***TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
200.83 AND 240.24B-2
CIMA LABS INC.
DEVELOPMENT AND LICENSE OPTION AGREEMENT
WITH
NOVARTIS CONSUMER HEALTH, INC.
THIS DEVELOPMENT AND LICENSE OPTION AGREEMENT (the "Agreement") is
entered into by and between CIMA LABS INC., a Delaware corporation ("CIMA")
and Novartis Consumer Health, Inc., a Delaware corporation ("Novartis"), on
this 18th day of November, 1997 (the "EFFECTIVE DATE").
RECITALS
WHEREAS, CIMA owns or has rights to certain patented oral drug-delivery
technology referred to as ORASOLV-Registered Trademark-, which has
applications in the field of pharmaceutical product formulation; and
WHEREAS, Novartis has substantial expertise and experience in the
development, commercialization and marketing of human pharmaceutical
products; and
WHEREAS, the parties desire to explore the possibility of entering into
future agreements regarding the development and commercialization of
Orasolv-Registered Trademark- formulations of a certain pharmaceutical
product for sale [...***...] markets in [...***...]; and
WHEREAS, Novartis wishes to sponsor the development by CIMA of a
prototype of a certain pharmaceutical product formulation for Novartis'
evaluation, subject to the granting by CIMA to Novartis of an option to enter
into a license agreement with CIMA on terms further described herein.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants set forth below, the parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 "AFFILIATE" shall mean any entity which directly or indirectly
Owns, is Owned by or is under common Ownership with, a party to this
Agreement, where Own or Ownership means direct or indirect possession of at
least fifty percent (50%) of the outstanding voting securities of a
corporation or a comparable equity interest in any other type of entity.
1.2 "ACTIVE INGREDIENT" shall mean compounds useful for the treatment
of [...***...], including [...***...] in combination with any of the
foregoing.
1.3 "DEVELOPMENT PLAN" shall mean the initial plan set forth on Exhibit
A for the development of the Prototypes, as may be amended from time to time.
1.4 "FIELD" shall mean [...***...] approved for [...***...] as of the
Effective Date, for the treatment of [...***...] or conditions and having as
active ingredients only the Active Ingredients, in any formulation or dosage.
1.5 "OPTION" shall have the meaning assigned thereto in Section 3.1.
1.6 "ORASOLV-Registered Trademark- TECHNOLOGY" shall mean CIMA's
effervescent, fast-dissolving, oral drug-delivery tablet technology, which
technology includes, to the extent applicable to the formulation of a
product, the active ingredients of which are Active Ingredients, (i) the
inventions disclosed in patents and patent applications owned, controlled or
licensed (with the right to sublicense) by CIMA during the term of this
Agreement, including but not limited to those listed on Exhibit B, and (ii)
all know-how, technology, trade secrets, data, processes and methods, or
other information owned, controlled or licensed (with the right to
sublicense) by CIMA during the term of this Agreement.
1.7 [...***...] shall mean suitable for, and specifically labeled,
packaged, marketed or indicated for, [...***...].
1.8 "PRODUCT" shall mean the pharmaceutical products which are
formulated using OraSolv-Registered Trademark- technology [...***...] and
which contain, as their only active ingredients, any of the Active
Ingredients, PROVIDED THAT as of the Effective Date, all such active
ingredients are approved by the appropriate regulatory agency for sale
[...***...] in the relevant country of the Territory.
1.9 "PROTOTYPES" shall mean the prototype of each Product containing
the active ingredients set forth on Exhibit D, to be developed by CIMA
pursuant to the Development Plan and in accordance with the general
specifications set forth on Exhibit C and any further specifications agreed
to by the parties.
1.10 "RESULTS" shall mean information, data and results obtained or
developed from conduct of evaluations under this Agreement relating to the
Prototypes.
1.11 "TERRITORY" shall mean [...***...].
ARTICLE 2
PROTOTYPE DEVELOPMENT
2.1 DEVELOPMENT SCHEDULE. During the term of this Agreement CIMA will
continue with development of the Prototypes delineated in the Development
Plan and shall use commercially responsible best efforts to meet the
deadlines specified in the Development Plan. CIMA will develop the
Prototypes in such flavors as are determined by mutual agreement of the
parties consistent with the criteria set forth in Exhibit C.
