
among the Parties and the Parties agree that until such Program Amendment Orders
or other writings are executed, PCT may not be able to proceed with some or all
of the Services set forth in this Agreement.  Any additional services performed
by PCT will be performed at Client’s cost and expense.

 

(C)   If at any time any applicable GMP documents associated with the Services
in PCT’s document control system need to be updated and/or revised with any
pertinent changes

 

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emerging from the experience and results obtained from performing the Services,
such updates and/or revisions will be provided by PCT to Client, at Client’s
cost and expense, and reviewed, approved and executed by Client.  Client will
update any Client documents within PCT’s document control system accordingly and
release the final versions to PCT.

 

(D)  The ability of PCT to perform the Services is contingent upon:

 

(i)          Client and Adaptimmune reasonably cooperating with PCT in
connection with the performance of the Services, including but not limited to,
providing, staff and resources required to enable PCT to perform the Services,

 

(ii)      Client providing or purchasing materials or Raw Materials for which it
is responsible as provided in this Agreement; and

 

(iii)  Client and Adaptimmune being reasonably responsive to PCT and providing
responses in an expeditious manner.

 

If there is a delay in Client and/or Adaptimmune satisfying its obligations
under this Agreement or Client and/or Adaptimmune is either non-responsive or if
responsive is not responsive in an expeditious manner, the Services may be
affected.

 

(6)      Fees for Services; ***.  As consideration for PCT’s performance of the
Services more particularly described in above and in addition to the
reimbursable amounts payable by to PCT pursuant to Section 4(b) of Attachment A
and subject to the terms of this Agreement, including Attachment A, as of the
Effective Date, Client will pay to PCT fees (the “Fees”) as follows:

 

(A)  Room 6 Fee. Client will pay PCT a monthly Room 6 fee (the “Room 6 Fee”) in
the amount of $*** as follows:

 

(i)          On the Execution Date, the Room 6 Fee for the month that the
Effective Date occurs.

 

(ii)      On the first day of the month following the Effective Date and each
month thereafter through and including the month in which the earlier of (a) the
Room 6 Termination Date or (b) Termination Date occurs.

 

Except for the Room 6 Fee on the Execution Date, monthly Room 6 Fees are payable
prior to the first day of each month.  PCT has no obligation to schedule or
commence a Run or perform any other Services in Room 6 unless PCT has received
the applicable monthly Room 6 Fees as provided herein.

 

Except for the Room 6 Fee on the Execution Date, invoices for monthly Room 6
Fees may be issued by PCT in advance of the first date of the month and be
payable as provided in accordance with Section 4 of Attachment A.

 

(B)   Room 1 Fee. Client will pay PCT, as applicable, a monthly Room 1 fee (the
“Room 1 Fee”) in the amount of (i) $*** from and including the month in which
the Room 1 Initial Services Start Date occurs through but excluding the month in
which the Room 1 Product Manufacturing Start Date occurs and (ii) $*** from and
including the month in which the Room 1 Product Manufacturing Start Date occurs
through the month in which the Termination Date occurs. The Room 1 Fee is
payable by Client as follows:

 

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(i)          Within *** days of the occurrence, as applicable, the Room 1
Initial Services Start Date ($***) and the Room 1 Product Manufacturing Start
Date ($***).  If Client has previously paid the Room 1 Fee in the amount of $***
for the month in which the Room 1 Product Manufacturing Start Date occurs,
Client will pay the balance ($***) of the Room 1 Fee for the month in which the
Room 1 Product Manufacturing Start Date occurs within the *** day period
described above.

 

(ii)      On first day of the month following the Room 1 Initial Services Start
Date and each month thereafter through and including the month in which the
Termination Date occurs, as provided in Paragraph 6(B) and Paragraph
6(B)(i) above.

 

Except for the first Room 1 Fee payable as provided in Paragraph 6(B)(i) above,
the monthly Room 1 Fees are payable prior to the first day of each month.  PCT
has no obligation to schedule or commence a Run or perform any other Services in
Room 1 unless PCT has received the applicable monthly Room 1 Fees as provided
herein.

 

Except for the Room 1 Fee(s) payable by Client as provided in Paragraph
6(B)(i) above, invoices for monthly Room 1 Fees may be issued by PCT in advance
of the first date of the month and be payable as provided in accordance with
Section 4 of Attachment A.

 

(iii)  Notwithstanding anything to the contrary in this Paragraph 6(B), if
Client provides a Client Mitigation Plan Request containing Resolution
Corrective Items within *** days of Client’s receipt of the Room 1 Availability
Notice, the Room 1 Fee *** $*** until the first day of the month following PCT’s
satisfaction of the Resolution Corrective Items as set forth in the Mitigation
Plan.

 

(C)   PCT Team Member Fees.  Commencing on the Effective Date (which may also be
the Start Date for various PCT Team Members), for each PCT Team Member,
commencing on the Start Date for such PCT Team Member and each month thereafter
during the Services Period, as long as such PCT Team Member remains in the PCT
Team, Client will pay a monthly fee (the “PCT Team Member Fee”) for each PCT
Team Member in the amount of $***.

 

(i)          If the applicable PCT Team Member’s Start Date is not the first day
of the month, the monthly PCT Team Member Fee for such month will be prorated
and reduced by $*** for each day in such month that the PCT Team Member is not
on the PCT Team.  If the applicable PCT Team Member at any time during a month
ceases to be part of the PCT Team, the monthly PCT Team Member Fee for such
month will be prorated and be equal to the number of days that such PCT Team
Member was part of the PCT Team multiplied by a daily rate equal to $***.  ***

 

 

 

 

 

.

 

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(ii)      PCT is entitled to the applicable PCT Team Member Fee for all PCT Team
Members for the applicable month. If Client has paid, in advance, the monthly
PCT Team Member Fee for a PCT Team Member that ceases to be a PCT Team Member
prior to the last day of the month for which such PCT Team Member Fee has been
paid, PCT will provide Client with a credit, to be applied to subsequent
invoices for PCT Team Member Fees in an amount equal to $*** less an equal to
$*** for each day that such PCT Team Member was part of the PCT Team. ***     
                                                         
                                                                                
                                                                  
                                                                             
                                                                      
                                                                                
                                                    .

 

(iii)  Except for the month in which the PCT Team Member’s Start Date occurs,
for each PCT Team Member Client will pay in advance the monthly PCT Team Member
Fee for each PCT Team Member.  PCT Team Member Fees will be paid by Client in
accordance with Section 4 of Attachment A.

 

(D)  ***.  Commencing on the Effective Date and ending of the last day of the
month twelve (12) months later (for purposes of clarity, the first annual period
ends July 31, 2016) and thereafter for each twelve (12) month period:

 

(i)          if ***

 

 

; and

 

(ii)      if ***

 

 

 

 

:

 

 

***

***

***

***

***

***

***

***

 

(iii)  ***

 

 

 

 

 

 

 

 

 

.

 

(iv)  ***

 

 

 

 

 

 

 

.

 

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.

 

(E)    Close-Out Fees.  In lieu of the Close-Out Fee (as defined in the Prior
Agreements), each time PCT performs Close-out Services as provided in Paragraph
4 above, Client will pay for such Close-Out Services on a time and materials
basis at the hourly rate equal to $*** for each individual providing Close-Out
activities.  PCT shall invoice Client for the applicable close-out activities on
a periodic basis for the close-out activities performed.  Each such invoice
shall set forth the number of hours spent per PCT staff member and, as
applicable, include receipts and other documentation evidencing the out of
pocket costs incurred by PCT, in performing such services, including as provided
in Section 4 of Attachment A.  Client shall pay each invoice as provided in
Attachment A.

 

(F)     Storage Fee.  If samples or Product remain in storage/cryostorage at PCT
after the Termination Date, Client shall pay PCT for each sample and lot of
Product remaining at the Allendale Facility at PCT’s then standard rates for
storage/cryostorage and extraction from storage until such time as pursuant to
this Agreement, such samples and Product are either delivered or destroyed.

 

(7)      Adjustments to Fees.

 

(A)  The various Fees set forth in this Agreement are estimates based on
(a) Client-provided process information as of the Execution Date for Client’s
Manufacturing Process for various Products, exclusive of the analysis and
resolution of Product lot-specific deviations and corrective and preventive
actions, required for the manufacture, quality control testing and quality
assurance release of Product, on a per lot basis as well as the assumptions set
forth in this Agreement (the “Assumptions”).  The Fees set forth above,
therefore may be affected by the results obtained from the performance of the
Services (the “New Information”).

 

(B)   If PCT reasonably determines at any time that the Assumptions, as a result
of the New Information were incorrect or incomplete and, therefore, the Fees
need to be adjusted to reflect the New Information, PCT will advise Client upon
becoming aware of such determination and the need to adjust the Fees to reflect
such New Information and the basis and the amount of such proposed adjustments
to the Fees.  If PCT advises Client as provided above, then changes to the Fees
as set forth in the written notice to Client will be handled in accordance with
the terms regarding Program Amendment Orders as set forth in the Agreement. 
Until such Program Amendment Order(s) are executed PCT may elect not to continue
to perform applicable Stage Services until such Program Amendment Order
reflecting adjustments in the Fees are executed by the Parties.

 

(8)      Additional Fees:

 

(A)  In anticipation of the costs and expenses to be incurred by PCT in
performing the Services hereunder, on the Execution Date and thereafter on the
first day of each month commencing after the Effective Date until the Agreement
is terminated, PCT will invoice and Client will pay, in advance, the sum of ***
United States dollars ($***) (each an

 

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“Expense Payment”) for such costs and expenses.  PCT will use the monthly
Expense Payments for costs and expenses set forth in Section 4(b) of Attachment
A. In the event the monthly expenses exceed the applicable monthly Expense
Payment, PCT will invoice Client the amount of the expenses in excess of the
Expense Payment and Client will pay such invoice as provided in this Agreement.
PCT will credit against the first Expense Payment payable pursuant to this
Agreement any Expense Prepayments (as defined in the applicable Prior
Agreements) that as provided in such Prior Agreements, PCT would return to
Client in the ordinary course.  PCT will provide Client with a monthly invoice
documenting such costs and expenses and offsetting such amounts by the amount of
the Expense Payment actually paid by the Client.  If the expenses in a
particular month do not equal such month’s Expense Payment, an amount equal to
the difference between the Expense Payment amount and the actual monthly
expenses will be applied to an excess costs and expenses in subsequent months.