CIMA and Novartis each acknowledge and agree that the Development Plan is
expected to be completed by [...***...]. To that end, during the
implementation of the Development Plan, Novartis agrees to evaluate promptly
each iteration of each Prototype and/or report of results delivered by CIMA
and respond to CIMA as agreed upon in the Development Plan. Novartis'
response will indicate the acceptability of such proposed Prototype and/or
the need, if any, for modification of the specifications in light of the
results of Novartis' evaluation.
2.2 DEVELOPMENT FEES. In consideration for CIMA's development and
production of the Prototypes in accordance with this Agreement, Novartis
shall make non-refundable payments to CIMA as specified in the Development
Plan. Such payments will be made [...***...] from CIMA.
ARTICLE 3
OPTION; EXCLUSIVITY; LICENSE
3.1 OPTION. Effective upon delivery of the Option Fee described in
Section 3.3 below, CIMA hereby grants to Novartis an option to enter into
[...***...] to utilize the OraSolv-Registered Trademark- Technology for the
development, marketing, distribution and sale of the Product in the Territory
(the "OPTION"). The term of such Option shall extend from the Effective Date
until [...***...]. Novartis may exercise the Option by (i) providing CIMA
with written notice thereof, and (ii) negotiating and entering into a
mutually agreed upon license agreement with CIMA (the "License Agreement")
prior to the end of the Option term, PROVIDED, HOWEVER, that if Novartis does
not exercise the Option, it shall pay to CIMA [...***...] as set forth in
Section 3.4, unless any of the events set forth in Section 4.2.3 occur. If
Novartis fails to enter into the License Agreement by the end of the Option
term [...***...], on any terms CIMA may, in its sole discretion, deem
appropriate.
3.2 [...***...]. In consideration for the Option Fee, CIMA hereby
agrees that from the Effective Date until [...***...], CIMA [...***...] of
the Products in the Field and in the Territory.
3.3 OPTION FEE. In consideration for the [...***...] set forth in
Section 3.2, the Option granted in Section 3.1 and the rights granted in
Section 3.5, Novartis shall pay to CIMA the sum of [...***...] (the "OPTION
FEE") on the Effective Date. The total Option Fee payable hereunder shall be
creditable against any upfront license fee or milestone payments payable to
CIMA upon execution and during the course of the License Agreement.
3.4 OPTION WAIVER BUYOUT. If Novartis fails to exercise its Option and
the cause for such failure is other than the events set forth in Section
4.2.3, Novartis shall pay to CIMA the sum [...***...] upon the earlier of
notification to CIMA that Novartis will not exercise the
Option or termination of this Agreement, but in any event no later than the
expiration date of the Option Term.
3.5 [...***...]. For the period from the Effective Date until the
expiration or termination of the Option term set forth in Section 3.1, CIMA
hereby grants to Novartis [...***...] which contain as an active ingredient a
compound approved for sale [...***...] after the Effective Date (the
[...***...]). For the same period, CIMA hereby grants to Novartis [...***...]
, PROVIDED THAT the [...***...] shall only be [...***...].
3.5.1 EXERCISE OF [...***...]. If during the term of the
[...***...] CIMA decides to [...***...], which product contains as an active
ingredient a compound approved for sale [...***...] after the Effective Date,
CIMA will notify Novartis in writing of such decision. Novartis shall
[...***...] within [...***...] from CIMA (whether or not the Option Term has
expired), and [...***...] if accepted by CIMA within [...***...]. CIMA may
[...***...] in its discretion. If CIMA elects to [...***...], the rights to
be acquired by Novartis shall be incorporated in the License Agreement on
terms agreeable to both parties.
3.5.2 EXERCISE OF [...***...]. If during the term of the
[...***...] CIMA receives [...***...] the Products in the Field in [...***...]
, CIMA shall [...***...]. Novartis shall [...***...] set forth in Section
3.1 (but where such date is less than [...***...], Novartis shall [...***...]
to consider [...***...] and may [...***...] in its discretion. Upon the
expiration of the [...***...]. If Novartis [...***...], the rights to be
acquired by Novartis shall be incorporated in the License Agreement on terms
agreeable to both parties and consistent [...***...].
3.6 COMMERCIALIZATION AND SUPPLY AGREEMENT. Simultaneously with the
execution of the License Agreement, the parties shall enter into a
commercialization and supply agreement on mutually agreeable terms pursuant
to which CIMA shall [...***...]. Such agreement shall also set forth the
obligations of CIMA with respect to finalization of development, scale-up and
validation of the Product.
3.7 FACILITIES VISITS. During the term of this Agreement, CIMA shall
allow personnel of Novartis, at Novartis' expense, to visit the manufacturing
and research facilities of CIMA and to consult with CIMA personnel, at
mutually agreeable times, to discuss and review the development of the
Product.
3.8 MARKET RESEARCH REPORT. Novartis shall provide to CIMA, at CIMA's
request, a copy of Novartis' final summary market research report relating to
market research testing of the Prototypes. CIMA acknowledges that this
report is Confidential Information and shall be governed by the
confidentiality provisions of Section 4.3.
ARTICLE 4
GENERAL PROVISIONS
4.1 LIMITATIONS ON USE. CIMA and Novartis each agree that it shall use
the Prototypes, and the Confidential Information (as defined in Section
4.3.1) of the other, solely for the purposes specified in this Agreement and
for no other purpose, including without limitation, use of the Prototypes in
any research or commercial activities other than those which relate directly
to the purposes specified herein. Each party's permitted use of the
Prototypes shall be in compliance with all applicable laws and regulations.
Upon expiration or termination of the Agreement, Novartis shall destroy, as
directed by CIMA, all unused quantities of the Prototypes, and that CIMA
shall be permitted to retain reasonable quantities of the Prototypes for
CIMA's internal use, and shall be permitted to retain archive copies of any
and all Results. Novartis shall not sell, transfer, disclose or otherwise
provide access to the Prototypes or the Results, any method or process
relating thereto or any material that could not have been made but for access
to the foregoing, to any person or entity without the prior expressed written
consent of CIMA, except that Novartis may allow access to the Prototypes and
the Results to employees, subcontractors or agents during the term of, and
solely for purposes consistent with, this Agreement. Novartis will make
diligent efforts to ensure that such employees, agents and subcontractors
will use the Prototypes and the Results in a manner consistent with the terms
of this Agreement.
4.2 TERM AND TERMINATION.
4.2.1 TERM. Unless sooner terminated in accordance with
Section 4.2.2 or 4.2.3 below, this Agreement shall expire upon the expiration
or termination of the Option.
4.2.2 TERMINATION BY CIMA. CIMA may terminate this Agreement
upon [...***...] written notice to Novartis in the event Novartis commits a
material breach of a provision of this Agreement and fails to cure such
breach prior to the end of such [...***...].
4.2.3 TERMINATION BY NOVARTIS. Novartis shall have the right
to terminate this Agreement prior to exercise of the Option in the event
(i) CIMA commits a material breach of a provision of this
Agreement and fails to cure such breach prior to the end of such [...***...]
days' written notice to CIMA;
(ii) the [...***...] set forth on Exhibit E;
(iii) Novartis notifies CIMA, within [...***...] of the
Effective Date, of a [...***...] (other than patents which CIMA owns or to
which CIMA has the right to grant licenses, and the patents set forth on
Schedule 1) which would be [...***...] and CIMA fails, prior to the
expiration of the Option, [...***...] the Product, (b) obtain for Novartis
[...***...] the Product, or (c) take other steps which cause Novartis to
withdraw its notice to CIMA;
(iv) the parties do not agree upon [...***...] of the Product,
[...***...] to be incorporated in the License Agreement or [...***...] to be
incorporated in the Supply Agreement.
4.2.4 EFFECT OF TERMINATION. Upon termination or expiration of
this Agreement pursuant to Sections 4.2.1, 4.2.2, or 4.2.3 above, (i)
Novartis shall [...***...] of the Option Fee, and (ii) CIMA shall [...***...]
of Products. Nothing in this Agreement shall be construed to relieve either
party of any obligations incurred by it hereunder prior to the effective date
of termination hereof. This Article 4 shall survive any termination or
expiration of this Agreement.