 

(B)   Provided Client has satisfied all of its obligations to PCT pursuant to
the terms of this Agreement (including the payment of all storage fees), upon
the termination of this Agreement, PCT will promptly return to Client any unused
Expense Payments paid in advance that have not been used to pay costs and
expenses pursuant to this Agreement less any other amounts owed by Client to PCT
to this Agreement.

 

(9)      Miscellaneous:

 

(A)  The Client Point of Contact for PCT with respect to the Services will be
designated in a written notice from the Client to PCT’s Point of Contact from
time to time.  Depending on the particular Product, the Client may have separate
Client Point of Contacts at Client for PCT. The Client Point of Contact shall
have responsibility over all matters relating to the performance of the Services
on behalf of both Adaptimmune and Client without PCT having any responsibility
to communicate with and/or contact any other person at either Client or
Adaptimmune.  PCT may deal with the designated Client Point of Contact as to a
particular matter or concern relating to either Client or Adaptimmune, provided
that invoicing shall be delivered to Client.  The designated Client Point of
Contract has sole responsibility for keeping both Client and Adaptimmune
informed of all matters which PCT has contacted the designated Client Point of
Contact.  In the event of PCT’s receipt of conflicting notices/communications
from the Client and Adaptimmune, PCT shall rely on the notice or communication
received from the designated Client Point of Contact (or if not from the
designated Client Point of Contact, then from an authorized person at Client).

 

(B)   All communications between PCT and Client and/or Adaptimmune shall be
addressed to or routed through each Party’s Point of Contact.  PCT shall
endeavor to address any communication to Client and Adaptimmune, provided,
however, failure to provide notices to both Client and Adaptimmune will not
affect the validity of PCT’s communication to the Client and/or Adaptimmune if
PCT’s communication was addressed to or routed through the designated Client
Point of Contract.

 

(C)   The terms and conditions of Attachment A and Attachment B are incorporated
herein by reference in their entirety and shall be deemed to be a part hereof to
the same extent as if such terms and conditions had been set forth in full
herein.  By executing this Agreement Client and Adaptimmune each acknowledges
that it has read Attachment A and

 

 

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Attachment B and that the terms and provisions of Attachment A and Attachment B
are an integral part of this Agreement.

 

(D)  ***

 

 

 

.  Client staff members shall first obtain PCT’s Point of Contact’s approval to
observe particular Services with sufficient notice to enable PCT to reasonably
accommodate such requested access.  In PCT’s reasonable discretion, PCT may
refuse access to particular areas of the Allendale Facility if other processes
or activities not associated with the Run are being conducted by PCT and Client
staff shall be given access only at such times as is reasonable for such client
staff to observe ongoing activities associated with a Product Run.

 

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This AGREEMENT has been duly executed by the Parties as of the Execution Date
and shall be effective as of the Effective Date.

 

PCT, LLC, A CALADRIUS COMPANY

 

ADAPTIMMUNE LIMITED

 

 

 

 

 

 

 

 

 

By:

/s/ George S. Goldberger

 

 

 

By:

/s/ James Noble

 

Name: George S. Goldberger

 

Name: James Noble

Title: VP Business Development

 

Title:CEO

 

 

 

 

 

 

 

 

ADAPTIMMUNE, LLC

 

 

 

 

 

 

 

 

By:

/s/ H. K. Tayton-Martin

 

 

 

 

Name: H. K. Tayton-Martin

 

 

Title: COO

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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ATTACHMENT A

 

TERMS AND CONDITIONS

 

Terms not defined herein have the meaning in the Agreement

 

1.    Services. Client and PCT have agreed upon the Services set forth in the
Agreement. PCT’s performance of Services is based on information provided to
PCT. Timelines and cost figures are estimates made by PCT based upon such
information and are not guarantees that the Services can be performed within
such estimates. Services, time durations and fees may need to be adjusted.  Any
changes to or additions to the Services will be provided pursuant to a document
executed by the Parties (a “Program Amendment Order”) or other writing between
the Parties or as an Additional Service as defined below. Services may be
provided in various stages (each a “Stage”) as more particularly provided in the
Agreement and, if applicable, may overlap or occur in parallel. PCT’s
performance of the Services is subject to Client’s timely performance of
Client’s obligations that are required to enable PCT to timely perform the
Services.

 

2.    Conduct of Services to be Performed; Points of Contact; Alliance Managers.

 

a.    Subject to Section 11(a)(ii) and 11(b) below, PCT will comply, in all
material respects, with all laws and regulations of any United States federal,
state or local government or regulatory agency and, as applicable, any
applicable European Union laws and regulations (collectively, “Regulatory
Agency”) that governs the Services (the “Applicable Laws”) including, when
applicable, those concerning current Good Manufacturing Practice (“GMP”)
regulations, as set forth in, as applicable the U.S. Code of Federal Regulations
Title 21 (21 C.F.R. §§ 210 and 211) or the European Union Commission Directive
2003/94/EC of 8 October 2003 and, in effect from time to time, and appropriate
for the particular phase trial conducted by Client or type of Services. If
Applicable Laws change, PCT will, subject to Section 11 below, make commercially
reasonable efforts to satisfy the new requirements.

 

b.    Unless otherwise provided in the Agreement, PCT shall perform the Services
at one or more of PCT’s facilities located in the United States, as determined
by PCT and Client (each a “Facility”); provided, however, that if the Agreement
provides that Services will be performed at a specific Facility, then Services
will only be provided at such Facility.  If Client desires Services, including
but not limited to manufacturing Services, to be performed at another PCT
Facility, Client agrees that performance of Services at such additional PCT
Facility, if provided by PCT, will be for additional fees and at Client’s costs
and expenses pursuant to a Program Amendment Order or other writing between the
Parties or as an Additional Service as defined below.  Such fees, costs and
expenses at such additional Facility include, without limitation, those
associated with (i) technology transfer to the additional Facility,
(ii) training of PCT staff and (iii) validation and qualification of equipment,
people, space resources, Services related processes, methods and procedures and
(iv) other activities associated with providing the desired services at the
additional PCT Facility.  Providing Services at such additional PCT
facility(ies) will be pursuant to a Program Amendment Order or other writing
between the Parties or as an Additional Service as defined below.

 

c.    Within thirty (30) days after PCT’s or Client’s request, the Parties will
negotiate and execute such quality agreement (a “Quality Agreement”) with regard
to the Services contained in this Agreement setting forth the
(i) responsibilities of each Party’s personnel in relation to quality assurance
matters and (ii) responsibilities for material compliance with Applicable Laws,
including GMP as appropriate. PCT is responsible for compliance while Product is
in the possession of PCT and Client is responsible for compliance at all other
times. Failure to execute a Quality Agreement will not be a default nor be the
basis of a termination of the Agreement. If there is a discrepancy between the
Quality Agreement and this Agreement, this Agreement shall control, except that
with respect solely to quality assurance/quality control, the terms of the
Quality Agreement shall control. Until the execution of a new Quality Agreement
pursuant to this Agreement, the quality agreement, if any, executed in
connection with one or both Prior Agreements shall be applicable.

 

d.    Unless otherwise provided in the Agreement, PCT’s designated day-to day
point of contact (the “Point of Contact”) at PCT for Client is ***
                                                , or any other individual
designated in writing from PCT to Client.  The PCT Point of Contact will work
with the respective designated Client Point of Contact to coordinate the
performance of Services with one another. Communications regarding the conduct
of Services shall be addressed to or routed through each Party’s Point of
Contact.  ***   
                                                               , will act as
alliance manager (“Alliance Manager”) for PCT and will work with Client’s
designated Alliance Manager as identified in writing by Client to PCT or, in the
absence of a Client designated Alliance Manager, Client’s Point of Contact, to
facilitate and oversee the relationship and strategic alignment of Services
between the Parties. The Alliance Managers will ensure the flow of information
and collaboration between the Parties, and facilitate the resolution of
potential or pending Service related issues or disputes in a timely manner to
enable the Parties to reach consensus and avert escalation of such issues or
disputes.  Either Party may replace its Alliance Manager at any time upon
written notice (including by email) to the other Party’s Alliance Manager. The
Alliance Managers shall meet (whether in person or by other means) as often as
reasonably necessary and determined by them to oversee the relationship between
the Parties.

 

e.    Client will provide PCT with sufficient amounts of Client provided
reagents, materials and supplies and Raw Materials (as defined in
Section 10(c) below) with which to perform Services, as well as all
documentation and other data as may be available to apprise PCT of the stability
of such reagents, materials, supplies and Raw Materials, describe process
characteristics, processing, and proper storage and safety requirements.

 

f.     No breach of the Agreement exists if a Party fails to fulfill its
obligation due to the action or inaction by the other Party or any person or
entity, provided, in the case of PCT, such person or entity is not providing
“core” Services as described in paragraph (h) immediately below.

 

g.  With Client’s prior written consent (except as noted below) not to be
unreasonably withheld, delayed or conditioned, PCT may subcontract the
performance of certain Services related obligations of PCT pursuant to the
Agreement to a third party including an Affiliate (as defined in
Section 17(d) below) of PCT or a qualified non-Affiliate third party; provided
that such third party performs those Services related obligations of PCT

 

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pursuant to the Agreement in a manner consistent with the terms and conditions
of the Agreement.  PCT will use reasonable due diligence in selecting all
subcontractors ***

 

.  The Parties agree that *** Services include, but are not limited to,
purification, transduction, freezing, storing and testing of Product by PCT. PCT
will cause all permitted subcontractors to be bound by written obligations to
keep Confidential Information confidential and not use Confidential Information
and to comply with, the terms of, quality assurance, regulatory and other
obligations and requirements of PCT set forth in the Agreement.  Notwithstanding
anything to the contrary in this paragraph, PCT is not required to obtain prior
written consent for use of subcontractors who are generally used by PCT to
maintain and operate PCT’s Facility or provide services ***          that are
generally applicable to services provided to other clients of PCT.  Except as
provided above, PCT may utilize suppliers, vendors, contractors and
subcontractors provided that PCT qualifies such suppliers, vendors, contractors
and subcontractors and utilizes such suppliers, vendors, contractors and
subcontractors in accordance with PCT’s standard quality requirements and SOPs.
If requested by Client, PCT will solicit quotations from third party suppliers,
vendors, contractors and subcontractors selected by Client and acceptable to PCT
and if Client requires PCT to use any such third party supplier, vendor,
contractor or subcontractor, Client shall be responsible for PCT’s costs and
expenses which PCT may incur in qualifying such third party vendor, supplier,
contractor or subcontractor.