4.3 CONFIDENTIALITY. Each of the parties shall be bound by the
following terms and conditions:
4.3.1 Subject to the limitations set forth in Section 4.3.2
below, all information disclosed to the other party and identified by the
disclosing party as confidential shall be deemed "CONFIDENTIAL INFORMATION"
of the disclosing party. In particular, Confidential Information shall be
deemed to include, but not be limited to, the Prototypes and any
documentation relating thereto, the Results, any patent application or
drawing or potential patent claim the subject matter of which is directly or
indirectly derived from information disclosed hereunder, any trade secret,
information, invention, idea, samples, process, method, procedures,
formulations, packaging designs and materials, test data relating to any
research project, work in process, future development, engineering,
manufacturing, regulatory, marketing, servicing, financing, or personnel
matter relating to the disclosing party, its present or future products,
sales, suppliers, clients, customers, employees, investors or business,
whether in oral, written, graphic or electronic form.
4.3.2 The term "Confidential Information" shall not be deemed
to include information which (i) is now, or hereafter becomes, through no act
or failure to act on the part of the receiving party, generally known or
available; (ii) is known by the receiving party at the time of receiving such
information, as evidenced by its records; (iii) is hereafter furnished to the
receiving party by a third party, as a matter of right and without
restriction on disclosure; (iv) is independently developed by the receiving
party without use of Confidential Information of the other party; (v) is the
subject of a written permission to disclose provided by the disclosing party
(vi) is required to be disclosed by law; or (vii) is required to be disclosed
to establish rights or enforce obligations under this Agreement, but only to
the extent such disclosure is necessary.
4.3.3 During the term of this Agreement and for a period of
[...***...] after termination hereof ([...***...] with respect to information
pertaining to manufacturing processes and know-how), each party shall
maintain all Confidential Information in trust and confidence and shall not
disclose any Confidential Information to any third party or use any
Confidential Information for any unauthorized purpose. Each party may use
such Confidential Information only to the extent required to accomplish the
purposes of this Agreement. Confidential Information shall not be used for
any purpose or in any manner that would constitute a violation of any laws or
regulations, including without limitation the export control laws of the
United States. Each party hereby agrees that it will not in any way attempt
to obtain, either directly or indirectly, any information regarding any
Confidential Information from any third party who has been employed by,
provided consulting services to, or received in confidence information from,
the other party.
4.3.4 The parties under this Agreement shall advise their
employees who might have access to Confidential Information of the
confidential nature thereof and agree that their
employees and agents shall be bound by the terms of this Agreement. No
Confidential Information shall be disclosed to any employee who does not have
a need for such information.
4.4 OWNERSHIP. Title and ownership rights in the OraSolv-Registered
Trademark- Technology and other Confidential Information of CIMA shall remain
at all times with CIMA. Novartis acknowledges that the OraSolv-Registered
Trademark- Technology and such Confidential Information shall remain the sole
property of CIMA and Novartis will acquire no title thereto as a result of
this Agreement. Title and ownership rights in the Prototypes and Results and
Confidential Information of Novartis shall remain at all times with Novartis,
PROVIDED, HOWEVER that if for any reason Novartis does not exercise its
Option under Section 3.1, title and ownership rights in the Prototypes and
Results shall revert to CIMA, except that if Novartis does not exercise its
Option under Section 3.1 because it has instead exercised its rights under
Section 4.2.3(i), CIMA shall not own any Results comprised of [...***...] by
Novartis or by a third party on behalf of Novartis, and CIMA [...***...].
CIMA acknowledges that Novartis' Confidential Information shall remain the
sole property of Novartis and CIMA will acquire no title thereto as a result
of this Agreement. Nothing in this Agreement shall be construed as
conferring on either party an expressed or implied license or option to
license any disclosed Confidential Information, technology, or any patent or
patent application except as expressly provided herein.