 

h.   PCT shall maintain, complete and accurate Records (as defined below)
relating to the Services in accordance with GMP and PCT’s quality assurance
SOPs.  Records will be available for inspection, examination and copying by or
on behalf of Client during Business Hours upon reasonable notice provided by
Client to PCT.  If Records are requested which have not previously been provided
to Client in connection with PCT’s performance of the Services, PCT will at, the
direction and written request of Client and at Client’s cost and expense (which
will include the reasonable time incurred by PCT personnel at its then current
and standard hourly rates required to provide and deliver Records) provide such
Records to Client.  Records shall be retained by PCT for at least *** years
after termination of the Agreement.  Subject to the need to retain Records
pursuant to Applicable Laws PCT, at Client’s direction and written instruction
and at Client’s cost and expense, will dispose of the Records, provided, further
that PCT may retain one (1) copy of such Records as evidence of PCT’s
obligations under the Agreement ***

 

. “Records” means records (including reports, accounts, notes, data, and records
of all information and results obtained from performance of Services by PCT
under the Agreement) and all raw data, reports, authorizations, certificates,
methodologies, batch documentation, raw material specifications, SOPs, standard
test methods, certificates of analysis, certificates of compliance and other
documentation in the possession or under the control of PCT relating to the
Manufacturing Process of Product.  ***

 

.

 

i.     All materials provided by or on behalf of Client to PCT or generated by
PCT in connection with the Agreement, including without limitation all apheresis
and Product (collectively “Materials”), shall be used by PCT only as necessary
to perform the Services in accordance with the Agreement.  PCT agrees to retain
control over the Materials and, except as otherwise expressly directed by Client
in writing, not to transfer the Materials to any person or entity other than
those employees or permitted subcontractors working on the Services under the
direct supervision of PCT.  PCT acknowledges that the Materials are experimental
in nature and may have unknown characteristics and therefore agrees to use
prudence and reasonable care in the use, handling, storage, transportation and
disposition and containment of the Materials.  PCT may not undertake efforts to
ascertain the structure or sequence of any Materials or produce or synthesize
any Materials from structural and/or sequence information provided hereunder
without the prior express written permission of Client.  PCT shall not reverse
engineer, disassemble or decompile any Materials.  Upon completion or
termination of the Services, PCT shall, at Client’s cost and expense, return any
unused Materials to Client or its designee or destroy such Materials, as
directed by Client. PCT agrees not to obtain or attempt to obtain patent
coverage on the Materials, or any other materials or methods that could not have
been made but for the Materials, or the use of any of the foregoing.

 

j.      Client may also provide equipment for use in any dedicated rooms and for
the provision of the Services. Any equipment provided by Client shall be used
solely for the performance of the Services and for no other purpose. PCT shall
maintain such equipment at its Facility and take reasonable care of such
equipment all at Client’s cost and expense.

 

3.    Investigation of Deviations and Corrective Action; Defective Product.

 

a.    If Client in connection with the Manufacturing Process (which includes the
manufacture, testing, release, packaging, labeling, storage or shipping) of
Product either (i) instructs PCT to take actions/steps resulting from PCT
notifying Client of a deviation in such Manufacturing Process and such
actions/steps result in PCT preparing reports documenting such deviations and/or
taking corrective actions to address such deviations or (ii) requests PCT to
take additional steps and/or actions to address any deviation and/or corrective
action, in either case, above those that PCT reasonably determines are necessary
to address the same, in each instance, PCT, at its option, may treat the time
required to address either of the above as Additional Services (as defined in
Section 17(m) below) which will be invoiced to Client as provided in
Section 17(m) unless Client and PCT have otherwise agreed to in writing.

 

b.   Client shall accept or reject Product based upon batch documentation
review, including release testing results, against the specifications for
Product.  Based upon the batch documentation review, Client shall notify PCT in
writing of any Product which has not been manufactured, tested, packaged,
labeled, quality control tested, released, stored or shipped in compliance with
GMP, if the Services require compliance with GMP and/or in accordance with the
Agreement (“Defective Product”) within *** days of the date of Client’s or its
designee’s receipt of such batch documentation, including release testing
results; provided that with respect to any failure or non-conformity which could
not reasonably have been discovered by or on behalf of Client during such
period, Client shall have the right to notify PCT in writing of such Defective
Product

 

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within the earlier to occur of (a) *** days after becoming aware of the failure
or non-conformity and (b) *** days of the date of Client’s or its designee’s
receipt of the Defective Product. If a dispute exists as to whether Product is a
Defective Product and/or the Parties’ respective Share of Responsibility (as
defined below) for the Defective Product and/or whether such Defective Product
is ***                                           , any Party may request an
investigation to determine whether a Product is a Defective Product and/or the
Parties’ applicable Share of Responsibility for the Defective Product and/or
whether such Defective Product
***                                                      . A Party, as provided
in the Quality Agreement, will bear the upfront costs of the investigation. If a
Quality Agreement does not exist, Client is responsible for the upfront costs.
Following the investigation’s completion, the Parties will retrospectively share
the costs of such investigation equal to the share of responsibility (“Share of
Responsibility”) the Parties agree should be assigned to each Party for the
Defective Product. If no agreement as to Share of Responsibility is reached, the
Parties shall appoint a third party, the costs of which shall initially be
shared equally by the Parties, to review the results of the investigation and,
if possible, apportion each Party’s Share of Responsibility for the costs of the
investigation and the costs of the third party between the Parties based on a
root cause analysis of the cause of the Defective Product. If the Parties cannot
agree upon a single third party, then each Party shall appoint a third party and
such third party shall appoint a third party, the costs of which shall initially
be shared by the Parties. The third party(ies) shall review the results of the
investigation and, if possible, apportion each Party’s Share of Responsibility
for the Defective Product and the costs of the investigation and the costs of
the third party(ies) between the Parties based on a root cause analysis of the
cause of the Defective Product. The Parties agree to be bound by the third
party(ies) ruling.

 

c.   If a Defective Product exists and PCT, at Client’s written request,
manufactures additional product on a mutually scheduled date to replace the
Defective Product, unless expressly agreed to by PCT, the costs of any reagents,
materials, supplies and/or Raw Materials incurred in connection with
manufacturing such replacement product shall be an expense reimbursable by
Client to PCT. Unless set forth to the contrary in writing by the Parties, the
costs for manufacturing such replacement product shall be (i) borne by PCT if
the Share of Responsibility for the Defective Product lies solely with PCT,
(ii) borne by Client if the Share of Responsibility for the Defective Product
lies solely with Client and (iii) apportioned between them if both Parties are
responsible for the Defective Product in an amount equal to such Party’s Share
of Responsibility for the Defective Product.  If the Parties are unable to agree
on the Share of Responsibility or are unable to determine the root cause of the
Defective Product or the investigation is unable to determine the root cause of
the Defective Product and/or Share of Responsibility for the Defective Product
and/or whether the Defective Product
***                                                           , if Client
requests replacement Product, unless otherwise agreed to by PCT, PCT will not be
responsible for the costs of processing such replacement Product.

 

4.   Payment for Services, Other Costs.

 

a.   The amount and timing of payments are set forth in the Agreement and all
amounts are payable in United States Dollars.

 

b.   Client shall pay and PCT will separately invoice Client for all reasonable
out of pocket costs and expenses incurred by PCT in performing the Services,
including, but not limited to:

(i)   Costs of reagents, materials and Raw Materials (as defined below).

(ii)  Costs of travel, accommodations and meals incurred in connection with the
Services with such travel, accommodation and meal costs to be approved by Client
in writing, with such writing to include email or other electronic
communication.

(iii)  Costs associated with outsourced or outside testing/analytical services,
including, but not limited to, sterility testing, mycoplasma testing, karyotype
testing, viral/adventitious agent testing, γ-irradiation services and other
assays not performed by PCT.

(iv) Packaging and shipping costs (including test samples and product) to or
from PCT or Client or to or from any third party, including but not limited to
contract laboratories or testing facilities and Client designated clinical
and/or storage sites.

(v)  Costs of providing or receiving in-process or final product quality control
test methods beyond those detailed in the Agreement.

 

c.   Except to the extent expressly provided in this Agreement, in addition to
the above, unless the Parties otherwise agree in writing to the contrary, Client
shall pay and PCT will separately invoice Client for the following services,
costs and expenses which will be provided by PCT either pursuant to a Program
Amendment Order or other writing executed by the Parties, with such writing to
include email or other written, electronic communication or as an Additional
Service as provided in Section 17 below:

(i)     Costs associated with providing, developing and/or validating/qualifying
test methods, including assay services or assay methods and the costs of process
and assay test method validation to a level required for submission to the U.S.
Food and Drug Administration, or any successor agency thereto (the “FDA”) beyond
those detailed in the Agreement.

(ii)     Costs of any equipment purchased, installed, validated and required
solely for the Services provided, but only to the extent such costs are approved
in advance in writing by Client.

(iii)    Costs associated with storage of any product or specific materials past
the duration of the Agreement, unless otherwise provided in this Agreement.

(iv)    Costs associated with (A) any stability assessment or trial for the
Product, Raw Materials or Product intermediates or (B) any shipping
qualification for Raw Material or Product, in each case, requested by Client
beyond those, if any, detailed in the Agreement.

(v)    Environmental monitoring or Facility cleaning costs beyond that currently
executed by PCT.

(vi)    Costs of the preparation and submission of documentation provided to
Regulatory Agencies beyond those detailed in the Agreement.

(vii)   Costs of regulatory services beyond those detailed in the Agreement.

(viii)  Costs related to regulatory and quality services and interactions,
including, but not limited to, costs of any additional qualification and/or
validation activities to address specific requests received from any Regulatory
Agency.

(ix)    Costs of the technology transfer of Services or any part thereof to any
third party GMP manufacturing facility/organization as requested by Client.

 

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d.    In connection with the above Sections 4(b)(i), 4(b)(iii) and
4(b)(iv) costs, a ***          handling fee will be added by PCT to any
invoice.  Adaptimmune may request evidence of any third party costs and expenses
for which it is invoiced and following such request, PCT shall provide receipts
or other documentation evidencing the incurring of such costs and expenses.

 

e.    Except as provided in the Agreement, payments are due no later than the
scheduled date for payment provided an invoice has been received in advance of
such scheduled date (or if no such scheduled date, no later than ***     days
after the receipt of such invoice), provided, however, notwithstanding the
preceding, invoices for the reimbursement of expenses as set forth in
Section 4(b) of this Attachment A are payable by Client within ***   days of
receipt of such invoice. Client must advise PCT, in writing within ***     days
of its receipt of an invoice if it has a good faith dispute as to some or all of
the charges (the “Disputed Charges”) set forth in such invoice (with such
written notice to state, with specificity, Client’s reason for the Disputed
Charges).  As to the Disputed Charges only, the Parties agree that until such
Disputed Charge is resolved, such Disputed Charge is not payable, provided,
however, Client understands and agrees that to the extent expressly provided in
the Agreement, if payment is required for the commencement of the performance of
particular Services and such payment is a Disputed Charge, PCT may (in each case
subject to PCT using reasonable efforts to resolve the relevant dispute) refuse
to perform the particular Service until the resolution of the particular
Disputed Charge occurs and payment is made thereon. Undisputed amounts and
amounts which are no longer in dispute (after either resolution thereof or the
issuance of a new invoice) which remain unpaid for more than *** days after
Client’s receipt of such invoice shall accrue interest at the rate of ***    per
annum from the date such applicable amount as evidenced by the invoice was
originally due until paid in full, ***

 

.

 

f.     If a Quality Agreement does not exist or does not address the disposal of
product, Client is responsible for such reasonable costs.

 

g.    Payments and Fees are subject to a cost of living adjustment (“COLA”)
effective January 1 of the year following the Effective Date and on January 1 of
each successive year (each a “Determination Date”). For the twelve (12) month
period following the applicable Determination Date, payments and fees may be
increased by COLA.  PCT will notify Adaptimmune of any COLA increase and the
changes, if any, in the various payments and fees payable by Client to PCT which
increases will be based upon the percentage increase in the U.S. Bureau of Labor
Statistics Consumer Price Index For All Urban Consumers (CPI-U) in the state in
which the majority of the Services have been provided during the twelve (12)
month period ending in the month preceding the month in which PCT notifies
Adaptimmune of the applicable COLA adjustment. Such increases will become
effective on the Determination Date set forth in such COLA notification and such
COLA notification will be binding and enforceable against Client absent manifest
error.

 

5.    Confidential Information.

 

a.    “Confidential Information” is information received by one Party (the
“Receiving Party”) from or on behalf of any other Party (the “Disclosing Party”)
and includes the terms and provisions of this Agreement. Confidential
Information includes any and all non-public scientific, technical, financial,
regulatory or business information, or data or trade secrets in whatever form
(written, oral or visual) that is furnished or made available by or on behalf of
the Disclosing Party to the Receiving Party or developed by either Party under
the Agreement.  Confidential Information does not include information which
(i) is or becomes a part of the public domain through no act or omission of the
Receiving Party, (ii) is or was in the Receiving Party’s lawful possession prior
to the disclosure by or on behalf of the Disclosing Party, (iii) is disclosed to
the Receiving Party by a third party entitled to disclose such Confidential
Information other than disclosure on behalf of the Disclosing Party or (iv) was
independently developed by the Receiving Party without use of or access or
reference to the Confidential Information of the Disclosing Party.

 

b.    Receiving Party may disclose the other Party’s Confidential Information to
a Receiving Party’s member, Affiliate (as defined in Section 17(d) below) (but
limited to such Affiliate’s executive and director level officers), employee or
agent who have a need to know such Confidential Information in order to perform
obligations or exercise rights under the Agreement and who are under similar
obligations not to use or disclose and keep the Confidential Information
confidential. If disclosure is requested by legal process, the Receiving Party
will make reasonable efforts to notify the Disclosing Party prior to disclosure
to permit Disclosing Party to oppose such disclosure or seek confidential
treatment, at Disclosing Party’s cost by appropriate legal action, and the
Receiving Party agrees to cooperate reasonably with Disclosing Party in any
efforts to seek a protective order or other appropriate remedy.  If Receiving
Party becomes obligated to disclose such Confidential Information in any legal
or administrative proceeding which is not the result of a legal or
administrative proceeding primarily involving or against the Receiving Party,
then Disclosing Party shall reimburse Receiving Party all of Receiving Party’s
reasonable out of pocket costs and expenses related thereto, including the time
Receiving Party’s personnel spend in complying with such disclosure obligations.

 

c.    Receiving Party shall not use or disclose Disclosing Party’s Confidential
Information except to perform its obligations or to exercise its rights
hereunder or as otherwise expressly permitted under the Agreement. 
Notwithstanding the preceding, nothing shall prohibit (i) Client from using or
disclosing PCT’s Confidential Information in regulatory filings or
correspondence with regulatory authorities in connection with the development
and commercialization of any Product and (ii) the Receiving Party from
summarizing the terms of this Agreement, or from filing the Agreement as an
exhibit, in documents the Receiving Party is required to file with any
Regulatory Agency, including, but not limited to, the Securities and Exchange
Commission; provided that in the case of both (i) and (ii) immediately above,
Receiving Party shall provide the proposed disclosure to the other Party with a
reasonable amount of time for the other Party to review and provide comments,
which comments shall be incorporated to the extent reasonable and in compliance
with Applicable Laws, and the Receiving Party shall seek confidentiality
treatment in consultation with the other Party to the fullest extent permitted
by Applicable Laws.  Notwithstanding this Section 5(c) to the contrary, PCT may
disclose the Agreement to bona fide actual or prospective underwriters,
investors, lenders or other financing sources or to potential or actual
acquirers of PCT’s business to which this Agreement relates as part of due
diligence requirements, and who have a specific need to view the Agreement and
who are bound by a written obligation of confidentiality and restrictions on use
substantially the same as those herein.

 

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d.    Upon termination of the Agreement, Receiving Party shall, except to the
extent otherwise expressly permitted under the Agreement (i) immediately cease
using the Disclosing Party’s Confidential Information and (ii) at the written
request of Disclosing Party, promptly, at the Disclosing Party’s cost, destroy
or return the tangible embodiments of such Confidential Information. Receiving
Party may retain one (1) copy of Confidential Information for the purpose of
determining its obligations under the Agreement. The confidentiality and non-use
obligations shall continue for a period of *** years after the termination of
the Agreement.

 

e.    Money damages would not be a sufficient remedy for any breach of the
confidentiality obligations set forth herein and, in addition to all other
remedies, the Disclosing Party is entitled to seek injunctive or other equitable
relief as a remedy for such breach without posting a bond.

 

f.     Notwithstanding anything above to the contrary, (X) Client and
Adaptimmune may disclose Confidential Information of PCT relating to the
Services to entities (i) with whom Client or Adaptimmune
***                                       or (ii) ***

 

, and who in the case of both (i) and (ii) have a specific need to know such
Confidential Information and who are bound by a written obligation of
confidentiality and restrictions on use substantially the same as those herein;
and (Y) Client and Adaptimmune may disclose Confidential Information of PCT to
each other.

 

g.    In addition in the event of a ***          to the extent reasonably
possible without breaching any obligations under Applicable Laws or regulatory
requirements, PCT shall not, without the prior written consent of Client,
provide access to the Client’s Product MBR or access to Room 1 or Room 6 (to the
extent the Room 6 Termination Date has not occurred) ***                    and
will not provide to such individuals any Client Confidential Information in
violation of this Section 5.

 

6.    Disclosure; Intellectual Property.

 

a.    PCT shall disclose and provide to Client documentation of its processes
utilized by PCT in connection with the Services provided pursuant to the
Agreement.  All such documentation and disclosure will constitute Confidential
Information within the meaning of section 5(a) of these Terms and Conditions.

 

b.    As applicable, PCT, its members or Affiliates shall retain ownership of
all of PCT know-how, processes and procedures that existed and that PCT owned or
was controlled by, as applicable PCT, its members or Affiliates before PCT
commenced providing Services to Client under the Agreement (the “PCT Background
Intellectual Property”).  Adaptimmune shall retain ownership or control of all
know-how, processes and procedures that existed and that Adaptimmune owned or
controlled before PCT commenced providing Services to Client under the
Agreement, including without limitation the Manufacturing Process and
subpopulation of cells of a Product (the “Client Background Intellectual
Property”).  For purposes hereof, “controlled” means, with respect to a Party’s
Background Intellectual Property, the right, not subject to consent and without
violating any legal rights of a third party, to grant a license or sublicense.

 

c.    Client owns and shall own all right, title and interest in and to the
Manufacturing Process and any Product, deliverable, process, product and/or
process change, improvement, development, invention, discovery, work of
authorship, formulation, technique, information, results and data including new
uses for Product or improvements to the Client Background Intellectual Property
or the PCT manufacturing know-how, process and procedures, that result from the
Services provided by PCT pursuant to the Agreement (excluding any intellectual
property rights and rights in know-how therein). Adaptimmune shall own all
right, title and interest in and to all intellectual property rights and
know-how in and to the Manufacturing Process and any Product, deliverable,
process, product and/or process change, improvement, development, invention,
discovery, work of authorship, formulation, technique, information, results and
data including new uses for Product or improvements to the Client Background
Intellectual Property or the PCT manufacturing know-how, process and procedures,
that result from the Services provided by PCT pursuant to the Agreement, whether
or not patentable, made, conceived or reduced to practice by or on behalf of PCT
alone or with others resulting from the Services (collectively, “New
Intellectual Property”). New Intellectual Property shall constitute the
Confidential Information of Adaptimmune and Adaptimmune shall be deemed to be
the Disclosing Party for the purposes of Section 5 in relation to such New
Intellectual Property. PCT shall notify Adaptimmune in writing of any and all
New Intellectual Property promptly after its conception, development or
reduction to practice. Without additional consideration but at Adaptimmune’s
cost and expense, PCT hereby assigns and transfers to Adaptimmune pursuant to
Adaptimmune provided documentation reasonably acceptable to PCT, all of PCT’s
right, title and interest in and to the New Intellectual Property and agrees to
take, and to cause its employees, agents, contractors and consultants to take,
all further acts reasonably required to evidence such assignment and transfer to
Adaptimmune, at Adaptimmune’s cost and expense.