4.5 REPRESENTATIONS AND WARRANTIES.
4.5.1 CIMA WARRANTS THAT DEVELOPMENT AND PILOT-SCALE MANUFACTURE BY CIMA
OF THE PROTOTYPE SHALL BE CONDUCTED IN A WORKMANLIKE MANNER AND, WHERE
PROVIDED HEREIN, IN ACCORDANCE WITH (A) CURRENT GOOD MANUFACTURING PRACTICES
PROMULGATED BY THE U.S. FDA AND ALL OTHER APPLICABLE LAWS AND REGULATIONS,
(B) PRODUCT SPECIFICATIONS FOR THE PROTOTYPES AS SHALL BE MUTUALLY AGREED
UPON BY THE PARTIES. CIMA FURTHER WARRANTS THAT THE PROTOTYPES SHALL NOT BE
ADULTERATED OR MISBRANDED WITHIN THE MEANING OF THE U.S. FOOD, DRUG AND
COSMETIC ACT AND THE REGULATIONS PROMULGATED THEREUNDER. EXCEPT AS SET FORTH
ABOVE, THE PROTOTYPES ARE BEING SUPPLIED TO NOVARTIS WITH NO WARRANTIES OF
ANY KIND, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OR THAT IT IS FREE FROM THE RIGHTFUL CLAIM
OF ANY THIRD PARTY, BY WAY OF INFRINGEMENT OR THE LIKE, OF ANY PATENT OR
OTHER PROPRIETARY RIGHTS OF SUCH PARTY.
4.5.2 CIMA represents and warrants that:
(i) CIMA is a corporation duly organized, existing and in
good standing under the laws of the State of Delaware, with full right, power
and authority to enter into and perform this Agreement and to grant all of
the rights, powers and authorities herein granted.
(ii) The execution, delivery and performance of this Agreement
do not conflict with, violate or breach any agreement to which CIMA is a
party, or CIMA's Certificate of Incorporation or Bylaws.
(iii) This Agreement has been duly executed and delivered
by CIMA and is a legal, valid and binding obligation enforceable against CIMA
in accordance with its terms.
(iv) CIMA has the right, title and interest in and to the
intellectual property which is the subject of this Agreement necessary to
grant the rights granted hereunder. To the best of CIMA's knowledge having
undertaken no investigation, the practice of the patents relating to the
OraSolv-Registered Trademark- Technology does not infringe any valid patents
or other proprietary rights of third parties.
4.5.3 Novartis represents and warrants that:
(i) Novartis is a corporation duly organized, existing and in
good standing under the laws of the State of Delaware, with full right, power
and authority to enter into and perform this Agreement and to grant all of
the rights, powers and authorities herein granted.
(ii) The execution, delivery and performance of this Agreement
do not conflict with, violate or breach any agreement to which Novartis is a
party, or Novartis' Certificate of Incorporation or Bylaws.
(iii) This Agreement has been duly executed and delivered
by Novartis, and is a legal, valid and binding obligation enforceable against
Novartis in accordance with its terms.
4.6 INDEMNITY.
4.6.1 CIMA agrees to and hereby does indemnify, defend and hold
Novartis harmless from and against all claims, suits and proceedings, and all
damages, losses, costs, recoveries and expenses, including reasonable legal
expenses and costs (including attorneys' fees), which Novartis may incur,
arising out of any third party claim of property damages or personal injury
or death arising from CIMA's negligent or willful misconduct in its
performance of this Agreement or any breach of a representation or warranty
given herein by CIMA.
4.6.2 Novartis agrees to and hereby does indemnify, defend and
hold CIMA harmless from and against all claims, suits and proceedings, and
all damages, losses, costs, recoveries and expenses, including reasonable
legal expenses and costs (including attorneys' fees) which CIMA may incur,
arising out of any third party claim relating to the products developed by
CIMA for Novartis hereunder or any aspect of Novartis' performance of this
Agreement, to the extent such liability results from the negligence or
willful misconduct of Novartis, or any breach of a representation or warranty
given herein by Novartis.
4.7 INDEPENDENT CONTRACTORS. The parties shall perform their
obligations under this Agreement as independent contractors and nothing
contained in this Agreement shall be construed to be inconsistent with such
relationship or status. This agreement shall not constitute, create or in
any way be interpreted as a joint venture or partnership of any kind.