 

d.    Adaptimmune hereby grants PCT an irrevocable, non-assignable,
non-transferable, world-wide royalty-free, non-exclusive, non-sublicensable
license to use Improvements for PCT’s own benefit and the benefit of PCT’s
members, Affiliates and all of their respective clients for products other than
the Product delivered pursuant to this Agreement but excluding from such license
(i) products containing engineered T cell receptors (“TCRs”) whereby T cells
have been transduced with genes for the expression of an alpha beta T cell
receptor, this being defined as a protein that contains a TCR alpha variable
domain, (ii) any subpopulation of cells of the Product and (iii) any new use for
Product intellectual property. “Improvements” shall mean, for purposes of this
provision, that subset of New Intellectual Property consisting of improvements,
developments or modifications made, conceived, or reduced to practice by PCT to
PCT Background Intellectual Property in the course of providing Services to
Client.

 

e.    Work output will be prepared on PCT’s standard format and, except as
provided above, Client will have exclusive title to all Products delivered
pursuant to the Agreement including related data, documentation including batch
records documentation and testing results, Records, specimens and other reports
generated pursuant to the Agreement, all of which shall be Confidential
Information of Client and Client shall be deemed to be the Disclosing Party for
the purposes of Section 5. PCT shall keep complete and accurate records
pertaining to any New Intellectual Property and shall record, to the extent
practical, all data and information relating to the Services in standard
laboratory notebooks,

 

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which shall be signed, dated, or kept electronically.  Such documentation shall
be kept for a period of *** years following the termination of the Agreement. 
In addition, such documentation shall be in a form suitable for filing with
Regulatory Agencies as part of or in support of (directly or indirectly) any
regulatory filings or submissions.

 

f.     Without additional consideration, PCT hereby grants to Client and
Adaptimmune a perpetual, irrevocable, worldwide, non-exclusive, royalty-free,
fully paid up, license under PCT Background Intellectual Property, and to use or
otherwise exploit PCT Background Intellectual Property that is incorporated into
Product or is otherwise used in the performance of the Services, to the extent
necessary for Client and Adaptimmune to develop, make, have made, use, sell,
offer for sale, export and import Product and any other product comprising an
engineered T-cell receptor (“TCR”) and whereby T-cells have been transduced with
the gene for the expression of an alpha-beta TCR.  The license granted hereunder
may be sublicensed by Client or Adaptimmune to its affiliates and to third
parties who license Product from Client or Adaptimmune or who make Product for
Client or Adaptimmune.

 

7.    Relationship of Parties. The Agreement does not create an
employer-employee relationship between Client, Adaptimmune and PCT. No Party
shall hold itself out as an agent or representative of the other. PCT shall
perform the Services as an independent contractor of Client and has complete and
exclusive control over its Facilities, equipment, employees and agents. Nothing
in the Agreement shall constitute PCT, or anyone furnished or used by PCT in the
performance of the Services, as an employee, joint venturer, partner, or servant
of Client or Adaptimmune.

 

8.    Representations, Warranties and Covenants.

 

a.    General Representations, Warranties and Covenants. Each Party has the
necessary right and authority to enter into the Agreement. No Party makes any
representation, warranty or covenant except as specified in the Agreement and
Quality Agreement.

 

b.    Representations, Warranties and Covenants of PCT. PCT hereby represents,
warrants and covenants (and with respect to subsection (iv) certifies) to Client
that:

(i)    PCT’s employees and agents have expertise in the relevant subject matter
and will perform the Services with due care in accordance with reasonable
industry standards.

(ii)   PCT Facilities shall operate and Services shall be performed in
compliance with Applicable Laws.

(iii)  PCT has all necessary permits, licenses (excluding third party
intellectual property right licenses) and authorizations to provide Services as
required by Applicable Laws.

(iv)  Neither PCT nor any person or entity staff involved in providing the
Services shall be, at the time of performance of Services: (a) disqualified or
debarred by the FDA or any other Regulatory Agency for any purpose pursuant to
21 U.S.C. § 335a or equivalent European Union provision; or (b) convicted of a
crime under United States federal or state law or European Union laws for
conduct relating to the development or approval, or otherwise relating to the
regulation, manufacture, research or development of biological products.  If PCT
or to PCT’s actual knowledge, any individual or entity involved in providing
Services becomes debarred, receives notice of an action or threat of action of
debarment or becomes convicted as described above, PCT shall notify Client in
writing within five (5) Business Days.

(v)   PCT is not party to any agreement, instrument or understanding, oral or
written, that would conflict with or interfere with PCT’s rendering of Services
or Client’s use thereof.

(vi)  PCT (a) shall not knowingly infringe upon any U.S. or foreign copyright,
patent, trademark, trade secret or other proprietary right, or misappropriate
any trade secret of any third party in any manner that would cause any
liability, loss or damage to Client; and (b) has neither assigned nor entered
into any agreement assigning or transferring any right, title or interest to any
intellectual property that would conflict with its obligations under the
Agreement.

 

c.    Representations, Warranties and Covenants of Client.  Client hereby
represents, warrants and covenants to PCT that:

(i)    Except for those permits, licenses and authorization possessed by PCT, or
would ordinarily be expected to be possessed by PCT, and necessary for PCT to
perform the Services, Client has and will maintain during the term hereof all
necessary permits, licenses (excluding any third party intellectual property
right licenses), approvals, registrations, certifications and authorizations
with respect to the research, use, distribution, transfer and/or sale of Product
which is the subject of the Agreement and to permit PCT to provide Services
pursuant to the Agreement, to the extent such permits, licenses and
authorizations are necessary with respect to the above.

(ii)   Neither Client nor Adaptimmune Client is a party to any agreement,
instrument or understanding, oral or written, that would conflict with or
interfere with PCT’s rendering of Services.

(iii)  Client and Adaptimmune (a) shall not knowingly infringe upon any U.S. or
foreign copyright, patent, trademark, trade secret or other proprietary or
intellectual property right, or misappropriate any trade secret of any third
party in any manner that would cause any liability, loss or damage to PCT; and
(b) has neither assigned nor entered into any agreement assigning or
transferring any right, title or interest to any technology or Intellectual
Property that would conflict with its obligations under the Agreement.

(iv) Client has the unlimited and unrestricted right to deliver to PCT all
documentation, including SOPs, development/qualification/audit reports, Master
Production Records and PNSs or has obtained the necessary permission to make
such transfer and/or delivery to PCT.

(v)   All products, materials and reagents required for the Services can be
sourced and are of a grade/nature/origin acceptable for their intended use in
accordance with the Agreement and, as applicable, for human administration
according to all Applicable Laws and PCT’s standards.

(vi)  Client shall perform its obligations under the Agreement and the Quality
Agreement in a professional manner with due care and will cooperate with PCT in
connection with PCT’s performance of Services.

(vii) Client acknowledges that PCT may have relationships with one or more
vendors/providers of equipment, supplies and materials used in connection with
the Services.

 

d. Covenants relating to use of ***          used or required to be used in
Client’s Product Manufacturing Process for Product as part of the Services
(“***  “). In relation to the use of the ***   in the performance of Services
for Client, PCT covenants:

 

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(i)    To only use the *** obtained in connection with the Services on behalf of
Client and solely for the purpose of performing the Services and for no other
purpose;

(ii)   To use the *** only as instructed and agreed with Client as part of the
Services;

(iii)  Except as explicitly agreed as part of the performance of the Services
not to reverse engineer, decompile or modify the *** in any way;

(iv) Not to transfer the *** to any third party (except Adaptimmune) or to use
the *** on behalf of any third party (except Adaptimmune) including in each case
any information relating to the *** or data derived from the use of the *** in
connection with the Services; and

(v)  Not to remove or deface or cover any proprietary labels, notices or
trademarks attached to or supplied with the *** received by PCT in connection
with the Services.

 

e.    WITHOUT AFFECTING THE SCOPE OF THE PROVISIONS IN SECTION 3 OF ATTACHMENT A
RELATING TO DEFECTIVE PRODUCT, PCT DOES NOT WARRANT THAT PRODUCT RESULTING FROM
THE AGREEMENT IS SAFE OR EFFICACIOUS OR SUCCESSFUL. PCT EXPRESSLY MAKES NO
WARRANTY OR GUARANTY WHATSOEVER THAT ANY FDA SUBMISSION PREPARED AS A RESULT OF
PERFORMING SERVICES WILL SATISFY THE REQUIREMENTS OF ANY REGULATORY AGENCY AT
THE TIME OF SUBMISSION.

 

f.     EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THE AGREEMENT TO THE CONTRARY,
THE PARTIES SPECIFICALLY DISCLAIM ALL EXPRESS OR IMPLIED REPRESENTATIONS OR
WARRANTIES WITH RESPECT TO THE SERVICES, INCLUDING ANY WARRANTY OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR ANY IMPLIED WARRANTY
ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE OF TRADE.

 

9.    Duration, Default and Termination.

 

a.    The Agreement and the performance of Services by PCT hereunder shall end
on the earlier to occur of (i) December 31, 2021 (unless extended in writing by
the Parties) and (ii) termination of the Agreement pursuant to this Section 9 of
Attachment A. The obligations in Sections 2(i), 5, 6, 8, 9, 10, 12, 14, 16 and
17 of Attachment A shall survive termination of the Agreement.