4.8 PUBLICITY. Any public disclosure of this Agreement or of the
activities or rights hereunder, including but not limited to press releases,
shall be reviewed and consented to by each
party prior to such disclosure; PROVIDED, HOWEVER, that either party may make
such disclosures as may be required by law (including securities laws)
without such consent. Any consent required hereunder shall not be untimely
or unreasonably withheld by either party. Notwithstanding the foregoing, the
parties consent to a press release announcing this Agreement, in the form
attached hereto as Exhibit F
4.9 FINAL AGREEMENT; AMENDMENTS. This Agreement sets forth the
complete and final agreement of the parties and supersedes all prior and
contemporaneous negotiations, understandings and agreements with respect to
the subject matter hereof. No subsequent amendment or modification to this
Agreement shall be binding upon the parties hereto unless reduced to writing
and signed by the respective officers of the parties hereto.
4.10 ASSIGNMENT. Except as otherwise provided herein, neither this
Agreement nor any interest hereunder will be assignable in part or in whole
by any party without the prior written consent of the other; PROVIDED,
HOWEVER, that either party may assign this Agreement to an Affiliate or any
successor by merger or sale of substantially all of its business unit to
which this Agreement relates without such consent. This Agreement will be
binding upon the successors and permitted assigns of the parties and the name
of a party appearing herein will be deemed to include the names of such
party's successors and permitted assigns to the extent necessary to carry out
the intent of this Agreement. Any assignment which is not in accordance with
this Section 4.10 will be void.
4.11 MISCELLANEOUS. This Agreement shall be governed by the laws of the
State of Delaware. If any provision of this Agreement is found by a proper
authority to be unenforceable, that provision shall be severed and the
remainder of this Agreement will continue in full force and effect. This
Agreement may be executed in two or more counterparts, each of which shall be
deemed an original.
4.12 NOTICES. Any notices required or permitted hereunder shall be
given in writing to the appropriate party at the address specified below or
at such other address as the party shall specify in writing.
IN WITNESS WHEREOF, the parties have by duly authorized persons,
executed this Agreement, as of the date first written above.
CIMA LABS INC. NOVARTIS CONSUMER HEALTH, INC.
10000 Valley View Road _____________________________
Eden Prairie, Minnesota 55344 _____________________________
Tel: (612) 947-8700 Tel:_________________________
FAX: (612) 947-8770 FAX:_________________________
By: /s/ Jack Khattar By: /s/ Fred Huser
------------------------ --------------------------
Name: Jack Khattar Name: Fred Huser
Title: Vice President, Title: President
Business Development
EXHIBIT A
DEVELOPMENT PLAN*
Cost Target Completion Dates
I. Formulation Development [...***...]
- Finalize Prototypes of [...***...] [...***...]
- Analytical development and support, and [...***...] [...***...]
II. Scale-Up of Three Prototypes [...***...]
- GMP manufacturing of [...***...] for each Prototype [...***...] [...***...]
- [...***...] under [...***...] per Prototype [...***...] [...***...]
- Delivery of samples for [...***...] [...***...]
III. Full Scale Manufacturing [...***...]
- GMP manufacturing of [...***...] formulation [...***...] [...***...]
- GMP manufacturing of [...***...] for each product [...***...] [...***...]
- [...***...] under [...***...] on the [...***...] [...***...]
- Delivery of [...***...] [...***...]
IV. Validation/Commercialization [...***...]
- Manufacture of [...***....] per product: [...***...]
1. If saleable . . . . . . . . .
[...***...]
2. If not saleable . . . . . [...***...]
- - Stability on above [...***...] under
[...***...] up to [...***...]
--[...*** ...]
--Subject to NCH [...***...] [...***...]
- - Validation Testing and Documentation Costs for [...***...] [...***...]
*DOES NOT INCLUDE TOOLING
EXHIBIT B
PATENTS AND PATENT APPLICATIONS
Country Patent/Application No. Filing/Issue Date
- ------- ---------------------- -----------------
US [...***...] JANUARY 12, 1993
US [...***...] JULY 6, 1993
US [...***...] APRIL 21, 1994
US [...***...] APRIL 1, 1997
- -----------------------------------------------------------------------------
CAN [...***...] FEBRUARY 26, 1992
- -----------------------------------------------------------------------------
- ------------------------
(1) Issued Patents
(2) Pending Patent Applications
EXHIBIT C
GENERAL SPECIFICATIONS
- - TABLET SIZE/SHAPE
[...***...]
- - FLAVOR
Tablet flavor(s) [...***...] based upon [...***...] and [...***...].
- - COLOR
Tablet color(s) will [...***...].
- - TABLET DISINTEGRATION
Targeted tablet disintegration [...***...] or less.
- - PACKAGING
The tablet will be packaged in [...***...].
- - STABILITY
Prototype development (implementation of the Development Plan) will
include [...***...].
EXHIBIT D
PROTOTYPE ACTIVES
- - [...***...]
- - [...***...]
- - [...***...]
EXHIBIT E
[...***...]
- ---------------------------------------------------------------------------------------------------------
TEST DESIGN [...***...] PRODUCT PRODUCT PRODUCT TOTAL [...***...]
PROTOTYPE PROTOTYPE PROTOTYPE PRODUCT
[...***...] [...***...] [...***...] PROTOTYPE
- ---------------------------------------------------------------------------------------------------------
CELL 1 2 3 4 2+3+4 5
- ---------------------------------------------------------------------------------------------------------
DOSE [...***...] [...***...] [...***...] [...***...] [...***...]
- ---------------------------------------------------------------------------------------------------------
RESPON- [...***...] [...***...] [...***...] [...***...] [...***...]
DENTS
- ---------------------------------------------------------------------------------------------------------
- ---------------------------------------------------------------------------------------------------------
OVERALL
LIKING
- ---------------------------------------------------------------------------------------------------------
TOP TWO BOX A B C D E F
- ---------------------------------------------------------------------------------------------------------
1. The [...***...] results are considered to be acceptable to Novartis in
either of the following cases:
- [...***...]
- [...***...] and not less than [...***...] and is higher than
[...***...].
2. If the [...***...] results are acceptable, and either [...***...] with
statistical significance at [...***...], then Novartis and CIMA will
consider [...***...] the product type.
EXHIBIT F
PRESS RELEASE
FOR IMMEDIATE RELEASE: Contact: John M. Siebert, Ph.D
President and Chief Executive Officer
CIMA LABS INC.
(612) 947-8700
Keith P. Salenger
Vice President and Chief Financial Officer
CIMA LABS INC.
(612) 947-8700
CIMA LABS INC. ANNOUNCES DEVELOPMENT &
LICENSE OPTION AGREEMENT WITH NOVARTIS
NOVARTIS' PRODUCT TO BE COMBINED WITH ORASOLV-REGISTERED TRADEMARK-
Eden Prairie, MN, XXXXXXXXXX,XX, 1997 - CIMA LABS INC. (NASDAQ: CIMA) today
announced the signing of a development and license option agreement pertaining
to one of Novartis' currently marketed non-prescription products. In exchange
for its development work and license option, CIMA will receive an option fee
and development fees.
"Our partnership with Novartis combines one of their major non-prescription
drugs with a second generation improved OraSolv-Registered Trademark- fast-
dissolve dosage form," commented John M. Siebert, Ph.D., President and Chief
Executive Officer of CIMA LABS INC. "This key milestone provides additional
confirmation of the progress by CIMA and its efforts to further commercialize
OraSolv-Registered Trademark-."
OraSolv-Registered Trademark- is a patented oral dosage form which incorporates
microencapsulated drug ingredients into tablets that dissolve quickly in the
mouth. OraSolv-Registered Trademark- is designed to improve taste acceptance,
address difficulty of swallowing traditional tablets and capsules, while
offering a convenient oral dosage form that can be taken anywhere and anytime,
therefore increasing compliance.
CIMA LABS INC. is a drug delivery company that develops and manufactures
products based upon its OraSolv-Registered Trademark- technology for marketing
by multinational pharmaceutical companies to improve patient compliance and
drug efficacy. CIMA was founded in 1986 and has been publicly held since July
1994. The Company's corporate headquarters and manufacturing facility is
located in Eden Prairie, MN and its Research and Development facility is
located in Brooklyn Park, MN.
###
SCHEDULE 1
1. [...***...]