 

b.    PCT’s default. If PCT defaults with respect to material obligations under
the Agreement, Client will promptly notify PCT’s Point of Contact by certified
mail, return receipt requested or by overnight courier (“Written Notice”) of
such material default. PCT has *** days from receipt of such Written Notice
within which to cure such default. If PCT fails to cure such default as
identified in the Written Notice, then the Agreement and Quality Agreement may,
at Client’s option, terminate upon delivery to PCT of a Written Notice
terminating the Agreement and applicable Quality Agreement. Upon receipt of such
Written Notice of termination, PCT shall terminate the Services, subject to
PCT’s continuing obligation to provide any close-out services as provided in
this Agreement and subject to Client’s payment for such close-out services.
Notice of termination from Client shall constitute notice of termination from
Adaptimmune as well.

 

c.    Client’s/Adaptimmune’s default. If Client or Adaptimmune default with
respect to material obligations under the Agreement, PCT will promptly provide
Client’s Point of Contact with Written Notice of such material default (with
such Written Notice being deemed to constitute Written Notice to Adaptimmune as
well). Client and/or Adaptimmune, as applicable, has *** days from receipt of
such Written Notice by Client within which to cure such default. If Client
and/or Adaptimmune, as applicable, fails to cure such default as identified in
the Written Notice, then, at PCT’s option, the Agreement, Quality Agreement and
all other agreement(s) then in existence between the Parties may be terminated
upon delivery to Client of a Written Notice (with such Written Notice to Client
being deemed Written Notice to Adaptimmune as well) terminating the same and/or
PCT may immediately cease performing Services under the Agreement.

 

d.    Other Termination Rights.

 

(i) For convenience - A Party may terminate the Agreement without cause upon
providing no less than ***

 

notice ***, of the notifying Party’s intent to terminate the same. Termination
occurs on the last day of the month following ***, the ***           day notice
period.  Notwithstanding this Section 9(d)(i) to the contrary, if the Room 1
Product Manufacturing Start Date has occurred, neither Party shall cause the
Termination Date (as defined in the Agreement) to occur prior to the
***           following the ***         of the *** day of the month following
the month in which the Room 1 Product Manufacturing Start Date has occurred.

 

(ii) ***: Client shall be entitled to ***

 

following the expiration of such ***    period ***

 

involving any third party that is set forth in Attachment C (“Attachment C”)
attached hereto and made a part hereof ***

 

. At any time during ***

 

Client may ***                                                    change ***

 

listed in Attachment C (provided
***                                                at the time of inclusion in
Attachment C ***

 

) by providing Written Notice to EACH of PCT’s then designated Point of
Contract, Alliance Manager and President that contains a revised Attachment C
setting forth the then ***                                            . Upon
receipt by ALL of the PCT Point of Contact, Alliance Manager and President of
such Written Notice with the revised Attachment C, from an after receipt of such
Written Notice, Attachment C will be deemed amended and modified, without any
further amendment or writing between the Parties.  Client’s ability to ***

 

is conditioned upon Client ***

 

set forth on the latest version of Attachment C provided ***

 

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as permitted in the preceding two sentences as a result ***

 

 

 

.

 

e.    Payments Upon Termination. No later than the date of termination of the
Agreement and provided an invoice has been received in relation to all require
amounts, Client will pay PCT (i) all amounts to be paid through the date of
termination (including room fees and fees for personnel) plus reimbursable out
of pocket costs and expenses incurred by PCT prior to the date of termination
for which Client is liable to reimburse PCT, (ii) the Close Out Fee, if any, set
forth in the Agreement and (iii) reasonable out of pocket costs and expenses for
Services which PCT is irrevocably obligated to pay after the termination of the
Agreement (provided such irrevocable obligations were incurred prior to PCT’s
receipt of Written Notice of termination and provided PCT uses commercially
reasonable efforts to reduce such irrevocable obligations); and provided that
Client would have been required to pay for such costs and expenses had the
Agreement not been terminated).

 

f.     No default caused by Force Majeure (as defined in Section 15 below) shall
constitute a default under the Agreement.

 

g.    The Agreement may be automatically and immediately terminated by a Party,
upon providing Written Notice to the other Party that such termination is the
result of the other Party having a liquidator, receiver, manager, or
administrator appointed in bankruptcy.

 

h.    UNDER NO CIRCUMSTANCES SHALL ANY PARTY BE ENTITLED TO OR LIABLE TO THE
OTHER PARTY FOR, PUNITIVE, EXEMPLARY, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR
SPECIAL DAMAGES ARISING IN CONNECTION WITH THE DEFAULT OF ANY OBLIGATION UNDER
THE AGREEMENT, EVEN IF A PARTY KNEW OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF
SUCH DAMAGES.

 

10.  Indemnification and Limitation of Liability.

 

a.    PCT shall indemnify Client, Adaptimmune and Client’s and Adaptimmune’s
agents, trustees, directors, officers and employees (“Client/Adaptimmune’s
Agents”) from all third party claims of any nature, including reasonable
attorney’s fees and disbursements (collectively, “Claims”) arising out of or in
connection with the negligence or willful act or omission by PCT or PCT’s
agents, directors, officers, members and employees (“PCT’s Agents”) related to
(i) the performance of the Services and/or (ii) PCT’s breach of the warranty set
forth in Section 8(d), except to the extent any Claim was incurred or occasioned
by the negligent or willful acts or omissions of Client, Adaptimmune and/or the
respective Client/Adaptimmune’s Agents.

 

b.    PCT shall not indemnify Client, Adaptimmune or Client/Adaptimmune’s Agents
for any bodily injury (including death) caused by any Product resulting from the
Services or Defective Product unless, subject to the terms and provisions of the
Agreement such bodily injury (or death) was caused by Product/Defective Product
which was solely the result of PCT’s negligence or willful acts or omissions.

 

c.    Except to the extent, in the case of each of the following, of any Claim
for which PCT is obligated to indemnify Client or Adaptimmune pursuant to
clauses (a) or (b) above, Client and Adaptimmune shall indemnify PCT and PCT’s
Agents from all Claims to the extent arising out of or resulting from: (i) the
acts or omissions of Client, Adaptimmune and/or their respective
Client/Adaptimmune’s Agents in connection with the Services and any Products and
Defective Product therefrom; (ii) personal injury to a participant in any
clinical trial using any Product or Defective Product or personal injury to any
person, including any PCT’s Agents, directly or indirectly caused by Product or
Defective Product, (iii) PCT’s use of Product, the Manufacturing Process
(excluding any PCT Background Intellectual Property or New Intellectual
Property) or Client Background Intellectual Property in connection with the
Services violating or infringing on the patents, trademarks, trade names,
service marks or copyrights of any third party (excluding any use in breach of
any obligation of this Agreement); and (iv) the harmful or otherwise unsafe or
unknown effect of any materials, Materials, and/or reagents and/or product
required for or derived from the Services performed and/or provided by or on
behalf of Client or Adaptimmune, including any apheresis and blood collections
as well as cellular blood products (such apheresis, blood collections and
cellular blood products, collectively, “Raw Materials”), the Product or
Defective Product to any person, including without limitation, a Claim based
upon Client, Adaptimmune or any other person or entity’s use, consumption,
contact, sale, distribution or marketing of any Raw Material, Defective Product
or Product.

 

d.    Upon receipt of notice of any Claim, the Party seeking indemnification
(the “Indemnified Party”) shall give written notice thereof to the other Party
(the “Indemnifying Party”). The Indemnified Party shall permit the Indemnifying
Party, at its option and expense, to promptly assume the complete defense and
settlement of such Claim, provided that; (i) the Indemnified Party has the right
to participate in the defense and settlement of such Claim at its own cost; and
(ii) the Indemnifying Party, prior to making any settlement, notifies the
Indemnified Party, in writing, of such settlement offer and subsequently
consults with the Indemnified Party as to the terms of such settlement where
such settlement would involve any obligation on the Indemnified Party or
admission of liability by the Indemnified Party. The Indemnifying Party will
not, except with the prior written consent of the Indemnified Party, consent to
the entry of any judgment or enter into any settlement which does not include,
as an unconditional term thereof, the giving by the claimant or plaintiff to the
Indemnified Party of a release from all liability in respect thereof.

 

e.    The indemnification obligations shall survive for a period of *** years
following the termination of the Agreement.

 

f.     PCT’s liability shall not, under any circumstances, exceed the
***          that PCT ***

.

 

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g.    AS TO A CLAIM, NO PARTY IS ENTITLED TO PUNITIVE,
EXEMPLARY, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES.

 

11.  Prospective Events.

 

a.    “Prospective Cost Increase” means either the (i) occurrence of an event
outside the control of PCT, including, any Force Majeure event or (ii) the
enactment or modification of a foreign, state or federal statute or regulation
thereof, including Applicable Laws, in either case, after the Execution Date not
contemplated before the Execution Date, as to which compliance by PCT with the
terms and provisions of the Agreement would impose an unanticipated financial
expense upon PCT which PCT has determined is not de minimis. “Prospective
Illegality” means any foreign, state or federal statute or regulation now
existing or enacted or promulgated or re-interpreted after the Execution Date,
including Applicable Laws, that is enacted, interpreted by judicial decision, a
Regulatory Agency or legal counsel in such manner as to result in the conclusion
that any service required of PCT or Client under the Agreement is in violation
of such law, rule, guidance or directive.

 

b.    If a Prospective Illegality or Prospective Cost Increase occurs, Client
and PCT shall promptly negotiate in good faith a Program Amendment Order as
necessary to address such occurrence. Pending agreement thereof, either Client
or PCT, on fourteen (14) days written notice to the other, may cease to perform
a questioned act; provided, however, that the Agreement will nevertheless be
performed by both Client and PCT to the extent possible. If an agreement cannot
be reached, then, Client shall have the option whether to continue the
unaffected portions of the Agreement or terminate the Agreement on the last day
of the month which first occurs after thirty (30) days written notice to PCT.

 

12.  Regulatory Assistance.

 

a.    PCT and Client shall permit Regulatory Agencies to conduct inspections of
the Facility(ies) where Services are performed as may reasonably be requested
during normal business hours and PCT shall cooperate, at Client’s cost, with
such Regulatory Agencies (to the extent such inspections or audits relate
primarily to Product or Services set forth in this Agreement). Each Party shall
give the other prior written notice, to the extent practicable, of such
inspections and keep the other Party informed about the progress, results and
conclusions of each regulatory inspection. If prior notice is not possible, PCT
shall, within *** Business Days of said inspections, inform Client of a
regulatory inspection relating to or that may reasonably affect Services under
the Agreement.  In the event that an inspection/audit by a Regulatory Agency of
a Facility where Services are being performed relates solely to the Product or
Services provided to Client in this Agreement, and such inspection/audit is not
the result of the negligence or willful misconduct of PCT, then Client agrees
that PCT may charge Client the standard hourly rates for the PCT staff involved
(in accordance with the table of hourly rates set forth in Section 17(m) below,
as such rates may be adjusted from time to time) with such audit/inspection.

 

b.    PCT shall, within *** Business Days, promptly provide to Client copies of
correspondence received from any Regulatory Agencies in connection with such
inspections or relating to any Product, the Facility (if it relates to or
affects the Services and/or Product) or the Manufacturing Process, including,
but not limited to, FDA Form 483 notices or warning letters.  PCT will consult
with, and obtain approval from, Client (which approval will not be unreasonably
withheld or delayed) before responding to each such communication from a
Regulatory Agency that relates to the Product or the Manufacturing Process. 
Client will be given the opportunity to have a representative, at Client’s cost
and expense, present during an FDA or other Regulatory Agency inspection
relating to or that may reasonably affect Services under the Agreement.  In the
event that an inspection/audit by the Regulatory Agency of the Facility solely
relates to the Product or Services provided to Client in the Agreement, and such
inspection/audit is not the result of the negligence or willful misconduct of
PCT, then Client agrees that PCT may charge Client the standard hourly rates for
the PCT staff involved (in accordance with the table of hourly rates set forth
in Section 17(m) below, as such rates may be adjusted from time to time) with
such audit/inspection.

 

13.  Facility Obligations; Consultations; Maintenance Period.

 

a.    Excluding, as applicable, the Initial Room 1 Turnover Inspection and/or
Room 1 Turnover Inspection, if requested by the Client with a minimum of
***           prior written notice delivered to PCT’s Point of Contact, audits
and or investigations (each an “Audit”) and QP Inspections of the Services,
Facility and/or the Facility’s quality systems may be performed by Client, as
mutually scheduled and at ***

 

.  Notwithstanding the preceding sentence and excluding from the scope of this
sentence any Initial Room 1 Turnover Inspection or Room 1 Turnover Inspection,
within any ***           period (with the Parties agreeing that the first
***                                          , Client may request *** QP
Inspection and *** Audit (and in connection with each such QP Inspection or
Audit PCT will provide ***

 

.  If the aggregate number of hours incurred by PCT in performing such QP
Inspection or Audit (including but not limited to the time required to respond
to Client observations or findings and prepare and deliver corrective actions
and/ or responses) ***                                      
                                     , PCT will deliver to Client ***

 

and Client will pay ***                       as provided herein. For all other
Audits or QP Investigations (each an “Additional Audit”) in such
***                period), prior to such Additional Audit’s commencement,
Client will ***            (the “***   “) for ***

 

.  ***                   .  If the aggregate number of hours incurred by PCT in
performing such Additional Audit (including but not limited to the time required
to respond to Client observations or findings and prepare and deliver corrective
actions and/ or responses) exceeds the applicable ***   , PCT will ***

 

and Client will ***              as provided herein. In addition, if subsequent
to an update, Client requests additional findings or updates or desires
responses to further inquiries from an earlier Audit, QP Investigation or
Additional Audit, such responses, finding and/or updates will be provided by PCT
to Client on ***

 

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.  Additional Audits may be requested provided PCT receives a minimum of ***
days prior written notice of the Additional Audit.

 

b.    In the event Client has requested an Audit, QP Investigation or Additional
Audit ***                                             , Additional Audit or
Regulatory Agency inspection, Client shall not
***                                                   as long as such Audit is
***                          .

 

c.    PCT, upon no less than *** Business Days’ written notice from Client to
PCT’s Point of Contact, will permit Client during Business Hours, to observe
and/or consult with PCT at the facility where Services are performed or at other
locations mutually agreed to by the Parties in writing (“Consultations”)
regarding the performance of Services under this Agreement.  ***

 

 

 

.

 

d.    Client acknowledges and agrees that unless notified by PCT to Client, in
writing to the contrary, that the Facility will be unavailable for the
performance of any Services for a period (the “Maintenance Period”) of up to ***
consecutive calendar days and *** consecutive Business Days within such ***    
calendar period around and during each ***          period in order that PCT can
perform maintenance, repairs, cleaning and other activities, including
recertification and validation of applicable areas within the Facility
(“Maintenance”).  In the alternative, PCT on not less than *** months prior
written notice to the Client may select a different Maintenance Period at
another time during an applicable calendar year, in lieu of the Maintenance
Period around the ***              period in order to conduct Maintenance during
such alternative Maintenance Period and during such alternative Maintenance
Period Services will not be performed at the Facility.

 

14.  Insurance.

 

a.    During the Agreement and for ***     years after the termination of the
Agreement, each Party shall at all times maintain, at its own expense fully paid
insurance coverage, in the amounts set forth below, for:

(i)    Comprehensive General Liability (including coverage for bodily injury and
property damage) with limits no less than ***      Dollars ($***) per
occurrence/ ***               Dollars ($***) in the aggregate; and

(ii)   Workers Compensation with limits no less than the minimum statutory
amounts under Applicable Laws.

 

b.    PCT shall maintain Professional Liability and Product insurance coverage
with limits no less than *** Dollars ($***) per occurrence or per event/ ***
Dollars ($***) in the aggregate.

 

c.    Immediately prior to the initiation of any human clinical trials using any
Product and for a period of *** years following the termination of the
Agreement, Client shall maintain, at its own expense, Clinical Trial insurance
coverage for each clinical trial in which any Product is involved each with
limits no less than *** ($***) per occurrence/ *** Dollars ($***) in the
aggregate.

 

d.    As requested, each Party shall ***

 

provide that should the policies be canceled before the expiration date thereof,
***

 

.

 

e.    Any combination of renewal policies and tail (extended reporting periods)
endorsements may be used to satisfy the timeframes for maintaining coverage.

 

f.     Any combination of primary and excess liability and/or umbrella liability
policies may be used to satisfy the limits requested.

 

15.  Force Majeure. A Party shall be excused from performing its obligations
under the Agreement if performance or performance by a person or entity under
the control of such Party is delayed or prevented by Force Majeure, provided
that such performance shall be excused only to the extent of and during such
disability. “Force Majeure” means any cause beyond the reasonable control of the
Party (or the person or entity under the control of such Party) in question,
including, without limitation, governmental actions, wars, riots, terrorism,
criminal acts of third parties, civil commotions, fires, floods, earthquakes,
epidemics, pandemics, labor disputes (excluding labor disputes involving the
work force or any part thereof of the Party in question), embargoes, trade
restrictions, restraints or delays affecting shipping or carriers, acts of God
or nature, shortages in supplies as a result of vendor/supplier delays in
shipping supplies (provided such shortages are not the result of such Party’s
non-payment for such supplies and is otherwise beyond the reasonable control of
such Party) and prolonged losses of one or more utilities to the applicable
Facility(ies). If any part of the Services is invalid as a result of such
disability, PCT will, upon written request from Client, but at Client’s expense,
repeat that part of the Services affected by the disability. If the Party
suffering a Force Majeure is unable to perform for a period in excess of ***
(***) days, then the Parties agree to negotiate in good faith a mutually
satisfactory approach to resolve the delay resulting from the Force Majeure
including the possibility of moving the Services to an alternative Facility or
possibly moving the Services to a different part of the same Facility (depending
on the nature of the Force Majeure and at all times to PCT’s other commitments
and projections for other clients of PCT without any obligation of disclosing
such commitments or projections to Client). If no agreement is reached, then any
Party may terminate the Agreement upon providing the other Party(ies) with no
less than *** (***) days written notice of termination of the Agreement as a
result of the continuing Force Majeure event.

 

16.  Governing Law: Jurisdiction; Service of Process. This Agreement and any
Quality Agreement is and will be governed by the laws of New York, without
reference to choice of law principles. Any legal action may be brought in any
State or Federal court located in the City, County and State of New York as PCT
may elect. Each Party submits to the jurisdiction of the aforesaid courts. Each
Party irrevocably consents to service of process in any such action by the
mailing of copies thereof by registered or certified mail, postage prepaid, to
the Party at its address set forth in the Agreement (and in the case of
Adaptimmune by internationally recognized courier). Adaptimmune further hereby
irrevocably appoints and designates Adaptimmune LLC as its duly authorized agent
for service of legal process and Adaptimmune agrees that service of such process

 

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upon Client shall constitute personal service of such process upon Adaptimmune
(regardless of whether Client provides notice of such service of process to
Adaptimmune) and that service of any summons and complaint and/or other process
in any action may be made by registered or certified mail directed to Client on
both Clients. Service of legal process will be complete on the date such process
is delivered to the Client (and in the case of Adaptimmune, upon Client as
Adaptimmune’s agent authorized to receive such legal process).  The foregoing,
however, shall not limit any Party’s rights to serve process in any other manner
permitted by law.  Each Party irrevocably waives (a) any objection it may now or
hereafter have to the laying of venue of any action and (b) any claim that New
York is not a convenient forum for such action.

 

17.  Miscellaneous.

 

a.   Conflicting Terms. To the extent the terms or provisions of the Agreement
conflict with the terms and provisions of Attachment A and/or Attachment B, the
terms and provisions of the Agreement control.

 

b.   Return of Materials. All supplies, reagents, materials and equipment
supplied by Client or for which Client has reimbursed PCT, data, reports,
Records and documents and related to Products or the Manufacturing Process
associated with such Product will be promptly delivered to Client, at Client’s
cost and expense, upon expiration or termination of the Agreement if requested
by Client, as provided in the Agreement.

 

c.   Notices. Except for Written Notices, notices shall be in writing and be
sent (i) by registered or certified mail, postage prepaid with a return receipt
requested, or (ii) by an overnight express delivery service, addressed to the
other Party at the address provided in the Agreement or at such other address
for which such Party gives notice herein. Notice shall be effective upon the
date received.  PCT shall endeavor to address all notices, including Written
Notice to both Clients, provided, however, failure to provide notices to both
Clients will not affect the validity of the notice provided such notice has been
sent to the Client designated Point of Contact.  In addition, PCT agrees that it
will endeavor to provide Written Notices, if any, (excluding invoices) which may
be transmitted by electronic and/or facsimile transmission) to Adaptimmune by
internationally recognized express courier. Clients agree that any notices
provided by PCT to the Client designated Point of Contact or to any of Client
and Adaptimmune is deemed notice provided to both Client and Adaptimmune.

 

d.   Assignment. The Agreement may not be assigned in whole or in part by any
Party without the prior written consent of the non-assigning Party(ies) which
consent will not be unreasonably withheld, delayed or conditioned, provided
however, that no such consent shall be required in the case of an assignment to
(A) an Affiliate (and in the case of PCT to a member of PCT) or (B) a third
party with which any Party merges or that purchases substantially all of the
assets of such Party. “Affiliate” shall mean a present or future entity that
controls, is controlled by or under common control of such Party, where
“control” means (i) the legal or beneficial ownership of (i) more than fifty
percent (50%) of the outstanding voting stock of a corporation, (ii) more than
fifty percent (50%) of the voting equity of a limited liability company,
partnership, or joint venture or (iii) more than a fifty percent (50%) voting
general partnership interest in a partnership or joint venture; or (iv) the
power to exercise a controlling influence over the management or policies of a
legal entity.  Any purported transfer, assignment or delegation in violation of
the foregoing will be null and void and of no force or effect. Client shall give
PCT notice of any proposed permitted assignment within a reasonable time
thereafter. Any permitted assignee will assume the rights and obligations of its
assignor under this Agreement without releasing the assignor therefrom. The
Agreement shall be binding upon the successors and permitted assigns of the
Parties.

 

e.   Attorneys’ Fees. Client agrees to pay or reimburse PCT for all costs and
expenses incurred in connection with the enforcement, attempted enforcement, or
preservation of any rights or remedies under this Agreement.

 

f.    Publicity. The Parties shall treat the existence and material terms of
this Agreement as confidential and shall not disclose such information to third
parties without the prior written consent of the other Party or except as
provided in Section 5 of the Terms and Conditions or this Section. 
Notwithstanding the preceding, Client agrees that in company presentations only,
PCT (or CLBS (as defined below)) may include Client’s name and/or its logo it in
a list of clients that have engaged PCT for services. Except as permitted in the
preceding sentences or otherwise required by applicable law or applicable stock
exchange requirements, no Party shall issue or cause the publication of any
press release or public announcement with respect to the subject matter of this
Agreement without the express prior approval of the other Party(ies).

 

g.   Non-Disparagement. No Party will, at any time, disparage the business
reputation of another Party or its Affiliates or any of the other Party’s (or
Affiliates) employees, officers, directors, agents and/or clients.

 

h.   Non-Solicitation. Unless otherwise agreed to by the non-soliciting Party,
as long as the Agreement remains in effect and for a ***     after the
expiration or termination of this Agreement, no Party will, directly or
indirectly, alone (including through any Affiliate, officer, employee, director
or agent) or in concert with others, solicit or encourage any employee or
consultant of another Party or such Party’s Affiliates to leave his or her
employment or terminate his or her consultancy. The above restriction shall not
prevent or be meant to prohibit any employee or consultant from one Party
responding to published employment or consulting advertisements of the other
Party, and, under these limited circumstance, this restriction shall not prevent
either Party from interviewing, hiring or otherwise retaining such an employee
or consultant.

 

i.    Other Activities.  Client recognizes and acknowledges that PCT is a
subsidiary of Caladrius Biosciences, Inc. (“CLBS”).  CLBS, on its own and
through its subsidiaries, is engaged in the development of cell based
therapeutics.  Certain of these development programs, or future programs, could
be similar in scope, disease indication, or other aspects to those development
programs underway or contemplated by Client. Except as may be specifically set
forth herein, nothing in this Agreement shall be construed by representations,
inference or otherwise to prohibit or in any way restrict CLBS or its
subsidiaries from developing, or having developed, such therapeutic products or
pursuing therapeutic programs.

 

j.    Entire Agreement. This Agreement constitutes the entire agreement between
the Parties with respect to the subject matter thereof and supersedes all prior
or contemporaneous negotiations, promises or agreements (including, but not
limited to any proposal submitted by PCT to Client relating to Services to be
provided by PCT) of every nature with respect thereto, all of which have become
merged and integrated into or be deemed to be merged into the Agreement. No
modification to the Agreement shall be effective unless it is in writing signed
by each Party.

 

k.   Waiver and Construction. No waiver of any provision of the Agreement, in
any one or more instances, shall be deemed to be or be construed as a further or
continuing waiver of any such provision. No waiver shall be effective unless
made in writing and signed by the waiving Party. If any

 

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provision of the Agreement is declared void or unenforceable, such provision
will be severed and the balance of the Agreement will remain in full force and
effect.

 

l.                 Signatures and Counterparts. The Agreement may be executed by
an original, facsimile or electronic signature from a duly authorized person of
the respective Parties, and be in two or more counterparts, with such
counterparts constituting one instrument.

 

m.         Additional Fees:

(i)             Client will pay PCT the ***          for each GMP Audit that is
scheduled PRIOR to the commencement of any GMP Audit.

(ii)          If Client requests PCT to perform services of any kind which are
not expressly covered by the Agreement or which PCT reasonably determines are
beyond the scope of the Services of the Agreement (collectively, “Additional
Services”), such Additional Services will be provided pursuant to a Program
Amendment Order or other writing executed by the Parties. If Additional Services
are requested and the Parties either elect not to execute or fail to execute a
Program Amendment Order or other writing reflecting the Additional Services and
payment thereof, provided that Client has, despite such failure to have a
Program Amendment Order or other writing executed Client, requested that PCT
perform such Additional Services, Client agrees that, in addition to reimbursing
PCT for amounts provided in Section 4 of Attachment A, Client will pay the
actual time incurred by PCT in providing such Additional Services which will be
based upon PCT’s hourly rates set forth in the table below (subject to the COLA
adjustment) which hourly rates will be dependent on the PCT staff providing the
applicable Additional Services. PCT will determine the appropriate PCT staff to
provide such Additional Services. Upon written notice to Client, PCT may notify
Client of changes in the below hourly rates, which revisions to the hourly rates
will be effective immediately upon Client’s receipt of such written notification
and will apply to the requested Additional Services rendered after the effective
date thereof, provided, however, in the event that at the time of such
notification PCT is currently undertaking requested Additional Services, the
revision in the hourly rates will NOT apply to such Additional Services. Hourly
charges are applied to the total time devoted to the performance of such
Additional Services, including any related travel.

 

PCT Staff

Rates

Executive Management

$***

All Other PCT Staff

$***

 

n.             WAIVER OF JURY TRIAL. PCT, ADAPTIMMUNE AND CLIENT WAIVE ANY
RIGHTS THEY MAY HAVE TO A TRIAL BY JURY OF ANY DISPUTE ARISING UNDER OR RELATING
TO THE AGREEMENT. PCT, ADAPTIMMUNE AND CLIENT AGREE THAT ANY SUCH DISPUTE SHALL
BE TRIED BEFORE A JUDGE SITTING WITHOUT A JURY.

 

o.            Anti-Bribery. The Parties will not directly or indirectly, offer
or pay or authorize such offer or payment of any money or other consideration to
improperly influence or seek to influence any governmental official. In
performing its respective obligations under this Agreement each Party will
comply with all applicable statutes, regulations and government rules relating
to anti-bribery and anti-corruption including the United States Foreign Corrupt
Practices Act and the United Kingdom Bribery Act 2010.

 

p.            Privacy and Personal Data. In the performance of the Services, PCT
may receive, use and process Personal Data (as defined below). PCT agrees in
relation to any Personal Data to (a) use and process the Personal Data to the
extent necessary for the performance of the Services and for no other Services;
(b) keep the Personal Data confidential and not permit any third party access to
such Personal Data except as provided in this Agreement; (c) implement and have
in place appropriate measures to prevent misuse or unauthorized release of
Personal Data; (d) provide reasonable assistance to Client as reasonably
required by Client, for Client to address any PCT unauthorized use or processing
of Personal Data; (e) process Personal Data only in accordance with Client’s
instructions and as mutually agreed between the Parties; (f) make amendments or
modifications to any Personal Data as directed in writing by Client and as soon
as reasonable practicable after receipt of such written direction; (g) forward
on any requests for access to Personal Data or requests for information received
by PCT in writing and relating to Personal Data to Client and, at Client’s cost
and expense, reasonably respond to such requests as requested by Client and as
necessary to comply with Applicable Laws. On termination of this Agreement to
the same extent as provided in Section 5 above, PCT will, at Client’s cost and
expense, return any Personal Data to Client or at Client’s written instruction
to the original third party provider save where such retention of Personal Data
is required by PCT to comply with its obligations under Applicable Laws or this
Agreement or is incorporated in Records PCT maintains and associated with the
Services (such as batch records) but in any event in accordance with Applicable
Laws and time frames provided in patient informed consent forms which have been
explicitly notified to PCT. In addition where Personal Data will be transferred
from the European Union to PCT, the Parties will work together, at Client’s cost
and expense, to put in place any additional or further provisions relating to
the processing of Personal Data as the Parties in good faith determine are
required in order to comply with Applicable Laws, such additional or further
provisions to include agreement as to any costs and expenses payable by Client
which are necessary to enable PCT to receive Personal Data transferred from the
European Union in compliance with Applicable Laws. Personal Data for the
purposes of this Section shall mean any data which relates to a living
individual who can be identified from those data, or from those data and other
information which is in the possession of, or is likely to come into the
possession of PCT or Client.

 

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ATTACHMENT B

 

RESOLUTION ACTIVITIES

 

***

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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